louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05093751: Automated Segmentation and Volumetry for Meningioma Using Deep Learning
Official title: Automated Meningioma Segmentation and Volumetry Using a nnU-Net Based Architecture on Contrast-enhanced MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningioma
Artificial Intelligence
Keywords: Meningioma
Artificial intelligence
autosegmentation
volumetry
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intracranial meningioma patients who were diagnosed by MRI are study population of this study. Inclusion in this study have not been decided according to whether or not surgery for tumor resection was performed or MRI thickness and magnetic power.

Brief summary: U-Net-based architectures will be applied to 500 contrast-enhanced axial MR images of different patients from a single institution after manual segmentation of meningioma, of which 50 were used for testing. Tumor volumetry after autosegmentation by trained U-Net-based architecture is final goal.

Detailed description: U-Net-based architectures will be applied to 500 contrast-enhanced axial MR images of different patients from a single institution after manual segmentation of meningioma, of which 50 were used for testing. After preprocessing with Z-isotropification and intensity normalization of images, 3 U-Net-based networks (2D U-Net, Attention U-Net, 3D U-Net) and 3 nnU-Net-based networks (2D nnU-Net, Attention nnU-Net, 3D nnU-Net) will be trained with meningioma-segmented images. For applying to 3D networks, sagittal and coronal images will be reconstructed using axial images. After prediction, the cut-off of the probability function, which is a trade-off, will be obtained with the Gaussian Mixture Modeling algorithm using the probability density function. The voxels having a probability function higher than that will be finally predicted as meningioma. Tumor volume is calculated as the sum of the product of segmented area and thickness of axial images. For performance evaluation, dice similarity coefficient (DSC), precision, and recall will be evaluated compared with manually segmented voxels for validation datasets. The results of volumetry of each model will be compared with manual segmentation-based volume through Pearson's correlation analysis.

Eligibility criteria: Inclusion Criteria:

* Radiologically diagnosed meningioma by MRI

Exclusion Criteria:

* under 18 years old
* Multiple meningiomas
* Orbital meningioma
* Any prior treatment for intracranial meningioma before registration

Primary outcomes:
measure: Accuracy compared with ground truth
timeFrame: 10-01-2020 until 09-30-2021
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01468051: Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients
Official title: A Randomized Controlled Trial of Two Schedules of Hepatitis B Vaccination in Predialysis Chronic Renal Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
Keywords: predialysed
chronic
renal failure patients
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 51
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with chronic renal disease have to be vaccinated as soon as dialysis is forestalled and this could improve seroconversion rate of hepatitis B vaccination.

In this study, the investigators aimed to compare seroconversion rates and immune response rates using four doses of 40 μg and three doses of 20 μg of Euvax B recombinant hepatitis B surface antigen (HBsAg) vaccine given to predialysis CKD patients.

Detailed description: In an open, randomized clinical trial, the investigators compared seroconversion rates in 51 predialysis patients with mild and moderate chronic renal failure using either 40 μg 4 doses or 20 μg 3 doses of Euvax B recombinant hepatitis B vaccine administered at 0, 1, 2, 6 and 0, 1, 6 months respectively.

Eligibility criteria: Inclusion Criteria:

* predialysis patients,
* \> 18 years with mild and moderate chronic renal failure,
* serum creatinine between 1.5-6 mg/dl

Exclusion Criteria:

* patients with severe renal failure,
* serum creatinine \> 6 mg/dl,
* requiring dialysis or expected to require dialysis within 1 year,
* receiving immunosuppressive treatment,
* known lymphoproliferative disorder.

Primary outcomes:
measure: Hepatitis B surface antibody mIU/ml
timeFrame: 8-10 weeks after the 6-month dose of vaccine
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06141551: Intradural Disc Herniation: a Case Report and Review of Complications
Official title: Intradural Disc Herniation: a Case Report and Review of Complications
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Disc Herniation
Keywords: Intradural disc herniation
Complications
Degenerative spinal disease
Decompression
Lead sponsor: Gansu Provincial Hospital
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 1
Sex: MALE
Minimum age (years): 40
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A male 40-year-old patient with IDH

Brief summary: This observational study collects clinical data as well as pathological reports from a patient with an intradural disc herniation, reports on the course of the patient's recovery through surgical treatment, summarizes the complications of this type of disease, and provides new ideas for improving the chances of preoperative diagnosis.

Detailed description: We collect the patient's personal history, family history, reason for visit, visit flow, clinical data, pathology reports, and surgical images and videos.

Eligibility criteria: Inclusion Criteria:

* IDH patients

Exclusion Criteria:

* no

Primary outcomes:
measure: physiology
timeFrame: 07/2023
Secondary outcomes:
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Gansu Provincial People's Hospital
state: 甘肃
Study officials:
affiliation: Gansu Provincial People's Hospital
name: Hui Zhang, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT02264951: Fat-induced Release of GLP-1 in Humans
Official title: Short Fatty Acids-induced Release of GLP-1 in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Short fatty acids
2-oleoyl glycerol
GLP-1 secretion
C8-diet oil
GIP secretion
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
First posted: 2014-10-15
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study compared the incretin-releasing effect of C8-diet oil and tributyrin with that of 20 ml olive oil on a molar basis in human volunteers.

Detailed description: A structured triglyceride (1,3-di-octanoyl-2-oleoyl-glycerol, called C8-diet oil), which upon digestion results in generation of two medium-chain fatty acids and 2-oleoyl-glycerol (2-OG), may lead to activation of GPR119 only, since medium fatty acids are poor agonists for fatty acid receptors.

Eligibility criteria: Inclusion Criteria:

* Caucasian healthy male subjects
* Body mass index (BMI) 19 to 25 kg/m2
* Informed consent

Exclusion Criteria:

* Anaemia
* Diabetes mellitus
* Gastrointestinal diseases or operations interacting with intestinal absorption

Primary outcomes:
measure: plasma GLP-1
timeFrame: 2 hours postprandial
measure: plasma GIP
timeFrame: 2 hours postprandial
Secondary outcomes:
measure: plasma insulin
timeFrame: 2 hours postprandial
measure: plasma PYY
timeFrame: 2 hours postprandial
measure: plasma glucose
timeFrame: 2 hours postprandial
measure: plasma neurotensin
timeFrame: 2 hour postprandial
measure: plasma CCK
timeFrame: 2 hour postprandial
Other outcomes:
Locations:
Study officials:
affiliation: Biomedical Sciences, University of Copenhagen
name: Jens J Holst, Professor
role: STUDY_CHAIR
affiliation: Glostrup Hospital; Biomedical Sciences, University of Copenhagen
name: Mette J Mandøe, Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mandoe MJ, Hansen KB, Hartmann B, Rehfeld JF, Holst JJ, Hansen HS. The 2-monoacylglycerol moiety of dietary fat appears to be responsible for the fat-induced release of GLP-1 in humans. Am J Clin Nutr. 2015 Sep;102(3):548-55. doi: 10.3945/ajcn.115.106799. Epub 2015 Jul 15.
Clinical trial NCT06809751: Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy
Official title: Evaluating Efficacy and Safety of Oral Melatonin in Acute Central Serous Chorioretinopathy (CSCR): a Double-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Central Serous Chorioretinopathy
Melatonin
Ocular Diseases
Visual Acuity
Macula Abnormality
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 48
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: The goal of this clinical trial is to learn if oral melatonin can enhance visual acuity and central macular thickness in central serous chorioretinopathy (CSCR) in adults. The main questions it aims to answer are:

1. How does melatonin affect central macula thickness in CSCR?
2. How does melatonin affect visual acuity in CSCR? Researchers will compare placebo (a look-like substance that contains no drug) to see if melatonin works to treat CSCR.

Participants will:

1. Take melatonin or placebo twice a day for one month
2. Visit the clinic after finishing a course of treatment, and 1 and 3 months after that for visual acuity assessment and tests
3. Keep a diary of their symptoms


Eligibility criteria: Inclusion Criteria:

1. Patients whose diagnosis of central serous chorioretinopathy is confirmed based on clinical and imaging criteria within the past 6 weeks
2. Patients with minimum age of 18 years old
3. Consent to participate in the study

Exclusion Criteria:

1. A history of vitrectomy
2. A history of laser surgery in the eye being studied in the past 3 months
3. A history of anti-VEGF injection in the eye being studied in the past 3 months
4. History of patient suspicious for choroidal neovascularization (CNV)
5. Pregnant or nursing patients
6. Patients with significantly compromised visual acuity in the eye being studied due to concomitant ocular condition
7. Patients participating in any other investigational drug study
8. Inability to obtain OCT photographs

Primary outcomes:
measure: central macular thickness (CMT)
timeFrame: From enrollment to 3 month later
measure: best visual acuity (BCVA)
timeFrame: From enrollment to 3 months later
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Isfahan University of Medical Sciences, Feiz Hospital, Isfahan Isfahan, Isfahan, Iran
name: Mohsen Pourazizi
role: STUDY_DIRECTOR
References:
Clinical trial NCT06824051: A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight
Official title: A Phase 1, Double-blind, Two-arm, Mechanism of Action Study to Investigate the Effect of Orforglipron on Body Composition in Adult Participants With Obesity or Overweight, Without Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Obesity
Overweight
Keywords: Visceral adipose tissue
Energy intake
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2025-02-13
Enrollment: 120
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: The main purpose of this study is to see how orforglipron affects the amount of body fat compared with placebo in participants with obesity or overweight. Participation in the study will last approximately 8 months.


Eligibility criteria: Inclusion Criteria:

* Have a Body Mass Index (BMI)

  * ≥30.0 kilograms per square meter (kg/m2), or
  * ≥27.0 kg/m2 with comorbidities

Exclusion Criteria:

* Have type 1 diabetes, type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
* Have an unstable body weight within 90 days prior to screening
* Have acute or chronic hepatitis
* Are taking other medications or alternative remedies to manage weight loss

Primary outcomes:
measure: Percent Change from Baseline in Visceral Adipose Tissue (VAT)
timeFrame: Baseline, Week 36
Secondary outcomes:
measure: Percent Change from Baseline in Energy Intake
timeFrame: Baseline, Week 36
measure: Percent Change from Baseline in Appetite
timeFrame: Baseline, Week 36
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 36
measure: Percent Change from Baseline in Fasting Total Cholesterol
timeFrame: Baseline, Week 36
measure: Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hs-CRP)
timeFrame: Baseline, Week 36
measure: Change from Baseline in International Physical Activity Questionnaire-Long Form (IPAQ-L) Scores
timeFrame: Baseline, Week 36
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Dilworth
country: United States
facility: Axis
state: Minnesota
city: Columbus
country: United States
facility: Ohio Clinical Trials
state: Ohio
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02808351: Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes
Official title: Multicenter Randomized Controlled Study of Berberine for Prevention of Contrast-Induced Acute Kidney Injury in Patients With Diabetes and Renal Insufficient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus
Chronic Kidney Disease
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2016-06-21
Enrollment: 800
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: The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced nephropathy (CIN). Major risk factors for CIN include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.

The aim of this multicenter prospective, randomized, controlled study is to evaluate whether berberine treatment during and after the perioperative period would reduce the risk of CIN in a high-risk population of patients with both DM and CKD undergoing coronary angiography or noncoronary angiography, and the influence of such potential benefit on short-term outcome.


Eligibility criteria: Inclusion Criteria:

* Planned diagnostic coronary or peripheral artery angiography
* Type 2 diabetes mellitus
* CKD stages ≥2
* Statin naive, or not on statin treatment for at least 14 days
* Withdrawal metformin or aminophylline for 48h before angiography
* Total iodixanol volume

Exclusion Criteria:

* Hypersensitivity to iodine-containing compounds and berberine
* Ketoacidosis
* Lactic acidosis
* CKD stages 1, 5 (eGFR≥90ml/min per 1.73m2 or eGFR\<15ml/min per 1.73m2)
* STEMI
* NYHA class IV or hemodynamic instability
* Administration of any iodinated contrast medium within 14 days before randomization
* LDL-C\<1.82mmol/L（70mg/dL）
* Hepatic dysfunction (ALT 3 times greater than upper normal limit)
* Thyreoid insufficiency
* Renal artery Stenosis(unilateral \>70％ or bilateral stenosis\>50％)

Primary outcomes:
measure: Contrast-induced nephropathy
timeFrame: 72 hours
Secondary outcomes:
measure: Major adverse renal events
timeFrame: 30 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shaoliang Chen
role: STUDY_CHAIR
References:
Clinical trial NCT06524154: Effect of Verbal Positive Reinforcement, Contingent Escape and Rewarding on Behaviour of Children Undergoing Primary Molar Pulpotomy: a Randomized Clinical Study
Official title: Effect of Verbal Positive Reinforcement, Contingent Escape and Rewarding on Behaviour of Children Undergoing Primary Molar Pulpotomy: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Anxiety
Keywords: dental anxiety
Contingent Escape
Positive Reinforcement,
Pulpotomy
Behavior management
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 42
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study sample will comprise three groups, 14 children each randomly chosen. Group I: positive reinforcement, with praising the child with encouraging words and pleasing smiles.

Group II: contingent escape, by giving some rest of the procedure while the child on the chair.

Group III: rewarding the child with simple gifts like stickers at the end of the procedure.
Primary purpose: OTHER

Brief summary: The purpose of this study to evaluate the effect of verbal positive reinforcement, contingent escape and rewarding on behaviour of children undergoing primary molar pulpotomy.

Detailed description: this study evaluated Effect of Verbal Positive Reinforcement, Contingent Escape and Rewarding on Behaviour of Children Undergoing Primary Molar Pulpotomy

Eligibility criteria: Inclusion Criteria:

1. Children aged between 4 to 6 years of both sexes.
2. Children with behavior rating score 2,3 or 4 of Frankl 's behavior rating scale.
3. Children with carious lesions indicated for pulpotomy.
4. Restorable primary molars.

Exclusion Criteria:

1. Children with special health care needs.
2. Children suffering from systemic diseases.
3. Unrestorable tooth.
4. Extremely uncooperative children.

Primary outcomes:
measure: RMS Pictorial Scale (RMS-PS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Frankl Behavior Rating Scale
timeFrame: 12 weeks
Other outcomes:
measure: Pulse oximeter
timeFrame: 12 weeks
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
Study officials:
affiliation: Researcher of Pediatric Dentistry Faculty of Dentistry Mansoura University
name: khalid m aldhafeeri, master
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor and Head of Pediatric Dentistry Department- Department of Pediatric Dentistry- Faculty of Dentistry- Mansoura University
name: abeer Mostafa A, Prof
role: STUDY_DIRECTOR
affiliation: lecturer Pediatric Dentistry Department- Department of Pediatric Dentistry- Faculty of Dentistry- Mansoura University
name: Rizk A Elagamy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00533754: Y402H Comlement Factor H Polymorphism and Age-Related Macular Degeneration in the Austrian Population
Official title: Y402H Comlement Factor H Polymorphism and Age-Related Macular Degeneration in the Austrian Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age-Related Macular Degeneration
Keywords: age-related macular degeneration, genetics
Lead sponsor: Rudolf Foundation Clinic
Sponsor class: OTHER
First posted: 2007-09-21
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to show a higher expression of the Y402H polymorphism in the complement factor H in patients with AMD compared to healthy individuals.

Additionaly a correlation between a subsided infection with chlamydia and patients with AMD and a factor H polymorphism will be investigated. An interrelationship with the VEGF-plasma level shall give more hints into the pathomechanism of AMD.


Eligibility criteria: Inclusion Criteria:

* man and women over 18 years old
* Filled out informed consentBereitschaft zur Teilnahme
* Diagnosis of non-exudative/ exudative age related macular dgeneneration

Exclusion Criteria:

* inherited retinal diseases
* other aquired retinal/ macular
* missing informed consent

Primary outcomes:
measure: higher expression of the Y402H polymorphism in the complement factor H in patients with AMD compared to healthy individuals
Secondary outcomes:
measure: a correlation between a subsided infection with chlamydia and patients with AMD and a factor H polymorphism will be investigated. An interrelationship with the VEGF-plasma level shall give more hints into the pathomechanism of AMD
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Rudoulf foundation Clinic
Study officials:
affiliation: Rudoulf Foundation Clinic
name: Susanne Binder, M.D.
role: STUDY_CHAIR
References: