louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01748786: Online Mindfulness Training Versus Health Education for Fibromyalgia
Official title: Emotional Resilience in Fibromyalgia: A Pilot Study of Web-based Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Mindfulness
On-line intervention
Chronic pain
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: Arizona Institute for Mental Health Research
name: Pfizer
First posted: 2012-12-13
Enrollment: 94
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 compare an online 12-module intervention designed to improve emotion regulation and social relations via mindfulness training with a 12-module program that provides information about health behaviors to individuals with fibromyalgia. The mindfulness training program is expected to produce greater day-to-day improvements than the education condition in individuals' efficacy for coping with pain and stress, positive and negative affect, and positive engagement in social relations assessed via online diaries completed each evening during the intervention period.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Self-report of physician diagnosis of fibromyalgia
* Able to read and understand English
* Daily access to the internet

Exclusion Criteria:

* Self-report of more than 5 past episodes of depression

Primary outcomes:
measure: Daily Positive affect (10 items rated 1-5, averaged) and negative affect (10 items rated 1-5, averaged)
timeFrame: Daily during 6-week intervention
measure: Daily Pain Coping Efficacy (1 item rated 1-5) and Stress Coping Efficacy (2 item rated 1-5, averaged)
timeFrame: Daily over 6-week intervention
Secondary outcomes:
measure: Daily Enjoyment (1 item rated 1-5) and Stressfulness (1 item rated 1-5) of Family Relations
timeFrame: Daily during 6-week intervention
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Arizona State University
state: Arizona
Study officials:
References:
citation: Davis MC, Zautra AJ. An online mindfulness intervention targeting socioemotional regulation in fibromyalgia: results of a randomized controlled trial. Ann Behav Med. 2013 Dec;46(3):273-84. doi: 10.1007/s12160-013-9513-7.
Clinical trial NCT00464386: Continuous Glucose Monitoring (POC) in the ICU
Official title: Continuous Glucose Monitors (CGM) Versus Point-of-Care (POC) Glucometers in the Intensive Care Unit (ICU)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Burns
Trauma
Keywords: Severe burns
Severe Trauma
Closed loop insulin
continuous glucose monitoring
Lead sponsor: United States Army Institute of Surgical Research
Sponsor class: FED
First posted: 2007-04-23
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to prospectively evaluate whether the addition of continuous glucose monitoring to point-of-care (POC) glucometer monitoring improves glucose control.

Detailed description: Severe burns and traumatic injury can be associated with protracted illness and prolonged ICU course. The beneficial effects of strict serum glucose control in critically ill surgical patients have been demonstrated. Continuous glucose monitors may improve glucose control by providing close to real-time glucose measurements, giving the critical care team the ability to react to trends before hypo- or hyperglycemia is reached. These improvements may decrease the morbidity and mortality associated with severe thermal injury, thereby minimizing hospital stay and recovery. Burned and injured soldiers, airmen, sailors, and marines may return to duty in a more expeditious fashion, or at minimum, enjoy a better quality of life after discharge from the intensive care unit.

Eligibility criteria: Inclusion Criteria:

* remain 1 week in an ICU
* 18-72 years old
* severe trauma or thermal injury greater than 20% TBSA burn

Exclusion Criteria:

* cerebral arterial injury
* myocardial infarction
* pre-existing renal failure or liver failure
* history of hypoglycemia
* history or high risk of seizures
* pregnancy

Primary outcomes:
measure: To prospectively evaluate the reliability of continuous glucose monitors and the advisability of their use in patients with severe trauma and or thermal injury.
timeFrame: 90 days
Secondary outcomes:
measure: To investigate whether the use of continuous glucose monitoring systems in the ICU results in better glucose control.
timeFrame: 90 days
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: US Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: US Army Institute of Surgical Research
name: Heather Pidcoke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kerr D. Continuous blood glucose monitoring: detection and prevention of hypoglycaemia. Int J Clin Pract Suppl. 2001 Sep;(123):43-6.
Clinical trial NCT04665986: Neoadjuvant Study of Navelbine in Patients With HER2 Positive Breast Cancer
Official title: A Study to Evaluate Navelbine in Combination With Trastuzumab Plus Pertuzumab in Patients With HER2 Positive Early Stage or Locally Advanced Breast Cancer in Neoadjuvant Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy of neoadjuvant Navelbine plus trastuzumab and Pertuzumab versus Docetaxel plus trastuzumab and Pertuzumab given as neoadjuvant treatment in HER2 positive early-stage or locally advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

Female patients, 18 years ≤ age ≤ 80 years； Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 Histologically confirmed invasive breast cancer（early stage or locally advanced） HER2 positive (HER2+++ by IHC or FISH+) Known hormone receptor status. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO Signed informed consent form (ICF)

Exclusion Criteria:

Metastatic disease (Stage IV) or inflammatory breast cancer Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.

Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); Unable or unwilling to swallow tablets.

Primary outcomes:
measure: pCR
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: DFS
timeFrame: Following surgery until Year 3
measure: DDFS
timeFrame: Following surgery until Year 3
measure: ORR
timeFrame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03594786: Impact of Supra-renal Fixation of EVAR on Hemodynamics of Renal Arteries
Official title: To Assess Hemodynamic Disturbances to the Ostia of the Renal Arteries Generated by the Implantation of EVAR With a Suprarenal Fixation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Endovascular Procedures
Renal Artery Stenosis
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators conducted a bicentric prospective study to quantify the hemodynamic disturbances to the ostia of the renal arteries generated by the implantation EVAR with suprarenal fixation immediately postoperatively.


Eligibility criteria: Inclusion Criteria:

* elective EVAR with supra renal fixation
* women who have been postmenopausal for at least 24 months or are surgically sterilized, or for women of childbearing potential, use of an effective method of contraception
* consent to participate
* Affiliation to a French social security

Exclusion Criteria:

* stenosis of at least one renal artery
* dialysis
* rupture of abdominal aortic aneurysm
* renal stenting during the procedure
* fenestrated EVAR
* legal incapacity or limited legal capacity
* subject being in the exclusion period of another study
* pregnant woman

Primary outcomes:
measure: systolic maximum speed at the ostia of the renal arteries
timeFrame: one month
Secondary outcomes:
measure: systolic maximum speed at the ostia of the renal arteries
timeFrame: one year
measure: proportion of patients with renal artery stenosis
timeFrame: one year
measure: proportion of disappearance of the "notch" (pre-systolic notch)
timeFrame: one year
measure: proportion of increase in systolic rise time
timeFrame: one year
measure: proportion of decrease of the resistance index
timeFrame: one year
measure: proportion of post-stenotic turbulence
timeFrame: one year
measure: glomerular filtration rate
timeFrame: one year
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hosptalier Universitaire
city: Dijon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
citation: Salomon du Mont L, Parmentier AL, Puyraveau M, Mauny F, Guillon B, Rinckenbach S, Costa P. To assess hemodynamic disturbances to the ostia of the renal arteries generated by the implantation of EVAR with a suprarenal fixation. Medicine (Baltimore). 2020 May;99(18):e19917. doi: 10.1097/MD.0000000000019917.
Clinical trial NCT02348086: Outcomes Data of Adipose Stem Cells to Treat Rheumatoid Arthritis
Official title: Autologous Adipose Stromal Vascular Fraction Outcomes in Rheumatoid Arthritis Research Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: StemGenex
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: The purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual's own fat, known as the stromal vascular fraction (SVF), has on pain and functionality in people with rheumatoid arthritis (RA). SVF contains multiple cellular components, including stem cells, with both regenerative and anti-inflammatory properties. This therapy has shown promise for ameliorating the symptoms of RA. This study is designed to evaluate changes in pain and functionality in individuals with RA for up to 12 months following SVF treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with rheumatoid arthritis
* Subjects scheduled for a stem cell/SVF treatment
* Subjects willing and able to sign informed consent
* Subjects willing and able to perform follow-up interviews and surveys

Exclusion Criteria:

* Subjects with addition major health condition/disease diagnoses
* Subjects that are pregnant or breastfeeding

Primary outcomes:
measure: Change from Baseline in Overall Rheumatoid Arthritis Disease Activity Over the Course of a 12 Month Period as Measured by the Patient Activity Scale-II (PAS-II)
timeFrame: Baseline, 12 Months
Secondary outcomes:
measure: Change from Baseline in Overall Health at Month 12 as Measured by the Participants' Response to the Health Assessment Questionnaire-II (HAQ-II)
timeFrame: Baseline, Month 12
measure: Change from Baseline in Overall Pain at Month 12 as Measured by Participants' Response to the Patient Activity Scale-II (PAS-II) Pain Subscale
timeFrame: Baseline, Month 12
measure: Change from Baseline in Overall Global Activity at Month 12 as Measured by Participants' Response to the Patient Activity Scale-II (PAS-II) Global Activity Subscale
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: San Diego
country: United States
facility: StemGenex
state: California
Study officials:
References:
Clinical trial NCT03878563: Alterations in Intestinal Mucosal Barrier Visualized by Confocal Laser Endomicroscopy in Liver Cirrhosis: a Pilot Trial (AMBIC)
Official title: Alterations in Intestinal Mucosal Barrier Visualized by Confocal Laser Endomicroscopy in Liver Cirrhosis: a Pilot Trial
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Cirrhoses
Keywords: intestinal barrier dysfunction
Lead sponsor: Spital Limmattal Schlieren
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: University of Bern
First posted: 2019-03-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver cirrhosis and healthy controls, older than 18 years and younger than 80 years

Brief summary: Clinical trial with medical devices. A diagnostic trial conducted to find a better (less invasive) procedure for predicting the onset of spontaneous bacterial peritonitis(SBP), which is a complication of liver cirrhosis with ascites.The current recommendation for primary prophylaxis of SBP include a low protein content of the ascitic fluid or a gastrointestinal bleeding. This trial will use the CLE (confocal laser endomicroscopy) technic in order to quantify the intestinal permeability in patients with liver cirrhosis and correlate this to the onset of spontaneous bacterial peritonitis.We aim to evaluate a new diagnostic tool (the confocal laser endoscopy(CLE) technique -cellvizio- in the setting of endoscopy and defining parameters that are altered in cirrhotic patients of different severity and being at risk of developing a SBP (spontaneous bacterial peritonitis).The parameters assessed by confocal laser endomicroscopy will be correlated with the protein content in ascitic fluid and the patient will be monitored for time to occurrence of spontaneous bacterial peritonitis.

Defining a correlation between the quantified loss of intestinal integrity and i) total protein concentration in the ascitic fluid and ii) stadium of liver disease (Child class A, B or C)


Eligibility criteria: Inclusion Criteria:

Adult individual (\>18yo) with liver cirrhosis of any cause and healthy controls undergoing elective endoscopy

Exclusion Criteria:

* Patients younger than \< 18, older than 80 years
* Pregnant or breastfeeding women
* Known allergy to fluorescein.
* Cardiac disease
* Asthma bronchiale
* Patients with inability or unwillingness to provide blood samples or samples of ascitic fluid.
* patients unable to give informed consent
* non-resident patients
* contraindication for an endoscopic examination

Primary outcomes:
measure: occurrence of spontaneous bacterial peritonitis at 12 months
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Schlieren
country: Switzerland
facility: Limmattal Spital
state: Zürich
city: Bern
country: Switzerland
facility: Universitätsspital Bern
Study officials:
References:
Clinical trial NCT05703763: The Applanation Tonometry in GCA Pilot
Official title: The Applanation Tonometry in Giant Cell Arteritis Pilot
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Giant Cell Arteritis
Keywords: diagnosis
Lead sponsor: Hopital du Sacre-Coeur de Montreal
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 146
Sex: ALL
Minimum age (years): 50
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients referred for suspected GCA

Brief summary: The Applanation Tonometry in Giant Cell Arteritis (ATOM-GCA) study will answer the following questions:

1. How does PWV, measured by applanation tonometry of temporal arteries, differ between patients with and without a final diagnosis of GCA (based on pre-defined criteria 6 months after inclusion)?
2. What is the diagnostic accuracy and positivity cutoff of the PWV, measured by applanation tonometry, in detecting:

   1. A clinical diagnosis of GCA (based on pre-defined criteria 6 months after inclusion)?
   2. Inflammation of temporal arteries on high-resolution ultrasound?
3. What is the acceptability and adherence of repeat applanation tonometry during the follow-up period in patients with GCA?

Detailed description: ATOM-GCA is a single-center, cross-sectional vanguard study.

Eligibility criteria: Inclusion Criteria:

1. adult patient aged \> 50 years;
2. referred for suspected, new-onset or relapsing cranial GCA;
3. ability to understand and willingness to sign a written informed consent form.

Exclusion Criteria:

1. they had a temporal artery biopsy prior to the study visit;
2. they used systemic glucocorticoids for ≥ 14 consecutive days in the previous 30 days.

Primary outcomes:
measure: Mean PWV in patients with GCA to the mean PWV in individuals without GCA.
timeFrame: Baseline
Secondary outcomes:
measure: Diagnostic performance of the PWV to predict the presence of GCA-induced inflammation on high-resolution ultrasound
timeFrame: Baseline
Other outcomes:
measure: Feasibility of incorporating applanation tonometry into a routine GCA follow-up period (2 years)
timeFrame: Follow-up
Locations:
city: Montreal
country: Canada
facility: Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
state: Quebec
Study officials:
References:
citation: Zarka F, Rheaume M, Belhocine M, Goulet M, Febrer G, Mansour AM, Troyanov Y, Starnino T, Meunier RS, Chagnon I, Routhier N, Benard V, Ducharme-Benard S, Ross C, Makhzoum JP. Colour Doppler ultrasound and the giant cell arteritis probability score for the diagnosis of giant cell arteritis: a Canadian single-centre experience. Rheumatol Adv Pract. 2021 Nov 10;5(3):rkab083. doi: 10.1093/rap/rkab083. eCollection 2021.
citation: Baalbaki H, Jalaledin D, Lachance C, Febrer G, Rheaume M, Makhzoum JP. Characterization of visual manifestations and identification of risk factors for permanent vision loss in patients with giant cell arteritis. Clin Rheumatol. 2021 Aug;40(8):3207-3217. doi: 10.1007/s10067-021-05643-5. Epub 2021 Feb 12.
Clinical trial NCT04407663: Outpatient Clinic in Obesity Care During COVID-19 Outbreak: Physically Far, Virtually Near
Official title: Outpatient Clinic in Obesity Care During COVID-19 Outbreak: Physically Far, Virtually Near. Brief Correspondence on a Single Center Experience. Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery Candidate
Patient Underwent Bariatric Surgery
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 138/175 patients (78.8%) were eligible for telemedicine (66 established patients, 25 undergoing surgery within 30 days and 47 for the first time referred to our center).

Brief summary: Bariatric patients represent a peculiar and frail subset of subjects, constantly increasing. During the novel coronavirus disease outbreak, for the lockdown of any non-urgent and non-oncological activity, the access to healthcare services was severely limited, according to the International Federation for the Surgery of Obesity and Metabolic Disorders.

Detailed description: The constant and strict follow-up is mandatory in this special subset of patients. Therefore, starting from the telemedicine experience in different medical fields, in our bariatric surgery division we designed and started a dedicated project to follow-up obese patients using remote counselling.

Eligibility criteria: Inclusion criteria:

* obese adults (\> 18 years of age, BMI\> 40 or \> 35 with comorbidities) older than 18 years
* patients undergoing bariatric surgery within 6 months
* patients who required clinical and instrumental control
* presence of a caregiver in case of subject with cognitive impairment; patients with a history of bariatric surgery who requested a first outpatients access or established patients who requested an outpatients' visit for an emerging problem.

Exclusion criteria:

* virtual visit decline
* the internet or smart devices unavailability
* need for physical examination or radiological investigations established during a preliminary contact by phone.

Primary outcomes:
measure: Evaluation of feasibility of telemedicine in outpatient visit in bariatric patients
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Campania "Luigi Vanvitelli"
Study officials:
References:
Clinical trial NCT02747563: Evaluation of PSA Blood Levels Prior to and After Digital Rectal Examination
Official title: Evaluation of PSA Blood Levels in Men on Active Surveillance and Men With Benign Prostatic Hyperplasia Prior to and After Digital Rectal Examination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: prostate cancer
PSA
digital rectal examination
Lead sponsor: Kaplan Medical Center
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patients with know prostate cancer (PCa) under active surveillance and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination

Detailed description: Patients with know prostate cancer (PCa) under active surveillance (Gleason 6, PSA \< 10 ng/ml) and aged matched controls without evidence of PCa will have a PSA blood test prior to and following standardized digital rectal examination.

The change of PSA will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Males
* Intact Rectum
* Prostate Cancer eligible for active surveillance

Exclusion Criteria:

* Pror radiation therapy
* Under Androgen Deprivation Therapy
* Prior prostate surgery

Primary outcomes:
measure: Percentage of PSA elevation after DRE
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Rehovot
country: Israel
facility: Kaplan Medical Center
Study officials:
References: