louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05731154: Development of an AI Solution to Evaluate Clinical Activity of TAO Using Periocular Images Taken by Smartphones in Patients With Thyroid Dysfunction
Official title: Development of an Artificial Intelligence Solution to Evaluate Clinical Activity of Thyroid Associated Orbitopathy Using Periocular Selfie Images Taken by Smartphones in Patients With Thyroid Dysfunction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Eye Disease
Keywords: thyroid eye disease
artificial intelligence
machine learning
smartphone
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: THYROSCOPE INC.
First posted: 2023-02-16
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is conducted to develop AI solution using smartphone selfie images. Therefore, the number of subjects for this study was calculated as 200, the maximum number of patients with thyroid eye disease that can be prospectively recruited during the study period.

Brief summary: This study was conducted to develop an AI solution to evaluate clinical activity score (CAS) of thyroid associated orbitopathy (TAO) using periocular selfie images taken by smartphones in patients with thyroid dysfunction.

An AI solution to evaluate CAS in TAO was developed in previous retrospective study using periorbital digital images taken by DSLR camera in the studio. This AI solution will be adjusted to show its best performance with periocular selfie images taken by smartphones.


Eligibility criteria: Inclusion Criteria:

* Patients with thyroid eye disease

Exclusion Criteria:

* Patients who have prior facial anomaly or surgery
* Patients who cannot use smartphone camera app

Primary outcomes:
measure: Accuracy for clinical activity score (CAS) of thyroid eye disease (TED)
timeFrame: baseline (this study has no intervention)
measure: Diagnostic accuracy for active thyroid eye disease
timeFrame: baseline (this study has no intervention)
Secondary outcomes:
measure: Accuracy for redness of eyelids
timeFrame: baseline (this study has no intervention)
measure: Accuracy for redness of conjunctiva
timeFrame: baseline (this study has no intervention)
measure: Accuracy for swelling of eyelids
timeFrame: baseline (this study has no intervention)
measure: Accuracy for swelling of conjunctiva
timeFrame: baseline (this study has no intervention)
measure: Accuracy for swelling of caruncle
timeFrame: baseline (this study has no intervention)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Namju Kim, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01502254: Patients' Knowledge and Understanding of Cancer Clinical Trials - a Study of Audio Recorded Information
Official title: Patients' Knowledge and Understanding of Cancer Clinical Trials - a Randomised Study of Audio Recorded Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Informed consent
Cancer clinical trials
Patient information
Knowledge
Questionnaire
Patient Eligible for a Phase II or III Cancer Clinical Trial
Scheduled Clinical Visit for Information About a Trial
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2011-12-30
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to test if cancer patients who are informed about, and offered participation in a cancer clinical trial, are more knowledgeable about cancer clinical trials if they have access to an audio recording of their information visit.


Eligibility criteria: Inclusion Criteria:

* Informed in Swedish about a phase II or III clinical trial
* Signed a consent form

Primary outcomes:
measure: Patients' knowledge about clinical trials measured by the questionnaire Quality of Informed Consent
timeFrame: The questionnaire is sent to patients within a week after consenting to the trial.
Secondary outcomes:
measure: Patients' perceived understanding of clinical trials measured by the questionnaire Quality of Informed Consent
timeFrame: The questionnaire is sent to patients within a week after consenting to the trial.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Department of Oncology, Karolinska University Hospital
Study officials:
affiliation: Department of Oncology, Karolinska University Hospital and Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden
name: Mia Bergenmar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergenmar M, Molin C, Wilking N, Brandberg Y. Knowledge and understanding among cancer patients consenting to participate in clinical trials. Eur J Cancer. 2008 Nov;44(17):2627-33. doi: 10.1016/j.ejca.2008.08.013. Epub 2008 Sep 23.
citation: Bergenmar M, Johansson H, Wilking N. Levels of knowledge and perceived understanding among participants in cancer clinical trials - factors related to the informed consent procedure. Clin Trials. 2011 Feb;8(1):77-84. doi: 10.1177/1740774510384516. Epub 2010 Nov 25.
citation: Bergenmar M, Johansson H, Wilking N, Hatschek T, Brandberg Y. Audio-recorded information to patients considering participation in cancer clinical trials - a randomized study. Acta Oncol. 2014 Sep;53(9):1197-204. doi: 10.3109/0284186X.2014.921726. Epub 2014 Jun 9.
Clinical trial NCT04895254: Colonoscopy Using Motorized Spiral Enteroscope
Official title: Colonoscopy Using Motorized Spiral Enteroscope: Prospective Bi-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Disease
Keywords: Motorized Spiral enteroscopy
colonoscopy
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with failed colonoscopies using the conventional standrad colonoscopy devices.

Brief summary: The new technology of the motorized Spiral enteroscope, originally developed for deep small bowel enteroscopy, might potentially overcome some limitations of standard colonoscopy.

Detailed description: Cecal intubation rate represents a key procedural quality parameter in diagnostic colonoscopy. However, even in experienced hands, a significant percentage of colonoscopies (1.6-16.7%) remain incomplete because of a failure to intubate the cecum. The new technology of the motorized Spiral enteroscope, originally developed for deep small bowel enteroscopy, might potentially overcome some limitations of standard colonoscopy. The study aim was to evaluate the feasibility and safety of motorized Spiral enteroscopy for difficult colonoscopies.

Eligibility criteria: Inclusion Criteria:

- Indications for Spiral colonoscopy as a rescue procedure because of incomplete antecedent colonoscopy

Exclusion Criteria:

* Age under 18 years
* Known pregnancy
* Poor health status (ASA classification ≥ 4)
* Contraindication for sedation or standard colonoscopy
* Known coagulopathy (INR ≥ 2.0, platelets \< 70 /nl) or anticoagulants other than aspirin
* Medical history of chronic inflammatory bowel disease or suspected bowel obstruction

Primary outcomes:
measure: evaluate the feasibility of motorized PowerSpiral enteroscopy for difficult colonoscopies
timeFrame: during procedure
measure: evaluate the safety of motorized PowerSpiral enteroscopy for difficult colonoscopies
timeFrame: 7 days
Secondary outcomes:
measure: Endoscopic mucosal resection
timeFrame: during procedure
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Centre Groningen
city: Nieuwegein
country: Netherlands
facility: St Antonius hospital
Study officials:
affiliation: St. Antonius Hospital
name: Abdulbaqi Al-Toma, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06756854: Low-Level Laser Therapy and Injectable Platelet-Rich Fibrin for Thin Gingival Phenotype.
Official title: Evaluation of Low-Level Laser Therapy as Adjunctive to the Injectable Platelet-Rich Fibrin in the Management of Patients With Thin Gingival Phenotype.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontal Diseases
Keywords: I-PRF, thin gingival phenotype low level laser
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2025-01-03
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: group1: received I-PRF alone, and group 2: received I-PRF+LLLT
Primary purpose: PREVENTION

Brief summary: Management of thin gingival phenotype using non-surgical methods (injection of liquid platelet rich fibrin and exposure to low level laser therapy

Detailed description: Thin gingival phenotype can lead to recession and root exposure. Liquid prf can be obtained by centrifugion of blood sample on speed 700 rpm for 3 min, then injection of this liquid in the attached gingiva and muco-gingival junction (3 times with 7 days interval) for the first group. The second group will be injected with I-PRF in the same method in addition to exposure to Low Level Laser therapy (after each injection of I-PRF). This method is expected to increase the thickness of the gingiva.

Eligibility criteria: Inclusion Criteria:

* free systimatically good oral hygiene gingival thickness less than 1mm

Exclusion Criteria:

* pregnancy or lactation pereiodontitis periodontal surgery orthodontic ttt tooth mobility,bruxism,crowding,missing or supernumerary teeth smoking

Primary outcomes:
measure: Gingival thickness improvement in millimeters.
timeFrame: 6 months after treatment
measure: Keratinized tissue width improvement in millimeters.
timeFrame: 6 months after treatment
Secondary outcomes:
measure: Improvement of gingival index.
timeFrame: 6 months after treatment
measure: Improvement of bleeding on probing.
timeFrame: 6 months after treatment
measure: Improvement of sulcus depth.
timeFrame: 6 months after treatment
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Alaa Elsayed
Study officials:
affiliation: MINDRAY
name: Ahmed Eldawy, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06760754: Examining the Feasibility and Impact of a Clinic-based Food Farmacy and Digital Culinary Medicine Program Among Cancer Survivors Treated in a Safety Net Hospital
Official title: Examining the Feasibility and Impact of a Clinic-based Food Farmacy and Digital Culinary Medicine Program Among Cancer Survivors Treated in a Safety Net Hospital
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to develop and test the feasibility of a theory-driven digital culinary medicine program among food insecure cancer survivors referred from the University of Texas MD Anderson Cancer Center Oncology Clinic at LBJ to the LBJ Food Farmacy program.

Detailed description: Primary Objective:

Determine the feasibility of study recruitment goal, intervention adherence rate, attrition rate, data completion rate, and program satisfaction rate.

Secondary Objective:

Assess the preliminary efficacy of the digital culinary medicine intervention to improve diet quality, food security, quality of life, and downstream biological indicators of cardiometabolic health from baseline to post-intervention, as well as from baseline to 6 month follow up, among food insecure cancer survivors.

Eligibility criteria: Inclusion Criteria:

* Cancer survivors treated at the MD Anderson Oncology Program at LBJ Hospital over 18 years of age.
* Screen positive for food insecurity using the 2 question clinic-screener (Hunger Vital Signs)
* Receive referral to the LBJ Food Farmacy.
* Are within the first 5 years off of acute cancer treatment.
* Self-report having internet access.
* Self-report as being able to speak and read English or Spanish.
* Willing to complete study assessments.

Exclusion Criteria:

* Unwilling or unable to complete study assessments
* Anyone under 18 years of age
* Self-report to not speak or read English or Spanish

Primary outcomes:
measure: Safety and Adverse Events (AEs)
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas M. D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Margaret Raber, DRPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03092154: Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
Official title: Lipid-lowering Agents in Patients With Dermatomyositis and Polymyositis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Treatment Side Effects
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: with or without lipid-lowering agents
Primary purpose: TREATMENT

Brief summary: The use of lipid lowering agents in patients with idiopathic inflammatory myopathies is controversial. Therefore, the aim of the present study is to assess clinically and laboratory the impact of lipid-lowering agents in this population.

Detailed description: Impact of the lipid lowering agents on patients with dermatomyositis and polymyositis.

Eligibility criteria: Inclusion Criteria:

* fullfill all criteria of Bohan and Peter (1975)
* dyslipidemia
* age\> 18 years
* prednisone ≤ 0.25 mg/kg/day (or ≤ 15mg/ ay) in the last three months
* without changing nutritional habits in the last three months, and during the study period
* no change of lifestyle in the last three months, and during the study period

Exclusion Criteria:

Patients with:

* disease relapsing
* overlapping myositis
* neoplasia associated myositis
* diabetes mellitus
* current and/or chronic infections
* patients undergoing major surgery within six months prior to the study
* pregnant patients
* previous use of lipid-lowering agents in the last 6 months
* in the use of cyclosporin, erythromycin, clarithromycin, fibrates, niacin, azole antifungals, cimetidine, diltiazem
* active liver disease or persistent elevations of hepatic enzymes, with no apparent cause, exceeding three times the upper limit of normality

Primary outcomes:
measure: Endothelial function
timeFrame: 12 weeks
Secondary outcomes:
measure: Side effects
timeFrame: 12 weeks
measure: Patient/Parent Global Activity
timeFrame: 12 weeks
measure: Physician Global Activity
timeFrame: 12 weeks
measure: Manual Muscle Testing
timeFrame: 12 weeks
measure: Muscle enzymes
timeFrame: 12 weeks
measure: Myositis Disease Activity Assessment Tool
timeFrame: 12 weeks
measure: Health Assessment Questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Samuel Katsuyuki Shinjo
Study officials:
affiliation: Universidade de Sao Paulo - Rheumatology Division
name: Samuel K Shinjo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05946733: Two Approaches of Transversus Abdominis Block (TAP ) in Laparoscopic Cholecystectomy
Official title: Comparison Between The Analgesic Effect of Oblique Subcostal and Lateral Approach of Ultrasound-Guided Transverse Abdominis Blocks for Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly divided into three equal groups using SPSS. Group A: will receive bilateral oblique subcostal TAP block Group B: will receive bilateral lateral TAP block. GroupC:will receive postoperative morphine by patient-controlled analgesia (PCA).
Primary purpose: OTHER

Brief summary: the investigators will compare the effect of pre-operative oblique subcostal TAP and lateral TAP blocks on the total perioperative opioids consumption for patients undergoing elective laparoscopic cholecystectomy

Detailed description: General anesthesia induction will be achieved using a sleeping dose of fentanyl 1µg/kg intravascular(IV), propofol 2mg/kg (IV), and atracurium 0.5mg/kg (IV) to facilitate tracheal intubation. General anesthesia will be maintained with lungs ventilation by pressure controlled mode with isoflurane

During anesthesia maintenance Intraoperatively, if blood pressure BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine (3- 5mg) will be given to stabilize the patients' haemodynamics. Fifteen minutes before the end of surgery all patients will receive 1g intravenous paracetamol and 4 grams ondansetron.

Patients will be randomly divided into three equal groups:

Group A: will receive bilateral oblique subcostal TAP block Group B: will receive bilateral lateral TAP block. Group C :will receive postoperative morphine by patient-controlled analgesia (PCA).

Eligibility criteria: Inclusion Criteria:

* Eligible patients will be older than 21 years old with American society of anaesthesia physical status I\& II scheduled for elective laparoscopic cholecystectomy.

Exclusion Criteria:

* - Uncooperative.
* Patients who have allergy to any of the study drugs.
* Patients who are on opioids.
* Known abuse of alcohol or medication.
* Local infection at the site of injection or systemic infection.
* Pregnancy.
* Patients with coagulation disorders or on anticoagulation therapy.

Primary outcomes:
measure: opioid consumption
timeFrame: 48 hours
Secondary outcomes:
measure: patient satisfaction
timeFrame: 48 hours
measure: anesthesia recovery time
timeFrame: 1hour
measure: total perioperative analgesics requirements
timeFrame: 24 hours
measure: Post-operative anaesthetic care unit (PACU) stay
timeFrame: 2 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Menoufia University
state: Shibin Elkom
Study officials:
affiliation: Menoufia University
name: AMAL G SAFAN, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01372033: Effects of Manualized Treatment in a Seamless System
Official title: Effects of Manualized Treatment in a Seamless System of Care: Handling Probation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Substance Abuse
Offenders
Criminal Thinking
HIV Risk Behaviors
Keywords: drug treatment
substance abuse
offenders
high risk
Lead sponsor: George Mason University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-06-13
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The specific aims of this project are:

1. To conduct a randomized block experiment to test the effectiveness of different models of the seamless supervision/treatment system and traditional criminal justice supervision on reducing recidivism and drug use, and improving social adjustment among offenders;
2. To understand the differential impacts based on offender risk factors (e.g., propensity to engage in further criminal behavior) on criminal justice outcomes and to determine whether differences found between seamless and traditional system participants are moderated by offender risk level;
3. To understand differential treatment and social adjustment outcomes (e.g., treatment progress, employment status) of different types of offenders participating in various treatment services; and
4. To examine levels of systems and service integration between the supervision and treatment systems pre- and post-intervention and to measure the impact of integration on outcomes over time.


Eligibility criteria: Inclusion Criteria:

* Substance abusers

  * men and women
  * treatment

Exclusion Criteria:

* Parolees

  * Low threshold substance abuse
  * violent offenders

Primary outcomes:
measure: Arrest
timeFrame: 12 months
Secondary outcomes:
measure: Treatment Completion
timeFrame: 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Maryland Dvision of Parole and Probation
state: Maryland
Study officials:
affiliation: George Mason University
name: Faye S Taxman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04393233: Drug Management of Rheumatoid Arthritis in Covid-19 Context : Impact on Therapeutic De-escalation
Official title: Drug Management of Rheumatoid Arthritis in Covid-19 Context : Impact on Therapeutic De-escalation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
COVID
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis patients with ongoing DMARD therapy.

Brief summary: The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune diseases, there may be legitimates interrogations about the appropriateness of continuing treatment, without modification, in the current context. Most patients with Juvenile Rheumatoid Arthritis benefit from long-term immunmodulatory therapy (DMARD - disease modifying anti-rheumatic drug), more or less combined with regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.The present study will characterize this issue by defining the proportion of patients whose usual treatment of Rheumatoid Arthritis has been modified in relation to the actual sanitary crisis.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis satisfying ACR/EULAR criteria
* Ongoing DMARD therapy

Exclusion Criteria:

* Inhability to consent

Primary outcomes:
measure: Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: