louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05171634: Artificial Intelligence and Dysplasia Detection in Ulcerative Colitis (CUDISIA Study)
Official title: Impact of Artificial Intelligence in Dysplasia Detection During Colonoscopy in Patients With Long-data Ulcerative Colitis: a Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Dysplasia
Keywords: Virtual chromoendoscopy
Artificial intelligence
iSCAN
Dysplasia
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2021-12-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis.


Eligibility criteria: Inclusion Criteria:

* Ulcerative Colitis confirmed by endoscopy and histology.
* Involvement 30% of the colonic surface (or any extent if concomitant with PSC).
* Duration of the disease \>7 years (or any duration if concomitant with PSC).

Exclusion Criteria:

* Personal history of colorectal cancer or high-grade dysplasia.
* Previous colectomy (partial or complete).
* Coagulopathy that prevents biopsies or polypectomy.
* Colonoscopy performed in the previous 6 months.
* Pregnant or nursing women.
* Inadequate bowel preparation.
* Presence of endoscopic Ulcerative Colitis activity.
* Colonic stenosis and incomplete colonoscopy.

Primary outcomes:
measure: "Per lesion" dysplasia detection rate (DDR)
timeFrame: Immediately after the procedure.
measure: "Per patient" dysplasia detection rate (DDR)
timeFrame: Immediately after the procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Antonio López-Serrano
Study officials:
References:
citation: Lopez-Serrano A, Voces A, Lorente JR, Santonja FJ, Algarra A, Latorre P, Del Pozo P, Paredes JM. Artificial intelligence for dysplasia detection during surveillance colonoscopy in patients with ulcerative colitis: A cross-sectional, non-inferiority, diagnostic test comparison study. Gastroenterol Hepatol. 2025 Feb;48(2):502210. doi: 10.1016/j.gastrohep.2024.502210. Epub 2024 May 11. English, Spanish.
Clinical trial NCT06040034: Bolus vs. Continuous IV Lidocaine Against Post-Extubation Cough in Post-Thyroidectomy Patients
Official title: Comparison of Bolus Intravenous Lidocaine Administration With Continuous Intravenous Lidocaine Against Post-Extubation Cough Incidence in Post-Thyroidectomy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cough
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to compare the effect of lidocaine bolus intravenous administration to lidocaine continuous intravenous administration in post thyroidectomy patients to observe the effect against post-extubation cough. The main questions it aims to answer are:

* Cough incidence on both groups
* Which method is preferable to reduce post-extubation cough incidence


Eligibility criteria: Inclusion Criteria:

* ASA class 1 and 2
* Thyroidectomy patients in Hasan Sadikin Bandung Hospital

Exclusion Criteria:

* Subjects' refusal
* Had history of drug allergy, specifically lidaocaine
* Had history of asthma or other lung diseases
* Active smoker
* History of arrhythmia
* Bradycardia subjects (\<60 beats per minute)
* Pregnant people
* Perioperative upper respiratory tract infusion
* Routinely consume ACE inhibitor / bronchodilators / steroid
* Renal dysfunction
* Liver dysfunction

Primary outcomes:
measure: Post-Extubation Cough Grade
timeFrame: 24 hours post operative
Secondary outcomes:
measure: Number of participant experiencing tachycardia
timeFrame: 24 hours perioperative
measure: Number of participant experiencing bradycardia
timeFrame: 24 hours perioperative
measure: Number of participant experiencing hypertension
timeFrame: 24 hours perioperative
measure: Number of participant experiencing hypotension
timeFrame: 24 hours perioperative
Other outcomes:
Locations:
city: Bandung
country: Indonesia
facility: Hasan Sadikin General Hospital
state: West Java
Study officials:
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Iwan Fuadi, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Ardi Zulfariansyah, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine Universitas Padjadjaran Bandung
name: Ignatia K Hallis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03492034: IUD Insertion During Cesarean Section
Official title: Insertion of Intrauterine Contraceptive Device During Cesarean Section: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-04-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Insertion of Intrauterine Contraceptive Device during Cesarean Section: Randomized Clinical Trial


Eligibility criteria: Inclusion Criteria:

1. Pregnant woman aged between 18 to 40 years old.
2. Scheduled for elective cesarean section at gestational age between 37 to 42 weeks.
3. Body mass index between 19-30 kg/m2
4. Seeking contraception after delivery.

Exclusion Criteria:

1. History of menorrhagia or severe dysmenorrhea.
2. History of pelvic inflammatory disease or current pelvic infection (ex: puerperal sepsis, purulent cervicitis).
3. Patients who have bleeding disorders.
4. Anemia (Hb \< 9 g %).
5. Chronic depilating diseases reducing immunity such as Diabetes.
6. Structural uterine anomaly or large uterine fibroids distorting anatomy.
7. History of previous IUD expulsion or removal for complications.
8. Unexplained uterine bleeding.
9. Copper allergy or Wilson disease.
10. Gestational trophoblastic disease with persistently elevated Beta HCG.
11. Predisposing factor to postoperative infection (e.g. rupture of membranes prior to admission or delivery of a stillborn baby at cesarean section).
12. Complications during cesarean section e.g. postpartum hemorrhage.
13. Cesarean section during placenta previa.

Primary outcomes:
measure: IUD expulsion rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Bleeding
timeFrame: 6 weeks
measure: Degree of Pain
timeFrame: 6 weeks
measure: dyspareunia
timeFrame: 6 weeks
measure: patient satisfaction
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
References:
citation: Sothornwit J, Kaewrudee S, Lumbiganon P, Pattanittum P, Averbach SH. Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception. Cochrane Database Syst Rev. 2022 Oct 27;10(10):CD011913. doi: 10.1002/14651858.CD011913.pub3.
Clinical trial NCT00583934: Is Screening for Esophageal Pathology in Asymptomatic Patients Post-Treatment for Head and Neck Cancer Beneficial?
Official title: Is Screening for Esophageal Pathology in Asymptomatic Patients Post-Treatment for Head and Neck Cancer Beneficial?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Cancer
Keywords: esophageal cancer, head and neck cancer, dysplasia
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subject population will be recruited from the clinical practice of the investigators.

Brief summary: The purpose of this study is to evaluate the prevalence of esophageal pathology in asymptomatic patients with a history of head and neck cancer.

Detailed description: There are certain factors (i.e. alcohol, tobacco, decreased saliva production from radiation) that predispose patients with a history of head and neck cancer to have esophageal disease. Often, in the initial stages of the disease, patients do not have symptoms. However, the early detection of precancerous lesions or small cancers improves patients' chances of being cured. There is no direct data supporting the practice of screening patients with a history of head and neck cancer after treatment for esophageal disease if they are not experiencing symptoms. However, many argue that screening endoscopy is justified in high risk patients to detect early esophageal cancer or dysplasia at a curable state. We are, therefore, performing this study to determine the value of endoscopic screening of the esophagus after treatment for head and neck cancer in patients without symptoms.

Eligibility criteria: Inclusion Criteria:

* Head and neck cancer patients that are six months post treatment and asymptomatic for esophageal disease.

Exclusion Criteria:

* None if meets the inclusion criteria.

Primary outcomes:
measure: Early detection of esophageal cancer or dysplasia in patients without symptoms, after treating their primary cancer, may improve their chances of being cured of a secondary disease.
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
Study officials:
affiliation: University of California, Davis
name: Gregory Farwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02634034: A Comparison Study to Evaluate the Pharmacokinetics and Safety of NK-104-CR in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperlipidemia
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the pharmacokinetics and safety of a controlled release (CR) version of pitavastatin (also referred to as NK-104) to immediate release (IR) pitavastatin in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed.
* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive.
* Subject has no clinically significant abnormalities on the basis of medical history, physical examination findings, or vital sign measurements, as judged by the Investigator.
* Subject is able and willing to comply with the protocol and study procedures.

Exclusion Criteria:

* Subject is a woman who is pregnant or breastfeeding.
* Subject has clinically relevant abnormalities in the screening or check-in assessments.
* Subject has received an investigational drug within 30 days before the first dose of study drug.

Primary outcomes:
measure: Area Under the Curve
timeFrame: 0 to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT03807934: Cerebral Excitability and Cognitive Performance
Official title: Cerebral Excitability and Cognitive Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Change
Keywords: transcranial direct current stimulation
cognitive psychology
noninvasive brain stimulation
electrical brain stimulation
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2019-01-17
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Repeated-measures crossover design.
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the perceptual and cognitive influences of low-intensity electrical brain stimulation (transcranial direct current stimulation; tDCS), versus control (sham) conditions.


Eligibility criteria: Inclusion Criteria:

- Between ages of 18-65.

Exclusion Criteria:

* History of adverse reaction to tDCS (trans-cranial direct current stimulation).
* History of seizure activity.
* History of head injury (including neurosurgery).
* History of illness causing brain injury.
* History of other brain-related condition (such as traumatic brain injury).
* History of diagnosis with a neurological or psychiatric disorder.
* History of metal in head (outside of mouth), such as shrapnel, surgical clips, or fragments from welding or metalwork.
* History of sensitive scalp.

Primary outcomes:
measure: Visual perceptual performance
timeFrame: 36 weeks
measure: Verbal cognitive performance
timeFrame: 36 weeks
measure: Spatial cognitive performance
timeFrame: 72 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
References:
citation: Brunye TT, Hussey EK, Fontes EB, Ward N. Modulating Applied Task Performance via Transcranial Electrical Stimulation. Front Hum Neurosci. 2019 Apr 30;13:140. doi: 10.3389/fnhum.2019.00140. eCollection 2019.
citation: Brunye TT, Smith AM, Horner CB, Thomas AK. Verbal long-term memory is enhanced by retrieval practice but impaired by prefrontal direct current stimulation. Brain Cogn. 2018 Dec;128:80-88. doi: 10.1016/j.bandc.2018.09.008. Epub 2018 Nov 8.
citation: Brunye TT. Modulating Spatial Processes and Navigation via Transcranial Electrical Stimulation: A Mini Review. Front Hum Neurosci. 2018 Jan 9;11:649. doi: 10.3389/fnhum.2017.00649. eCollection 2017.
citation: Brunye TT, Moran JM, Cantelon J, Holmes A, Eddy MD, Mahoney CR, Taylor HA. Increasing breadth of semantic associations with left frontopolar direct current brain stimulation: a role for individual differences. Neuroreport. 2015 Mar 25;26(5):296-301. doi: 10.1097/WNR.0000000000000348.
citation: Brunye TT, Holmes A, Cantelon J, Eddy MD, Gardony AL, Mahoney CR, Taylor HA. Direct current brain stimulation enhances navigation efficiency in individuals with low spatial sense of direction. Neuroreport. 2014 Oct 22;25(15):1175-9. doi: 10.1097/WNR.0000000000000214.
Clinical trial NCT01820234: Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event
Official title: Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Screening
Telemedicine
Keywords: Skin cancer
Teledermatology
Screening
Store-and-forward
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine the diagnostic and management concordance of face-to-face dermatologist versus a store-and-forward teledermatologist at a skin cancer screening event.

The investigators' hypotheses include the following:

1. Compared to in-person assessment, store-and-forward teledermatology assessment will result in adequate diagnostic concordance.
2. Compared to in-person assessment, store-and-forward teledermatology results in adequate management concordance.
3. The sensitivity and specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant will be similar to that of in-person evaluation.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older at time of consent, may be male or female.
* Able to provide a brief medical history and have/allow an examination of their skin including photographs.
* Capable of giving informed consent.
* Will be able to receive notification of follow-up recommendations

Exclusion Criteria:

* Patients who will not provide informed consent
* Patient who are unable to fulfill tasks of this study

Primary outcomes:
measure: Aggregated diagnostic concordance
timeFrame: At the time of dermatologist evaluation (Day 1)
Secondary outcomes:
measure: Primary diagnostic concordance
timeFrame: At the time of dermatologist evaluation (Day 1)
measure: Categorical diagnostic concordance
timeFrame: At the time of dermatologist evaluation (Day 1)
measure: Management concordance
timeFrame: At the time of dermatologist evaluation (Day 1)
measure: Sensitivity
timeFrame: At the time of dermatologist evaluation (Day 1)
measure: Specificity
timeFrame: At the time of dermatologist evaluation (Day 1)
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Shifa Community Clinic
state: California
Study officials:
affiliation: University of California, Davis
name: April W Armstrong, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05826834: An Investigation of Ball Rolling Effects on Trigger Points
Official title: An Investigation of Ball Rolling Effects on Trigger Points
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trigger Point Pain, Myofascial
Lead sponsor: Memorial University of Newfoundland
Sponsor class: OTHER
Collaborators: name: Mitacs
First posted: 2023-04-24
Enrollment: 20
Sex: ALL
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: The current study aims to examine the potential effects of rolling a Myostorm ball on the trigger points in the upper back muscles.

Detailed description: The investigators will ask the participants to attend the laboratory in two sessions. They will seek the tender spots on the trapezius muscle. Then the participants will be asked to roll a Myostorm ball ( a small hard ball made of plastic with a layer of soft material cover) on their affected muscles. They will be tested for pain-pressure threshold (PPT), shoulder range of motion, electromyography (EMG), and force before and after the manipulation.

Eligibility criteria: Inclusion Criteria:

* trigger points on the trapezius muscle

Exclusion Criteria:

* back injury

Primary outcomes:
measure: Range of Motion before ball rolling
timeFrame: 3 minutes before the intervention (Ball-rolling)
measure: Pain pressure threshold before ball rolling
timeFrame: 3 minutes before the intervention (Ball-rolling)
measure: Range of Motion after ball rolling
timeFrame: up to 3 minutes after the intervention (Ball-rolling)
measure: Pain pressure threshold after ball rolling
timeFrame: up to 3 minutes after the intervention (Ball-rolling)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03598634: Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients
Official title: Epi Off Versus Epi on Corneal Collagen Cross-linking in Keratoconus Patients: a Comparative Study Throught 2 Years Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Keratoconus
Keywords: cross-linking
Lead sponsor: University of Molise
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.

Detailed description: The aim of the study is to evaluate two different techniques of cross linking: standard epithelium off (CXL epi off) versus trans-epithelial (CXL epi on) cross linking in patient with progressive keratoconus.

Forty eyes from 32 patients with progressive keratoconus were prospectively enrolled from June 2014 to June 2015 in this non-blinded, randomized comparative study. Twenty eyes were treated by CXL epi off and 20 by CLX epi on, randomly assigned and followed for 2 years. All patients underwent a complete ophthalmologic testing that included uncorrected and best corrected visual acuity, central and peripheral corneal thickness, corneal astigmatism, simulated maximum, minimum, and average keratometry, corneal confocal microscopy, Schirmer I and break-up time (BUT) tests, and the Ocular Surface Disease Index. Intra-and postoperative complications were recorded. The solution used for CXL epi off comprised riboflavin 0.1% and dextran 20.0% (Ricrolin), whereas the solution for CXL epi on (Ricrolin, TE) comprised riboflavin 0.1%, dextran 15.0%, trometamol (Tris), and ethylene-diamine-tetra-acetic acid. Ultraviolet-A treatment was performed with UV-X System at 3 mW/cm2.

Eligibility criteria: Inclusion Criteria:

* patients with evolving keratoconus
* aged between 18 and 40 years
* no evidence of corneal scarring

Exclusion Criteria:

* patients with central and paracentral corneal opacities
* Vogt's striae
* previous intraocular surgery
* history of herpetic keratitis
* history of severe dry eye
* concomitant autoimmune diseases.

Primary outcomes:
measure: Best-corrected visual acuity after treatment
timeFrame: up to 48 months from the recruitment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: