louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00070668: Inflammatory Genomics in Human Carotid Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Atherosclerosis
Carotid Artery Diseases
Inflammation
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2003-10-09
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To investigate the relationship between genetic variation in genes for inflammation and carotid artery atherosclerosis.

Detailed description: BACKGROUND:

Atherosclerotic vascular disease is a major source of morbidity and mortality. Inflammation plays an important role in atherosclerosis. The tools to systematically study the extent to which genetic variation determines risk of and progression of atherosclerosis are only now becoming available.

DESIGN NARRATIVE:

The study will evaluate the role of genetic variation in inflammatory pathway genes at 29 loci on the risk and progression of carotid artery atherosclerotic disease (CAAD). Genes to be evaluated include those potentially involved in plaque initiation and progression. The investigators will evaluate single nucleotide polymorphisms (SNPs) informative for the common locus haplotypes. Choice of informative polymorphisms for evaluation is based on the genes' evolutionary history. They will evaluate progression effects in subjects with CAAD followed longitudinally by noninvasive magnetic resonance (MR) techniques over 3 years. Risk will be evaluated by case-control comparisons. In additions to evaluating genetic polymorphisms, they will evaluate the intervening phenotypes of protein level for fibrinogen, C-reactive protein, serum amyloid A, and interleukin-6. Independence of genetic predictors from traditional cardiovascular risk factors will be evaluated.

The major specific aims are: Aim 1. Test for inflammatory genetic effects and protein level in CAAD progression in 550 subjects with CAAD (275 with 15-49% and 275 with 50-79% baseline CAAD stenosis) evaluated by 3-year magnetic resonance image follow-up of percent lumen stenosis; Aim 2. Determine whether the variation in the inflammatory genes or protein levels predicts 810 case vs. 810 control status with a case distribution of 335 subject with 15-49%, 275 with 50-75% and 200 with \>80% carotid artery stenosis at baseline. Age (onset of vascular disease for cases, current age for controls)-, sex-, race-, and hospital-matched controls will have less than 15% stenosis on carotid duplex ultrasound. Genes that are implicated in disease may eventually allow targeted therapy.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Gail Jarvik
References:
Clinical trial NCT02239068: CT Residual Gastric Fluid Volume
Official title: Residual Gastric Fluid With Administering Clear Liquids Within Two Hours of Anesthesia in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical CT Abdomen/Pelvic With Oral Contrast and Sedation
Keywords: CT, sedation, oral contrast
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 76
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from the Radiology CT schedule.

Brief summary: Hypothesis: The investigators hypothesize that more than 50% of the patients receiving enteric contrast material (ECM) \< 2 hours of anesthesia/sedation would have residual gastric fluid volume (GFV) \> 0.4 ml/kg. The investigators also hypothesize that measuring GFV by using region of interest in the CT technique is accurate compared to blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.

Detailed description: The purpose of our study is to examine the residual gastric fluid volume when oral contrast is administered within 2 hours of anesthesia /sedation and to validate the accuracy of measuring the residual gastric volume by using region of interest in the CT image by using blind aspiration of the gastric contents with a syringe and a multi-orificed orogastric tube.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for CT abdomen with contrast and require anesthesia/sedation
* Subjects must be 1 month to 10 years of age (inclusive)
* The subject's legally authorized representative has given written informed consent to participate in the study

Exclusion Criteria:

* Subjects violate the institution fasting guideline before anesthesia /sedation with the exception of the oral contrast

Primary outcomes:
measure: Residual gastric fluid volume (GFV) < 0.4ml/kg or > 0.4 ml/kg
timeFrame: Approximately 2 hours
Secondary outcomes:
measure: Residual gastric fluid volume (GFV) < 0.8 ml/kg or > 0.8 ml/kg
timeFrame: Approximate 2 hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Mohamed Mahmoud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01748968: Veterans Living With HIV/AIDS: A Pilot Study Examining Risk Factors Associated With Self-Directed Violence
Official title: Veterans Living With HIV/AIDS: A Pilot Study Examining Risk Factors Associated With Self-Directed Violence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS)
Self-Directed Violence
Keywords: Veterans
Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS)
Self-Directed Violence
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: Public Health Grant Program, Veterans Health Administration Office of Public Health
First posted: 2012-12-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans with HIV/AIDS

Brief summary: The purpose of this project is to gather pilot data related to risk factors associated with suicide in Veterans with Human Immunodeficiency Virus (HIV)/ Acquired Immune Deficiency Syndrome (AIDS) and to develop an educational and interventional tool and instructional guide that can be utilized by local and national providers to increase understanding regarding suicide risk assessment. There are no hypotheses associated with this qualitative pilot study.

Detailed description: To achieve these goals, a semi-structured interview will be conducted to gather this qualitative information. Specifically, this study aims to gather the following information from Veterans with HIV/AIDS: a) information regarding disease acquisition; b) psychosocial stressors; c) social supports; d) protective factors; and e) previous suicidal ideation and behaviors. Further, additional exploratory questions will be asked regarding proposed modifications to the Suicide Risk Assessment Guide Pocket Card, an existing VA tool, so that it can be modified for use by local and national HIV/AIDS providers.

Eligibility criteria: Inclusion Criteria:

* Between ages 18 to 90
* Have a diagnosis of HIV/AIDS
* Currently receiving HIV/AIDS treatment
* Currently receiving or eligible to receive physical and/or mental health care through the VA Eastern Colorado Health Care System

Exclusion Criteria:

* Psychosis at time of interview as determined by observation and/or interview.
* Intoxication via alcohol or other illicit drugs at time of assessment as determined by observation and/or interview.

Primary outcomes:
measure: Semi-Structured Interview
timeFrame: Interview conducted one time per participant (completion time: approximately 1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver VA
state: Colorado
Study officials:
affiliation: VISN 19 Denver VA MIRECC
name: Gina Signoracci, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01702168: Implementation of CPT for PTSD in Diverse Communities
Official title: Implementation of Cognitive Processing Therapy (CPT) for Posttraumatic Stress Disorder (PTSD) in Diverse Communities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress Disorders, Post-Traumatic
Keywords: PTSD
EBT
EST
Community
Latino
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2012-10-05
Enrollment: 107
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: We will be working with community mental health workers and stakeholders at a community clinic, MGH Chelsea.

Brief summary: Aim: To identify, assess, and address organizational context and provider-level barriers and facilitators of implementation of Evidence-based treatments (EBTs) using a mixed-methods approach in a diverse community mental health center (CMHC), Massachusetts General Hospital Chelsea Health Clinic (MGH Chelsea).

Hypothesis: Anticipated barriers may include, but are not limited to, organizational climate, heavy case-loads, community mental health workers (CMHW) beliefs about EBTs, and provider motivation to learn EBT.


Eligibility criteria: Inclusion Criteria:

* Be over 18 years of age
* Speak English
* Be employed at least part time at MGH
* Willing to have focus group/interview audiotaped and transcribed for data analysis

Exclusion Criteria:

* inability to meet the above inclusion criteria

Primary outcomes:
measure: EBPAS-50
timeFrame: up to 5 years
measure: ORC
timeFrame: up to 5 years
measure: OSC
timeFrame: up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chelsea
country: United States
facility: Massachusetts General Hospital Chelsea Health Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT01065168: Serial Measurement of Serum Antimullerian Hormone in Women Undergoing Laparoscopic Cystectomy of Endometrioma
Official title: Serial Measurement of Serum Antimullerian Hormone in Women Undergoing Laparoscopic Cystectomy of Endometrioma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Keywords: endometriosis
endometrioma
antimullerian hormone
cystectomy
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 43
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ovarian endometrioma performed laparoscopic cystectomy

Brief summary: The purpose of this trial is to study ovarian reserve after laparoscopic endometrioma cystectomy by measuring antimullerian hormone. The measurements were measured before the surgery and one week and three months after the surgery.

Detailed description: Antimullerian hormone will be obtained in patients with ovarian endometrioma before laparoscopic cystectomy is done. The measurements were compared with antimullerian hormone after one week and three months after the surgery. Forty three patients will be included in this study.

Eligibility criteria: Inclusion Criteria:

* 20-40 years
* ovarian endometrioma \> or = 3 cms
* laparoscopic cystectomy treatment

Exclusion Criteria:

* previous ovarian surgery
* other ovarian pathology
* previous drugs or hormonal treatment for endometrioma

Primary outcomes:
measure: Ovarian reserve before and after ovarian endometrioma cystectomy.
timeFrame: one week and three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mahidol University
name: Singpetch Suksompong, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03763968: Multicentre REtrospective StuDy of Treatment and OUtComes in STEMI Patients in Fujian Province
Official title: Multicentre REtrospective StuDy of Treatment and OUtComes in ST-elevatION Myocardial Infarction(STEMI) Patients in Fujian Province
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ST-segment Elevation Myocardial Infarction
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
Collaborators: name: Longyan City First Hospital
name: The Affiliated Hospital of Putian University
name: The Second Affiliated Hospital of Fujian Medical University
name: The MinDong Hospital of Ningde City
First posted: 2018-12-04
Enrollment: 7000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: STEMI patients with symptom onset within 30 days

Brief summary: This is a multicentre observational study planned to gather follow up data for a period of 1 year in order to understand the treatments and outcomes of ST-segment elevation myocardial infarction(STEMI) and improve medical care quality in Fujian province for China. Consecutive patients who were admitted and diagnosed with STEMI between January 2014 December 2018 were conducted at five regional representative hospitals in Fujian province, which included the Fujian Provincial Hospital,Longyan First Hospital, the affiliated hospital of putian university,the Second Affiliated Hospital of Fujian Medical University and Mindong Hospital of Ningde City.


Eligibility criteria: Inclusion Criteria:

* STEMI patients with symptom onset within 30 days

Exclusion Criteria:

-

Primary outcomes:
measure: In-hospital mortality
timeFrame: 5years
Secondary outcomes:
measure: other in-hospital complications
timeFrame: 5years
measure: MACEs for long-term follow up
timeFrame: 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital
name: Kai-yang Lin, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03152968: To Observe Ability of Fundamental Movement Skills in School Children of Age 5 to 10-year-old in Udupi District
Official title: Proficiency of Fundamental Movement Skills in 5 -10 Years Old School Children in Udupi District
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Keywords: FMS
Lead sponsor: Manipal University
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 461
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children between age 5 to 10 years going to school in Udupi district, who will get consent sign from the parent will be included.

Brief summary: Fundamental movement skill is the precursor for physical activity in later life. Proficiency of Fundamental Movement Skills in Indian School Children is unknown. This observational trial shall tell us how proficient are our Udupi District Children.

Detailed description: After IRC and IEC approval and approval from district educational officers, proper assent and consent will be given to the principal of the respective school.

1-week prior to the study, parents will be explained about the study during parent meeting and even school leaving and opening times, a parent who visits the school to drop their children will be addressed.

Children of age above 7 yr. will be explained the class about the study.

Inform sheets will be distributed after conveying the information.

Only the children who get an informed sheet signed will be included in the study.

Eligibility criteria: Inclusion Criteria:

* All children in the age group 5 to 10 year old

Exclusion Criteria:

* Cerebral palsy
* Attention deficit/hyperactivity disorder
* Autism

Primary outcomes:
measure: Fundamental movement skill score
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Udupi
country: India
facility: Center for Sport Science Medicine and Research
state: Karnataka
Study officials:
References:
citation: Mukherjee S, Ting Jamie LC, Fong LH. Fundamental Motor Skill Proficiency of 6- to 9-Year-Old Singaporean Children. Percept Mot Skills. 2017 Jun;124(3):584-600. doi: 10.1177/0031512517703005. Epub 2017 Apr 4.
citation: Birch S, Cummings L, Oxford SW, Duncan MJ. Examining Relative Age Effects in Fundamental Skill Proficiency in British Children Aged 6-11 Years. J Strength Cond Res. 2016 Oct;30(10):2809-15. doi: 10.1519/JSC.0000000000000526.
citation: Morgan PJ, Barnett LM, Cliff DP, Okely AD, Scott HA, Cohen KE, Lubans DR. Fundamental movement skill interventions in youth: a systematic review and meta-analysis. Pediatrics. 2013 Nov;132(5):e1361-83. doi: 10.1542/peds.2013-1167. Epub 2013 Oct 28.
Clinical trial NCT05509868: Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Pain
Lead sponsor: Pharmbio Korea Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 225
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: The primary objective is to evaluate the analgesic efficacy of PBK_L1704 compared with placebo in patients with moderate to severe acute pain after bunionectomy.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo primary, unilateral, first metatarsal bunionectomy with osteotomy and internal fixation
* Able to understand and comply with the study procedures and requirements, and able to provide written informed consent before any study procedure.

Exclusion Criteria:

* Participated in another oliceridine clinical study.
* Received any investigational drug, device or therapy within 35 days before surgery.
* Clinically significant medical, surgical, postsurgical, psychiatric or substance abuse condition or history of such condition that could confound the interpretation of efficacy, safety or tolerability data in the study.
* American Society of Anesthesiologists (ASA) Physical Status Classification System classification III or worse.

Primary outcomes:
measure: SPID-48
timeFrame: 48 hours
Secondary outcomes:
measure: Responder rate
timeFrame: 48 hours
measure: Time to rescue pain medication use
timeFrame: 48 hours
measure: Proportion of rescue pain medication use
timeFrame: 48 hours
measure: Total rescue pain medication use
timeFrame: 48 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Asan medical Center
Study officials:
affiliation: Seoul Asan Medical Center
name: Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00166972: Molecular Mechanism of Trophinin in Cancer Invasion and Metastasis
Official title: Molecular Mechanism of Trophinin in Cancer Invasion and Metastasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: metastasis, survival, malignancy, female, trophinin
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: NATURAL_HISTORY
Time perspective: OTHER

Brief summary: Our study established a model combine the in silico biology and empirical methods to identify clinically useful biomarker from information of microarray gene expression profiles in public domain. Through this method, we found trophinin as a novel prognostic marker for early stage lung cancer, which provide insight towards the process of cancer metastasis and the potential target for treatment.

Detailed description: This study was to combine the in silico biology and empirical methods to identify clinically useful biomarker of lung cancer from microarray gene expression profiles in public database.

Using the expression profile of a known metastasis suppressor, CRMP-1, as a template to search for and compare transcriptome expressions in publicly accessible microarray datasets, trophinin (TRO) was identified as the best correlated gene. The expression pattern of trophinin in a lung cancer cell lines of invasion model was investigated using quantitative RT-PCR. The role of trophinin in cancer metastasis was investigated by measuring the change of invasion activity in trophinin gene-transfected cell lines. The relationship of trophinin and the clinicopathological characteristics of lung cancer were further examined by immunohistochemical staining.

Eligibility criteria: Inclusion Criteria:

* patients who underwent surgery for non-small-cell lung cancer at the National Taiwan University Hospital from 1991 to 2000 with available stored tissue blocks were included as potential subjects in this study.

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Kuan-Yu Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06926972: NutritiOUs fRuIts and veggieS to Improve Health: A Culinary Medicine Intervention
Official title: NOURISH: NutritiOUs fRuIts and veggieS to Improve Health: A Culinary Medicine Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer, Nos
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study includes a 12-week culinary medicine intervention integrated within the existing YMCA Suncoast Survivorship and Wellness Program Powered by Moffitt. Members of the John Geigle YMCA will be assigned to the NOURISH intervention, which includes biweekly provision of fruit and vegetable bundles, recipe cards, and nutritional education handouts plus 30-minute culinary medicine demonstrations with skill-building training (six total demonstrations focused on fruit and vegetable recipes).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with cancer.
* Able to speak and read English.
* Without documented or observable psychiatric or neurologic diagnoses that could interfere with participation (e.g., dementia, active psychosis).
* Able to provide informed consent.

Exclusion Criteria:

* Not meeting all of the above inclusion criteria.

Primary outcomes:
measure: Participant Recruitment Rate
timeFrame: Up to 1 year
measure: Participant Retention
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Sylvia Crowder, PhD
role: PRINCIPAL_INVESTIGATOR
References: