louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02432885: Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy - ACE Inhibitor Therapy Trial
Official title: Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy - Angiotensin-Converting-Enzyme (ACE) Inhibitor Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Fibrosis
Muscular Dystrophies
Keywords: cardiac magnetic resonance
myocardial fibrosis
muscular dystrophies
Lead sponsor: InCor Heart Institute
Sponsor class: OTHER
Collaborators: name: Federal University of Minas Gerais
name: University of Sao Paulo
First posted: 2015-05-04
Enrollment: 76
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial intends to evaluate myocardial Fibrosis progression in Duchenne and Becker Muscular Dystrophy, as well the influence of ACE inhibitors in fibrosis progression. Additionally, this study aims to determine genetic predictors of cardiac involvement in these dystrophies.

Detailed description: Duchenne and Becker muscular dystrophies (DMD/BMD) are diseases characterized by progressive skeletal muscle degeneration and replacement by fibrofatty tissue. Data on cardiac involvement (defined as myocardial fibrosis), effect of ACE-inhibitors and specific genetic mutations on myocardial involvement detected by cardiac magnetic resonance (CMR) is lacking.

The study will include 76 patients with DMD/BMD. All patients will be referred to two CMRs for assessment of ventricular function and myocardial fibrosis. Patients with myocardial fibrosis and normal left ventricle ejection fraction (LVEF) will be randomized into two groups, each group receiving ACE-inhibitor treatment or no treatment for cardiomyopathy. A genetic profile will be performed in every patient to identify possible mutations related to cardiac involvement.

Eligibility criteria: Inclusion Criteria:

* Patients with biopsy-proven Muscular Dystrophy of Duchenne or Becker

Exclusion Criteria:

* Contraindications to cardiovascular magnetic resonance imaging

Primary outcomes:
measure: Quantitative Myocardial Fibrosis by CMR in patients with and without ACE inhibitor therapy
timeFrame: 2 years
Secondary outcomes:
measure: Specific genetic mutations as predictors of cardiac involvement
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: InCor, Heart Institute, University of Sao Paulo Medical School
name: Carlos E Rochitte, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silva MC, Magalhaes TA, Meira ZM, Rassi CH, Andrade AC, Gutierrez PS, Azevedo CF, Gurgel-Giannetti J, Vainzof M, Zatz M, Kalil-Filho R, Rochitte CE. Myocardial Fibrosis Progression in Duchenne and Becker Muscular Dystrophy: A Randomized Clinical Trial. JAMA Cardiol. 2017 Feb 1;2(2):190-199. doi: 10.1001/jamacardio.2016.4801.
Clinical trial NCT00408785: A Study Of BOTOX For The Treatment Of Glabellar Lines
Official title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of BOTOX? (Botulinum Toxin Type A) in Subjects With Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Lines
Keywords: Botulinum Toxin Type A
safety
efficacy
glabellar lines
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-12-07
Enrollment: 256
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 is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. The subjects will receive a single intramuscular treatment consisting of 5 injections of either BOTOX? 20U or placebo.


Eligibility criteria: Inclusion criteria:

* Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator's assessment.

Exclusion criteria:

* Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites will not be eligible.
* Patient with severe complications related to heart, kidney, liver disease or respiratory system will not be eligible.

Primary outcomes:
measure: The investigator's rating of Glabellar line severity at maximum frown
timeFrame: Day 30 after injection
Secondary outcomes:
measure: Investigator's rating of Glabellar line severity at rest, subject's global assessment of change in appearance of glabellar lines, the subject's perception of age and safety evaluations.
timeFrame: Day 7, 30, 60, 90, 120 after injection
Other outcomes:
Locations:
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Beijing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02768285: Apical Patency and Postoperative Pain.
Official title: Influence of Maintaining Apical Patency on Postoperative Pain in Posterior Teeth With Necrotic Pulp and Apical Periodontitis: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain Postoperative
Keywords: apical patency
root canal treatment
Lead sponsor: Isparta Military Hospital
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 320
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether maintaining an apical patency causes postoperative pain in posterior teeth with necrotic pulp and apical periodontitis.

Detailed description: Apical patency (AP) is a procedure that prevents accumulation of soft and hard tissue debris within the cement canal. However, some RCTs indicate that maintaining an AP causes postoperative pain, whilst some RCTs pointed out there is no difference in terms of pain when AP has been performed. We, therefore, would like to conduct a RCT to increase the sample size of the previously performed RCTs to do an systematic review.

Eligibility criteria: Inclusion Criteria:

* Mature permanent teeth having plural necrosis and apical periodontitis

Exclusion Criteria:

* Systemic disorders
* Diabetes
* Pregnancy
* Less than 18 years of age
* Immunocompromised
* Patients who had taken antibiotics in the past 1 month
* Patients who had a positive history of analgesic use within the past 3 days
* Previously accessed teeth

Primary outcomes:
measure: 100-mm Visual Analog Scale (VAS).
timeFrame: 7 days.
Secondary outcomes:
measure: The number of patients taking an analgesic following the endodontic treatment.
timeFrame: 7 days.
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Isparta Military Hospital
Study officials:
affiliation: Isparta Military Hospital
name: Ibrahim E YAYLALI, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04070885: Cohort Follow-up: Progression and Consequences of Chronic Kidney Disease.
Official title: Cohort Follow-up: Progression and Consequences of Chronic Kidney Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Diseases
Renal Function Disorder
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participation in NephroTest will be offered to eligible patients by the doctors of the Nephrology Department, during consultations or as a result of hospitalization.

Brief summary: This study aims to conduct a prospective collection of clinical and para-clinical data in patients with Chronic Renal Diseases to identify disease progression factors, markers of renal function, and the pathophysiology of Chronic Renal Diseases complications.

Detailed description: Chronic Renal Diseases have a growing incidence and prevalence in France, with significant consequences in terms of morbidity and mortality, especially cardiovascular, and Public Health.

It is necessary to know better:

* the mechanisms leading to the progression of the Chronic Renal Diseases
* markers to quantify renal function and progression of the Chronic Renal Diseases
* the pathophysiology of Chronic Renal Diseases complications, cardiovascular, nutritional, or mineral metabolism in particular.

This study aims to conduct a prospective collection of clinical and para-clinical data in patients with Chronic Renal Diseases to identify disease progression factors, markers of renal function, and the pathophysiology of Chronic Renal Diseases complications.

Eligibility criteria: Inclusion Criteria:

* Patients with Chronic Renal Disease, stage 2 to 5, non-dialysis patients over the age of 18,
* followed in the Nephrology Department of the Bordeaux University Hospital
* agreeing to participate in NephroTest
* affiliated with social security.

Exclusion Criteria:

* Patients under 18 years
* Patients with acute or rapidly progressive renal failure
* Patients with severe comorbidities or comorbidities that are life-threatening in the short term (\<1 year)
* Patients who did not give their written consent to be included in the study
* Major incapacitated patients and psychiatric patients admitted to hospital

Primary outcomes:
measure: Estimated Glomerular Filtration Rate measurement
timeFrame: At 1 year after inclusion
measure: Estimated Glomerular Filtration Rate measurement
timeFrame: At 2 year after inclusion
measure: Measured Glomerular Filtration Rate
timeFrame: At 1 year after inclusion
measure: Measured Glomerular Filtration Rate
timeFrame: At 2 years after inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Christian COMBE, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04919785: Deep Brain Stimulation in Severe Obsessive-compulsive Disorder
Official title: Deep Brain Stimulation in the Bed Nucleus of Stria Terminalis in Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: Deep brain stimulation
Bed nucleus of stria terminalis
Obsessive-compulsive disorder
Lead sponsor: University Hospital, Umeå
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Deep brain stimulation is an established treatment for movement disorders. New indications for deep brain stimulation are under investigation, among them severe and treatment-resistant obsessive-compulsive disorder. Here, the investigators investigate clinical outcomes, safety and mechanism of action of DBS in the BNST in a series of 11 participants with severe therapy-refractory OCD.


Eligibility criteria: Inclusion Criteria:

* Severe OCD according to the Diagnostic and Statistical Manual of Mental Disorders: DSM-IV
* YBOCS score of at least 25/40
* Disease duration of ≥5 years with persistent disabling symptoms despite adequate trials with at least 3 different serotonergic acting antidepressants, augmentation with antipsychotics, and CBT
* Only patients between 18 and 65 years of age who could understand and comply with instructions and provide their own written consent.

Exclusion Criteria:

* Current psychotic or substance abuse disorder
* Clinically significant medical disorder, or previous brain surgery

Primary outcomes:
measure: Measuring the effect on obsessive-compulsive symptoms after treatment with DBS in the bed nucleus of stria terminalis using YBOCS
timeFrame: 1 year
Secondary outcomes:
measure: Measuring the effect on depressive symptoms after treatment with DBS in the bed nucleus of stria terminalis using the Montgomery-Asberg Depressive Rating Scale
timeFrame: 1 year
measure: Measuring the effect on functioning after treatment with DBS in the bed nucleus of stria terminalis using the Global Assessment of Functioning scale
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Naesstrom M, Blomstedt P, Bodlund O. A systematic review of psychiatric indications for deep brain stimulation, with focus on major depressive and obsessive-compulsive disorder. Nord J Psychiatry. 2016 Oct;70(7):483-91. doi: 10.3109/08039488.2016.1162846. Epub 2016 Apr 22.
citation: Naesstrom M, Hariz M, Stromsten L, Bodlund O, Blomstedt P. Deep Brain Stimulation in the Bed Nucleus of Stria Terminalis in Obsessive-Compulsive Disorder-1-Year Follow-up. World Neurosurg. 2021 May;149:e794-e802. doi: 10.1016/j.wneu.2021.01.097. Epub 2021 Feb 1.
Clinical trial NCT00205985: Operative Versus Conservative Treatment of Scaphoid Fractures
Official title: Comparison of Time to Return to Previous Activity Between Operative Treatment and Cast Immobilization of Complete Fracture of the Middle Part of the Scaphoid Without Dislocation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Scaphoid Fracture
Keywords: Return to work
Scaphoid fracture
Operative treatment
Activity level
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the time to return to previous activity

level between operative treatment and non-operative cast immobilization of

patients with an acute complete fracture of the middle part of the scaphoid,

without any dislocation or comminution visible CT-scan.


Eligibility criteria: Inclusion Criteria:

* Mature skeleton
* Isolated, acute complete fracture of the mid third of the scaphoid

Exclusion Criteria:

* acute fractures of both hands
* one hand missing
* other injuries than scaphoid fractures
* rheumatoid, osteoarthritis or polyarthritis
* previous soft tissue injuries of the hand
* drug or alcohol abuse
* participant in trial during the previous month

Primary outcomes:
measure: Time to return to previous activity level
measure: Time to return to full work and household duties
Secondary outcomes:
measure: DASH
measure: SF-36
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Klinikum der Philipps Universitaet Marburg
Study officials:
affiliation: Klinikum der Universitaet Marburg
name: Markus Schaedel-Hoepfner, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfeiffer BM, Nubling M, Siebert HR, Schadel-Hopfner M. A prospective multi-center cohort study of acute non-displaced fractures of the scaphoid: operative versus non-operative treatment [NCT00205985]. BMC Musculoskelet Disord. 2006 May 11;7:41. doi: 10.1186/1471-2474-7-41.
Clinical trial NCT05014685: PPI-amoxicillin for H. Pylori Treatment
Official title: Proton Pump Inhibitor and Amoxicillin Combined Bismuth or Metronidazole for Helicobacter Pylori First-line Treatment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 732
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This randomized controlled clinical trial will identify the additional benefit of bismuth or metronidazole in proton pump inhibitor-amoxicillin-containing therapy for Helicobacter pylori first-line treatment. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.


Eligibility criteria: Inclusion Criteria:

* Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
* 18-75 years old on the day of signing the ICF.
* Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
* Have not received Helicobacter pylori eradication treatment before.

Exclusion Criteria:

* Have received Hp eradication treatment.
* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
* Subjects or guardians refused to participate in the trial.
* Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
* Have taken antibiotics, bismuth, PPI or Chinese traditional medicine 4 weeks before treatment.
* Pregnant or lactating women.
* Active peptic ulcer.
* allergic to drugs used in the trial.
* any other circumstances that are not suitable for recruitment.

Primary outcomes:
measure: Eradication rate of Helicobacter pylori
timeFrame: At least 4 weeks after completion of therapy
Secondary outcomes:
measure: Eradication rate of Helicobacter pylori resistant strains
timeFrame: At least 4 weeks after completion of therapy
measure: Eradication rate of Helicobacter pylori susceptible strains
timeFrame: At least 4 weeks after completion of therapy
Other outcomes:
measure: Adherence rate
timeFrame: At least 1 weeks after completion of therapy
measure: Frequency of adverse events
timeFrame: At least 1 weeks after completion of therapy
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Taotao Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02084485: PH-797804 LPS Study in Healthy Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study to Determine the Effects of a Single Oral Dose of Ph-797804 on Induced Sputum Inflammatory Markers Following Inhaled Lipopolysaccharide (Lps) Challenge in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: COPD
LPS
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-03-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study was performed to assess the effect of PH-797804 on neutrophils (white cells) in the sputum after a challenge with an endotoxin (inhaled LPS). Neutrophils are a sign of inflammation and PH-797804 is being developed as a potential anti-inflammatory treatment for patients with Chronic Obstructive Pulmonary Disease (COPD).


Eligibility criteria: Inclusion Criteria:

* Healthy male or female (WONCBP), non atopic volunteers aged 18-50 years
* Able to produce sputum

Exclusion Criteria:

* Current Smokers
* Abnormal liver function test
* Respiratory Tract Infection within 4 weeks

Primary outcomes:
measure: Sputum Cell Counts
timeFrame: 6 hours post LPS challenge
measure: Sputum Cytokines
timeFrame: 6 hours post LPS challenge
Secondary outcomes:
measure: Systemic Inflammatory Indices
timeFrame: 1, 4, 6 and 7 hours post LPS
Other outcomes:
Locations:
city: Denmark Hill
country: United Kingdom
facility: Pfizer Investigational Site
state: London
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02110056: Modulation of Visual-Spatial Learning in Healthy Older Adults by tDCS
Official title: Modulation of Visual-Spatial Learning in Healthy Older Adults by Transcranial Direct Current Stimulation - Proof of Principle and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Older Adults
Keywords: healthy older adults
tDCS
LOCATO task
visual-spatial learning
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether a combination of intensive training of visual-spatial abilities (LOCATO task) with anodal transcranial direct current stimulation (tDCS) leads to an improvement of learning and memory in healthy older adults and to examine the underlying neuronal mechanism.


Eligibility criteria: Inclusion Criteria (old healthy controls):

* right handedness
* unobtrusive neuropsychological screening
* age: 50-90 years

Exclusion Criteria:

* severe internal or psychiatric disease
* epilepsy
* other severe neurological diseases, e.g. previous major stroke or brain tumor
* DMS-IV manifest dementia
* contraindication for MRT (claustrophobia, metallic implants, tattoos)

Primary outcomes:
measure: Performance in LOCATO task (Visual-Spatial learning and memory) after a combination of intensive visual-spatial training and tDCS
timeFrame: immediately after the end of a 3 day training period in tDCS condition compared to sham condition
Secondary outcomes:
measure: long term effects
timeFrame: after 1 month vs baseline
measure: functional changes: Connectivity
timeFrame: after end of 3-day period of training vs baseline
measure: cortical excitability
timeFrame: at baseline
measure: Quality of life
timeFrame: after 1 month vs baseline
measure: memory
timeFrame: immediately after end of 3-day of cognitive training, after 1 month vs. baseline
measure: affective state
timeFrame: immediately after the end of 3-day cognitive training, after 1 month vs. baseline
measure: genotyping of learning related polymorphisms
timeFrame: once
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Flöel, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Antonenko D, Kulzow N, Cesarz ME, Schindler K, Grittner U, Floel A. Hippocampal Pathway Plasticity Is Associated with the Ability to Form Novel Memories in Older Adults. Front Aging Neurosci. 2016 Mar 22;8:61. doi: 10.3389/fnagi.2016.00061. eCollection 2016.
citation: Antonenko D, Kulzow N, Sousa A, Prehn K, Grittner U, Floel A. Neuronal and behavioral effects of multi-day brain stimulation and memory training. Neurobiol Aging. 2018 Jan;61:245-254. doi: 10.1016/j.neurobiolaging.2017.09.017. Epub 2017 Sep 28.