louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03275142: Icare Tonometry Effects on Keratometry Readings, Topography Readings, and Corneal Staining
Official title: Icare Tonometry Effects on Keratometry Readings, Topography Readings, and Corneal Staining
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluation of Corneal Stability Post-applanation
Lead sponsor: Comprehensive EyeCare of Central Ohio
Sponsor class: OTHER
Collaborators: name: Icare USA
First posted: 2017-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: To demonstrate that the Icare tonometer does not alter Keratometry readings, topography, or corneal staining. This would therefore allow intraocular pressure (IOP) testing to be done at any time during an exam, without affecting other testing. This may improve office-flow and spare patients from returning for another exam for additional testing.

Detailed description: Four sites will enroll fifteen subjects each. Individual sites will identify their patients using numbers 1-15. The link to their identity will be stored in their records but will not be forwarded to other investigators. Only the originating site will have the identity log linking the participants to the study records. All patients over age 18 in the patient clinic are eligible for inclusion. Staff members and employees may also participate. Following informed consent, each patient will undergo visual acuity testing, keratometry readings by IOL Master, topography testing by Pentacam, and corneal staining evaluation with fluorescein using the Oxford scoring scale on both eyes. Once all three tests are completed, the Icare tonometer will be used to check the intraocular pressure (IOP) on one eye only. The investigator will be masked as to which eye will undergo applanation. Immediately following the IOP check, corneal staining, topography and keratometry readings will be repeated. The unchecked eye will serve as a control as there may be mild variations in topography or IOL Master even without applanation. Following the repeated testing, the control eye will also undergo applanation to document IOP.

Eligibility criteria: Inclusion Criteria:

* 18 years of age

Exclusion Criteria:

* Under 18 years of age

Primary outcomes:
measure: Demonstration of corneal stability post-applanation with the Icare tonometer.
timeFrame: 30 minutes
Secondary outcomes:
measure: Average keratometric measurement differences pre and post- tonometry with ICare Tonometer.
timeFrame: 10 minutes
measure: Total cylinder differences pre and post-tonometry with ICare tonometer.
timeFrame: 10 minutes
measure: Difference in corneal staining pre and post-tonometry with ICare Tonometer.
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Westerville
country: United States
facility: Comprehensive EyeCare of Central Ohio
state: Ohio
Study officials:
affiliation: Comprehensive EyeCare of Central Ohio
name: Kenneth A Beckman, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03965442: Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome
Official title: Effects of Intraoperative Esmolol on Post-mastectomy Pain Syndrome: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post-mastectomy Pain Syndrome
Keywords: Post-mastectomy Pain Syndrome
Esmolol
Perioperative
Lead sponsor: Hospital de Base
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously submitted to the study Analgesic Effect of Intraoperative Esmolol in Mastectomies: a randomized placebo controlled trial, will be submitted to a questionnaire of adapted from DNS4.

Brief summary: Chronic postoperative pain is an entity that is usually neglected by anesthetists, but several studies show that the choice of anesthetic technique may interfere with this prevalence. Esmolol is a selective beta-blocker of ultra fast duration that has been studied as a perioperative venous adjuvant with antihyperalgesic and opioid sparing action. The investigators ventured the possibility of this anti-hyperalgesic effect attenuating the chronic pain syndrome post-mastectomy.


Eligibility criteria: Inclusion Criteria:

- Patients previously submitted to the study Analgesic Effect of Intraoperative Esmolol in Mastectomies: a randomized placebo controlled trial

Exclusion Criteria:

* Patient aged less than 18 years and over 65 years;
* Patients who refuse to participate in the study;
* Patients with pulmonary disease;
* Patients with cardiac, renal or hepatic disease;
* Use of psychoactive drug;
* Patients with sinus bradycardia;
* Pregnant women;
* Patients with allergy to dipyrone, morphine;
* Patients with chronic pain prior to the surgical procedure;
* Patients with neurological disorders;
* Patients undergoing surgical resurfacing

Primary outcomes:
measure: Incidence of post-mastectomy chronic pain syndrome
timeFrame: Through study completion, an average of 6 to 9 month
Secondary outcomes:
measure: Assess the intensity of pain: Pain Scores on the Visual Analog Scale
timeFrame: Through study completion, an average of 6 to 9 month
measure: Identify possible risk factors
timeFrame: Through study completion, an average of 6 to 9 month
measure: Stratify the possible types of pain
timeFrame: Through study completion, an average of 6 to 9 month
Other outcomes:
Locations:
city: Brasilia
country: Brazil
facility: Hospital de Base do Distrito Federal
state: DF
Study officials:
affiliation: Hospital de Base do Distrito Federal
name: Fabricio T Mendonça, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568.
Clinical trial NCT02504242: A Multi-center, Comparative Clinical Trial to Evaluate the Efficacy and Safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody Fusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Transforaminal Lumbar Interbody Fusion
Lead sponsor: BioAlpha Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-21
Enrollment: 128
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Subject-Assessor Blind, Multi-center, Comparative Clinical Trial to evaluate the efficacy and safety of Inject BMP in Patients Undergoing Transforaminal Lumbar Interbody Fusion.


Eligibility criteria: Inclusion Criteria:

The subject needs the infusion between the first lumbar vertebrato and the first ilium from those who require posterior spinal instrumentation and interbody fusion for the following reasons,

* Spinal stenosis
* Spinal disc herniation requiring broad laminectomy
* Spondylolisthesis or spondylolysis
* Recurrent herniated disc

Exclusion Criteria:

* Patients with BMD T-score \< -3.0
* Women who are pregnant or plan to be pregnant within study period

Primary outcomes:
measure: Bone Fusion With CT and Dynamic radiographs(X-ray)(post operative 48 weeks)
timeFrame: at 48 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00723242: The Role of Dendritic Cells in Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Hepatitis C Infection
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2008-07-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: BASIC_SCIENCE

Brief summary: The role of the dendritic cells, the most potent antigen presenting cells, in the establishment of chronic hepatitis C is not established. The study aims to define whether the dendritic cells are affected by the hepatitis C virus and whether that bears an impact on the antiviral immune response they generate. The hypothesis is explored by investigating a group of patients prior to and after the initiation of standard treatment for hepatitis C with pegylated Interferon and Ribavirin.


Eligibility criteria: Inclusion Criteria:

* anti-HCV positive
* HCV RNA positive

Exclusion Criteria:

* contraindications for antiviral treatment
* concurrent chronic viral infections

Primary outcomes:
measure: Basic science research (immunology of hepatitis C)in hepatitis c patients receiving established, standard antiviral treatment (pegylated Interferon+Ribavirin)
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College Hospital
Study officials:
References:
Clinical trial NCT03537742: Cardiac Allograft Vasculopathy Inhibition with Alirocumab
Official title: PCSK9 Inhibition After Heart Transplantation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Vasculopathy
Keywords: Heart Transplant
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-05-25
Enrollment: 120
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 focus of this study is to test the safety and efficacy of the PCSK9 inhibitor, alirocumab when administered early after heart transplantation (HT).The main objective of this project is to test the safety and impact on cardiac allograft vasculopathy (CAV) of alirocumab when given early after HT.


Eligibility criteria: Inclusion Criteria:

* Heart Transplant recipient

Exclusion Criteria:

* impaired liver function

Primary outcomes:
measure: Change in volume of plaque at 1 year post study drug start post heart transplant
timeFrame: Baseline and one year
Secondary outcomes:
measure: Change in LDL-C
timeFrame: Baseline, 3, 6 and 12 months
measure: Change in lipoprotein (a)
timeFrame: Baseline, 3, 6 and 12
measure: Change in apolipoprotein B
timeFrame: Baseline, 3, 6 and 12
measure: Percent change in coronary vessel size by fractional flow reserve
timeFrame: baseline and one year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: William F Fearon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06569342: Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB)
Official title: Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB): a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Incontinence, Daytime Urinary
Incontinence, Nighttime Urinary
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 43
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children refractory to standard treatment for OAB and incontinence.

Brief summary: A non-intervention cohort study on the use of Botulinum Neurotoxin Type A (BoNT-A) in Paediatric Non-neurogenic Therapy Resistant Overactive Bladder (OAB). Primary endpoint was the reduction of urinary incontinence.

Detailed description: The investigators wanted to cunduct an analysis of children with urinary incontinence who received intradetrusor injection of BoNT-A in the period 01.01.2016 to 31.12.2020 at their centre. All patients were refractory to standard urotherapy, anticholinergics, mirabegron and combination of treatments. Patients with neurogenic bladder were excluded.

Primary endpoints were the effect on the frequency of urinary incontinence episodes. Secondary endpoints included urodynamic parameters and uroflow characteristics in relation to side effects and response to treatment.

Eligibility criteria: Inclusion Criteria:

* OAB
* Intradetrusor BoNT-A

Exclusion Criteria:

* Neurogenic OAB

Primary outcomes:
measure: Incontinence episodes
timeFrame: 1 month after treatment until request for additional treatment (up to 12 months)
Secondary outcomes:
measure: Response
timeFrame: 1 month after treatment until request for additional treatment (up to 12 months)
measure: Side effects
timeFrame: 1 month after treatment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospiral
state: Region Midt
Study officials:
References:
Clinical trial NCT00606242: Dose Response Effects of Inhaled Fluticasone on Airway Effects of Hypertonic-saline in Asthma
Official title: A Randomized Double Blind Study of the Dose Response Effects of Fluticasone Propionate on Hypertonic-saline Induced Bronchoconstriction in Asthmatic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: GlaxoSmithKline
First posted: 2008-02-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the effect of a inhaled corticosteroid (fluticasone or "Flovent") on airway narrowing induced by hypertonic saline (salty water). The study hypothesis is that fluticasone will be more effective in preventing saline-induced airway narrowing than methacholine-induced narrowing.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of asthma

Exclusion Criteria:

* Habitual cigarette smoking

Primary outcomes:
measure: FEV1
timeFrame: Measured every 2 weeks
Secondary outcomes:
measure: PC20 methacholine
timeFrame: Measured every 2 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References:
Clinical trial NCT02253342: Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects
Official title: A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intrapulmonary Pharmacokinetics of WCK 2349
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
Collaborators: name: Clinartis
First posted: 2014-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy adult males or females, 18 to 55 years of age (both inclusive) at the time of screening.
* Medical history without any major pathology as judged by the Principal Investigator.

Exclusion Criteria:

* History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Positive urine drug/alcohol testing at screening or confinement.
* Positive testing for HIV, Hepatitis B or Hepatitis C.
* History or presence of alcohol or drug abuse within the 2 years prior to screening.
* Excessive intake of alcohol, defined as an average daily intake of greater than three units, or an average weekly intake of greater than 21 units (one unit is equivalent to 1 can or bottle (12 oz) of beer, or 1 measure (1.5 oz) of spirits, or 1 glass (5 oz) of wine) in the last 6 months prior to screening.
* Known hypersensitivity to quinolones/fluoroquinolones.
* History of allergic or other serious adverse reactions to benzodiazepines or lidocaine.

Primary outcomes:
measure: Concentrations of levonadifloxacin in WCK 2349 Epithelial lining fluid (ELF) and alveolar macrophage (AM)
timeFrame: 5 days
Secondary outcomes:
measure: Steady-state plasma pharmacokinetics of levonadifloxacin
timeFrame: 5 days
measure: Safety and tolerability parameters-number of adverse event , change in clinical laboratory tests, ECG readings, change in physical examination and vital sign
timeFrame: 14 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pulmonary Associates, 1112 E. McDowell Rd.
state: Arizona
Study officials:
affiliation: Pulmonary Associates, PA
name: Mark H Gotfried, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodvold KA, Gotfried MH, Chugh R, Gupta M, Yeole R, Patel A, Bhatia A. Intrapulmonary Pharmacokinetics of Levonadifloxacin following Oral Administration of Alalevonadifloxacin to Healthy Adult Subjects. Antimicrob Agents Chemother. 2018 Feb 23;62(3):e02297-17. doi: 10.1128/AAC.02297-17. Print 2018 Mar.
Clinical trial NCT03344042: Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour
Official title: Effect of Epidural Opioid Administered in the First A Period on the Progress of Labour
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia, Epidural
Opioid
Labor Pain
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Epidural anesthesia is used to relieve labour pain which helps reduce labour stress, increase comfort and improve cooperation with medical personnel. Administering opioid into the epidural space before cervical dilation of 4cm in the primigravida or 3cm in the multiparous can effectively reduce the pain levels with no effect on the labour progress. The aim of the study is to compare different opioids administered in this early labour stage.


Eligibility criteria: Inclusion Criteria:

* parturient in labour without cervical dilation and regular uterine contractions

Exclusion Criteria:

* no consent
* known allergy to administered opioid
* contraindications to epidural analgesia
* coagulopathies including platelet count of less than 100,000
* spine surgery in past

Primary outcomes:
measure: Pain intensity according to Numerical Rating Scale (NRS)
timeFrame: up to 24 hours
Secondary outcomes:
measure: Fetal heart rate
timeFrame: up to 24 hours
measure: Blood pressure parturient
timeFrame: up to 24 hours
measure: Heart rate of parturient
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Uniwersyteckie Centrum Zdrowia Kobiety i Noworodka, WUM
state: Mazowieckie
Study officials:
References:
Clinical trial NCT05529342: Long-term Follow-up of Study Participant Treated With Lentiviral-Based Genetically Modified Autologous Cell Product ,AGT103-T
Official title: A Long-Term Follow-Up Study of Participants Treated With the Lentiviral-Based Genetically Modified, Autologous Cell Product, AGT103-T
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: HIV
Keywords: Long term follow-up
Genetically modified CD4 T cells
Gene Therapy
Lentivirus vector
Lead sponsor: American Gene Technologies International Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-07
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject who received the investigational product AGT103-T in the AGT-HC168 clinical trial

Brief summary: Long-term follow-up of study subjects who received AGT103-T product in HIV study. The AGT103-T is genetically modified cells that resist infection with HIV causing a depletion of HIV in HIV-infected study participants.

Detailed description: The primary objective of this study is to monitor study participant who receive the genetically modified gag specific CD4 T cells for the long term adverse event, evaluate sustained impact on immunity and the persistence of vector modified CD4 T cells.

Eligibility criteria: Inclusion Criteria:

1. Received the investigational product, AGT103-T, in the AGT-sponsored AGT-HC168 clinical trial
2. Provided written informed consent, signed and dated by the study participant in the long-term follow-up study

Exclusion Criteria:

1. Did not receive the investigational product, AGT103-T

Primary outcomes:
measure: Assess the incidence of delayed adverse events (AE) to gene therapy
timeFrame: 1year to 15years post infusion
Secondary outcomes:
measure: The persistence and the immunity impact of the vector-modified T cells
timeFrame: 1year to 15 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
city: Washington
country: United States
facility: Washington Health Institute
state: District of Columbia
Study officials:
References: