louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02621034: Comparative Evaluation of Post-endodontic Pain Using Two Rotary Instrumentation Systems
Official title: Comparison of Post-endodontic Pain Using Reciproc and Oneshape Rotary Instrumentation Systems: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Root canal treatment
pain
endodontic instruments
Lead sponsor: Zahedan University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study the investigators aim to compare the post-operative pain using two single-file endodontic rotary systems : Reciproc and One shape.

Detailed description: Comparison of the post operative pain with two rotary systems including Reciproc and One shape.

Confounding factors were neutralized and the rotary systems were compared.

Eligibility criteria: Inclusion Criteria:

* Systematically healthy patients
* First or second molars with irreversible pulpitis without periapical pathosis.
* Single visit endodontic treatment

Exclusion Criteria:

* Root canal retreatment
* Pregnancy
* The presence of a difficult root canal anatomy
* Internal or external resorption
* Teeth with open apices
* Any accident of complication occurred during treatment
* Presence of periapical lesion, abscess or sinus tract

Primary outcomes:
measure: Post-operative Pain on the Visual Anlogue Scale (VAS) at the 6-hour Post-operative Interval
timeFrame: 6 hours
measure: Comparison of Post-operative Pain in the Reciproc and Oneshape Groups Through Out the Intervals
timeFrame: 72 hours
measure: Comparison of Post-operative Pain Between the Three Groups at the 72-hour Interval
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Zahedan
country: Iran, Islamic Republic of
facility: Zahedan Dental School
Study officials:
affiliation: Head of the department of Endodontics, Zahedan university of medical sciences
name: Eshagh Ali Saberi, DDS,MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06589934: Clinical Study of CT 5400 RT for Precise Image Validation
Official title: Clinical Study of CT 5400 RT for Precise Image Validation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Precise Image (AI Reconstruction Feature of CT 5400 RT System)
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
Collaborators: name: Philips Healthcare (Suzhou) Co., Ltd.
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the effectiveness of the Precise Image (PI), an AI feature of CT 5400 RT System


Eligibility criteria: Inclusion Criteria:

* 30 image raw data generated from CT 5400 RT system validation clinical trial (protocol name: Clinical study of CT 5400 RT for system validation, ClinicalTrials.gov ID: NCT06466577)
* Applicable body parts include: head, neck, chest, abdomen and coronary

Exclusion Criteria:

* Raw data is considered inappropriate for inclusion

Primary outcomes:
measure: Clinical image quality(IQ)
timeFrame: 14 days (anticipated)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
Study officials:
References:
Clinical trial NCT01211834: Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-09-30
Enrollment: 90
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 purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in patients with moderate to severe active RA and inadequate response to current DMARD treatment


Eligibility criteria: Inclusion Criteria:

* adult patients, \>= 18 years of age
* Active RA of \> 6monts duration
* Received permitted DMARDs each at a stable dose for at least 8 weeks

Exclusion Criteria:

* Rheumatic autoimmune disease other than RA
* Significant systemic involvement secondary to RA
* ALT or AST \> ULNⅹ1.5
* Platelet count \< 100,000/mm3
* Hemoglobin \< 8.5 g/dL
* White blood cells \< 3,000/mm3
* Absolute neutrophil count \< 2,000/mm3
* Absolute lymphocyte count \< 500/mm3

Primary outcomes:
measure: Proportion of patients with ACR20 responses
timeFrame: 24weeks
Secondary outcomes:
measure: Proportion of patients with ACR50 and ACR70 responses at post therapy
timeFrame: 24weeks
measure: Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin
timeFrame: 24weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National Univ. Hospital
Study officials:
References:
citation: Choi IA, Sagawa A, Lee EY, Lee EB, Song YW. Tocilizumab Increases Body Weight and Serum Adipokine Levels in Patients with Rheumatoid Arthritis Independently of Their Treatment Response: a Retrospective Cohort Study. J Korean Med Sci. 2020 Jun 8;35(22):e155. doi: 10.3346/jkms.2020.35.e155.
Clinical trial NCT04937634: Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation
Official title: Pharmacokinetic Study of Melphalan in Pediatric Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hematopoietic Stem Cell Transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Food and Drug Safety Evaluation (Republic of Korea)
First posted: 2021-06-24
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an investigator-initiated clinical trial to analysis melphalan pharmacokinetics in pediatric hematopoietic stem cell transplantation patients.


Eligibility criteria: Inclusion Criteria:

* The patient who will receive a conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation (HSCT).
* Age is below 19 at the time of diagnosis of a disease which is HSCT indication
* Written Study Informed consent and/or assent from the patient, parent, or guardian

Exclusion Criteria:

* Female patients who are pregnant or breast feeding
* Study treatment would deteriorate patient's disease.
* The patient may have problems with study participation due to a psychotic disorder.
* Any condition that would, in the Investigator's judgement, interfere with participation in the study

Primary outcomes:
measure: Melphalan concentration
timeFrame: pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI
measure: Melphalan concentration
timeFrame: pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI
measure: Melphalan concentration
timeFrame: pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI
measure: Melphalan concentration
timeFrame: pre dose, within 5 minutes from end of melphalan infusion(EOI), 40 minutes from EOI, 70 minutes from EOI, 170 minutes from EOI
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyoung Jin Kang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05071534: Implementation of the Robson Classification of Cesearn Section in Sohag University Hospital
Official title: Implementation of the Robson Classification of the Cesearn Section in Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Robson Classification System
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 1234
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women more than 28wks who will be admitted for labour in sohag university hospital

Brief summary: Aim Of The Work find out the frequency and indications for CS in sohag university hospitals and to analyze them according to Robson' ten group classification. This would be helping in adopting suitable measures to reduce the CS rate and identifying various challenges in our setting.

Detailed description: Cesarean Section Is A Surgical Procedure Used to Deliver A Baby Through Incisions In The Abdomen And Uterus . The incidence of Caesarean deliveries is increasing every day passing faraway beyond WHO recommended rate of 15% for all deliveries(1).

The rates of maternal morbidity and mortality are higher after CS compared to vaginal birth. CS is associated with an increased risk of abnormal placentation, uterine rupture, ectopic pregnancy, stillbirth, and preterm birth.

therefor Increase rate of unnecessary caesarean sections has been a growing concern in most parts of the world,Worldwide Caesarean section rates have risen from around 7% in 1990 to 21% in 2021 and are projected to continue over current decade if this trend continuees,by 2030 the highest rates are likely to be in Eastern Asia(63),Latin America and the Caribbean (54),Western Asia (50), Northen Africa (48),Southern Europe (47) and Australia and New Zealand(45) . According to the latest survey , one in five women in the world now deliver by caesarean section .Egypt has the highest rate of Caesarean section of 54 % in the Eastern Mediterranean Region , with no furthermore improvement to maternal and child mortality rates(2).

Eligibility criteria: Inclusion Criteria:

* Pregnant women more than 28 wks who will be admitted for labour

Exclusion Criteria:

* pregnant women less than 28wks
* pregnant women presented with rupture uterus

Primary outcomes:
measure: Frequency of cesearn sections in sohag university hospital
timeFrame: Within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
Study officials:
References:
Clinical trial NCT06940934: Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
Official title: ANCRAGE: Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Aneurysms
Lead sponsor: Acandis GmbH
Sponsor class: INDUSTRY
First posted: 2025-04-23
Enrollment: 100
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: Each cohort will consist of subjects with an intracranial aneurysm whom the physician wishes to treat with one or more Acandis devices.

Each subject will be followed according to the standard of care within the participating sites.

All treated (and intended to treat with at least 1 Acandis device inserted) cases will be captured in the ANCRAGE study database, from the date of agreement with French authorities; that means it will be a consecutive prospective enrollment to demonstrate the exhaustivity at the site, even the cases are captured in the database retrospectively.

There is a minimum of 50 consecutive cases to be enrolled per device family, from the time the device has been put on the French market and until the needed report to the authorities (for instance the renewal of the device registration/reimbursement).

Brief summary: The aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks associated with the use of the commercial device(s) and to ensure the long-term safety and performance of Acandis Device(s) after its placing on the French market. On top of this, these cohorts will generate data for getting the renewal of the device's reimbursement on the French market.


Eligibility criteria: Inclusion Criteria:

* The subject has an intracranial aneurysm that can be treated with one of the Acandis device indicated for the treatment of intracranial aneurysms.
* The subject is 18 years of age or older.
* The subject is willing to comply with scheduled visits and examinations, per institution standard of care.

Exclusion Criteria:

* The subject has provided tacit opposition to data collection.
* Any IFU warning will be considered for exclusion in the cohort.

Primary outcomes:
measure: Morbi-mortality related to the device and/or procedure at 12+/-3 months post implantation
timeFrame: 12+/-3 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Neuroradiologie Interventionnelle, CHU de Rouen (Charles Nicolle)
Study officials:
References:
Clinical trial NCT03511534: Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder
Official title: Open/Aftercare Treatment for Participants Diagnosed With Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: OCD
Keywords: treatment, psychotherapy, pharmacotherapy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants will choose to enter the psychotherapy or pharmacotherapy arm.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide participants diagnosed with obsessive compulsive disorder (OCD) and completed one of the active study protocols at the Rodriguez Lab, with open/aftercare treatment.

Detailed description: After completing one of the active clinical studies participants have the option to enroll in this protocol that offers open treatment.

The goal is to compare two forms of current standard treatments, psychotherapy vs pharmacotherapy.

Eligibility criteria: Inclusion Criteria:

1. Ability to speak and understand English
2. Capacity to consent (e.g. as determined by assessing the patient's understanding of the risks, benefits, and procedures of the study)
3. Completed an active study protocol at the Rodriguez Lab at Stanford University

Exclusion Criteria:

1. Children younger than 18
2. Active suicidality

Primary outcomes:
measure: Improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Up to 14 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Assistant Professor, Stanford University
name: Carolyn Rodriguez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04260334: Preoperative Care In Ovarian Cancer Patients
Official title: Preoperative Care in Ovarian Cancer: Effects of Relaxation-Focused Nursing Program in Women With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adnexal Mass
Perioperative Complication
Outcome, Fatal
Keywords: Adnexal mass
Preoperative education
Anxiety
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A randomised controlled trial study consisting of two-group pretest-post-test.

Detailed description: This study was designed as a randomized controlled trial with pretest and posttest model. The sample of the research consisted of patients who would undergo ovarian cancer surgery at the gynecologic oncology unit of a university hospital in Turkey between June 2019-August 2020.

The women were randomly assigned using "a random number generation program (Research Randomizer (https://www.randomizer.org/)" by an independent researcher who was not included in the study, intervention and control groups were formed. Women were not informed about the group they would be a part of. However, the groups of women were known by the researchers.

Eligibility criteria: Inclusion Criteria:

* 18 years and over
* women who know diagnosis
* women who have not psychiatric illness
* women who have preoperative period
* hospitalization two days before surgery

Exclusion Criteria:

-

Primary outcomes:
measure: Anxiety
timeFrame: 3 days
measure: analgesia
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Health Science University Tepecik Education and Research Hospital
Study officials:
affiliation: Dokuz Eylul University
name: Buse Güler, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04205734: Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease
Official title: Methotrexate Polyglutamate Measurements in Patients With Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: IBD
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with IBD being treated with methotrexate (oral or subcutaneous)

Brief summary: There are currently no serum levels to help guide appropriate methotrexate therapy. Data from this study will assess the correlation between dosing and whole blood methotrexate(MTX) polyglutamate measurements in children and adolescents with IBD.

Detailed description: This is a cross-sectional study design. Subjects will be requested to provide one blood sample to be collected during the conduct of their routine clinical care. Data related to the diagnosis and interval assessment of enrolled subjects will also be collected.

Eligibility criteria: Inclusion Criteria:

* IBD
* Methotrexate Therapy

Exclusion Criteria:

* Inability to provide relevant samples

Primary outcomes:
measure: Methotrexate Polyglutamate Level
timeFrame: Samples will collected within 16 weeks of consent.
Secondary outcomes:
measure: The correlation between Methotrexate Polyglutamate Levels and Lab Parameters
timeFrame: Samples will collected within 16 weeks of consent.
measure: The correlation between Methotrexate Polyglutamate Levels and Clinical History
timeFrame: Samples will collected within 16 weeks of consent.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: PAUL A RUFO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01297634: Radial Diffusion of the Botulinum Toxin Type A (Botox®): Electromyographic Evaluation of the Frontal Muscle
Official title: Phase IV Study of Radial Diffusion of the Botulinum Toxin Type A: Electromyographic Evaluation of the Frontal Muscle.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wrinkles
Keywords: Botulinum toxin type A
Hyperfunctional forehead lines
Randomized controlled trial
Double-blinded trial
Electromyogram (EMG)
Electromyographic activity
Frontal Area
Lead sponsor: Ivo Pitanguy Institute
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2011-02-17
Enrollment: 64
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the diffusion area (cephalic, lateral, medial and caudal points) of the botulinum toxin type A in the frontal muscle for usual concentrations and dilutions of the drug. A basal line control and After the application control will be made, and the investigators will evaluate the drug effects, based on clinical aspects, photographic registers and through electromyography exam (EMG).

Considering the results of our investigation, the investigators may propose a pattern of application of BOTULINUM TOXIN TYPE-A Botox® in the frontal area.


Eligibility criteria: Inclusion Criteria:

* Subjects who have indication for aesthetic treatment of the frontal dynamic wrinkles, in maximal contraction of the frontal muscle.
* Availability and understanding of the patient, for complete all the steps throughout the duration of the study.
* Medical history and physical examination compatible with the study.
* Informed consent signed.

Exclusion Criteria:

* Subjects with previous forehead face lifting or blepharoplasty surgery.
* Previous use of Botulinum toxin in the last 6 months.
* Forehead or eyelid asymmetry.
* Subjects with infections on site of injection or inflammatory skin diseases.
* Subjects with hypersensitivity to any component of the formulation, including albumin.
* Subjects with neuropathic or neuromuscular diseases.
* Subjects using aminoglycosides, penicillamine antibiotics, quinine and Ca2+ channel blockers.
* Subjects with pregnancy and lactation, or that planning become pregnant during the time of the study.
* Subjects with dimorphism or others psychological disorders.

Primary outcomes:
measure: Treatment Area
timeFrame: Change from baseline at day 30
Secondary outcomes:
measure: Complete Treatment Phase
timeFrame: Day 30
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Ivo Pitanguy Institute
state: RJ
Study officials:
References: