louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00979524: Addressing Mental Health in African American Job Training Adolescents and Young Adults
Official title: Addressing Mental Health in African American Job Training Adolescents and Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Depressive symptoms
Mental health services
Adolescents
Young adults
African-American
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2009-09-18
Enrollment: 782
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project's focus is twofold-to change the culture of an employment training program for adolescents and young adults (Youth Opportunities, or "YO") to more fully address the many mental health issues faced by its participants and to expand and improve the quantity and quality of mental health services for YO members. Four project components have been carefully selected to address the mental health issues of YO members: (1) Mental health education/training for YO staff and peer leaders, (2) Mental health education activities for YO members, (3) mental health screening on all newly enrolling YO members, and (4) comprehensive mental health services for YO members. These project components will be implemented at the HEBCAC YO Program (subsequently referred to as "Eastside" YO), with the Westside YO Program initially participating as a control site. Researchers at the Johns Hopkins University Center for Adolescent Health, led by Dr. Darius Tandon of the Department of Pediatrics, will conduct the research examining the effectiveness of these mental health services and supports.

There are four project objectives. First, the proposed activities will increase YO members' knowledge of mental health resources and decrease stigma associated with seeking mental health services. Second, the investigators will see an increase in YO members' receipt of needed mental health services. Third, the investigators will see improvement in YO members' mental health. Fourth, as a result of their improved mental health, YO members will more actively engage in YO program activities and achieve more key program milestones (e.g., GED completion). These objectives are sequential, with later objectives predicated on the achievement of earlier ones.


Eligibility criteria: Inclusion Criteria:

* All newly enrolling Eastside and Westside YO members during the study period will be eligible for study participation.

Exclusion Criteria:

* We will not enroll YO members currently in foster care in this study.

Primary outcomes:
measure: Depressive symptoms
timeFrame: November 2008-November 2012
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore City Eastside and Westside Youth Opportunity Centers
state: Maryland
Study officials:
References:
Clinical trial NCT01339624: Nasal Fentanyl And Renal Colic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Renal Colic
Keywords: analgesia
renal colic
ketorolac
nasal fentanyl
morphine.
treatment of acute renal colic
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2011-04-20
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 nasal fentanyl is effective in the treatment of renal colic in adults in emergency department.


Eligibility criteria: Inclusion Criteria:

* The patients were adults aged 18 to 65 years, presenting in ED with classical clinical symptoms of renal colic (sudden monolateral flank pain with inguinal irradiation) with a 10-cm visual analog scale (VAS) greater than or equal to 7

Exclusion Criteria:

* Were analgesia within 6 hours of arrival
* Allergy to opiates and NSAIDs
* Opiates abuse, known or suspected abdominal aortic dissection or aneurism,
* Presence of peritonitis
* Hemodynamic instability
* Pregnancy, breastfeeding, anticoagulant therapy.
* Patients with known renal, pulmonary, cardiac or hepatic failure, as well as those with renal transplantation, were also excluded.

Primary outcomes:
measure: Change in visual analogue scale pain intensity score
timeFrame: 30 and 60 minutes
Secondary outcomes:
measure: Use of rescue therapy at 30 minutes
timeFrame: 30 MINUTES
measure: The occurrence of adverse events
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Como
country: Italy
facility: Valduce Hospital
Study officials:
References:
Clinical trial NCT00560924: Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women
Official title: Preventive Effect of Treatment With Estradiol Vaginal Tablets on Recurrent Urinary Tract Infections in Post-menopausal Women (RUTI) in Post-menopausal Women With Signs of Urogenital Ageing (UGA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Menopause
Urinary Infections
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2007-11-20
Enrollment: 6
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to investigate the preventive effect of treatment with estradiol vaginal tablets on recurrent urinary tract infections (RUTI) in post-menopausal women with signs of urogenital ageing (UGA).


Eligibility criteria: Inclusion Criteria:

* Post-menopausal woman with Urogenital ageing (UGA)
* Recurrent urinary tract infections defined as three or more urinary tract infections within the past twelve months

Exclusion Criteria:

* Known or suspected allergy to trial product or related products
* Present UTI
* History of RUTI during fertile period of life

Primary outcomes:
measure: Time to first symptom of urinary tract infection (UTI)
Secondary outcomes:
measure: Number of urinary tract infection (UTI)
timeFrame: During the 12 months of treatment
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06403124: Outcome of Operative Management of Posterior Wall of Acetabulum Fracture
Official title: Outcome of Operative Management of Posterior Wall of Acetabulum Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Wall of Acetabulum Fracture
Keywords: Posterior wall of acetabulum, operative management
Lead sponsor: Chittagong Medical College
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Historically, acetabular fractures were treated conservatively which leading to long lasting morbidity like severe pain, limitation of movement and osteoarthritis. Now, evidence suggest surgery for all acetabular fractures for better outcome.

Objectives: To evaluate the clinical and functional outcomes of open reduction and internal fixation of posterior wall of acetabulum fractures.

Methods: This prospective clinical trial was conducted at Chittagong Medical College hospital, Chattogram, from January 2022 to February 2024. Sample size was 32 with fractures as per set criteria and was treated surgically. The outcome variables were functional (according to modified Merle D'Aubigne and Postel score) and radiological (according to Matta's grading). Evaluation was done at 6th weeks and at 03rd, 06th, 09th months. Detailed history, clinical examination, investigations, operative details, post-operative outcome and other parameters were documented. Data were collected in data collection form and were analyzed at the end of the study by using SPSS-25. P-value was considered as statistically significant when it was less than 0.05 and confidence interval was set at 95% level.


Eligibility criteria: Inclusion Criteria:

* Posterior wall fracture with unstable hip joint
* Posterior wall fracture with posterior column or transverse fracture
* incarcerated osteochondral fragment
* Age more than 18 years and less than 60 years
* injury within 03 weeks.

Exclusion Criteria:

* open fracture
* associated other acetabular fracture

Primary outcomes:
measure: Functional outcome
timeFrame: 09 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chittagong
country: Bangladesh
facility: Chittagong Medical College
Study officials:
References:
Clinical trial NCT06348524: Ferumoxytol-enhanced Magnetic Resonance Imaging
Official title: Ferumoxytol-enhanced Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Transmed Solutions
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: There are no current alternatives to diagnostic contrast-requiring imaging for patients with an eGFR \<30mL/min due to the association of gadolinium-based imaging modalities to nephrogenic systemic fibrosis and iodinated contrast-induced kidney injury. Ferumoxytol-enhanced imaging may offer an alternative approach.

Detailed description: This is a case control study which will assess the resolution by which the coronary arteries can be visualized using ferumoxytol-enhanced cardiac magnetic resonance angiography (fcMRA) in patients with prior regional cardiac ischemia localized by stress-induced echocardiography. Resolution will be compared to invasive coronary arteriography completed in all patients that will be analyzed at the end of the study.

Masked experts will interpret fcMRA images to determine if coronary stenosis is present or absent. By strict definitions, this is a single-arm study. However comparison will be made between fcMRA and invasive coronary arteriography performed in each patient. With a prevalence of disease of approximately 0.35 in the study population, it is anticipated that both sensitivity and specificity of fcMRA to identify the absence of coronary artery stenosis can be calculated.

Eligibility criteria: Both female and male participants are being studied aged 18-85 years old with an estimated glomerular filtration rate (eGFR) of less than 30ml/min/1.73 meters squared. Patients will have undergone cardiac screening tests that warrant further evaluation. Patients will be excluded with an eGFR \>30ml/min/1.73 meters squared.

Inclusion criteria:

Diagnosis of chronic kidney disease Diagnosis of anemia of chronic kidney disease

Exclusion criteria:

Hypersensitivity to intravenous iron products

Primary outcomes:
measure: Detect the absence of ≥50% stenosis in the coronary artery tree
timeFrame: 12 months
Secondary outcomes:
measure: Detect stenosis in proximal and distal segments of the coronary artery tree
timeFrame: 12 months
measure: Compare ferumoxtyol enhanced magnetic resonance angiography with stress echocardiography
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: authorized representative
name: Andrew M Siedlecki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05246124: The Effect of Demographic, Mental, and Physical Activity Profiles Towards Burnout in Frontline Healthcare Workers Facing COVID-19 Pandemics in Dr. Soetomo General Hospital Surabaya
Official title: The Effect of Demographic, Mental, and Physical Activity Profiles Towards Burnout in Frontline Healthcare Workers Facing COVID-19 Pandemics in RSUD Dr. Soetomo Surabaya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Psychological
Anxiety
Keywords: Mental health
COVID-19
Healthcare workers
Anxiety
Burnout
Biomarkers
Lead sponsor: Dr. Soetomo General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Universitas Airlangga
First posted: 2022-02-18
Enrollment: 61
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This was a randomized controlled trial study to measure the effect of intervention of Zumba dance towards psychological and biological markers in hospital residents managing COVID-19 patients

Detailed description: A study to compare the effect of Zumba dance exercise towards psychological and biological markers in control and intervention groups of residents managing COVID-19 patients. Psychological markers were assessed using State Trait Anxiety Inventory (STAI), Brief Resilience Scale (BRS), and Maslach Burnout Inventory (MBI) questionnaires. Biological markers being measured were neutrophil to lymphocyte ratio (NLR), CD4, Interleukin-6 (IL-6), and salivary cortisol. Measurements were done at the beginning of self-isolation after shift and 2 weeks after self-isolation.

Eligibility criteria: Inclusion Criteria:

* Residents of anesthesiology and internal medicine department at Dr. Soetomo General Hospital Surabaya
* Residents managing COVID-19 patients in the special isolation room

Exclusion Criteria:

* Residents that did not fill in the questionnaires completely
* Residents with comorbidities (diabetes, hypertension, heart disease or autoimmune disorders)
* Residents that were infected with COVID-19
* Residents currently or previously diagnosed with psychosis
* Residents refusing to participate in the study.

Primary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 2 weeks
measure: Brief Resiliency Scale (BRS)
timeFrame: 2 weeks
measure: Maslach Burnout Inventory (MBI)
timeFrame: 2 weeks
measure: Cortisol
timeFrame: 2 weeks
measure: CD4
timeFrame: 2 weeks
measure: Interleukin-6 (IL-6)
timeFrame: 2 weeks
measure: Neutrophil to lymphocyte ratio (NLR)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Dr. Soetomo General Hospital
state: East Java
Study officials:
affiliation: Dr. Soetomo General Hospital
name: Margarita M Maramis, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06572124: Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions
Official title: Clinical Performance of Universal Adhesive with and Without Acid Resistant Silane Coupling Agent in Carious Cervical Lesions :A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Carious Lesion
Cervical Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of composite restorations done in carious cervical lesions restored by a conventional universal adhesive in comparison to a universal adhesive that contains and resistant silane coupling agent according to the Modified United States Public Health Service (USPHS) criteria over 18 months.

Detailed description: The presence of acidic monomers in the bottle during storage can lead to the hydrolysis of silane contained in universal adhesives, potentially reducing its effectiveness and causing instability,The acid resistant silane coupling agent has a protective structure against attacks from acidic monomers. Therefore, long-term storage stability can be expected by suppressing hydrolysis. The protective structure is removed when the concentration of acidic monomers increases by air drying after application. This activates ARS, exerting the silane coupling effect.

Eligibility criteria: Inclusion Criteria:

* Participants Inclusion:

  • Adults aging from 21-67 years old who were in need of restoration of at least one notch-shaped cervical lesion
* Teeth Inclusion:

  * Vital teeth with carious cervical lesions in incisors , canines ,premolars\& molars

Exclusion Criteria:

* Participants Exclusion:

  * Patients with fewer than 20 teeth
  * Poor oral hygiene
  * Uncontrolled periodontal disease
  * Xerostomia
  * Known allergy to resin-based materials
  * Medically compromised, pregnant, or breast-feeding
* Teeth Exclusion:

  * Non vital teeth
  * Teeth that are out of occlusion
  * Previously restored teeth

Primary outcomes:
measure: Retention (Success rate)
timeFrame: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
Secondary outcomes:
measure: Marginal adaptation
timeFrame: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
measure: Marginal discoloration
timeFrame: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
measure: Secondary caries
timeFrame: T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT02917824: Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics
Official title: Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Inspiratory muscle training (IMT) can reverse or delay the complications from the deterioration of inspiratory muscle function in asthma. Thus, the IMT has been considered a treatment option for people with asthma. The aim of this study is to investigate the training principles of intensity, specificity and reversibility of IMT in asthmatics.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of asthma
* Adults (18 - 60 years)

Exclusion Criteria:

* Inability to perform the protocol established by the study
* Others respiratory diseases
* Request for study withdrawal

Primary outcomes:
measure: Change in inspiratory muscle strength
timeFrame: Baseline, 6 weeks later and 6 weeks after training
measure: Change in expiratory muscle strength
timeFrame: Baseline, 6 weeks later and 6 weeks after training
Secondary outcomes:
measure: Change in asthma control
timeFrame: Baseline, 6 weeks later and 6 weeks after training
measure: Change in quality of life
timeFrame: Baseline, 6 weeks later and 6 weeks after training
measure: Change in six minute walk test distance
timeFrame: Baseline, 6 weeks later and 6 weeks after training
measure: Change in forced vital capacity
timeFrame: Baseline, 6 weeks later and 6 weeks after training
measure: Change in forced expiratory volume
timeFrame: Baseline, 6 weeks later and 6 weeks after training
measure: Change in forced expiratory volume/forced vital capacity
timeFrame: Baseline, 6 weeks later and 6 weeks after training
measure: Change in inspiratory muscle activity
timeFrame: Baseline, 6 weeks later and 6 weeks after training
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Gardenia Maria Holanda Ferreira
state: Rio Grande Do Norte
Study officials:
References:
Clinical trial NCT00312624: Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies
Official title: Morphological Predictors of Sudden Cardiac Death in Patients With Known Cardiomyopathies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathy
Keywords: ICD implantation
cardiac MRI
cardiomyopathy
ventricular arrhythmias
LVEF 35% or less
indication for ICD implantation as part of standard of care
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2006-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with cardiomyopathy

Brief summary: This is a pilot study to find a correlation between MRI and ICD therapy in patients with known cardiomyopathies, aiming to determine if cardiac scarring identified by MRI correlates with ventricular arrhythmias and the occurrence of ICD therapy.

Detailed description: This is an observational study over a 3 year period of 50 patients with known cardiomyopathy and LVEF of 35% or less who will have ICD implantation as part of their standard of care. All subjects will undergo a contrast-enhanced cardiac MRI using gadolinium to determine the morphological characteristics of their left ventricle prior to ICD implant. Subjects will not be offered sedation to minimize risk, thus those suffering from claustrophobia will be excluded or dropped from participation. MRI will be evaluated, and subjects will be followed during standard of care device interrogations for 12 months after implant.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* cardiomyopathy with LVEF 35% or less
* indication for ICD implantation
* able to provide informed consent

Exclusion Criteria:

* prior device implantation
* contraindication for MRI (i.e., metallic foreign body)
* claustrophobia
* pregnant women

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Samir Saba, MD
role: PRINCIPAL_INVESTIGATOR
References: