louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03065036: Safety and Efficacy Study of the Hydrus Aqueous Implant in Subjects With POAG
Official title: A Prospective, Multi-Center Evaluation of the Hydrus Aqueous Implant (Standard and Low-Profile) for Lowering Intraocular Pressure (IOP) in Subjects With Mild to Advanced Primary Open Angle Glaucoma (POAG) With or Without a Cataract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Primary Open Angle Glaucoma
Keywords: Primary Open Angle Glaucoma
POAG
Lead sponsor: Ivantis, Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the ocular hypotensive effect of the Hydrus Aqueous Implant (Standard and Low-Profile), as determined by the change in IOP from baseline (preoperative) and change in the number of glaucoma medications from baseline.

Detailed description: This is a prospective, multi-center study that will examine subjects with documented mild to advanced primary open angle glaucoma (POAG), who may or may not have a cataract requiring removal and placement of an intraocular lens.

Study subjects will be grouped by the severity of their disease (either mild/moderate or advanced). If all inclusion and exclusion criteria are met subjects in all four groups will be implanted with the Hydrus Aqueous Implant. Subjects in whom a cataract is present will undergo standard cataract removal and IOL implantation concurrent with implantation of the Hydrus.

Postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals.

Eligibility criteria: Inclusion Criteria:

* Elevated intraocular pressure (IOP)
* Diagnosis of mild to advanced open-angle glaucoma
* Shaffer Grade III
* Mental capacity to cooperate when undergoing operative and postoperative examination
* 18 years of age or older
* Provide written informed consent
* Willing and able to return to scheduled follow-up examinations for 24-months

Exclusion Criteria:

* Closed-angle and narrow-angle forms of glaucoma
* Secondary glaucomas
* Congenital or developmental glaucoma

Primary outcomes:
measure: Change in IOP of study eye between each randomized group
timeFrame: Baseline & One year
Secondary outcomes:
measure: Change in glaucoma medications
timeFrame: Baseline & One year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University Medical Center Vienna
city: Recklinghausen
country: Germany
facility: Aurelios Augenzentrum
state: Erlbruch
city: Berlin
country: Germany
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg-Universitat Mainz Augenklinik und Poliklinik
city: Tijuana
country: Mexico
state: Baja California
Study officials:
affiliation: Augentagesklinik Spreebogen Berlin
name: Prof. Dr. Manfred Tetz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00953836: Plasma Pharmacokinetics of Alkylresorcinol Metabolites; New Candidate Biomarkers for Whole Grain Rye and Wheat Intake
Official title: Kinetic Study of Two Known Alkylresorcinol Metabolites in Human Subjects After the Intake of Rye Fiber, the Most Abundant Source of Alkylresorcinols in Diet.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kinetics of Alkylresorcinol Metabolites
Keywords: kinetics
alkylresorcinol metabolites
rye fiber
Lead sponsor: University of Helsinki
Sponsor class: OTHER
Collaborators: name: Samfundet Folkhälsan
name: Sigrid Jusélius Foundation
First posted: 2009-08-06
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy, free-living females and males

Brief summary: The purpose of this study is to investigate the kinetics of two known alkylresorcinol metabolites in human subjects after intake of high-fiber rye bread. Whole grain rye is the most abundant source of alkylresorcinols.


Eligibility criteria: Inclusion Criteria:

* Healthy, volunteer

Exclusion Criteria:

* Hemoglobin below 125 mmol/L in females and below 135 mmol/L in males use of antibiotics within 3 months before entering the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Folkhälsan Research Center
Study officials:
affiliation: Department of Medicine, University of Helsinki, Helsinki, Finland
name: Matti J Tikkanen, M.D., prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04233736: Erector Spinae Plane Blocks (ESP) for Postoperative Pain in Lumbo-sacral Spine Surgery
Official title: Bilateral Erector Spinae Plane Blocks (ESP) for Postoperative Pain in Lumbo-sacral Spine Surgery: A Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erector Spinae Plane Block
Lumbar Spine Surgery
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the analgesic efficacy of bilateral erector spinae plane (ESP) blocks after lumbar and lumbo-sacral spine surgery by assessing postoperative pain scores and opiate requirements as the primary outcome measures. We are aiming to investigate how ESP blocks, performed under ultrasound guidance at the T12 vertebral level, contribute to postoperative pain control. This will be determined by measuring numerical rating pain scores repeatedly following surgery and opiate consumption until patient discharge from hospital. These primary outcome measures will be compared between a treatment group of participants, who will receive ESP blocks and a control group who will receive a sham block. Our primary hypothesis is that ESP blocks significantly reduce postoperative pain and opiate requirements


Eligibility criteria: Inclusion Criteria:

* Spine surgery at or below the L1 vertebral level
* Midline surgical approach

Exclusion Criteria:

* Previous lumbar or lumbo-sacral surgery with or without hardware placement
* Evidence of dura pathology (including CSF leak)
* Spine tumor
* Non-English speaking

Primary outcomes:
measure: Postoperative pain scores
timeFrame: During hospitalization, typically lasting between 1 and 5 days
measure: Perioperative opiate consumption
timeFrame: During hospitalization, typically lasting between 1 and 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Claas Siegmueller, MD PhD MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01607736: Pilot Study of Virtual Gait Training in Older Adults
Official title: Pilot Study of Effects of Virtual Gait Training on Walking Stability in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frail Elderly
Keywords: falls
walking
healthy older individuals
virtual gait training
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2012-05-30
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Older individuals suffer from falls and fear of falling. The purpose of this study was to determine the effectiveness of a novel virtual gait training on walking performance and fear of falling in older adults, and to evaluate the feasibility of the virtual gait training program. The investigators hypothesize that virtual gait training in older adults over a three week period will both improve gait parameters as measured by a GAITRite® electronic walkway system, and reduce their fear of falling as measured by the Falls Efficacy Scale-International version.

Detailed description: The objectives of this study are to determine the effectiveness of virtual gait training on walking performance and fear of falling in older adults and to evaluate the feasibility of the virtual gait training. This prospective interventional study plans to include twelve residents of senior assisted living facilities in Basel, Switzerland, aged 65 years or older with no severe physical or cognitive disabilities, and who had fallen at least once in the preceding 12 months. Each participant will complete 14 12-minute virtual gait training sessions within a three-week period. Gait parameters will be quantified with the GAITRite® electronic walkway system, and fear of falling evaluated with the Falls Efficacy Scale-International version. The investigators hypothesize that 14 virtual gait training sessions in older adults over a three week period will both improve gait parameters as measured by a GAITRite® electronic walkway system, and reduce their fear of falling as measured by the Falls Efficacy Scale-International version.

Eligibility criteria: Inclusion Criteria:

* older than 65 years of age
* fall within last 6 months

Exclusion Criteria:

* cognitive deficits
* physical disability

Primary outcomes:
measure: gait speed
timeFrame: Change from baseline in gait speed at 3 weeks
Secondary outcomes:
measure: fear of falling
timeFrame: change from baseline at end of week 3
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Mobility Center
state: BS
Study officials:
affiliation: Dept. of Geriatrics, University Hospital Basel, Basel, Switzerland
name: Reto W Kressig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06082336: Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Official title: Prospective Clinical Performance Evaluation of the In-Vitro Diagnostics Medical Device MaGIA IBC for the CombIned screENing of HIV, Hepatitis B and Hepatitis C
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Combined Point of Care Diagnostic of HIV, HBV and HCV
Keywords: point of care diagnostic
HIV
HCV
HBV
Lead sponsor: MagIA Diagnostics
Sponsor class: INDUSTRY
First posted: 2023-10-13
Enrollment: 252
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prospective, cross-sectional, adaptative study to evaluate the clinical performance of the In-Vitro Diagnostics Medical Device MagIA IBC (a Multiplex Point-of-Care Test for the detection of HIV, HBV and HCV) in detecting anti-HIV antibodies (HIV-Ab), anti-HCV antibodies (HCV-Ab), and HBs antigens (HBs-Ag) in serum, plasma, venous blood and capillary blood. If not prescribed for the patient care, blood drawings, and finger pricks will be performed on the patient for the purpose of the clinical study.

The Study includes a Technical Adjustment Phase (to identify optimized acquisition parameters and to define the decision threshold for the diagnostic) followed by a Validation Phase (to validate the concordance between the matrices and to evaluate the Specificity and the Sensibility of the diagnostics)


Eligibility criteria: Inclusion Criteria:

IC1. A Male or Female aged of at least 18 years

IC2. A person taken care at Hôpital Européen de Marseille and responding to at least one of the following conditions:

* known or suspected having HIV infection
* known or suspected having HBV infection
* known or suspected having or having had HCV infection IC3. A person having given consent to participate the study, IC4. A person covered by a medical insurance.

Exclusion Criteria:

EC1. A person for whom blood sampling would represent a risk, EC2. A person protected by law (minor, under guardianship or curatorship, childbearing, or breastfeeding female, hospitalized without consent, under administrative or judicial supervision)

Primary outcomes:
measure: Performance measurement for the diagnostics of HIV, HBV or HCV
timeFrame: 24 hours
measure: Proportion with positive test result among participants with HIV, HBV or HCV
timeFrame: 24 hours
measure: Proportion with negative index test result among participants without HIV, HBV or HCV
timeFrame: 24 hours
Secondary outcomes:
measure: Concordance of the diagnostic results obtained when it is performed in different matrices : Capillary blood, veinous blood, serum and plasma.
timeFrame: 24 hours
measure: Number of participants with study related adverse events.
timeFrame: 1 day
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Européen de Marseille
Study officials:
References:
Clinical trial NCT02360436: Analysis of the Glutathione Cycle in Children With Rett Syndrome
Official title: EPITRA-14-001: Analysis of the Glutathione Cycle in Children With Rett Syndrome
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rett Syndrome
Keywords: Rett
MeCP2
Glutathione
Cysteine
ROS
Lead sponsor: Edison Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2015-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 2-10 with genetically confirmed diagnosis of Rett syndrome with MeCP2 mutation

Brief summary: Analyis of the Glutathione Cycle in Children with Rett Syndrome

Detailed description: To analyze the levels of glutathione and relevant glutathione metabolites in children with Rett syndrome in an effort to better understand disease pathology and biochemistry.

Eligibility criteria: Inclusion Criteria:

* Age between 2 and 10, inclusive
* Genetically-confirmed diagnosis of Rett syndrome with MeCP2 mutation
* No change in dietary supplements in three months prior to the initial blood draw
* No participation in interventional pharmaceutical clinical trials in prior 12 months

Exclusion Criteria:

* None other than meeting Inclusion criteria

Primary outcomes:
measure: Analysis of changes in levels of glutathione and relevant glutathione metabolites in children with Rett syndrome from baseline to the end of month 6
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Alan Percy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05198336: Immunogenicity of an Inactivated COVID-19 Vaccine
Official title: Immunogenicity of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Population Aged 3-11 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 395
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is an open phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity of the CoronaVac in healthy children aged 3-11 years old.

Detailed description: This study is an open phase 4 clinical trial to evaluate the immunogenicity of an inactivated COVID-19 vaccine(CoronaVac)in healthy children aged 3-11 years old.A total of 400 healthy subjects who have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose will be enrolled, including 200 subjects aged 3-5 years and 200 subjects aged 6-11 years old.All of subjects will be collected 3ml venous blood to evaluate the immunogenicity of the CoronaVac.

Eligibility criteria: Inclusion Criteria:

* Have received two doses of inactivated COVID-19 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd and is currently 28-42 days after the second dose;
* The subjects and/or guardians can understand and voluntarily sign the informed consent form (for subjects aged 8 years, both subjects and guardians need to sign the informed consent form);
* The subjects and their legal guardians voluntarily participate the study and comply with the study procedure to collect 3ml venous blood;
* Proven legal identity.

Exclusion Criteria:

* Haven't received two doses of inactivated COVID-19 vaccine(CoronaVac);
* Have received COVID-19 vaccines from other manufacturers;
* The interval between blood collection and the second dose is less than 28 days or more than 42 days;
* The subjets and their legal guardians can't cooperate to complete 3ml venous blood collection.
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Primary outcomes:
measure: Immunogenicity index-Seropositivity rate of the neutralizing antibody to SARS-CoV-2
timeFrame: Day 28(+14 days) after the second dose of vaccine
measure: Immunogenicity index-GMT of the neutralizing antibody to SARS-CoV-2
timeFrame: Day 28(+14 days) after the second dose of vaccine
Secondary outcomes:
Other outcomes:
Locations:
city: Weihai
country: China
facility: Rushan City Center for Disease Control and Prevention
state: Shandong
Study officials:
affiliation: Shandong Provincial Center for Disease Control and Prevention
name: Qing Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01300936: Trunk Strength Study
Official title: Abdominal Wall Hernias and Abdominal Wall Function: A Quantitative Study of Trunk Strength.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventral/Incisional Hernia Repairs
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who will undergo laparoscopic ventral hernia repair or open repair. People between the ages of 18 to 65 in relative good health.

Brief summary: The purpose of this study is to measure abdominal wall strength both preoperatively and postoperatively in patients undergoing ventral/incisional hernia repairs. The investigators hypothesize that abdominal wall strength is improved in hernia repairs that reapproximate the rectus musculature to the midline. Abdominal wall strength measurements would be obtained utilizing various abdominal strength testing.


Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for hernia repair.

Exclusion Criteria:

* Pregnant females.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Scott Roth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06494436: Microvention AnEurysm & STroke Real-life Data cOllection
Official title: Microvention Aneurysm & Stroke Real-life Data Collection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Aneurysm
Intracranial Aneurysm, Wide Neck Aneurysm, Large Neck Aneurysm Lesion
Aneurysmal Subarachnoid Hemorrhage
Keywords: endovascular treatment
stent
flow diverter
hydrocoil
coil
implantable device
FRED
LVIS
WEB
Lead sponsor: Microvention-Terumo, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 750
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ruptured or unruptured intracranial aneurysms who are treated endovascularly with commercially available MicroVention implant devices at the direction of the treating physician

Brief summary: The MAESTRO-1 registry is a post-market, single-arm, non-interventional, multicenter registry

Detailed description: Electronic platform to collect real-world clinical data, evaluate and periodically report safety and effectiveness of CE approved and commercially available Microvention implant devices used for the endovascular treatment of Intracranial aneurysms.

Eligibility criteria: Inclusion Criteria:

* Patient or legally authorized representative (LAR) is informed of the data collection and gives non-opposition or consent prior to the data collection in accordance with institutional and geographic requirements.
* Patient is treated for a ruptured or unruptured intracranial aneurysm using a commercially available MicroVention implant device as the primary treatment device and the decision to use this device has been made by the treating physician outside the context of the MAESTRO-1 study.

Exclusion Criteria:

* Patient is or is expected to be inaccessible for follow-up.
* Patient is participating or intends to participate in another study that changes the site practice.
* Patient has been previously enrolled into the MAESTRO-1 study.

Primary outcomes:
measure: Proportion of aneurysms with complete occlusion
timeFrame: 18 (±6) months
Secondary outcomes:
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Álvaro Cunqueiro Hospital - University Hospital Complex of Vigo, Department of Radiology
state: Pontevedra
Study officials:
affiliation: University Hospital Vall D'Hebron
name: Alejandro Tomasello, MD
role: STUDY_CHAIR
affiliation: Bonn University Hospital
name: Franziska Dorn, Prof.
role: STUDY_CHAIR
affiliation: Beaumont Hospital
name: Sarah Power, MD
role: STUDY_CHAIR
affiliation: John Paul II Independent Public Specialist Western Hospital
name: Krzysztof Kadziolka, MD
role: STUDY_CHAIR
affiliation: Hôpital Pellegrin, CHU de Bordeaux
name: Gaultier Marnat, MD
role: STUDY_CHAIR
References: