louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00268138: Elmex Gel Efficacy in Preventing White Spot Lesions
Official title: Phase 4 Study Prevention of Incipient Carious Lesions (White Spot Lesions) in Patients With Fixed Orthodontic Appliances Following the Application of Elmex Gel
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dental Caries
Keywords: amine fluoride
white spot lesions
qlf
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Gaba International AG
First posted: 2005-12-22
Enrollment: 314
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: the objective of this phase IV study: to establish the efficacy of elmex gel with a fluoride concentration of 1.25% compared with placebo by determining prevention of white spot lesions in patients wearing fixed orthodontic appliances.

Detailed description: 314 healthy subjects undergoing orthodontic treatment will be examined. follow up will take place from bonding the appliance till debonding, at least 12 months and no more than 30 months.

tooth brushing with product (test product or control) once per week during the entire study.

4 times a year additional tray application of test product or control. subjects wiil clean their teeth with the toothpaste they usually use during the entire study.

toothbrush and a sandglass will be provided every 6 weeks

Eligibility criteria: Inclusion Criteria:

* treatment plan: minimum of 10 teeth to be bonded labially at least 10 years old
* written declaration of informed consent

Exclusion Criteria:

* known allergy to components of test products
* handicapped patients who have difficulties brushing their teeth
* pathological desquamation changes
* known pregnancy, breast feeding
* eating disorders
* disease that effect dental hard tissue
* participation in another clinical trial either currently or within the lase 30 days

Primary outcomes:
measure: time and frequency of visually detected WSL (white spot lesions)
timeFrame: 3 month
Secondary outcomes:
measure: mineral loss according to QLF readings
timeFrame: 3 month
measure: Frequency and chronoloy of WSL
timeFrame: 3 month
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite University
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Hadassah Medical Center, Dept of Orthodontics
name: Meir Redlich, DMD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite - Berlin, Dept of Orthodontics, Center of Dentistry
name: Paul George Jost-Brinkmann, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05440838: Identification of Factors Associated With Treatment Response in Patients With Polycythemia Vera, Essential Thrombocythemia, and Pre-myelofibrosis.
Official title: Identification of Factors Associated With Treatment Response in Patients With Polycythemia Vera, Essential Thrombocythemia, and Pre-myelofibrosis.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myeloproliferative Neoplasm
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Brest
name: Nantes University Hospital
name: Poitiers University Hospital
name: Rennes University Hospital
name: University Hospital, Tours
First posted: 2022-07-01
Enrollment: 120
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: Adults with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis requiring first-line treatment with hydroxyurea or pegylated interferon.

Brief summary: First-line treatment for patients with polycythemia vera, essential thrombocythemia, and pre-myelofibrosis is based on hydroxyurea or pegylated interferon. The objective of treatment is to prevent thrombotic complications and leukemic transformation. Despite overall good response rates, some patients do not respond to treatment and others lose their response over time. Both situations are associated with worse survival and there are to date no clear predictive factors for response although the existence of additional mutations seems unfavorable.

In this exploratory study, we hypothesize that biological factors at diagnosis are associated with hematological response at 12 months. We will more specifically study the association between mutational profile, assessed by next-generation sequencing, and cytokine profile with hematological response.

This study will help in identifying patients who will not respond to hydroxyurea or pegylated interferon and give the opportunity to try other treatments upfront, in the perspective of precision medicine. On the basic science side, this study will help in understanding the molecular and immunological factors involved in resistance to treatment.


Eligibility criteria: Inclusion Criteria:

* Adults with polycythemia vera, essential thrombocythemia, or pre-myelofibrosis.
* Indication for first-line treatment with hydroxyurea or pegylated interferon.
* Consent to participate.
* Affiliated to social security.

Exclusion Criteria:

* Previous treatment.
* Other on-going malignancy, including overt myelofibrosis.
* Other treatment such as phlebotomy solely, ruxolitinib, anagrelide, or pipobroman.

Primary outcomes:
measure: Complete hematological response
timeFrame: 12 months
Secondary outcomes:
measure: Complete hematological response
timeFrame: 24, 36, 48, and 60 months
measure: Molecular response
timeFrame: 12 and 24 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03899038: Minimum Effective Dose of 0.5% Bupivacaine for Ultrasound-guided Spinal Anesthesia Using Taylor's Approach
Official title: Minimum Effective Dose of 0.5% Bupivacaine for Ultrasound-guided Spinal Anesthesia Using Taylor's Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Surgery
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 56
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: TREATMENT

Brief summary: This study aims to determine the minimum effective dose of bupivacaine 0.5% in 90% of patients undergoing lower limb surgery with ultrasound-guided spinal anesthesia using Taylor's approach. A biased coin design up-and-down sequential method is applied. The initial dose is 15 mg of bupivacaine 0.5%. After 45 successful spinal anesthesia, the ED90 of bupivacaine 0.5% will be calculated.

Detailed description: The minimum effective dose of local anesthetics for spinal anesthesia using Taylor's approach is not known. This study aims to determine the minimum effective dose of bupivacaine 0.5% using a biased coin design up-and-down sequential method. Patients will receive real-time ultrasound guided spinal anesthesia using Taylor's approach. The initial dose is chosen as 15 mg on the basis of clinical experience. Subsequently, if a patient has an inadequate block, the bupivacaine dose is increased by 2 mg in the next subject. If a patient has a successful block, the next subject is randomized to receive either a lower dose (with a decrement of 2 mg), with a probability of b = 0.11, or the same dose, with a probability of 1 - b = 0.89. Forty five successful blocks will be accomplished. MED90 will be calculated by isotonic regression.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical statusⅠ- Ⅲ
* Lower limb surgery, expected operation time within 2 hours

Exclusion Criteria:

* Patient refusal
* American Society of Anesthesiologists physical status IV/V
* Peripheral neuropathy
* skin infection at the site of injection
* allergy to bupivacaine or lidocaine
* BMI \> 35 kg/m2
* coagulation disorders

Primary outcomes:
measure: The minimum effective dose of bupivacaine in spinal anesthesia using Taylor's approach
timeFrame: up to 6 months
Secondary outcomes:
measure: the upper level of the sensory block 25 min after bupivacaine injection
timeFrame: 25 min
measure: the incidence of hypotension
timeFrame: during anethesia and operation
measure: the duration of sensory spinal anaesthesia for the lower extremity
timeFrame: up to 3 days postoperation
measure: postoperative neurological complications
timeFrame: up to 3 months postoperation
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital,Wuhan
name: Mujun Chang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03733938: Microsurgery Using a Bioceramic Root End Filling Material
Official title: Outcome of Periradicular Microsurgery Using a Bioceramic Root End Filling Material
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Resorption
Symptoms
Keywords: rarifaction
root end filling
bioceramic
outcome
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2018-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients attending the postgraduate clinics over a 7 months period and meet the inclusion criteria will be included in the study

Brief summary: Endodontic failures are not uncommonly encountered despite improvements in routine root canal therapy. Endodontic microsurgery is one way to manage such failure. The placement of a retrograde filling material is considered the most important prognostic factor in endodontic microsurgery. The aim of this study was to investigate the clinical and radiographic outcome of a fast set bioceramic root end filling material in human teeth.

Detailed description: Patients who were referred to the endodontic postgraduate clinics in the period between January 2017 till August 2017 were assessed for inclusion in the study according to preset criteria. Endodontic microsurgery was performed following modern techniques including magnification, root resection with minimal angle, ultrasonic root end preparation and placement of a fast set bioceramic putty as retrograde filling material. The case was subsequently evaluated clinically and radiographically at 3, 6 and 12 months. And will be followed subsequently at 2 years and 4 years post treatment.

Eligibility criteria: Inclusion Criteria:

1. medically fit patient
2. Tooth has adequate coronal seala nd judged restorable
3. previously root filled tooth with persistent periapical lesion
4. previously retreated tooth with persistent symptoms 5.previously tretaed tooth with inaccessable canal for retreatment 6. combined nonsurgical and surgical approach for teeth with large periapical lesions

Exclusion Criteria:

* medically compromised patients
* nonrestorable teeth cracked roots

Primary outcomes:
measure: Resolution of signs of failure in the root treated tooth
timeFrame: 6 months -1 year
Secondary outcomes:
Other outcomes:
Locations:
city: IRbid
country: Jordan
facility: Dental teaching centre
Study officials:
affiliation: Jordan University of Science and Technology
name: Nessrin Taha, DCD
role: STUDY_CHAIR
References:
citation: Taha NA, Aboyounes FB, Tamimi ZZ. Root-end microsurgery using a premixed tricalcium silicate putty as root-end filling material: a prospective study. Clin Oral Investig. 2021 Jan;25(1):311-317. doi: 10.1007/s00784-020-03365-7. Epub 2020 Jun 2.
Clinical trial NCT00792038: Effect of Cognitive Behavioral Therapy in OCD Highlighted by Neuropsychological Tests and MRI: Pathophysiology and Treatment Outcome Predictors
Official title: Effect of Cognitive Behavioral Therapy in OCD Highlighted by Neuropsychological Tests and MRI: Pathophysiology and Treatment Outcome Predictors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive-Compulsive Disorder
Keywords: Psychological tests
Magnetic Resonance Imaging
Cognitive therapy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-11-17
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OCD patients from the primary care clinics in middle Jutland, Denmark

Brief summary: OCD patients are assessed before and after treatment using diagnostic tools, rating scales neuropsychological assessment and functional and structural MR-scans.


Eligibility criteria: Inclusion Criteria:

1. Steady state medication 3 months prior to the study

Exclusion Criteria:

1. History of head trauma or other organic brain disease
2. Pregnancy.
3. Pacemaker or other ferromagnetic materials in the body.
4. Comorbid psychiatric illnesses assessed using SCAN- interview (30) other than moderate depression (Ham-D\<17) or anxiety disorders.
5. Antipsychotics

Primary outcomes:
measure: Y-Bocs
timeFrame: Before and after treatment approx 20 weeks apart
Secondary outcomes:
Other outcomes:
Locations:
city: Risskov
country: Denmark
facility: Aarhus University Hospital, Risskov
Study officials:
affiliation: Aarhus University Hospital, Risskov
name: Tue BH Hartmann
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarhus University Hospital, Risskov
name: Sanne Kjær
role: STUDY_DIRECTOR
References:
citation: Vandborg SK, Hartmann TB, Bennedsen BE, Pedersen AD, Thomsen PH. Memory and executive functions in patients with obsessive-compulsive disorder. Cogn Behav Neurol. 2014 Mar;27(1):8-16. doi: 10.1097/WNN.0000000000000021.
Clinical trial NCT00195338: Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
Official title: A Post-Marketing Surveillance Looking At Safety And Adherence To Treatment Of Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Innovex, Inc
First posted: 2005-09-19
Enrollment: 25
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be included after the physician decided to prescribe Enbrel.

Brief summary: The purpose of the study is to determine the long term safety of Enbrel in adults with active rheumatoid arthritis in Luxemburg. This is a post-marketing surveillance study in rheumatology practice patients. All patients initiated with Enbrel will be observed from the start of the study in Feb 2003 for a period of at least 5 years.


Eligibility criteria: Inclusion Criteria:

* Have moderate to severe active rheumatoid arthritis
* Be aged of 17 years or more
* Have inadequate response to DMards
* Give written informed consent
* Physician decides to prescribe Enbrel

Exclusion Criteria:

n/a

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Month 66
Secondary outcomes:
measure: Percentage of Participants With Completion of Study Treatment
timeFrame: Month 12 through Month 72
measure: Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66
timeFrame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66
measure: Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66
timeFrame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66
measure: Mean Dose of Concomitant Methotrexate (MTX) and Steroids
timeFrame: Baseline up to Month 66
Other outcomes:
Locations:
city: Luxembourg
country: Luxembourg
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02149238: Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects
Official title: Acute Study to Investigate the Interaction of Cocoa Methylxanthines With Cocoa Flavanol Related Vascular Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: flavanols
cardiovascular effects
nutrition-nutrition interaction
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. Dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. Endothelial dysfunction is the key event in the development and progression of cardiovascular disease. Aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure.

However, in addition to flavanols, other potentially bioactive compounds are present in cocoa, in particular methylxanthines. Little is known about the vascular effects of cocoa methylxanthines, i.e. mainly theobromine, in particular when consumed together with flavanols in cocoa products. The aim of the study is to characterize the nutrient-nutrient interaction between cocoa flavanols and cocoa methylxanthines.


Eligibility criteria: Inclusion Criteria:

* healthy male subjects
* \>18 years

Exclusion Criteria:

* acute inflammation
* cardiac arrhythmia
* renal failure
* heart failure (NYHA II-IV)
* diabetes mellitus
* CRP \> 1 mg/dl
* malignant disease

Primary outcomes:
measure: Endothelial function
timeFrame: 2 hours
measure: Plasma flavanol metabolites
timeFrame: 2 hours
Secondary outcomes:
measure: Pulse wave velocity
timeFrame: 2 hours
measure: Ambulatory blood pressure
timeFrame: 2 hours
measure: Circulation angiogenetic cells
timeFrame: 2 hours
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonology and Vascular Medicine
Study officials:
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine
name: Christian Heiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonology and Vascular Medicine
name: Malte Kelm, MD
role: STUDY_CHAIR
References:
citation: Sansone R, Ottaviani JI, Rodriguez-Mateos A, Heinen Y, Noske D, Spencer JP, Crozier A, Merx MW, Kelm M, Schroeter H, Heiss C. Methylxanthines enhance the effects of cocoa flavanols on cardiovascular function: randomized, double-masked controlled studies. Am J Clin Nutr. 2017 Feb;105(2):352-360. doi: 10.3945/ajcn.116.140046. Epub 2016 Dec 21.
Clinical trial NCT05174208: Study of Imaginomics Predicting Early Surgical Rates in Crohn's Disease
Official title: Study of Imaginomics Predicting Early Surgical Rates in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn Disease
Prognostic Model
Radiomics
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 2017-2020 CD patients in the IBD center of Sixth Affiliated Hospital of Sun Yat-Sen University.

Brief summary: Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is a chronic intestinal recurrent inflammatory disease involving the entire digestive tract. Most CD patients require surgery for complications, including stenosis, perforation, and severe intestinal bleeding. Predicting early-onset surgery risk is of great importance to assist launching of therapeutic strategies. We aim to establish a digital prognostic model and nomogram using radiomics, which will help clinical practice.


Eligibility criteria: Inclusion Criteria:

patients with a confirmed diagnosis of CD; a follow-up more than 1 year; without previous CD-associated intestinal surgeries; complete data of CTE.

Exclusion Criteria:

patients without a confirmed diagnosis of CD; with incomplete data and a follow-up less than 1 year; patients have previous intestinal surgeries; patients who have never undergone CTE examination.

Primary outcomes:
measure: percentages of surgery at one-year after diagnosis
timeFrame: 2017-2021
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT00485108: Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty
Official title: Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty (SLT): A Randomized, Masked, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Pseudoexfoliation Glaucoma
Keywords: primary open angle glaucoma
pseudoexfoliation glaucoma
selective laser trabeculoplasty
intra ocular pressure
anti-inflammatory therapy
prednisolone acetate 1%
ketorolac tromethamine 0.5%
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Glaucoma Research Society of Canada
First posted: 2007-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The type of anti-inflammatory medication used post selective laser trabeculoplasty (SLT) may have an impact on the intra-ocular pressure (IOP) lowering effect of SLT. This study will evaluate the IOP lowering effect of SLT following the topical administration of one of the following: prednisolone 1%, ketorolac 0.5% or artificial tears.

Detailed description: Patients who have been chosen to undergo SLT for glaucoma will be randomized to receive one of prednisolone 1%, ketorolac 0.5% or artificial tears four times a day for 5 days following administration of the laser treatment. The IOP will be measured at various time points following SLT: 1 hour, 2 days, 1 week, 1 month, 3 months, 6 months, and 1 year.

Eligibility criteria: Inclusion Criteria:

* primary open angle glaucoma, pseudo exfoliation glaucoma

Exclusion Criteria:

* previous incisional glaucoma surgery

Primary outcomes:
measure: Intraocular pressure lowering effect
timeFrame: 1 hour, 2 days, 1 month, 3 months, 6 months and 1 year
Secondary outcomes:
measure: intraocular pressure elevation
timeFrame: 1 hour, 2 days, 1 month
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
Study officials:
affiliation: Queen's University
name: Rob J Campbell, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen's University
name: Delan Jinapriya, MD
role: STUDY_DIRECTOR
References: