louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03626363: Mindfulness and Neural Cardiovascular Control in Humans
Official title: Randomized, Active-Control Study to Determine the Effect of Mindfulness-Based Stress Reduction on Sympathetic Activity and Arterial Stiffness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elevated Blood Pressure
Lead sponsor: Michigan Technological University
Sponsor class: OTHER
Collaborators: name: Emory University
name: Texas Tech University
name: Purdue University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-08-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the impact of mindfulness-based stress reduction (MBSR) on sympathetic nerve activity and arterial stiffness. The investigator's central hypothesis is that MBSR will reduce sympathetic activity and arterial stiffness.

Detailed description: This study will recruit male and female subjects with elevated blood pressure who will participate in a randomized, active control study to examine the impact of mindfulness-based stress reduction (MBSR) on blood pressure, muscle sympathetic nerve activity and arterial stiffness. The study will utilize established techniques for assessing blood pressure patterns (24-hour ambulatory monitoring), peripheral sympathetic activity (microneurography) and vascular stiffness (applanation tonometry) in humans. This study includes a stress management education class for the active control.

Eligibility criteria: Inclusion Criteria:

* Seated systolic blood pressure \>119 mmHg and/or diastolic blood pressure \>79 mmHg
* Body mass index \<30 kg/m2

Exclusion Criteria:

* Smokers
* Diabetes
* Pregnant women
* History of autonomic dysfunction
* Cardiovascular medication

Primary outcomes:
measure: Muscle Sympathetic Nerve Activity
timeFrame: Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).
Secondary outcomes:
measure: Arterial Stiffness
timeFrame: Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).
Other outcomes:
measure: Nocturnal Blood Pressure Dip
timeFrame: Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).
Locations:
city: Hammond
country: United States
facility: Purdue University Northwest
state: Indiana
Study officials:
affiliation: Purdue University Northwest Biological Sciences
name: John Durocher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180063: Characterization of Local Vascular Effects of LNMMA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2005-09-16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Characterization of an unexpected venodilative effect of higher L-NMMA-doses in dorsal human hand veins.


Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* any relevant disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Institute of Clinical Pharmacology, Medical Faculty, University of Technology
Study officials:
affiliation: Institute of Clinical Pharmacology
name: Wilhelm Kirch, MD
role: STUDY_CHAIR
References:
citation: Schindler C, Leuschner S, Schwanebeck U, Kirch W. Characterization of local vascular effects of the nitric oxide inhibitor NG-monomethyl-L-arginine on dorsal hand veins. J Clin Pharmacol. 2012 Jun;52(6):859-69. doi: 10.1177/0091270011406277. Epub 2011 May 12.
Clinical trial NCT01233063: Diet and Activity Promotion Among Older Working Adults
Official title: Diet and Activity Promotion Among Older Working Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Diabetes
Obesity
Aging
Keywords: behavior change
physical activity
nutrition
fruits and vegetables
saturated fat
trans fat
added sugars
email
web
obesity
aging
Lead sponsor: Berkeley Analytics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 610
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The trial will test whether the Alive email-delivered health behavior program can improve subjects' physical activity, fruits and vegetables and saturated/trans fats and added sugars.


Eligibility criteria: Inclusion Criteria:

* aged 50+
* currently employed
* access to email/web

Exclusion Criteria:

* angina

Primary outcomes:
measure: Change in physical activity
timeFrame: 3, 6, 9, 12 months
measure: Change in Fruits and Vegetables
timeFrame: 3, 6, 9, 12 months
measure: Change in saturated fats
timeFrame: 3, 6, 9, 12 months
measure: Change in added sugar
timeFrame: 3, 6, 9, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Berkeley Analytics, Inc.
state: California
Study officials:
affiliation: Berkeley Analytics, Inc.
name: Gladys Block, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05836363: Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement
Official title: Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bicuspid Aortic Valve
Ascending Aorta Aneurysm
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bicuspid aortic valve and supra-coronaric ascending aorta aneurysm requiring ascending aorta replacement. Aortic valve regurgitation is no more than moderate, so it is left untreated following the guidelines.

Brief summary: Aortic valve bicuspid disease is the most common congenital heart disease. It affects 0.5-2% of the population and is associated with an increased risk of developing aortic or ascending aortic valve complications.

There is no agreement regarding the opportunity for a "prophylactic" simultaneous aortic valve replacement in the case of mild or moderate aortic valve disease in the bicuspid valve, in patients with an indication for replacement of the ascending aorta due to an aneurysm involving its supra-coronary tract.

The aim of this study is to evaluate the long-term evolution of mild and moderate aortic valve disease in untreated bicuspid valve during supracoronary ascending aortic replacement surgery at our institution.


Eligibility criteria: Inclusion Criteria:

* Adult patients;
* Bicuspid aortic valve;
* Presence of ascending aortic aneurysm in the supra-coronary tract treated with replacement using a prosthetic tube between 2002 and January 2020;
* Untreated aortic valve disease of no more than moderate degree (\<2+) at the time of ascending aorta surgery.

Exclusion Criteria:

* Emergency/urgency procedures;
* Presence of aneurysm extending to the aortic arch or aortic root, with indication for aortic root or aortic arch surgery;
* Tricuspid aortic valve tricuspid;
* Absence of aortic valve disease;
* Presence of moderate-severe or severe aortic valve disease, with indication to a concomitant aortic valve replacement.

Primary outcomes:
measure: Aortic valve regurgitation
timeFrame: Through study completion, a minimum of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT02557763: To Compare Anterior Knee Pain Between Non Severe and Severe Patellofemoral Arthritis After Oxford UKA
Official title: Study of Oxford Unicompartmental Knee Arthroplasty to Determine Anterior Knee Pain, Pain Score, Knee Score and Functional Score Between Patients Without Severe Patellofemoral Arthritis and Patients With Severe Patellofemoral Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Oxford UKA
anterior knee pain
lateral facet of patella
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this study is to compare the results between patients without severe patellofemoral arthritis and patients with severe patellofemoral arthritis after mobile bearing UKA.

The investigators prospective compute the results including anterior knee pain, knee society score, pain score, functional score, range of motion, operative time, blood loss, and component alignment.

Detailed description: The patients were performed surgery. The Oxford UKA was applied for all patient.

Eligibility criteria: Inclusion Criteria:

* anteromedial osteoarthritis knee,
* older than 40 years old,
* range of motion \> 90 degrees,
* varus deformity \< 25degrees,
* flexion contracture\< 20degrees,
* intact anterior cruciate ligament

Exclusion Criteria:

* younger than 40,
* osteonecrosis of knee,
* rheumatoid,
* posttraumatic arthritis,
* absent of anterior cruciate ligament

Primary outcomes:
measure: visual analog scale for anterior knee pain
timeFrame: 1 year
Secondary outcomes:
measure: Knee society score
timeFrame: 1year
Other outcomes:
Locations:
city: Pathum Thani
country: Thailand
facility: Boonchana Pongcharoen
state: Pathumthani
Study officials:
affiliation: Thammasat University
name: Boonchana Pongcharoen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04237363: Recovery of Walking in Persons With Complete Spinal Cord Injury
Official title: Recovery of Walking Without Epidural Spinal Cord Stimulation in Adults With Complete Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Spinal Cord Injury
Exercise
Walking
Aquatics
Lead sponsor: Middle Tennessee State University
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We documented the impact of 1 year of underwater treadmill training and supplemental overground walk training in five adults with chronic motor-complete SCI (cSCI) who had not undergone programmed epidural spinal cord stimulation (eSCS).

Detailed description: Regular exposure to self-initiated treadmill walking in water, a unique sensorimotor exercise setting that makes stepping movements easier to perform, may capitalize on the adaptability of the neuromuscular system and enhance locomotor function in persons with cSCI who have not undergone eSCS. In our study, a combined aquatics- and land-based approach to gait training was employed over a 12-month period that featured underwater treadmill training and supplemental overground walk training.

Eligibility criteria: Inclusion Criteria

* At least 21 years of age
* Presence of traumatic or non-traumatic spinal cord injury for at least 1 year
* Medical diagnosis of paraplegia (T1 or below)

Exclusion Criteria

* Presence of complex comorbidities that could limit involvement in training activities
* Surgical implantation or removal of a medical device six months prior to training
* Skin breakdown
* Use of electrical implants to promote ambulation

Primary outcomes:
measure: Overground walking capacity
timeFrame: Change from Baseline WISCI-II score at 6 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Middle Tennessee State University
name: Don W Morgan, PhD
role: STUDY_DIRECTOR
affiliation: Middle Tennessee State University
name: Sandra L Stevens, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04579263: Assessment of the Health Improvement of Obese Patients After Fecal Microbiota Transplantation (FMT)
Official title: Assessment of Improvement in Glycemic Control, Weight, and Insulin Sensitivity in Obese Patients After Fecal Microbiota Transplantation (FMT) Against the Background of Glucose-lowering Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity; Familial
Lead sponsor: Federal Research and Clinical Center of Physical-Chemical Medicine
Sponsor class: OTHER
Collaborators: name: Endocrinology Research Centre, Moscow
First posted: 2020-10-08
Enrollment: 2
Sex: MALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two obese patients selected according to the inclusion criteria will undergo fecal microbiota transplantation from a healthy donor with a normal body mass index against the background of glucose-lowering therapy
Primary purpose: TREATMENT

Brief summary: Search for mechanisms of the effect of fecal microbiota transplantation on patients with obesity

Detailed description: 1. To select recipients of fecal samples according to eligibility criteria;
2. To perform fecal microbiota transplantation for patients with obesity;
3. To analyze the efficacy of fecal microbiota transplantation for patients with obesity within six months after therapy.

Eligibility criteria: Inclusion Criteria:

* age of patients - from 18 to 75 years, both sexes;
* patients with obesity (body mass index ≥40
* patient's informed consent to perform fecal microbiota transplantation

Exclusion Criteria:

* presence of a concomitant chronic infectious disease or malignancy
* patients with a proven allergy to foods not excluded from the donor's diet
* absence of the patient for one or more intermediate stages of the examination.
* informed refusal to continue therapy

Primary outcomes:
measure: Change in insulin sensitivity within FMT, 6 months after FMT]
timeFrame: 6 months after FMT
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Endocrinology Research Centre, Moscow
city: Moscow
country: Russian Federation
facility: Federal Research and Clinical Center of Physical-Chemical Medicine, Moscow (FRCC PCM)
Study officials:
affiliation: Federal Research and Clinical Center of Physical-Chemical Medicine
name: Elena Ilina, MD
role: STUDY_DIRECTOR
affiliation: Endocrinology Research Centre, Moscow
name: Marina Shestakova, MD
role: STUDY_DIRECTOR
affiliation: Federal Research and Clinical Center of Physical-Chemical Medicine
name: Elena Zhgun, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrinology Research Centre, Moscow
name: Elena Pokrovskaya
role: PRINCIPAL_INVESTIGATOR
affiliation: Endocrinology Research Centre, Moscow
name: Igor Sklyanik
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02855463: Study of Giant Viruses of Amoebas Infections in Children Suffering From Gastroenteritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroenteritis
Keywords: Giant virus
Amoeba
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 1000
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children admitted for gastroenteritis who need a microbiological exam to confirm diagnosis

Brief summary: The discovery in 2003 by isolation of amoebas Mimivirus, the world's largest virus at the Research Unit on Tropical and Emerging Diseases in Marseille revealed fascinating information about the definition and evolution of viruses. Its genome encodes about 1,000 proteins. Three other viruses were then isolated from amoebas in this unit:Two other giant viruses, Mamavirus Marseillevirus then, and the first virus a virus, named virophage, which led to highlight the role of amoeba (Acanthamoeba spp. ) such as spawning giant viruses and compounds of bacterial origin or cellular proteins This project focuses on the detection and analysis of new viral agents (viruses and virophages giant amoeba environmental) and their involvement in human pathology.

The objectives of this study are observational: detect and document the presence of giant viruses and virophages of amoebae in the faeces of children presenting to the pediatric emergency reception service of the North Hospital in AP -HM with or without clinical evidence of gastroenteritis.


Eligibility criteria: Inclusion Criteria:

* Patient admitted in the Pediatric Emergency Service of Northern Hospital, Marseille, France
* Patient aged ≤ 15.3 years, male or female;
* Patient for whom a microbiological exam should be performed during the clinical management, with or without a clinical diagnosis of gastroenteritis (ie including diarrhea which will be defined by the issuance of at least three molded or watery stools per day for more than 24 hours) at the time of the collection of stool;
* Patient for whom informed consent was read, understood, signed by a parent or legal representative.

Exclusion criteria

* Patient aged \> 15.3 years;
* Patient for whom informed consent is not signed by a parent or legal representative.

Primary outcomes:
measure: Number of children carriers in their digestive tract of giant viruses (and their virophages) associated with amoebae
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT01675063: Minimally Invasive Cardiac Output Monitoring Device
Official title: Development of a Minimally Invasive Cardiac Output Monitoring Device for Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Event
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Retia Medical
First posted: 2012-08-29
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The overall goal of this collaborative study is to advance the novel "pulse contour analysis" to the point at which it can be incorporated into a real-time device. The specific objective is to establish an auto-calibration algorithm that conveniently yields cardiac output (CO) in units of liters-per-minute. To achieve this objective, the waveforms for analysis and reference pulmonary artery catheter CO measurements will be recorded from critically ill patients and then analyzed off-line at Retia Medical. Successful completion of this study may ultimately help lead to improved outcomes of critically ill patients.


Eligibility criteria: Inclusion Criteria:

* All adult patients admitted to the University of Michigan ICU following cardiac surgery with both a pulmonary and radial artery catheter.

Exclusion Criteria:

* Adult patients with mechanical cardiac support including intra-aortic balloon pumps, LVAD, or ECMO, and persistent ventricular arrhythmias.

Primary outcomes:
measure: Establishment of a Dataset to Create an Algorithm to Measure Cardiac Output
timeFrame: 8 hours post cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: James M Blum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01760863: Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
Official title: The Utility of Oral Antibiotic Therapy Following 2-stage Revision Arthroplasty for Infected Prosthetic Hips and Knees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prosthesis-Related Infections
Keywords: Revision
Knee
Hip
Arthroplasty
Oral
Antibiotics
Infection
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2013-01-04
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to compare the re-infection rates in patients undergoing 2-stage revision arthroplasty who receive additional oral antibiotic therapy to those patients who received in-hospital perioperative antibiotic only. Patients will be monitored for re-infection following hospital discharge, defined as deep infection of the joint space/capsule that requires return to the operating room within 24-months of the re-implantation procedure.


Eligibility criteria: Inclusion criteria:

Adult patients undergoing 2-stage revision arthroplasty of the knee or hip with the causative organism(s) identified using tissue culture and/or joint fluid analysis that is amenable to oral antibiotic therapy. Patients must be able to tolerate oral antibiotics and agree to participate in the study.

Exclusion criteria:

Patients with a fungal prosthetic joint infection, unable to tolerate or refuse to undergo oral antibiotic therapy, unable to follow-up at the specified intervals, allergic to the therapy of preference, or have an organism that is not amenable to oral antibiotic therapy.

Primary outcomes:
measure: Infection Rate
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Winfield
country: United States
facility: Central DuPage Hospital
state: Illinois
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
Study officials:
References:
citation: Zywiel MG, Johnson AJ, Stroh DA, Martin J, Marker DR, Mont MA. Prophylactic oral antibiotics reduce reinfection rates following two-stage revision total knee arthroplasty. Int Orthop. 2011 Jan;35(1):37-42. doi: 10.1007/s00264-010-0992-x. Epub 2010 Mar 7.