louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01139203: Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Transplantation
Hepatitis B
Keywords: HBV recurrence
entecavir
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Zhejiang University
First posted: 2010-06-08
Enrollment: 300
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: PREVENTION

Brief summary: Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver transplantation patients with Hepatitis B Virus (HBV) related diseases.


Eligibility criteria: Inclusion Criteria:

1. patients into the transplant waiting list with HBV-related liver disease.
2. HBsAg-positive.
3. serum HBV-DNA negative.
4. no HCV, HDV and HIV co-infection.
5. without renal dysfunction.
6. No lamivudine, adefovir and entecavir drug allergy history.
7. no HBV-YMDD mutation for patients who have a long-term use of lamivudine.

Exclusion Criteria:

1. patients with HBV-related hepatocellular carcinoma beyond Milan criteria.
2. HBsAg-negative.
3. serum HBV-DNA positive.
4. HCV, HDV and HIV co-infection.
5. patients with severe renal dysfunction or failure.
6. lamivudine, adefovir and entecavir drug allergy history.
7. HBV-YMDD mutation for patients who have a long-term use of lamivudine.

Primary outcomes:
measure: serological markers of HBV
timeFrame: every three month after liver transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai First People's Hospital
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Zhi-Hai Peng, MD PHD
role: STUDY_CHAIR
References:
citation: Patterson SJ, Angus PW. Post-liver transplant hepatitis B prophylaxis: the role of oral nucleos(t)ide analogues. Curr Opin Organ Transplant. 2009 Jun;14(3):225-30. doi: 10.1097/MOT.0b013e32832b1f32.
citation: Angus PW, Patterson SJ. Liver transplantation for hepatitis B: what is the best hepatitis B immune globulin/antiviral regimen? Liver Transpl. 2008 Oct;14 Suppl 2:S15-22. doi: 10.1002/lt.21614.
citation: Riediger C, Berberat PO, Sauer P, Gotthardt D, Weiss KH, Mehrabi A, Merle U, Stremmel W, Encke J. Prophylaxis and treatment of recurrent viral hepatitis after liver transplantation. Nephrol Dial Transplant. 2007 Sep;22 Suppl 8:viii37-viii46. doi: 10.1093/ndt/gfm655.
citation: Carey I, Harrison PM. Monotherapy versus combination therapy for the treatment of chronic hepatitis B. Expert Opin Investig Drugs. 2009 Nov;18(11):1655-66. doi: 10.1517/13543780903241599.
Clinical trial NCT04792203: The Evaluation of the Ultrasound-guided Clinical Procedure Simulation Curriculum
Official title: The Evaluation of the Ultrasound-guided Clinical Procedure Simulation Curriculum
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ultrasound Performance
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: inexperience doctors including the 1st-3rd post-graduate year residents

Brief summary: Ultrasound is a non-radiated diagnostic tool that can be performed at the bedside in emergency departments and critical care settings. Traditionally, junior residents learn from patients by performing sonography on them. However, patient rights, patient safety, and medical quality are raising concerns.

How to enable junior doctors to be effectively familiar with ultrasound operations and to effectively integrate them into daily practice has become a major challenge in medical education. Also, the ultrasound-guided clinical procedure is included in the ultrasound core applications in the American College of Emergency Physicians statements.

This aim of this study is to establish an ultrasound-guided simulation curriculum and to evaluate the efficacy. The subjects of the study are junior doctors who are interested in clinical procedures in the emergency department or other relevant medical departments, and it is estimated that 200 people will be enrolled.


Eligibility criteria: Inclusion Criteria:

* participants attended the curriculum.

Exclusion Criteria:

* not attended the curriculum

Primary outcomes:
measure: ultrasound-guided clinical procedure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Emergency Medicine, National Taiwan University Hospital
Study officials:
affiliation: NTUH
name: WAN-CHING LIEN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04729803: Attention, Teleconferencing and Social Anxiety
Official title: Investigating Attentional Processes: Teleconferencing and Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study involves completing some online assessments and an intervention for social anxiety that all involve interactions with other people on a teleconferencing call.


Eligibility criteria: Inclusion Criteria:

* Age 18-75
* Fluent in English because the data collection materials have not yet been standardized in other languages
* Having access to a computer with a webcam and ability to record audio
* Personal Report of Communication Apprehension \> 80
* Leibowitz Social Anxiety Scale \> 30
* Meets DSM-5 Criteria for Social Anxiety Disorder

Exclusion Criteria:

* Significant visual impairment precluding the use of the eye tracking equipment
* Current, or history of bipolar disorder; current, or history of psychosis

Primary outcomes:
measure: Personal Report of Communication Apprehension Questionnaire
timeFrame: prior to the first treatment session, an average of 2 days
measure: Personal Report of Communication Apprehension Questionnaire
timeFrame: 1-week follow-up
measure: Personal Report of Communication Apprehension Questionnaire
timeFrame: 2-week follow-up
measure: Leibowitz Social Anxiety Scale Questionnaire
timeFrame: prior to the first treatment session, an average of 2 days
measure: Leibowitz Social Anxiety Scale Questionnaire
timeFrame: 1-week follow-up
measure: Leibowitz Social Anxiety Scale Questionnaire
timeFrame: 2-week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT03800303: Integrated Treatment for Youth With Mood Disorders
Official title: Healthy Youth & Families: An Integrated Approach to Treating Mood Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disorders in Children and Adolescents
Keywords: depression
bipolar
caregivers
children
adolescents
treatment
parents
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-01-11
Enrollment: 84
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In an effort to understand the effects of evidence-based interventions on children and adolescents, the aims of this study are to:

1. evaluate the feasibility of utilizing wearable devices to track health information (i.e., sleep, physical activity);
2. evaluate the effectiveness of evidence-based intervention components on mood and interpersonal functioning, family engagement, and sleep and physical activity level outcomes.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents between the ages of 10 and 18 years;
* Diagnosed with a primary depressive or bipolar disorder;
* Admitted to the Child and Adolescent Integrated Mood Program (CAIMP) at Mayo Clinic.

Exclusion Criteria:

* Individual's not eligible for admission to the Child and Adolescent Integrated Mood Program (CAIMP)at Mayo Clinic.

Primary outcomes:
measure: Conner's Comprehensive Behavior Rating Scales
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jarrod M Leffler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01365403: A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers
Official title: A SINGLE CENTER, OPEN LABEL, FIXED SEQUENCE, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE CARBAMAZEPINE ON SINGLE DOSE PHARMACOKINETICS OF RO4917838 IN HEALTHY MALE VOLUNTEERS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-06-03
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This open-label, fixed sequence, two-period study will assess the effect of multiple dose carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of 3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose of RO4917838 on Day 16.


Eligibility criteria: Inclusion Criteria:

* Adult healthy male volunteers, 18-65 years of age inclusive
* Body mass index (BMI) 18-30 kg/m2 inclusive

Exclusion Criteria:

* History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk or interfere with the ability of the subject to complete the study in the opinion of the investigator
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic or psychiatric disease, or cancer
* Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
* Native Asians or subjects with Asian racial origin

Primary outcomes:
measure: Area under the concentraion-time curve/maximum concentration (AUC/Cmax) of single dose RO4917838 with multiple dose carbamazepine administration
timeFrame: approximately 4 weeks
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: up to 13 weeks
Other outcomes:
Locations:
city: Rennes
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03550703: Open Label Immunotherapy of Myoma
Official title: Open Label Phase II Clinical Trial of Myoma Immunotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Myoma;Uterus
Fibroid Uterus
Leiomyoma
Fibroma
Lead sponsor: Immunitor LLC
Sponsor class: INDUSTRY
First posted: 2018-06-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label, single arm study
Primary purpose: TREATMENT

Brief summary: Myoma of the uterus or uterine fibroids are benign tumors that appears in the myometrium or the muscular layer of the uterus. It is one of the most common diseases in pre-climax women, reaching 12-25% of all gynecological diseases. There is an opinion that the true prevalence of myoma is much larger and reaches up to 80%, i.e., practically every second woman has it, often without knowing about. For the treatment of MM, surgical removal of the nodes or removal of the uterus is used. In addition, GnRH-agonist therapy is practiced, as well as embolization to block blood flow in the tumor. We propose to evaluate the immunotherapy approach in an open label Phase II study in 20 women with myoma, for whom no alternative therapy is available.

Detailed description: Myoma or uterine fibroids are one of the most common gynecological diseases, which occurs in at least one third of women older than 35 years, and after 40 - in every second. We will test a new tablet preparation, V3-Myoma, obtained from hydrolyzed, inactivated blood and tumor tissues of patients with uterine myoma. When administered orally, V3-Myoma should cause a specific anti-tumor immune response and an anti-inflammatory effect. Such an effect is due to the phenomenon known in immunology, called oral tolerance, leading to a reduction in tumor mass and a decrease in inflammation. An important advantage of our approach is the absence of any negative side effects. In the next three month, we will conduct Phase II open label clinical study of this intervention in 30 women with confirmed diagnosis of myoma.

Eligibility criteria: Inclusion Criteria:

diagnosed myoma with single or multiple tumors presence of typical clinical symptoms associated with myoma -

Exclusion Criteria:

other gynecological diseases not related to myoma hysterectomy

-

Primary outcomes:
measure: Change in tumor size compared to baseline
timeFrame: Once monthly for three months
Secondary outcomes:
measure: Changes in bleeding pattern at and between menstruations
timeFrame: During and between periods for three months
measure: Changes in level of pain associated with myoma, low back and legs, pelvic pressure and pain, if any
timeFrame: 3 months
measure: Changes in frequent urination or difficulty in emptying the bladder or constipation
timeFrame: 3 months
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Immunitor LLC
Study officials:
affiliation: Immunitor LLC
name: Aldar Bourinbaiar, PhD, MD/PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01134003: A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System
Official title: A Large Multi-Center Database of Women Who Have Had and Are Going to Have Surgical Correction of Their Pelvic Organ Prolapse Using the Gynecare Prolift System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Keywords: Gynecare Prolift
Pelvic organ prolapse
forming a large database of women who have recieve Gynecare prolift system
Lead sponsor: The Institute of Pelvic Medicine & Reconstructive Surgery, Allentown, Pennsylvania
Sponsor class: OTHER
First posted: 2010-05-31
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: women receiving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift

Brief summary: retrospective and prospective data collection for a database. Patients will have had or are going to have a repair of their pelvic organ prolapse using the Gynecare mesh Prolift System


Eligibility criteria: Inclusion Criteria:

* women recieving surgery for their pelvic organ prolapse using the Gynecare mesh kit called Prolift

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00224003: Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
Official title: Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Keywords: Anemia
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 23
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.


Eligibility criteria: Inclusion Criteria:

* Male or female pediatric ESRD, Patients \>_ 2 and \<_ 16 years of age, whose legally authorized representative provided signed informed consent.
* Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
* Predetermined TSAT and serum Ferritin (at the screening visit).
* Receiving a stable EPO dosing regimen.

Exclusion Criteria:

* Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
* Hypersensitivity to Ferrlecit or any of its inactive components.
* High TSAT level.
* High Serum Ferritin

Primary outcomes:
measure: Serum Ferritin
timeFrame: 14 weeks
measure: Transferrin Saturation
timeFrame: 14 weeks
Secondary outcomes:
measure: Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety.
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Stanford
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Boston
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Bronx
country: United States
state: New York
city: Dallas
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: Watson Laboratories, Inc.
name: Gary Hoel, RPh, PhD
role: STUDY_DIRECTOR
References:
citation: Warady BA, Zobrist RH, Finan E; Ferrlecit Pediatric Study Group. Sodium ferric gluconate complex maintenance therapy in children on hemodialysis. Pediatr Nephrol. 2006 Apr;21(4):553-60. doi: 10.1007/s00467-006-0042-5. Epub 2006 Mar 7.
Clinical trial NCT05135403: ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
Official title: ASSURE WCD Clinical Evaluation - Post Approval Study (ACE-PAS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sudden Cardiac Arrest
Lead sponsor: Kestra Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 5179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The ASSURE Wearable Cardioverter Defibrillator (WCD) system is indicated for adult patients who are at risk or at perceived risk of sudden cardiac arrest (SCA) and are not immediate candidates for, or refuse, an implantable defibrillator.

Brief summary: Active surveillance study using real-world data collected in the ASSURE Patient Registry. Outcome measures are based on analysis of ASSURE Registry data including data recorded by the WCD then annotated by clinical experts in electrophysiology.


Eligibility criteria: Inclusion Criteria:

* Adult patient prescribed the ASSURE wearable cardioverter defibrillator
* Provided written informed consent to participate in the ASSURE Patient Registry

Exclusion Criteria:

* Patients who do not meet the Inclusion criteria

Primary outcomes:
measure: Overall shock conversion rate
timeFrame: Up to 3 years
measure: Inappropriate shocks per patient month
timeFrame: Up to 3 years
Secondary outcomes:
measure: First shock conversion rate
timeFrame: Up to 3 years
measure: Inappropriate shock rate
timeFrame: Up to 3 years
Other outcomes:
measure: Appropriate shock rate per month
timeFrame: Up to 3 years
measure: Appropriate shock rate
timeFrame: Up to 3 years
measure: Total Shocks delivered
timeFrame: Up to 3 years
measure: Shocks diverted
timeFrame: Up to 3 years
measure: False positive shock alarm rate
timeFrame: Up to 3 years
measure: True positive shock alarm rate
timeFrame: Up to 3 years
measure: Adverse events
timeFrame: Up to 3 years
measure: Average daily device use
timeFrame: Up to 3 years
measure: Cumulative device use
timeFrame: Up to 3 years
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Jeanne Poole, M.D.
role: PRINCIPAL_INVESTIGATOR
References: