louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06458270: Salt Warning Label Restaurant Study
Official title: Perceived Effectiveness of Salt Warning Labels on a UK Restaurant Menu: a Real-world Pilot Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Selection
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: NIHR BRC
First posted: 2024-06-13
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This between-subjects randomised controlled trial aims to test the effect of a menu featuring salt warning labels on perceived message effectiveness relative to a menu with no labels in a real-world restaurant environment. The study will also act as a pilot experiment for examining the impact of the salt warning label on food choice and subsequent salt intake in real-world conditions.

Primary objectives:

* To measure the PME of a menu featuring salt warning labels relative to a menu with no labels
* To measure label awareness, perceived knowledge gain, and perceived influence of the label on food choice

Secondary objectives:

* To identify whether there is an effect of the salt warning label on:

  * Food choice (label/no label)
  * Total salt selected
  * Total salt intake
* To examine support for the introduction of a salt warning label policy in the UK


Eligibility criteria: Inclusion Criteria:

* Are a UK resident
* Are aged 18 years and above
* Are fluent in English
* Eat an out-of-home meal at least once a month on average
* Have no dietary allergies
* Are not vegan

Primary outcomes:
measure: Perceived message effectiveness (PME)
timeFrame: Post - meal assessment (within 10 minutes)
measure: Label awareness
timeFrame: Post - meal assessment (within 10 minutes)
measure: Salt awareness
timeFrame: Post - meal assessment (within 10 minutes)
measure: Perceived knowledge gain
timeFrame: Post - meal assessment (within 10 minutes)
measure: Perceived influence
timeFrame: Post - meal assessment (within 10 minutes)
measure: Policy support
timeFrame: Post - meal assessment (within 10 minutes)
Secondary outcomes:
measure: Total salt purchased
timeFrame: Post - meal assessment (within 10 minutes)
measure: Labelled item selected
timeFrame: Post - meal assessment (within 10 minutes)
measure: Total salt consumed
timeFrame: Post - meal assessment (within 10 minutes)
measure: Later salt intake
timeFrame: Follow-up assessment (next morning, 8AM, to be completed within 24 hours)
measure: Other macronutrient intake
timeFrame: Post - meal assessment (within 10 minutes)
Other outcomes:
measure: Food choice motives
timeFrame: Post - meal assessment (within 10 minutes)
measure: Aim guessing
timeFrame: Post - meal assessment (within 10 minutes)
Locations:
city: Liverpool
country: United Kingdom
facility: University of Liverpool
state: Merseyside
Study officials:
References:
Clinical trial NCT00067470: Study of Recombinant Human N-acetylgalactosamine 4-sulfatase (rhASB) in Patients With MPS VI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mucopolysaccharidosis VI
Lead sponsor: BioMarin Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2003-08-25
Enrollment: 39
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the ability of rhASB versus placebo to enhance endurance in patients with Mucopolysaccharidosis VI (MPS VI), as evidenced by an increase in the number of meters walked in the 12 minute walk test at Week 24 compared with baseline.


Eligibility criteria: Inclusion Criteria

* Patient consent
* Patient must be seven years of age or older
* Patient must have documented biochemical or genetic proof of MPS VI
* The patient must be able to walk independently at least 5 meters and no more than 270 meters in the first 6 minutes, or no more then 400 meters total in 12 minutes, in the screening 12-minute walk test
* If female of childbearing potential, patient must have a negative pregnancy test

Exclusion Criteria

* Patient is under consideration for or has undergone a successful bone marrow transplant (BMT)
* Patient refuses or is unable to complete all screening evaluations
* Pregnant or lactating patient
* Patient has received an investigational drug within 30 days prior to study enrollment
* Patient has been previously treated with rhASB
* Patient has a medical condition, serious intercurrent illness, or other extenuating circumstance that may significantly confound study results or decrease study compliance
* The patient has clinically significant spinal cord compression
* The patient has known hypersensitivity to rhASB or to components of the active or placebo test solutions

Primary outcomes:
measure: Change From Baseline in 12-minute Walk Test at 24 Weeks
timeFrame: baseline and 24 weeks
Secondary outcomes:
measure: Change From Baseline in 3-minute Stair Climb at 24 Weeks
timeFrame: baseline and 24 weeks
measure: Change From Baseline in Urinary GAG (uGAG) at 24 Weeks
timeFrame: baseline and 24 weeks
Other outcomes:
Locations:
city: Novato
country: United States
facility: BioMarin Pharmaceutical Inc.
state: California
Study officials:
References:
citation: Tandon PK, Kakkis ED. The multi-domain responder index: a novel analysis tool to capture a broader assessment of clinical benefit in heterogeneous complex rare diseases. Orphanet J Rare Dis. 2021 Apr 19;16(1):183. doi: 10.1186/s13023-021-01805-5.
Clinical trial NCT03179670: Interest of a Systematic Assessment of the Treatment of LUTS in the Management of BPH
Official title: Interest of a Systematic Assessment of the Treatment of Lower Urinary Tract Symptoms (LUTS) in the Management of Benign Prostatic Hyperplasia (BPH) in Urology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: RECORDATI GROUP
Sponsor class: INDUSTRY
Collaborators: name: ClinSearch
First posted: 2017-06-07
Enrollment: 625
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The frequency of patients with IPSS score \<8 after three months of treatment with alpha-blockers is about 40%. The sample size required to detect a proportion of 40% with a precision of 0.04 is 550 patients. Based on a literature review of Lacoin et al, the frequency of treated patients with LUTS associated with BPH with an IPSS ≥ 8 is approximately 60%. Thus, 917 patients will be needed to obtain a sample of 550 patients with treatment of alpha-blockers (550/0.6 = 917).

Considering 10% of patients lost for follow-up or refusing treatment change, the total number required is estimated at about 1,000 patients.

Brief summary: The high level of unsatisfactory outcome observed in patients treated for LUTS associated with BPH with respect to the different existing therapeutic options strongly emphasizes the need for treatment optimisation in daily practice by a careful LUTS monitoring and treatment adjustment when needed. The poorer outcome observed in patients for whom treatment has been initiated recently suggests that the duration of the disease itself may influence the patient satisfaction.To achieve this goal, we propose to systematically assess LUTS associated with BPH in patients treated for at least 6 months and to assess whether an alpha-blocker therapy initiation/modification may improve the outcome in case of persisting symptoms. We also investigate the influence of the symptom duration on the frequency of unsatisfactory outcome.


Eligibility criteria: Inclusion Criteria:

Patients aged 60 years or more suffering from LUTS/BPH AND medically treated for at least 6 months.

Exclusion Criteria:

* Patients with prostate cancer
* Patients requiring surgical treatment
* The absence of Lower Urinary Tract Symptoms
* Treatment initiation for less than 6 months
* Cognitive disorders or other pathologies leading to the inability to give its consent to the collection of data.
* Refusal to participate.

Primary outcomes:
measure: Percentage of patients treated for LUTS associated with BPH displaying unsatisfactory outcome after at least 6 months of treatment and not requiring surgical treatment.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Puteaux
country: France
facility: LBR
Study officials:
References:
Clinical trial NCT00077870: A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis
Official title: A Randomized, Placebo-Controlled, Multicenter, Blinded Phase I/II Study of the Safety of Escalating Doses of Ocrelizumab (PRO70769) in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Moderate to severe rheumatoid arthritis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-02-16
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and subject-blinded study of the safety of escalating doses of ocrelizumab in combination with MTX in subjects with moderate to severe RA


Eligibility criteria: Inclusion Criteria:

* Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
* Diagnosis of RA for at least 6 months according to the revised 1987 ACR criteria for the classification of RA
* Positive serum RF
* Current treatment for RA on an outpatient basis
* Contact your local site that is listed for more inclusion criteria

Exclusion Criteria:

* Bone or joint surgery (including joint fusion) within 8 weeks prior to screening or joint surgery planned within 24 weeks after randomization
* Rheumatic autoimmune disease other than RA or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis, or Felty�s syndrome)
* Functional Class IV as defined by the ACR classification of functional status in RA
* History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic rheumatic disorders (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, overlap syndrome)
* Contact your local site that is listed for more exclusion criteria

Primary outcomes:
measure: Safety and tolerability of ocrelizumab in subjects with moderate to severe RA
Secondary outcomes:
measure: Pharmacokinetics of ocrelizumab
measure: Pharmacodynamics of ocrelizumab
measure: Percentage of subjects with clinical responses according to American College of Rheumatology (ACR) criteria
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Wolfgang Dummer, M.D.
role: STUDY_DIRECTOR
References:
citation: Genovese MC, Kaine JL, Lowenstein MB, Del Giudice J, Baldassare A, Schechtman J, Fudman E, Kohen M, Gujrathi S, Trapp RG, Sweiss NJ, Spaniolo G, Dummer W; ACTION Study Group. Ocrelizumab, a humanized anti-CD20 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: a phase I/II randomized, blinded, placebo-controlled, dose-ranging study. Arthritis Rheum. 2008 Sep;58(9):2652-61. doi: 10.1002/art.23732.
Clinical trial NCT00285870: Quantification of Upper Extremity Hypertonia
Official title: Quantification of Upper Extremity Hypertonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dystonia
Muscle Hypertonia
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2006-02-02
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with cerebral palsy and/or dystonia.

Brief summary: Dr. Sanger and the research team want to learn about upper extremity hypertonia (stiffness) in children and young adults with cerebral palsy. Specifically, they want to learn about ways to measure the stiffness in the joints of hypertonic arms. The information the research team will collect includes any physical exams or computer generated data about your arm movements.


Eligibility criteria: Inclusion Criteria:Dystonia in at least one arm Age 4 to no upper limit

Exclusion Criteria:increased risk of participation botulinum toxin within 6 months

Primary outcomes:
measure: Observation
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Terence D. Sanger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03689270: Corneal Edema After Phacoemulsification
Official title: Central Corneal Thickness Assessment After Phacoemulsification: Subluxation Versus Divide-and-Conquer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: subluxation
Divide and conquer
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 96
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 underwent phacoemulsification cataract surgery over a 6-month period.

Brief summary: To compare the impact of two phacoemulsification techniques (subluxation versus divide-and-conquer) on postoperative corneal edema at postoperative hour 1 and day 4.

Detailed description: Phacoemulsification is the procedure of choice for most surgeons performing cataract surgery. Alternative techniques have been in development over the last twenty years, with the hope of optimizing operating times, total ultrasound energy used, patient safety, patient satisfaction and visual recovery associated with cataract surgery.

Divide-and conquer is the parent nucleofracture technique.The subluxation technique is a newer technique that is less frequently used because of an increased risk of corneal endothelium damage.

The aim of this comparative study was to evaluate corneal edema immediately after surgery performed with the subluxation technique versus divide-and-conquer. Corneal edema was determined by measuring central corneal thickness (CCT).

Eligibility criteria: Inclusion Criteria:

* The presence of a senile cataract with equivalent grades and history of visual acuity regression
* Informed written consent

Exclusion Criteria:

* Patients with total white cataract
* With history of ocular surgery and other eye diseases (corneal pathology, uveitis, glaucoma)
* With systemic diseases with the potential to affect vision

Primary outcomes:
measure: Corneal edema preoperative
timeFrame: Day 1
Secondary outcomes:
measure: Corneal edema postoperative
timeFrame: Day 4
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01929070: A Pilot Study to Evaluate the Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007
Official title: A Pilot Study to Evaluate the Pharmacokinetics of Omega-3 Between Rosuvastatin and Omega-3 Coadministration and HCP1007 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: HCP1007
Rosuvastatin
Omega-3
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2013-08-27
Enrollment: 12
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
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 pharmacokinetics of omega-3 between rosuvastatin and omega-3 coadministration and HCP1007 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Adult male aged 20 to 55 years
* A body mass index between 19 and 27 kg/m2

Exclusion Criteria:

* History of hepatobiliary, renal, gastrointestinal, respiratory, musculoskeletal, endocrinal, hemato-oncologic or cardiovascular disease
* SBP \< 90 or ≥ 150 mmHg, DBP \< 60 or ≥90 mmHg
* Use of herbal medicine within 30 days, prescriptive medicine within 14 days, or over-the-counter drug within 7 days
* Heavy alcohol consumption (140 g/day)

Primary outcomes:
measure: Cmax_adj of DHA and EPA
timeFrame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only)
measure: AUClast_adj of DHA and EPA
timeFrame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h (on the high-fat diet only)
Secondary outcomes:
measure: Cmax of DHA, EPA
timeFrame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
measure: AUClast of DHA, EPA
timeFrame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
measure: AUClast of DHA and EPA
timeFrame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
measure: tmax of DHA and EPA
timeFrame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
measure: t1/2 of DHA and EPA
timeFrame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
measure: AUCinf of DHA and EPA
timeFrame: -24, -22, -20, -19, -18, -16, -14, -12, 0 (predose), 2, 4, 5, 6, 8, 10, 12, 24, 48 h, 72 h(only on the high fat diet)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical center
Study officials:
affiliation: Samsung Medical Center
name: JaeWook Ko, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00831870: EndoSure Sensor for Long-term Follow-up After Endovascular AAA Repair
Official title: PRessure and Imaging-Using the CardioMEMS EndoSure Sensor for Long-term Follow-up After EVAR With Standard Surveillance (Prospective Registry)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm, Abdominal
Keywords: EndoSure Sensor
s2 Sensor
abdominal aortic aneurysm
Lead sponsor: CardioMEMS
Sponsor class: INDUSTRY
First posted: 2009-01-29
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female subjects, at least 18 years of age, who are post-EndoSure AAA Pressure Sensor implantation at time of enrollment.

Brief summary: The purpose of this study is to collect and compare EndoSure and EndoSure s2 Wireless AAA Pressure Sensor measurements with measurements from CT scan imaging, ultrasound, and other tests used to measure your AAA sac size and endoleaks following AAA repair, and during follow-up visits with your physician. An antenna is held over the patient's abdomen to measure pressure inside the aneurysm sac. The reading does not cause any discomfort, and dye or radiation is not needed to take the pressure measurement. To qualify, the patient must have a previously implanted EndoSure Sensor.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from subject or legal guardian
* Males or females, at least 18 years of age
* Subjects who are post-EndoSure Wireless AAA Pressure Sensor implantation, with pressure measurements at implant.
* Subjects willing to comply with the site-specific follow-up requirements of the investigator.

Exclusion Criteria:

* Subjects whose clinical condition, in the Investigator's opinion, would not allow them to complete participation in the registry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00132470: Treatment With AX200 for Acute Ischemic Stroke
Official title: AXIS IIa - Treatment With AX200 for Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Stroke
Lead sponsor: Axaron Bioscience AG
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The AXIS study is a randomized, double-blind, placebo-controlled, dose-escalating phase IIa trial to investigate treatment with AX200 (granulocyte-colony stimulating factor; G-CSF) for acute ischemic stroke. The primary objective of the present phase IIa study is to assess the safety and tolerability of AX200 compared to placebo in subjects suffering from acute stroke. The secondary objective is to assess the effect of AX200 on subject outcome in comparison to placebo.


Eligibility criteria: Inclusion Criteria:

* Stroke onset within 12 hours prior to start of study agent administration
* Ischemic stroke in the middle cerebral artery (MCA) territory confirmed by magnetic resonance imaging (MRI)

Exclusion Criteria:

* Time interval since stroke onset impossible to determine
* Carotid T-occlusion (magnetic resonance angiography \[MRA\])
* Subarachnoid hemorrhages
* Several safety parameters

Primary outcomes:
measure: Safety
Secondary outcomes:
measure: Neurological outcome
measure: ischemic lesion growth
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Neurology University of Heidelberg
city: Muenster
country: Germany
facility: Neurology University of Muenster
Study officials:
affiliation: Universität Münster
name: Wolf-Rüdiger Schäbitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneider A, Kruger C, Steigleder T, Weber D, Pitzer C, Laage R, Aronowski J, Maurer MH, Gassler N, Mier W, Hasselblatt M, Kollmar R, Schwab S, Sommer C, Bach A, Kuhn HG, Schabitz WR. The hematopoietic factor G-CSF is a neuronal ligand that counteracts programmed cell death and drives neurogenesis. J Clin Invest. 2005 Aug;115(8):2083-98. doi: 10.1172/JCI23559. Epub 2005 Jul 7.
citation: Schabitz WR, Laage R, Vogt G, Koch W, Kollmar R, Schwab S, Schneider D, Hamann GF, Rosenkranz M, Veltkamp R, Fiebach JB, Hacke W, Grotta JC, Fisher M, Schneider A. AXIS: a trial of intravenous granulocyte colony-stimulating factor in acute ischemic stroke. Stroke. 2010 Nov;41(11):2545-51. doi: 10.1161/STROKEAHA.110.579508. Epub 2010 Oct 14.