louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03199092: Rhythmic Reading Training Compared to 'Abilmente' Method
Official title: Effectiveness of Intervention for Developmental Dyslexia: Rhythmic Reading Training Compared to 'Abilmente' Method
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Developmental Dyslexia
Keywords: Reading
Developmental Dyslexia
Music
Rhythm
Intervention
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2017-06-26
Enrollment: 32
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to compare the effectiveness of Rhythmic Reading Training (RRT), a computer-assisted intervention method that combines sublexical reading exercises with rhythm processing, and that of a multimodal intervention comprising different methodology, called 'Abilmente'. All interventions were delivered for a period ranging 1-2,5 months, in 60 minutes biweekly sessions.


Eligibility criteria: Inclusion Criteria:

* having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice

Exclusion Criteria:

* presence of comorbidity with other neuropsychiatric or psychopathological conditions (whereas comorbidity with other learning disabilities were allowed)
* exclusion criteria for the use of tDCS (e.g. epilepsy, pregnancy).

Primary outcomes:
measure: Text reading accuracy expressed in number of errors change
timeFrame: 1 month
measure: Text reading speed expressed in syllables per seconds change
timeFrame: 1 month
measure: Word reading speed expressed in syllables per seconds change
timeFrame: 1 month
measure: Word reading accuracy expressed in number of errors change
timeFrame: 1 month
measure: Pseudo-word reading speed expressed in syllables per seconds change
timeFrame: 1 month
measure: Pseudo-word reading accuracy expressed in number of errors change
timeFrame: 1 month
measure: Text reading accuracy expressed in number of errors change
timeFrame: 2.5 months
measure: Text reading speed expressed in syllables per seconds change
timeFrame: 2.5 months
measure: Word reading speed expressed in syllables per seconds change
timeFrame: 2.5 months
measure: Word reading accuracy expressed in number of errors change
timeFrame: 2.5 months
measure: Pseudo-word reading speed expressed in syllables per seconds change
timeFrame: 2.5 months
measure: Pseudo-word reading accuracy expressed in number of errors change
timeFrame: 2.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Catholic University of the Sacred Heart
city: Milan
country: Italy
facility: Studio Abilmente
Study officials:
affiliation: Catholic University of the Sacred Heart
name: Alessandro Antonietti, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02238392: Adenosine vs AF Termination for Paroxysmal AF Ablation
Official title: Arrhythmia Inducibility Versus Elimination of Dormant PV Conduction as a Procedural Endpoint of Catheter Ablation for Paroxysmal Atrial Fibrillation: a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Keywords: paroxysmal atrial fibrillation
pulmonary vein isolation
adenosine
AF terminatin
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 150
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: This study investigates impact of adenosine versus AF inducibility and subsequent termination on the acute and long-term outcome of paroxysmal AF ablation.

Detailed description: Despite intensive efforts to increase single procedure success rates of pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (AF), an arrhythmia-free surveillance has not raised beyond 80%. This prospective, randomized study investigates the efficacy of two different procedural endpoints in terms of single-procedure arrhythmia-free outcome.

A total number of 152 patients undergoing de-novo catheter ablation for paroxysmal AF will be randomized to two different treatment arms. In group-A patients, PVI will be performed with the patient either in spontaneous or induced AF. If AF will not terminate with PVI, ablation will be continued by targeting extra-PV AF sources with the desired endpoint of termination to sinus rhythm (SR). The ablation procedure in group-B patients consists of PVI exclusively, regardless to the underlying rhythm. In this group, all isolated PVs will be challenged to adenosine administration in the attempt to reveal and ablate dormant conduction. The primary endpoint is arrhythmia-free survival during a follow-up of 1 year.

Eligibility criteria: Inclusion Criteria:

* patients with paroxysmal AF
* de-novo AF ablation
* age \> 18 years

Exclusion Criteria:

* persistent AF
* previous cardioversion

Primary outcomes:
measure: Arrhythmia-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Recurrence if PV conduction after ablation in PVs with abolished dormant conduction
timeFrame: 1 year
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Hospital Mainz, Department of Medicine II
Study officials:
affiliation: University Hospital Mainz, Dept. of Cardiology
name: Thomas Rostock, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Theis C, Konrad T, Mollnau H, Sonnenschein S, Kampfner D, Potstawa M, Ocete BQ, Bock K, Himmrich E, Munzel T, Rostock T. Arrhythmia Termination Versus Elimination of Dormant Pulmonary Vein Conduction as a Procedural End Point of Catheter Ablation for Paroxysmal Atrial Fibrillation: A Prospective Randomized Trial. Circ Arrhythm Electrophysiol. 2015 Oct;8(5):1080-7. doi: 10.1161/CIRCEP.115.002786. Epub 2015 Aug 21.
Clinical trial NCT05844592: First in Human, Single Ascending Dose Study
Official title: A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of INV-101 Administered Orally to Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Lead sponsor: Innovo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the safety and tolerability of single ascending oral doses of INV-101 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy, adult, male or female (of non-childbearing potential only), 19-55 years of age, inclusive, at the screening visit.
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.

Exclusion Criteria:

* Mentally or legally incapacitated or had significant emotional problems at the time of the screening visit or expected during the conduct of the study.
* History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.

Primary outcomes:
measure: AE
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Innovo Therapeutics, Inc.
Study officials:
affiliation: New Drug development Center
name: Minjeong Kim, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT01957592: A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Sri Lanka
Official title: A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Sri Lanka
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People having been treated for at least a year are eligible for the study. The selection of the patients will be done randomly by the individual physician involved in the study.

Brief summary: This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Sri Lanka.


Eligibility criteria: Inclusion Criteria:

* People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months
* Patients willing to sign informed consent form

Exclusion Criteria:

* Previous participation in this study
* Unable to comply with protocol requirements
* Confirmed or suspected pregnancy

Primary outcomes:
measure: Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7%
timeFrame: Evaluated at the first visit (only one study visit)
Secondary outcomes:
measure: Mean Fasting Plasma Glucose (FPG) of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Mean Postprandial Plasma Glucose (PPG) of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Mean HbA1c of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having dyslipidemia
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having hypertension
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having cardiovascular complications
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having peripheral vascular disease
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having diabetic nephropathy
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having diabetic eye complications
timeFrame: Evaluated at the first visit (only one study visit)
Other outcomes:
Locations:
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04636892: Evaluating Infrasonic Hemodynography
Official title: Clinical Correlation of a Novel Wearable Sensor to Detect Cardiovascular Mechanical and Electrical Properties Through Infrasonic Hemodynography
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aortic Stenosis
Mitral Regurgitation
Pulmonary Hypertension
Heart Failure, Systolic
Cardiovascular Diseases
Coronary Artery Disease
Keywords: infrasonic hemodynography
biomedical device
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 25
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system.

Detailed description: This comparative diagnostic accuracy study will determine the accuracy of a noninvasive wearable infrasonic sensor to detect the mechanical, electrical, and hemodynamic function of the cardiovascular system. 25 patients with cardiovascular disease will undergo a comprehensive echocardiogram, electrocardiogram, and cardiac catheterization while wearing a infrasonic earbud device. The infrasonic and hemodynamic waveforms will be analyzed using machine learning with the goal of correlating infrasound data captured by the earbud to the patient's cardiovascular hemodynamics.

Eligibility criteria: Inclusion Criteria:

* Normal Sinus Rhythm
* LV systolic function \>53%

Exclusion Criteria:

* 1. Known history of carotid artery disease
* 2. Moderate or greater valvular disease in Group 1
* 3. Other implantable devices (pacemaker, ICD, CardioMems, TENS unit, continuous glucose monitors, etc)
* 4. Active arrhythmia
* 5. Reduced Ejection Fraction (\< 35%) other than Group 4
* 6. Hearing loss

Primary outcomes:
measure: Infrasound Hemodynography
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Health
state: California
Study officials:
affiliation: Scripps Health
name: Sanjeev Bhavnani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03989492: Role of the Sympathetic Nervous System in Rosacea
Official title: Role of the Sympathetic Nervous System in Rosacea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rosacea
Keywords: autonomic nervous system
skin blood flow
skin sympathetic nerve activity
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2019-06-18
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Rosacea is a common skin disorder which causes facial redness and inflammation in about 16 million Americans, from an unknown cause. Many triggers of rosacea symptoms are stressors that affect the sympathetic ("fight or flight") portion of the nervous system, and a recent pilot study suggests there is sympathetic dysfunction in rosacea. This project will benefit patients, clinicians, and basic scientists by increasing our understanding of sympathetic nervous system involvement in rosacea symptoms in order to develop improved treatments for patients with rosacea.


Eligibility criteria: Inclusion Criteria:

* Otherwise healthy males and non-pregnant/non-lactating females with mild to moderate erythematotelangiectactic rosacea, as well as age-sex matched healthy control subjects.

Exclusion Criteria:

* Neurological, cardiovascular, respiratory, metabolic, muscular, or other dermatological disorders
* Current history of alcohol and/or drug abuse
* Known allergies or hypersensitivities to medications/drugs that are used in the protocol
* Current smoking or regular smoking within the last 2 years
* Body mass index \> 35 kg/m2
* Medications or supplements which are known to affect neural, cardiovascular, or muscular responses

Primary outcomes:
measure: Skin blood flow
timeFrame: Immediate (during the single-day study). This study consists of a one-day protocol, during which this outcome is measured.
measure: Skin sympathetic nerve activity
timeFrame: Immediate (during the single-day study). This study consists of a one-day protocol, during which this outcome is measured.
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Kristen Metzler-Wilson, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01310192: Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography
Official title: Cancer Localization in the Prostate With F-18 Fluorocholine Positron Emission Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Queen's Medical Center
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2011-03-08
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this project is to develop and evaluate fluorine-18 (F-18) fluorocholine (FCH) positron emission tomography (PET) as an imaging technique that can be used to delineate malignant tumors in the prostate gland. The proposed technique works by measuring the tissue metabolism of FCH, a substrate that is preferentially metabolized by cancer cells due to malignant over-expression of the choline transporter and choline kinase enzyme. The project scope covers a clinical study to recruit men with prostate cancer who have elected treatment by radical prostatectomy surgery. These men will undergo pre-operative PET scanning to measure F-18 FCH uptake in anatomical sextants of the prostate gland. Imaging results will be compared to histopathologic analyses of the prostatectomy specimen to determine the accuracy of F-18 FCH PET for detecting cancerous prostate sextants.


Eligibility criteria: Inclusion Criteria:

* Clinically Organ Confined Prostate Cancer Electing Radical Prostatectomy

Exclusion Criteria:

* Weight \> 300 lb

Primary outcomes:
measure: Histopathologic Diagnosis - sextant diagnosis by whole-prostate step section histopathologic analysis
timeFrame: Immediate - no longitudinal data collected
Secondary outcomes:
Other outcomes:
Locations:
city: Tripler AMC
country: United States
facility: Tripler Army Medical Center
state: Hawaii
Study officials:
References:
citation: DeGrado TR, Kwee SA, Coel MN, Coleman RE. The impact of urinary excretion of (18)F-labeled choline analogs. J Nucl Med. 2007 Jul;48(7):1225. doi: 10.2967/jnumed.107.040667. No abstract available.
citation: Kwee SA, Coel MN, Lim J, Ko JP. Prostate cancer localization with 18fluorine fluorocholine positron emission tomography. J Urol. 2005 Jan;173(1):252-5. doi: 10.1097/01.ju.0000142099.80156.85.
citation: Kwee SA, Thibault GP, Stack RS, Coel MN, Furusato B, Sesterhenn IA. Use of step-section histopathology to evaluate 18F-fluorocholine PET sextant localization of prostate cancer. Mol Imaging. 2008 Jan-Feb;7(1):12-20.
citation: Kwee SA, DeGrado TR, Talbot JN, Gutman F, Coel MN. Cancer imaging with fluorine-18-labeled choline derivatives. Semin Nucl Med. 2007 Nov;37(6):420-8. doi: 10.1053/j.semnuclmed.2007.07.003.
Clinical trial NCT05958992: Effects of e-Cigarettes on Perceptions and Behavior - Remote Substudy # 2
Official title: Effects of e-Cigarettes on Perceptions and Behavior - Remote Substudy # 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Cigarette Use
Cigarette Smoking
Cigarette Use, Electronic
Vaping
Keywords: vaping
e-cigarette
vape
nicotine
tobacco
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2023-07-25
Enrollment: 461
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to use an e-liquid
Primary purpose: OTHER

Brief summary: This study assess the ways in which e-cigarette product characteristics, such as flavors and nicotine salts, impact user experience to inform potential regulations.

Detailed description: There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile.

Eligibility criteria: Inclusion Criteria:

Vapers/E-cigarette Users - Regular use of e-cigarettes/vaping devices containing nicotine

Cigarette Smokers

- Regular use of cigarettes containing nicotine

Exclusion Criteria:

* Pregnant or planning to become pregnant

Primary outcomes:
measure: Subjective Appeal
timeFrame: 1 hour
measure: Sensory Attributes
timeFrame: 1 hour
measure: Vaping Delay
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
References:
Clinical trial NCT00267592: Safety and Efficacy of Talampanel in Glioblastoma Multiforme
Official title: A Phase II Trial of Talampanel in Conjunction With Radiation Therapy With Concurrent and Adjuvant Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glioblastoma Multiforme
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-21
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to estimate overall survival for adult patients with newly diagnosed glioblastoma multiforme treated with talampanel during radiation therapy with concurrent and adjuvant temozolomide. This study will also determine the toxicity and toxicity rate of talampanel for this therapeutic regimen.


Eligibility criteria: Inclusion Criteria:

* Patients must be 18 years of age
* Patients must have histologically confirmed supratentorial Grade IV astrocytoma (glioblastoma multiforme)
* Patients must not have prior radiation therapy, chemotherapy (including Gliadel wafer), immunotherapy or therapy with a biologic agent, or hormonal therapy. Glucocorticoid therapy is allowed.
* Patients must have recovered from the immediate post-operative period and be maintained on a stable corticosteroid regimen (on increase for 5 days) prior to the start of treatment.
* Patients must have a Karnofsky performance of at least 60% or more.

Exclusion Criteria:

* Patients with serious concurrent infection or medical illness.
* Patients receiving concurrent chemotherapeutics or investigational agents.

Primary outcomes:
measure: Overall Survival
timeFrame: 24 months
Secondary outcomes:
measure: Talampanel-related toxicity
timeFrame: 29 months
Other outcomes:
Locations:
Study officials:
References: