louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01141517: Predictors of Teen Smoking-cessation
Official title: Predictors of Smoking Cessation Among Teen Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cigarette Smoking
Keywords: adolescent quit-smoking program.
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-06-10
Enrollment: 147
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be adolescent smokers between the ages of 13-19 recruited from local high-schools (Franklin county; Pike county, and Scioto County in Ohio), shopping malls, and newspaper ads.

Brief summary: The primary objective of this research is to explore relations between impulsive behavior and smoking-cessation success among treatment-seeking teens enrolled in a quit-smoking program.

It is hypothesized that teens who do not successfully stop smoking (or who drop out of the treatment program) will be more impulsive (from measures taken just prior to treatment) than those who do successfully stop or significantly reduce rate of smoking.


Eligibility criteria: Inclusion Criteria:

* Ages of 13 and 19
* Enrolled in the NOT program offered by Nationwide Children's Hospital
* Currently smoke at least one cigarette per day

Exclusion Criteria:

* Adolescents must be English speaking

Primary outcomes:
measure: Number of adolescents that quit/reduce smoking and those who do not quit/reduce.
timeFrame: 8.5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Brady A Reynolds, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00720317: Diabetic Retinopathy and Sickle Trait
Official title: Diabetic Retinopathy and Sickle Cell Trait
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Sickle Cell Trait
Keywords: Diabetic Retinopathy
Sickle Cell Trait
Vision Loss
Eye disease
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2008-07-22
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: African-Americans with type II diabetes mellitus experience increased systemic vascular morbidity and mortality, even after adjustment for socioeconomic factors.

Brief summary: To more clearly ascertain the relationship between ocular manifestations of sickle cell disease and diabetes, specifically; whether the presence of sickle cell trait exacerbates the disease progression of diabetic retinopathy.

Detailed description: The objective of this research study is to evaluate the relationship between sickle cell trait and the progression of diabetic retinopathy. People with diabetes have high blood sugar that damages small blood vessels. Damage to the blood vessels that supply the retina in the back of the eye is called diabetic retinopathy. Diabetic retinopathy is worse in African-Americans with diabetes, with earlier and more severe disease progression and common complications including vitreous hemorrhage - where these blood vessels in the eye leak - and retinal detachment - the separation of the nerves of the retina from the back of the eye which may lead to blindness. One explanation for this increased severity of diabetes in African-Americans is the presence of sickle cell disease, or even just sickle trait, which causes damage to red blood cells and blood vessels under conditions of stress; like low oxygen levels, or hyperglycemic acidosis.

Eligibility criteria: Inclusion Criteria:

* Self-identified African-American patients with diabetes will be identified from Dr Bowie's retina clinic at Storm Eye Institute.
* These subjects are either being screened or treated for the progression of diabetic retinopathy.

Exclusion Criteria:

* None

Primary outcomes:
measure: We aim to screen African-American diabetic patients with retinopathy to ascertain whether sickle trait is present, and if so whether there is increased severity of diabetic retinopathy in the group with sickle trait.
timeFrame: One Year
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina, Storm Eye Institute
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina, Storm Eye Institute
name: Esther M. Bowie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06626217: Comparison of Perfusion Index Monitoring Using a Smartwatch and a Pulse Oximeter
Official title: Comparison of Perfusion Index Monitoring Using a Smartwatch and a Pulse Oximeter
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perfusion Index
Keywords: Pulse oximetry
Perfusion index
Finger replantation
Smartwatch
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional prospective single-arm study
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to experimentally compare measured perfusion index values between smartwatch and a medical grade pulse oximeter in healthy subjects at rest and with and without motion artifacts and during exercise.

Detailed description: Perfusion index (PI) is one of the many vital signs monitored to assess the clinical status of a patient. PI is determined from the pulsatile part of the plethysmographic curve, with typical values measured on the fingers ranging from 0.02% to 20%. Although PI is a relatively newly measured parameter, it has already found application in many areas of clinical medicine. For example, continuous measurement of the perfusion index has been used to monitor changes in finger blood flow after finger replantation (surgical reattachment of the finger to the patient's body). As the ability to monitor the perfusion index begins to become part of the monitored parameters of smartwatches, this new feature could be used in situations where the use of finger sensors is not appropriate. However, no comparison of perfusion index measurements between smartwatch and pulse oximeter has been made to date.

Eligibility criteria: Inclusion Criteria:

* Healthy Adult Volunteer

Exclusion Criteria:

* Post-traumatic upper limb conditions affecting finger or arm perfusion
* Injuries or diseases of the skin of the fingers and arm
* Any acute phase of any disease

Primary outcomes:
measure: Comparison of measured perfusion index values between pulse oximeter and smartwatch during different interventions.
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Czech Technical University, Fac. of Biomedical Engineering
name: Karel Roubik
role: STUDY_CHAIR
References:
Clinical trial NCT01883817: Effect of Omega-3 Fatty Acid on Cortical Function in ADHD
Official title: Docosahexaenoic Acid Augmentation of Cortical Attention Networks in ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder
Keywords: ADHD
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2013-06-21
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study hypothesis is that DHA is more effective than placebo in increasing brain activation and reducing symptoms in psychostimulant-free children with ADHD.

Detailed description: This study aims to determine the effects of 10-week dietary supplementation with the long-chain omega-3 fatty acid docosahexaenoic acid (DHA) or placebo on prefrontal cortical structural and functional connectivity using several neuroimaging techniques: DTI (Diffusion Tensor Imaging), 1H MRS(Proton Magnetic Resonance Spectroscopy), and fMRI (Functional Magnetic Resonance Imaging) in psychostimulant-free children with attention deficit hyperactivity disorder (ADHD). It is postulated that DHA supplements will increase brain activation and reduce ADHD symptomatology.

Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent/assent
* Ages 5-15 years old
* Meets DSM-IV-TR criteria for ADHD as determined by the KSADS

Exclusion Criteria:

* Contraindication to an MRI scan (i.e., braces, claustrophobia)
* A history of a major medical (e.g., diabetes) or neurological illness (e.g., epilepsy)
* Greater than 1 year outside appropriate age/grade level
* A history of intolerance or hypersensitivity to omega-3 fatty acids
* Currently taking omega-3 supplements
* Not proficient in English language
* Any history of a hematological disorder or concomitant use of anticoagulant medications
* Personal history of an Axis I psychiatric disorder other than ADHD
* Inability to swallow capsules

Primary outcomes:
measure: Attention-Deficit Hyperactivity Disorder Symptom Ratings Using the ADHD Rating Scale (ADHD-RS-IV)
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Robert K McNamara, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00349817: Genetics Education: Preparing Physicians for the Future
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Care Genetics
Hereditary Colorectal Cancer
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2006-07-10
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: This study examines the best way to teach genetics to family medicine residents. First year family medicine residents at the University of Toronto will be taught basic clinical genetics as well as a specific disease in genetics via 3 different educational methods. All participants will undergo an oral examination and written knowledge test 3 months after this education. Results between groups will be compared, and the best way to teach genetics to residents determined.

Detailed description: An educational module will be prepared by the investigators outlining important genetic fundamentals and hereditary colorectal cancer. Sixty four family medicine resident participants will take part in this study. Participants will be divided into 4 groups. Group 1 will be the control and receive no education. Group 2 will be given access to the self-study web-based educational module to do on their own time. Group 3 will be given a lecture on the material using the educational module, followed by a discussion. Group 4 will also be given this lecture and discussion, followed by an interactive standardized patient role-play experience.

Three months later, all participants will complete an simulated oral examination, an written knowledge test and an attitude survey. By comparing the results between the 4 groups, the best way to teach genetics will be determined. This template can then be used to develop a curriculum for teaching clinical genetics to family medicine residents.

Eligibility criteria: Inclusion Criteria:

* all first year family medicine residents in the Department of Family and Community Medicine at the University of Toronto

Exclusion Criteria:

-

Primary outcomes:
measure: knowledge in approach to family medicine genetics
measure: attitude towards family medicine genetics and genetic testing
measure: skill in discussing these issues with patients
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Deanna Telner
state: Ontario
Study officials:
affiliation: Department of Family and Community Medicine, University of Toronto
name: Deanna Telner, MD, MED, CCFP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02220517: Randomized Study Comparing MR-guided in Bore Versus MRI/US Fusion-guided Prostate Biopsy
Official title: A Prospective Randomized Study Comparing the Diagnostic Efficacy of MR-guided in Bore Prostate Biopsy Versus MRI/US Fusion-guided Prostate Biopsy in Men With at Least One Negative Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: MRI/US fusion-guided prostate biopsy
MR-guided in-bore prostate biopsy
prostate cancer
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2014-08-20
Enrollment: 480
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The hypothesis of the study is that targeted MRI/US fusion-guided prostate biopsy with additional systematic transrectal ultrasound (TRUS)-guided biopsy significantly detects more prostate cancers than targeted MR-guided in-bore prostate.

Detailed description: In men with previously negative prostate biopsy and persistent elevated prostate-specific antigen (PSA) value, it is unclear which strategy offers the highest detection rate for prostate cancer. The hypothesis of this study is that targeted MRI-guided biopsy combined with transrectal ultrasound (TRUS)-guided biopsy may potentially detect more cancers than MRI-guided prostate biopsies alone.

Men with at least one previously negative TRUS-guided biopsy and persistently elevated PSA values will be submitted to a multiparametric MRI examination of the prostate. Subsequently, all participants will be randomized (1:1) into both study arms. In study arm A patients will be submitted to targeted prostate biopsy based on the multiparametric MRI findings. Targeted biopsies will be performed using MRI-guided in-bore prostate biopsy. In study arm B targeted biopsies will be performed using MRI/TRUS-fusion-guided prostate biopsy with software-registration (MRI/TRUS image fusion). Patients of study arm B undergo additional systematic 12-core TRUS-guided prostate biopsy.

Eligibility criteria: Inclusion Criteria:

* At least one prior negative prostate biopsy
* Prostate-specific antigen (PSA) \> 4 ng/ml

Exclusion Criteria:

* Known prostate cancer
* Contraindications against MRI
* Contraindications against prostate biopsy

Primary outcomes:
measure: Prostate cancer detection rate
timeFrame: 1 week after biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: University Hospital Düsseldorf
Study officials:
affiliation: Department of Urology, University of Düsseldorf
name: Christian Arsov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00183417: Depression Prevention Program for Adolescents
Official title: Depression Prevention Program for High-Risk Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Adolescent
CBT
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 350
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare the effectiveness of two programs designed to prevent depression in adolescents.

Detailed description: Major depression is one of the most common psychiatric disorders in adolescents. In many cases, the condition is recurrent and can result in serious psychological impairment. A high number of depressed adolescents never receive treatment; therefore, it is crucial to develop prevention programs for this disorder that are effective and can be easily disseminated. This study will evaluate and compare the effectiveness of cognitive behavior therapy (CBT) and supportive/expressive (S/E) therapy in preventing depressive symptoms in adolescents.

This study will last 2 years. Participants will be randomly assigned to receive six sessions of CBT, S/E therapy, or standard depression education over 2 years. The CBT intervention will focus on reducing negative thoughts and increasing engagement in pleasant activities. S/E therapy is designed to allow adolescents to express their negative emotions and talk about recent stressful events in a supportive environment of their peers. Surveys and psychiatric interviews will be completed by all participants and their parents at the beginning and the end of the study. The surveys and interviews will assess depressive symptoms.

Eligibility criteria: Inclusion Criteria:

* Beck Depression Inventory score higher than 10
* Parent or guardian willing to provide informed consent

Exclusion Criteria:

* Diagnosis of depression

Primary outcomes:
measure: Depressive symptoms
timeFrame: Measured at Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Eric M. Stice, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gau JM, Stice E, Rohde P, Seeley JR. Negative life events and substance use moderate cognitive behavioral adolescent depression prevention intervention. Cogn Behav Ther. 2012;41(3):241-50. doi: 10.1080/16506073.2011.649781. Epub 2012 Mar 13.
Clinical trial NCT03711617: Uremic Toxins and Outcomes in Chronic Kidney Disease
Official title: The Association Between Uremic Toxins and Outcomes and Comorbidities in Patients With CKD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Diseases
Keywords: chronic kidney disease
uremic toxin
prognosis
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CKD patients from hospitals

Brief summary: The aim of this cohort study is:

To investigate the etiology and epidemiology of comorbidities in CKD; To find out risk factors associated with the mortality of CKD; To find out uremic toxins which are related to the mortality and comorbidities of CKD; To focuse on the association between uremic toxins and inflammation, oxidative stress and nutritional status in CKD.

Detailed description: To investigate the etiology and epidemiology of comorbidities in CKD; To find out risk factors associated with the mortality of CKD; To find out uremic toxins which are related to the mortality and comorbidities of CKD; To focuse on the association between uremic toxins and inflammation, oxidative stress and nutritional status in CKD.

Eligibility criteria: Inclusion Criteria:

* age ≥18 years old;
* clinically diagnosed with chronic kidney disease, according K/DOQI criteria.

Exclusion Criteria:

* acute kidney injury
* history of kidney injury \<3 months
* malignancy
* pregnancy
* incomplete clinical data

Primary outcomes:
measure: all cause mortality
timeFrame: 5 years
Secondary outcomes:
measure: comorbidities
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
Study officials:
affiliation: Division of Nephrology, Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
name: Feng Ding, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01803217: Evaluation of Pacemaker Algorithms to Avoid Unnecessary Right Ventricular Pacing
Official title: AV-Hysteresis Versus Mode Switch to AAI (MVP) for the Avoidance of Unnecessary Right Ventricular Pacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker Implantation for Sinus Node Disease
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
Collaborators: name: Klinikum Bamberg
name: Krankenhaus Peißenberg
name: Medtronic
First posted: 2013-03-04
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Unnecessary right ventricular pacing has been shown to be detrimental in recipients of implantable pacemaker or defibrillators.

The ADVANTAGE study evaluates the efficacy of two pacemaker based algorithms (atrioventricular hysteresis function versus mode switch to atrial pacing) to reduce right ventricular pacing.

Detailed description: Comparison of the effect of an atrioventricular hysteresis function with a mode switch to atrial pacing on the right ventricular pacing percentage in a multi-centre, prospective, randomized, single blinded, cross-over study.

Eligibility criteria: Inclusion Criteria:

Indication for the implantation of a dual-chamber pacemaker

Exclusion Criteria:

Persistent or permanent atrial tachyarrhythmias atrioventricular block 2nd or 3rd degree indication or the implantation of an defibrillator

Primary outcomes:
measure: Right ventricular pacing percentage
timeFrame: 3 months
Secondary outcomes:
measure: BNP levels
timeFrame: 3 months
Other outcomes:
measure: Occurrence of atrial tachyarrhythmias
timeFrame: 3 months
Locations:
city: Bamberg
country: Germany
facility: Klinikum Bamberg
state: Bayern
city: München
country: Germany
facility: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
state: Bayern
city: Peißenberg
country: Germany
facility: Krankenhaus Peißenberg
state: Bayern
Study officials:
References:
Clinical trial NCT02562417: Impact of iv Dexamethasone on Reversal of Rocuronium-induced Neuromuscular Block by Sugammadex
Official title: Impact of iv Dexamethasone on Reversal of Rocuronium-induced Neuromuscular Block by Sugammadex
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Neuromuscular Blockade
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 0
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: Sugammadex is used as a reversal drug for rocuronium- or vecuronium-induced neuromuscular block during general anaesthesia. IV dexamethasone is injected as a prophylactic measure against postoperative nausea and vomiting. Recent animal data have shown that dexamethasone may impair the reversal effect of sugammadex. The objective of this randomised controlled trial is to confirm in the clinical practice these preliminary results.


Eligibility criteria: Inclusion Criteria:

* patients scheduled to undergo microlaryngoscopy and ear-nose-throat endoscopic procedures

Exclusion Criteria:

* contraindication to dexamethasone administration
* contraindication to sugammadex administration
* contraindication to rocuronium administration

Primary outcomes:
measure: Mean recovery time for T4/T1 ratio > 90% after sugammadex administration
timeFrame: surgical procedure
Secondary outcomes:
measure: Mean recovery time for T4/T1 ratio > 80% after sugammadex administration
timeFrame: surgical procedure
measure: Mean recovery time for T4/T1 ratio > 70% after sugammadex administration
timeFrame: surgical procedure
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: VAud
Study officials:
References: