louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06923384: SBI for PSM and PSD
Official title: Screening and Brief Intervention for Prescription Stimulant Misuse and Diversion: Refining and Piloting a Curriculum for College Health Providers
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Prescription Stimulant Misuse
Prescription Stimulant Diversion
Keywords: prescription stimulants
Lead sponsor: California State University, Long Beach
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-04-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of three conditions: control, face-to-face intervention with trained providers, or e-Intervention that involves watching a video from a health provider and responding to questions.
Primary purpose: OTHER

Brief summary: A pilot randomized controlled trial to assess the feasibility, acceptability, and impact of screening and brief intervention to address prescription stimulant misuse and diversion among college students.

Detailed description: A screening and brief intervention including a control group, face-to-face group, and e-intervention group where the focus is prevention or brief intervention or referral to treatment related to students prescription stimulant misuse and diversion behaviors. Students will complete assessments at three time points, and the health providers who implement the intervention will also complete assessments.

Eligibility criteria: Inclusion Criteria:

Age 18 and student at the campus serving as the intervention site; Passive recruitment: Student has a scheduled appointment for a physical/wellness exam. Active recruitment: Student has a past 3 month history of PSM or PSD.

Exclusion Criteria:

Any eligible student who, during the course of the session, demonstrates the need for immediate mental health services, will have the study session terminated so that participant can receive needed care.

Primary outcomes:
measure: Prescription Stimulant Misuse
timeFrame: 30 days
measure: Prescription Stimulant Diversion
timeFrame: 30 days
Secondary outcomes:
measure: PSM Intentions
timeFrame: 30 days
measure: PSD Intentions
timeFrame: 30 days
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: CSULB
state: California
Study officials:
References:
Clinical trial NCT05810584: Revision LR Femoral Stem for Hip Replacement
Official title: A Retrospective and Prospective Clinical Study Evaluating Safety and Performance of Revision LR Stem in Total Hip Arthroplasty (THA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Arthropathy
Orthopedic Disorder
Lead sponsor: Limacorporate S.p.a
Sponsor class: INDUSTRY
First posted: 2023-04-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent a hip arthroplasty with Revision LR stem at Spedali Civili (Brescia) from 1st January 2012 will be screened for the retrospective part of the study. Patients who require a hip arthroplasty with a large femur resection will be screened for the prospective part of the study.

Brief summary: This is a post-market, monocentric Retrospective and prospective, observational, open-label and baseline clinical study in order to evaluate the performance and safety of Revision LR femoral stem


Eligibility criteria: Inclusion Criteria:

* Males and females of any race
* Age ≥ 18 years old
* A diagnosis or condition in the target hip of one or more of the following: Primary tumors or metastasis and relative outcomes; Advanced articular destruction generated by primary degenerative or post-traumatic arthrosis or rheumatoid arthritis;Fracture or avascular necrosis; Congenital or acquired deformity; Failures of previous operations, like osteosynthesis, articular reconstruction, arthrodesis, hemi-arthroplasty or total arthroplasty; Epiphyseal region general trauma, Willingness to comply with prescribed rehabilitation and study evaluation and ability to return for follow-up visits
* Signed study-specific Informed Consent Form

Exclusion Criteria:

* Acute or chronic infections, local or systemic infections,
* Septicaemia
* Persistent acute or chronic osteomyelitis
* Serious muscular, neurological or vascular diseases affecting the concerned limb
* Mass higher than 60 kg

Primary outcomes:
measure: Revision rate of the femoral component
timeFrame: from baseline to FU 10 Years
Secondary outcomes:
measure: Implant stability
timeFrame: from baseline to FU 10 Years
measure: Functionality evaluation
timeFrame: from baseline to FU 10 Years
measure: Incidence of device-related adverse events or serious adverse events.
timeFrame: from baseline to FU 10 Years
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: A.S.S.T Spedali Civili di Brescia
Study officials:
References:
Clinical trial NCT04600284: Evaluating the Pharmacokinetic Interaction Between AD-2101 and AD-2102
Official title: A Randomized, Open Label, Multiple Dose, Crossover Study to Evaluate Drug-drug Interaction of AD-2101 and AD-2102 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 25
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: The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2101 and AD-2102 in healthy male subjects.

Detailed description: To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination compared with the administration of AD-2101 and AD-2102.

Eligibility criteria: Inclusion Criteria:

* Healthy male between 19 and 50 years of age at the time of screening
* Weight above 50 kg and body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2

Exclusion Criteria:

* Clinically significant disease or history of clinically significant disease such as cardiovascular, respiratory, liver, kidney, digestive, hematologic/oncologic, endocrine, immunologic, urinary, psychiatric
* Gastrointestinal problem or history of gastrointestinal problem and history of gastrointestinal surgery
* A person who has a history of drug abuse
* AST, ALT, Total bilirubin values over than 2 times of UNL at screening
* Creatinine clearance under 80mL/min

Primary outcomes:
measure: Peak Plasma Concentration
timeFrame: pre-dose to 24 hours
measure: Area under the plasma concentration versus time curve
timeFrame: pre-dose to 24 hours
Secondary outcomes:
measure: Time to reach Cmax
timeFrame: pre-dose to 24 hours
measure: Clearance
timeFrame: pre-dose to 24 hours
measure: Bottom Plasma Concentration
timeFrame: pre-dose to 24 hours
measure: Number of participants with adverse events
timeFrame: From Day 1 up to Day 66
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: HyeWon Chung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00843284: Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA
Official title: Assessing the Treatment of Patients With Neuropathic Pain Using LYRICA; A Non Interventional Post-marketing Study (NI-PMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Keywords: neuropathic, pain, pregabalin, Lyrica
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-02-13
Enrollment: 691
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neuropathic pain

Brief summary: A Non-Interventional, Post-Marketing Surveillance (NI-PMS) study whose objectives were to assess the impact of pregabalin on subjects' pain, quality of sleep, and their general wellbeing, as well as the tolerance and safety of pregabalin in subjects with neuropathic pain.

Detailed description: A non-interventional study of patients diagnosed with neuropathic pain administered pregabalin and followed up for 8 weeks

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of neuropathic pain and inclusion according to the current Summary of Product Characteristics.

Exclusion Criteria:

* The patients were excluded according to the current Summary of Product Characteristics.

Primary outcomes:
measure: Daily Average Pain Scores
timeFrame: Baseline, Final Visit (Week 8 or discontinuation)
measure: Pain Related Sleep Interference
timeFrame: Baseline, Final Visit (Week 8 or discontinuation)
Secondary outcomes:
measure: Anxiety and Depression Symptoms
timeFrame: Baseline, Final Visit (Week 8 or discontinuation)
measure: Clinician Global Improvement of Change (CGIC) at Final Visit (Week 8 or Discontinuation)
timeFrame: Final Visit (Week 8 or discontinuation)
measure: Patient Global Improvement of Change (PGIC) at Final Visit (Week 8 or Discontinuation)
timeFrame: Final Visit (Week 8 or discontinuation)
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01101984: Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Official title: A Randomized, Parallel- Group Comparison Study of DE-089 Ophthalmic Solution in Patients With Dry Eye (Comparison With 0.1% Sodium Hyaluronate Ophthalmic Solution) - A Multinational Study -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-04-12
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Safety and efficacy of DE-089 ophthalmic solution in patients with dry eye will be evaluated in comparison with sodium hyaluronate ophthalmic solution.


Eligibility criteria: Inclusion Criteria:

* Those who show:

  * Keratoconjunctival disorder confirmed with vital dye staining
  * Abnormal Schirmer score results

Exclusion Criteria:

* Eye disease that needs therapy other than that for dry eye
* Those who need to wear contact lenses during the clinical study

Primary outcomes:
measure: Changes in the fluorescein and rose bengal staining score
timeFrame: 2 weeks and 4 weeks from baseline.
Secondary outcomes:
measure: Changes in tear film breakup time (second)
timeFrame: 2 weeks and 4 weeks from baseline.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye & Ear Hospital of Fudan University
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
Study officials:
References:
citation: Gong L, Sun X, Ma Z, Wang Q, Xu X, Chen X, Shao Y, Yao K, Tang L, Gu Y, Yuan H, Chua WH, Chuan JC, Tong L. A randomised, parallel-group comparison study of diquafosol ophthalmic solution in patients with dry eye in China and Singapore. Br J Ophthalmol. 2015 Jul;99(7):903-8. doi: 10.1136/bjophthalmol-2014-306084. Epub 2015 Jan 28.
Clinical trial NCT04211584: The TENDERA Multicenter Clinical Trial
Official title: Randomized Controlled Trial Comparison Between Traditional ENtry Point and Distal puncturE of RAdial Artery (TENDERA Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Artery; Thrombosis
Keywords: Transradial intervention,radial artery,anatomic snuffbox
Lead sponsor: Center of Endosurgery and Lithotripsy, Moscow, Russia
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: TENDERA is a multicenter randomized controlled trial to compare traditional entry point in the radial artery for TRI and distal puncture at the anatomical snuffbox area for transradial Interventions. The Investigators hypothesized that novel entry point in radial artery may lessen vascular access site complication rate and especially the radial artery late occlusion rate.

Detailed description: the forearm access will be made using traditional technique what was well described previously in the literature. The novel puncture site is located in the snuffbox area distal to the traditional radial access point. Thanks to surrounded anatomical conditions in anatomical snuffbox area vascular access site complications may be lessened comparing to forearm radial access site.

Eligibility criteria: Inclusion Criteria:

age 18-75 primary radial artery puncture radial artery diameter \>1,5mm by ultrasound stable coronary disease less than 6F sheath needed patient height \>185cm

Exclusion Criteria:

ACS AMI critically ill patients previous TRI procedure Raynaud's disease

Primary outcomes:
measure: Radial artery late occlusion
timeFrame: 1 year
Secondary outcomes:
measure: vascular access site related complications
timeFrame: 1 week, 3 months, 6 moths, 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Center of Endosurgery
Study officials:
affiliation: Center of Endosurgery
name: Avtandil M Babunashvili, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North West state University Saint Petersburg
name: Alexander Kaledin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00368784: T Cell Repertoire Analysis of Immune Mediated Skin Diseases
Official title: T Cell Repertoire Analysis of Immune Mediated Skin Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Mycosis Fungoides
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2006-08-25
Enrollment: 426
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects aged 18 years to 55 years who have an immune mediated skin disease, such as psoriasis or mycosis fungoides, and age-matched controls (subjects who do not have an immunce midiated skin disease).

Brief summary: This study is designed to identify the cells of the immune system that cause skin disease such as psoriasis and mycosis fungoides. Blood samples from many patients will be compared in hopes of finding common cells and molecules responsible for skin diseases. Results of this study will increase our knowledge about immune mediated skin disease.

Detailed description: The aim of the study is to characterized the T cell repertoire of individuals with immune mediated skin disease (e.g. psoriasis and mycosis fungoides). Peripheral blood with be collected from volunteers with psoriasis, mycosis fungoides and age matched controls. Fifteen tablespoons of blood will be collected prior to the initiation of treatment and again after the patient shows a clinical response to treatment. The time between blood draws will be no less than 3 months. There will be no more than two blood draws per patient. Blood samples will be used to determine the patient's HLA haplotype via PCR and DNA sequencing. After the patient's haplotype has been established the activated T cell repertoire will be analyzed for clonal expansions. Clonal expansions in the T cell repertoire will be determined by immunoscope analysis, which is a PCR based technique.

Eligibility criteria: Inclusion Criteria:

* Have an immune mediated skin disease, such as psoriasis or mycosis fungoides
* Are not taking immunosuppressive medications, which may interfere with T cell analysis.

Exclusion Criteria:

* are taking immunosuppressive medications, which may interfere with T cell analysis

Primary outcomes:
measure: Peripheral blood will be collected from adults ages 18-85.
timeFrame: 2 Years
Secondary outcomes:
measure: T cell repertoire
timeFrame: 2 Years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis Department of Dermatology
state: California
Study officials:
affiliation: University of California, Davis
name: Emanual Maverakis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02993484: The Role of Mitochondrial Respiration in the Cardioprotective Capacity of IPC in Diabetic and Non-diabetic Patients
Official title: The Role of Mitochondrial Respiration in the Cardioprotective Capacity of IPC in Diabetic and Non-diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reperfusion Injuries, Myocardial
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The overall aim of this study is to examine the role of mitochondrial respiration in human diabetic tissue before and after ischemia. Furthermore we will examine the ability of ischemic preconditioning (IPC) to preserve the mitochondrial function and hemodynamic performance of both non-diabetic and diabetic fibers after ischemia. To increase our understanding on the metabolic changes during ischemia in both non-diabetic and diabetic tissue we will use Dimethyl Malonate and examine the impact of this blockade on post-ischemic mitochondrial respiration.

Detailed description: 20 diabetic and 20 non-diabetic patients undergoing elective CABG surgery or other heart surgery where extracorporal circulation is used will be included in the study. The patiens will not be given any treatment prior to the operation. During the cardiac surgery a small sample of the heart is routinely removed when the patient is connection to the heart-lung machine. From this tissue sample it is possible to isolate muscle trabeculae which will be used in an atrial strip model and randomized to one of four types of treatment. Simultaneously with the isolation of the trabeculae, a fifth trabecular will be used to assess mitochondrial respiration at baseline. Group 1 will serve as a sham control, group 2 will serve as ischemic control and receive an extended period of hypoxia, Group 3 will be treated with ischemic preconditioning, where short periods of non lethal lack of oxygen will be given directly to the tissue (after removal from the patient) prior to the extended period of hypoxia, Group 4 will receive dimethyl malonate prior to the prolonged hypoxia.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing CABG or other surgery where extracorporal circulation will be used.

Exclusion Criteria:

* raise in ischemic markers within 4 weeks
* ejection fraction \<30
* Atrial fibrilation
* Oral opioid treatment

Primary outcomes:
measure: Mitochondrial respiration of individual complexes
timeFrame: Outcome will be assessed within a year when the inclusion of patients is complete
Secondary outcomes:
measure: Hemodynamic performance
timeFrame: Outcome will be assessed within a year when the inclusion of patients is complete
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02641184: Evaluation of Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction
Official title: A Multicenter Prospective Observational Study to Evaluate the Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction (AMI)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Percutaneous Coronary Intervention
Acute Myocardial Infarction
Keywords: Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Infarction
Diabetes
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Yangzhou No.1 People's Hospital
name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Huaian first people's hospital
First posted: 2015-12-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to an emergency room and diagnosed as acute myocardial infarction

Brief summary: The aim of this study is to investigate the potential novel risk factors for acute myocardial infarction. Predictors of poor outcomes will be also evaluated.


Eligibility criteria: Inclusion Criteria:

* Less than 12 hours after the onset of myocardial infarction symptoms
* Myocardial necrosis, as evidenced by increased Creatine Kinase Isoenzyme (CK-MB) or troponin levels

Exclusion Criteria:

* Age under 18 years-old

Primary outcomes:
measure: Major adverse cardiovascular events (MACE)
timeFrame: maximum 5 years
Secondary outcomes:
measure: Length of hospital stay
timeFrame: in the phase of hospital stay, maximum 30 days
measure: New-onset diabetes
timeFrame: the duration of follow-up, maximum 5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang provincial people's hospital
state: Zhejiang
Study officials:
affiliation: Department of Cardiology, Zhejiang Provincial People's Hospital
name: Baiming Qu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00822484: Study Evaluating Single Doses of ILV-095 in Healthy Japanese Male Subjects
Official title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-095 Administered Subcutaneously to Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-14
Enrollment: 48
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy Japanese male subjects.


Eligibility criteria: Inclusion Criteria:

* Men aged 20 to 45 years inclusive at screening. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after study drug administration.
* Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg.
* Healthy as determined by the investigator on the basis of screening evaluations.
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
* Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study.
* Any subject who had orthopedic surgery within 12 weeks of the screening visit or has planned (elective) orthopedic surgery within 12 weeks of study drug administration.
* Acute disease state (eg, nausea, vomiting, infection, fever, active infection, or diarrhea) within 7 days before enrollment.

Primary outcomes:
measure: Safety and tolerability will be evaluated from the reported AEs including any injection-site reactions, physical examinations, vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results.
timeFrame: 3 weeks per group
Secondary outcomes:
measure: Pharmacokinetic parameters
timeFrame: 3 weeks per group
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: