louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02310893: Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care
Official title: Effectiveness of Peer Navigation and Contingency Management on Retention in HIV Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 579
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Consistent treatment with anti-retroviral therapy (ART) suppresses viral load (VL), prolonging life and improving quality of life for HIV+ persons. Suppressing VL benefits communities by reducing transmission to others. Mere availability of ART and care, however, is insufficient; the benefits of ART depend upon HIV+ persons' continuous visits to the health care provider, regular monitoring and regular delivery of medications, - known as retention in HIV care. In spite of national efforts, up to a quarter of HIV+ persons, especially low-income minorities are out of care. Innovative interventions are therefore urgently needed to maximize engagement and retention in HIV care, self-reported adherence, as well as HIV-1 RNA viral load suppression. In pursuit of these aims, the proposed study will assess outcomes of the following interventions in comparison to usual care: 1) contingency management (CM) only; 2) peer navigation (PN) only; and 3) a combined approach that integrates both CM and PN (CA) which the investigators hypothesize to be most effective in improving HIV clinical outcomes.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed HIV+
2. Age 18 years or older
3. English or Spanish speaking
4. Residence in Los Angeles County
5. prescribed ART in prior 24 months
6. \< 3 visits in prior 12 months or have detectable viral load, as identified in the Ryan White CaseWatch database

Exclusion Criteria:

Not meeting any of the criteria identified above

Primary outcomes:
measure: Change in retention-in-care behaviors over 12 months
timeFrame: Basline, follow-ups at month 2, 6, 12
measure: Change in HIV RNA viral load suppression and medication adherence over 12 months
timeFrame: Basline, follow-ups at month 2, and 12
Secondary outcomes:
measure: Cost effectiveness
timeFrame: 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Center for Health Justice
state: California
city: Los Angeles
country: United States
facility: Los Angeles Sheriff's Department
state: California
city: Los Angeles
country: United States
facility: AltaMed Health Services Corporation
state: California
city: Los Angeles
country: United States
facility: Oasis Clinic
state: California
city: Sylmar
country: United States
facility: Olive View Medical Center
state: California
city: Van Nuys
country: United States
facility: Northeast Valley Health Corporation
state: California
Study officials:
affiliation: University of California, Los Angeles
name: William Cunningham, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05547893: Clinical Learning Through Extended Immersion in Medical Simulation (CLEIMS)-A New Approach to Teaching Clinical Ethics
Official title: Clinical Learning Through Extended Immersion in Medical Simulation (CLEIMS)-A New Approach to Teaching Clinical Ethics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Educational Activities
Patient Simulation
Keywords: medical ethics education
simulation
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Study objective: This study is planning to develop a new simulation-based ethics education model and evaluate the effectiveness of the model to develop medical students' knowledge, moral reasoning, communication skills, and problem-solving abilities. Several strategies will be conducted to achieve this goal, including faculty development, ethics courses development, and case scenario development.

Methods: The transnational learning and workshops will be arranged for faculty to develop competence for simulation-based ethics education. The workshops will gather the interdisciplinary experts together to discuss and develop the core curriculum and case scenario. The students will be assigned randomly into the simulated clinical ethical situation with simulation patients for the intervention group, and into the workshop discussing clinical ethics case scenario for the control group. The instruments will be developed and the quantitative and qualitative analysis will be conducted.


Eligibility criteria: Inclusion Criteria:

* medical students in Kaohsiung Medical University
* agree to participate the study

Exclusion Criteria:

* disagree to participate

Primary outcomes:
measure: Defining Issues Test (DIT) and self-developed questionnaire
timeFrame: through study completion, an average of 2 years
measure: ethical decision-making clinical examination
timeFrame: through study completion, an average of 2 years
measure: Problem Identification Test (PIT) and self-developed questionnaire
timeFrame: through study completion, an average of 2 years
measure: knowledge test questionnaire
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: results of Objective Structured Clinical Examination
timeFrame: through study completion, an average of 2 years
measure: participant satisfaction questionnaire
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
Study officials:
References:
Clinical trial NCT03878693: 4-methylpyrazole and Acetaminophen Metabolism
Official title: The Effect of 4-methylpyrazole on Oxidative Metabolism of Acetaminophen in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Adult Volunteers
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Oxidative metabolism of APAP will be studied with and without 4-MP.


Eligibility criteria: Inclusion Criteria:

* Healthy
* No APAP use in previous 2 weeks
* No ingestion of alcohol or drugs that affect CYP 2E1 over previous 5 days
* No allergy to APAP or fomepizole
* BMI \< 29

Exclusion Criteria:

* Pregnant or lactating
* History of alcohol abuse
* Allergy to APAP or fomepizole
* Screening LFTs above normal range

Primary outcomes:
measure: Oxidative metabolism of APAP
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: BUMCP - Department of Medical Toxicology
state: Arizona
Study officials:
References:
citation: Kang AM, Padilla-Jones A, Fisher ES, Akakpo JY, Jaeschke H, Rumack BH, Gerkin RD, Curry SC. The Effect of 4-Methylpyrazole on Oxidative Metabolism of Acetaminophen in Human Volunteers. J Med Toxicol. 2020 Apr;16(2):169-176. doi: 10.1007/s13181-019-00740-z. Epub 2019 Nov 25.
Clinical trial NCT06196593: Visual Outcomes Following Bilateral Implantation of the Vivity Toric Intraocular Lens
Official title: Visual Outcomes Following Bilateral Implantation of a Non-diffractive Wavefront-shaping Extended Depth of Focus Toric Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract Senile
Intraocular Lens Complication
Keywords: cataract surgery
intraocular lens
non-diffractive extended depth of focus
Lead sponsor: LEC Eye Centre
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2024-01-09
Enrollment: 30
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 objective of this study was to evaluate the clinical and patient reported outcomes after bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens.

Detailed description: This is a prospective interventional case series of 30 patients who underwent cataract surgery and bilateral implantation of the AcrySof™ IQ Vivity™ Toric intraocular lens. This study is represented by an Asian cohort of patients and the study evaluations were focused not only on clinical visual outcomes but also on "real-life" patient reported outcomes such as dysphotopsias, spectacle independence and daily visual tasks all of which were measured at 1 month and up to 3 months postoperatively. The objective would be to provide insight into the performance of this intraocular lens in Asian patients.

Eligibility criteria: Inclusion Criteria:

* patients aged 18 years or older
* bilateral significant cataracts
* bilateral significant corneal astigmatism

Exclusion Criteria:

* previous refractive surgery
* amblyopia
* strabismus
* any ocular co-morbidity which could impact on final visual acuity
* pre-existing zonular weakness
* capsular instability or compromise

Primary outcomes:
measure: Binocular UDVA
timeFrame: 3 months
measure: Binocular UIVA
timeFrame: 3 months
measure: Binocular UNVA
timeFrame: 3 months
Secondary outcomes:
measure: CDVA
timeFrame: 3 months
measure: DCIVA
timeFrame: 3 months
measure: DCNVA
timeFrame: 3 months
measure: MRSE
timeFrame: 3 months
measure: Rotational Stability
timeFrame: 1 month
measure: Binocular Defocus Curve
timeFrame: 3 months
measure: Contrast Sensitivity
timeFrame: 3 months
measure: QUVID
timeFrame: 3 months
measure: VF-14
timeFrame: 3 months
Other outcomes:
Locations:
city: Ipoh
country: Malaysia
facility: LEC Eye Centre
state: Perak
Study officials:
References:
Clinical trial NCT04810793: The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
Official title: The Study on the Selection of Time for Retreatment of Helicobacter Pylori After Eradication Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Helicobacter Pylori
Keywords: Re-eradication time
Remedial treatment
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Taian City Central Hospital
name: Dezhou People's Hospital
name: Weifang Medical University
name: The Affiliated Hospital of Qingdao University
name: Shengli Oilfield Hospital
First posted: 2021-03-23
Enrollment: 820
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients in Shandong province,aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included.

Brief summary: The patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.

Detailed description: Helicobacter pylori (HP) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer.

At present, due to the non-standard Helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of HP eradication treatment failure is more and more common. However, there is still no conclusion on the most appropriate time for remedial treatment in patients with Hp eradication failure.

Eligibility criteria: Inclusion Criteria:

* Patients, aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Primary outcomes:
measure: The most suitable re-eradication time
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01560793: Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
Official title: Phase I Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: Influenza
Vaccines
H5N1
Lead sponsor: VaxInnate Corporation
Sponsor class: INDUSTRY
First posted: 2012-03-22
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety and immunogenicity of VAX161B \[STF2.HA5 H5N1\], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.

Detailed description: The purpose of this study is to test an investigational vaccine known as "VAX161B". VAX161B is a vaccine for the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject will receive the VAX161B vaccine at one of five doses to see which does might be the best. VaxInnate want to find out how safe these vaccines are and how well they are tolerated by people who receive them. To measure how effective each type of vaccine is, VaxInnate will test the ability of the body to develop an immune response, which means how well the body recognizes and defends itself against the influenza virus.

Eligibility criteria: Inclusion Criteria:

* male or female aged 18 - 49 years inclusive
* give written informed consent to participate
* healthy, as determined by medical history, physical examination
* comprehension of the study requirements
* willing to provide multiple blood specimens collected by venipuncture.

Exclusion Criteria:

* Subjects who have a psychiatric illness, a chronic illness that would interfere with participation or interpretation of results
* clinically significant abnormal liver function tests
* positive serology for HBsAg or HCV antibodies
* impaired immune responses
* history of anaphylactic type reaction to injected vaccines
* history of drug or chemical abuse in the year prior to screening
* history of Guillain-Barré Syndrome
* history of chronic obstructive pulmonary disease or history of other lung disease

Primary outcomes:
measure: Safety
timeFrame: 1 year
Secondary outcomes:
measure: Immunogenicity
timeFrame: 6 mos.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
Study officials:
affiliation: Miami Research Associates
name: Eric Sheldon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johnson County Clin-Trials
name: Casey Johnson, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03016793: Alveolar Cleft Grafting Using Two Different Alloplastic Grafts
Official title: Evaluation of Esthetic Satisfaction and Bone Augmentation Quality Using Purabone Added to β-tricalcium Phosphate Versus β-tricalcium Phosphate Alone in Secondry Alveolar Cleft Grafting . Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alveolar Cleft Grafting
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: P-patients with unilateral alveolar clefts I-purabone with -β-tricalcium phosphate graft C-β-tricalcium phosphate graft alone O-clinical out come Outcome name Measurement device Measurement unit Esthetic satisfaction (Primary outcome) Numerical rating scale(NRS) Number 0-10

Radiographic outcome:

Outcome name Measurment Device Measurment unite Bone volume

(Secondary out come) (CBCT)machine Cranex 3D Sordex Cubic millimeter Bone Density

(Secondary Outcome) (CBCT)machine Cranex 3D Sordex Hounsfield Unite Research Question Would purabone addition to β-tricalcium phosphate be more effective and esthetically satisfying than tricalcium phosphate alone in alveolar cleft grafting?


Eligibility criteria: Inclusion Criteria:

1. Patients with unilateral alveolar cleft indicated for bone grafting.
2. Patients age range between 8-12years.

Exclusion Criteria:

1. Patients with any systemic diseases that can affect normal bone and/or wound healing.
2. Patients with bilateral alveolar clefts.

Primary outcomes:
measure: Esthetic satisfaction
timeFrame: 6 months
Secondary outcomes:
measure: bone volume
timeFrame: 6 months
measure: bone density
timeFrame: 6 months
Other outcomes:
Locations:
city: Suez
country: Egypt
facility: Mohamad hamed Maklad
Study officials:
affiliation: faculty of oral and dental medicine
name: Samar Swelam, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT06195293: Anti-cancer Neoantigen Polypeptide Vaccine to Treat Solid Tumors
Official title: Anti-cancer Neoantigen Polypeptide Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor, Adult
Keywords: Solid Tumor
Polypeptide Vaccine
Immunotherapy
Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate polypeptide sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the polypeptide vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.

Detailed description: 1. Choose appropriate patients with advanced solid cancers, with written consent for this study;
2. Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis;
3. Produce appropriate polypeptide vaccine for human use and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required;
4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
5. Evaluate the clinical results as needed.

Eligibility criteria: Inclusion Criteria:

1. Patients with advanced cancer; 2. Life expectancy \>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

-

Exclusion Criteria:

1. Had accepted gene therapy before;
2. Severe virus infection such as HBV, HCV, HIV, et al;
3. Known HIV positivity;
4. Active infectious disease related to bacteria, virus,fungi,et al;
5. Other severe diseases that the investigators consider not appropriate;
6. Pregnant or lactating women;
7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
8. Other conditions that the investigators consider not appropriate.

Primary outcomes:
measure: Number of Patients with Dose Limiting Toxicity
timeFrame: Six months
Secondary outcomes:
measure: Percent of Patients with best response as either complete remission or partial remission.
timeFrame: Six months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Second Affiliated Hospital of Guangzhou Medical University
Study officials:
affiliation: Second Affiliated Hospital of Guangzhou Medical University
name: Zhenfeng Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004393: Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tourette Syndrome
Keywords: Tourette syndrome
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Yale University
First posted: 1999-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 7
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Conduct a randomized, double blind, placebo controlled, parallel study of the atypical neuroleptic risperidone (RIS) in the treatment of children and adults with moderate to severe Tourette Syndrome.

II. Evaluate further the safety of RIS in this population.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. Initially, all patients receive placebo capsules twice daily in a single blind fashion during the first 2 weeks of study.

Then, patients are randomized to receive either risperidone (RIS) or placebo for 8 weeks. The dose of RIS is increased weekly over the first 4 weeks of treatment, as tolerated.

Patients continue RIS for 4 additional weeks at the dose prescribed during week 4.

All patients receive diagnostic evaluations at the beginning and end of the 2 week initial single blind phase, and at the end of weeks 2, 4, 6, and 8 of the active treatment phase.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

DSM-IV diagnosis of Tourette Syndrome (TS)

Tic symptoms greater than 3 (moderate or worse) on the Global Clinical Impression Scale for TS

--Prior/Concurrent Therapy--

No concurrent use of other medications during study

A minimum of 4 weeks since prior use of other medications and 8 weeks for neuroleptics or fluoxetine

--Patient Characteristics--

Hepatic: No hepatic disease

Renal: No renal disease

Cardiovascular:

* No heart disease
* No hypertension

Pulmonary: No pulmonary disease

Other:

* Not pregnant
* IQ at least 70 required
* No other movement disorder allowed, such as tardive dyskinesia
* No major depression
* No pervasive developmental disorder
* No autism or psychotic disorder based on DSM-IV
* No alcohol or substance abuse
* No hypersensitivity to risperidone
* All subjects must be in good health

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Bradley S. Peterson
role: STUDY_CHAIR
References: