louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04899180: Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis
Official title: Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis: A Community Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Aortic Stenosis
Transthyretin Amyloidosis
Transthyretin Amyloid Cardiomyopathy
Transthyretin Cardiac Amyloidosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 4
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine the prevalence of transthyretin cardiac amyloidosis (TTR-CA) among patients with moderate and severe aortic stenosis in Southeast Minnesota using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT).

Detailed description: Residents of Southeast Minnesota over 75 years of age with an inpatient or outpatient diagnosis of moderate or severe aortic stenosis will be consecutively identified using an automated bi-weekly review of the echo lab calendar (on Mondays and Fridays) at Mayo Clinic Rochester (MCR) and Mayo Clinic Health System (MCHS) sites. Participants will be consented to undergo venipuncture, urine collection and 99mTc-PYP SPECT/CT imaging to rule in/out the diagnosis of TTR-CA. Hence, the prevalence of TTR-CA will be defined. To place this prevalence in perspective of the global aortic stenosis cohort in the community, a rigorous screening log will be maintained to allow generation of a comprehensive CONSORT diagram. Importantly, baseline characteristics of patients who qualify for our study but decline to consent will still be collected provided that consent for use of their records for medical research had previously been granted.

Eligibility criteria: Inclusion Criteria:

* Resident of Southeastern Minnesota (Olmsted, Dodge, Fillmore, Mower, Freeborn, Wabasha, or Steele County)
* Age ≥ 75 years
* Current diagnosis of moderate or severe aortic stenosis by most recent (within 6 months at most) echocardiogram as defined by:

  * Moderate AS: 1.0 cm2 \< aortic valve area (AVA) ≤ 1.5 cm2
  * Severe AS: AVA ≤ 1.0 cm2

Exclusion Criteria:

* Any cardiac surgery or major chest trauma within 4 weeks of PYP scan
* Myocardial infarction within 4 weeks of PYP scan defined by typical angina, EKG changes and significant change in serial troponins. (Note that chronic troponin elevation is extremely common in cardiac amyloidosis).
* Prior or current exposure to Plaquenil (Hydroxychloroquine)

Primary outcomes:
measure: Prevalence of TTR-CA in patients with moderate and severe aortic stenosis
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Omar F Abou Ezzeddine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06868680: A Digital Balance Program With Comparison Group
Official title: Prospective, Balance Program Study With Comparison Group
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Falls
Keywords: balance
falls prevention
older adults
exercise therapy
telerehabilitation
Lead sponsor: Hinge Health, Inc
Sponsor class: INDUSTRY
First posted: 2025-03-11
Enrollment: 687
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research study evaluates a digital musculoskeletal care program specifically focused on balance improvement and falls prevention. The primary goal is to determine if the program results in fewer falls compared to a comparison condition where people will get educational/information articles on falls prevention. Study participants are asked to participate in their assigned condition and complete surveys throughout the study.

Detailed description: The digital Balance Program is accessible through a smartphone or tablet and includes tailored exercise therapy, educational content spanning a variety of topics related to balance improvement and fall prevention, a personalized clinical approach to improving balance, and access to a board-certified health coach and physical therapist. The comparison group consists of a series of emailed articles on falls prevention. In addition to participating in the assigned condition, participants are asked to answer surveys that ask questions related to your balance, mental health, demographic information, and lifestyle. The surveys are sent before, during and at the end of the program.

Eligibility criteria: Inclusion Criteria:

* had an email account and owned a smartphone
* had a moderate-high fall risk based on the Stopping Elderly Accidents, Deaths, and Injuries (STEADI) questionnaire (≥ 4 points)

Exclusion Criteria:

* undergone musculoskeletal surgery within three months prior to recruitment
* a history of opioid, alcohol, or drug abuse within the last year
* a diagnosis of cognitive, behavioral, neurologic, or psychiatric disorders
* any contraindication for light physical activity as directed by the prospective participant's doctor

Primary outcomes:
measure: Annualized fall rate
timeFrame: 3 months
Secondary outcomes:
measure: Fall Severity
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Hinge Health
state: California
Study officials:
affiliation: Hinge Health, Inc
name: Cynthia M Castro Sweet, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03929380: Acute Effects of Squat Protocols in Muscular Power, Postural Sway and Tendinous Thickness.
Official title: Acute Effects of Squat Protocols in Muscular Power, Postural Sway and Tendinous Thickness.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Squat Training Effects
Keywords: Squat
Acute effect
Tendon thickness
Counter movement jump test
Postural sway
Muscular power
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2019-04-26
Enrollment: 0
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The objective of this study is to know the acute effects of a squat protocol in: 1- lower limb muscle power analyzed by countermovement jump on force platform and upper limb through a bench press with encoder test; 2 - the unipodal postural equilibrium by force platform; 3 - the patellar tendinous thickness measured by ultrasound.


Eligibility criteria: Inclusion Criteria:

* Males, with at least a year of experience in heavylift exercises, age between 20 and 35 years.

Exclusion Criteria:

-

Primary outcomes:
measure: Muscle power
timeFrame: 30 minutes
measure: Patellar thickness
timeFrame: 60 minutes
measure: Monopodal Postural Sway
timeFrame: 10 minutes
Secondary outcomes:
measure: Muscular fatigue
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: UCAM Sports Center
Study officials:
affiliation: Universidad Católica San Antonio de Murcia
name: Fco Javier Orquín Castrillón
role: STUDY_DIRECTOR
affiliation: Universidad Católica San Antonio de Murcia
name: Iñigo Fernández de Luco Santamaría
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butcher S. J, Judd T. B, Benko C. R, Horvey K. J, Pshyk A. D, (2015). Relative intensity of two types of crossfit exercise: Acute circuit and high-intensity interval exercise. Journal of Fitness Research, 4 (2), 3-15.
citation: Fredberg U, Bolvig L, Andersen NT, Stengaard-Pedersen K. Ultrasonography in evaluation of Achilles and patella tendon thickness. Ultraschall Med. 2008 Feb;29(1):60-5. doi: 10.1055/s-2007-963027. Epub 2007 Aug 16.
citation: Fisker FY, Kildegaard S, Thygesen M, Grosen K, Pfeiffer-Jensen M. Acute tendon changes in intense CrossFit workout: an observational cohort study. Scand J Med Sci Sports. 2017 Nov;27(11):1258-1262. doi: 10.1111/sms.12781. Epub 2016 Oct 7.
citation: Mate-Munoz JL, Lougedo JH, Barba M, Garcia-Fernandez P, Garnacho-Castano MV, Dominguez R. Muscular fatigue in response to different modalities of CrossFit sessions. PLoS One. 2017 Jul 28;12(7):e0181855. doi: 10.1371/journal.pone.0181855. eCollection 2017.
Clinical trial NCT05802680: Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation
Official title: Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Attention Difficulties
Attention Deficit
Cognitive Deficit
Wellness
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2023-04-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inattentiveness and impulsivity in healthy adults and individuals with attention deficit hyperactivity disorder (ADHD) diminish these individuals' quality of life. Cortical hypometabolism has been hypothesized to contribute to inattentiveness in ADHD. Transcranial photobiomodulation (tPBM) is a safe and non-invasive modality for activation of the prefrontal cortex. tPBM in healthy adults has been shown to augment brain oxygenation, cognition, and mood. The cognition-enhancing effect of tPBM on sustained attention in adults with ADHD remains unstudied. The investigators will evaluate whether tPBM administration to adults with and without ADHD can improve their attention. Each participant will be screened for eighteen criteria based on the Diagnostic and Statistical Manual (DSM-IV, text revised), using the validated instrument Adult ADHD Self-Report Scale (ASRS-v1.1). Blinded participants will be randomized into (I) Active-tPBM or (II) Sham-tPBM groups. After undergoing an 8-minute administration of Sham or 1064 nm tPBM to the lateral and medial right prefrontal cortex, each participant will complete a 14-minute, computer-based Conner's continuous performance task-3 (CPT-3). The investigators will examine whether adults with and without ADHD who receive Active-tPBM improve in measures of inattention, impulsivity, sustained attention, or vigilance compared to the Sham-tPBM group. Cognitive assessments of attention like the CPT-3 may evaluate the efficacy of tPBM to increase cortical metabolism in healthy adults and individuals with conditions like ADHD. The investigators anticipate their investigation will be a starting point for more sophisticated studies that focus on the implications of tPBM on cognition.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older

Exclusion Criteria:

* None

Primary outcomes:
measure: Continuous Performance Task
timeFrame: Up to two months
Secondary outcomes:
measure: Functional near-infrared spectroscopy
timeFrame: Up to two months
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Douglas W Barrett, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT07015580: The Characteristics of Oral Microbiota in Chronic Pancreatitis and Autoimmune Pancreatitis
Official title: The Characteristics of Oral Microbiota in Chronic Pancreatitis and Autoimmune Pancreatitis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral Microbiota
Pancreatitis
Pancreatic Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with chronic pancreatitis or autoimmune pancreatitis or pancreatic cancer

Brief summary: There are more than 700 different bacteria colonized in human oral cavity, which are collectively referred to as oral microbiota. Emerging evidence suggests that oral microbiota plays a series of important roles in human health, such as immune response, carcinogen metabolism and nutrient digestion. The changes of oral microbiota composition are closely related to the occurrence and development of pancreatic diseases. Previous studies have found that there are dense bacterial biofilms in the pancreatic duct of patients with calcified pancreatitis, including oral bacterial types. However, most studies only focused on the changes of gut microbiota in patients with chronic pancreatitis, and there were lack of research and description on the changes of oral microbiota in patients with chronic pancreatitis. In this study, we will extract and sequence bacterie's full-length 16S rRNA to describe the characteristics of oral microbiota in patients with chronic pancreatitis, confirming that there are changes in oral microbiota in patients with chronic pancreatitis, and compare the differences of oral microbiota in patients with chronic pancreatitis, pancreatic cancer and autoimmune pancreatitis.


Eligibility criteria: Inclusion Criteria:

* A dated and signed informed consent form cooperate to complete sample collection

Exclusion Criteria:

* Previous digestive system surgery; During pregnancy or lactation; Complicated with infectious diseases, malignant tumors or other digestive system diseases (such as inflammatory bowel disease, irritable bowel syndrome, abdominal diseases, gastroesophageal reflux, etc.); Antibiotics and immunosuppressive drugs were used within 30 days before sampling; Those who take probiotics daily.

Primary outcomes:
measure: characteristic of oral microbiota in patients with chronic pancreatitis
timeFrame: From enrollment to the end at 2 weeks
Secondary outcomes:
measure: Differences in oral microbiota profiles between chronic pancreatitis and autoimmune pancreatitis, pancreatic cancer healthy controll.
timeFrame: From enrollment to the end at 2 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gastroenterolog, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai, China
Study officials:
References:
Clinical trial NCT02157740: Assessment of Teleconsulting in Nursing Homes
Official title: Assessment of Teleconsulting in Nursing Homes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functionally-Impaired Elderly
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Agence Regionale de Sante d'Ile de France
First posted: 2014-06-06
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nursing home residents

Brief summary: The purpose of this study is to determine whether teleconsulting would be effective and cost-effective by reducing the patients transportations and the use of emergency units for nursing home residents requiring emergent or elective care.


Eligibility criteria: Inclusion Criteria:

* All residents of selected nursing homes

Exclusion Criteria:

* None

Primary outcomes:
measure: Patient transportation to a emergency unit
timeFrame: Within 1 year after start of the study
Secondary outcomes:
measure: Transportation of the patient for a consultation
timeFrame: Within 1 year after start of the study
measure: Mean length of hospital stay
timeFrame: Within 1 year after start of the study
measure: Number of hospitalizations
timeFrame: Within 1 year after start of the study
measure: Overall costs
timeFrame: Within 1 year after start of the study
Other outcomes:
Locations:
city: Chatenay Malabry
country: France
facility: Résidence Le Sequoia
city: Domont
country: France
facility: Résidence Val de France
city: Le Pré St Gervais
country: France
facility: Résidence la Chanterelle
city: Montereau-Fault Yonne
country: France
facility: Résidence les Noues
city: Poigny la Foret
country: France
facility: Résidence La Cerisaie
city: Saint-Clair-sur-Epte
country: France
facility: Résidence du Vexin
city: St Rémy Les Chevreuse
country: France
facility: Résidence Saint Rémy
city: Tournan en Brie
country: France
facility: Résidence Klarene
city: Valenton
country: France
facility: Résidence Les Pastoureaux
Study officials:
affiliation: DRCD URC Eco. Assistance Publique, Hôpitaux de Paris
name: Isabelle Durand-Zaleski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kidholm K, Ekeland AG, Jensen LK, Rasmussen J, Pedersen CD, Bowes A, Flottorp SA, Bech M. A model for assessment of telemedicine applications: mast. Int J Technol Assess Health Care. 2012 Jan;28(1):44-51. doi: 10.1017/S0266462311000638.
citation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.
Clinical trial NCT01496040: Clinical Gene Therapy Protocol for the Treatment of Retinal Dystrophy Caused by Defects in RPE65
Official title: Prospective Monocentric Open Label Non Randomized Uncontrolled Phase I/II Clinical Gene Therapy Protocol for the Treatment of Retinal Dystrophy Caused by Defects in RPE65
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leber Congenital Amaurosis
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 9
Sex: ALL
Minimum age (years): 6
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of the study is to assess the safety and efficacy of the active substance rAAV-2/4.hRPE65 in patients with Leber Congenital Amaurosis or Congenital severe early-onset retinal degeneration associated with RPE65 mutation.


Eligibility criteria: Inclusion Criteria:

* Mutations that code for abnormal RPE65 protein
* Presence of characteristic abnormalities in fundus
* Dramatic reduction of both rods ans cones ERG responses
* Low visual acuity \<0.32
* inform consent signed

Exclusion Criteria:

* Patients with chronic conditions such a haematological, cardiac, renal diseases
* Patients with, within the past 6 months, a clinically significant cardiac disease or known congestive heart failure, cardiac rhytm and conduction abnormalities
* Patients with pulmonaty dysfunction
* Patients with suspected rheumatoid arthritis
* Patients with current systemic infection........

Primary outcomes:
measure: The drug safety evaluation after administration
timeFrame: After administration of the gene therapy product.The patient will be folloed for the duration of the hospital stay, an average of 7 days
Secondary outcomes:
measure: Different efficacy parameters and immune parameters have to be measured to conclude on the overall amelioration of quality of life of enrolled patients
timeFrame: Between Day -120 and Day-7, Day 5, Day 14, Day 30 Day 60, Day 90, Day 120, Day 180, Day 360
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
Study officials:
affiliation: Nantes University Hospital
name: Michel WEBER, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04500340: Effectiveness of Cognitive Behavioral Therapy of Reduction of Test Anxiety
Official title: Test Anxiety: Pervasiveness, Link With Academic Achievement and Impact of Cognitive-behavioral Intervention in Its Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Test Anxiety
Lead sponsor: University Grants Commission
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the role of Group Cognitive Behavioral Therapy in test anxiety. The study participants will be psychology undergraduates with social work and psychology majors. The students will be selected among those who score three or more in Westside Test Anxiety Scale will participate in the study. Westside Test Anxiety will be used two weeks after completion of the group Cognitive Behavioral Therapy protocol (Flaxman, Bond \& Keogh. 2004). The result will be analyzed using the t-test and Cohen's d.


Eligibility criteria: Inclusion Criteria:

* Those Studying Social work and Psychology as Major subjects, Those who have scored 3 and above in Westside Test Anxiety scale

Exclusion Criteria:

* Those scoring below 3 in Westside Test Anxiety Scale

Primary outcomes:
measure: Westside Test Anxiety Scale (WTAS)
timeFrame: Change from Baseline Test Anxiety Scores after completion of Group Cognitive Behavioral Therapy ( after one and half month)
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Nepal Mega College and K and K International College
state: Bagmati
Study officials:
affiliation: Tribhuvan University
name: Khem R. Bhatta, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05020340: External Cephalic Version Immediately Before a Caesarean Delivery
Official title: Reattempt of External Cephalic Version After Regional Anaesthesia Immediately Before a Caesarean Delivery - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malpresentation Before Labor Affecting Fetus or Newborn
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-08-25
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fetal malpresentation at term affects around 5% of pregnancy and breech presentation is the most common type of malpresentation. It is a common indication for a Caesarean delivery. External cephalic version (ECV) refers to turning the fetus manually and aims to increase the success of vaginal birth by reducing the need for Caesarean section.

Detailed description: Several factors affect the chance of a successful ECV which include multiparity, use of tocolytic and regional anaesthesia during the procedure. Anticipating or not tolerating a painful procedure is another factor that affects the willingness to and success of ECV.

ECV can be reattempted under regional anaesthesia immediately just before the Caesarean section to increase the vaginal birth rate in women who have failed an ECV. Therefore, the aim of this study is to evaluate whether this approach could increase the rate of vaginal birth and reduce the non-cephalic presentation at labour and Caesarean section rate.

Eligibility criteria: Inclusion Criteria:

* All women age ≥ 18 years old
* Singleton pregnancy
* Malpresentation
* Have failed an ECV
* Pregnant ≥ 37 weeks of gestation

Exclusion Criteria:

* Condition requiring emergency delivery
* Other indication for Caesarean section
* History of antepartum haemorrhage in the past 7 days
* Oligohydraminos with amniotic fluid index \<5cm
* Intrauterine growth restriction with abnormal fetal Doppler or cardiotocography
* Rhesus isoimmunization
* Rupture of membranes
* Gross fetal anomaly
* Major uterine anomaly
* Contraindication or refusal to regional anaesthesia
* Spontaneous cephalic version on the day of scheduled Caesarean section

Primary outcomes:
measure: Vaginal birth
timeFrame: Delivery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: