louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01646281: Vernakalant Versus Flecainide: Atrial Contractility
Official title: Effects of Vernakalant and Flecainide on Atrial Contractility in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Vernakalant
Flecainide
Echocardiography
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2012-07-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Atrial fibrillation (AF) is associated with decreased atrial contractility which is associated with stroke. Decreased contractility becomes apparent after cardioversion of atrial fibrillation, a short period (weeks) during which stroke risk is increased. Improved contractility immediately after cardioversion may prevent arrhythmia progression. In addition, it may reduce the stroke risk. Vernakalant is a new antiarrhythmic drug able to convert atrial fibrillation to sinus rhythm and at the same time increase atrial contractility. The latter has not yet been shown in humans and is subject of the present investigation. Our hypothesis is that in humans the contractility of the atria is higher after administration of vernakalant compared to flecainide. If indeed vernakalant improves atrial contractility after cardioversion further studies into the effect on long-term arrhythmia progression and stroke prevention may follow.


Eligibility criteria: Inclusion Criteria:

* persistent AF or paroxysmal AF
* eligible for treatment with vernakalant or flecainide infusion to restore sinus rhythm
* receiving adequate anticoagulant therapy (or having an episode of AF lasting \< 24 hours)

Exclusion Criteria:

* refusal or inability to give informed consent to participate in this study
* atrial flutter
* contra-indications for receiving vernakalant or flecainide according to MUMC+ protocol (unstable hemodynamic condition, LVEF \< 40%, inadequate potassium levels, acute ischaemia, sinus node dysfunction)
* age \< 18 years

Primary outcomes:
measure: Atrial contractility measured by echocardiography
timeFrame: After successful cardioversion to sinus rhythm (this can be during infusion of medication or during the first hour after infusion) an echocardiography will be performed within one hour.
Secondary outcomes:
measure: Conversion to sinus rhythm
timeFrame: Within one hour after drug administration
measure: Recurrence of AF
timeFrame: At one month follow-up
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
Study officials:
affiliation: Maastricht University Hospital
name: Harry Crijns, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05494281: Serratus Anterior Plane Block to Prevent Chronic Postoperative Pain in Breast Cancer
Official title: Serratus Anterior Plane Block to Prevent Chronic Pain in Breast Cancer Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Neoplasms
Pain, Postoperative
Pain, Chronic
Post-Mastectomy Chronic Pain Syndrome
Lead sponsor: Moroccan Society of Surgery
Sponsor class: OTHER
First posted: 2022-08-09
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem.

The hypothesis of this trial is that a peripheral block of the serratus anterior plane block type preoperatively after a modified radical mastectomy makes it possible to reduce the intensity and incidence of chronic post-surgical pain in breast cancer.


Eligibility criteria: Inclusion Criteria:

* Having an age greater than or equal to 18 years and less than 70 years
* Having given written consent for participation in the study and the use of personal and medical data
* Having a physical status of class I, II or III of the American Society of Anesthesiologists

Exclusion Criteria:

* Patients who expressed their refusal to participate in the study
* Patients unable to express their non-objection to participation in the study
* American Society of Anesthesiologists class \> III patients
* Known allergy to local anesthetics
* A contraindication to performing a peripheral nerve block (such as an acquired, constitutional or drug clotting disorder or infection at the nerve block injection site)
* Morbid obesity (body mass index greater than 40 kg/m²)
* Chronic use of opioids
* Inability to use the patient controlled analgesia device
* The existence of preoperative pain
* History of neuropathy or neurological pathology
* The existence of catastrophism or anxiety diagnosed preoperatively

Primary outcomes:
measure: Chronic postoperative pain at 3 months
timeFrame: 3 months after surgery
measure: chronic postoperative pain intensity
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Chronic Pain intensity and quality
timeFrame: 3 months after surgery
measure: Neuropathic pain screening
timeFrame: 3 months after surgery
measure: Morphine consumption
timeFrame: 0-24 hours after operation
Other outcomes:
Locations:
city: Rabat
country: Morocco
facility: Anesthesia & Critical care department - National Institut of Oncology in Rabat. Ibn Sina teaching Hospital. Mohammed V university of Rabat
Study officials:
affiliation: Mohammed V University in Rabat
name: Abdelilah GHANNAM, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02853981: Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy
Official title: Clamp-crush Technique Versus Harmonic Scalpel in Living Donor Hepatectomy. A Single Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hepatic Transplantation
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether clamp-crush technique for liver parenchymal transection is as safe as Harmonic scalpel device. outcomes will include: perioperative mortality, surgery-related complications, blood loss, amount of blood loss during hepatectomy, operating time, transection speed, markers of liver parenchymal injury and hospital stay.


Eligibility criteria: Inclusion Criteria:

* Liver right lobe donors

Exclusion Criteria:

-

Primary outcomes:
measure: blood loss during hepatectomy
timeFrame: intraoperative
Secondary outcomes:
measure: transection speed
timeFrame: intraoperative
measure: liver pathology from the cut margin
timeFrame: intraoperative
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Gastro-enterolgy surgical center, Mansoura University
state: Al-Dakahleia
Study officials:
affiliation: Assistant prof of general surgery
name: Ahmad M Sultan, MD
role: STUDY_DIRECTOR
References:
citation: Sultan AM, Shehta A, Salah T, Elshoubary M, Elghawalby AN, Said R, Elmorshedi M, Marwan A, Shiha U, Fathy O, Wahab MA. Clamp-Crush Technique Versus Harmonic Scalpel for Hepatic Parenchymal Transection in Living Donor Hepatectomy: a Randomized Controlled Trial. J Gastrointest Surg. 2019 Aug;23(8):1568-1577. doi: 10.1007/s11605-019-04103-5. Epub 2019 Jan 22.
Clinical trial NCT06276881: Visual Stimulation for Pain Relief
Official title: Pain Relief Through Artificial Intelligence (AI) -Guided Dynamic Neuromodulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Dandelion Science
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2024-02-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Participants of both sexes
* Participants of diverse ethnic and racial backgrounds
* Participants who speak, read, and understand English and are willing and able to provide written informed
* 18 to 50 years old

Exclusion Criteria:

* Participants with neurologic, endocrine, renal, gastrointestinal, and chronic pain disease
* Participants who use unprescribed drugs or medications
* Chronically medicated participants
* Participants with photosensitivity and epileptic seizures
* Participants who have undergone major surgery within two months of the experiment date
* Participants with cardiac disorders
* Participants who are pregnant
* Prisoners
* Participants who are unable to provide consent
* Participants diagnosed with a psychiatric disorder that is likely to interfere with the conduct of the study
* Participants with implanted electronic devices of any kind, including pace-makers, electronic infusion pumps, stimulators, defibrillators

Primary outcomes:
measure: Visual Analog Scale (VAS) Score
timeFrame: Up to 2 hours
measure: Event-related Potential (ERP)
timeFrame: Up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hoboken
country: United States
facility: Dandelion Science
state: New Jersey
Study officials:
affiliation: Dandelion Science Corp
name: Chief Executive Officer (CEO)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06785181: Dynamic Cardio-vascular, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects
Official title: Dynamic Cardio-, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Disease
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: IDEALE aims to assess the status of autonomic function, cerebral autoregulation (CA) and cortical activity in healthy subjects and correlate these functions with the psychological dimension of the subjects.

To this end, parameters of cardiac, cortical, vascular and cerebrovascular variability derived from electrocardiographic, electroencephalographic, respiratory movement, blood pressure, transcranial Doppler signals will be acquired and analysed for each healthy volunteer (TCD) and Laser-Doppler transcutaneous, during a phase of clinostatism (REST) and one of active orthostatism (STAND). In addition, volunteers will be submitted to psychometric tests (Chieti Affective Action Videos, CAAV) to assess the presence of depressive symptoms.


Eligibility criteria: Inclusion Criteria:

* age older than 18 years
* spontaneous sinus rhythm
* signed informed consent

Exclusion Criteria:

* Definite diseases of the Autonomic Nervous System (SNA) or the cardiovascular system
* Central nervous system disorders
* subjects under drug therapy that may affect the cardiovascular system
* pregnancy
* previous diagnosis of depression

Primary outcomes:
measure: Autoregulation index (ARI)
timeFrame: 36 months
measure: Baroreflex sensitivity
timeFrame: 36 months
measure: Cortical activity
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Milano
Study officials:
References:
Clinical trial NCT05583695: Mindfulness-based Music Therapy in Blind Elderly Women
Official title: Effects of Mindfulness-based Music Therapy on Emotional Regulation in Blind Elderly Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Music Therapy
Blind
Elderly
Mood
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 90
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial aims to examine effects of mindfulness-based music therapy on mood regulation in blind elderly women.


Eligibility criteria: Inclusion Criteria:

* female
* blind with visual acuity (the best eye) of 20/400 or below
* aged 65 years or above
* cognitive intact, measured using Hong Kong Montreal Cognitive Assessment (6th version) with a score ≥ 12
* able to speak Cantonese

Exclusion Criteria:

* none

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: at baseline
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: In the 8th week from baseline
Secondary outcomes:
measure: Depression Anxiety Stress Scales-21 (DASS-21)
timeFrame: at baseline
measure: Depression Anxiety Stress Scales-21 (DASS-21)
timeFrame: In the 8th week from baseline
measure: Geriatric Depression Scale (GDS)
timeFrame: at baseline
measure: Geriatric Depression Scale (GDS)
timeFrame: In the 8th week from baseline
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Hong Kong Society for the Blind
Study officials:
References:
Clinical trial NCT05685095: Programmes de Marche Active et qualité de Vie Dans la Maladie de Parkinson
Official title: Impact de Programmes de Marche Active Sur la Marche en Situation de Vie Quotidienne et la qualité de Vie Dans la Maladie de Parkinson
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parkinson Disease
Keywords: adapted physical activity
gait
quality of life
actimetry
Parkinson's disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: University Grenoble Alps
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2023-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this randomized controlled pilot trial is to assess the impact of different gait rehabilitation programs on the level of physical activity and gait in daily life in patients with Parkinson's disease (PD).

Two groups of 25 patients with PD will benefit from one of two gait training programs (treadmill vs. nordic walking), 3 times a week for 12 weeks. Activity level and number of steps will be remotely recorded over 7 days before, at the end, 3 and 6 months after the end of the program. Quality of life will be recorded at each time point.

The impact of the gait programs on the patients' level of daily activity will be examined, comparing the changes brought about by the two programs, taking into account the modulating influence of age and cognitive function.

Gait under conditions of daily life will be compared to gait parameters collected in the laboratory.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease, diagnosed for at least 2 years,
* Medical treatment (if any) unchanged in the past 4 weeks at least
* Hoehn \& Yahr score \< 3
* Montreal cognitive assessment (MOCA) score between 20 and 30
* Able to understand the aim and methods of the study and provide signed informed consent-

Exclusion Criteria:

* Atypical parkinsonian syndrome
* Cardiovascular pathology preventing moderate physical exercise
* Orthostatic hypotension
* Any condition (other than PD) interfering with gait
* pregnant or nursing

Primary outcomes:
measure: Changes in daily energy expenditure
timeFrame: recording 7 days in a row, at 3 months, 6 months and 9 months.
Secondary outcomes:
measure: Evolution of gait parameters
timeFrame: 3 months, 6 months and 9 months.
measure: Evolution of exercise functional capacity
timeFrame: 3 months, 6 months and 9 months.
measure: Evolution over time of the Parkinson's Disease Questionnaire-39 scale score.
timeFrame: 3 months, 6 months and 9 months.
measure: Evolution over time of the Parkinsons' Disease Fatigue Scale score.
timeFrame: 3 months, 6 months and 9 months.
measure: Adherence to the training program
timeFrame: 3 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: Grenoble Alpes University Hospital
name: Moro Elena, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06346795: Class II Restorations With High-Filled Flowable Composites
Official title: Clinical Evaluation of Class II Restorations Made With Highly Filled Flowable Composite Resins
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Caries
Class II Dental Caries
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the study, Class II restorations will be performed with G-aenial Universal Injectable (GC/ Tokyo, Japan), Grandio Flow (VOCO/ Germany), and Clearfil Majesty Flow (Kuraray/ Japan) composites will evaluated. Restorations will be assessed according to modified USPHS criteria in 1st week, 6th months, and 12th months from the placement date. The Chi-square test will used for statistical analysis of the difference between the groups, and the Cochran Q test will used for the significance of the difference between time-dependent changes within each group (p\<0.05).


Eligibility criteria: Inclusion Criteria:

A patient presenting with;

1. over 18 years of age
2. a normal periodontal status and good general health
3. proximal caries that are similar in size to premolar and molar teeth
4. vital teeth
5. teeth in contact with the opposing tooth and subjected to normal occlusal forces
6. attend follow-up appointments

Exclusion Criteria:

1. poor oral hygiene status
2. those with severe or chronic periodontitis
3. absence of adjacent and antagonist teeth
4. potential behavioral problems (e.g. bruxism)
5. allergy to any product used in the study
6. exposure of the pulp during cavity preparation
7. systemically unhealthy
8. pregnant and lactating women

Primary outcomes:
measure: Retention
timeFrame: 7th day, 6th month, 12th month.
measure: Color match
timeFrame: 7th day, 6th month, 12th month.
measure: Marginal discoloration
timeFrame: 7th day, 6th month, 12th month.
measure: Marginal adaptation
timeFrame: 7th day, 6th month, 12th month.
measure: Secondary caries
timeFrame: 7th day, 6th month, 12th month.
measure: Surface texture
timeFrame: 7th day, 6th month, 12th month.
measure: Anatomical form
timeFrame: 7th day, 6th month, 12th month.
measure: Postoperative sensitivity
timeFrame: 7th day, 6th month, 12th month.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University, Faculty of Dentistry, Restorative Dentistry Department
Study officials:
affiliation: Selcuk University, Faculty of Dentistry, Department of Restorative Dentistry
name: Merve Gürses
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00403195: Clinical and Pathophysiological Description of Ocular Ischemic Syndrome
Official title: Pathophysiological Analysis of Ocular Ischemic Syndrome and the Response to Vascular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Degeneration
Diabetic Retinopathy
Keywords: Ocular Ischemic Syndrome
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: University Hospital, Gentofte, Copenhagen
First posted: 2006-11-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the disease ocular ishemic syndrome. Patients will be screened through vascular surgery departments.

Brief summary: The purpose of this study is to characterize the disease Ocular Ischemic Syndrome.

Detailed description: The disease Ocular Ischemic Syndrome (OIS) is not a well described entity. It occurs after a long-standing period of extremely low blood supply to the retina caused by atherosclerosis of the carotid arteries. In this study we will analyze why OIS is developed in some patients and not developed in others. The patients with OIS will be thorough examined and will be compared with 1) a control group of healthy people and 2) with control group of patients with diabetic retinopathy. Furthermore the impact of vascular surgery on OIS will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Ocular ischemic syndrome

Exclusion Criteria:

* Any other active ocular disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Ophthalmology, Glostrup Hospital, University of Copenhagen
Study officials:
name: Michael Larsen, Professor
role: STUDY_DIRECTOR
References:
citation: Kofoed PK, Munch IC, Sander B, Holfort SK, Sillesen H, Jensen LP, Larsen M. Prolonged multifocal electroretinographic implicit times in the ocular ischemic syndrome. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):1806-10. doi: 10.1167/iovs.09-4555. Epub 2009 Nov 20.
Clinical trial NCT05293795: 3D U/S Maternal Fetal Bonding in African American Women
Official title: The Impact of 3D Ultrasound on Maternal-Fetal Attachment Among African American Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maternal-Fetal Relations
Maternal Behavior
Lead sponsor: Creighton University
Sponsor class: OTHER
First posted: 2022-03-24
Enrollment: 144
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3D ultrasound and picture of ultrasound or 3D ultrasound and printed model of fetal face and normal controls
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal and paternal attachment, lower stress, anxiety and depression and have improved life-style choices during pregnancy in African-American women.One-third of participants will receive 3D model and complete questionnaires, one-third will receive a picture of 3D ultrasound of their baby and complete questionnaires, and one-third will only complete the questionnaires


Eligibility criteria: Inclusion Criteria:

* Age - Female 19-45 years of age
* Fluent in English
* African American
* Currently pregnant (between 26- and 31-weeks' gestation)
* Have normal 20-week ultrasound

Exclusion Criteria:

* Having received more than 3 ultrasounds prior to study
* Medical need for additional ultrasounds
* Multiple fetuses
* \> 31 weeks gestation
* Is not African American
* Is not fluent in English

Primary outcomes:
measure: Maternal Antenatal Attachment Scale (MAAS)
timeFrame: 5 minutes
measure: Maternal Anxiety
timeFrame: 3 minutes
measure: Maternal Depression
timeFrame: 3 minutes
measure: Maternal Stress
timeFrame: 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Megan Kalata, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: