louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01889693: Imaging of Atherosclerosis With 68Ga-MSA
Official title: Identification of Vascular Inflammatory Image Using a 68Ga-MSA(Gallium-68 Neomannosyl Human Serum Albumin) in Patients With Atherosclerotic Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Noninvasive Imaging of Atherosclerosis
Keywords: positron emission tomography
macrophage
neomannosyl human serum albumin
Lead sponsor: Korea University
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2013-06-28
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients with acute coronary syndrome, 20 patients with chronic stable angina and 20 control subjects wihout coronary artery disease of the Cardiovascular Center at Korea University Guro Hospital

Brief summary: Despite of intensive efforts, no specific ath¬erosclerosis-targeting agent labeled with positron emitter is not yet available. Fortunately, some scientists made the major advance in the field of clinical atherosclerosis molecular imaging by the metabolic PET reporter agent 18F(fluorine-18)-FDG(Fludeoxyglucose) applied to noninvasively image plaque macrophages in carotid arteries. However, coronary and cerebral arterial segments remain uninterpretable due to metabolic property of 18F-FDG. Applying the character of the terminal mannose residues of MSA binding with the mannose receptors of macrophages in atherosclerosis, we investigate whether 68Ga-MSA can be a novel agent for non-invasive molecular imaging of atherosclerotic lesion in PET.


Eligibility criteria: Inclusion Criteria:

* acute coronary syndrome(acute myocardial infarction, unstable angina)
* chronic stable angina
* control without coronary artery disease

Exclusion Criteria:

* pregnancy, allergy to albumin, chronic inflammatory disease

Primary outcomes:
measure: comparison of SUV(standard uptake unit) at atherosclerotic plaque of aorta and carotid arteries among 3 groups
timeFrame: 1 day at the time of PET(positron emission tomogram) imaging
Secondary outcomes:
measure: side effect of PET imaging with 68Ga-MSA
timeFrame: with 7 days after PET imaging
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References:
Clinical trial NCT03847493: Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death
Official title: Analysis of Sublingual Glycocalyx Damage at ICU Admission to Predict Risk of Death - the ASGARD Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Septic Shock
Endothelial Dysfunction
Keywords: perfused boundary region
PBR
Sepsis
endothelial glycocalyx
ICU
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2019-02-20
Enrollment: 100
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: Non-consecutive patients admitted in the ICU of University Hospital Münster, Germany.

Brief summary: The aim of this observative, prospective study is to evaluate if and to what extent glycocalyx damage/microcirculation data at admission in the ICU as well as during ICU stay can be predictive of mortality and clinical course in patients presenting with the suspicion of sepsis/septic shock. Therefore, the enrollment of ca 100 ICU patients is planned.


Eligibility criteria: Inclusion Criteria:

* ICU patients admitted to the ICU with the clinican suspicion of sepsis/septic shock.

Exclusion Criteria:

* Underage persons, pregnant women, patients with inflammation or trauma of sublingual mucosa.

Primary outcomes:
measure: Predictive value of glycocalyx thickness regarding clinical course.
timeFrame: Hospital stay, an expected time of 4 weeks.
measure: Predictive value of glycocalyx thickness regarding mortality.
timeFrame: Hospital stay, an expected time of 4 weeks.
Secondary outcomes:
measure: Correlation of glycocalyx thickness with disease severity.
timeFrame: Hospital stay, an expected time of 4 weeks.
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Universitiy Hospital Muenster
Study officials:
affiliation: University Hospital Muenster
name: Philipp Kümpers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00649493: Fed Study of Rabeprazole Sodium Tablets 20 mg and Aciphex® Tablets 20 mg
Official title: Single-Dose Food In Vivo Bioequivalence Study of Rabeprazole Sodium Tablets (20 mg; Mylan) and Aciphex® Tablets (20 mg; Eisai) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 72
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study was to investigate the bioequivalence of Mylan's rabeprazole sodium 20 mg tablets to Eisai's Aciphex® 20 mg tablets following a single, oral 20 mg (1 x 20 mg) dose administration under fed conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: blood collections through 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Fargo
country: United States
facility: PRACS Institute, Ltd.
state: North Dakota
Study officials:
affiliation: PRACS Institute Ltd.
name: James D Carlson, Pharm. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06886893: Optical Coherence Tomography in Retinal Vein Occlusion
Official title: Optical Coherence Tomography Data As a Prognostic Indicator in Retinal Vein Occlusion
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Optical Coherence Tomography (OCT)
Keywords: OCT
retinal vein occlusion
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. Adults aged 18 or older with branch or central retinal vein occlusion. Patients must have macular edema confirmed by OCT and no previous RVO in the affected eye.

Brief summary: This study aims to evaluate how optical coherence tomography (OCT) can help predict outcomes in patients with retinal vein occlusion (RVO), a condition that affects blood flow in the retina. RVO can cause macular edema, which is swelling in the part of the eye responsible for central vision. The study will use OCT scans to assess changes in the retina and how these changes relate to vision improvement over time.

Detailed description: Objectives Evaluate how OCT data can predict visual outcomes by analyzing retinal changes and macular edema characteristics.

Assess the correlation between baseline OCT biomarkers and visual acuity improvements over time.

Study Design Type: Cross-sectional study.

Setting: Conducted at several eye care centers in Egypt.

Participants Inclusion Criteria: Adults with branch or central RVO, macular edema confirmed by OCT, and no prior RVO in the affected eye.

Exclusion Criteria: Other retinal diseases, recent intraocular surgery, or significant media opacities.

Procedures Informed Consent and History Taking.

Ophthalmologic Examination: Includes BCVA, IOP, slit-lamp biomicroscopy, and fundus examination.

OCT Imaging: Using NIDEK RS-330 Retina scan duo 2 (SD-OCT) to assess macular changes.

OCT Image Evaluation: Classification of macular edema types and assessment of biomarkers like subretinal fluid and cystoid changes.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older.

Patients diagnosed with branch or central retinal vein occlusion.

Patients with macular edema confirmed by OCT due to vein occlusion.

Patients with no prior history of RVO in the affected eye.

Exclusion Criteria:

* Presence of other retinal diseases that could affect OCT interpretation (e.g., diabetic retinopathy, age-related macular degeneration).

History of intraocular surgery within the last three months.

Presence of significant media opacities (e.g., dense cataract, vitreous hemorrhage) that interfere with OCT imaging.

Primary outcomes:
measure: changes in OCT biomarkers and visual acuity post-treatment.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02453893: Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia
Official title: Double-blind,Double-simulation,Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Iloperidone
Risperidone
PANSS
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-27
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical study. Chinese subjects with Ischemic Schizophrenia.

Detailed description: Subjects will randomly enter into one of two groups,the period of treatment is 8 weeks.

Eligibility criteria: Inclusion Criteria:

* men and women aged 18 to 65 years with schizophrenia;
* PANSS total score of at least 70 at screening and baseline;
* at least 2 more than 4 points in 7 of PANSS-P;
* informed consent.

Exclusion Criteria:

* allergy with iloperidone or risperidone;
* psychotic symptoms failing to improve after sufficient exposure to 2 antipsychotic treatment;
* any other primary Axis 1 psychiatric diagnosis;
* a history of alcohol or drug dependence in recent 1 year;
* at imminent risk of harm to self or others;
* systolic blood pressure≤90mmHg。

Primary outcomes:
measure: the score of Positive and Negative syndrome scale to evaluation the severity of schizophrenia
timeFrame: 8 weeks
Secondary outcomes:
measure: the score of clinical global impressions to evaluation the severity of illness
timeFrame: 8 weeks
measure: the score of clinical global impressions to evaluation the improvement of illness
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Li hua fang, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT05634993: Disability Level and Trunk Control in Individuals With Multiple Sclerosis
Official title: The Relationship Between Disability Level and Trunk Control in Individuals With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
disability level
trunk control
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Bandırma Onyedi Eylül University
First posted: 2022-12-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of the study will consist of patients who applied to the Neurology Outpatient Clinic for outpatient treatment and were diagnosed with Multiple Sclerosis by a neurologist and volunteered to participate in the study.

Brief summary: Trunk control disorders are frequently encountered in individuals with MS. Trunk control is very important for safe and quality movement. Impairment of trunk control reduces the level of independence of individuals during activities of daily living. For this reason, it is extremely important to evaluate the trunk in the examination and treatment of individuals. When the literature was examined, it was seen that studies examining trunk control were insufficient. Therefore, our study was planned to investigate the relationship between disability level and trunk control in individuals with MS.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65
* Having a definite diagnosis of MS
* Expanded Disability Status Scale (EDSS) score of 8.5 and below
* Not having an attack in the last 3 months

Exclusion Criteria:

* Having another musculoskeletal, cardiovascular, pulmonary, metabolic, or neurological disease severe enough to preclude participation in the study.
* Having severe vision and hearing problems
* The presence of severe cognitive impairment detected by the physician at a level that prevents the tests from being performed.

Primary outcomes:
measure: Expanded Disability Status Scale
timeFrame: baseline
measure: Trunk Impairment Scale
timeFrame: baseline
measure: "Sit-ups" test
timeFrame: baseline
measure: Modified "Push-ups" test
timeFrame: baseline
measure: Lateral bridge test
timeFrame: baseline
measure: Modified "Biering-Sorensen" trunk extension test
timeFrame: baseline
measure: Trunk flexion test
timeFrame: baseline
measure: "Prone Bridge" test
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bandırma
country: Turkey
facility: Melike Sumeyye Ozen
state: Balıkesir
Study officials:
References:
Clinical trial NCT00719693: Assessment of the Effect of Food on ABT-143 Bioavailability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetic Variables
Keywords: Food effect, phase I
adverse events
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-22
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Single-dose, open-label, two-period crossover study of ABT-143


Eligibility criteria: Inclusion Criteria:

* 18-55 years of age (inclusive)
* BMI 19 to 29 inclusive

Exclusion Criteria:

* Asian ancestry
* Concurrent participation in another study
* Females pregnant or breastfeeding

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 7 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 30 days
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Site Reference ID/Investigator# 9242
state: Indiana
Study officials:
affiliation: AstraZeneca
name: Torbjörn Lundström, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04827693: The Cortical Shield for Facial Bone Reconstruction
Official title: The Cortical Shield for Facial Bone Reconstruction of Severely Damaged Sockets With Simultaneous Implant Placement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tooth Loss
Tooth Diseases
Tooth Fracture
Tooth Injuries
Periodontal Bone Loss
Periodontitis
Peri-Implantitis
Tooth Decay
Keywords: tooth socket
bone grafting
bone regeneration
dental implant
osseointegration
Lead sponsor: Verdugo, Fernando, DDS
Sponsor class: INDIV
First posted: 2021-04-01
Enrollment: 34
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: Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics. Options of immediate or delay placement will be chosen based on the current status of the site to be restored at the time of referral.

The present cross-sectional quasi-experimental study is conducted in a specialty clinic in accordance to the requirements of the 1964 Helsinki Declaration

Brief summary: To evaluate a novel technique of bone regeneration and simultaneous implant placement in severely damaged sockets.

Detailed description: Patients requiring a single implant, presenting severe facial bone loss as a result of previous infection, failed socket grafting or trauma, will enter this cross-sectional study. Socket reconstruction and simultaneous implant placement will be performed through periosteal-guided bone regeneration (PGBR). Implant timing: immediate or delayed. Implants will be encased in a customized shield of autogenous cortical bone harvested from an adjacent site. A re-entry surgery will be performed at 12-17-weeks to evaluate bone regeneration. Peri-implant tissues will be assessed following established success criteria. Implants will be evaluated for the presence of Periimplantitis.

Eligibility criteria: Inclusion Criteria:

* ASA1 or ASA2 (American Society of Anesthesiologists)
* Healthy individuals with good oral hygiene and motivation
* No systemic uncontrolled diseases
* Not taking drugs known to modify bone metabolism

Exclusion Criteria:

* Individuals with untreated \& generalized severe periodontitis
* Heavy smokers (\>10 cigarettes/day)
* Poor oral hygiene
* Diabetes (HbA1C \>6.5% as cutoff value)
* Uncontrolled cardiovascular disease
* Poor overall health (ASA IV)

Primary outcomes:
measure: Individuals presenting alveolar Facial Bone regeneration at re-entry
timeFrame: 1 year
Secondary outcomes:
measure: Pink Esthetic Scores
timeFrame: 1 year
measure: Facial implant transparency
timeFrame: 1 year
measure: Band of Keratinized tissue
timeFrame: 1 year
measure: Implant crestal bone loss
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Fernando Verdugo, DDS, Corp
state: California
Study officials:
affiliation: University of Sacro Cuore
name: Fernando Verdugo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04019093: Acute Effects of Alcohol Use on Chronic Orofacial Pain
Official title: Acute Effects of Alcohol Use on Chronic Orofacial Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Keywords: alcohol effects
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-07-15
Enrollment: 48
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: People with and without jaw pain, including temporomandibular joint and muscle disorder (TMD) will receive an active oral dose of alcohol or placebo in a counterbalanced manner.
Primary purpose: BASIC_SCIENCE

Brief summary: Self-medication of pain with alcohol is a common, yet risky, behavior among individuals with chronic orofacial pain. Chronic pain status may affect the degree to which alcohol use relieves pain, but the independent contributions of pain chronification and alcohol-related expectations and conditioning have not been previously studied. This project addresses this gap in knowledge and will inform further research and clinical/translational efforts for reducing risk associated with these behaviors.


Eligibility criteria: Inclusion Criteria:

* Positive diagnosis of jaw pain, including temporomandibular joint and muscle disorder (TMD) (jaw pain group only)
* Consume at least 1 drink/month over the past 6 months

Exclusion Criteria:

* History of chronic pain other than jaw pain or TMD
* Current use of opioids
* Current major depression
* History of any psychotic disorder
* Undercontrolled hypertension or diabetes
* History of neurologic disease
* History of serious medical illness
* History of drug or alcohol dependence, including nicotine, or a pattern of hazardous alcohol use

Primary outcomes:
measure: Pressure Pain Threshold
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Pressure Pain Intensity
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
measure: Perceived Relief
timeFrame: Day 1; Day 2 (Laboratory sessions will be separated by at least 48 hours.)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Center for Pain Research and Behavioral Health at UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Jeff Boissoneault, PhD
role: PRINCIPAL_INVESTIGATOR
References: