louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00513968: Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine
Official title: A Single Center, Randomized, Open-label, Dose Escalating Phase I Study to Evaluate the Safety of Intramuscularly Administered DNA Vaccine (HB-110) Combined With Oral Antiviral (Adefovir) in Subjects With Chronic Hepatitis B Over a 48-week Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2007-08-09
Enrollment: 27
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: This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.


Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis B infected patient documented with positive HBsAg for 3 months and more at screening
* Chronic hepatitis B infected patient with positive HBeAg at screening
* Patient who has not treated with interferon alpha, lamivudine or adefovir within 3 months before study entry
* HBV DNA more than 1x10\^5 copies/mL through COBAS Amplicor HBV monitor assay or bDNA method at screening
* Patient with HBV DNA decrease more than 10-fold compared to the baseline after 8 weeks treatment with adefovir
* Patient with ALT value between ULN x 1.5 and ULN x 5 at screening
* Patient given a written consent voluntarily

Exclusion Criteria:

* Have uncompensated liver disease
* Serum creatinine \> ULN x 1.5
* Are positive for Hepatitis C, hepatitis D or HIV infection (confirmed by ELISA assay)
* Had a previous liver or bone marrow transplant
* Are currently taking any immunosuppressant or any possible immune modulatory drugs
* Women who are pregnant or breastfeeding
* Woman or man who plans a birth for study duration
* Any experience of severe adverse drug reaction or any medical history of severe allergic disease
* Patient with any severe disease (for example, heart failure, renal failure, pancreatitis, diabetes mellitus) affecting the study in discretion of investigator except liver disease
* Patient with any other liver disease but hepatitis B (for example, hemochromatosis, Wilson's disease, alcoholic/non-alcoholic liver diseae)
* Patient with intrahepatic tumors confirmed by imaging (liver biopsy)and abnormally increased alpha-fetoprotein
* Patient with any present malignant tumor except liver or its history
* Other inappropriate patient in discretion of investigator

Primary outcomes:
measure: Adverse events and clinical laboratory abnormalities
timeFrame: 48 weeks
Secondary outcomes:
measure: HBeAg/HBsAg seroconversion rate, HBV Ag specific T cell immunity
timeFrame: 24, 28, 32, 42, 44, and 48 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam St. Mary's Hospital
Study officials:
affiliation: The Department of Gastroenterology at Seoul St. Mary's Hospital
name: Prof. Seung-kyu Yoon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04909268: Prevention of Missed Opportunities for HIV Diagnosis by Promoting HIV Testing of Patients With Pneumococcal Pneumonia at Nice University Hospital (PneumoVIH)
Official title: PneumoVIH : Prevention of Missed Opportunities for HIV Diagnosis by Promoting HIV Testing of Patients With Pneumococcal Pneumonia at Nice University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia, Pneumococcal
Hiv
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with positive pneumococcal antigenuria

Brief summary: According to usual practices, HIV testing should be performed for each patient diagnosed for pneumococcal pneumonia. Unfortunately, in 2018, only 27% of patients were tested for HIV following pneumococcal pneumonia in Nice University Hospital. The aim of PneumoVIH protocol is to promote HIV testing by reminding good practices to physicians. To achieve this, the team of the bacteriology laboratory will contact physicians for each patient positive for pneumococcal antigenuria to suggest HIV testing. This prospective public health action will aim to integrate this HIV test into routine care and to evaluate benefits through the number of HIV positive patients that will be diagnosed.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 years or older with validated diagnosis of bacterial pneumococcal pneumonia.

Exclusion Criteria:

* documented history of HIV infection.

Primary outcomes:
measure: Testing rate
timeFrame: 1 year
Secondary outcomes:
measure: Rate of HIV-positive status discovery
timeFrame: 1 year
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
Clinical trial NCT02246868: An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Official title: An Open Study to Investigate the Safety and Efficacy of Optivate® in Severe Haemophilia A Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilia A
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-09-23
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with Optivate® when treating a bleed. The secondary objectives are to evaluate the clinical tolerance and safety of Optivate®.


Eligibility criteria: Inclusion Criteria:

* Immunocompetent with severe Haemophilia A without inhibitor to FVIII, at least 12 years of age, currently receiving FVIII concentrates and have more than 150 exposures. Subjects who require elective surgergy within 6 months of starting on OPTIVATE® are permitted to be included in this study providing that the surgery could be performed using OPTIVATE® as FVIII cover.

Exclusion Criteria:

-

Primary outcomes:
measure: Incremental Recovery
timeFrame: Comparison of Baseline with 3 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Klinika Haematologii, Akademia Medyczna w Bialymstokiu, ul.
city: Gdansk
country: Poland
facility: Klinika Haematologii, Akademia Medyczna w Gdansku, u.
city: Lodz
country: Poland
facility: Klinika Haematologii, Akademia Medyczna w Lodzi, ul.
city: Lublin
country: Poland
facility: Klinika Haematologii, Akademia Medyczna w Lublinie, ul.
city: Poznan
country: Poland
facility: Klinika Haematologii, Akademia Medyczna w Poznaniu, ul.
city: Wroclaw
country: Poland
facility: Klinika Haematologii, Akademia Medyczna w Wroclawiu, ul.
city: Cambridge
country: United Kingdom
facility: Haemophilia Centre, Addenbrooke's Hospital, Hills Road
city: Manchester
country: United Kingdom
facility: Haemophilia Centre, University Department of Haemophilia Manchester Royal Infirmary
city: Nottingham
country: United Kingdom
facility: Haemophilia Centre, University Hospital, Queen's Medical Centre, Clifton Boulevard
city: Sheffield
country: United Kingdom
facility: Sheffield Haemophilia & Thrombosis Centre, Royal Hallamshire Hospital, Glossop Road
city: Southampton
country: United Kingdom
facility: Haemophilia Centre, Southampton General Hospital, Tremona Road
Study officials:
References:
Clinical trial NCT02175368: Adhese One F Upgrade in Direct Filling Therapy
Official title: Clinical Evaluation of AdheSE One F Upgrade in Direct Filling Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Adhesive
Keywords: total etch protocol
direct filling therapy
Lead sponsor: Ivoclar Vivadent AG
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigation on the clinical performance of a new dental adhesive when used in direct filling therapy after phosphoric acid etching.

Hypothesis: The new adhesive shows an acceptable clinical performance and allows a good filling quality.


Eligibility criteria: Inclusion Criteria:

* indication for class I or II filling
* max. 2 restorations per patient
* vital teeth
* sufficient language skills

Exclusion Criteria:

* dry working field cannot be established
* if the patient is known to be allergic to any of the materials' ingredients
* severe systemic diseases
* pregnancy
* non-vital or pulpitic teeth
* indication for indirect restoration

Primary outcomes:
measure: Number of Participants With Clinical Success
timeFrame: 1 week
Secondary outcomes:
measure: Clinical Quality
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Ivoclar Vivadent AG
name: Arnd Peschke, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06449768: Effectiveness Of Suprachoroidal Injection In Diabetic Macular Edema
Official title: Effectiveness Of Suprachoroidal Injection In Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Diabetic Macular Edema
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 36
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic Macular Edema patient having Diabetes for more than 2 years

Brief summary: It will investigate a novel treatment approach for diabetic macular edema (DME), which causes vision impairment in diabetic patients. It will focuse on the efficacy and safety of administering triamcinolone acetonide via suprachoroidal injection, targeting the space between the sclera and choroid.

Detailed description: This method aims to enhance drug delivery to the retina, potentially improving outcomes compared to conventional treatments. Participants receive suprachoroidal injections, and the study measures changes in macular thickness and visual acuity. The study's findings could offer a promising alternative to existing DME treatments, aiming to provide better management of the condition and improved patient quality of life.

Eligibility criteria: Inclusion Criteria:

* Above 30 years old patients male and female
* Diabetic patient
* Diabetic patient for more than 2 years
* Macular thickness of more than 280um

Exclusion Criteria:

* Patient below 30 years
* Patients having media opacity
* Patients with other systemic problems
* Uncooperative patients

Primary outcomes:
measure: Visual Acuity Testing
timeFrame: 12 Months
measure: Optical Coherence Tomography
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Lions Medical Complex , Main Market, Gulberg ll
state: Punjab
Study officials:
References:
Clinical trial NCT00266968: Outcomes of Children With Congenital Single Ventricle Heart
Official title: Assessment of the Outcomes of Children With Congenital Single Ventricle Heart
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Disorders
Keywords: pediatric
cardiac
single ventricle
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-12-20
Enrollment: 200
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects seen at Children's Healthcare of Atlanta with single ventrical heart

Brief summary: Congenital heart disease affects 1 in 100 newborn babies each year and more than 2,000,000 Americans have a congenital heart defect. One common defect treated at Children's Healthcare of Atlanta at Egleston is single ventricle heart. Due to these overwhelming numbers, the use of diagnostic imaging technology to assess these defects and heart function is an important step in the evolving care of this patient group.

Detailed description: The definition of single ventricle can mean a ventricle that is hypoplastic, too small, or completely absent. Either the right or left ventricle may be affected. There may also be other cardiac anomalies present. Infants with a single ventricle develop distress after birth when the ductus arteriosus and foramen ovale close. This may happen within hours or days of delivery. The severity of symptoms is determined by the degree of defect. But, single ventricle patients will not survive without treatment. Patients with only one functioning ventricle can usually expect either a heart transplant or a series of palliative surgeries or sometimes both. Their care is very complex requiring a team of dedicated practitioners to manage drug therapy, medical support and surgery.

At Children's Healthcare of Atlanta at Egleston, it is standard of care for a patient with a single ventricle heart to undergo many non-invasive imaging studies and sometimes invasive studies such as heart catheterization. Results of the studies provide valuable information used for treatment decisions and evaluation of heart function. We propose to do a retrospective chart review of patient data including a review of their invasive and non-invasive studies.

Eligibility criteria: Inclusion Criteria:

* Single Ventrical heart

Exclusion Criteria:

* those patients who do not have single ventrical heart

Primary outcomes:
measure: We propose to do a retrospective chart review of patient data including a review of their invasive and non-invasive studies.
timeFrame: 13 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Angel Cuadrado, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03056768: Taiwan Health Promotion Intervention Study for Elders
Official title: Taiwan Health Promotion Intervention Study for Elders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly Syndrome
Cognitive Impairment
Cognitive Decline
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2017-02-17
Enrollment: 1080
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives: 1-year multidomain health promotion on prevention of physical and cognitive decline for community-living older people.

Design:

Methods: Randomized controlled trial

Setting:

Five cities(Taipei, Taichung, Kaohsiung, Kinmen, I-Lan) in Taiwan Participants: age 65 or older community-dwelling prefrail or frail adults Intervention: 1-year multidomain health promotion (physical, cognitive, nutritional intervention)

Measurements:

Primary outcome includes frailty status and cognitive performance. Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; All the variables were measured at 0, 6, 12 months. The effect of intervention was investigated by intention-to-treat analysis.

Detailed description: Eligibility criteria includes: community-dwelling older people aged 65 or older, and those with confirmed diagnosis of dementia or dependent on activities of daily living were excluded.

Primary outcome includes frailty status measured by CHS frailty score. general and sub-domain cognitive performance measured by Montreal Cognitive Assessment (MoCA). Secondary outcomes include depressive symptoms, nutrition assessment, and functional capacity; which were evaluated by 5-item Geriatric Depression scale(GDS-5), Mini-nutrition Assessment(MNA), and instrumental activities of daily living (IADL) individually.

Eligibility criteria: Inclusion Criteria:

* Prefrail or frail community-dwelling people

Exclusion Criteria:

* Institutionalized or ADL dependent
* Diagnosed dementia
* Limited life expectancy

Primary outcomes:
measure: Change from baseline frailty score at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Director, Center for Geriatrics and Gerontology, Taipei Veterans General Hospital
name: Liang-Kung Chen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00954668: ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)
Official title: ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non-ST-elevation Myocardial Infarction
Keywords: Non-ST-elevation myocardial infarction
angiography
percutaneous coronary intervention
timing
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Stiftung Institut fuer Herzinfarktforschung
First posted: 2009-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Of estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). The currently available evidence led to current guideline recommendations that a systematic approach of immediate angiography in NSTEMI patients stabilized with contemporary antiplatelet treatment is not mandatory. However, this immediate invasive approach is appealing because it allows treating the underlying cause (the plaque rupture) as early as possible with subsequent reduction of death and recurrent myocardial infarction. In the IDEAL NSTEMI trial we test an immediate invasive approach (\<2 h) with an approach 12-72 h according top guidelines with respect to 6 months death and mortality.


Eligibility criteria: Inclusion Criteria:

* NSTEMI with

  * ischemic symptoms \>10 minutes within 24 h
  * elevated troponin or creatine kinase above the upper limit of normal
  * ST-segment depression or transient ST-segment elevation, T-wave inversion
  * informed consent.

Exclusion Criteria:

* Age \< 18 years
* Age \> 90 years
* persistent angina
* hemodynamic instability
* overt congestive heart failure
* life-threatening arrhythmias
* STEMI
* limited life-expectancy \< 6 months
* chronic oral anticoagulation
* fibrinolysis \< 48 hours
* PCI \< 14 days
* contraindication for treatment with glycoprotein IIb/IIIa inhibitors, heparin, aspirin and clopidogrel
* recent major trauma or surgery

Primary outcomes:
measure: Death and non-fatal recurrent infarction
timeFrame: 6 months
Secondary outcomes:
measure: Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization
timeFrame: 6 months
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig - Heart Center
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Holger Thiele, MD
role: STUDY_CHAIR
affiliation: Institut für Herzinfarktforschung
name: Uwe Zeymer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04267068: Single Session Intervention to Prevent Common Mental Disorders and Among College Students
Official title: Single Session Intervention to Prevent Common Mental Disorders and Among College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 375
Sex: ALL
Minimum age (years): 17
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The present study aims to determine the effect of presenting psychoeducation emphasizing "growth-mindset," and information on depression and anxiety symptom severity. The investigators hypothesize that psychoeducation emphasizing that mental health is malleable will increase the participant's engagement with risk factors outlined in the intervention

Detailed description: Depression and anxiety disorders (or common mental disorders; CMDs) are increasingly common among college students, with rates comparable to the general population. As such, brief, scalable and transdiagnostic prevention efforts targeting CMDs are needed. In order to address this need, this study aims to evaluate the impact of a single session intervention (SSI) utilizing growth mindset (GM) on CMD symptom severity and investigate the mediating role of changes in modifiable risk factors in the relationship between intervention and CMD symptom reduction. The intervention will adapt existing GM interventions for college students to engage mechanisms in the prevention and management of common mental disorders including engagement in modifiable risk factors. College students will be randomly assigned to complete either a GM intervention or a psychoeducation control.

Eligibility criteria: Inclusion Criteria:

* Age 17-26
* College student at the University of Nevada, Reno

Exclusion Criteria:

* Under the age of 17, over the age of 26
* Participated in pilot study
* Not a college student at the University of Nevada, Reno

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer & Williams, 2001)
timeFrame: 6 months
measure: Generalized Anxiety Disorder-7 (GAD-7; Spitzer, Kroenke, Williams & Lowe, 2006)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reno
country: United States
facility: University of Nevada, Reno
state: Nevada
Study officials:
affiliation: University of Nevada, Reno
name: Anthony Papa, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: