louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06127667: Brain Vascular and Neural Function Linked to Balance Across the Adult Lifespan
Official title: Brain Vascular and Neural Function Linked to Balance Across the Adult Lifespan
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurotypical
Cognitively Normal
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 102
Sex: ALL
Minimum age (years): 21
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single-arm, two-visit, non-randomized, cross sectional study identified as an intervention due to the use of a single bout of aerobic exercise to assess cerebrovascular function under the NIH rules. This study is not masked and its primary purpose is to develop a basic science understanding of the relationship between cerebrovascular health and balance control with aging. This study will involve 102 individuals classified as younger adults, middle-aged adults, and older adults who are neurotypical and cognitively normal. The primary outcome from a clinical trials perspective will be cerebrovascular response to a bout of aerobic exercise (i.e. change in cerebral blood flow with the performance of aerobic exercise on a recumbent stepper exercise machine). Non-interventional outcomes will be EEG measures of cortical activity and biomechanical kinetic and kinematic data recorded during standing balance reactions, as well as biological blood samples for genomic analysis.


Eligibility criteria: Inclusion Criteria:

* Age within the following 3 group age ranges, 21-30yo; middle-aged: 40-55yo; older: 65-95yo adults
* the absence of major orthopedic disability
* cognitively normal (MoCA score ≥ 26/30 in older adult group)
* vision that is 20/40 or better with or without corrective lenses, (5) the ability to consent and communicate with researchers
* English speaking
* ability to stand for 3 minutes and walk 10 meters with or without an assistive device and without the assistance of another person.

Exclusion Criteria:

* insulin-dependent diabetes
* peripheral neuropathy
* myocardial infarction or symptoms of coronary artery disease within 2 years
* congestive heart failure or class IV heart failure
* any significant sensory impairment affecting balance or cognition; visual, vestibular, or auditory impairments.

Primary outcomes:
measure: cerebral blood flow velocity assessed using transcranial Doppler ultrasound
timeFrame: 1 week
measure: Kinetic center of pressure rate of rise post-balance perturbation, assessed biomechanically.
timeFrame: 1 week
measure: Prefrontal-M1 coherence an S1-M1 coherence post-balance perturbation, assessed using EEG
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jacqueline Palmer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02007967: Non-Contrast Magnetic Resonance Angiography Assessment of Patients Referred for Transcatheter Aortic Valve Implantation
Official title: Can Non-Contrast Magnetic Resonance Angiography Accurately Define Arterial Access and Aortic Root Anatomy in Patients Referred for Transcatheter Aortic Valve Implantation?
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Aortic Valve Stenosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 12
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: Study population will include patients undergoing clinically indicated computed tomography angiography for evaluation for possible transcatheter aortic valve implantation.

Brief summary: The overall objective of this proposal is to examine the feasibility and accuracy of non-contrast magnetic resonance angiography (MRA) to comprehensively evaluate individuals referred for transcatheter aortic valve implantation (TAVI).


Eligibility criteria: Inclusion Criteria:

* Adults with severe aortic stenosis referred for possible transcatheter aortic valve implantation with clinically indicated computed tomography imaging

Exclusion Criteria:

* Inability or unwillingness to consent
* Inability to complete magnetic resonance imaging (MRI) study
* Contraindication to MRI
* Participation in another research study
* Non-diagnostic computed tomography scan

Primary outcomes:
measure: Minimal luminal size for aorta and ileofemoral arteries
timeFrame: 3 hours
Secondary outcomes:
measure: Graded image quality
timeFrame: 3 hours
measure: Annular size
timeFrame: 3 hours
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cardiovascular Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Troy M LaBounty, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06028867: Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis
Official title: Validation of the Clinical and Antimicrobial Effectiveness of a Clorexidine and Sodium DNA Based Mouthwash in Patients With Stage III and IV Periodontitis: a Randomized-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.
Primary purpose: TREATMENT

Brief summary: Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCT study is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.12% + Sodium DNA and Chlorhexidine 0.20% at two weeks, compared with a placebo, on patients with stage III or IV periodontitis.

Detailed description: Sodium DNA has several properties that may be beneficial in the management of bacterial biofilm in periodontitis. The aim of this RCTstudy is to clinically evaluate the antimicrobial and oral biofilm control properties of two mouthwashes containing Chlorhexidine 0.12% + Sodium DNA and Chlorhexidine 0.20% at two weeks, compared with a placebo, on patients with stage III or IV periodontitis. The study was designed as a double-blind randomized controlled trial (RCT) with three parallel groups of individuals.

Eligibility criteria: Inclusion Criteria:

• Clinically diagnosed with stage III or IV periodontitis according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

* Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Systemic diseases.

Primary outcomes:
measure: Subgingival biofilm
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
Study officials:
References:
Clinical trial NCT01772667: Long Term Effects of an Inpatient Pulmonary Rehabilitation Program in Patients With Pulmonary Fibrosis
Official title: Long Term Effects of a 3-week Inpatient Pulmonary Rehabilitation Program in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: pulmonary fibrosis
interstitial lung disease
pulmonary rehabilitation
exercise capacity
physical activity
quality of life
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2013-01-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There is evidence that an inpatient pulmonary rehabilitation of 3 weeks improves exercise capacity and quality of life in patients with idiopathic pulmonary fibrosis. However, there are no data available regarding long-term effects of this multimodal program. The aim of this study is to investigate the long-term impact of a rehabilitation program 3 month after finishing on exercise capacity and physical activity.


Eligibility criteria: Inclusion Criteria:

* want to start a rehabilitation program in "Schoen Klinik Berchtesgadener Land"
* patients with idiopathic pulmonary fibrosis (vital capacity \> 50% pred.)

Exclusion Criteria:

* exacerbation in the last 4 weeks

Primary outcomes:
measure: Delta of 6-minute walking distance from 1 week pre rehabilitation to 3 month post rehabilitation
timeFrame: 1 week before rehabilitation to 3 month after finishing rehabilitation
Secondary outcomes:
measure: Delta of physical activity level from 1 week pre rehabilitation to 3 month post rehabilitation
timeFrame: 1 week before rehabilitation to 3 month after finishing rehabilitation
measure: Delta of SF36-score (questionnaire to measure quality of life) from 1 week pre to 3 month post rehabilitation
timeFrame: 1 week before rehabilitation to 3 month after finishing rehabilitation
Other outcomes:
Locations:
city: Schoenau Am Koenigssee
country: Germany
facility: Schoen Klinik Berchtesgadener Land
state: Bavaria
Study officials:
affiliation: Head physician in the department of pulmology
name: Klaus Kenn, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00997867: Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks
Official title: Perineural Catheter Insertion Distance for Continuous Peripheral Nerve Blocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lower Extremity Surgery
Upper Extremity Surgery
Post-operative Pain
Keywords: Pain
Surgery
Catheter
Nerve Block
Popliteal
Sciatic
Femoral
Interscalene
UCSD
Moderate-to-severe pain
Perineural Catheter
Orthopedic Surgery
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 350
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: This is a research study to determine if the effects of continuous peripheral nerve blocks are influenced by the distance of insertion past the needle tip of the perineural catheter.

Detailed description: Specific Aim: Research study to determine the relationships between perineural catheter insertion distance and subsequent continuous peripheral nerve block effects.

Hypothesis: during ultrasound-guided perineural catheter placement, inserting the catheter 0-1cm past the needle tip is associated with decreased postoperative pain compared with inserting the catheter 5-6cm past the needle tip.

Eligibility criteria: Inclusion Criteria:

* undergoing surgery with a planned popliteal perineural catheter for postoperative analgesia
* age 18 years or older

Exclusion Criteria:

* pregnancy
* inability to communicate with the investigators and hospital staff
* incarceration
* clinical neuropathy in the surgical extremity
* chronic high-dose opioid use
* history of opioid abuse

Primary outcomes:
measure: Average pain in the three hours previous to a phone call the day following surgery as measured on a numeric rating scale (0-10, 0=no pain, 10=worst imaginable pain).
timeFrame: Day 1 after surgery, 3 hours prior to phone call
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UCSD Medical Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Brian M Ilfeld, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02020967: Programme of Acromegaly Screening in Patients With Associated Somatic Disorders
Official title: Programme of Acromegaly Screening in Patients With Associated Somatic Disorders, Who Are Observed at the Moscow Board of Health Endocrinology Dispensary and Endocrinology Hospital at First Moscow State Medical University for the Purpose of Early Identification of the Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acromegaly
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2013-12-25
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with somatic disorders associated with acromegaly, who are observed at the Moscow Board of Health Endocrinology dispensary and Endocrinology Hospital at First Moscow State Medical University

Brief summary: The primary objective of the protocol is to define percentage of patients with acromegaly in relation to the total number of screened patients with confirmed clinically significant set of associated somatic disorders with the help of laboratory (Insulin-like Growth Factor I, Growth Hormone, Oral Glucose-Tolerance Test \[IGF-1, GH, OGTT\]) and instrumental examination methods (Magnetic Resonance Imaging \[MRI\]).


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 years and above with associated somatic disorders observed at the Moscow Endocrinology dispensary or Endocrinology Hospital at First Moscow State Medical University
* Patients who signed the Informed Consent Form for participation in the survey before collection of any information.

Exclusion Criteria:

* Patient already diagnosed with acromegaly
* Patient's refusal to participate in the survey.

Primary outcomes:
measure: Percentage of Participants Diagnosed With Acromegaly
timeFrame: Participants were screened over approximately 21 months
Secondary outcomes:
measure: Number of Participants Diagnosed With Acromegaly Using Biochemical Assays (IGF-1, GH, OGTT) and Instrumental Examination Methods (MRI)
timeFrame: Participants were screened over approximately 21 months
measure: Percentage of Participants With Associated Concurrent Somatic Disorders
timeFrame: At baseline (Day 1)
measure: Percentage of Participants With Microadenomas and Macroadenomas
timeFrame: Participants were screened over approximately 21 months
measure: Percentage of Participants With the Most Pathognomonic Subjective and Objective Signs for Tracing Acromegaly
timeFrame: Participants were screened over approximately 21 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Board of Health Endocrinology Dispensary
city: Moscow
country: Russian Federation
facility: Endocrinology Hospital at First Moscow State Medical University
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06725667: Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy
Official title: Ultrasound-Guided Transversalis Fascia Plane Block Versus Caudal Block for Postoperative Analgesia in Children Undergoing Inguinal Herniorrhaphy: A Randomized Controlled Non-Inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ultrasound
Transversalis Fascia Plane Block
Caudal Block
Postoperative Analgesia
Children
Inguinal Herniorrhaphy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare ultrasound-guided transversalis fascia plane block and caudal block for postoperative analgesia in children undergoing inguinal herniorrhaphy.

Detailed description: Surgical repair of inguinal hernia is one of the most common day-case surgeries in the pediatric population. It is associated with significant postoperative pain and discomfort.

Caudal block analgesia is a popular and reliable technique for lower abdominal surgeries and found to be safe and effective for providing intra and postoperative analgesia in pediatric patients.

transversal fascia plane block (TFPB) aims to provide analgesia for invasive procedures of the inguinal and sublingual areas by blocking the subcostal (T12), ilioinguinal (L1) and iliohypogastric (T12-L1) nerves. Several studies have reported TFPB as the analgesic method of choice for procedures involving the T12-L1 dermatome region, including iliac bone graft harvesting, cesarean section, and inguinal hernia repair

Eligibility criteria: Inclusion Criteria:

* Age from 1 to 7 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Scheduled for inguinal herniorrhaphy under general anesthesia (GA).

Exclusion Criteria:

* Repeated surgeries.
* Known allergic reactions to any of the study's drugs.
* Infection at the site of block needle entry.
* Bleeding diathesis.
* Neurological disorders.

Primary outcomes:
measure: Time to the 1st rescue analgesia
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Total paracetamol consumption
timeFrame: 24 hours postoperatively
measure: Intraoperative fentanyl consumption
timeFrame: Intraoperatively
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Hear rate
timeFrame: Every 15 min till the end of surgery (Up to 2 hours)
measure: Mean arterial pressure
timeFrame: Every 15 min till the end of surgery (Up to 2 hours)
measure: Degree of patient's parents satisfaction
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT02130167: Low Concentration Atropine for Myopia Progression in School Children
Official title: Low Concentrations of Atropine for Controlling Myopia Progression in School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia Progression
Keywords: Myopia progression
Low concentration atropine
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the higher risk of high myopia in later life and complications such as retinal detachment and maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the effect on retarding the myopia progression. Recently the 0.01% atropine was also reported effective and with less visual side effects such as mydriasis. The aim of this study is to compare the efficacy in controlling myopia progression and visual side effects of 2 low concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.


Eligibility criteria: Inclusion Criteria:

Myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.

Exclusion Criteria:

strabismus, amblyopia. cataract, glaucoma or any ocular diseases ocular surgery history systemic diseases (ex. asthma, heart disease...)

Primary outcomes:
measure: Cycloplegic spherical refraction change
timeFrame: 1 year
Secondary outcomes:
measure: Axial length change
timeFrame: 1 year
Other outcomes:
measure: pupil size
timeFrame: 6 months
measure: accommodation
timeFrame: 6 months
measure: Questionnaire
timeFrame: baseline and 6 months
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Dep. of Ophthalmology, Kaohsiung Chang Gung Memorial Hospital, Taiwan
name: Pei-Chang Wu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04393467: Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
Official title: Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
ALS
transcranial magnetic stimulation
static magnetic field
tSMS
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate safety and efficacy of tSMS in ALS patients and to obtain preliminary data about the effects of tSMS on cortical excitability.

To this purpose, 40 ALS patients will be recruited and randomized to real or sham tSMS. After at least 3 months follow-up, they will undergo tSMS, daily for 120 min, at home, for 6 consecutive months.

Clinical status will be tested before, during and after the stimulation period. Moreover, cortical excitability will be tested by transcranial magnetic stimulation (TMS) before and after the stimulation period.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 75 years
* diagnosis of ALS according to revised El Escorial criteria and Awaji-Shima criteria
* disease duration \< 24 months
* ALSFRS-R \> 30 at the recruitment
* ALSFRS-R decline \> 1 in the at least 3-months period before the intervention
* normal respiratory functionality (FVC \> 80% and ALSFRS-R items 10,11,12 \> 4) at the recruitment
* treatment with riluzole 50 mg x 2/die

Exclusion Criteria:

* inclusion in other clinical trials
* presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy)
* contraindications to magnetic fields exposure
* pregnancy or breast-feeding
* history of epilepsy or seizures
* assumption of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.
* cognitive impairment
* lack of informed consent

Primary outcomes:
measure: Disease progression
timeFrame: 9 months
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 6 months
measure: Compliance
timeFrame: 6 months
measure: Effect on resting motor threshold (RMT) and active motor threshold (AMT)
timeFrame: 6 months
measure: Effect on motor evoked potentials (MEP) size
timeFrame: 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS
city: Rome
country: Italy
facility: Neurology Unit, Campus Biomedico University
Study officials:
References: