louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01494272: Analgesia in Children Using Caudal Epidural Ropivacaine
Official title: Preemptive Analgesia in Children Using Caudal Epidural Ropivacaine: A Prospective, Randomized, Double-blinded, Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Circumcision
Keywords: caudal epidural analgesia
elective circumcision
elective inguinal herniorrhaphy
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2011-12-16
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children under 2 years of age having an elective inguinal herniorrhaphy or orchiopexy.

Brief summary: Caudal epidural analgesia (caudal block)is used in standard pediatric anesthesia practice. It has been shown to be effective in managing postoperative pain in children undergoing abdominal and infraumbilical surgery (Tobias et al 1994). Furthermore, studies have shown that children receiving caudal blocks have secondary benefits such as lower narcotic and anesthetic requirements, more rapid awakening from general anesthesia, decreased time to discharge home, and fewer pain-related behaviors postoperatively (Conroy et al 1993, Tobias et al 1995, Tobias 1996).

This proposed study involves the use of a caudal block in children undergoing elective inguinal herniorrhaphy or orchiopexy to evaluate the role of preemptive analgesia in pediatric pain management. We hypothesize that by inhibiting peripheral pain receptors with a caudal block before the onset of a painful stimulus, we can decrease central nervous system sensitization and reduce postoperative analgesic requirements


Eligibility criteria: Inclusion Criteria:

1. Age 2 months to 2 years
2. Weight 25kg or less
3. ASA class 1, 2, 3
4. Elective inguinal herniorrhaphy or orchiopexy

Exclusion Criteria:

1. Contraindications to caudal epidural analgesia
2. parent's refusal
3. skeletal or spinal cord anomaly
4. coagulopathy
5. infection at the insertion site
6. ongoing bacteremia
7. allergy to ropivacaine

Primary outcomes:
measure: Usage of pain medications
timeFrame: over 24 hours
Secondary outcomes:
measure: Pain scores
timeFrame: At various intervals for first 24 hours
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Outpatient Surgery Center
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: Shannon Mulder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01456572: Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People
Official title: Gastric and Intestinal Satiation in Obese and Normal Weight Healthy People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endocrine System Diseases
Keywords: glucagon-like peptide-1
peptide tyrosine tyrosine
ghrelin
stomach
small intestine
gastric emptying
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2011-10-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the reciprocal control between gastric functions and intestinal parameters in the development of satiation in obese people.

Detailed description: Obesity has reached pandemic proportions, obesity-associated complications are extensive and the current treatment options are limited. These facts demonstrate the need for an improved understanding of the pathogenesis of obesity. The gastrointestinal tract plays a key element in the control of satiation; discrepancies exist, however, for the role of gastric and intestinal parameters in the control of satiation in relation to body mass. To achieve a comprehensive understanding for the reciprocal control between gastric functions and intestinal parameters in the development of satiation in obese people the investigators will compare satiation parameters, gastric emptying and plasma glucagon-like peptide-1 (GLP-1), peptide tyrosine tyrosine (PYY) and ghrelin levels between normal and obese healthy volunteers.

Time needed to reach the level of satiation and total calorie intake will be measured by a standardized nutrient drink test; gastric emptying of solids by a 13C-octanoic acid breath test; and plasma GLP-1, PYY and ghrelin levels will be measured after a standardized nutrient drink.

Eligibility criteria: Inclusion Criteria:

* healthy subjects
* age 18-45

Exclusion Criteria:

* smoking
* substance abuse
* regular intake of medication
* medical or psychiatric illness
* gastrointestinal disorders or food allergies

Primary outcomes:
measure: gastrointestinal peptide secretion
timeFrame: 2 hours blood sampling
Secondary outcomes:
measure: gastric emptying
timeFrame: 240 minutes end-expiratory breath sample collection
measure: time needed to reach the level of satiation
timeFrame: up to 30 min
measure: total calorie intake
timeFrame: up to 30 min
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Phase 1 Research Unit
state: Basel-Stadt
Study officials:
affiliation: Phase 1 Research Unit, University Hospital Basel
name: Christoph Beglinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer-Gerspach AC, Wolnerhanssen B, Beglinger B, Nessenius F, Napitupulu M, Schulte FH, Steinert RE, Beglinger C. Gastric and intestinal satiation in obese and normal weight healthy people. Physiol Behav. 2014 Apr 22;129:265-71. doi: 10.1016/j.physbeh.2014.02.043. Epub 2014 Feb 28.
Clinical trial NCT05762172: Dynamic F-DOPA PET for Differential Diagnosis Between Recurrence and Radionecrosis of Brain Metastasis
Official title: Interest of the Early Dynamic F-DOPA PET Examination for Differential Diagnosis Between Recurrence and Radionecrosis of Brain Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Metastases
Radiation Necrosis
Keywords: silicon PET/CT
18F-DOPA
short time examination
Brain Metastases
Radiation Necrosis
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Contrast-enhanced magnetic resonance imaging is the most widely used examination for detecting the presence of brain metastasis. Functional sequences such as perfusion weighted imaging makes it possible to differentiate tumor recurrence from cerebral radionecrosis. However, this imaging technique may exhibit limitations, especially for brain lesions consisting of a mixture of necrotic tissue and tumor progression or depending on the location of the lesion in the brain. The use of 18F-DOPA PET is another option available to oncologists. Many studies on gliomas showed the superiority of this imaging technique over contrast-enhanced MRI. However, this imaging solution has been very poorly studied for brain metastases. The new PET technology equiped with silicon detectors makes it possible to obtain greater sensitivities than those of previous generations. It also make possible to obtain images in very short acquisition times. After injection, the hardware allows to obtain the perfusion kinetics of the lesion thanks to a very short temporal sampling (i.e. three seconds).

The main objective of this pilot study is to evaluate the association between early activity measurements (\< 4 minutes post-injection) of 18F-FDOPA in PET and the differential diagnosis between radionecrosis and recurrence of cerebral metastases treated by radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Patient referred for cerebral 18F-FDOPA PET examination prescribed as part of his usual medical care for brain metastasis
* Age ≥ 18 years old
* Affiliation to a social security program
* Ability of the subject to understand and express opposition

Exclusion Criteria:

* Age under 18
* Person under guardianship or curators
* Pregnant woman

Primary outcomes:
measure: difference between the maximum activity (in Bq/mL) in the venous sinus and the maximum activity present in the region of interest encompassing the lesion being studied.
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
state: Picardie
Study officials:
References:
Clinical trial NCT00035672: Genetic Predictors of Incident Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2002-05-06
Enrollment: 0
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE

Brief summary: To evaluate how current genetic information about cardiovascular disease susceptibility genes contributes to the prediction of future cardiovascular disease outcomes.

Detailed description: BACKGROUND:

During the 1980s and 1990s, genetic research in cardiovascular disease (CVD), as well as other common chronic diseases, has been dominated by single gene linkage and association studies focused on understanding of the genetics of prevalent disease. Rarely have there been studies of the longitudinal predictive value of these genetic variations. Furthermore, few studies have attempted to address the complex and high-dimensional genetic reality that underlies an individual's risk of disease. A crucial next step in CVD genetic research is the evaluation of the contribution of variations in many genes simultaneously, and their interactions with traditional risk factors, to the longitudinal prediction of CVD in individuals and families.

DESIGN NARRATIVE:

The study uses participants from the Rochester Family Heart Study (RFHS) which provides one of the richest genetic epidemiological resources for this type of study. The RFHS represents 3941 individuals distributed among 552 three- generation pedigrees ascertained without regard to health status during two phases of collection. Phase I was from 1984 - 1988 and Phase II was from 1988 - 1991. These participants have extensive demographic, physiological, genetic, and clinical information measured at baseline. This study builds upon this already established resource by conducting a longitudinal follow-up of the RFHS participants to address two central questions: 1) Do measured genetic variations in known susceptibility genes provide additional predictive information about risk of future CVD outcomes beyond the information provided by more traditional risk factors? and 2) Do these measured genetic variations explain patterns of disease aggregation in families and can these patterns be used to predict disease in future generations?

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan
name: Sharon Kardia
References:
citation: Kardia SL, Modell SM, Peyser PA. Family-centered approaches to understanding and preventing coronary heart disease. Am J Prev Med. 2003 Feb;24(2):143-51. doi: 10.1016/s0749-3797(02)00587-1.
citation: Sing CF, Stengard JH, Kardia SL. Dynamic relationships between the genome and exposures to environments as causes of common human diseases. World Rev Nutr Diet. 2004;93:77-91. doi: 10.1159/000081252. No abstract available.
Clinical trial NCT01192672: Use of Expressive Writing in Irritable Bowel Syndrome (IBS)
Official title: Use of Expressive Writing in Irritable Bowel Syndrome (IBS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: Takeda Pharmaceuticals North America, Inc.
First posted: 2010-09-01
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test whether disease-related expressive writing is effective in the treatment of Irritable Bowel Syndrome (IBS).

Detailed description: Expressive writing involves writing about traumatic, stressful or emotional events. Expressive writing, for as little as 3-5 sessions of 20 minutes, has been found to improve both physical and psychological health based on health outcome measures such as number of doctor's visits and hospital days, blood pressure control, lung and immune function, and pain. Given its simplicity, and obvious advantages in terms of cost efficiency, expressive writing appears to have great potential as a therapeutic tool or as a means of self-help, either alone or as an adjunct to traditional therapies. This modality has not been studied in irritable bowel syndrome (IBS), a common gastrointestinal condition, which is lacking well-defined etiology or treatments and is best understood in a biopsychosocial context.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Irritable Bowel syndrome

Exclusion Criteria:

* Non-English Speakers

Primary outcomes:
measure: IBS-Specific Quality of Life (IBS-QOL)
timeFrame: 3 months
Secondary outcomes:
measure: CT3
timeFrame: 3 months
measure: Health care Utilization (HCU)
timeFrame: 3 months
measure: IBSSS
timeFrame: 3 months
measure: Demographics (DEM-MED)
timeFrame: Baseline
measure: Cognitive Scale for Functional Bowel Disorders (CGFBD)
timeFrame: 3 months
measure: Writing Evaluation Questionnaire (WEQ)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Boston University
name: Albena Halpert, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04975672: Efficacy of Myofunctional Therapy in Class II Patients
Official title: Efficacy of Myofunctional Therapy in Class II Patients With Functional Orthopedic Appliances. ECA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Efficacy
Myofunctional Therapy
Orthopedics
Keywords: Efficacy
Myofunctional Therapy
Dentofacial Orthopedics
Lead sponsor: Fundación Universitaria CIEO
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial with two parallel arms
Primary purpose: TREATMENT

Brief summary: Randomized clinical trial , with a sample of 60 children with atypical swallowing, class II and with SN1 orthopedic appliances these patients were randomly divided into, group 1: 30 patients with SN1 orthopedic appliances and myofunctional therapy and group 2: 30 patients with SN1 orthopedic appliances and without myofunctional therapy.

Detailed description: Randomized clinical trial with two parallel arms, on a sample of 60 children with atypical swallowing, class II and with SN1 orthopedic appliances, these patients were randomly divided into, group 1: 30 patients with SN1 orthopedic appliances and myofunctional therapy and group 2: 30 patients with SN1 orthopedic appliances and without myofunctional therapy for the study. Both groups carried out the evaluation of the protocol that included: 1) evaluation of the dental occlusion class and skeletal classification 2) swallowing function test using the Payne technique; 3) Mioscaner analysis to measure perioral forces, i.e. tongue extension force, lip pressure, masseter contraction force.

Eligibility criteria: Inclusion Criteria:

* the inclusion criteria the participants will be between

  * 8 and 10 years old
  * mixed dentition
  * canine class II diagnosis and 2 to 4 mm
  * molar according to Angle and overjet between 4 to 6 mm

Exclusion Criteria:

* Patients with systemic involvement

  * congenital malformations
  * facial deformities
  * Open bite
  * oral breathing
  * finger sucking habit will be excluded

Primary outcomes:
measure: Therapy Efficacy / Tongue Position
timeFrame: 9 months
measure: 41 / 5000 Resultados de traducción Efficacy of therapy / mandibular advancement
timeFrame: 9 months
measure: Muscle contraction
timeFrame: 9 months
measure: Contraction of the masseter muscles and muscle activity of the chin
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01123772: Phase I Dose-Escalation Study to Evaluate Tolerability, Safety & PK of INO-8875 in Healthy Older-Adult Volunteers
Official title: Phase I, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate Tolerability, Safety & PK of BID Topical Ocular Application of INO-8875 in Healthy Older-Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Health
Keywords: adenosine agonist
eye drop
elderly volunteer
older healthy volunteer
Lead sponsor: Inotek Pharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 70
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate how tolerable and safe it is to give INO-8875 eye drops at different concentrations to normal older healthy adult volunteers for two weeks.


Eligibility criteria: Inclusion Criteria:

* male, or a female with a negative pregnancy test and without childbearing potential
* aged 35 to 65 years
* body weight is ≥50 kg and ≤115 kg

Exclusion Criteria:

* Subject has glaucoma or any active ophthalmologic disease including conjunctivitis
* Subject has a central retinal vein occlusion in either eye at any time in the past
* Subject is currently on any drug that might affect IOP including oral or ocular glucocorticoids or ephedrine
* Subject has history of ocular trauma or surgery (except for non-incisional surgery performed at least 3 months prior to the Screening visit)
* Subject has a prosthetic eye or any ocular abnormality precluding reliable applanation tonometry in either eye including an immobile pupil.
* Subject is not able to refrain from use of contact lenses during the Treatment Period

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Evansville
country: United States
state: Indiana
Study officials:
References:
Clinical trial NCT05101772: 25G and 22G Puncture Needles
Official title: Multicenter, Randomized, Self-matched Design, Positive Control, Non-inferiority Clinical Study of 25G and 22G Puncture Needles in Solid or Submucosal Pancreatic Masses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Submucosal Tumor
Pancreas Tumor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects were 18 years of age or older (inclusive) who were clinically diagnosed with solid pancreatic masses or submucosal masses and required endoscopic ultrasound-guided puncture examination. Seventy-three subjects are planned to be enrolled.

Brief summary: The screened patients were randomly assigned 25G puncture needles and 22G puncture needles in a 1;1 ratio, based on the computer-generated random order, before receiving an ultrasound endoscope puncture. Each puncture needle puncture lesions 2 needles, the same type of puncture needle tissue samples taken in the same tissue pathology bottle, all tissues after the completion of the necessary cytological smears, are placed in the Formalin solution to send tissue pathology, pathologists do not know the order of distribution of 2 puncture needles to evaluate the tissue results, all pathology results are reported by the hospital pathology center, audit.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of real pancreatic swelling or submuscular swelling;
* Patients need to be guided by ultrasound endoscopy under the guidance of puncture to eliminate malignant lesions or clear lesions;
* Fully communicate before surgery, understand the risks and benefits of endoscopic operation, and sign an informed consent form.

Exclusion Criteria:

* There are endoscopic operation contraindications, including abnormal blood clotting, or long-term oral anticoagulant antiplatelet drugs, can not guarantee INR \< 1.5, or platelets less than 5 x 10 x 9 / L;
* Pregnant woman

Primary outcomes:
measure: The acquisition rate of the core tissue sample
timeFrame: One week
Secondary outcomes:
measure: The length of the tissue strip
timeFrame: One week
measure: the technical success rate 、the success rate of immunogrouping dyeing and the retention of the organizational structure
timeFrame: One week
measure: the incidence of adverse events and the incidence of device defects
timeFrame: one week
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: