louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03744052: Using Neuroscience to Optimize Digital Health Interventions Across Adulthood
Official title: Using Neuroscience to Optimize Digital Health Interventions Across Adulthood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke University: Bass Connections
name: National Institutes of Health (NIH)
First posted: 2018-11-16
Enrollment: 44
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this study is to investigate the extent to which brain imaging data predict health behavior change, compared to participant self-reports.


Eligibility criteria: Inclusion Criteria:

* Healthy adults ages 30-80 who read/understand English, 50% male and 50% female, and a maximum of 50% will be white.

Exclusion Criteria:

* Pregnancy
* History of head injury
* Mental illness diagnosis
* Psychoactive medication
* Psychiatric or neurological history
* Claustrophobia
* Ferrous metal implanted within the body (those with fMRI-compatible implanted devices will not be excluded, but the eligibility of their devices will be first verified.)
* Asthma, injuries, or other health conditions which inhibit daily physical activity
* Subjects must not already meet the recommended amount of physical activity of moderate-intensity physical activity for 150 minutes a week or 75 minutes at vigorous-intensity a week.
* Duke students are excluded from this study

Primary outcomes:
measure: Change in Physical Activity as measures by FitBit
timeFrame: Baseline (14 days after the 1st visit), End of study (80 days after the MR visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Gregory Samanez-Larkin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06276452: Supporting Resilience Among Re-entered Seniors
Official title: Supporting Resilience Among Re-entered Seniors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Disease
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-02-26
Enrollment: 8
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The first goal (Aim 1) of this clinical trial is to learn about specific strengths, challenges, and desired areas of knowledge and skill-building among older adults who re-entered their communities from a period of incarceration and to then develop a new psychoeducational intervention tailored to these older adults. The second goal (Aim 2) of this clinical trial is to test if the intervention increases chronic disease management and whether the intervention is considered appropriate and acceptable by older adults who re-entered their communities from a period of incarceration.

Aim 1 participants will:

* complete a baseline survey
* participate in a focus group

Aim 2 participants will:

* complete a baseline survey
* participate in an 8-week once weekly intervention
* complete three follow up surveys

Detailed description: The protocol for Aim 2 will be developed once the focus group data is analyzed.

Eligibility criteria: Inclusion Criteria:

* at least 45 years old
* have re-entered the community from a period of incarceration from jail or prison
* have at least one chronic health condition
* able to speak and understand English

Exclusion Criteria:

* aged 44 or younger
* have not re-entered the community from a period of incarceration from jail or prison
* does not have at least one chronic health condition
* unable to speak and understand English

Primary outcomes:
measure: Chronic disease self managment
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: New Legacy Reentry
state: Kentucky
Study officials:
References:
Clinical trial NCT05590052: Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques
Official title: Bipolar Electrosurgery Versus Thermocautery in Circumcision With Safe Anesthetic Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circumcision
Keywords: Circumcision
Electrosurgery
Thermocautery
Lead sponsor: Damanhour Teaching Hospital
Sponsor class: OTHER_GOV
First posted: 2022-10-21
Enrollment: 120
Sex: MALE
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: Circumcision is the most commonly performed surgical procedure done among the pediatric age group worldwide and is considered to be one of the oldest operations done. Circumcision should be performed properly with safe surgical techniques, with the least possibility of complications.

Objective: To compare bipolar electrosurgery versus thermocautery in the circumcision of infants under combined general and local anesthesia.

Patients and Methods: This prospective randomized comparative study was carried out on 110 infants who were candidates for elective circumcision under combined general and local anesthesia. Infants were randomly allocated into two equal groups (55 infants each); in group A, circumcised by bone-cutting forceps with cutting foreskin using a scalpel and achievement of hemostasis using bipolar electrosurgery, and in group B, circumcised by bone-cutting forceps with cutting foreskin and achievement of hemostasis using thermocautery.


Eligibility criteria: Inclusion Criteria:

* Infants of families who applied for circumcision
* Age from 1 to 12 months, of the male sex
* Infants should have normal preoperative laboratory investigations

Exclusion Criteria:

* Infants with congenital malformations especially hypospadias and epispadias, congenital inguinal hernia, and undescended testis
* Infants with acute penile infection, or excess suprapubic fat
* Infants with cardiovascular, neurological, respiratory, liver, renal, endocrine, blood, or immune diseases
* Allergy to any drug will be used in this study

Primary outcomes:
measure: Mean and Standard deviation of postoperative analgesic doses (mean±SD)
timeFrame: 72 hours after the end of the operation
Secondary outcomes:
measure: Mean and Standard deviation of Operative duration (minutes) (mean±SD)
timeFrame: 2 minutes after the end of the operation
measure: Number of participants and Rate of Intraoperative complications
timeFrame: 2 minutes after the end of the operation
measure: Number of participants and Rate of Postoperative complications
timeFrame: 4 weeks after the end of the operation
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour Teaching Hospital
state: El-Beheira
Study officials:
affiliation: Damanhour Teaching Hospital
name: Ahmed M Shaat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03614052: Tamsulosin as Adjuvant Treatment Prior to Endoscopic Ureterolithotomy
Official title: Efectividad de la Tamsulosina Como Tratamiento Adyuvante Previo a Ureterolitotomia Endoscopica
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ureterolithiasis
Ureteral Calculi
Urolithiasis
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 14
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 a study aiming to compare treatment with tamsulosin versus placebo in patients undergoing endoscopic treatment for urolithiasis. The main outcome is the rate of stone free patients.

Detailed description: Endoscopic treatment of urolithiasis has increased during the last several years. Adrenergic receptors have been described mainly in the distal ureter. Blockage of adrenergic receptors has been associated to a decrease in ureteral resistance. In this study the investigators hypothesized that alpha blockers are associated to a decrease in ureteral resistance with an increase in successful endoscopic management of urolithiasis.

Only patients with urolithiasis undergoing to endoscopic treatment are offered to participate. Patients are randomized between placebo arm or tamsulosin 0.4 mg/day. Demographic characteristics, stones characteristics and information related to surgery are recorded. Main study outcome is stone free rate and successful insertion of semirigid ureteroscope 8,0 - 9,8 Fr. All patients are follow-up for 30 days after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with urolithiasis undergoing to endoscopic ureterolithotomy

Exclusion Criteria:

* Patients with previous ureteral catheter

  * Patients with allergy to tamsulosin
  * Patients currently in treatment with tamsulosin for other disease different than ureterolithiasis
  * Multiple ureterolithiasis
  * Patients with impairment of their mental status

    * Patients with open surgeries in the affected ureter or urinary diversion
    * Pregnancy

Primary outcomes:
measure: stone free rate
timeFrame: 30 days
Secondary outcomes:
measure: failed ureteroscopy rate
timeFrame: 05 days
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clinico Pontificia Universidad católica de Chile
state: Metropolitana
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Gaston Astroza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02741752: The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans
Official title: The Influence of Cortical Bone Perforation on Guided Bone Regeneration in Humans: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alveolar Bone Loss
Keywords: histomorphometry
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 14
Sex: ALL
Minimum age (years): 25
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized clinical trial was to evaluate the effect of cortical bone decortication on the angiogenesis and osteogenesis of augmented ridge by GBR.

Detailed description: Background: The purpose of the current study was to evaluate the effect of cortical bone perforation on angiogenesis and osteogenesis of augmented ridge by guided bone regeneration.

Methods: Fourteen patients (mean age: 52) who were in need of dental implants at areas with osseous defects in the mandible were selected. In the test group (n=7), alveolar cortical bone at the area of regeneration was perforated using a #2 high speed round bur. No decortication of cortical bone was performed in the control group (n=7). Subsequently, defects were augmented by guided bone regeneration using resorbable membrane and bovine bone. After a healing period of 7 months, implant sites were created and trephine cores harvested for histological and histomorphometric analysis of the grafted areas.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were presence of atrophic mandibular ridges with bucco-lingual width ranging between 2-5 mm, as measured on serial sections of a computerized axial tomography (CAT) scan.

Exclusion Criteria:

* Exclusion criteria included patients with diabetes, osteoporosis or other metabolic disorders, smokers, pregnant patients and patients who had any systemic or local factors that would inhibit normal wound healing process.

Primary outcomes:
measure: The amount of vital bone formation by histomorphometric analysis after cortical bone perforation
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02282852: Can Steerable Capsule Endoscopy Enhance Gastric Emptying?
Official title: Randomised Comparison of a Standard Protocol Using Metoclopramide Versus a Hand Held Magnet to Enhance Gastric Emptying of the Small Bowel Capsule.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Attending Hospital for Small Bowel Endoscopy
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Small bowel wireless capsule endoscopy is the investigation modality of choice for suspected diseases of the small bowel. The procedure is safe and noninvasive, the main risk being capsule retention occurring in approximately 2% of procedures. Other problems such as incomplete examinations occur in 10-20% of procedures. Reasons include delayed gastric emptying, slow small bowel transit, faulty equipment and poor bowel preparation.

Some protocols identify the capsule position 30 minutes after ingestion using a 'realtime' viewer. If the capsule remains in the stomach, mobilisation is encouraged followed by an intramuscular prokinetic injection if this fails. This approach has disadvantages since an intramuscular injection is uncomfortable for patients. Additionally metoclopramide, commonly used for this purpose, has a risk of acute dystonic reactions particularly in young patients.

Recently a handheld magnet (Intromedic Ltd.) has been developed to enable control of the capsule in the upper GI tract. We propose that this could be used, alongside positional changes, to expedite capsule transit through the stomach thus improving completion rates and avoiding the risks of unnecessary medication. We wish to undertake a randomised controlled study comparing a standard protocol for small bowel capsule endoscopy against a hand held magnet and positional change protocol to enhance gastric emptying of the wireless capsule.


Eligibility criteria: Inclusion Criteria:

* Patients aged 20 years or over
* Patients attending hospital for small bowel endoscopy examination

Exclusion Criteria:

* Patients under the age of 20 years
* Patients with a permanent pacemaker, or implantable cardioverter-defibrillator
* Patients with any electronic/magnetic/mechanically controlled devices
* Patients that are pregnant
* Patients who are unable to understand or speak English

Primary outcomes:
measure: Completion rate of small bowel endoscopy examination
timeFrame: Baseline
measure: Duration of time taken for camera capsule to enter duodenum.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Mark McAlindon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05145075: Surveying the Receptivity for Telemedicine Pre-operative Consultation in UZ Brussel.
Official title: Surveying the Receptivity for Telemedicine Pre-operative Consultation in UZ Brussel.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Remote Consultation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: We will be surveying patients coming to UZ Brussels for their pre-operative consultation, how they feel about changing these consultations to teleconsultations.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to a planned in-hospital pre-operative consultation at UZ Brussels.

Exclusion Criteria:

* Language barrier
* Inability to provide informed consent

Primary outcomes:
measure: Willingness to have a teleconsultation: Survey
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels
Study officials:
References:
Clinical trial NCT03877575: Lyon Uveitis Study
Official title: Lyon Uveitis Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uveitis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is proposed to all patients diagnosed for uveitis and referred to the Department of Internal Medicine of the Croix-Rousse hospital, Lyon, France for the first visit corresponding to etiologic diagnosis or treatment.

Brief summary: Uveitis or inflammation of the uveal tract results from a heterogeneous collection of disorders of varying etiologies and pathogenic mechanisms. Uveitis is relatively frequent in industrial countries with an estimation of 115 cases for 100 000 persons and is associated with a blindness risk of 10%. Causes of uveitis can be related to different etiologies (infectious, inflammatory or general inflammatory diseases). Therapeutic care is based on ophthalmologic and systemic diagnosis and treatment strategy depends on the severity of inflammation.

The main objective of the Lyon uveitis study is to analyze the uveitis ophthalmologic etiology and diagnostic and therapeutic care of the patients. This study is proposed to all patients diagnosed for uveitis and referred to the Department of Internal Medicine of the Croix Rousse hospital, Lyon, france for etiologic diagnosis or treatment.

Analysis of i) patients' characteristics, ii) the relevance of complementary exams to determine the uveitis etiology, iii) treatment used.

This study will allow a better characterization of the disease on diagnosis practices and therapeutic care.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of uveitis
* First consultation in the Department of Internal Medicine at the Croix-Rousse hospital, Lyon, France

Exclusion Criteria:

-

Primary outcomes:
measure: Clinical evolution (persistence or resolution) evaluated by gradation of SEN
timeFrame: At one year after diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of Internal Medicine, Croix-Rousse Hospital, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT02116075: Caudal Corticosteroid vs. Dextrose Injection for Lumbosacral Radicular Pain.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: no Conditions
Lead sponsor: VA Long Beach Healthcare System
Sponsor class: FED
First posted: 2014-04-16
Enrollment: 50
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: Study comparing caudal prolotherapy to conventional steroid for chronic low back pain


Eligibility criteria: INCLUSION CRITERIA

1. Participants must satisfy diagnostic criteria for lumbar radicular pain at L4 nerve root level or below with consistent MRI or X ray findings.
2. Evidence of low back pain base upon one or more of the following:

   i. Lumbar back pain episodes lasting greater than 6 months and current pain level is greater than 6/10 on VAS.

   ii. Has received at lest 2 types of ancillary treatment (i.e. physical therapy, oral analgesia, acupuncture, etc.)
3. Men or women age greater than or equal to 18 years.
4. No significant alcohol use (7 or fewer drinks per week).
5. Patient has a history of at least 2 failed epidural CS injections.

EXCLUSION CRITERIA

1. Treatment risk factors including one or more of the following:

   i. Unstable or symptomatic cardiac complaints ii. Unstable or symptomatic respiratory complaints iii. Unable to reliably comprehend the protocol or reliably record data
2. Pregnancy. A serum pregnancy test must be performed and negative in all women of child bearing potential within 2 weeks prior to enrollment.
3. History of Malignancy
4. Any medical (i.e. malignancy, infection, thrombo-embolic states, autoimmune disease, polyneuropathy) or psychosocial condition that in the opinion of the investigator, could jeopardize the subject's participation, and compliance with the study criteria.

Primary outcomes:
measure: Pain relief as measured by VAS pain scale.
timeFrame: 1 year
Secondary outcomes:
measure: Change in the frequency and amount of opioid use.
timeFrame: 1 year
measure: Disability score as determined by Oswstery questionnaire.
timeFrame: 1 year
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Veteran'S Affairs Healthy System
state: California
Study officials:
References:
Clinical trial NCT00501475: NAC in Preventing CIN in CRF Patients Who Need Enhanced CT Scan in ED
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Renal Failure
Keywords: N-acetylcysteine
nephropathy
bicarbonate
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2007-07-16
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effect of NAC or sodium bicarbonate in preventing the aggravation of renal function in chronic renal failure when enhanced computed tomography scan is checked in emergency room.

Detailed description: CIN is frequent in CRF patients. However most studies about CIN has been focusing on elective PCI patients. There is no study that the NAC nor sodium bicarbonate would help in preventing CIN in CRF patients who need enhanced CT scan in ED.

Our intention was to investigate the effect of NAC or sodium bicarbonate in preventing the aggravation of renal function in chronic renal failure when enhanced computed tomography scan is checked in emergency room.

Eligibility criteria: Inclusion Criteria:

* CRF patients who need enhanced CT scan

Exclusion Criteria:

* less than 15 years old
* hypersensitivity to NAC
* on dialysis
* no consent from patient or next of kin

Primary outcomes:
measure: the rate of CIN
timeFrame: 3 days after CT scan
Secondary outcomes:
measure: mortality
timeFrame: 30 days after CT scan
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: 28 Yongon-dong, Chongro-gudo
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeongi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Kyuseok Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: