louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05285293: Periodontal Regeneration Using Vitamin A and PRF Compared to PRF Alone Treating Intra-bony Defects
Official title: Clinical Evaluation of Periodontal Regeneration Using Vitamin A Added to PRF in Comparison to PRF Alone in Treatment of Intra-bony Defects: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intrabony Periodontal Defect
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Will the addition of vitamin A (Retinol) to PRF add more periodontal regenerative value in the treatment of intra-bony defects compared to PRF alone, clinically?

Detailed description: Vitamin A has been extensively studied for its role in bone health. Vitamin A can be consumed in two forms, i.e., preformed retinol and pro-vitamin A. Preformed retinol is often found in food originated from animals, such as dairy, liver and eggs. Provitamin A, such as alpha (α)-carotene, beta (β)-carotene orβ-cryptoxanthin, are commonly found in plant-based food, such as fruits and vegetables (Toti et al., 2018). At certain concentrations, it has been proven to enhance the pluripotency of periodontal cells for regeneration (Fawzy El-Sayed, Hein and Dörfer, 2019).

Yet, to the best of our knowledge no clinical trials have evaluated the effect of Vitamin A added to PRF in the regeneration of intra-bony defects. This study is to fill the gap of knowledge.

Eligibility criteria: Inclusion Criteria:

* Stage III periodontitis patient (Papapanou et al., 2018) with 3 walled or 2 walled intra-bony defects.
* Non-smokers
* No pregnancy
* Medically free
* Presence of intra-bony defect of three or two walls (as predominant component) with a radiographic intra-bony component of ≥3 mm;
* Presence of ≥2 mm of keratinized gingiva at the tooth with the defect.
* Willingness to optimal compliance with the study procedures

Exclusion Criteria:

* Uncontrolled systemic or local infection in the tissue of interest,
* History or clinical evidence or positive tests for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV).
* History of chronic autoimmune disease
* Participation in an intervention trial in the same quadrant in the previous two months.
* Type III tooth mobility, vertical root fracture in the selected tooth.
* Contraindications for periodontal surgery.

Primary outcomes:
measure: Radiographic linear defect depth
timeFrame: 6 Month
Secondary outcomes:
measure: Clinical attachment level
timeFrame: 6 Month
measure: Probing pocket depth
timeFrame: 6 Month
measure: Radiographic defect bone density
timeFrame: 6 MOnth
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Cairo University
name: Abdallah H. Mostafa, M.Sc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03305393: Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
Official title: Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
CRT
Cardiac Recynchronization Therapy
left bundle branch block
atrio-ventricular conduction
Lead sponsor: Stern Cardiovascular Foundation, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-10
Enrollment: 1
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: IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observational study. The purpose of this clinical study is to test the hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm have an incremental benefit in improving CRT response in a chronic CRT non responder population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition compared to CRT devices with traditional biventricular pacing delivery methods at generator replacement.


Eligibility criteria: Inclusion Criteria:

* Normal AV conduction (SAV\<220 ms or PAV\<270 MS)
* Left Bundle Branch Block (defined as \> or = to 140 ms (male) or \> or = 130 (female), QR or rS in leads V1 and V2, and Mid QRS notching or slurring in v 2 of leads V1, V2, V5, V6 and I and aVL.)
* Patient and/or physician assessment or unchanged or worsened heart failure status at the time of recommended replacement time (RRT) for previous CRT device.
* Sinus Rhythm at the time of enrollment

Exclusion Criteria:

* Moderate to severe Aortic Stenosis
* Moderate to severe Mitral Regurgitation
* Patient age \<18 years old
* AF burden \>15%
* Severe pulmonary disease requiring supplemental oxygen use
* ESRD
* System Modification at RRT Generator Changeout
* AdaptivCRT prior to enrollment
* Expected patient longevity \< 1 year
* Persistant or chronic atrial fibriliation
* Women who are pregnant or who plan to become pregnant during the clinical trial

Primary outcomes:
measure: Ejection fraction
timeFrame: 12 Months
measure: NYHA functional class
timeFrame: 12 months
Secondary outcomes:
measure: Atrial fibrillation burden
timeFrame: 12 Months
measure: Heart failure hospitalizations
timeFrame: 12 months
measure: Left ventricular end systolic volume
timeFrame: 12 months
measure: Time to first appropriate therapy for VT and/or VF
timeFrame: 12 months
measure: Percentage of RV synchronized LV pacing
timeFrame: 12 months
Other outcomes:
Locations:
city: Germantown
country: United States
facility: Stern Cardiovascular Foundation
state: Tennessee
Study officials:
References:
Clinical trial NCT00961493: RCT of an Acceptance-based Behavior Therapy for GAD
Official title: Randomized Controlled Trial of an Acceptance-based Behavior Therapy for Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: University of Massachusetts, Boston
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-08-19
Enrollment: 81
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: The purpose of this study is to determine whether acceptance-based behavior therapy for GAD results in greater symptom reduction and increased quality of life than applied relaxation.


Eligibility criteria: Inclusion Criteria:

* principal diagnosis of GAD
* at least moderate (4 on a scale from 0 to 8) on the ADIS Severity Scale for GAD symptoms
* willing to maintain current psychotropic medication levels (and have been stabilized on any current medications for at least three months) and refrain from other psychosocial treatments for anxiety or mood problems during the course of therapy
* fluent in English
* 18 years or older

Exclusion Criteria:

* bipolar disorder
* psychotic disorders
* substance dependence
* active suicidal intent
* if anxious symptomatology is due to a medical/physical condition

Primary outcomes:
measure: Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD
timeFrame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
measure: Hamilton Anxiety Rating Scale
timeFrame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
measure: Penn State Worry Questionnaire
timeFrame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Secondary outcomes:
measure: Beck Depression Inventory - II
timeFrame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
measure: Quality of Life Inventory
timeFrame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Center for Anxiety and Related Disorders at Boston University
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Boston
name: Lizabeth Roemer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06587893: Anatomical Observational Study of the Characteristics of the Suprascapular Notch Using Ultrasound.
Official title: Anatomical Observational Study of the Characteristics of the Suprascapular Notch Using Ultrasound.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Suprascapular Nerve Block
Keywords: anatomy
suprascapular notch
sono-anatomy
bones variations
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adult volunteers

Brief summary: Carrying out an anatomical study to describe the suprascapular notch. The project is to determine the characteristics (measured dimensions and shapes) of the suprascapular notch by ultrasound measurements on a series of healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* all adult hospital workers from the two departments concerned

Exclusion Criteria:

* refusal to participate in the study

Primary outcomes:
measure: lenght
timeFrame: The ultrasound measurement will be carried out only once for each volunteer participant. The time spent participating in the study will be approximately 10 minutes per participant (time required for ultrasound measurements).
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: MontLegia Hospital, Groupe Santé CHC
Study officials:
affiliation: Groupe Santé CHC - Liège - Belgium
name: Pierre Goffin, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04684693: Effect of Laser Puncture on Rheumatoid Arthritis Patients
Official title: Effect of Laser Puncture on Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studying the effect of laser puncture on rheumatoid arthritis patients


Eligibility criteria: Inclusion Criteria:

* Meeting the criteria of ACR classification for rheumatoid arthritis
* Meeting the criteria of EULAR classification for rheumatoid arthritis

Exclusion Criteria:

* Having malignancy
* Having connective tissue disease
* Smokers

Primary outcomes:
measure: HAQ (Change)
timeFrame: Pre-intervention, 4 weeks
measure: RAQoL (Change)
timeFrame: Pre-intervention, 4 weeks
measure: CRP (Change)
timeFrame: Pre-intervention, 4 weeks
measure: IL-6 (Change)
timeFrame: Pre-intervention, 4 weeks
measure: ATP (Change)
timeFrame: Pre-intervention, 4 weeks
measure: MDA (Change)
timeFrame: Pre-intervention, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: M. Sedky
Study officials:
References:
citation: Adly AS, Adly AS, Adly MS, Ali MF. A novel approach utilizing laser acupuncture teletherapy for management of elderly-onset rheumatoid arthritis: A randomized clinical trial. J Telemed Telecare. 2021 Jun;27(5):298-306. doi: 10.1177/1357633X211009861. Epub 2021 May 9.
Clinical trial NCT02080793: STUDY OF PREFERENCES IN MEN FACED WITH THE DIFFERENT TREATMENT OPTIONS FOR LOCALIZED PROSTRATE CANCER WITH A GOOD OR INTERMEDIATE PROGNOSIS
Official title: STUDY OF PREFERENCES IN MEN FACED WITH THE DIFFERENT TREATMENT OPTIONS FOR LOCALIZED PROSTRATE CANCER WITH A GOOD OR INTERMEDIATE PROGNOSIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Seen at a Urology Consultation
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2014-03-06
Enrollment: 652
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: OTHER

Brief summary: This study will be based on two questionnaires

1. One specific questionnaire that has already been developed from social sciences interviews conducted in men who have been treated for localized prostrate cancer, with a good or intermediate prognosis. This questionnaire comprises 11 pairs of scenarios. Each scenario gathers in a random manner, the modalities of 7 possible characteristics of the management strategy for localized prostrate cancer, with a good or intermediate prognosis:

   * the risk of death at 5 years (modalities: 5%, 15%),
   * the risk of impotence (modalities: 0%, 25%, 50%, 75%),
   * the presence of urinary leaks (modalities: no protection during the day, one protection pad per day, several protection pads per day),
   * the duration and frequency of care provided (modalities: 2 days of care in your whole life, 7 days of care in your whole life, 5 half-days of care per week for 8 weeks, every 3 months for 2 years then every 6 months for life),
   * ablation of the prostate (modalities: Yes, No),
   * the existence of possible treatments in case of aggravation or recurrence (modalities: Yes, No),
   * the nature of the technology used (modalities: innovative technology, standard technology).

   The objective is to ask each participant of the study for each pair of scenarios, to choose from the two scenarios (binary-choice survey), the scenario he prefers.
2. The "Spielberger Inventory Trait" scale to evaluate stable characteristics in the propensity to anxiety in study participants.


Eligibility criteria: Inclusion Criteria:

Men:

* aged 50 to 70 years
* seen at a urology consultation
* able to understand written and spoken French
* who have provided written informed consent

Exclusion Criteria:

Men:

* under guardianship or wards of court
* who have already been diagnosed withor treated for prostrate cancer
* with recently diagnosed cancer or on treatment for this cancer

Primary outcomes:
measure: Identification of personal factors linked to the management strategy chosen with regard to the preferences of patients.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Chalon-sur-saone
country: France
facility: Clinique St Marie
city: Dijon
country: France
facility: CHU de DIJON
city: Paris
country: France
facility: Hôpital TENON
city: Tours
country: France
facility: CHU de TOURS
Study officials:
References:
Clinical trial NCT01369693: In-vivo Extraction of Pb, Cd and TSNA From Swedish Snus
Official title: In-vivo Extraction of Lead, Cadmium and Tobacco Specific Nitrosamines From Four Brands of Swedish 'Snus' in Regular Snus Users.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Smokeless Tobacco
Harm Reduction
Keywords: smokeless tobacco
Nicotine
Cadmium
lead
Tobacco Specific Nitrosamines
Lead sponsor: Contract Research Organization el AB
Sponsor class: INDUSTRY
Collaborators: name: Swedish Match AB
First posted: 2011-06-09
Enrollment: 32
Sex: MALE
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: In an open label, randomized, two-way cross-over study, 32 male healthy regular snus users will be given repeated doses of four different types of portion snus: "General", "Catch", "Catch Mini" and "Catch Dry Mini". Each portion of used snus will be collected and frozen (-20 oC) pending analysis of lead (Pb), cadmium (Cd), nicotine and tobacco specific nitrosamines (TSNAs). Unused snus is collected and deep frozen for analysis and calculation of extracted dose. Calculations of extracted amount of lead, cadmium, nicotine and tobacco specific nitrosamines (TSNAs) respectively, will be done for each type of snus.

Detailed description: Comparisons:

A= "General Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

B= "Catch Licorice Portion" 1 g portion snus containing approximately 8 mg nicotine per portion.

C= "Catch Licorice Portion Mini" 0.5 g portion snus containing approximately 4 mg nicotine per portion.

D= "Catch Dry Licorice Portion Mini" 0.3 g portion snus containing approximately 4 mg nicotine per portion.

Swedish portion snus will be administered once every hour (4 administrations/brand) and will be kept between the upper lip and the gum for 30 minutes. Preload of own brand each morning.

Eligibility criteria: Inclusion Criteria:

* non-smokers, 18 to 50 years of age.
* Habitual use of \> 7 portions snus daily since minimum 1 year.
* Healthy according to the health declaration and interview.
* Written informed consent given.

Exclusion Criteria:

* Concurrent participation in another clinical trial.
* History of allergy.
* History of allergy.

Primary outcomes:
measure: In-vivo extraction of cadmium
timeFrame: 30 minutes' use
Secondary outcomes:
measure: in-vivo extraction of tobacco specific nitrosamines (TSNAs)
measure: In-vivo extraction of lead
timeFrame: 30 minutes' use
measure: In-vivo extraction of nicotine
timeFrame: 30 minutes' use
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: CROel AB
Study officials:
affiliation: Croel AB
name: Erik Lunell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05502471: Occludin and Zonulin in Attention-deficit/Hyperactivity Disorder
Official title: Serum Occludin and Zonulin Levels in Attention-deficit/Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention-deficit/Hyperactivity Disorder
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 79
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The association between levels of zonulin and occludin and behavioral/emotional problems in children with ADHD are investigated.

Detailed description: Inclusion criteria for the ADHD group are (a) newly diagnosed ADHD (b) no prior psychotropic treatment for ADHD or any psychiatric disorder (c) age 6-12 years. Exclusion criteria were: (a) history of history of inflammatory/noninflammatory, metabolic, or autoimmune disease (b) any special diet history within the past year (c) use of corticosteroids or regular intake of medication in the last 6 months, (d) body mass index (BMI) \[kg/m2\] \> 30), and (e) cognitive deficits by developmental history.

Eligibility criteria: Inclusion Criteria:

* (a) newly diagnosed ADHD
* (b) no prior psychotropic treatment for ADHD or any psychiatric disorder
* (c) age 6-12 years.

Exclusion Criteria:

* (a) history of history of inflammatory/noninflammatory, metabolic, or autoimmune disease
* (b) any special diet history within the past year
* (c) use of corticosteroids or regular intake of medication in the last 6 months,
* (d) body mass index (BMI) \[kg/m2\] \> 30),
* (e) cognitive deficits by developmental history

Primary outcomes:
measure: Zonulin level
timeFrame: 1 month
measure: Occludin level
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Hospital
Study officials:
affiliation: Ataturk University
name: Hicran Dogru, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02548871: Evaluation of the Teen Outreach Program in Chicago Public Schools
Official title: Evaluation of the Teen Outreach Program in Chicago Public Schools: Replication of an Evidence-Based Teen Pregnancy Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Behavior
Lead sponsor: Chapin Hall at the University of Chicago
Sponsor class: OTHER
Collaborators: name: Chicago Public Schools
First posted: 2015-09-14
Enrollment: 12253
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to determine the impact of TOP® on sexual health behavior.

Detailed description: The cluster-randomized study was conducted in 9th grade classrooms in Chicago Public Schools (CPS) with equal number of schools randomized to intervention and comparison groups for two cohort years. Students were administered a scannable paper survey at three time points: baseline, post-program and 1-year post program. The primary impact analysis used an intent-to-treat approach. Implementation of TOP® was assessed by conducting classroom observations. TOP® was delivered in a variety of classroom settings over the school year by facilitators from CPS and partner organizations.

Eligibility criteria: Inclusion Criteria:

* First-time 9th grade student
* Passive parental consent and student assent

Exclusion Criteria:

* Inability to complete survey in languages provided

Primary outcomes:
measure: Sex without a condom in the last 90 days
timeFrame: 9 months after baseline
Secondary outcomes:
measure: Sex in the last 90 days
timeFrame: 9 months after baseline
measure: Sex without a condom in the last 90 days, by race/ethnicity
timeFrame: 9 months after baseline
measure: Sex without a condom in the last 90 days
timeFrame: 21 months after baseline
Other outcomes:
Locations:
Study officials:
References:
citation: Seshadri R, Smithgall C, Goerge R, Ippolito J, Dasgupta D, Wiegand E, Guiltinan S, Wood M. (2015) Evaluation of the Teen Outreach Program: Findings from the Replication of an Evidence-Based Teen Pregnancy Prevention Program. Chicago, IL: Chapin Hall at the University of Chicago