louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01376063: Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects
Official title: A Phase 1, Single-Center, One-Sequence, Open-Label Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Lead sponsor: FibroGen
Sponsor class: INDUSTRY
First posted: 2011-06-20
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to assess the effect of multiple doses of FG-4592 on the plasma pharmacokinetic of rosiglitazone in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males, 18 to 45 years
* Body weight ≥ 75 kg
* Good health
* Non-smoker
* Blood pressure not greater than 140/90 mm Hg

Exclusion Criteria:

* Positive for any of the following: Human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab)
* Blood donation or significant blood loss within 60 days prior to Day 1
* Use of prescription and over the counter medications/herbal preparations is not allowed within 14 days prior to Day 1 and through treatment phase
* History or presence of alcoholism or drug abuse within 2 years prior to Day 1
* Consumption of alcohol within 7 days prior to Day 1 or during treatment phase
* Positive urine drug/alcohol testing at screening or check-in visit

Primary outcomes:
measure: Change in plasma concentration of Rosiglitazone
timeFrame: Day 1- Day 11
Secondary outcomes:
measure: Change in plasma concentration of Rosiglitazone metabolites
timeFrame: Day 3 - Day 11
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01398163: A f-MRI Study Of Affective Changes Associated With Four Weeks Consumption Of A Fermented Dairy Product In Healthy Women
Official title: A f-MRI STUDY OF AFFECTIVE CHANGES ASSOCIATED WITH FOUR WEEKS CONSUMPTION OF A FERMENTED DAIRY PRODUCT IN HEALTHY WOMEN
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adult Women
Keywords: probiotics
digestive well-being
fMRI
brain-gut axis
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2011-07-20
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on the brain activity within specific neural circuits regulating the subjective experience of emotional valence and digestive well-being.


Eligibility criteria: Inclusion Criteria:

* Healthy women, right-handed, aged from 18 to 60 years
* Subject of normal body weight or with overweight i.e. not obese (body mass index between 18 and 30 kg/m2).
* For fertile women, complying with one of the other medically approved methods of contraception

Exclusion Criteria:

* Subject with any current psychiatric or eating or suicidal attempt disorder, or history of such disorder.
* Subject with any history of chronic GI disorder or disease.
* Subject with any significant active or prior metabolic disorder or disease.
* Subject with any use of probiotic supplements or antibiotics in the previous month.
* Subject with current use of any medications with potential central nervous system effects (antidepressants, anxiolytics, opiate pain medications...).
* Subject with allergy or hypersensitivity to milk proteins or lactose intolerance or immunodeficiency
* Subjects with claustrophobia or other condition (such as metallic implants) that would preclude MRI scanning

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA - University
state: California
Study officials:
References:
Clinical trial NCT04631263: New Dermal Filler for Chin Correction and Augmentation
Official title: A Randomized, Evaluator-blinded, Parallel Group, no Treatment Controlled, Multi-center Study to Evaluate Effectiveness and Safety of GP0109 for Augmentation and Correction of Retrusion in the Chin Region
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chin Augmentation and Correction
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2020-11-17
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GP0109 for augmentation and correction or retrusion in the chin region in Canada


Eligibility criteria: Inclusion Criteria:

* subject willing to comply with the requirements of the study
* subject intent to receive treatment for augmentation and correction of retrusion in the chin region
* subject with mild or moderate (grade 1 or 2) on the GCRS

Exclusion Criteria:

* subjects presenting with know allergy to HA (hyaluronic acid) filler or amide local anesthetics
* subjects with any previous facial surgery below the nasal line or previous HA filler or collagen below the nasal line within 12 months
* subjects in any other interventional clinical study within 30 days before baseline

Primary outcomes:
measure: Responder rate based on the Galderma Chin Retrusion Scale as assessed live by the Blinded Evaluator
timeFrame: 3 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Galderma Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Galderma Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Galderma Research Site
state: British Columbia
city: Vancouver
country: Canada
facility: Galderma Research Site
state: British Columbia
city: Burlington
country: Canada
facility: Galderma Research Site
state: Ontario
city: Toronto
country: Canada
facility: Galderma Research Site
state: Ontario
city: Toronto
country: Canada
facility: Galderma Research Site
state: Ontario
city: Woodbridge
country: Canada
facility: Galderma Research Site
state: Ontario
city: Westmount
country: Canada
facility: Galderma Research Site
state: Quebec
Study officials:
affiliation: Galderma R&D
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00417963: ViVEXX Carotid Revascularization Trial (VIVA)
Official title: The ViVEXX Carotid Revascularization Trial (VIVA) for High Surgical Risk Patients With Extracranial Carotid Artery Stenosis Using the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carotid Artery Stenosis
Keywords: Carotid
Artery
Stenosis
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2007-01-04
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of the Bard ViVEXX Carotid Stent and Emboshield BareWire Rapid Exchange Embolic Protection System in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid endarterectomy.

Detailed description: Patients with clinically significant stenosis within the common and/or internal carotid artery who are at high risk for carotid endarterectomy and are amenable to percutaneous treatment including embolic protection, balloon angioplasty and the carotid stent placement.

Eligibility criteria: Inclusion Criteria:

* The patient has a symptomatic or asymptomatic carotid artery stenosis that meets one of the following criteria:

  * Symptomatic: \> than or = to 50% carotid stenosis by angiography and a history of non-disabling stroke, transient ischemic attack (TIA) in the hemisphere supplied by the target vessel within 180 days of the procedure.
  * Asymptomatic: \> than or = to 80% carotid stenosis by angiography without neurological symptoms.
* High risk for carotid endarterectomy: anatomical and co-morbid.

Exclusion Criteria:

* History of symptoms of stroke or TIA within 24 hours of the procedure
* Extensive or diffuse atherosclerotic disease
* Severe vascular tortuosity or anatomy that would preclude the safe introduction of the device

Primary outcomes:
measure: Percentage of Patients Experiencing Major Adverse Events (MAE)
timeFrame: 365 days from implantation
Secondary outcomes:
measure: Number of Participants Experiencing Target Lesion Revascularization(s) (TLR)
timeFrame: 12 months from implantation
measure: Number of Patients Experiencing Access Site Complications
timeFrame: 30 days following implantation
measure: Number of Participants Experiencing Stroke Related Neurologic Deficit
timeFrame: 30 days from implantation
measure: Number of Participants Experiencing Device Success
timeFrame: at time of implantation
measure: Number of Participants Experiencing Lesion Success
timeFrame: at time of implantation
measure: Number of Participants Experiencing Restenosis
timeFrame: 12 months after implantation
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Kenneth Rosenfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03805763: Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity
Official title: Clinical Research on the Effect of Different Extents of Internal Limiting Membrane Peeling on Macular Hole Closure and Visual Acuity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Holes
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Observing and describing the surgical effects of different extents of internal limiting membrane peeling combined with internal limiting membrane insertion for macular hole


Eligibility criteria: Inclusion Criteria:

* Clear diagnosis of macular hole;
* The minimum diameter of the macular hole is \>400 μm;
* Without serious systemic disease that make patients can not be operated;

Exclusion Criteria:

* suffering from severe retinal diseases such as: diabetic retinopathy, age-related macular degeneration, peripheral retinal detachment, PVR, etc.;
* opacitas in the refractive medium can not perform Angio-OCT and visual acuity examination;
* eye acute and chronic inflammation, such as acute contagious conjunctivitis, acute and chronic keratitis, acute dacryocystitis;
* traumatic macular hole, secondary macular hole, high myopia macular hole, etc.;
* having a history of vitrectomy surgery;
* glaucoma in stage of preclinical, severe stenosis or closure;

Primary outcomes:
measure: Condition of postoperative healing of macular holes
timeFrame: 1 year
measure: Mean change from baseline in best-corrected visual acuity (BCVA)
timeFrame: 1 year
measure: change from baseline in foveal avascular zone (FAZ) areas and diameter
timeFrame: 1 year
measure: change from baseline in the area and diameter of deteriorated circulation zone in superficial and deep retina vessels
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Eye Hospital of Wenzhou Medical University
name: Zongduan Zhang, M.D,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05439863: TAVR for Aortic Valve Disease
Official title: Transcatheter Aortic Valve Replacement for Severe Aortic Valve Disease: Multi-center, Real-word Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Disease
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 5000
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: All patients undergoing transcatheter aortic valve replacement due to severe aortic valve stenosis or regurgitation were eligible into this registry.

Brief summary: Transcatheter aortic valve replacement (TAVR) has became an important treatment of severe aortic stenosis (AS). Several randomized clinical trials showed that TAVR was non-inferior or superior to surgical aortic valve replacement (SAVR). However, many different issues have emerged: TAVR in younger patients? valve leaflet thrombosis? transcatheter valve durability? coronary reaccess after TAVR? TAVR in bicuspid aortic valve? TAVR in aortic regurgitation? etc. Hence, a prospective, multicenter database is created to provide the real-word data for these questions.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of severe aortic stenosis or aortic regurgitation
2. Patients undergo transcatheter aortic valve replacement

Exclusion Criteria:

patients refuse the clinical follow-up

Primary outcomes:
measure: all-cause death during follow-up
timeFrame: 5 years
Secondary outcomes:
measure: cardiac death during follow-up
timeFrame: 5 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT02822963: Impact of Anticoagulants and Antiplatelets in Patients on Transurethral Resection of the Prostate
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Benign Prostatic Hyperplasia
Prostate Cancer
Keywords: Transurethral resection of the prostate
Anticoagulants
Platelet aggregation inhibitors
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2016-07-06
Enrollment: 0
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male admitted to National Cheng Kung University Hospital for TURP.

Brief summary: Benign prostatic hyperplasia(BPH) is a common disease in urology among old men. If BPH symptom cannot be controlled by drugs, then transurethral resection of the prostate (TURP), is recommended. Although the procedure is quit safe, these old men often take anticoagulants and antiplatelets to control cardiovascular diseases, which arose some concerns for their bleeding risk. The management of anticoagulation in patients undergoing surgical procedures is challenging because interrupting anticoagulation increases the risk of thrombotic events. At the same time, surgery and invasive procedures have associated bleeding risks that are increased by the anticoagulant administration. Now, the recommendation about anticoagulants and antiplatelets discontinuation had no concrete evidence, especially in TURP. Furthermore, there is no relative studies done in Taiwan population, which calls for further investigation.


Eligibility criteria: Inclusion Criteria:

* Admitted to National Cheng Kung University Hospital Urology during the study
* Older than 20 years old
* Agree to participate this study
* Receiving transurethral resection of the prostate for benign prostatic hyperplasia or prostate cancer

Exclusion Criteria:

* Poor expression ability and without close care givers to answer questions

Primary outcomes:
measure: Perioperative blood transfusion
timeFrame: in 1 week after surgery
measure: Bladder clots
timeFrame: in 10 days after surgery
measure: Hematuria
timeFrame: in 10 days after surgery
measure: Urine tract infection
timeFrame: in 10 days after surgery
measure: Duration of catheter
timeFrame: in 10 days after surgery
measure: Duration of hospitalization
timeFrame: in 1 week after surgery
measure: Cardiovascular event
timeFrame: In 28 days after surgery
measure: Major bleeding
timeFrame: In 28 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT04983563: Actigraphy and Neonatal Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units
Official title: Assessment of Actigraphy in the Management of Neonatal Opioid Abstinence Syndrome of Hospitalized Newborn in Intensive Care Units
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neonatal Abstinence Syndrome
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to analyse the correlation between actigraphy and Lipsitz scoring system in neonatal opioid abstinence syndrome of hospitalized newborn in intensive care units

Detailed description: Hospitalized newborn in intensive care units can receive opioids to manage pain or sedation. Neonatal opioid abstinence syndrome can occur when newborn receive opioid treatment for a long time.

Many scoring systems, like Lipsitz scoring system, are used to diagnose and manage neonatal abstinence syndrome but they are subjective. The majority of items in these scores are motor skills items.

Actigraphy allows to measure objectively the newborn motricity. This study will analyse the correlation between actigraphy and Lipsitz scoring system.

Eligibility criteria: Inclusion Criteria:

* Newborn \> 22 gestation weeks
* Hospitalization in neonatal intensive care unit at CHU de Caen.
* Opioids treatment \> 48 hours.

Exclusion Criteria :

* ante or post-natal brain injury diagnosis
* upper arm motor deficit
* palliative care

Primary outcomes:
measure: Correlation between actigraphy and Lipsitz scoring system
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: CHU CAEN
name: Elodie EL LECORPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04372563: Study of Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.
Official title: Clinical Study of Diagnosis and Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ascending Aorta Aneurysm
Dilation of the Ascending Aorta
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with computed tomography-diagnosed ascending aortic dilation greater than 45 mm, less than 55 mm with tricuspid aortic valve compared to patients with bicuspid aortic valve and healthy volunteers

Brief summary: Clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta

Detailed description: Expanding indications for surgical treatment of patients with borderline values of the ascending aorta

Eligibility criteria: Inclusion Criteria:

1. Extension of the ascending aorta less than 55 mm
2. Tricuspid Aortic Valves.
3. Extension of the ascending aorta more than 45 mm

Exclusion Criteria:

1. Age less 45 years
2. Age more 75 years
3. Multiple organ failure
4. oncological disease

Primary outcomes:
measure: death
timeFrame: 30 day after operation
measure: aorto-associated complications
timeFrame: 30 day
Secondary outcomes:
measure: increasing the diameter of the ascending aorta
timeFrame: 1 year
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
city: Tomsk
country: Russian Federation
facility: Tomsk National Research Medical Center of the Russian Academy of Sciences
Study officials:
affiliation: Tomsk National Research Medical Center of the Russian Academy of Sciences
name: Evgeniya V Lelik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05559463: Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis
Official title: Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the effect of anti-inflammatory diet on clinical and biological outcomes in patients with knee osteoarthritis

Detailed description: The investigators would like to evaluate how inflammation occurs in the joints of subjects with osteoarthritis, and identify molecules and bacteria that can predict whether a patients with knee osteoarthritis will have more or less pain . Blood, urine and stool will be evaluated in the laboratory and compared to their own samples after changes in diet. This is an exploratory study, which is meant to gather preliminary data about the quick effects of changes in diet and treatment on molecules in blood/urine and bacteria in stools. These studies can provide clues to the cause of disease and might ultimately lead to new therapies.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed of Knee Ostoeaarthritis
* without changes in treatment in the last 3 months

Exclusion Criteria:

* food allergies
* pregnancy

Primary outcomes:
measure: Change of baseline pain measured by visual analogue scale (0-10) after 28 days
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD
state: California
Study officials:
References: