louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002402: A Study of AIDSVAX B/B and AIDSVAX B/E, Two Possible Vaccines
Official title: Phase I/II Trial to Evaluate the Safety and Immunogenicity of AIDSVAX B/B and B/E Vaccines in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV-1
Dose-Response Relationship, Drug
Acquired Immunodeficiency Syndrome
AIDS Vaccines
HIV Seronegativity
Antigens, Viral
Alum Compounds
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to see if it is safe and effective to give AIDSVAX B/B or AIDSVAX B/E, two potential HIV vaccines, to HIV-negative volunteers.

Detailed description: Patients are randomized to 1 of the 2 following arms and administered 1 or 2 injections into the deltoid muscle at 0, 1, 6, and 12 months:

Arm A: Patients receive 1 of 3 doses of AIDSVAX B/B vaccine (MN rgp120/HIV-1 plus GNE8 rgp120/HIV-1) in alum adjuvant.

Arm B: Patients receive AIDSVAX B/E (MN rgp120/HIV-1 plus A244 rgp120/HIV-1) vaccine in alum adjuvant.

Patients are evaluated at 1 hr, 3 days, and 14 days after each immunization and at 18 months after the first immunization.

An interim analysis is performed after all patients receive the second dose (at 1 month).

Eligibility criteria: Patients must:

Be HIV-uninfected men and women at low or intermediate risk for HIV-1 infection.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Dr Frank Judson / Director of Public Health Dept
state: Colorado
city: Washington
country: United States
facility: Johns Hopkins Bloomberg School of Public Health
state: District of Columbia
city: Boston
country: United States
facility: Fenway Community Health Ctr
state: Massachusetts
city: Saint Louis
country: United States
facility: Saint Louis Univ Health Sciences Ctr
state: Missouri
Study officials:
References:
citation: Mayer K, Judson F, Gorse G, Harro C, Peterson M, Zaharias E, Good J, Shibata R, Lee S, Eastman D, Chernow M, Francis D, Berman P. A phase I/II trial to evaluate the safety and immunogenicity of the AIDSVAX B/B vaccine in the United States (final report). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 178)
Clinical trial NCT05218902: A Study of Azacitidine in Participants With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS), or Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
Official title: A Prospective/Retrospective Non-Interventional Study of Vidaza® (Azacitidine) in Patients With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes, or Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia With 20-30% Blasts and Multi-lineage Dysplasia in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Leukemia, Myelomonocytic, Chronic
Leukemia, Myeloid, Acute
Keywords: Myelodysplastic syndromes (MDS)
Azacitidine (AZA)
Chronic myelomonocytic leukemia (CMML)
Acute myeloid leukemia (AML)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-02-01
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of participants enrolled retrospectively, who initiate azacitidine (AZA) before enrollment and participants enrolled prospectively, who initiate AZA initiation at enrollment.

Brief summary: The purpose of this study is to assess the safety and effectiveness in the real-world setting among participants who are treated with Azacitidine in accordance with the China Product Label.

Detailed description: This study will have participants both enrolled retrospectively and prospectively for azacitidine (AZA) treatment.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of intermediate-2/ high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML) with 20-30% bone marrow blasts and multi-lineage dysplasia
* Initiated azacitidine (AZA) treatment per approved China Product Label after April 2017

Exclusion Criteria:

* Contraindicated for the use of AZA according to China Product Label
* Simultaneously participating in a treatment intervention study

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 12 Months
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 12 Months
measure: Incidence of Adverse Drug Reactions (ADRs)
timeFrame: Up to 12 Months
Secondary outcomes:
measure: Best Overall response rate (ORR) defined as the proportion of participants who achieved best response of superior to stable disease
timeFrame: Up to 12 Months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Local Institution - 0001
state: Tianjin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01493102: Discontinuation Order of Vasopressors in Septic Shock
Official title: Incidence of Hypotension Based on the Discontinuation Order of Vasopressors in the Management of Septic Shock
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Septic Shock
Keywords: septic shock
norepinephrine
vasopressin
hypotension
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.

Detailed description: There are little data regarding the discontinuation of vasopressors in patients with septic shock. Therefore, the investigators intend to evaluate the incidence of hypotension based on the discontinuation order of norepinephrine and vasopressin in patients receiving concomitant norepinephrine and vasopressin infusions for the treatment of septic shock.

Eligibility criteria: Inclusion Criteria:

* patients 20 years of age or older
* patients of receiving concomitant therapy with norepinephrine and vasopressin for teh management of septic shock
* patients began to reduce the vasopressor

Exclusion Criteria:

* patients who expired or had care withdrawn while receiving norepinephrine and vasopressin
* patients being transferred into the ICU from an outside facility or the operating room
* patients who are suspected to have vasopressin deficiency (eg. HPA axis dysfunction, empty sella)
* acute myocardial infarction or Congestive heart failure (NYHA functional classification III or IV)
* acute mesenteric ischemia
* patients who were received other vasopressor except for norepinephrine or vasopressin

Primary outcomes:
measure: Incidence of hypotension
timeFrame: One hour after dose reduction of vasopressors
Secondary outcomes:
measure: Time of hypotension
timeFrame: One hour after dose reduction of vasopressors
measure: Vasopressor free day
timeFrame: 28 days after dose reduction of vasopressors
measure: 28-day mortality
timeFrame: 28 days
measure: ICU mortality
timeFrame: 3 months
measure: In-hospital mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: kyeongman Jeon, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeon K, Song JU, Chung CR, Yang JH, Suh GY. Incidence of hypotension according to the discontinuation order of vasopressors in the management of septic shock: a prospective randomized trial (DOVSS). Crit Care. 2018 May 21;22(1):131. doi: 10.1186/s13054-018-2034-9.
Clinical trial NCT06446102: Bifurcation Coronary Lesion 0-0-1
Official title: Bifurcation Coronary Lesion 0-0-1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Bifurcation Stenosis
Lead sponsor: RCF@ICPS
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In this trial, approximately 300 patients will be recruited from the Hôpital Privé Jacques Cartier in Massy, Clinique Pasteur in Toulouse, and Maasstad Hospital in Rotterdam between 2016 and 2022.

Brief summary: Research Involving Human Persons (RIHP 3) focusing on the treatment of type 0-0-1 bifurcation lesions in routine practice. Multicenter Study.

To retrieve and analyze the details of different angioplasty techniques used in this type of bifurcation lesion (Medina 0-0-1) in order to describe current practice and search for predictors of clinical events.

Detailed description: The primary objective of the trial is to estimate the frequency of Major Adverse Cardiac Events (MACE), including cardiac death, myocardial infarction within the territory of the treated lesion, and revascularization of the target lesion in a representative population of patients treated by coronary angioplasty of type 0-0-1 bifurcation lesions.

The sample size will be determined by the number of angioplasties of type 0-0-1 bifurcation lesions performed at each center between 2016 and 2022.

Since the trial is observational in nature and there are no previously published studies, the sample size cannot be calculated based on the desired precision of the estimation.

Furthermore, the purpose of the study is also to assess the techniques used to treat this type of coronary bifurcation and to highlight any differences between different centers and with other types of coronary bifurcation lesions described in the literature.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18 years and older,
* Who underwent angioplasty for a coronary bifurcation lesion of type 0-0-1 between 2016 and 2022.

Exclusion Criteria:

- Opposing the collection and processing of necessary data and refusing additional telephone follow-up

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: 3 years
Secondary outcomes:
measure: Target lesion revascularization
timeFrame: 3 years
Other outcomes:
Locations:
city: Massy
country: France
facility: Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier
city: Toulouse
country: France
facility: Clinique Pasteur
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
Study officials:
affiliation: ICPS
name: Francesca SANGUINETI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06845202: A Phase 1 Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Obese or Overweight Healthy Volunteers
Keywords: siRNA
RNAi therepeutic
Lead sponsor: Alnylam Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2025-02-25
Enrollment: 84
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: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324.


Eligibility criteria: Inclusion Criteria:

* Has a body mass index (BMI) of ≥27 kg/m\^2 and \<40 kg/m\^2

Exclusion Criteria:

* Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection

Note: other protocol defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Frequency of Adverse Events (AEs)
timeFrame: Up to 9 months
Secondary outcomes:
measure: Area Under the Plasma Concentration-time Curve (AUC) of ALN-4324 in Plasma
timeFrame: Predose and up to 3 days postdose
measure: Maximum Observed Plasma Concentration (Cmax) of ALN-4324 in Plasma
timeFrame: Predose and up to 3 days postdose
measure: Time to Maximum Plasma Concentration (Tmax) of ALN-4324 in Plasma
timeFrame: Predose and up to 3 days postdose
measure: Fraction of ALN-4324 excreted in urine
timeFrame: Predose and up to 24 hours postdose (fe)
Other outcomes:
Locations:
city: Laval
country: Canada
facility: Clinical Trial Site
state: Quebec
Study officials:
affiliation: Alnylam Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03799302: Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model
Official title: Facilitating Sustainment Through Implementation Feedback: The SIC Coaching Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evidence Based Practice
Lead sponsor: Oregon Social Learning Center
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to test the impact of an empirically derived implementation strategy-under real-world conditions and across multiple child service systems-on successful adoption and sustainment of two evidence-based programs that address adolescent substance abuse: Treatment Foster Care Oregon (TFCO; formerly Multidimensional Treatment Foster Care) and Multidimensional Family Therapy (MDFT), both developed with funding from NIDA. Methods for this study utilize "technology-based approaches" for "implementing large-scale change." Leveraging previous data focused on developing and testing the 8-staged Stages of Implementation Completion (SIC) tool, a randomized evaluation of a SIC Coaching Strategy (SIC-CS) is proposed. Study activities include extending the SIC into the Sustainment Phase and testing the SIC-CS to support the adoption of new evidence-based programs.


Eligibility criteria: Inclusion Criteria:

* Senior leadership staff from teams that either currently are sustaining or who achieve 1-year sustainment post certification during the first year of the project

Exclusion Criteria:

* none

Primary outcomes:
measure: Stages of Implementation Completion (SIC)
timeFrame: Baseline through month 60
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Social Learning Center
state: Oregon
Study officials:
affiliation: Oregon Social Learning Center
name: Lisa Saldana, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06803602: HIFEM Technology for Post-Radical Prostatectomy and Post-Holmium Laser Prostate Surgery
Official title: Evaluating the Efficacy of High-Intensity Focused Electromagnetic Technology in Improving the Time of Recovery of Urinary Control of Continence and Quality of Life for Post-Surgical Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Holmium Laser Prostate Surgery
Radical Prostatectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 2100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy of High-Intensity Focused Electromagnetic (HIFEM) technology in improving the recovery time of urinary control and quality of life for male patients after radical prostatectomy (RP) and Holmium laser prostate surgery (HoLEP).


Eligibility criteria: Inclusion Criteria:

* Subjects who are male
* Post-radical prostatectomy or post HoLEP
* Experiencing urinary incontinence one-month post-RP
* Have the capacity to make their own medical decisions
* Able to complete the questionnaires and visits required.

Exclusion Criteria:

* Subjects who are not male
* Not post-radical prostatectomy or post HoLEP
* Neurologic disease
* Atonic or hypofunctional bladder (bladder contractility index (BCI) \< 100; BCI = pDetQmax+5Qmax)
* Status post pelvic radiation
* Past surgical history of other GU surgeries
* Gross hematuria
* Concomitant use of medications that cause muscle relaxation or inhibition
* Indwelling foley catheter at time of treatment
* Documented urine leak
* Not experiencing urinary incontinence
* Do not have the capacity to make their own medical decisions
* Unable to complete the questionnaires provided.

Primary outcomes:
measure: Change in International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF)
timeFrame: Baseline, 6 weeks, 15 weeks
measure: Pad weight test
timeFrame: Baseline, 6 weeks, 15 weeks
Secondary outcomes:
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: Baseline, 6 weeks, 15 weeks
measure: Change in Male Sexual Health Questionnaire Short-Form (MSHQ-EjD-SF)
timeFrame: Baseline, 6 weeks, 15 weeks
measure: Change in Quality of Life Scale
timeFrame: Baseline, 6 weeks, 15 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Mitchell R Humphreys, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03557879: Exome Analysis in Hearing Impaired Patients
Official title: Exome Analysis on Hearing Impaired Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hearing Impairment
Keywords: Hearing impairment
familial
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hearing impaired patients and relatives

Brief summary: Hearing impairment is the most frequent sensory deficit in humans and affects one newborn out of 500. The prevalence rises to 3,5/1000 in teenagers due to retarded forms. Most of hearing impairments (about two thirds) have a genetic origin, with recessive, dominant or X-linked mode of inheritance. Some rare forms can be linked to mitochondrial DNA. Molecular diagnosis (i.e. defining the molecular basis of the disease, genes and precise DNA variants) is essential for the follow-up of patients and families.

The project intends to perform exome sequencing on 30 samples of families presenting with hearing impairment. Families have been included based on the genetic origin of the hearing impairment (familial cases) and the exclusion of the involvement of 74 known deafness genes. Exome sequencing (sequencing of the coding regions of all known genes, about 22,000) in these cases may underly new gene/disease relationships.

Detailed description: Exome sequencing will be performed of 10 trios that each include two affected and one non affected members of a family. Filtering of variants will be performed based on frequency. For each trio, data will be analysed in parallel to follow segregation of the variant(s) in candidate genes. The selected candidate genes will be further characterized in order to ascertain their involvement in hearing function.

Finally, once these new genes are well defined as "deafness genes" , their screening will be added to existing diagnostic panels.

Eligibility criteria: Inclusion Criteria:

* Families presenting with familial hearing impairment, underlying the genetic basis, for whom 74 deafness genes have already been excluded (no evidence of pathogenic genotype)

Exclusion criteria:

- sporadic cases of hearing impairment, or resolved familial cases

Primary outcomes:
measure: identification of candidate genes
timeFrame: 1 day
Secondary outcomes:
measure: Quality assessment of the exome sequencing
timeFrame: 1 day
measure: Quality assessment of the bioinformatics pipelines used
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Anne Françoise ROUX
role: STUDY_DIRECTOR
References:
Clinical trial NCT01709279: Clinical Trial of Autologous Adipose Tissue Derived Stromal Cell Therapy for Ischemic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Heart Failure
Keywords: Ischemic heart failure
Myocardial regeneration
ADRC
Lead sponsor: Kanazawa University
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mesenchymal stem cells have capability to differentiate into myocardium, vascular endothelial cell, vascular smooth muscle cell and will be useful for heart regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell compared to bone marrow tissue. In this trial, eligible ischemic heart failure patients will be proceeded intracoronary administration of autologous adipose tissue derived stromal cells by cardiac catheterization.

Detailed description: The population of the ischemic heart failure patients is enormous in Japan and the only radical treatment for them is heart transplantation: however, the number of giving donor is extremely limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage cells as well as endodermal-lineage cells such as myocardial cell. They reside in the mesenchymal tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the ischemic heart failure patients will undergo intracoronary administration of autologous adipose tissue derived stromal cells through cardiac catheterization.

Eligibility criteria: Inclusion Criteria:

* Heart failure patients occured by prior ischemic event whose ejection fraction must be less than 40%.

Exclusion Criteria:

* Complicated severe other organ disease.
* Patient with malignancy.
* History of chemotherapy or irradiation within 4 weeks.
* Patient with immunodeficiency
* Pregnancy or possibility of pregnancy
* Candidate who are judged to be not applicable to this study by doctors.

Primary outcomes:
measure: all cause harmful events
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
state: Ishikawa
Study officials:
References: