louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03732898: Coordinated Reset Deep Brain Stimulation
Official title: Coordinated Reset Deep Brain Stimulation (RESET-DBS) and RESET-DBS - Extension (Sub-study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease (PD)
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will explore the viability of an alternative/novel programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).

Detailed description: The study will explore the feasibility of utilizing an alternative/novel programming technique in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).

Eligibility criteria: Key Inclusion Criteria:

1. Subject with PD implanted bilaterally in the STN and receiving DBS therapy for at least 3 months.
2. Tolerates \> 12 hours OFF medication and, per clinical judgment, be able to perform all study related procedures.
3. Able to understand the study requirements and the treatment procedures and must provide written informed consent before any study-specific tests or procedures are performed.

Key Exclusion Criteria:

1. Exhibits significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator.
2. A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant

Primary outcomes:
measure: Improvement in Quality of Life using new programming paradigm: PDQ-39
timeFrame: approximately 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: University Berlin, Charite Virchow
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
Study officials:
affiliation: Boston Scientific Neuromodulation Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References:
Clinical trial NCT04278898: Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose
Official title: Targeting the Neurobiology of Restricted and Repetitive Behaviors in Children With Autism Using N-acetylcysteine: a Single-dose Challenge Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Keywords: Magnetic Resonance Imaging
N-acetylcysteine
Restricted and Repetitive Behaviors
electroencephalography
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-02-20
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this study is to target the neurobiology of restricted and repetitive behaviors in children with autism spectrum disorder using N-acetylcysteine (NAC), a well-tolerated nutritional supplement that has shown promise for reducing symptom severity in recent small-scale trials. The findings from this research will shed light on the mechanisms of action underlying the clinical benefits of NAC.


Eligibility criteria: Inclusion Criteria:

* children between 3 years and 12 years 11 months at the time of consent
* diagnosis of Autism Spectrum Disorder confirmed with the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2), or Brief Observation of Symptoms of Autism (BOSA), or Childhood Autism Rating Scale- Second Edition (CARS-2).
* at least moderate Restricted and Repetitive Behaviors severity defined by a Children's Yale-Brown Obsessive Compulsive Scale for children with autism spectrum disorder score ≥ 11,
* physical development indicative of prepubescence as defined by the criteria for Tanner Stage 1,
* medically stable,
* passes MR safety screening (e.g., no metal in the body).

Exclusion Criteria:

* presence of known genetic abnormalities associated with Autism Spectrum Disorder (e.g. Fragile X),
* current or life-time diagnosis of severe psychiatric disorder (e.g., schizophrenia),
* presence of significant medical problems that would interfere with participation,
* the inability of at least one caregiver to speak/read English to a sufficient level to complete study requirements and materials,
* individuals taking antioxidant agents and glutathione prodrugs, or
* the inability/unwillingness to swallow an agent during the screening visit.

Primary outcomes:
measure: Change in glutamatergic neurometabolites (Glx) measured by proton spectroscopy Magnetic Resonance Imaging (MRI)
timeFrame: 1 hour after single dose
Secondary outcomes:
measure: Change in Gamma band amplitude and synchronization measured by electroencephalography
timeFrame: 1 hour after single dose
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: John Hegarty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02037698: Role of CT Scan for the Successful Recanalization of Chronic Total Occlusion; a Randomized Comparison Between 3D CT-guided PCI vs. Conventional Treatment (CT-CTO Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Obstructive Disease
Chronic Total Occlusion Lesions
Keywords: CTO
CT
Revascularization
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The revascularization of chronic total occlusion of coronary arteries (CTO) is the most challenging procedure for the coronary intervention. For the initial period for CTO intervention, percutaneous coronary artery intervention (PCI) of CTO lesions are associated with low procedural success rates about 70%. Recently, the success rate of the recanalization of CTOs has been raised in several studies.

Coronary CT angiography (CCTA) is an effective noninvasive diagnostic modality for detecting coronary artery disease. CCTA can visualize the complete anatomy of coronary arteries in contrast to conventional coronary angiography, reducing the deferral rates from CTO intervention. Assessment of characteristics of CTO lesions by pre-procedural CCTA could help to determine revascularization strategy and estimate the procedure time, leading to lower procedural complications. We suggest that success rates and clinical outcome of intervention of CTO lesion can be improved by pre-procedural CCTA.


Eligibility criteria: Inclusion Criteria:

* Patients (age \>19 years) with CTO (TIMI = 0 and estimated duration of occlusion at least 3 months)
* Typical symptomatic angina or positive stress test in various functional studies evaluating ischemia
* Eligible patients for pre-procedural CT scan and coronary angiogram

Exclusion Criteria:

* Cardiogenic shock or ejection fraction \< 25%
* CTO lesions at DES restenosis or graft occlusion lesion
* Significant left main stenosis
* Retry of same CTO lesion within 2 weeks
* Acute myocardial infarction within 48 hours
* Hypersensitivity to aspirin, clopidogrel, or -limus families / or contraindication to antiplatelet agents
* Severe hepatic dysfunction (≥3 times normal reference values)
* Life expectancy \< 1 years
* Pregnant women or women with potential childbearing

Primary outcomes:
measure: Successful CTO recanalization
timeFrame: Immediately after CTO PCI
Secondary outcomes:
measure: Incidence of MACEs
timeFrame: 12 months after index PCI
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Severance Cardiovascular Hospital
Study officials:
References:
citation: Hong SJ, Kim BK, Cho I, Kim HY, Rha SW, Lee SH, Park SM, Kim YH, Chang HJ, Ahn CM, Kim JS, Ko YG, Choi D, Hong MK, Jang Y; CT-CTO Investigators. Effect of Coronary CTA on Chronic Total Occlusion Percutaneous Coronary Intervention: A Randomized Trial. JACC Cardiovasc Imaging. 2021 Oct;14(10):1993-2004. doi: 10.1016/j.jcmg.2021.04.013. Epub 2021 Jun 16.
Clinical trial NCT00928798: Topical Rapamycin for Fibrofolliculomas
Official title: Topical Rapamycin to Treat Fibrofolliculomas in Birt-Hogg-Dubé Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Birt-Hogg-Dubé Syndrome
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Myrovlytis Trust
First posted: 2009-06-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether topical application of rapamycin can lead to reduction in size and/or number of fibrofolliculomas in BHD patients and may prevent the growth of new ones. Secondary we evaluate rapamycin safety, formula acceptance and patient satisfaction.


Eligibility criteria: Inclusion Criteria:

* Minimum age of 18 years.
* At least 10 facial fibrofolliculomas, histologically confirmed.
* Entered in a screening program and free of malignancy as determined during screening (already had a baseline MRI or CT-scan).
* Being able to understand instructions.
* Mutation status must be known.
* For females: not pregnant and willing to use both oral and barrier contraceptives during the treatment period.

Exclusion Criteria:

* Not capable of informed consent.
* Age under 18 years.
* Pregnancy or failure to comply with contraceptive measures.
* Proven or suspected malignancy of skin or other organs.
* No histological confirmation.
* Skin lesions other than fibrofolliculoma that might worsen under sirolimus such as active infections.
* Not able to comprehend instructions.
* No proven mutation.
* Less than 10 fibrofolliculomas.
* Planned facial surgery in the treatment period.
* Concomitant disease requiring systemic immunosuppressive treatment
* Concomitant disease requiring facial topical immunosuppressive treatment or facial topical drugs that interfere with rapamycin during trail period or in the 30 days before start trial.
* Tendency to form keloids or hypertrophic scars.
* Drug or alcohol abuse.

Primary outcomes:
measure: Significant regression of lesions (reduction of fibrofolliculoma size and count) in the treated area.
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Side effects
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU Medical Centre Amsterdam
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
affiliation: Department of Dermatology
name: Maurice van Steensel, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gijezen LM, Vernooij M, Martens H, Oduber CE, Henquet CJ, Starink TM, Prins MH, Menko FH, Nelemans PJ, van Steensel MA. Topical rapamycin as a treatment for fibrofolliculomas in Birt-Hogg-Dube syndrome: a double-blind placebo-controlled randomized split-face trial. PLoS One. 2014 Jun 9;9(6):e99071. doi: 10.1371/journal.pone.0099071. eCollection 2014.
Clinical trial NCT01382498: Effect of Doxium on High Sensitivity CRP and Endothelin-1 Serum Levels in Patients With Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetic Retinopathy
Keywords: Endothelin-1 high sensitivity CRP
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Diabetic retinopathy (DR) is a highly specific vascular complication of type 1 and type 2 diabetes mellitus. Calcium dobesilate(CD) or Doxium has been tested in the treatment of diabetic retinopathy showing a slowdown of the progression of the disease after long-term oral treatment,as a potent antioxidant. Endothelin-1 (ET-1) Besides being a very potent vasoconstrictor,acts as a mitogen on the vascular smooth muscle and play the main role in the failure of autoregulation that it is an important and often early feature of diabetic retinopathy.several studies have been confirmed that inflammation besides oxidative stress are the main mechanisms,in the pathogenesis of DR and hsCRP can play a sensitive role in detecting inflammation in these patients. The aim of this study was to determine the effects of CD on decreasing ET-1 and hsCRP serum levels in patients with diabetic retinopathy.


Eligibility criteria: Inclusion Criteria:

* BS 120-200 mg/dl
* Age 40-70
* Severe NPDR(non proliferative diabetic retinopathy) or PDR(proliferative diabetic retinopathy)
* type II diabetes
* no history of doxium consumption

Exclusion Criteria:

* Allergy to doxium
* incidence of active hepatic disease or rising of hepatic enzymes during the intervention

Primary outcomes:
measure: high sensitivity CRP and Endothelin-1 serum levels
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Tabriz University of Medical Sciences
state: Eastern Azerbayjan
Study officials:
References:
Clinical trial NCT06484998: Relationship Between Children's Colour Preferences and Their Dental Anxiety
Official title: Evaluation Of The Relationship Between Dental Anxiety Levels Of Children And Their Compomer Restoration Colour Preferences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Child Development
Keywords: Colour
Compomer
Dental Anxiety
Dental Caries
Primary teeth
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 275
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study was to examine the relationship between children's color preferences and their dental anxiety. It aims to answer are:

1. Is there a relationship between children's compomer restoration colour preferences and dental anxiety?
2. Do children's compomer restoration colour preferences vary according to age and gender?
3. Are children's compomer restoration colour preferences the same as their favourite colours?

Detailed description: Background: Dental fear and anxiety, which are frequently encountered in children, are recognised as an important public health problem in many countries and this situation leads to postponement and neglect of dental treatments. The aim of this study is to evaluate the relationship between colored compomer color preferences and dental anxiety levels, which are frequently used in the restorative treatments of pediatric patients who need restorative treatment of primary molar teeth.

Methods: In this study, the relationship between anxiety levels and compomer restoration color preferences was evaluated in 275 patients aged between 5 and 10 years who required restorative treatment in primary molar teeth. Children's dental anxiety levels were determined using the Modified Child Dental Anxiety Scale, face version (MCDAS-f). Children with identified anxiety levels were asked to choose colors for their fillings. A scale consisting of 9 colors (pink, blue, gold, silver, orange, yellow, green, purple, white) was used for color selection by adding white to the colored compomer scale.

Eligibility criteria: Inclusion Criteria:

* the child must be between 5-10 years old
* who needed restorative treatment of their deciduous molars
* no systemic disease or syndrome

Exclusion Criteria:

* the child is under 5 years old and over 10 years old
* who not needed restorative treatment of deciduous molars and haven't those teeth
* having any systemic disease or syndrome

Primary outcomes:
measure: anxiety level
timeFrame: before dental treatment to 30 minutes
measure: colour preference
timeFrame: before dental treatment to 30 minutes
measure: favorite color
timeFrame: before dental treatment to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Bülent Ecevit Univercity
state: Kozlu
Study officials:
affiliation: Bülent Ecevit University
name: Edanur 1 çakır
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05535998: TACE-HAIC Combined With TKIs and Immunotherapy Versus TACE Alone for Hepatocellular Carcinoma With PVTT
Official title: TACE-HAIC Combined With Targeted Therapy and Immunotherapy Versus TACE Alone for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Propensity Score Matching Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: HCC
TACE-HAIC
TACE
TKIs
PD-1 Inhibitors
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 743
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We reviewed data of 743 patients diagnosed as HCC patients with PVTT at Sun Yat-Sen University Cancer Center. 604 patients received TACE, and 139 patients received combination therapy.

Brief summary: Hepatocellular carcinoma (HCC) is characterized with vascular invasion, particularly of the portal vein, resulting in portal vein tumor thrombus (PVTT) in 10%-40% of HCC patients at the time of HCC diagnosis. The prognosis of these patients is extremely poor.Treatment efficacy and safety using a combined therapy (TACE-HAIC combined with TKIs and PD-1 inhibitors) were compared with TACE alone in treatment of HCC patients with PVTT.


Eligibility criteria: Inclusion Criteria:

* (a) HCC patients with PVTT (Vp1-4) treated by TACE, or the combination therapy (TACE-HAIC combined with TKIs or an PD-1 inhibitors) as initial treatment; (b) age between 18 and 75 years; (c) Child-Pugh A or B liver function; (d) Eastern Cooperative Oncology Group (ECOG) performance status 0-1; (e) adequate hematologic blood counts (white blood cell count \>3ⅹ109/L, absolute neutrophil count \>1.5ⅹ109/L, platelet count \>10ⅹ109/L, hemoglobin concentration \>85 g/L); (f) no extrahepatic metastasis.

Exclusion Criteria:

* (a) severe underlying cardiac, pulmonary, or renal diseases; (b) history of a second primary malignant tumor; (c) incomplete medical data; (d) loss to follow-up.

Primary outcomes:
measure: Tumor Response
timeFrame: 24 months
measure: Overall survival
timeFrame: 24 months
measure: Progression-free survival
timeFrame: 24 months
Secondary outcomes:
measure: Conversion rate
timeFrame: 24 rates
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yunfei Yuan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06250998: Prediction of Abdominal Aortic Aneurysm Shrinkage After Stent-placement With Artificial Intelligence
Official title: Prediction of Abdominal Aortic Aneurysm Shrinkage After Endovascular Repair With Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: AAA - Abdominal Aortic Aneurysm
Keywords: AAA
aneurysm shrinkage
EVAR
aneurysm remodeling
artificial intelligence
AI
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
name: Amsterdam UMC, location VUmc
name: Medisch Spectrum Twente
name: Karolinska Institutet
First posted: 2024-02-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, electively treated with EVAR for an infrarenal AAA, will be included from the hospital records of 5 experienced vascular centers, 4 sites in the Netherlands and 1 site in Sweden.

Brief summary: The goal of this observational study is to find out what factors contribute to a good treatment outcome in patients who have received a stent for their dilation of the main abdominal artery (abdominal aortic aneurysm or AAA). The primary goal of this study is to build a prediction model for abdominal aortic aneurysm shrinkage one year after the treatment.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years;
* Elective, initially technically successful (as described by the ESVS guidelines11), infrarenal EVAR for unruptured infrarenal AAA;
* Implanted endograft is a Gore Excluder, Medtronic Endurant, Cook Zenith, Cordis Incraft, Endologix AFX, Jotec E-Tegra, or Vascutek Anaconda endograft;
* Follow-up of the AAA of at least one year with imaging of the same modality as the preoperative imaging;
* Axial reconstructions of preoperative CT angiography available, preferably in the arterial phase and with 3 mm or smaller slice thickness.

Exclusion Criteria:

* Patients with ruptured or symptomatic AAA;
* Patients that were treated with fenestrated or branched endografts, iliac branched devices, non-CE marked devices within trial setting, other endografts (EVAS cases) or chimney procedures;
* Acute procedures;
* Reintervention before one year follow-up;
* Revision cases after previous open or endovascular aneurysm repair of an AAA;

Primary outcomes:
measure: Prediction model for AAA shrinkage
timeFrame: Preoperative, peroperative and postoperative (until 1-year visit) data
Secondary outcomes:
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Non US/Canada
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Stockholm
country: Sweden
facility: Karolinksa Institutet
Study officials:
References: