louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06054971: NSAA NON-Interventional Study Protocol
Official title: Use of Telemedicine and At-Home Video for Remote Administration of the North Star Ambulatory Assessment (NSAA): a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy
Lead sponsor: Red Nucleus Enterprise Solutions, LLC
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2023-09-26
Enrollment: 31
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with confirmed diagnosis of DMD

Brief summary: The purpose of this non-interventional study is to evaluate the feasibility of remotely administering the North Star Ambulatory Assessment (NSAA) to participants with Duchenne muscular dystrophy (DMD). The iTakeControl (iTC) software platform will be utilized to remotely administer and score the NSAAs.


Eligibility criteria: Inclusion Criteria:

1. Evidence of a signed and dated informed consent document indicating that the participant's legally authorized representative (LAR) has been informed of all pertinent aspects of the study, along with evidence of age-appropriate child assent.
2. Confirmed diagnosis of DMD
3. Participant with DMD aged 4 to12 (inclusive) at t Enrollment date
4. Participant with DMD is ambulatory without assistive devices, braces, or aids throughout the study
5. Caregiver has access to and/or willingness to learn use of a smart phone and the iTC study mobile application
6. Participant and caregiver are based in the US throughout study
7. Participant and caregiver are fluent in the English language (verbally and in writing)

Exclusion Criteria:

1. Non-ambulatory DMD participant at any study timepoint
2. Caregiver/participant unwilling or unable to administer/perform the NSAA
3. Anticipated deterioration of participant's ambulatory status during the study

Primary outcomes:
measure: Comparison of performance and ratings of the NSAA using three methods: 1) Live Telemedicine scores 2) Subsequent Recorded Telemedicine scores 3) Caregiver Asynchronous Video scores
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Malvern
country: United States
facility: Red Nucleus Solutions
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01459471: Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial
Official title: Staple-line Reinforcement During Laparoscopic Sleeve Gastrectomy Using Three Different Techniques: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complication of Surgical Procedure
Leak; Blood
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 120
Sex: ALL
Minimum age (years): 28
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main drawback of laparoscopic sleeve gastrectomy (LSG) is the severity of post-operative complications. Staple line reinforcement (SLR) is strongly advocated.

Detailed description: The aim of this study was to prospectively and randomly compare three different techniques of SLR during LSG: oversewing (group A), buttressed transection with a polyglycolide acid and trimethylene carbonate (group B) and staple-line roofing with a gelatin fibrin matrix (group C).

Eligibility criteria: Inclusion Criteria:

* Morbidly obese patients waiting for sleeve gastrectomy

Exclusion Criteria:

* BMI\<35 Kg/m2,
* Important comorbidities

Primary outcomes:
measure: safety of staple line reinforcement during laparoscopic sleeve gastrectomy by measuring the number of adverse effects, i.e. bleeding and leaks.
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Tor Vergata, Rome, Italy
name: Paolo Gentileschi, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT07019571: tDCS and Urge in BFRBs
Official title: Evaluating the Impact of Transcranial Direct Current Stimulation on Urge in Body-Focused Repetitive Behaviors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Repetitive Compulsive Behavior
Keywords: picking
biting
transcranial stimulation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to find out if brain stimulation can help people stop skin-picking or nail-biting. The study wants to answer two main questions:

1. Does brain stimulation reduce the urge to pick skin or bite nails after those urges are triggered?
2. Does brain stimulation reduce how often people pick their skin or bite their nails?

Participants will:

* Talk about their skin-picking, nail-biting, and other mental health concerns
* Be placed in situations that make them want to pick or bite
* Rate how strong their urges are before and after brain stimulation Researchers will compare real brain stimulation to a placebo (a fake version that looks the same but has no effect) to see if the real stimulation works to reduce skin-picking and nail-biting urges and behaviors.


Eligibility criteria: Inclusion Criteria:

* Ability to provide informed consent (as established by clinical interview), and voluntary, signed informed consent prior to the performance of any study specific
* Ability and willingness to perform study-relevant clinical assessments and tDCS
* Endorses mild to extreme intensity of urges to pick or bite their skin or nails

Exclusion Criteria:

* Any unstable medical, psychiatric, or neurological condition (including active or otherwise problematic suicidality) that may necessitate urgent treatment
* Daily use of psychotropic medications that substantially lower seizure threshold (e.g., clozapine)
* History of psychosis, mania, major neurological disorder, significant head trauma, or seizures/epilepsy
* Current suicidal intent
* Any major neurological disease or history of major head trauma, including concussion with extended loss of consciousness, or of psychosurgery
* Current or suspected pregnancy
* Endorsing possible contraindications for tDCS

Primary outcomes:
measure: Change in subjective urge
timeFrame: baseline and post intervention, approximately 90 minutes
measure: Change in subjective distress
timeFrame: baseline and post intervention, approximately 90 minutes
measure: Change in picking or biting behavioral frequency
timeFrame: baseline and post intervention (approximately 90 minutes)
measure: Change in picking or biting behaviors duration
timeFrame: baseline and post intervention (approximately 90 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Gopalkumar Rakesh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04660071: Ultrasound Imaging of Quadriceps Muscle in Patients With Knee Osteoarthritis
Official title: Ultrasound Imaging of Quadriceps Muscle in Patients With Knee Osteoarthritis: Reliability of Echo Intensity Measurement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Keywords: Reliability,Echo intensity,Knee Osteoarthritis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-12-09
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients had tibiofemoral joint OA in at least one knee according to the American College of Rheumatology classification criteria with knee pain most days of the past month, and osteophytes apparent on knee radiograph were included to the study. Patients were excluded if they had a history of lower limb joint replacement and fracture, rheumatoid arthritis, diabetic neuropathy or polyneuropathy, and cardiovascular and neuromuscular problems.

Brief summary: Echo intensity (EI) assessment using ultrasonography helps monitoring disease-induced muscle quality changes. However, there are no study investigating the reliability of EI in patients with knee osteoarthritis (OA). The primary aim of the present study was to investigate the inter and intra-rater reliability of EI evaluation by grayscale histogram analysis of quadriceps femoris muscle in patients with knee OA. The second aim was to compare the mean grayscale values obtained using both the Free Hand Tool (FHT) and Rectangular Marquee Tool (RMT) methods in ImageJ. Thirty patients with knee OA were included in this cross-sectional study. The echogenicity measurements of the Rectus Femoris, Vastus Inter-medius, Vastus Lateralis and Vastus Medialis were performed by two different researchers. Reliability analysis of EI measurements were calculated with using intraclass correlation coefficient (ICC), standard error of measurement (SEM) and coefficient of variation (CV) and Bland and Altman plot analysis.


Eligibility criteria: Inclusion Criteria:

* Patients had tibiofemoral joint OA in at least one knee according to the American College of Rheumatology classification criteria with knee pain most days of the past month and osteophytes apparent on knee radiograph were included to the study

Exclusion Criteria:

* Patients were excluded if they had a history of lower limb joint replacement and fracture, rheumatoid arthritis, diabetic neuropathy or polyneuropathy, and cardiovascular and neuromuscular problems.

Primary outcomes:
measure: Muscle Echogenicity Assessment ( Physiological parameter)
timeFrame: Thirty minute
Secondary outcomes:
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Merve Karapinar
Study officials:
References:
Clinical trial NCT06581471: The TRICURE EU Pivotal Study
Official title: The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tricuspid Valve Regurgitation
Heart Valve Disease
Cardiovascular Diseases
Lead sponsor: TRiCares
Sponsor class: INDUSTRY
First posted: 2024-09-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Detailed description: The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.

Eligibility criteria: Inclusion Criteria:

* Adult patients
* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
* Institutional Heart Team evaluates patient as being at increased operative risk

Exclusion Criteria:

* Patient in need of emergent intervention
* Patient who is hemodynamically unstable
* Anatomical contraindications for implantation with study device
* Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet

Primary outcomes:
measure: Composite of MAE
timeFrame: 30 day post-intervention
measure: Investigational Device Success
timeFrame: immediately post-intervention
Secondary outcomes:
measure: Six minute walk test
timeFrame: 30 days, 6 months, annual for five years post-intervention
measure: Reduction in Tricuspid Regurgitation (TR) Grade
timeFrame: 30 days, 6 months, annual for five years post-intervention
measure: New York Heart Association (NYHA) Function Class
timeFrame: 30 days, 6 months, annual for five years post-intervention
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Algemeen Stedelijk Ziekenhuis
city: Antwerpen
country: Belgium
facility: ZNA Middelheim
city: Bruxelles
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc UCL
city: Liège
country: Belgium
facility: Centre hospitalier universitaire CHU de Liège
city: Roeselare
country: Belgium
facility: AZ Delta
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg University Mainz
city: Munich
country: Germany
facility: Ludwig Maximilian University Hospital
Study officials:
affiliation: LMU Munich
name: Jörg Hausleiter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03690271: Study PIEB vs PIEB: the Dose is it Variable According to the Patients
Official title: Study Programmed Intermittent Epidural Bolus (PIEB) vs PIEB: the Dose is it Variable According to the Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Epidural
Pregnancy
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant patient, during labor, for whom a PIEB is desired / programmed.

Brief summary: the main objective of this study is to compare the effectiveness of three groups of epidurals with three different programmed intermittent epidural bolus (PIEB)settings.

Detailed description: In a PIEB, the concentration of local anesthetics administered is standardized in the services according to the recommendations. What is left to the judgement of the clinician, taking care of the patient during the work, is the administered dose. This often varies according to clinician deductions that take notice of height, weight, previous pregnancies In the CHU of Rennes, three dosages are used in common practice. The objective by comparing these three dosages is to show if there is a significant difference between the groups.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old.
* Pregnant patient, during labor, live fetus, for whom a PIEB is desired / programmed.
* Patient not objecting to their participation in the study.

Exclusion Criteria:

* Hemostasis disorder contraindicated the epidural
* Eclampsia
* Caesarean section straightaway
* Patient under legal protection (guardianship, curatorship, safeguard of justice).

Primary outcomes:
measure: number of additional injections during work.
timeFrame: two days after infclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Eric WODEY, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05671471: Accidental Reactions in Peanut/Tree Nut Allergic Children
Official title: Accidental Reactions in a French Cohort of Children With Peanut and/or Tree Nut Allergy.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peanut and Tree Nut Allergy
Keywords: Peanut allergy
tree nut allergy
peanut immunotherapy
anaphylaxis
real life
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients followed in the Pediatric Allergy and Pulmonology Unit, CHU Lille, aged 0-18 years with peanut and/or tree nut allergy

Brief summary: Food allergy is an immune reaction, triggered by food protein allergens, of varying severity, from mild local reaction to life threatening anaphylaxis and fatalities.

Peanut is a plant from the botanical family of the Fabaceae, more commonly known as legumes. The prevalence of peanut and tree nut allergy is increasing. In France (ELFE cohort), it is estimated to 0.93%. The tree nuts include mainly almond, hazelnut, pistachio, cashew nut, walnut, pecan nut and Brazil nut. Allergy's prevalence is estimated to 0.54% in children up to 5.5 years. Peanut allergy is a main cause of anaphylaxis and deaths due to food allergy.

Recurrence of food allergy is a main concern. The risk has been estimated to 10% per year for peanut.

In France, Data in real-life on the rate of recurrence of allergic reactions and anaphylaxis to peanut/tree-nut as well as risk factors, are lacking.

The objective of this study is to assess the frequency of allergic reaction to peanut and tree-nuts, to describe the reactions' characteristics and risk factors.


Eligibility criteria: Inclusion Criteria:

* Confirmed allergy to peanuts and/or nuts

Exclusion Criteria:

* Other chronic diseases, except allergic comorbidities (asthma, rhinitis, atopic dermatitis, other food allergy)

Primary outcomes:
measure: the number of episode of allergic reactions in real life
timeFrame: At 1 year
Secondary outcomes:
measure: the severity of the allergic reactions according to a validated scale (FASS scale)
timeFrame: At 1 year
measure: interview for the characteristics of the allergic reactions
timeFrame: At 1 year
measure: interview to defined the risks factor associated
timeFrame: At 1 year
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Antoine DESCHILDRE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04901871: Remimazolam Bolus for General Anesthesia
Official title: ED50 and ED95 of Remimazolam Intravenous Bolus on the Loss of Consciousness in Patients Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Loss of Consciousness
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: It is important to estimate the adequate dose of remimazolam intravenous bolus injection to induce the loss of consciousness. We will determine the ED50 and ED95 of remimazolam intravenous bolus on the loss of consciousness in patients undergoing general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for general anesthesia

Exclusion Criteria:

1. Patients scheduled for liver surgery
2. Uncontrolled hypertension
3. Uncontrolled diabetes mellitus
4. Liver disease
5. Kidney disease
6. Intolerance or hypersensitivity to benzodiazepine
7. Addiction
8. Glaucoma
9. Heart failure
10. Peripheral vascular disease
11. Obstuctive lung disease
12. Patients scheduled for regional anesthesia before general anesthesia
13. Pregnancy

Primary outcomes:
measure: Loss of consciousness within 5 minutes
timeFrame: At 5 minutes after infusion
Secondary outcomes:
measure: Time to loss of consciousness
timeFrame: At 5 minutes after infusion (time to loss of consciousness)
measure: blood pressure
timeFrame: At 5 minutes after infusion
measure: heart rate
timeFrame: At 5 minutes after infusion
measure: sedline
timeFrame: At 5 minutes after infusion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: GangnamSeveracne Hospital
name: Dong Woo Han
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chae D, Kim HC, Song Y, Choi YS, Han DW. Pharmacodynamic analysis of intravenous bolus remimazolam for loss of consciousness in patients undergoing general anaesthesia: a randomised, prospective, double-blind study. Br J Anaesth. 2022 Jul;129(1):49-57. doi: 10.1016/j.bja.2022.02.040. Epub 2022 May 11.
Clinical trial NCT00999271: Glucose-dependent Insulinotropic Polypeptide (GIP) and Lipid Metabolism
Official title: On the Role of Glucose-dependent Insulinotropic Polypeptide, GIP, in Postprandial Metabolism in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Subjects
Keywords: Glucose-dependent insulinotropic polypeptide
gastric emptying
appetite
energy intake
lipid metabolism
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2009-10-21
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The aim of this proposal is to examine whether endogenous GIP and exogenous GIP alone and in combination with insulin affect gastric emptying (GE), appetite, energy intake, energy expenditure (EE) and plasma levels of triglycerides (TAG), free fatty acids FFA) and glycerol in man.


Eligibility criteria: Inclusion Criteria:

* Informed oral and written consent
* Caucasians over the age of 18 years
* Normal 75 g oral glucose tolerance test (OGTT)
* Normal blood haemoglobin concentration
* Normal plasma lipid profile

Exclusion Criteria:

* First-degree relatives with diabetes and familial hypertriglyceridemia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
Study officials:
References: