louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04104490: Angiotensin Converting Enzyme (ACE2), Brain, Gut Dysbiosis in Pulmonary Hypertension
Official title: Angiotensin Converting Enzyme (ACE2), Brain, Gut Dysbiosis in Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Mayo Clinic
name: Federal University of Health Science of Porto Alegre
First posted: 2019-09-26
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from pulmonary circulation clinic (Brazil) and the Mayo Clinic (Cardiovascular Division) in Jacksonville, FL

Brief summary: Pulmonary arterial hypertension (PAH) is fatal with right heart failure due to raised pulmonary vascular pressure. Gut dysbiosis was identified in animals with pulmonary hypertension. Deidentified human samples will be tested for gut dysbiosis in PAH, circulating bacterial metabolites and markers of inflammation and gut leakiness. The gut microbiome and circulating metabolites, markers of inflammation and gut leakiness of PAH patients and healthy subjects will be compared in deidentified fecal samples and blood.

Detailed description: Stool samples will be collected from people with no, mild-moderate or severe pulmonary arterial hypertension. Bacterial DNA will be extracted from the feces and sequenced by whole genome sequencing (shotgun sequencing). The DNA sequences will be used to identify the bacteria present in the feces, and to model the functions of the gut microbial community in each of the three groups. This will test for gut dysbiosis in pulmonary arterial hypertensive patients compared to healthy subjects. Gut dysbiosis is a condition where the gut bacterial communities are unbalanced and has been implicated in disease processes.

In subjects recruited in the USA, blood samples will be tested for markers of gut leakiness and inflammation as well as gut bacterial metabolites found in the circulation.

Eligibility criteria: Inclusion Criteria:

* severe, mild-moderate or no pulmonary arterial hypertensive subjects

Exclusion Criteria:

* Patients with pulmonary hypertension due to left heart disease, lung diseases and / or hypoxia, chronic thromboembolic pulmonary hypertension, and pulmonary hypertension with unclear multifactorial mechanisms.

Primary outcomes:
measure: Gut-microbial dysbiosis
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciências da Saúde de Porto Alegre
Study officials:
affiliation: University of Florida
name: Mohan Raizada
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00248690: ICP Versus Intracranial Compliance Guided Management in SAH
Official title: Intracranial Pressure (ICP) Versus Intracranial Compliance (ICC) Guided Management in Subarachnoid Hemorrhage; - a Prospective, Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subarachnoid Hemorrhage (SAH)
Keywords: Subarachnoid hemorrhage
Intracranial hypertension
Intracranial pressure
Diagnostic techniques and procedures
Compliance
Treatment outcome
Intensive care, surgical
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2005-11-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether treatment guided also by ICP mean wave amplitude improves outcome compared to international standard care in patients with SAH.

Detailed description: In this study SAH-patients are randomized to treatment based on international standard care (ICP/CPP guided therapy) or intracranial compliance (ICP mean wave amplitude) guided therapy in addition to ICP/CPP guided therapy. Main outcome variables are survival and neurological outcome after 3 and 12 months.

Eligibility criteria: Inclusion Criteria:

* Subarachnoid hemorrhage, acute
* Intracerebral pressure monitoring device inserted

Exclusion criteria:

* No intracranial pressure monitoring
* Age \< 18 years

Primary outcomes:
measure: All cause mortality and neurological outcome
timeFrame: 3 and 12 months
Secondary outcomes:
measure: Length of stay (ICU, hospital); complications; effect of treatment modalities on mean ICP, CPP, ICP mean wave amplitude.
timeFrame: Hospital stay
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Gunnar Bentsen, MD
role: STUDY_DIRECTOR
References:
citation: Eide PK, Sorteberg A, Bentsen G, Marthinsen PB, Stubhaug A, Sorteberg W. Pressure-derived versus pressure wave amplitude-derived indices of cerebrovascular pressure reactivity in relation to early clinical state and 12-month outcome following aneurysmal subarachnoid hemorrhage. J Neurosurg. 2012 May;116(5):961-71. doi: 10.3171/2012.1.JNS111313. Epub 2012 Feb 10.
Clinical trial NCT00269490: Yoga as a Therapy for Traumatic Experiences
Official title: Yoga as an Adjunctive Therapy for Post-Traumatic Stress Disorder: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Traumatic Stress Disorder
Keywords: Post-Traumatic Stress Disorder
Yoga Nidra
Lead sponsor: Samueli Institute for Information Biology
Sponsor class: OTHER
Collaborators: name: Walter Reed Army Medical Center
First posted: 2005-12-23
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The purpose of the proposed research is to conduct a feasibility study of yoga as an adjunctive therapy for the treatment of posttraumatic stress disorder (PTSD) in 15 military personnel at the Walter Reed Army Medical Center (WRAMC) in Washington, DC. Participants will complete 10 weeks of yoga training, in addition to the continuing their usual and customary care for PTSD at WRAMC. The style of yoga chosen for this study, Yoga Nidra, uses deep relaxation, deep breathing and meditation to systematically reduce physical, emotional, mental, and even subconscious tension. After a diagnostic mental health assessment at baseline, participants will attend a total of 18 classes taught over a 10-week period and will practice daily at home using a compact disk provided by the instructor. Baseline measures will include the Patient Health Questionnaire, PD-HAT Trauma Questions, PTSD Symptom Scale - Interview, Fear of Loss of Vigilance Scale, and expectation of efficacy. The primary outcome measure will be the PTSD Checklist. Changes in health status, locus of control, and pain will be assessed over the course of the study. An additional goal of this study is to gather preliminary data on the anticipated effect size and feasibility of conducting a larger clinical study of the adjunctive use of yoga for the treatment of PTSD symptoms in enlisted military personnel.


Eligibility criteria: Inclusion Criteria:

* Active Duty military personnel
* Aged 18 and over
* A minimum score of 40 on the Posttraumatic Stress Disorder Checklist (PCL-M), a brief, self-report instrument used to assess PTSD severity.

Exclusion Criteria:

* Active suicidal or homicidal ideation
* Severe cognitive impairment or history of cognitive disorder
* Serious surgical procedures within the last two months or planned
* Treatment for refractory pain
* New or dose adjusted psychotropic medication (i.e. SSRIs and anxiolytics) in last month
* Unwilling or unable to practice Yoga Nidra at home
* Amputation of any body part

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Deployment Health Clinical Center, Walter Reed Army Medical Center
state: District of Columbia
Study officials:
affiliation: Walter Reed Army Medical Center
name: COL Charles C Engel, MD, MPA
role: PRINCIPAL_INVESTIGATOR
affiliation: Samueli Institute for Information Biology
name: Christine Goertz Choate, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06120790: Investigation of a 3 oz Water Protocol on Patients With Tracheostomies
Official title: Investigation of a 3 oz Water Protocol on Patients With Tracheostomies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tracheostomy
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a tracheostomy (dysphagia).

Brief summary: Examining the validity of a novel 3 oz protocol in patients with tracheostomies as compared to the gold standard of instrumental swallow assessments (Flexible Endoscopic Evaluation of the Swallow or Modified Barium Swallow Study).

Detailed description: The purpose of this research study is to determine if a 3 oz water screening protocol is an effective screen for patients with openings in their airways (i.e. tracheostomies). This procedure is already in use for many different populations and is particularly useful for clinicians who want to understand who is at risk for having food or liquid enter the lungs while eating or drinking (i.e. aspiration).

Eligibility criteria: Inclusion Criteria:

* Has a tracheostomy
* Able to remain alert for testing
* Not on a modified diet for pre-existing dysphagia
* No head of bed restrictions
* Not NPO by physician for any reason other than possible dysphagia
* At least 18 years old

Exclusion Criteria:

* Does not have a tracheostomy
* Unable to remain alert for testing
* On a modified diet due to pre-existing dysphagia
* Head of bed restrictions for greater than or equal to 30 degrees
* NPO by physician for reasons other than possible dysphagia
* Less than 18 years old

Primary outcomes:
measure: Swallow screen
timeFrame: End of participation study within 7 days of enrollment
measure: Penetration Aspiration Scale Score
timeFrame: End of participation study within 7 days of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Miguel Escalon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04686890: Comparison of Erector Spinae Plane Block and Intravenous Analgesic in Nefrectomy
Official title: Erector Spinae Plane Block for Nefrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia Morbidity
Nephrectomy
Keywords: nefrectomy
erector spinea plane block
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The efficacy of erector spinae plane block versus intravenous analgesics compared relate to the morphine consumptions

Detailed description: Patients undergoing elective nefrectomy were enrolled. Patients divided into two groups with a sealed envelope technique to ESP+ pca morphine group or iv analgesic + pca morphine group. All patients will premedicated. then esp will applied to one group before surgery at the preoperative care unit by the same anesthesiologist. The other group will receive intravenous tramadol 1 mg/kg + NSAID 1 ampule + parol 10 mg/ kg + ondansetron 4 mg bolus. İntravenous morphine pca with a concentration of 0.5 mg/cc were applied. And administered 1 mg boluses every 15 minutes lock time and 4 hour limit as 4 mg arranged. An anesthesia nurse who is responsible of all pcas' in the hospital was recorded the variables of these patients in the service

Eligibility criteria: Inclusion Criteria:18-65 years age

* ASA I-II
* undergoing elective nephrectomy

Exclusion Criteria:- ASA\>3

* heart disease
* pregnancy
* lung disease
* scoliosis
* bleeding disorder
* infection at the manipulation side

Primary outcomes:
measure: Postoperative intravenous morphine patient controlled analgesia consumption
timeFrame: during postoperatively
measure: Peroperative remifentanyl consumption
timeFrame: Peroperatively
Secondary outcomes:
measure: Visual analog rating scores
timeFrame: during postoperative surgery
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
Study officials:
affiliation: Kocaeli University Medical Faculty
name: Zehra Arslan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04235790: Examining Behaviors of Teachers of Invasive Bedside Procedures Using an Eye Tracking Device
Official title: Examining Behaviors of Teachers of Invasive Bedside Procedures Using an Eye Tracking Device: Towards Improving Supervisor Expertise and Decreasing Complications in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Complication
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Researchers are studying the behaviors in teachers of invasive bedside procedures to improve the safety of invasive bedside procedure in the Intensive Care Unit (ICU).


Eligibility criteria: Inclusion Criteria:

* Novice and expert Invasive bedside procedure (IBP) teachers from Pulmonary Critical Care Medicine and Anesthesia-Critical Care at Mayo Clinic Rochester
* Expert teachers will be identified based on years as faculty, number of supervised procedures, prior teacher awards, and participation in IBP teaching at international conferences
* Novice teachers will include those that have performed less than 50 CVCs
* Medical student or resident

Exclusion Criteria:

* \<25% FTE in the ICU

Primary outcomes:
measure: Fixation Frequency
timeFrame: Duration of procedure (approximately 4 hours)
measure: Visit Frequency
timeFrame: Duration of procedure (approximately 4 hours)
measure: Dwell Time
timeFrame: Duration of procedure (approximately 4 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Diana Kelm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02001090: Vascular Function on the First Day After Cardiac Surgery
Official title: Vascular Function on the First Day After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Cardiac Surgical Procedures
Heart-Lung Machine
Coronary Artery Bypass
Brachial Artery
Vasodilation
Regional Blood Flow
Ultrasonography
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-12-04
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing coronary artery bypass surgery.

Brief summary: This study examines the flow mediated dilation (FMD) of the brachial artery before and after cardiac surgery. FMD is measured with ultrasound technique. Increased flow is achieved trough obstructing blood flow with a cuff around the forearm for five minutes. FMD is measured before surgery and on the first morning after the operation.


Eligibility criteria: Inclusion Criteria:

* admitted for coronary artery bypass surgery

Exclusion Criteria:

* Ongoing treatment with nitrates or RAAS inhibiting drugs
* unstable coronary syndrome
* unstable circulation/shock
* renal failure
* hepatic failure
* autoimmune or inflammatory disease
* untreated hypertension.

Primary outcomes:
measure: flow mediated dilation of the brachial artery
timeFrame: one day
Secondary outcomes:
measure: Reactive hyperemia
timeFrame: one day
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital
state: Sør Trøndelag
Study officials:
affiliation: Department of Cardiothoracic Anesthesiolgy and Intensive Care, St. Olav's Hospital, Trondheim, Norway
name: Idar Kirkeby-Garstad, Md. PhD.
role: STUDY_DIRECTOR
References:
citation: Dedichen HH, Hisdal J, Skogvoll E, Aadahl P, Kirkeby-Garstad I. Reduced reactive hyperemia may explain impaired flow-mediated dilation after on-pump cardiac surgery. Physiol Rep. 2017 May;5(10):e13274. doi: 10.14814/phy2.13274.
Clinical trial NCT01577290: An Internet-administered, Mindfulness Training Program for the Treatment of Anxiety
Official title: An Internet-administered, Mindfulness Training Program for the Treatment of Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Insomnia
Keywords: Anxiety
Depression
Insomnia
Mindfulness
Internet
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2012-04-13
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effects of a 10 week mindfulness training program -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of life, and insomnia symptoms will also be studied.

Detailed description: Previous research has provided evidence for the thesis that training in mindfulness can decrease symptoms of anxiety and depression. This study will examine the effects of a 10 week mindfulness training program -- without therapist-support -- as treatment of anxiety. Effects on depression, quality of life, and insomnia symptoms will also be studied.

Eligibility criteria: Inclusion Criteria:

* Satisfy DSM-IV criteria for an anxiety disorder
* Living in Sweden and being able to read Swedish
* Access to computer with internet connection

Exclusion Criteria:

* Currently receiving other psychological treatment
* Non-stable use of psychoactive medication
* Deemed suicidal
* Deemed to suffer from other psychological disorder, e.g. psychosis, bipolarity etc.

Primary outcomes:
measure: Change from baseline in Beck Anxiety Inventory (BAI)
timeFrame: 24 hours
measure: Change from baseline in Beck Anxiety Inventory (BAI)
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline in Beck Depression Inventory (BDI)
timeFrame: 24 hours
measure: Change from baseline in Beck Depression Inventory (BDI)
timeFrame: 6 months
measure: Change from baseline in Quality Of Life Inventory (QOLI)
timeFrame: 24 hours
measure: Change from baseline in Quality Of Life Inventory (QOLI)
timeFrame: 6 months
measure: Change from baseline in Insomnia Severity Index (ISI)
timeFrame: 24 hours
measure: Change from baseline in Insomnia Severity Index (ISI)
timeFrame: 6 months
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Psychology, Umeå University
state: Västerbotten
Study officials:
affiliation: Department of Psychology, Umeå University
name: Per Carlbring, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boettcher J, Astrom V, Pahlsson D, Schenstrom O, Andersson G, Carlbring P. Internet-based mindfulness treatment for anxiety disorders: a randomized controlled trial. Behav Ther. 2014 Mar;45(2):241-53. doi: 10.1016/j.beth.2013.11.003. Epub 2013 Nov 25.
Clinical trial NCT05179590: Factors Associated With Quality of Dreams During General Anesthesia
Official title: Factors Associated With Quality of Dreams During General Anesthesia: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dream
General Anesthesia
Perioperative Factors
Depression
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We recruited patients who were more than 20 years of age and who were scheduled for elective surgery under general anesthesia regardless of the type of surgery

Brief summary: Patients frequently report having dreams during general anesthesia. The incidence of dreams during general anesthesia that have been reported by patients upon awakening has been reported to range from 10 to 36% \[1\] and to be higher in younger patients, female patients \[2\], and patients who received ketamine \[3\]. The quality of dreams during general anesthesia is often reported as pleasant, but some patients report unpleasant or not pleasant dreams \[4, 5\]. However, the factors associated with the quality of dreams have remained to be elucidated. Therefore, the aim of this study was to determine the relationships between the quality of dreams during general anesthesia and perioperative factors.


Eligibility criteria: Inclusion Criteria:

* We recruited patients who were more than 20 years of age
* Patients who were scheduled for elective surgery under general anesthesia regardless of the type of surgery

Exclusion Criteria:

* diagnosis of a psychological disorder,
* major afective disorder
* major drug dependence disorder,
* inability to understand the content of our study,
* planned postoperative ventilation,
* anticipation of unavailability for postoperative interviews

Primary outcomes:
measure: Anesthesia information
timeFrame: During the operation
measure: Dream interview
timeFrame: After extubation, patients were interviewed about intraoperative dreams in the operating room as soon as they were oriented to time, place, and person
measure: Depression level
timeFrame: the day before surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: