louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03324724: Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders
Official title: Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders (ICAT-A)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Emotional Disorder
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Eating Disorders Association
First posted: 2017-10-30
Enrollment: 17
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Recently, Integrative Cognitive-Affective Therapy (ICAT), a novel intervention for bulimia nervosa (BN) and binge eating disorder (BED) that targets emotion regulation deficits, has shown promise in reducing eating disorder symptoms as well as improving emotion regulation capacities in adults. However, this treatment has not been investigated in an adolescent sample. Given the contributing role of emotion regulation in adolescent eating disorder symptoms and limited treatment options for adolescents with BN and BED, the aim of this study is to adapt the existing adult ICAT treatment for adolescents with clinically significant binge eating (ICAT-A) and to evaluate the extent to which ICAT-A is helpful in reducing binge eating and associated eating disorder symptoms in a younger sample.


Eligibility criteria: Inclusion Criteria:

* Subject with full and sub-threshold bulimia nervosa and binge eating disorder (that is binge eating weekly)
* No major weight loss (defined as a reduction of 10% baseline body weight or more)
* Subject who meet criteria for any Diagnostic and Statistical Manual of Mental Disorders (DSM-5) eating disorder characterized by binge eating with or without compensatory behavior
* Subjects who take medications that do not directly impact weight or appetite (including Selective serotonin reuptake inhibitors (SSRI) antidepressants) will be included if their dose has been stable for at least six weeks
* Subject must be living at home
* At least one parent/guardian is willing to participate in the treatment.

Exclusion Criteria:

* Subject on medications that influence weight or appetite (including antipsychotic medications)
* Subject who is medically or psychiatrically unstable (defined as requiring hospitalization within the past 3 months)
* Acutely suicidal requiring current hospitalization or who meet criteria for substance use disorder in the past month
* Subjects who become or psychiatrically unstable during the study will be re-evaluated, removed from the study, and referred for appropriate treatment.

Primary outcomes:
measure: Change in Eating Disorder Examination (EDE)
timeFrame: baseline, end of treatment (approximately 8 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jocelyn R Lebow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01236924: Effectiveness of Global Postural Reeducation in Patients With Chronic Symptomatic Lumbar Disc Herniation
Official title: Effectiveness of Global Postural Reeducation in Patients With Chronic Symptomatic Lumbar Disc Herniation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lumbar Disc Herniation.
Lead sponsor: Universidade Gama Filho
Sponsor class: OTHER
First posted: 2010-11-09
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Slipped disc is the rupture of the fibrous ring, with subsequent displacement of the nucleus pulposus in intervertebral spaces, which may cause compression of nerve structures. It is estimated that 2-3% of the population have taken with this process, whose prevalence is 4.8% in men and 2.5% in women over 35 years. Thus, the purpose of this study is to verify the effectiveness of global postural reeducation in patients diagnosed with chronic symptomatic lumbar disc herniation with the application of a randomized controlled trial. Will be measured pain, disability and functional flexibility.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed with chronic symptomatic lumbar disc herniation

Exclusion Criteria:

Patients who work with severe overloading of the spine, patients with central neurological pathology, wheelchair users, patients who use bracing and support those who submit two consecutive absences to the treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Gama Filho University
state: RJ
Study officials:
References:
Clinical trial NCT06626724: A Retrospective Cohort Study on Predicting Delayed Graft Function in Liver Transplant Patients with Hepatocellular Carcinoma: a Nomogram and Machine Learning Approaches.
Official title: A Retrospective Cohort Study on Predicting Delayed Graft Function in Liver Transplant Patients with Hepatocellular Carcinoma: a Nomogram and Machine Learning Approaches.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma (HCC)
DGF
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving a liver transplant between January 2020 and April 2024.

Brief summary: Background: This study aimed to develop a predictive model for delayed graft function (DGF) in liver transplant patients with hepatocellular carcinoma (HCC) based on preoperative biochemical indicators, using both logistic regression and XGBoost machine learning algorithms.

Methods: A retrospective cohort study was conducted, including 131 liver transplant patients from January 2020 to April 2022. Preoperative biochemical markers and hematological parameters were analyzed. Logistic regression and XGBoost models were constructed to predict DGF, and their performance was evaluated using the area under the ROC curve (AUC). Shapley Additive Explanations (SHAP) analysis was employed to interpret the feature contributions.


Eligibility criteria: Inclusion Criteria:

1. Patients with liver cancer aged between 18 and 75 years.
2. Patients who have received liver transplantation.
3. Complete preoperative and postoperative medical imaging data, clinical records and pathological test reports are available.

Exclusion Criteria:

1. Primary non-hepatocellular carcinoma
2. Recipients were younger than 18 years and older than 75 years
3. Due to incomplete or missing clinical data, this dataset did not meet the criteria for inclusion in the statistical analysis.
4. Serious complications associated with liver transplantation, such as acute transplant rejection or transplant liver failure, occur within 7 days after surgery.
5. Re-surgery within 7 days after surgery due to liver transplant-related complications or other surgical procedures, such as transplant site infection or other major surgery.

Primary outcomes:
measure: TBIL/AST/ALT/INR
timeFrame: Results of biochemical examination on the 7th day after liver transplantation in patients with hepatocellular carcinoma.
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References:
Clinical trial NCT00568724: Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis
Official title: Urinary Biomarkers as Predictors on Renal Function in Congenital Hydronephrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ureteral Obstruction
Keywords: Hydronephrosis
Ureteral obstruction
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2007-12-06
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children referred to surgical treatment of congenital hydronephrosis caused by ureteral obstruction.

Brief summary: The purpose of this study is to detect new urinary biomarkers that can be used as predictors on renal function in congenital hydronephrosis caused by unilateral ureteral obstruction (UUO) and to elucidate the pathophysiology of UUO.


Eligibility criteria: Inclusion Criteria:

* Children referred to surgical treatment of congenital hydronephrosis caused by ureteral obstruction.
* Declining function of the hydronephrotic kidney more than 5 %, and to less than 40 % of the total renal function OR ipsilateral flank pain.

Exclusion Criteria:

* Bilateral hydronephrosis
* Previous operation in the urinary system except operation for phimosis and other deformations of the external genital organs.
* Deformations in the lower part of the ureter, bladder and urethra. Urinary stones. Reflux. Urinary tract infections \< 6 months.
* Neurogenic bladder dysfunction.
* GFR \< 40 % standardized to age.
* Non-compliance. Linguistic difficulties.

Primary outcomes:
measure: Urinary cytokines
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Institute of Clinical Medicine, University of Aarhus
Study officials:
affiliation: Department of Urology, Aarhus University Hospital Skejby
name: Troels M Jørgensen, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madsen MG, Norregaard R, Palmfeldt J, Olsen LH, Frokiaer J, Jorgensen TM. Urinary NGAL, cystatin C, beta2-microglobulin, and osteopontin significance in hydronephrotic children. Pediatr Nephrol. 2012 Nov;27(11):2099-2106. doi: 10.1007/s00467-012-2217-6. Epub 2012 Jun 19.
Clinical trial NCT04859634: Real-time Artificial Intelligence System for Detecting Multiple Ocular Fundus Lesions by Ultra-widefield Fundus Imaging
Official title: Real-time Artificial Intelligence System for Detecting Multiple Ocular Fundus Lesions by Ultra-widefield Fundus Imaging: A Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Artificial Intelligence
Diagnostic Imaging
Abnormality of the Fundus
Diagnostic Screening Programs
Keywords: Artificial Intelligence
Deep learning
Ultra-widefield Fundus Imaging
Ocular Fundus Lesions
Diagnostic Screening Programs
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Shenzhen Eye Hospital
name: Xudong Ophthalmic Hospital
name: IKang Physical Examination Center
name: Beijing Tongren Hospital
name: Guangdong Provincial People's Hospital
name: Yangxi General Hospital People's Hospital
First posted: 2021-04-26
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the participants who agree to take ultra-widefield fundus images.

Brief summary: This prospective multicenter study will evaluate the efficacy of a real-time artificial intelligence system for detecting multiple ocular fundus lesions by ultra-widefield fundus imaging in real-world settings.

Detailed description: The ocular fundus can show signs of both ocular diseases (e.g., lattice degeneration, retinal detachment and glaucoma) and systemic diseases (e.g., hypertension, diabetes and leukemia). The routine fundus examination is conducive for early detection of these diseases. However, manual conducting fundus examination needs an experienced retina ophthalmologist, and is time-consuming and labor-intensive, which is difficult for its routine implementation on large scale.

This study will develop an artificial intelligence system integrating with ultra-widefield fundus imaging to automatically screen for multiple ocular fundus lesions in real time and evaluate its performance in different real-world settings. The efficacy of the system will compare to the final diagnoses of each participant made by experienced ophthalmologists.

Eligibility criteria: Inclusion Criteria:

All the participants who agree to take ultra-widefield fundus images.

Exclusion Criteria:

1. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths.
2. Patients who do not agree to sign informed consent.

Primary outcomes:
measure: Accuracy
timeFrame: 8 months
Secondary outcomes:
measure: Sensitivity
timeFrame: 8 months
measure: Specificity
timeFrame: 8 months
measure: Cohen's kappa coefficient
timeFrame: 8 months
measure: False-positive rate
timeFrame: 8 months
measure: False-negative rate
timeFrame: 8 months
measure: Data processing time of AI system
timeFrame: 8 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT04910334: Long-term Cognitive and Functional Status After COVID-19 Treatment at Danish ICUs
Official title: Long-term Cognitive and Functional Status After COVID-19 Treatment at Danish ICUs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: covid-19
danish icu
long-term follow-up
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is all Danish speaking COVID-19 patients, admitted and treated at one of the 29 Danish ICUs, and enrolled in the 'Danish ICU COVID-19 database' from March 10th and forward. Patients are 18 of age and above with a positive polymerase chain reaction (PCR) test for SARS-CoV-2 either prior to or during ICU admission

Brief summary: This study is a prospective observational cohort study of 6 and 12 months long-term outcome of Danish speaking patients with COVID-19.

Detailed description: To describe frailty, cognitive function, functional status, fatigue, mortality and the quality of life 6 and 12 months after ICU admission of the COVID-19 patients enrolled in the Danish ICU COVID-19 database. Furthermore to investigate the association between ventilator days and Clinical Frailty Score (CFS) and the MiniMoCA, respectively at 6 and 12 months after ICU admission

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* enrolled in the 'Danish ICU COVID-19 database'

Exclusion Criteria:

* non danish speaking patients

Primary outcomes:
measure: The cognitive status at 6 and 12 months after ICU admission using the validated instrument MiniMoCA
timeFrame: at 6 and 12 months after ICU admission
measure: The functional status at 6 and 12 months after ICU admission using the validated instrument CFS
timeFrame: at 6 and 12 months after ICU admission
Secondary outcomes:
measure: The association between ventilator days and CFS 6 and 12 months after ICU admission
timeFrame: at 6 and 12 months after ICU admission
measure: The association between ventilator days and MiniMoCA 6 and 12 months after ICU admission
timeFrame: at 6 and 12 months after ICU admission
measure: Mortality 6 and 12 months after ICU admission
timeFrame: at 6 and 12 months after ICU admission
measure: EQ-5D-5L score 6 and 12 months after ICU admission
timeFrame: at 6 and 12 months after ICU admission
measure: Barthel ADL score 6 and 12 months after ICU admission
timeFrame: at 6 and 12 months after ICU admission
measure: Lawton-Brody IADL score 6 and 12 months after ICU admission
timeFrame: at 6 and 12 months after ICU admission
measure: FAS score 6 and 12 months after ICU admission
timeFrame: at 6 and 12 months after ICU admission
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Department of Anaesthesiology
Study officials:
affiliation: Department of Anaesthesiology and Intensive Care
name: Lone Poulsen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05139134: Immunohistochemical Expression of CXCL5 as a Valuable Prognostic Marker in Urinary Bladder Urothelial Carcinoma
Official title: Immunohistochemical Expression of CXCL5 as a Valuable Prognostic Marker in Urinary Bladder Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Bladder Urothelial Carcinoma
Keywords: CXCL5
Urothelial Carcinoma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifty specimens of urothelial carcinoma obtained from patients in Urology Department of Sohag Faculty of Medicine,

Brief summary: Urothelial carcinoma is common malignant tumor worldwide, it remains a challenge in the oncology field, it is an ideal for research on biomarkers that could identify tumor progression and prognosis. CXCL5 have been implicated in progression of many cancers, but their significance in urinary bladder UC remains unclear.

Detailed description: Bladder carcinoma has become a common cancer globally, Incidence rates are highest in Europe, the United States and Egypt. In Egypt, bladder carcinoma was considered the third most common tumor; Egyptian males have the highest mortality rates. UC of the urinary bladder represents about 90% of all bladder cancers.

CXCL5 is a chemokine, belonging to ‗ELR+' subgroup. It plays an important role in angiogenesis and tumor migration. Numerous reports have indicated that CXCL5 plays important roles in cancer progression, including cholangiocarcinoma, prostate cancer, and gastric cancer. Studying the IHC expression of CXCL5 in UC to assess its role in tumor cell proliferation, migration and spread is needed.

Eligibility criteria: Inclusion Criteria:Patients with primary invasive and non-invasive urinary bladder urothelial carcinomas.

-

Exclusion Criteria:

* - Patients received pre-operative chemotherapy or radiotherapy.
* Patients with insufficient clinical data.
* Specimens with extensive necrosis
* Tiny specimens which are insufficient for accurate diagnosis.

Primary outcomes:
measure: assess the expression of CXCL5 in urothelial carcinoma
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University
Study officials:
affiliation: Sohag University
name: Nagwa Ahmed, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03299634: Oral Mucosal Lesions Among Smokers in an Egyptian Population Study.
Official title: Prevalence of Oral Mucosal Lesions Among Smokers in an Egyptian Cohort: A Hospital-based Cross-Sectional Study (I)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smokers
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 840
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The participants will be selected from the pool of the Clinics of Oral Medicine, Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry - Cairo University. For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.

Brief summary: This cross-sectional study will assess the prevalence of oral changes among smokers in an Egyptian cohort (patients attending to the hospital of Faculty of Dentistry - Cairo University), aiming that this study can serve as a baseline for future studies with the goal of finding ways to improve oral health and increase awareness of the hazards of smoking in Egypt

Detailed description: The participants will be selected from the pool of the Clinics of Oral Medicine, Periodontology and Diagnosis Department and the Diagnostic center, Faculty of Dentistry - Cairo University. For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.

Eligibility criteria: Inclusion Criteria:

* Gender: males and females.
* Age: all age groups.
* Smokers.
* Individuals who agreed to sign the informed consent.

Exclusion Criteria:

* Individuals suffering from any systemic disease.
* Individuals on medications.
* Non-Egyptians.

Primary outcomes:
measure: oral mucosal lesions
timeFrame: one year
Secondary outcomes:
measure: Oral health-related quality of life (OH-QoL) evaluation
timeFrame: one year
measure: dysplasia
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06297434: Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of J2H-1702 for Non-alcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-alcoholic Steatohepatitis
Lead sponsor: J2H Biotech
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH.

Detailed description: Subjects will be randomized to the study group 1 (J2H-1702 A mg), study group 2 (J2H-1702 B mg), study group 3 (J2H-1702 C mg), or control group (placebo of J2H-1702) in a 1:1:1:1 ratio and administered the investigational product (IP) for 12 weeks. After the IP administration, the safety and efficacy will be evaluated at V4, V8 and V12 (end of treatment, EOT).

Eligibility criteria: Inclusion Criteria:

1. A subject aged ≥19 years to ≤75 years
2. Meeting all of the following criteria:

   * Screening MRI-PDFF with ≥8% steatosis
   * Screening MRE with liver stiffness ≥2.5 kPa
   * ALT or AST ≤250 IU/L at screening
3. Willing to maintain the same lifestyle (exercise, alcohol consumption, diet, etc.) during the study
4. Voluntarily provide written consent to participate in the study

Exclusion Criteria:

1. A subject who has past or current history of liver diseases
2. A subject who has the following medical or surgical history

   * Severe cardiac diseases, Malignant tumors, Clinically significant hypersensitivity reaction to any drugs containing components of the 11β-HSD1 inhibitor or same class
3. A subject who has the following concomitant diseases

   * liver disease, uncontrolled hypertension, uncontrolled DM, etc.
4. A subject who has taken the following medications

   * Systemic glucocorticoids, NSAIDs, any medication that may induce fatty liver disease, etc.
5. A subject who has taken IP of another study
6. A subject who does not agree with appropriate methods of contraception

Primary outcomes:
measure: Changes from baseline in results on MRI-PDFF at week12.
timeFrame: Baseline and week12
measure: Changes from baseline in results on MRE at week12.
timeFrame: Baseline and week12
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: J2H Biotech
state: Gyeonggi-do
Study officials:
References: