louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06092853: Inflammatory Stress and Periodontal Tissue Destruction
Official title: Inflammatory Stress and Periodontal Tissue Destruction in Patients With Metabolic Syndrome and Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxidative Stress
Inflammation
Keywords: Metabolic syndrome
periodontitis
interleukin-20
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
Collaborators: name: Recep Tayyip Erdogan University
First posted: 2023-10-23
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The sample size of the study was calculated using the G\*Power program with an effect size of 0.4, 80% power, and a margin of error of 0.05.

Brief summary: Metabolic syndrome and periodontitis are diseases that lower the quality of life and their incidence rates are increasing. Since both of these diseases are associated with systemic inflammation and insulin resistance, they may be comorbid. The aim of this study was to evaluate the effect of interleukin-20 (IL-20) on periodontal destruction in individuals with metabolic syndrome while considering the relationship between metabolic syndrome and periodontitis.

This study included a total of 80 individuals who were systemically and periodontally healthy (CG, n=20), were systemically healthy and had periodontitis (PG, n=20), had metabolic syndrome and were periodontally healthy (MG, n=20), or had both metabolic syndrome and periodontitis (MPG, n=20). Gingival crevicular fluid (GCF) and serum samples were collected from all participants for biochemical analyses.


Eligibility criteria: Study groups were created based on the guidelines of the 2017 Classification of Periodontal Diseases and the 2005 Metabolic Syndrome Diagnostic Criteria of the Endocrinology and Metabolic Society of Turkey

Inclusion Criteria:

* all participants were required to have at least 20 teeth and be between the ages of 20 and 65 years

Exclusion Criteria:

* Smokers, patients who had used antibiotics or anti-inflammatory and antioxidant drugs in the last 6 months, patients who were pregnant or lactating, those who had cancer or autoimmune diseases, and those who had undergone any periodontal treatment in the last 6 months

Primary outcomes:
measure: concentration of gingival crevicular fluid (GCF) parameters
timeFrame: 1 year
measure: concentration of serum parameters
timeFrame: 1 year
Secondary outcomes:
measure: value of periodontal clinical parameters
timeFrame: 1 year
measure: value of patients' clinical metabolic syndrome parameters
timeFrame: 1 year
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University
Study officials:
References:
Clinical trial NCT03711253: Empiric Treatment for Acute HIV in the ED
Official title: Empiric Treatment for Suspected Acute HIV Infection in the Emergency Department
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute HIV Infection
Keywords: acute hiv infection
emergency department
antiretroviral therapy
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 40
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: An acceptance and feasibility study for immediate ART initiation and storage of laboratory specimens for individuals with suspected acute HIV infection who are diagnosed in one of the 7 participating emergency rooms

Detailed description: Individuals with suspected acute HIV infection willing to start immediate ART treatment will be given the ART regimen (bictegravir 50mg + tenofovir alafenamide 25 mg + emtricitabine 200 mg fixed dose combination) on the day of diagnosis. Those patients beginning immediate ART in the ED who are willing to have additional laboratory specimens drawn in the ED and become part of a cohort to receive ART and have ongoing biological specimens obtained and will be followed for 48 weeks.

Eligibility criteria: Inclusion Criteria:

* Suspected acute HIV infection
* agree to start immediate ART and to storage of laboratory specimens

Exclusion Criteria:

* Known chronic HIV infection
* severe renal or liver disease
* drug allergy/hypersensitivity
* prohibited medications
* pregnancy
* co-morbidity that the investigator feels would compromise safety, data interpretation, or achieving study objectives

Primary outcomes:
measure: Acceptance of immediate ART initiation
timeFrame: 1 day
Secondary outcomes:
measure: Impact on linkage and engagement in care
timeFrame: 48 weeks
measure: ART effects on cell associated HIV DNA
timeFrame: 48 weeks
measure: ART effects leukocytes
timeFrame: 48 weeks
measure: ART effects inflammation
timeFrame: 48 weeks
measure: ART effects monocyte activation
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LA County-USC Medical Center Emergency Department
state: California
city: Los Angeles
country: United States
facility: Rand Schrader Health and Research Clinic
state: California
Study officials:
affiliation: University of Southern California
name: Kathleen Jacobson, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01259453: Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
Official title: Hepatitis B Vaccination Through Syringe Exchange Programs: A Randomized, Controlled Trial of Vaccination Schedules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Keywords: Hepatitis B vaccination
Syringe exchange programs
Injection drug users
Hepatitis B prevention through vaccination
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: DePaul University
name: Hispanic Health Council, Inc.
name: Case Western Reserve University
name: National Institute on Drug Abuse (NIDA)
First posted: 2010-12-14
Enrollment: 595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators seek to provide immunization for individuals who are at high risk of contracting hepatitis B virus (HBV) infection because of their illicit drug use. The investigators will be using the syringe exchange programs (SEPs) in Hartford and Bridgeport, CT and Chicago, IL to contact high risk individuals and refer them for vaccination. The primary purpose of the study is to compare the standard schedule of hepatitis B vaccination at 0, 1, and 6 months to an accelerated schedule of vaccination at 0, 1, and 2 months. The investigators hypothesize that the accelerated scheduling will result in improved completion rates without significant loss in vaccine efficacy.


Eligibility criteria: Inclusion Criteria:

* Demonstrate evidence of recent injection drug use (injection stigmata),
* 18 years of age or older,
* Screened for and found susceptible to HBV
* Able to provide informed consent.

Exclusion Criteria:

* Evidence of intoxication that prevented provision of informed consent.

Primary outcomes:
measure: Vaccine Efficacy
timeFrame: 8 months from study enrollment
Secondary outcomes:
measure: Vaccine completion rate
timeFrame: 8 months from study enrollment
measure: Association of exchange status with completion
timeFrame: 8 months from study enrollment
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hispanic Health Council
state: Connecticut
city: Chicago
country: United States
facility: DePaul University
state: Illinois
city: Cleveland
country: United States
facility: Case Western Reserve Universtiy
state: Ohio
Study officials:
affiliation: Yale University
name: Robert Heimer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hu Y, Grau LE, Scott G, Seal KH, Marshall PA, Singer M, Heimer R. Economic evaluation of delivering hepatitis B vaccine to injection drug users. Am J Prev Med. 2008 Jul;35(1):25-32. doi: 10.1016/j.amepre.2008.03.028.
Clinical trial NCT00567853: Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair
Official title: Clinical Investigation Of The Sorin 3D Annuloplasty Ring For Mitral Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mitral Valve Regurgitation
Keywords: mitral valve regurgitation
mitral valve disease
mitral valve repair
mitral valve dysfunction
heart valve
valve disease
cardiac surgery
Lead sponsor: Sorin Group USA, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 278
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 collect data on the effectiveness and clinical outcomes of the MEMO 3D Annuloplasty ring as used for mitral valve repair.


Eligibility criteria: Inclusion Criteria:

* The subject is 18 years old or older
* An annuloplasty ring is indicated for reinforcement of a dysfunctional or diseased native mitral valve according to the current medical practice for valvular repair at each site.
* The subject is able to return for all follow-up evaluations of the study.

Exclusion Criteria:

* The subject or subject's legal representative is unwilling to sign the informed consent.
* The subject is or will be participating in another medical device or drug clinical trial.
* The subject is a minor, prisoner, institutionalized, or is unable to give informed consent.
* The subject has a life expectance of less than 1 year.

Primary outcomes:
measure: The percentage of patients with successful repair at 6 months.
timeFrame: One Year
Secondary outcomes:
measure: Freedom from re-operation at 12 months. Preoperative and postoperative mitral valve regurgitation and LV dimensions and mass assessed by echocardiography. Actuarial survival and freedom from clinical events at 12 months.
timeFrame: 12 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: Philadelphia
country: United States
facility: University of Pennsylvania Presbyterian Hospital
state: Pennsylvania
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: University of Pennsylvania Presbyterian Medical Center
name: Clark Hargrove, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06770153: Comparison Between the Use of the Tensioner and Standard Surgical Technique for Ligament Balancing of Total Knee Prostheses
Official title: Comparison Between the Use of the Tensioner and Standard Surgical Technique for Ligament Balancing of Total Knee Prostheses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Injuries
Keywords: Knee prosthesis
prosthesis
knee
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the objective of the present study is to compare the post-operative laxity using stress radiographs and clinical scores in two groups of patients undergoing primary PS TKA with identical prosthetic model performed in two specialized centers, of which one group implanted with standard technique and one group through the intraoperative use of the tensioner


Eligibility criteria: Inclusion Criteria:

* Male and female subjects candidates for primary cemented total knee prosthesis model Attune PS mobile plate DePuy.
* Patients who possess all the psychophysical capabilities to be able to undergo the operation and all the check-ups with radiological tests included (e.g. all patients who are not willing to go to the institute for all the scheduled follow-up visits will be excluded) .
* Patients who have signed the "informed consent" approved by the Ethics Committee.
* Patients who are aged between 50-85.

Exclusion Criteria:

* Social conditions that prevent participation in the study in all its phases (homeless patients, with restrictions on personal freedom, etc.)
* Patients suffering from deep venous insufficiency of the lower extremities or with a personal or family history of deep venous thrombosis or pulmonary embolism
* Patients with a history of erysipelas in the lower extremities
* Patients suffering from neurological or psycho-cognitive disorders
* Patients suffering from post-traumatic arthrosis
* Patients who have already undergone prosthetic surgery and/or arthrodesis at the level of a lower limb joint
* Patients with axial knee deformities \>15°
* Pregnant female patients
* Patients with rheumatic diseases

Primary outcomes:
measure: radiographical images
timeFrame: at baseline, after 3 months, after 6 months anfer 12 months
Secondary outcomes:
measure: Hip-Knee-Anke Angle
timeFrame: at baseline, after 3 months, after 6 months anfer 12 months
measure: Visual Analogue Scale
timeFrame: at baseline, after 3 months, after 6 months anfer 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
References:
Clinical trial NCT06168253: Text Message Safety Behavior Fading for Social Anxiety
Official title: Text Message Safety Behavior Fading Intervention for Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Keywords: Social Anxiety
Safety Behaviors
Intervention
Text-message
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in to one of two conditions
Primary purpose: TREATMENT

Brief summary: The current study aims to explore the efficacy of a text message based Safety Behavior Fading Intervention compared to an active control intervention.

Detailed description: Safety behavior fading may be a viable standalone intervention for social anxiety. In the present trial, participants high in social anxiety will be randomized to either receive a daily checklist exercise aimed at eliminating (1) safety behaviors or (2) unhealthy behaviors. Individuals randomly assigned to the safety behavior fading condition will receive instructions to decrease or eliminate their four most habitual social anxiety safety behaviors. In addition, they will receive daily reminders via text message to decrease these behaviors, along with a safety behavior monitoring checklist in which the participant indicates the extent to which they decreased and/or eliminated each safety behavior over the previous day. Individuals randomly assigned to the control condition will receive similar text messages and a daily checklist to encourage fading of unhealthy behaviors. Participants in both conditions will complete checklists for 28 days. After day 14 of treatment, participants will re-select their target safety behaviors or unhealthy behaviors, and will then be prompted to reduce these new behaviors for another 14 days.

Eligibility criteria: Inclusion Criteria:

* Social Phobia Inventory Score \>29
* Stable Psychotropic Medications for 4 weeks prior to participation

Exclusion Criteria:

* Currently participating in psychotherapy for social anxiety

Primary outcomes:
measure: Change in Social Phobia Inventory (SPIN)
timeFrame: Time Frame: Day 0, Day 14, Day 28, Day 56
Secondary outcomes:
measure: Change in Center For Epidemiological Studies Depression Scale, Ten Item Version (CESD-10)
timeFrame: Time Frame: Day 0, Day 28, Day 56
measure: Change in UCLA Loneliness Scale, Short Form (ULS-8)
timeFrame: Time Frame: Day 0, Day 28, Day 56
measure: Change in Self-Beliefs Related to Social Anxiety Scale (SBSA)
timeFrame: Time Frame: Day 0, Day 28, Day 56
measure: Change in Subtle Avoidance Frequency Examination (SAFE) scale
timeFrame: Time Frame: Day 0, Day 28, Day 56
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References:
Clinical trial NCT06690853: Effects of Coordinative Warm-Up Exercise Protocols on the Technical and Cognitive Performance of Soccer Players
Official title: Effects of Coordinative Warm-Up Exercise Protocols on the Technical and Cognitive Performance of Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soccer Performance
Keywords: soccer players
warm up
technical-coordination
cortisol
adrenaline
noradrenaline
dopamine
football
Lead sponsor: University of Molise
Sponsor class: OTHER
Collaborators: name: Marco Centorbi
name: Alessandra di Cagno
name: Giuseppe Calcagno
name: Andrea Buonsenso
First posted: 2024-11-15
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study is to evaluate the effects of 12 weeks of warm-up protocols administered to elite soccer players on technical-coordination performance and levels of cortisol, adrenaline, noradrenaline, and dopamine, measured before and after the intervention.

Detailed description: The warm-up protocols included coordination exercises using different types of balls, with combined activities involving both the upper and lower limbs

Eligibility criteria: Inclusion Criteria:

* elite soccer players

Exclusion Criteria:

* no injuries in the previous 6 months;
* no adherence to other training protocols;
* no use of prohibited drugs and/or supplements that could affect the test results and exercises

Primary outcomes:
measure: Illinois agility test
timeFrame: at 12 weeks
measure: Illinois agility test
timeFrame: at 12 weeks
measure: agility test
timeFrame: at 12 weeks
measure: agility test
timeFrame: at 12 weeks
measure: Loughborough Soccer Shooting Test
timeFrame: at 12 weeks
measure: Blood analysis
timeFrame: at 12 weeks
measure: Blood analysis
timeFrame: at 12 weeks
measure: Blood analysis
timeFrame: at 12 weeks
measure: Blood analysis
timeFrame: at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Campobasso
country: Italy
facility: Università degli Studi del Molise
state: CB
Study officials:
References:
Clinical trial NCT00989053: The Effect of Selective Serotonin Reuptake Inhibitor (SSRI) Treatment on Affective Symptoms and Fertility Treatment Outcome in Women Undergoing in Vitro Fertilization (IVF)
Official title: The Effect of SSRI Treatment on Affective Symptoms and Fertility Treatment Outcome in Women Undergoing In Vitro Fertilization for Unexplained Infertility - a Prospective Placebo-Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety
In Vitro Fertilization
Keywords: depression
anxiety
stress
antidepressant therapy
SSRI
infertility
in vitro fertilization (IVF)
immunological factors
depressive and anxiety symptoms in women undergoing IVF treatment
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-10-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women undergoing IVF show a high prevalence of depressive and anxiety symptoms. Furthermore, stress has harmful consequences on IVF and pregnancy outcomes. An immunological cascade was suggested to be involved in the process. Treatment in this setting is usually psychotherapy rather than pharmacotherapy, despite reasonable biological evidence suggesting beneficial influence of antidepressant therapy on pregnancy and well-being. Moreover, pharmacotherapy is more available and affordable than psychotherapy in the public health system. The investigators suggest to study the efficacy of antidepressant treatment in women undergoing IVF treatment, presenting with mild mood symptoms. The investigators hypothesize that treatment will result in a greater attenuation of affective symptoms, as well as in higher pregnancy success rates. Furthermore, certain immunological stress-reactive factors, may prove to be the biological mechanism underlying these effects.


Eligibility criteria: Inclusion Criteria:

1. Women 18 - 45 y.o.
2. A score higher then 45 on the Zung Self-Rating Anxiety Scale or a score higher then 16 on the Center for Epidemiologic Studies Depression Scale
3. Understanding of Hebrew
4. Willing to sign the informed consent

Exclusion Criteria:

1. An axis I DSM IVTR diagnosis other then a depressive, adjustment or anxiety disorder
2. Suicidal ideation
3. Current treatment with antidepressant medication
4. Physical illness explaining depressive symptoms (e.g. hypothyroidism, neurological disease, severe anemia, renal failure etc.)
5. Alcoholism or drug abuse and dependence
6. Past severe side effects to SSRIs
7. Failed IVF (4 trials of good quality embryo reinstatement without achieving pregnancy)

Primary outcomes:
measure: positive blood βHCG
timeFrame: 2 months from date of signing informed consent
Secondary outcomes:
measure: psychiatric evaluation questionnaires
timeFrame: 2 months
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT00005477: Hispanic and White Women's Cardiovascular Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To elucidate the influence of ethnicity and socioeconomic status (SES) on women's cardiovascular health, using recently completed risk factor and mortality data from the Stanford Five-City Project.

Detailed description: DESIGN NARRATIVE:

Two data sets were used to evaluate the specific aims: (1) survey risk factor data (e.g., blood pressure, cholesterol, blood lipids, smoking, etc.) on over 4500 girls and women; and (2) surveillance mortality data on over 1800 women.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Behera SK, Winkleby MA, Collins R. Low awareness of cardiovascular disease risk among low-income African-American women. Am J Health Promot. 2000 May-Jun;14(5):301-5, iii. doi: 10.4278/0890-1171-14.5.301.