louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05110430: Automated Detection of Metastatic Bone Disease on Bone Scintigraphy Scans
Official title: In Silico Clinical Trial Comparing the Reading Accuracy of Doctors and a Deep Learning Algorithm for Detection of Metastatic Bone Disease on Bone Scintigraphy Scans.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Bone Tumor
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: Aalborg University Hospital
name: Centre Hospitalier Universitaire de Liege
name: University Hospital, Aachen
name: University of Namur
First posted: 2021-11-08
Enrollment: 2365
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient who had an indication for undergoing bone scintigraphy in any of the participating centers.

Brief summary: Bone scintigraphy scans are two dimensional medical images that are used heavily in nuclear medicine. The scans detect changes in bone metabolism with high sensitivity, yet it lacks the specificity to underlying causes. Therefore, further imaging would be required to confirm the underlying cause. The aim of this study is to investigate whether deep learning can improve clinical decision based on bone scintigraphy scans.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent a bone scintigraphy scan that is available with the radiologic report between 2010-2018

Exclusion Criteria:

* The lack of a bone scan, or corresponding radiologic report

Primary outcomes:
measure: The classification performance of DL algorithm compared to the ground truth
timeFrame: June 2021
Secondary outcomes:
measure: Comparing the classification performance of the DL algorithm to that of physicians
timeFrame: June 2021
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References:
citation: Ibrahim A, Vaidyanathan A, Primakov S, Belmans F, Bottari F, Refaee T, Lovinfosse P, Jadoul A, Derwael C, Hertel F, Woodruff HC, Zacho HD, Walsh S, Vos W, Occhipinti M, Hanin FX, Lambin P, Mottaghy FM, Hustinx R. Deep learning based identification of bone scintigraphies containing metastatic bone disease foci. Cancer Imaging. 2023 Jan 25;23(1):12. doi: 10.1186/s40644-023-00524-3.
Clinical trial NCT01956630: Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT
Official title: Clinical Study of Genetically Modified Dendritic Cells Combining to Cytokine-Induced Killer Cells for Patients With Relapse Acute Leukemia After Allo-HSCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Leukemia
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 25
Sex: ALL
Minimum age (years): 8
Maximum age (years): 61
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Allogeneic hematopoietic cell transplantation(Allo-HSCT) is currently an effective treatment for Acute leukemia (AL). Relapse after transplantation, being a main obstacle for patient survival, is so far treated by second transplantation and donor leukocyte infusion (DLI), which seems to have high risk and low survival. Need for a new medication on relapse is urgent. The immunotherapy using Dendritic cells (DCs) combined with cytokine induced killer (CIK) cells holds promise for the adjuvant treatment of AL to eradicate or control residual disease. This randomized study was conducted to evaluate the feasibility and effective of genetically modified DCs combining to CIK immunotherapy in relapse AL after allo-HSCT.


Eligibility criteria: Inclusion Criteria:

* AL patients according to the WHO criteria
* expected survival duration of more than 3 months
* age between 8 and 61years

Exclusion Criteria:

* underlying autoimmune disease
* positive serology for HIV infection
* chronic active hepatitis

Primary outcomes:
measure: Overall survival
timeFrame: up to 3 years
Secondary outcomes:
measure: Gvhd incidence
timeFrame: 100 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Hematopoietic Stem Cell Transplantation
Study officials:
affiliation: Affiliated Hospital to Academy of Military Medical Sciences
name: Hu Chen, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang D, Huang XF, Hong B, Song XT, Hu L, Jiang M, Zhang B, Ning H, Li Y, Xu C, Lou X, Li B, Yu Z, Hu J, Chen J, Yang F, Gao H, Ding G, Liao L, Rollins L, Jones L, Chen SY, Chen H. Efficacy of intracellular immune checkpoint-silenced DC vaccine. JCI Insight. 2018 Feb 8;3(3):e98368. doi: 10.1172/jci.insight.98368. eCollection 2018 Feb 8.
Clinical trial NCT02797730: Study of Impact of Art Therapy Sessions Given to Family Caregivers of Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Keywords: Art Therapy
Caregiver's
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diagnostic of diabetes in childhood brought modification of family way of life, particularly in child and caregivers lifes.

The education patient programs are in France centered on curative competencies of care.

It is possible that art-therapy improve psycho-social competencies The aim of the study is to evaluate art-therapy sessions on quality of life of caregivers


Eligibility criteria: Inclusion Criteria:

* one of the family caregivers of child with diabetes enrolled in patient education programs of 3 hospitals (Hospital of Poitiers, Hospital of Niort and Hospital of La Rochelle)
* who accept the study
* ≥ 18 years
* free, with protection of vulnerable adult
* caregivers of child with who have insurance
* with free, enlightened, signed consent

Exclusion Criteria:

* other research participation
* \< 18 years
* host family
* with protection of vulnerable adult
* caregivers of child with who have not insurance

Primary outcomes:
measure: PedsQL Family Impact score to assess Family Quality of Life
timeFrame: 6 weeks
Secondary outcomes:
measure: Anxiety score of caregivers
timeFrame: 6 weeks
measure: self esteem score of caregivers
timeFrame: 6 weeks
measure: quality of life score
timeFrame: 6 weeks
measure: satisfaction score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: La rochelle
country: France
facility: La rochelle
city: Niort
country: France
facility: NIORT
city: Poitiers
country: France
facility: POITIERS
Study officials:
References:
Clinical trial NCT00764530: Cementless Alumina-Alumina Total Hip and Hybrid
Official title: Keramos Ceramic/Ceramic Total Hip System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Osteoarthritis
Post-traumatic Arthritis
Avascular Necrosis
Lead sponsor: Encore Medical, L.P.
Sponsor class: INDUSTRY
First posted: 2008-10-02
Enrollment: 342
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: Evaluate the safety and efficacy of the CeramTec Acetabular Alumina Insert and CeramTec Alumina head when used with the Foundation Porous Coated Acetabular Shell and an Encore hip stem.


Eligibility criteria: Inclusion Criteria:

* Patients with inflammatory tissue disorders (e.g. rheumatoid arthritis, lupus, etc), osteoarthritis, post-traumatic arthritis or secondary arthritis, or avascular necrosis.
* Less than 70 on preoperative HHS score
* Primary total hip replacement
* Patient is likely to be available for evaluation for the duration of the study.

Exclusion Criteria:

* Patients with physical conditions that would eliminate adequate implant support or prevent the use of an appropriately sized implant (e.g., tumor)
* Previous surgery that has adversely affected bone stock (such as some hip pinning or some osteotomies) or prior total hip replacement.
* Insufficient quality or quantity of bone resulting from conditions such as:

  * Cancer, where radiation has destroyed the available bonestock
  * Congenital dislocation
  * Metabolic bone disease of the upper femur or pelvis
  * Femoral osteotomy revision
  * Girdlestone revision
  * Active infection of the hip joint
  * Old or remote infection
  * Other conditions that lead to inadequate skeletal fixation
* Neurological conditions that might hinder patient's ability to follow study procedures, e.g., to restrict physical activities (e.g., Severe Parkinson's, CVA on affected side)
* Patient's mental condition that may interfere with his ability to give an informed consent or willingness to fulfill the required follow-up of the study

  * Mental illness
  * Senility
  * Drug Abuse
  * Alcoholism
* Conditions that place excessive demands on the implant

  * Charcot's joints
  * Muscle deficiencies
  * Multiple joint disabilities
  * Refusal to modify postoperative physical activities
  * Skeletal immaturity
  * Obesity (50% over recorded body weight mass index)
* Greater than or equal to 70 on preoperative HHS score

Primary outcomes:
measure: Alumina/Alumina articulation will perform as well as the alumina/polyethylene.
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Mark Newman, Inc.
state: California
city: Charleston
country: United States
facility: Charleston Orthopaedic Assoc.
state: South Carolina
city: Richmond
country: United States
facility: Advanced Orthopaedic Centers
state: Virginia
Study officials:
References:
Clinical trial NCT05488730: Role of Echocardiography in Guiding Fluid Therapy in Shocked Patients With Impaired Cardiac Contractility in Emergency Department
Official title: Role of Echocardiography in Guiding Fluid Therapy in Shocked Patients With Impaired Cardiac Contractility in Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shock
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: fluid therapy is one of the cornerstones in the management of shock but may result in iatrogenic fluid overload .The aim of this study was to assess the role of echocardiography in guiding fluid therapy in shocked patients with impaired cardiac contractility using straight leg raising test ,Inferior vena-cava collapsability index and Doppler imaging in Emergency Department in Alexandria main university hospital.


Eligibility criteria: Inclusion Criteria:

* shocked patient with impaired cardiac contractility

Exclusion Criteria:

* Trauma patients.
* Patient with unstable arrhythmias.
* Patients with lower limb amputation.
* Mechanically ventilated patients.
* Patients with prosthetic aortic valve.
* Patients less than 18 years old
* Pregnant.

Primary outcomes:
measure: LVOT VTI variability
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT05075330: SMART Trial: Community Stigma Reduction
Official title: SMART Trial: Reducing Stigma Towards Opioid Use Disorder at the Community Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Stigma, Social
Keywords: stigma
opioid use disorder
community
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-10-12
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants assigned to intervention or control based on zip code of primary residence.
Primary purpose: TREATMENT

Brief summary: The goal of this project is to engage community members from two low-income African American communities (N=200) in a survey study that assesses stigma toward those with Opioid Use Disorder (OUD). Those from the intervention community will be subject to a stigma reduction campaign via billboards. Those from the control community will not. Stigma will be re-assessed following the period of the campaign.


Eligibility criteria: Inclusion Criteria:

* Identify as African American or Mixed race
* Reside in Frayser or Orange Mound Communities
* Access to telephone for follow-up assessment

Exclusion Criteria:

* Unable to understand consent procedures

Primary outcomes:
measure: Stigma score
timeFrame: Change from baseline stigma score at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Karen Derefinko, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05977530: Teaching Young Children Swim Survival Skills
Official title: Teaching Young Children Swim Survival Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drowning
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study is designed to evaluate whether commercially-available swim self-rescue schools are effective to teach children ages 12-23 months to stay safely alive floating in the water (or grasping the pool's edge) without adult intervention. The investigators will measure children's water self-rescue skills at baseline and then they will engage in commercially-available training over the course of several weeks. The investigators will then measure their skills again. Assessments will be conducted using a standardized protocol with a certified lifeguard present. Parents will also complete a short survey concerning child and family demographics and child and family swim and lifeguard training experience.


Eligibility criteria: Inclusion Criteria:

* child ages 12-23 months
* enrolled in self-rescue course at participating swim facility

Exclusion Criteria:

* medical conditions counter-indicating training in water
* previous experience in self-rescue swim courses

Primary outcomes:
measure: Children's Self-rescue Ability
timeFrame: at completion of training intervention program, an anticipated average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Youth Safety Lab, University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT02281630: Phase II Dose-Finding Study of KWA-0711 in Patients With Chronic Constipation (CC)
Official title: Phase II, Randomized, Placebo-controlled, Double-blind, Parallel-group Study of KWA-0711 Administered Orally for 4 Weeks to Evaluate Its Efficacy and Safety, and to Determine Its Optimal Dose in Patients With Chronic Constipation (CC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Constipation
Keywords: Chronic Constipation
CC
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-11-02
Enrollment: 388
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of KWA-0711, and to determine its optimal dose in Chronic Constipation (CC) patients.


Eligibility criteria: Inclusion Criteria:

* The patients who experienced fewer than three SBMs per week for more than 6 months prior to the enrollment.
* The patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation.

Exclusion Criteria:

* Patients who have secondary constipation caused by systemic disorder.
* Patients who have organic constipation.
* Patients who received intestinal resection.

Primary outcomes:
measure: Change from baseline in the weekly number of Spontaneous Bowel Movements (SBMs) at Week 1
timeFrame: 1 week
Secondary outcomes:
measure: Complete SBM (CSBM) frequency and responder rate
timeFrame: 4 weeks
measure: SBM frequency and responder rate
timeFrame: 4 weeks
measure: Time to first SBM after the initial dose
timeFrame: 4 weeks
measure: Stool consistency
timeFrame: 4 weeks
measure: Degree of straining
timeFrame: 4 weeks
measure: Abdominal bloating and discomfort
timeFrame: 4 weeks
measure: Use of rescue medications
timeFrame: 4 weeks
measure: Global assessment of constipation severity
timeFrame: 4 weeks
measure: Japanese version of IBS-QOL
timeFrame: 4 weeks
measure: Global assessment of treatment effectiveness
timeFrame: 4 weeks
measure: Satisfaction rating for the condition of bowel movements
timeFrame: 4 weeks
measure: Adverse events, ECGs, vital signs, and clinical labs
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Tokyo and Other Japanese City
country: Japan
Study officials:
affiliation: Kissei Pharmaceutical Co., Ltd.
name: Tatsuro Takei
role: STUDY_DIRECTOR
References:
citation: Fukudo S, Endo Y, Hongo M, Nakajima A, Abe T, Kobayashi H, Nakata T, Nakajima T, Sameshima K, Kaku K; Mizagliflozin Study Group. Safety and efficacy of the sodium-glucose cotransporter 1 inhibitor mizagliflozin for functional constipation: a randomised, placebo-controlled, double-blind phase 2 trial. Lancet Gastroenterol Hepatol. 2018 Sep;3(9):603-613. doi: 10.1016/S2468-1253(18)30165-1. Epub 2018 Jul 25.
Clinical trial NCT03632330: Sedation Of Adult Patients Undergoing Gastrointestinal Endoscopy: A Network Meta-analysis
Official title: SEDATION OF ADULT PATIENTS UNDERGOING GASTROINTESTINAL ENDOSCOPY: A NETWORK META-ANALYSIS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Endoscopy
Sedation
Dexmedetomidine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-08-15
Enrollment: 6963
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two reviewers independently extract data, including outcomes of interests, demographics of the enrolled patients' population, inclusion and exclusion criteria for each study, the comparative drug used, the number of patients in each group, sedation target and posology.

Brief summary: The objective of this study is to compare the efficacy and safety of dexmedetomidine with other sedatives in sedation during endoscopy by analyzing the most recently published interventional trials and observational studies.

Detailed description: A variety of sedatives are available in procedural sedation and the efficacy \& safety have been compared in several trials for procedural sedation. However, none of clinical trial has enough number of patients to clarify the conclusive differences among sedatives. Thus, pooling all available studies together systematically by network meta-analysis for GI endoscopic procedure may provide a better understanding of efficacy and safety of sedatives. Therefore we would like to conduct a network meta-analysis to analyze the outcomes of GI endoscopy by using the most recently-published interventional trials.

Eligibility criteria: * Inclusion criteria We will include studies if they (1) the setting was using any sedative for endoscopy for an procedural sedation (2) the study compared dexmedetomidine with other sedative for sedative therapy and (3) the outcomes included satisfaction score and adverse events.
* Exclusion criteria We excluded studies if they (1) the number of sedative was different in two arms (2) did not report the specific results comparing dexmedetomidine with other sedatives.

Primary outcomes:
measure: Number of subjects who experience desaturation
timeFrame: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure.
Secondary outcomes:
measure: Number of subjects who experience Hypotension
timeFrame: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure
measure: Number of subjects who experience Bradycardia
timeFrame: From first infusion of the sedative agent until awakening approximately up to 2 hours after the procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer Korea
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01649830: Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
Official title: Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Astrocytoma
Oligodendroglioma
Oligodendroastrocytoma
Keywords: low-grade glioma
radiotherapy
chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2012-07-25
Enrollment: 290
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: Low-grade glioma (LGG) is a common primary brain tumor in young adults. The infiltrative nature and frequent growth in eloquent area in brain often makes total resection impossible. Until now, no agreement has been achieved on the treatment of LGG without total resection. Post-radiation adjuvant temozolomide (TMZ) is currently the standard of care for high-grade gliomas. Radiotherapy or TMZ is recommended for the treatment of residue low-grade gliomas. However, the efficacy of combined radiotherapy with adjuvant TMZ for residue LGG remains to be defined. In this randomized controlled trial, the investigators will test the hypothesis that radiotherapy with subsequent TMZ chemotherapy is superior to improve the progression-free survival of patients with residue LGG without significant impairment to quality of life compared to radiotherapy alone.


Eligibility criteria: Inclusion Criteria:

* Age: 18 years to 60 years
* Incompletely resected supratentorial WHO II astrocytoma, oligodendroglioma or oligodendroastrocytoma
* Karnofsky Performance Score ≥ 60
* Adequate bone marrow, liver and renal function
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent

Exclusion Criteria:

* Refusal to participate the study
* Known hypersensitivity or contraindication to temozolomide
* Previous irradiation, prior radiosurgery or prior chemotherapy
* Pregnant or lactating females
* Malignant tumor other than brain tumor
* Contraindicated for MRI examination
* Unable to comply with the follow-up studies of this trial

Primary outcomes:
measure: Progression-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Quality of life
timeFrame: 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Zhong-ping CHEN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: