louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05538884: A Novel Intertransverse Plane Block: a Magnetic Resonance Imaging and Volunteer Study
Official title: A Novel Intertransverse Plane Block: A Magnetic Resonance Imaging and Volunteer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intertransverse Process Block
Thoracic Nerve Block
Thoracic Paravertebral Block
Keywords: MRI study
Volunteer study
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The ITPB block at T5-6 level will be performed with a mixture of local anesthetic with MRI contrast 0.5% bupivacaine 10 ml and 0.5 ml contrast in concentration 3.09 mmol/l. Volunteers will be moved to MRI machine and imaged in a supine position for their whole thoracic spine.
Primary purpose: DIAGNOSTIC

Brief summary: Intertransverse process block (ITPB) is a thoracic nerve block technique where the LA is injected into the thoracic "intertransverse tissue complex" posterior to the superior costotransverse ligament (SCTL). It may be an attractive alternative to a TPVB for unilateral surgery on the thorax, when considering the risk for pleural puncture, since it does not require direct needle access to the thoracic paravertebral space. However, although ITPB is ultrasound guided, the LA is frequently injected using surrogate bony landmarks in the sagittal sonogram, and in most cases without even identifying the SCTL.

Detailed description: The knowledge regarding the spread of local anesthetic is a major prerequisite for a safe and effective use of all regional anesthetic methods in clinical practice. The primary outcome is the spread of injectate which will be evaluated on axial three-dimensional MRI with contrast medium. The secondary outcome is the sensory dermatomal blockade of this novel ITPB block.

Eligibility criteria: Inclusion Criteria:

* healthy Thai men with no diseases

Exclusion Criteria:

* inability to cooperate or communicate in Thai
* BMI ≥ 30 kg/m2 or body weight ≤ 45 kgs
* allergy to local anesthetics or contrast agents
* infection in the block area
* previous surgery or anatomical abnormalities of thoracic spines closed to block area
* coagulation disorder/thrombocytopenia/anticoagulation therapy
* contraindications to magnetic resonance imaging (MRI) (metal implants - pacemaker and others, claustrophobia)

Primary outcomes:
measure: Local anesthetic spreading from MRI image
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: Siriraj Hospital
name: Pawinee Pangthipampai
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01753284: First Episode Psychosis and Pathway to Care in Nordland
Official title: Patients and Carers Experiences With First Episode Psychosis and Pathway to Care in Nordland: A Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: First Episode Psychosis
Lead sponsor: Nordlandssykehuset HF
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients experiencing first and multiple episode psychosis carers siblings

Brief summary: First episode psychosis patients often experiences treatment delay. This reduces their prospects for recovery and makes unnecessary burdens for them and their carers. A better understanding of help seeking intentions is required, and has not been explored in a county like Nordland, Norway, with long distances and challenging access to health services. The purpose of this study is to explore the process of help seeking, including how patients and their careers discover and understand the psychotic symptoms. Research exploring the impact on families mainly focuses on parents' experiences, and there are less studies focusing on experiences and needs of siblings. This study will therefore explore siblings' experiences separate from their parents. Methods will be qualitative interviews with patients, their carers and siblings. Analysis will be influenced by Grounded theory.


Eligibility criteria: Inclusion Criteria:

* age 16-35,
* understand and speak Norwegian
* able to give consent
* no learning disabilities

Exclusion Criteria:

Primary outcomes:
measure: Patient experience
timeFrame: up to 100 weeks
measure: Carers experiences
timeFrame: up to 100 weeks
measure: Siblings experiences
timeFrame: up to 100 weeks
measure: Pathway to care
timeFrame: up to 100 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01692184: Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292
Official title: A Phase 1, Two-part Study to Investigate the Safety and Pharmacokinetics of AVL-292 Following Multiple Oral Doses and to Evaluate the Effect of Food on the Pharmacokinetics of AVL-292 Following a Single Oral Dose in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: AVL-292
Safety
Pharmacokinetics
Pharmacodynamics
Pharmacology, Clinical
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2012-09-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate the effect of food on the pharmacokinetics of a single oral dose of AVL-292.

Detailed description: Part 2 is an open-label, randomized, 2-period, 2-way crossover study to evaluate the effect of a standard high-fat breakfast on the pharmacokinetics of AVL-292. Ten subjects will be enrolled to receive 2 single doses of 200 mg AVL-292, one with food (i.e., fed) and the other without (i.e., fasted), in a randomized sequence.

Eligibility criteria: Inclusion Criteria:

* Healthy male or female subjects of any ethnic origin between ages of 18 and 65 with a body mass index between 18 and 33

Exclusion Criteria:

* Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, ophthalmological, allergic or other major disorders;
* Use of any prescribed systemic or topical medication within 30 days of the first dose;
* Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines, e.g., St. John's Wort) within 7 days of the first dose administration;
* Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 28 days after last AVL-292 dose
measure: PK-(Cmax)
timeFrame: 24 hours after the last AVL-292 dose on days 1 and 7
measure: PK-(AUC)
timeFrame: 24 hours after the last AVL-292 dose days 1 and 7
Secondary outcomes:
measure: Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells
timeFrame: 24 hours after the last AVL-292 dose days 1 and 7
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Clinical Research Unit
state: Texas
Study officials:
affiliation: Celgene Corporation
name: Maria Palmisano, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06771284: Problem Behavior Assessment and Intervention in IDEA Part C Services
Official title: Problem Behavior Assessment and Intervention in IDEA Part C Services: a Single-Case Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Problem Behavior
Developmental Delay
Developmental Disability
Keywords: Early childhood
Problem behavior
Home-based services
IDEA Part C services
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: Institute of Education Sciences
First posted: 2025-01-13
Enrollment: 9
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigators will use a multiple baseline design across participants with a baseline and intervention phase to evaluate the effects of the intervention on children's challenging behavior. Each of the 3 tiers of the multiple baseline will include a caregiver-child dyad. One early intervention professional will work with each caregiver-child dyad, for a total of 9 participants across 3 tiers.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of function-based assessment and intervention to reduce problem behavior in children with developmental disability or delay in the context of IDEA Part C services. The investigators will conduct a single-case study to evaluate the efficacy of the intervention.


Eligibility criteria: Child Inclusion Criteria:

* age birth to 5 years old
* has a developmental disability or delay based on caregiver report and/or receiving early intervention services
* has problem behavior, as reported by the caregiver and/or early intervention professional

Caregivers (e.g., parent, grandparent) of eligible child participants will participate with their child as the implementer of all procedures.

An early intervention professional will participate with each caregiver-child dyad to coach the caregiver, in addition to the researcher.

Primary outcomes:
measure: Problem Behavior
timeFrame: The investigators plan to conduct approximately weekly observations, with a total of 15 observations.
Secondary outcomes:
measure: Appropriate Behavior
timeFrame: The investigators plan to conduct approximately weekly observations, with a total of 15 observations.
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: University of Nevada Las Vegas
state: Nevada
Study officials:
References:
Clinical trial NCT06760884: Temporomandibular Joint Function, Oral Habits and Pain Complaints of Pregnant Women
Official title: Determination of Temporomandibular Joint Function, Oral Habits and Pain Complaints of Pregnant Women: a Cross-Sectional Case-Control Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Temporomandibular Disorders (TMD)
Pregnancy
Keywords: temporomandibular disorders
pregnancy
oral habits
pain
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 224
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The universe of the study consists of women who apply to the pregnancy clinic. In parallel, a control group of 112 healthy non-pregnant women (similar to the pregnant group in terms of age, height, weight, education level, etc. to ensure homogeneity) will be created.

Brief summary: The aim of this study is to examine the temporomandibular joint functions, oral habits and pain complaints of pregnant women. .

Detailed description: When looking at the literature, it is seen that physiological and hormonal changes that occur in pregnant women affect the musculoskeletal system and pain threshold of women. These changes seen in pregnant women and their psychological levels throughout the process also contribute negatively to the process.Due to the insufficiency of studies examining temporomandibular joint (TMJ) problems and oral habits in pregnant women and the contradictory results in existing studies, it is seen that new studies are needed.

Eligibility criteria: Inclusion Criteria (Pregnancy women):

* Being between the ages of 18-45,
* At least primary school graduate,
* Able to speak and understand Turkish,
* Women diagnosed with pregnancy by USG,
* Singleton pregnancy,
* Agreeing to participate in the study voluntarily.

Exclusion Criteria (Pregnancy women):

* Those with any systemic disease concerning the musculoskeletal system,
* Women with any type of disability,
* Having communication problems,
* Multiple pregnancy,
* Refusing to participate in the study.

Inclusion Criteria (Non-Pregnancy women):

* Being between the ages of 18-45,
* At least primary school graduate,
* Able to speak and understand Turkish,
* Agreeing to participate in the study voluntarily.

Exclusion Criteria (Non-Pregnancy women):

* Those with any systemic disease concerning the musculoskeletal system,
* Women with any type of disability,
* Having communication problems,
* Refusing to participate in the study.

Primary outcomes:
measure: Temporomandibular disorders function
timeFrame: 1 year
measure: Mandibular function
timeFrame: 1 year
Secondary outcomes:
measure: Oral Habits
timeFrame: 1 year
measure: Pain assessment
timeFrame: 1 year
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical Univerity
Study officials:
References:
Clinical trial NCT06860984: Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Official title: Evaluating the Safety and Efficacy of Duloxetine in the Prevention of Post Endoscopic Retrograde Cholangiopancreatography Pancreatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Biliary Disease
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endoscopic retrograde cholangiopancreatography (ERCP (, a key tool that is used in diagnosis and treatment of pancreato-biliary diseases. Post-ERCP pancreatitis (PEP) is the most common and serious complication that can occur following this procedure and can lead to significant morbidity and mortality. A variety of patient-related and procedure-related factors have been associated with higher rates of PEP.


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years old.
* Gender: Males and Females
* Patients with suitable indications for ERCP due to suspected pancreato-biliary disorders.
* Blood amylase and lipase levels before ERCP are within the normal limits

Exclusion Criteria:

* Uncontrolled diabetes mellitus (DM)
* Severe bleeding tendency
* Impaired renal function (serum creatinine \> 2 mg/dL), (creatinine clearance \<30 ml/min)
* Patients with severe heart disease.
* Subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct.
* Currently pregnant or nursing
* Admission due to established pancreatitis before ECRP
* Unwillingness to undergo ERCP.

Primary outcomes:
measure: The primary outcome that will be measured is the development of pancreatitis after the procedure
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta Unuversity
Study officials:
References:
Clinical trial NCT00646984: Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy
Official title: Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV-Associated Lipodystrophy Syndrome
Keywords: Lipodystrophy
Treatment interruption
HIV
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2008-03-31
Enrollment: 147
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: Aim: To assess the safety on the progression of HIV infection and the efficacy on the evolution of metabolic parameters and body fat of either viral load- or CD4 cell-driven strategies of intermittent treatment in chronically HIV-1-infected persons.

Design: Pilot, prospective, open, randomized, controlled 3-year study.

Setting and patients: University hospital. Patients with viral load \<200 copies/mL and CD4 cell count \>450/mm3 for at least the last 3 months. Three arms with 50 patients each, that will be randomized either to continue antiretroviral therapy, or to discontinue it as long as either HIV-1 RNA be lower than 30000 copies/mL or CD4 cell count be higher than 300/mm3.

Study end-points: evolution of plasma metabolic parameters, body fat, and bone mineral density; incidence of adverse effects due to antiretroviral therapy and symptoms consistent with acute retroviral syndrome; incidence of virological failure (plasma HIV-1 RNA \>200 copies/mL while on therapy), immunological failure (CD4 cell count \<200/mm3 while on therapy), or clinical failure (development of AIDS-defining illnesses); cost of antiretroviral therapy administered and time free of therapy in the arms assigned to intermittent treatment; and the evolution of T lymphocyte subpopulations and the development of proliferative and cytotoxic responses against HIV.


Eligibility criteria: Inclusion Criteria:

* HIV-infected patients
* On stable antiretroviral therapy
* Viral load below 200 copies/ml
* CD4 above 450 cells/mcl during last 3 months

Exclusion Criteria:

* Weight variation higher than 10% compared with previous stable weight
* Active (CDC-C) opportunistic events
* Major depression or schizophrenia under psychiatric treatment
* Lack of clinical stability
* Pregnant women or planning pregnancy

Primary outcomes:
measure: Limb fat content measured by dual X-ray absorptiometry
timeFrame: 96 weekks
Secondary outcomes:
measure: Other body composition analyses
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic of Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Jose M Gatell, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01850784: High Energy Formula Feeding in Infants With Congenital Heart Disease
Official title: High Energy Formula Feeding in Infants With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Growth Failure
Neurodevelopmental Disorder
Keywords: Congenital heart disease, Growth,Neurodevelopment
Lead sponsor: Dr. Sami Ulus Children's Hospital
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 100
Sex: ALL
Minimum age (years): 8
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: High energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Detailed description: Infants with congenital heart disease (CHD) usually show growth retardation as they can not intake enough calorie due to fluid restriction. We hypothesize that high energy formula more positively affect growth in infants with congenital heart disease compared to standard formula

Eligibility criteria: Inclusion Criteria:

* infants \>35 weeks of gestational age
* infants with CHD
* İnfants fed with formula feeding

Exclusion Criteria:

* Major congenital abnormalities except CHD
* infants could not be fed enterally

Primary outcomes:
measure: Weight gain
timeFrame: 6 weeks
Secondary outcomes:
measure: Neurodevelopmental evaluation
timeFrame: 18 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Sami Ulus CH
Study officials:
affiliation: Sami Ulus CH
name: Dilek Dilli
role: STUDY_DIRECTOR
References:
Clinical trial NCT05163184: Physiologic Tension of the Abdominal Wall
Official title: Physiologic Tension of the Abdominal Wall
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Wall Hernia
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing laparotomy without a ventral hernia.

Brief summary: Restoring the physiologic tension of the abdominal wall is a key concept in abdominal wall reconstruction. Yet little is known quantitatively about the normal tension of the abdominal wall. To better understand the ideal tension for abdominal wall reconstruction, the physiologic tension of the abdominal wall needs to be measured. This study aims to measure the tension of the abdominal wall during laparotomy closure.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparotomy
* Patient able to provide informed consent

Exclusion Criteria:

* Presence of a ventral hernia
* Patients unable to provide informed consent

Primary outcomes:
measure: Abdominal wall tension at laparotomy
timeFrame: Tension measurements will be recorded immediately. No further data collection or patient follow-up will occur postoperatively.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
References: