louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02136225: Reducing Youth Access to Firearms Through the Health Care Setting
Official title: Reducing Youth Access to Firearms Through the Health Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Youth Access to Guns in the Home
Keywords: youth
gun
access
home
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Colorado, Boulder
First posted: 2014-05-12
Enrollment: 76
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to examine the implementation and effectiveness of an intervention, delivered in a health care setting, to decrease home firearm access by youth. The investigators hypothesize that:

1. parents who receive means restriction education provided by their primary care provider will be more likely to report, at the one month and one year follow-up, that they are storing their guns locked compared to parents who do not receive means restriction counseling.
2. parents who receive a free gun locking device(s) will be more likely to report, at the one month and one year follow-up, that they are storing their guns locked compared to parents who receive means restriction counseling alone;
3. parents whose adolescents are assessed at high risk for violence (\> 5 on the Violence Injury Protection and Risk Screen (VIPRS)) or depression (\>9 on the Patient Health Questionnaire-9 (PHQ-9)) will be more likely to report storing their gun(s) locked at the one month follow-up compared to parents whose children are assessed as low risk, regardless of whether they receive the counseling alone or counseling plus free locking devices and 4) youth whose parents receive a free gun locking device(s) will be more likely to report less access to guns, at one year follow-up, compared to parents who receive means restriction counseling alone.


Eligibility criteria: Inclusion Criteria:

* Patient at the Children's Hospital Colorado in the Adolescent Medicine Clinic
* Scheduled for any type of appointment
* Reports having a gun in the home

Exclusion Criteria:

* Adolescent or parent speaks/reads a language other than English or Spanish
* Adolescent has cognitive disabilities
* Adolescent resides in a group home or detention center

Primary outcomes:
measure: Change from baseline to one month and one year in the reported number of guns locked in the home.
timeFrame: Baseline, one month, 1 year
measure: Change from baseline to one month and one year in the reported number of locking devices parents use to store their guns.
timeFrame: Baseline, one month, one year
Secondary outcomes:
measure: Change from baseline to one month and one year in the number of gun(s) reported locked in their home among parents whose youth are at high risk for violence or depression.
timeFrame: Baseline, one month, one year
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Eric Sigel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04599725: Feasibility of Telemedicine Medical Abortion
Official title: TelAbortion: Medical Abortion by Direct-to-patient Telemedicine and Mail
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 413
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People seeking abortion

Brief summary: This pilot study is designed to obtain data on the safety, acceptability, and feasibility of providing abortion by direct-to-patient telemedicine and mail.


Eligibility criteria: Inclusion Criteria:

* desires abortion

Exclusion Criteria:

* medically ineligible for procedure

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: Colorado
city: Washington
country: United States
facility: Carafem
state: District of Columbia
city: Atlanta
country: United States
facility: Carafem
state: Georgia
city: Honolulu
country: United States
facility: The University of Hawaii Women's Options Centers
state: Hawaii
city: Skokie
country: United States
facility: Carafem
state: Illinois
city: Iowa City
country: United States
facility: Emma Goldman Clinic
state: Iowa
city: Augusta
country: United States
facility: Maine Family Planning
state: Maine
city: Chevy Chase
country: United States
facility: Carafem
state: Maryland
city: Boston
country: United States
facility: Maine Family Planning
state: Massachusetts
city: Saint Paul
country: United States
facility: Planned Parenthood Minnesota, North Dakota, South Dakota
state: Minnesota
city: Billings
country: United States
facility: Planned Parenthood of Montana
state: Montana
city: Albuquerque
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: New Mexico
city: New York
country: United States
facility: Maine Family Planning
state: New York
city: Portland
country: United States
facility: Planned Parenthood Columbia Willamette
state: Oregon
city: Vancouver
country: United States
facility: Planned Parenthood Columbia Willamette
state: Washington
Study officials:
affiliation: Gynuity Health Projects
name: Elizabeth Raymond, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02935725: A Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Males
Official title: A Phase 1, Single-centre, Double-blind, Placebocontrolled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Autifony Therapeutics Limited
Sponsor class: INDUSTRY
Collaborators: name: University of Manchester
First posted: 2016-10-17
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Phase 1, Single-centre, Double-blind, Placebo controlled Crossover Study to Assess the pharmacoMRI Effects of AUT00206 in Healthy Male Participants


Eligibility criteria: Inclusion Criteria:

* Male aged 18 to 45 years, inclusive at Visit 1.
* Healthy on the basis of medical history, psychiatric history, physical examination, vital signs, 12-lead electrocardiogram (ECG), haematology, blood chemistry and urinalysis within 6 weeks of Visit 2.
* Right-handed.
* Not a regular smoker (maximum 5 cigarettes per week or equivalent).

Exclusion Criteria:

* History of, or current condition of, migraine headaches or has undergone operations to the head.
* History of significant claustrophobia.

Primary outcomes:
measure: Significant difference in BOLD phMRI signals after dosing with AUT00206 vs placebo
timeFrame: 15 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University Of Manchester
Study officials:
affiliation: University of Manchester
name: Bill Deakin, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04081025: Oral Health and Risk Factors for Oral Disease
Official title: A 10 Year Longitudinal Study of Oral Health and Risk Factors for Oral Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Dental Caries
Quality of Life
Lead sponsor: Dalarna County Council, Sweden
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 2500
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals in age Groups 35, 50, 65, 75 and 85 years

Brief summary: Oral health has improved considerably in recent decades in Sweden, as well as in other countries. However, despite great improvements with regard to periodontal disease and dental caries in recent decades, global problems still persist, and as a consequence of retaining natural teeth high up in age, the risk for oral disease increases.

Detailed description: Traditionally, the number of teeth has been a measure of good oral health, and the World Health Organization (WHO) stipulated goals of a minimum of 20 functional teeth at the age of 80 years have been reached in some industrialized countries. Oral Health means more than good teeth and is integral to general health. The relationship between oral and general health has been recognized. For example, periodontal disease is associated with diabetes and rheumatoid arthritis. The severity of periodontal disease and number of teeth have been associated with an increased burden of cardiovascular disease.

There is a lack of longitudinal studies of oral Health and risk factors for oral disease.

Eligibility criteria: Inclusion Criteria:

* None

Exclusion Criteria:

* None

Primary outcomes:
measure: Periodontal disease
timeFrame: 10 years (2008-2018)
measure: Periodontal disease
timeFrame: At one occasion (2018)
measure: Risk factors for periodontal disease
timeFrame: Ten years (2008-2018)
measure: Dental caries
timeFrame: 10 years (2008-2018)
measure: Dental caries
timeFrame: At one occasion (2018)
measure: Risk factors for dental caries
timeFrame: Ten years (2008-2018)
measure: Oral Health Related Quality of Life
timeFrame: One occasion (2018)
Secondary outcomes:
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Kristina Edman
state: Dalarna
Study officials:
affiliation: Region Dalarna
name: Karin Gunnars Hellgren
role: STUDY_CHAIR
References:
Clinical trial NCT05691725: Evaluation of Peripheral Neutrophils in Antisynthetase Syndrome
Official title: Evaluation of Peripheral Neutrophils in Patients With Antisynthetase Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antisynthetase Syndrome
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with antisynthetase syndrome

Brief summary: Antisynthetase syndrome (AS) is a rare overlapping myositis characterized by cellular and humoral autoimmune responses directed against aminoacyl-tRNA synthetases. A pathogenic role of neutrophils was described during inflammatory myopathies, with increased netosis correlated with disease activity and muscle damage. Higher number of alveolar neutrophils was observed in patients with rapidly progressive forms of interstitial lung disease.

Peripheral neutrophils could represent a simple biomarker of severity and activity in patients with antisynthetase syndrome.

The main objective is to compare circulating neutrophils between severe and non severe patients with antisynthetase syndrome. Secondary objectives are: 1) to evaluate correlation between circulating neutrophils and organ-specific severity, 2) to compare circulating neutrophils at time of diagnosis and circulating neutrophils after 6 months of treatment in patients with antisynthetase syndrome.


Eligibility criteria: Inclusion Criteria:

* Patients with antisyntheatse syndrome according to Solomon criteria

Primary outcomes:
measure: Number of circulating neutrophils
timeFrame: at diagnosis (Day 0)
measure: Global severity
timeFrame: at diagnosis (Day 0)
Secondary outcomes:
measure: Circulating neutrophils change over time
timeFrame: at 6 months of follow-up
measure: ILD severity
timeFrame: at diagnosis (Day 0)
measure: ILD severity
timeFrame: at diagnosis (Day 0)
measure: Muscular severity
timeFrame: at diagnosis (Day 0)
measure: Muscular severity
timeFrame: at diagnosis (Day 0)
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHU Nancy
Study officials:
References:
Clinical trial NCT01656525: A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients
Official title: A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Gantenerumab Following Subcutaneous Injection in Japanese AD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-08-03
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to moderate AD.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of probable AD dementia, based on NINCDS/ADRDA criteria
* Meet DSM-IV criteria for Dementia of the Alzheimer type
* MMSE score : 16 to 26 etc.

Exclusion Criteria:

* Meet the exclusion criteria of MRI at screening.
* A history of significant neurodegenerative diseases or dementia other than Alzheimer's disease.

etc.

Primary outcomes:
measure: Number of participants with Adverse Events
timeFrame: 36 weeks
measure: Pharmacokinetic parameters of Gantenerumab in plasma
timeFrame: 36 weeks
measure: CSF/plasma ratios of Gantenerumab.
timeFrame: Baseline, Day183
Secondary outcomes:
measure: Change from baseline in plasma Abeta
timeFrame: Baseline,Day183
measure: Change from baseline in plasma and CSF tau
timeFrame: Baseline,Day183
measure: Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog).
timeFrame: Baseline,Day85, 197, 253
Other outcomes:
Locations:
city: Kansai
country: Japan
facility: Kansai region
city: Kanto
country: Japan
facility: Kanto region,
city: Kyushu
country: Japan
facility: Kyushu region
city: Toakai
country: Japan
facility: Tokai region
city: Tohoku
country: Japan
facility: Tohoku region
Study officials:
References:
Clinical trial NCT03319225: Examining the Distal Gut Microbiome After Spinal Cord Injury
Official title: A Study of the Distal Gut Microbiome and Its Relation to Gastrointestinal Transit After Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons with a spinal cord injury; Neurologically-intact controls

Brief summary: The purpose of this research study is to learn more about the causes of gastrointestinal dysfunction after spinal cord injury. It has been thought that the microbiome (the community of bacteria in the body) may be one such cause. The study will examine whether changes in the distal gut microbiome are related to gastrointestinal dysfunction in persons with Spinal Cord Injury and Non-Disabled Controls.


Eligibility criteria: Persons with a Spinal Cord Injury:

Inclusion Criteria:

1. Age 18-65
2. ≥ 1 year post-injury
3. Spinal cord injury resulting in Tetraplegia or Paraplegia (C5-T6) and motor complete or incomplete (AIS A-C) impairment. Injury level and impairment will be confirmed by an American Spinal Injury Association (ASIA) exam conducted less than 2 years before study entry. If longer than 2 years, a certified rater will repeat the exam.
4. Self -reported history of constipation or other gastrointestinal dysfunction (e.g., extended bowel care time or difficulty in bowel emptying)
5. Willingness to participate in the study

Exclusion Criteria:

1. Currently hospitalized
2. American Spinal Injury Association (AIS) D-E
3. Self-reported history of Crohn's disease or diverticulitis, gastric blockage/obstruction or swallowing disorder
4. Gastrointestinal surgery ≤ 3 months prior to study
5. Implanted cardiac pacemaker, spinal cord stimulator, morphine (pain), or intrathecal pump
6. Concurrent use of surface functional electrical stimulation (FES)

Neurologically-Intact Persons:

Inclusion Criteria:

1. Age 18 or over
2. Willingness to participate in the study

Exclusion Criteria:

1. Self-reported history of Crohn's disease or diverticulitis, gastric blockage/obstruction or swallowing disorder
2. Gastrointestinal surgery ≤ 3 months prior to study
3. Implanted cardiac pacemaker, spinal cord stimulator, morphine (pain), or intrathecal pump

Primary outcomes:
measure: Characterize microbiome composition
timeFrame: Study day 7
Secondary outcomes:
measure: Gastrointestinal transit time
timeFrame: Study day 5
measure: Autonomic state
timeFrame: Baseline
measure: Inflammatory state
timeFrame: Baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
Study officials:
affiliation: University of Miami
name: Mark S Nash, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03558425: A Study to Compare PK, PD and Safety of CKD-381 and D026 in Healthy Subjects
Official title: A Randomized, Open-label, Multiple-dose, and Crossover Study to Compare Pharmacokinetics, Pharmacodynamics and Safety of CKD-381 and D026 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: GERD
Keywords: CKD-381
D026
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-06-15
Enrollment: 41
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Study to compare pharmacokinetics and safety of CKD-381 and D026 in healthy subjects


Eligibility criteria: Inclusion Criteria:

1. Between 19 aged and 50 aged in healthy male adult
2. Body weight more than 55kg
3. Body Mass Index more than 18.5 and under 25

Exclusion Criteria:

1. Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease.
2. Have a gastrointestinal disease history that can effect drug absorption or surgery.
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product, additives or benzimidazole family.

Primary outcomes:
measure: AUCtau,ss(Area under the plasma drug concentration-time curve within a dosing interval at steady state)
timeFrame: 0~24h
measure: Percent decrease from baseline in integrated gastric acidity for 24-hour interval after 7th dose
timeFrame: Baseline versus Multiple dose during 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Nat'l University Hospital
Study officials:
affiliation: Department of Clinical Pharmacology and Therapeutics, Seoul Nat'l University College of Medicine and Hospital
name: Kyung Sang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05663125: LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
Official title: Safety and Efficacy of LITT Combined With Early Use of Temozolomide for Recurrent Glioblastomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Recurrent Glioblastoma
Keywords: GBM
Glioblastoma
LITT
Laser Interstitial Thermal Therapy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 10
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: This study aims to investigate the safety and efficacy of Laser Interstitial Thermal Therapy (LITT) combined with postoperative early use of temozolomide in treating recurrent glioblastomas.

Detailed description: This is an open-label, non-randomized Phase II study, planning to recruit about ten patients.

The primary objective of this study is to investigate the safety of MRI-guided LITT in combination with the early application of temozolomide.

The secondary outcome is to explore the efficacy of MRI-guided LITT combined with the early use of temozolomide in treating recurrent glioblastomas.

Eligibility criteria: Inclusion Criteria:

1. Imaging (PET-MRI) indicates tumor progression or recurrence
2. Patient ≥18 years old
3. The tumor was the first-time recurrence
4. The pathology of the tumor is glioblastoma (IDH wild-type, WHO grade 4)
5. MRI indicated a single tumor or multiple tumors with visual enhancement =\<3cm
6. Maximum tumor diameter: single tumor =\<3cm; Multiple tumors, targeted lesion =\<3cm
7. Single tumor or one of the multiple tumor lesions involved deep functional areas such as the insula lobe or thalamus
8. KPS score \>=60 within 30 days before treatment
9. No serious liver or kidney dysfunction
10. Patients must be able to understand how to sign the informed consent document

Exclusion Criteria:

1. The tumor crossed the midline or involved bilateral cerebral hemispheres
2. Inability to perform MRI examination or intolerance to MRI contrast agent
3. There is an active infection of the patient
4. The patient had abnormal coagulation function
5. Imaging before treatment indicated signs of cerebral hernia or midline displacement \> 1.0cm
6. The patient received radiotherapy, chemotherapy (including immunotherapy), or other therapeutic measures after tumor recurrence
7. Patients who have participated in clinical trials of any other drug or medical device within three months of the screening.
8. KPS score =\<50 points

Primary outcomes:
measure: Adverse Events
timeFrame: From Day 1 throughout the study until 3 months
Secondary outcomes:
measure: Time to Progression (TTP)
timeFrame: 12 months
measure: Overall survival (OS)
timeFrame: 18 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Beijing Tiantan Hospital
name: Dabiao Zhou, MD
role: PRINCIPAL_INVESTIGATOR
References: