louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05066074: Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique
Official title: Comparison of the Safety and Efficacy Between the Distal and Proximal Radial Vascular Access Technique in Coronary Diagnostic and Therapeutic Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: radial artery
distal radial artery
vascular access
radial artery occlusion
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2021-10-04
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised Clinical Trial - Equivalence model (Two tailed) Based on a previous pilot study: SD 97 sec Allowable Diff: 90 sec, Patient loss 15%, Type I error 2.5%, Type II error 90% Mean Differences: 0
Primary purpose: TREATMENT

Brief summary: The investigators are conducting a randomized clinical trial, having as a primary objective, to compare vascular access time between distal and proximal radial approach. Secondary objectives include comparing incidence of distal and proximal radial artery occlusion, at 24 hrs and 30 days. As a tertiary objective investigators will compare the preference of the patients for each access in subsecuent interventional procedures.

Detailed description: Randomised Clinical Trial / Equivalence Model Permutted block asignation 1:1 Statistical Power 90% and Significance 2.5%. Sample Loss estimation - 15% Chi-square to categorical and T Student to numerical variables. Logistic regression binomial for adverse outcomes. If needed, an intention to treat analysis will be performed.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Clinical indication for coronary angiography / angioplasty
* Palpable radial and distal radial pulse
* Previous clinical Barbeau test
* Radial and distal radial patency via vascular ultrasound
* 24-hour and 30-day follow-up feasibility

Exclusion Criteria:

* Previous vascular punctions in the studied anatomic site
* Artery introductor relationship
* Arteriovenous fistula
* Current treatment with oral anticoagulants
* Contraindication for Heparin
* Incomplete medical records
* Vascular access sheath - radial artery mismatch
* Distal radial or ulnar fracture history

Primary outcomes:
measure: Vascular Access Time
timeFrame: Seconds during the procedure
Secondary outcomes:
measure: "Conventional" Radial Artery Occlusion
timeFrame: In the first 24 hours, and follow up to 30 days
measure: Distal Radial Artery Occlusion
timeFrame: In the first 24 hours, and follow up to 30 days
Other outcomes:
measure: Quality of life outcome
timeFrame: 30-day survey
Locations:
city: Tijuana
country: Mexico
facility: Instituto Mexicano del Seguro Social
state: Baja California
Study officials:
References:
Clinical trial NCT01693874: Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging
Official title: Mindfulness-based Stress Reduction and Cognitive Function in Stress and Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anxiety Disorders
Depression
Keywords: anxiety
depression
cognition
MBSR
mindfulness
stress
elderly
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: University of California, San Diego
First posted: 2012-09-26
Enrollment: 103
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are developing and then testing whether Mindfulness-Based Stress Reduction, a group-based instruction for increasing mindfulness, reduces anxiety and depressive symptoms and improves cognitive functioning in older adults.


Eligibility criteria: Inclusion Criteria:

* aged 65+
* current depressive and/or anxiety symptoms
* current depressive and/or anxiety disorder
* able to participate in behavioral study

Exclusion Criteria:

* unable to participate in study

Primary outcomes:
measure: cognitive functioning
timeFrame: approximately 2 months of study intervention
Secondary outcomes:
measure: mind-wandering
timeFrame: 2 months of intervention
measure: mindfulness
timeFrame: 2 months of intervention
measure: anxiety and depressive symptoms
timeFrame: 2 months of intervention
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: St Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Eric Lenze, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Julie Wetherell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kornfield SL, Nicol GE, Lenze EJ, Yingling M, Loebach Wetherell J. Mindfulness-Based Stress Reduction in Older Individuals: Who Benefits the Most? Adv Mind Body Med. 2022 Winter;36(1):4-12.
citation: Haddad R, Lenze EJ, Nicol G, Miller JP, Yingling M, Wetherell JL. Does patient expectancy account for the cognitive and clinical benefits of mindfulness training in older adults? Int J Geriatr Psychiatry. 2020 Jun;35(6):626-632. doi: 10.1002/gps.5279. Epub 2020 Mar 20.
citation: Wetherell JL, Hershey T, Hickman S, Tate SR, Dixon D, Bower ES, Lenze EJ. Mindfulness-Based Stress Reduction for Older Adults With Stress Disorders and Neurocognitive Difficulties: A Randomized Controlled Trial. J Clin Psychiatry. 2017 Jul;78(7):e734-e743. doi: 10.4088/JCP.16m10947.
Clinical trial NCT06138574: Effects of Dexmetomidine and Remifentanil Used for Controlled Hypotension in Septorhinoplasty Surgery on Cardiac Electrophysiology: Prospective Randomized Study
Official title: Effects of Dexmetomidine and Remifentanil Used for Controlled Hypotension in Septorhinoplasty Surgery on Cardiac Electrophysiology: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rhinoplasty Surgery
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 72
Sex: ALL
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our aim in this treatment was to reveal the effects of remifentanil and dexmetomidine, which we used to provide controlled hypotension in septorhinoplasty surgery, on cardiac electrophysiology. We planned to compare the patients by recording preoperative and postoperative ECGs. We also planned to record the patients' intraoperative blood pressure, saturation, and pulse rate, rickeragitation scale, and vas score.


Eligibility criteria: Inclusion Criteria:

* patients with an ASA score of I and between the ages of 17-45 years, who were to undergo general anesthesia with sevofulurane were included in the study.

Exclusion Criteria:

Patients aged \<17 and \>45 years, patients with liver and/or kidney failure, obese patients (BMI \>30), trauma patients, ASA II-III-IV patients, patients with bleeding disorders, those using drugs that may affect the coagulation system, patients with cardiomyopathy, cerebrovascular disease, immobility, and malnutrition were excluded from the study.

-

Primary outcomes:
measure: iceb
timeFrame: preoperative and postoperative (immediatly after extubation)
Secondary outcomes:
measure: Riker Agitation Scale
timeFrame: Immediately after extubation
measure: mean arterial pressure
timeFrame: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion
measure: heart rate
timeFrame: when you come to the operating room table after anesthesia induction Intraoperative 30 minutes after extubasion
measure: Numeric Rating Scale
timeFrame: Postoperative 0-2 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03832374: Association Between Subtypes of Anti Citrullinated Peptide Antibodies and Lung Damage in Rheumatoid Arthritis
Official title: Study of the Association Between Subtypes of Anti Citrullinated Peptide Antibodies and Lung Damage in Rheumatoid Arthritis in the West Indies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis with diffuse insterstitial lung disease

Brief summary: Rheumatoid arthritis is a genuine systemic disease associated with diffuse interstitial pneumopathy and bronchial disorders. According to the literature review, the prevalence of PID on thoracic CT scan is one-third of patients. Diffuse interstitial pneumopathy is responsible for a significant morbidity and mortality, is currently under-diagnosed and its treatment is poorly codified. The lung seems to have a central role in the genesis of rheumatoid arthritis. It also appears that some subtypes of anti citrullinated peptide antibodies are preferentially present in the lungs.

The hypothesis behind our project is that one or more subtypes of anti citrullinated peptide antibodies with a preferential tropism for the lung would attack the parenchyma and pulmonary airways.

Currently, there are no data on interstitial pneumopathy in black and Afro-Caribbean subjects with rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Patient with rheumatoid arthritis ACR/EULAR 2010
* Patient with a higher age or equal to 18
* Patient receiving social security
* Patient giving his free and informed written consent

Exclusion Criteria:

* Patient with overlap syndrome with another autoimmune disease
* Patients with known severe cardiopulmonary pathology
* Woman who is pregnant and breast feeding
* Patient with language difficulties or understanding

Primary outcomes:
measure: Frequency of the positivity of the anti citrullinated peptide antibodies and subtype
timeFrame: three years
Secondary outcomes:
measure: Genetic analysis of the main mutations
timeFrame: three years
Other outcomes:
Locations:
city: Fort-de-France
country: Martinique
facility: CHU Martinique
Study officials:
affiliation: CHU de Martinique
name: BLETTERY Marie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05757674: Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration
Official title: Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-Related Macular Degeneration
Lead sponsor: University of Ioannina
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed patients with neovascular age-related macular degeneration from the area of North-West Greece

Brief summary: Analysis of the Intestinal Microbiome in Patients With Wet Age-related Macular Degeneration


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed neovascular age-related macular degeneration.

Exclusion Criteria:

* Chronic gastrointestinal disorders

Primary outcomes:
measure: Intestinal microbiome profile
timeFrame: 2022-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Ioánnina
country: Greece
facility: University of Ioannina
state: Epirus
city: Ioánnina
country: Greece
facility: University of Ioannina
state: Epirus
Study officials:
References:
Clinical trial NCT04114474: Pre-operative Focused Transthoracic Echocardiography for Prediction of Post-operative Cardiac Complications
Official title: Pre-operative Focused Transthoracic Echocardiography for Prediction of Post-operative Cardiac Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diastolic Dysfunction
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2019-10-03
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligibility for participating in the study was assessed before assignment by the attending physician in the anesthesia clinic . Patients above 60 years of age ASAI and ASA II were included in the study unless history of cardiac disease, history of previous postoperative cardiac complications and symptoms or signs of cardiac diseases were found as theses patients were excluded from the study.

Brief summary: The extent focused transthoracic echocardiography when done pre-operatively to patients admitted for elective surgery and suspected to be at risk of cardiac disease specially the geriatric population can affect perioperative anesthetic management of these patients.


Eligibility criteria: Inclusion Criteria:

* Patients above 60 years of age ASAI and ASA II were included

Exclusion Criteria:

* history of cardiac disease, history of previous postoperative cardiac complications and symptoms or signs of cardiac diseases.

Primary outcomes:
measure: Lt. Ventricular EDV
timeFrame: Change from Baseline pre operative LVEDV to first day postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Study officials:
affiliation: Lecturer of Anesthesia, ICU and Pain Relief, South Egypt Cancer Institute.
name: ALAA A EALZOHRY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04627974: Long-term Effectiveness, Safety, and Performance of the Evoke Closed-Loop SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
Official title: A Prospective Study to Evaluate the Long-term Effectiveness, Safety, and Performance of the Saluda Medical's EvokeTM Closed-Loop Spinal Cord Stimulation System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pain
Lead sponsor: Saluda Medical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2020-11-13
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic trunk and/or limb pain.

Brief summary: The objective of this multicountry, multicentre, prospective study is to evaluate the long-term clinical effectiveness, safety, and performance of the Evoke System in the treatment of chronic pain of the trunk and/or limbs in a real-world population.


Eligibility criteria: Inclusion Criteria:

* Eligible for therapy according to the Evoke System indications for use statement and labelling requirements
* Willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits
* Baseline VAS pain rating ≥60 mm in the primary area of pain

Exclusion Criteria:

* No further exclusion criteria

Primary outcomes:
measure: Percent Change in Visual Analogue Scale (VAS) Pain
timeFrame: 3-months post-implant
Secondary outcomes:
measure: Incidence of device- and procedure-related adverse events
timeFrame: through 60-months post-implant
measure: Measurement of ECAPs by the Evoke SCS System
timeFrame: through 60-months post-implant
Other outcomes:
Locations:
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas Multidisciplinary Pain Center
state: East Flanders
city: Roeselare
country: Belgium
facility: AZ Delta Multidisciplinary Pain Center
state: West Flanders
city: Düsseldorf
country: Germany
facility: Universität Düsseldorf
state: North Rhine-Westphalia
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Velp
country: Netherlands
facility: Rijnstate
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
state: Essex
city: Middlesbrough
country: United Kingdom
facility: James Cook University Hospital
state: North Yorkshire
city: Bristol
country: United Kingdom
facility: Southmead Hospital
Study officials:
References:
Clinical trial NCT00890474: Moxibustion for Fetus in Breech Presentation
Official title: Moxibustion for Fetus in Breech Presentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breech Presentation
Keywords: Breech presentation at 34 to 36 weeks of gestation
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Loterie Romande
First posted: 2009-04-29
Enrollment: 212
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate moxibustion of the BL67 acupoint between 34 and 38 weeks of gestation to facilitate cephalic version of breech presentation in a Western setting. The hypothesis is that moxibustion increase the likelihood of cephalic version.

Design: Randomised controlled trial Setting: University hospital. Population: A total of 212 consenting women between 34 and 36 weeks of gestation with a single fetus in breech presentation will be randomised to moxibustion (n=106) or expectant management (n=106).

Main Outcome Measure: Cephalic presentation at delivery or before external cephalic version.


Eligibility criteria: Inclusion Criteria:

* Breech presentation
* 34 to 36 weeks of gestation
* Single fetus

Exclusion Criteria:

* Uterine malformation
* Placenta praevia
* Transverse lie

Primary outcomes:
measure: Cephalic presentation at delivery or before external cephalic version
timeFrame: end of pregnancy
Secondary outcomes:
measure: Mode of delivery
timeFrame: end of pregnancy
measure: Women's views on the intervention
timeFrame: end of pregnancy
measure: External cephalic version
timeFrame: end of pregnancy
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
Study officials:
References:
citation: Guittier MJ, Pichon M, Dong H, Irion O, Boulvain M. Moxibustion for breech version: a randomized controlled trial. Obstet Gynecol. 2009 Nov;114(5):1034-1040. doi: 10.1097/AOG.0b013e3181bc707a.
Clinical trial NCT02321774: Validation of a Wearable Sensor for Stress Response in a Virtual Reality Environment
Official title: Validation of a Wearable Sensor for Stress Response in a Virtual Reality Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Stress
Virtual Reality
Wearable Sensor
Wellness
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2014-12-22
Enrollment: 53
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be made up of 50 adult men and women who are in general good health. Individuals will be recruited locally through fliers, word of mouth and email blasts to the Scripps community.

Brief summary: Monitor stress response in a virtual reality environment using a wearable sensor to analyze and track heart rate variability (HRV).

Detailed description: Wearable sensor technology is being developed that may allow, for the first time, the ability for individuals to better recognized their level of stress in any given situation on a continuous basis. A major focus of many of these wearable sensors is being able to accurately analyze and track heart rate variability (HRV), which is indicative of primarily parasympathetic/vagal tone and emotional state.3 However there is a need to validate the reliability of this measured response and understand any inter-individual variability.

The present study will take advantage of virtual reality scenarios to expose healthy volunteers to controlled stressful situations during monitoring with several standardized lab-based non-invasive physiological sensors as well as a novel wrist band sensor device to track individual response to stress.

Eligibility criteria: Inclusion Criteria:

* Adults over age 18

Exclusion Criteria:

* History of seizures
* History of vertigo or other vestibular abnormalities
* History of a chronic anxiety disorder
* History of cardiovascular disease or heart disease

Primary outcomes:
measure: Changes in heart rate variability (HRV) as detected by the wristband sensor relative to measures of stress noted by lab-based physiologic monitoring equipment.
timeFrame: ~Four hours
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Virtual Reality Medical Center
state: California
Study officials:
affiliation: STSI
name: Steven Steinhubl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00725374: A Study to Investigate the Effects of Tibolone (Livial®) on Breast Tissue in Postmenopausal Women With Breast Cancer (Study 32971)(P06469)
Official title: A Exploratory, Double-blind, Randomized, Placebo-controlled Trial to Investigate the Tissue Specific Effects of 2.5 mg Tibolone on Breast Cancer in Postmenopausal Women, in Particular on Breast Tissue Proliferation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 102
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to compare changes in the expression of the proliferation marker Ki-67 in malignant breast tissue after treatment with tibolone or placebo in postmenopausal women who need to undergo surgery for primary breast cancer


Eligibility criteria: Inclusion Criteria:

* postmenopausal women of any age
* requiring surgery for early invasive primary breast cancer (clinically stage I or II; T1-T3; N0-1; M0), with estrogen receptor-positive tumor(s)
* body mass index between 18 and 2 kg/m2, inclusive
* must be willing to give voluntary written informed consent.

Exclusion Criteria:

* healthy subjects

Primary outcomes:
measure: The primary objective of this trial was to compare changes in the expression of the proliferation marker Ki-67 in malignant breast tissue after treatment with tibolone or placebo.
timeFrame: The primary outcome measure, the proliferation marker Ki-67, was measured at screening (from the screening biopsy) and about 14 days later (from the surgically removed breast tumour tissue)
Secondary outcomes:
measure: Apoptosis index; estrogen/progesterone/androgen receptors & isoforms; bcl-2, bax; pS2; SOX4; Apolipoprotein D; Angiogenesis parameters; estrogen levels, tibolone and tibolone metabolites.
timeFrame: Outcome parameters were measured during the trial as samples were received and at the end of the clinical phase.
Other outcomes:
Locations:
Study officials:
References:
citation: Kubista E, Planellas Gomez JV, Dowsett M, Foidart JM, Pohlodek K, Serreyn R, Nechushkin M, Manikhas AG, Semiglazov VF, Hageluken CC, Singer CF. Effect of tibolone on breast cancer cell proliferation in postmenopausal ER+ patients: results from STEM trial. Clin Cancer Res. 2007 Jul 15;13(14):4185-90. doi: 10.1158/1078-0432.CCR-06-2700.