louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06442722: Surgical Treatment of DDH With and Without Capsulorrhaphy
Official title: Evaluation of Surgical Treatment Outcomes for Developmental Dysplasia of Hip With and Without Capsulorrhaphy : a Comparative Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Developmental Dysplasia of the Hip
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to evaluates the surgical treatment outcomes of Developmental Dysplasia of Hip with and without capsulorrhaphy between 1-6 years of age . it compares the effectiveness of these approaches in improving postoperative stability , range of motion , and long-term success rates for DDH patients undergoing surgery .:


Eligibility criteria: Inclusion Criteria:

1. age: from 1 year to 6 years
2. sex: males and females
3. Children who received no operative treatment before.

Exclusion Criteria:

1. Children who were treated operatively before presentation.
2. Children who had teratologic, post septic or neuromuscular hip dislocation.

Primary outcomes:
measure: Severin's grading
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty Medicin
Study officials:
References:
Clinical trial NCT02883322: Adaptation Process of Patient-Reported Outcomes, an eVALuation Study
Official title: Adaptation Process of Patient-Reported Outcomes, an eVALuation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Disease
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Societe Francaise de Rhumatologie
name: Région Lorraine
First posted: 2016-08-30
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with a chronic condition, susceptible to answer the adapted questionnaire

Brief summary: Objectives: To identify the respective contributions of back-translations and of the expert committee in the process of cultural adaptation of patient reported outcome with an experimental design in the adaptation process :

Four translations of a questionnaire will be produced:

* A simple translation by two translators, who serves as the basis for the three other translations
* A translation made with the use of a back-translation.
* A translation with review by an expert committee.
* A translation the use of a back-translation and review by an expert committee.

Properties of each translation will be analyzed and compared


Eligibility criteria: Inclusion Criteria:

* Adult (other 18 years)
* Able to read, understand and answer the adapted questionnaire
* Having a medical condition targeted by the questionnaire

Primary outcomes:
measure: heiQ questionnaire
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Inserm, CHRU Nancy, Université de Lorraine, CIC 1433 Épidémiologie Clinique
name: Francis Guillemin, MD, PHD
role: STUDY_DIRECTOR
References:
citation: Epstein J, Santo RM, Guillemin F. A review of guidelines for cross-cultural adaptation of questionnaires could not bring out a consensus. J Clin Epidemiol. 2015 Apr;68(4):435-41. doi: 10.1016/j.jclinepi.2014.11.021. Epub 2014 Dec 17.
citation: Epstein J, Osborne RH, Elsworth GR, Beaton DE, Guillemin F. Cross-cultural adaptation of the Health Education Impact Questionnaire: experimental study showed expert committee, not back-translation, added value. J Clin Epidemiol. 2015 Apr;68(4):360-9. doi: 10.1016/j.jclinepi.2013.07.013. Epub 2013 Sep 29.
Clinical trial NCT02125422: Neurophysiological Study of tDCS Effects in Healthy Volunteers
Official title: Neurophysiological Study of tDCS Effects in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2014-04-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Transcranial direct current stimulation is a tool to modulate cortical excitability.

Detailed description: Anodal transcranial direct currenti stimulation over visual cortex is able to decrease the thermo-nociceptive sensibility and thermonociceptive potentials, whilst cathodal transcranial direct current stimulation has the opposite effect, it decreases VEP amplitude and habituation. This neuromodulation technique is probably a tool in the prevention in episodic and chronic migraine.

The aim of the study is to study short and long term effect of tDCS over pain treshold, contact heat evoked potentials, blink reflex and visual evoked potentials in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* age below 18 or above 65 years
* personal history of recurrent headache or other neurological diseases especially seizures,
* familial history of recurrent headache
* child migraine equivalents (motion sickness, cyclic vomiting or recurrent abdominal pain, somnambulism etc.. . .)
* chronic pain syndromes
* analgesics intake at the time of recording
* contra-indications to tDCS neurostimulation (metal prosthetics in the head or internal stimulation like a pacemaker).

Primary outcomes:
measure: Neurophysiological mesures changes
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
measure: VEP changes
timeFrame: up to 1 month
measure: Blink changes
timeFrame: up to 1 month
measure: CHEPS changes
timeFrame: up to 1 month
measure: Quantitave Sensory Testing
timeFrame: up to 1 month
Locations:
city: Liége
country: Belgium
facility: Roberta Baschi
Study officials:
affiliation: University of Liege
name: Delphine Magis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Liege
name: Jean Schoenen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05173922: "Safety in Dementia": An Online Caregiver Intervention
Official title: "Safety in Dementia": An Online Caregiver Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers
Decision Making
Alzheimer Disease
Social Media
Safety
Suicide
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In an online randomized trial of Safety in Dementia with national recruitment and longitudinal follow-up, we will recruit informal caregivers of community-dwelling adults with dementia who have firearm access.

Detailed description: Aim 1: To test the efficacy of Safety in Dementia (SiD) on firearm safety decision quality and behaviors, among a national sample of informal caregivers of community-dwelling people with dementia and firearm access (n=500).

Aim 2: To compare varied methods in reaching informal caregivers. Aim 3: To explore stakeholder longitudinal experiences with SiD and firearm-related decisions.

Eligibility criteria: Inclusion Criteria:

* Live in United States
* Speak English or Spanish
* Informal caregiver for community swelling person with dementia and firearm access
* Access to the internet

Exclusion Criteria:

* In legal custody or institutionalized

Primary outcomes:
measure: Change in Preparation for Decision Making
timeFrame: During baseline assessment (specifically, after receiving randomization allocation), 2 weeks, 2 months, 6 months
Secondary outcomes:
measure: Change in Decision Self-Efficacy
timeFrame: baseline/pre-intervention, 2 weeks, 2 months, 6 months
measure: Change in Firearm access
timeFrame: baseline/pre-intervention, 2 weeks, 2 months, 6 months
measure: Action to reduce firearm access
timeFrame: 2 weeks, 2 months, 6 months
measure: Firearm injury
timeFrame: baseline/pre-intervention, 2 weeks, 2 months, 6 months
measure: Caregiver burden
timeFrame: 2 weeks
measure: Positive Aspects of Caregiving
timeFrame: 2 weeks
measure: Website analytics
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz
state: Colorado
Study officials:
References:
Clinical trial NCT00370422: Bevacizumab Versus Combined Bevacizumab and Triamcinolone for Refractory Diabetic Macular Edema; a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Macular Edema
Keywords: Cystoid macular edema
Diabetic macular edema
Hard exudates
Intravitreal bevacizumab
Intravitreal triamcinolone
Macular thickness
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-08-31
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory diabetic macular edema.

Detailed description: According to the early treatment diabetic retinopathy study (ETDRS), the treatment of choice for diabetic macular edema is laser therapy, which may be neither effective nor curative in some patients. Corticosteroids may have a beneficial effect on diabetic macular edema. Other newly introduced medications for macular edematous lesions are anti-VEGF vascular endothelial growth factor)drugs. In this randomized, sham-controlled, multicenter, three-arm clinical trial,we try to evaluate the safety and efficacy of intravitreal bevacizumab alone and in combination with intravitreal triamcinolone in the treatment of refractory diabetic macular edema.

Eligibility criteria: Inclusion Criteria:

* Cases with clinically significant macular edema (CSME) with persistent retinal thickening after initial or supplemental macular photocoagulation

Exclusion Criteria:

* Monocularity,
* History of vitrectomy,
* Glaucoma or ocular hypertension,
* Significant media opacity,
* Existence of traction on the macula

Primary outcomes:
measure: Visual acuity
measure: Central macular thickness
Secondary outcomes:
measure: Cataract progression
measure: Intraocular pressure
measure: Anterior chamber reaction
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hamid Ahmadieh, MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Hamid Ahmadieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahmadieh H, Ramezani A, Shoeibi N, Bijanzadeh B, Tabatabaei A, Azarmina M, Soheilian M, Keshavarzi G, Mohebbi MR. Intravitreal bevacizumab with or without triamcinolone for refractory diabetic macular edema; a placebo-controlled, randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2008 Apr;246(4):483-9. doi: 10.1007/s00417-007-0688-0. Epub 2007 Oct 5.
Clinical trial NCT00178022: A Trial of Two On-Line Interventions for Child Brain Injury
Official title: A Trial of Two On-Line Interventions for Child Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Depression
Anxiety Disorders
Keywords: tbi
intervention
depression
anxiety
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Children's Hospital Medical Center, Cincinnati
name: Centers for Disease Control and Prevention
First posted: 2005-09-15
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The primary aims of this project are to examine the feasibility and relative efficacy of two models of on-line intervention for families of children with traumatic brain injury: one, a model emphasizing cognitive appraisals and problem solving skills; the other, emphasizing linking families to resources and providing professionally-moderated peer support.

Detailed description: The feasibility of the two interventions will be evaluated by examining family utilization of on-line materials and satisfaction with receiving services this way. Previous studies suggest the longer-term effects of TBI often create significant stress for both child and family and the need for psychological services.

Eligibility criteria: Inclusion Criteria:

* Child between 5 and 17 years old who experienced a TBI in the past 12 months

Primary outcomes:
measure: Previous investigations using problem solving therapy have documented large effect sizes on measures of problem solving and depression.
Secondary outcomes:
measure: Similarly, the single previous controlled intervention following pediatric traumatic brain injury (TBI) demonstrated a large effect on self-report measures of depression and anxiety.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Armando J Rotondi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wade SL, Fisher AP, Kaizar EE, Yeates KO, Taylor HG, Zhang N. Recovery Trajectories of Child and Family Outcomes Following Online Family Problem-Solving Therapy for Children and Adolescents after Traumatic Brain Injury. J Int Neuropsychol Soc. 2019 Oct;25(9):941-949. doi: 10.1017/S1355617719000778. Epub 2019 Aug 13.
citation: Wade SL, Kaizar EE, Narad M, Zang H, Kurowski BG, Yeates KO, Taylor HG, Zhang N. Online Family Problem-solving Treatment for Pediatric Traumatic Brain Injury. Pediatrics. 2018 Dec;142(6):e20180422. doi: 10.1542/peds.2018-0422. Epub 2018 Nov 9.
Clinical trial NCT02931422: Financial Incentives to Increase Pediatric HIV Testing Pilot Study (FIT-Pilot)
Official title: Financial Incentives to Increase Pediatric HIV Testing Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
financial incentive
pediatric HIV testing
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kenyatta National Hospital
name: University of Nairobi
First posted: 2016-10-13
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the pilot study is to evaluate the feasibility, acceptability and costs of a financial incentive intervention to motivate pediatric HIV testing in Western Kenya. The study will evaluate 3 cash incentive values and determine percent uptake of testing. A post-test questionnaire will explore parental satisfaction, mechanisms of incentive effectiveness and the impact of testing on emotional health and pediatric healthcare utilization.

Detailed description: The study will be a randomized trial with 3 arms (1:1:1 allocation) with small, medium, and large cash incentive. The investigators will randomize 60 parents with children of unknown status at Kisumu County Hospital in Western Kenya.

Eligibility criteria: Inclusion Criteria:

* Parent/caregiver receiving HIV care
* Parent/caregiver is female
* Parent/caregiver has one or more children \<13 years old
* Child is HIV exposed (parent/caregiver report or clinic confirmation)
* Caregiver reports child's HIV status is unknown

Exclusion Criteria:

-None

\*The investigators reserve the right to exclude any potential enrollee who is deemed to be a high personal risk, or whose children are at high personal risk, of interpersonal violence, by study participation.

Primary outcomes:
measure: HIV testing
timeFrame: Testing within 2 months of recruitment
Secondary outcomes:
measure: Parental satisfaction with incentives
timeFrame: 2 months of recruitment
measure: Motivational mechanism
timeFrame: 2 months
measure: Care seeking
timeFrame: 2 months
measure: Emotional impact
timeFrame: 2 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Kisumu County Hospital
Study officials:
affiliation: University of Washington
name: Jennifer A Slyker, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington/Kenyatta National Hospital
name: Irene N Njuguna, MBChB, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02801422: Neural Indices Associated With Relapse in Cannabis Dependence
Official title: Altered Neural Activation Patterns of Emotional Processing in Dependent Cannabis Users Associated With Relapse
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cannabis Dependence
Keywords: cannabis
fMRI
addiction
relapse
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
Collaborators: name: German Research Foundation
name: University Hospital, Bonn
First posted: 2016-06-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cannabis dependent individuals

Brief summary: The aim of this fMRI study is to investigate neural indices of relapse in cannabis dependence. The development and maintenance of drug addictions have been associated with deficits in cognitive control, craving and impaired stress regulation. Therefore, neural markers of brain processes underlying the beforementioned components will be studied. Subsequent follow-up drug use interviews will reveal associations between relapse in cannabis dependence and alterations in brain networks of cognitive control, craving and stress.


Eligibility criteria: Inclusion Criteria:

* Cannabis Dependence
* 24 hours abstinence

Exclusion Criteria:

* other DSM-4 diagnosis
* neurological disorder

Primary outcomes:
measure: fMRI neural activation patterns of emotional processing
timeFrame: one time point = fMRI assessment after minimum 24 hours of abstinence
Secondary outcomes:
measure: Timeline Followback Interviews
timeFrame: one time point = 12 months after fMRI data acquisition
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn
state: North Rhine Westfalia
Study officials:
References:
Clinical trial NCT06566222: Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors
Official title: Chemoradiotherapy After Surgery Versus Preoperative Chemoradiotherapy for Stage II/III Mid-low Rectal Cancer With or Without High-risk Factors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Radiotherapy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with low- and medium-level rectal cancer treated with chemoradiotherapy and surgery

Brief summary: The purpose of this observational study is to understand the effect of different timing of chemoradiotherapy on overall survival in patients with stage II/III low- and medium-level rectal cancer with or without high-risk factors


Eligibility criteria: Inclusion Criteria:

1. The patient is between 18 and 80 years old;
2. Adenocarcinoma confirmed by pathology;
3. Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal margin is ≤10cm;
4. ECOG score ≤2

(4) Imaging diagnostic analysis was cT1-3NxM0; (for Phase II/III) (5) CT examination of the chest and abdomen and pelvis showed no evidence of metastasis (6) Patients undergoing chemoradiotherapy and surgery

Exclusion Criteria:

1. History of malignant tumors in the past;
2. Diagnosis of simultaneous multiple primary colorectal cancer or other cancers;
3. History of chemotherapy or radiotherapy prior to this trial
4. Those with contraindications to laparoscopic surgery, such as severe cardiopulmonary insufficiency;
5. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc., requiring emergency surgery;
6. Pregnant or lactating women;
7. Evidence of distant metastases prior to surgery
8. T4b tumors were found to invade the uterus, vagina, bladder, seminal vesicles, prostate, bone, and pelvic plexus

Primary outcomes:
measure: Overall survival
timeFrame: 2024
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05814822: Targeting Insomnia to Improve Outcomes in Adults with Problematic Cannabis Use
Official title: Targeting Insomnia to Improve Outcomes in Adults with Problematic Cannabis Use
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: Cannabis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-04-18
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will compare the efficacy of telemedicine-delivered cognitive behavioral therapy for insomnia tailored for people using cannabis for sleep (CBTi-CB-TM) to telemedicine-delivered sleep hygiene education (SHE-TM) on sleep, cannabis use, and daytime functioning. We will also evaluate the effects of CBTi-CB-TM on fundamental sleep regulatory system - homeostatic sleep drive - and its association with clinical outcomes.


Eligibility criteria: Inclusion Criteria:

* Self-reported chronic insomnia
* Insomnia Severity Index (ISI) score indicative of at least mild insomnia
* Cannabis Use Disorder Identification Test-Revised (CUDIT-R) indicative of at least problematic cannabis use
* A positive urine drug screen (UDS) for cannabis
* Self-reported use of cannabis to manage insomnia at least three times weekly for the past month
* Stable residence (e.g., stable sleep arrangements), consistent access to Wi-Fi, and ability to travel to Ann Arbor for sleep laboratory assessments

Exclusion Criteria:

* Individuals who do not understand English
* Individuals judged unable to provide informed consent (e.g., intoxication, mental incompetence)
* Diagnosis or high suspicion of a sleep disorder other than insomnia
* Diagnosis of psychotic disorder, bipolar disorder, or post-traumatic stress disorder
* Terminal or progressive physical illness (e.g., cancer) or neurological degenerative disease (e.g., dementia)
* Use of medications known to have initiated their insomnia (e.g., steroids)
* Previous receipt of CBTi
* Self-reported pregnancy
* Self-reported regular work schedule of rotating or night (3rd) shift work.

Primary outcomes:
measure: Frequency of cannabis use as measured by the Timeline Followback (TLFB)
timeFrame: Up to 6 months after intervention, approximately 32 weeks
measure: Insomnia Severity Index (ISI) total score measured by the Insomnia Severity Index (ISI)
timeFrame: Up to 6 months after intervention, approximately 32 weeks
measure: Mental Composite Score (MCS-12) as assessed by the 12-item Short-Form Health Survey (SF-12)
timeFrame: Up to 6 months after intervention, approximately 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Todd Arnedt, PhD
role: PRINCIPAL_INVESTIGATOR
References: