louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01210300: Exploring Taiwanese Womens' Decision-making Regarding Vaginal Birth After Caesarean Section
Official title: Exploring Taiwanese Womens' Decision-making Regarding Vaginal Birth After Caesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caesarean Section
Keywords: caesarean section
vaginal birth after caesarean section
repeat caesarean section
childbirth expectation
childbirth experience
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women

Brief summary: The incidence of caesarean section (CS) has increased globally. Taiwan's statistics report a higher incidence of repeat CS compared to vaginal birth after caesarean (VBAC). This is concerning, as repeat CS are associated with increased maternal morbidity and mortality, and neonatal respiratory problems. VBAC is an approach which reduces the likelihood of such birth complications. However, there is limited information about Taiwanese women's decision regarding VBAC and their participation in decision-making. There is also a gap in literature about information for women about CS and VBAC.

Detailed description: Ajzen's Theory of Planned Behaviour will theoretically underpin the study. A qualitative descriptive design using purposive sampling of 20 Taiwanese pregnant women who have previously had a CS with a live baby will be recruited from Chang Gung Memorial Hospital in Taiwan. In-depth interviews will be carried out in three phases: (1) between 34 weeks to 38 weeks of women's pregnancy; (2) on the third day after childbirth; and (3) at the fourth week after birth, the end of confinement. Boyatzis' Data Driven approach will be adopted to thematically analyze the data.

Eligibility criteria: Inclusion Criteria:

* Have had a previous CS with a live baby
* Currently at 34 to 38 weeks of pregnancy
* Medically eligible for a VBAC
* Have chosen to have a natural birth
* 20 years old and over
* Able to converse in Mandarin and/or Taiwanese

Exclusion Criteria:

* Previous myomectomy
* Previous classical caesarean section
* Two previous caesarean section
* Pregnant with complications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Institute of Technology
Study officials:
affiliation: Department of Nursing, Chang Gung Institute of Technology
name: Mei-Man Chen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02041000: Adipose Derived Cells for Chronic Obstructive Pulmonary Disease
Official title: An Open-label, Non-Randomized, Multi-Center Study to Assess the Safety and Effects of Autologous Adipose-Derived Stromal Cells Delivered Intravenously in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
pulmonary
stem cells
emphysema
lungs
Lead sponsor: Bioheart, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 0
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: The intent of this clinical study is to answer the questions: 1) Is the proposed treatment safe and 2) Is treatment effective in improving the disease pathology of patients with diagnosed with chronic obstructive pulmonary disease (COPD).


Eligibility criteria: Inclusion Criteria:

* A prior diagnosis of moderate or severe COPD
* GOLD III and IV
* Age between 18 and 85 years

Exclusion Criteria:

* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study
* Life expectancy \< 6 months due to concomitant illnesses.
* Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
* Active infectious disease patients known to have tested positive for HIV, HTLV, HBV, HCV, CMV (IgM \> IgG) and/or syphilis. will have an expert consulted as to patient eligibility based on the patient's infectious status
* Any illness which, in the Investigator's judgment, will interfere with the patient's ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results
* Patients on chronic immunosuppressive transplant therapy
* Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or who in the opinion of the investigator are not suitable to participate.
* Severe asthma that would contraindicate surgery
* History of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years.
* Patients with Alpha-1
* Unwilling and/or not able to give written informed consent.

Primary outcomes:
measure: Safety
timeFrame: 6 months
measure: St. George Respiratory
timeFrame: 6 months
Secondary outcomes:
measure: Gold Classification
timeFrame: 6 months
measure: 6 Minute Walk Test
timeFrame: 6 months
Other outcomes:
Locations:
city: Sunrise
country: United States
facility: US Stem Cell Clinic
state: Florida
Study officials:
affiliation: Bioheart
name: Kristin Comella
role: STUDY_DIRECTOR
References:
Clinical trial NCT05814900: Investigation of Mohs Surgical Margins Using Two Photon Microscopy
Official title: Investigation of Mohs Surgical Margins Using Two Photon Microscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Basal Cell Carcinoma
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Rochester Dermatologic Surgery
First posted: 2023-04-18
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to compare the use of two photon fluorescence microscopy for detecting residual basal cell carcinoma during Mohs surgery. The main question it aims to answer is:

• How similar are diagnosis of surgical margins to on two photon fluorescence microscopy compared to frozen section histology

Detailed description: This study is an study of skin cancer that will evaluate the feasibility of two photon fluorescence microscopy (TPFM) to evaluate surgical margins followed by standard of care frozen section analysis (FSA) for confirmation. To protect patients, following TPFM imaging, patients will receive standard of care evaluation using cryosectioned H\&E slides, thus all patients will receive standard of care confirmation following experimental imaging.

Individual excisions from consenting patients will be selected, fluorescently labeled and diagnosed using TPFM. Following imaging, specimens will be cryosectioned as per normal procedure. Following treatment, the results of the TPFM evaluation of each Mohs excisions will be compared to the results from FSA to assess the overall accuracy of TPFM and to determine if TPFM would result in changes to patient care if used without FSA confirmation.

Eligibility criteria: Inclusion Criteria:

* Undergoing treatment for BCC with Mohs surgery at the performance site
* Able to read and understand consent form

Exclusion Criteria:

* None

Primary outcomes:
measure: Agreement between frozen sections and two photon microscopy on Mohs margins
timeFrame: During Mohs surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Victor
country: United States
facility: Rochester Dermatologic Surgery
state: New York
Study officials:
affiliation: University of Rochester
name: Michael G Giacomelli, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ching-Roa VD, Huang CZ, Ibrahim SF, Smoller BR, Giacomelli MG. Real-time Analysis of Skin Biopsy Specimens With 2-Photon Fluorescence Microscopy. JAMA Dermatol. 2022 Oct 1;158(10):1175-1182. doi: 10.1001/jamadermatol.2022.3628.
Clinical trial NCT03390400: Changes in Prostaglandin Levels in Laser Cataract Surgery (LCS) Subject to Laser Prevalence
Official title: Intraindividual Comparison of Prostaglandin E2 (PGE2) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device in Regard to the Sequence of Anterior Capsulotomy and Lens Fragmentation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age Related Cataracts
Keywords: Laser Cataract Surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Bilateral femtosecond-laser assisted cataract surgery will be performed in individuals with age-related cataract. Eyes will be randomized into two groups receiving either anterior capsulotomy before lens fragmentation or vice versa in the contralateral eye. After laser procedure samples of aqueous humor will be collected and when complete all samples will be analysed by ELISA for Prostaglandin.
Primary purpose: TREATMENT

Brief summary: The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery.

Cataract surgery will be performed in subjects who have signed an informed consent form. Aqueous humor will be collected and screening will be performed for Total Prostaglandin and Prostaglandin E2 via en-bloc Enzyme-linked Immunosorbent Assay (ELISA)-Kit.


Eligibility criteria: Inclusion Criteria:

* Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation
* Age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible)
* Preoperative pupil dilation in mydriasis ≥ 6.5 mm

Exclusion Criteria:

* Preceding ocular surgery or trauma
* Recurrent intraocular inflammation of unknown etiology
* Uncontrolled glaucoma
* Uncontrolled systemic or ocular disease
* Blind fellow eye
* Microphthalmus
* Corneal abnormality
* History of uveitis/iritis
* Iris neovascularization
* Pseudoexfoliation
* Proliferative diabetic retinopathy
* Pregnancy
* Lactation
* Females of childbearing age: not included

Primary outcomes:
measure: Total-Prostaglandin and PGE2 level in aqueous humor
timeFrame: 5 minutes after laser procedure (LCS)
Secondary outcomes:
measure: Change in Pupilsize
timeFrame: baseline, immediately after laser, 5 min after laser
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Rupert Menapace, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01580800: National Breast Cancer and Lymphedema Registry
Official title: National Breast Cancer and Lymphedema Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Lymphedema
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-04-19
Enrollment: 549
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: Breast cancer survivors

Brief summary: The purpose of the National Breast Cancer Lymphedema Registry is to collect health information in order to study the lymphedema as a complication of breast cancer treatment. The investigators hope to learn whether early diagnosis will help to prevent lymphedema or, if it does occur, to reduce the severity.

Detailed description: Historically, breast cancer-associated lymphedema has been relatively ignored, with mis-diagnosis, late diagnosis, and failure to treat. The condition has a measurable, substantial impact on patient function and perceived quality of life (QOL). Recent pilot studies suggest that interventions that are designed to facilitate early diagnosis and preventive strategies have a major impact on the incidence and severity of disease burden. This registry is designed to prospectively capture the relevant data to document the impact of preemptive diagnostic and treatment strategies.

Eligibility criteria: Inclusion Criteria:

* Breast cancer survivorship

Exclusion Criteria:

* Age \< 18 years old

Primary outcomes:
measure: Preemptive diagnostic and treatment strategies
timeFrame: Each enrolled patient will be followed for an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Stanley G Rockson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04687800: Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Cataract Surgery
Official title: A Randomized, Clinical Investigation of the Dextenza 0.4mg Intracanalicular Insert Delivery System Used in Conjunction With Cataract Surgery Performed in Combination With Minimally Invasive Glaucoma Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: The Eye Associates
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2020-12-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Open label prospective randomized comparative investigator -initiated study
Primary purpose: TREATMENT

Brief summary: To monitor intraocular pressure in glaucoma patients after cataract surgery preformed in conjunction with minimally invasive glaucoma surgery (MIGS)

Detailed description: The purpose of this study is to monitor glaucoma patients intraocular pressure (IOP) after cataract surgery performed in conjunction with minimally invasive glaucoma surgery. After qualifying for this study, subjects will be randomized in a 1:1 allocation of one of two arms. The purpose of this study is to determine if Dextenza (dexamethasone) 0.4mg intracanalicular insert delivery system, provides a decreased risk of elevated post-operative IOP vs. standard therapy controlled topical steroid Durezol (Difluprednate ophthalmic emulsion) 0.05%

Eligibility criteria: Inclusion Criteria:

* Age 18 or Older
* Mild-to-moderate primary open angle glaucoma and visually significant cataract with plans to undergo clear cornea cataract surgery with Phacoemulsification and implantation of posterior chamber IOL combined with minimally invasive glaucoma surgery ( MIGS) procedure in both eyes.

Exclusion Criteria:

* Use of Topical steroid, systemic steroid or intravitreal steroid implants within last 3 months
* Previous Corneal surgery or pathology
* Active or history of chronic or recurrent inflammatory eye disease in either eye
* Ocular Pain in either eye
* Proliferative diabetic retinopathy in either eye
* Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye.
* Laser or incisional ocular surgery during the study period and 6 months prior in either eye
* Systemic concomitant pain medication management with the pharmacology class of Oxycodone
* Systemic NSAIDS use \>/=750 mg daily
* Clinically significant macular edema
* History of cystoid macular edema in either eye

Primary outcomes:
measure: Mean Intraocular Pressure from Baseline
timeFrame: 30 days - IOP measured at day 1, day 14 and day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: The Eye Associates of Manatee
state: Florida
Study officials:
affiliation: The Eye Associates of Manatee
name: Cathleen M McCabe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06054100: The Effect of Colchicine on Inflammation in ACS Patients
Official title: The Effect of Colchicine on Inflammation in Acute Coronary Syndrome Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
STEMI
Keywords: Colchicine
Inflammation
ACS
STEMI
Atherosclerosis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate whether the anti-inflammatory effect of colchicine is beneficial in ACS patients

Detailed description: This study will evaluate the effect of colchicine on inflammation, cardiac remodeling, and atherosclerotic risk in STEMI patients through the assessment of the IL-1β, sST2, and lipid profile parameters as well as to examine the drug safety and tolerability in these patients.

Eligibility criteria: Inclusion Criteria:

* male or female
* \>18 yrs
* STEMI patients who were successfully treated with PCI.

Exclusion Criteria:

* Pregnant or breast-feeding women or women of childbearing potential.
* Active inflammatory, known malignancy, infectious diseases or current treatment with corticosteroids or anti inflammatory agents.
* Known hypersensitivity to colchicine or current chronic treatment with colchicine.
* Severe renal failure (estimated creatinine clearance \<30ml/min) or hepatic failure (Child Pugh score B or C )
* Cardiac arrest, ventricular fibrillation, cardiogenic shock or previous myocardial infarction.
* Patients using the following agents: Strong CYP3A4 inhibitors (ritonavir, clarithromycin, ketoconazole, voriconazole, itraconazole), intermediate CYP3A4 inhibitors (aprepitant, diltiazem, erythromycin, fluconazole, verapamil), P-gp inhibitor (amiodarone, clarithromycin, erythromycin, azithromycin, ranolazine, verapamil, ketoconazole, itraconazole) and grape fruit juice

Primary outcomes:
measure: Effect of colchicine therapy on sST2 levels in ACS patients
timeFrame: 3 months
Secondary outcomes:
measure: Effect of colchicine therapy on occurrence of ischemic events in ACS patients
timeFrame: 3 months
measure: Change in left ventricular ejection fraction
timeFrame: 3 months
measure: Change in serum levels of IL-1beta
timeFrame: 3 months
measure: Lipid profile parameters and TG/HDL-C ratio
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
affiliation: Faculty of Pharmacy, Ain Shams University
name: Marwa A Ahmed, Phd
role: STUDY_DIRECTOR
affiliation: Faculty of Pharmacy, Ain Shams University
name: Lamia El Wakeel, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT00380900: Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in Healthy
Official title: A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Test Article or Placebo Administered Orally to Healthy and Osteoarthritis Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Osteoarthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerbility of ascending multiple oral doses of AGG-523 in healthy subjects and in subjects with osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Healthy men or women, aged 18 to 40 years and subjects with osteoarthritis of the knee, aged 40 to 75 years.
* Women must be of non-childbearing potential, defined as surgically sterile with documentation of ultrasound.
* Must be nonsmoker or smoke less than 10 cigarettes per day.

Primary outcomes:
measure: Assess the safety of multiple doses of AGG-523 administered to subjects.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00335400: Anesthetic and Dilating Gel for Cataract Surgery
Official title: Comparison of an Anesthetic and Dilating Gel Cocktail Versus the Standard Pre-operative Pharmacologic Regimen for Cataract Surgery on Corneal Anesthesia and Pupil Dilation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2006-06-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To prepare the eye for cataract surgery, drugs must be given to the eye to allow for surgery to take place. Traditionally, dilating drops and drops containing NSAIDs (to control inflammation) are given to the patient well in advance of surgery at repeated time intervals. As well, a gel containing lidocaine is applied to the eye just prior to surgery to anesthetize (reduce pain and feeling) in the area of the eye. Although effective, the procedure is time-consuming and costly for nursing staff. Recently, a few hospitals have reported success in mixing the pupil-dilating and NSAID drops with the lidocaine gel, creating an "anesthetic dilating gel". Although success has been reported, there have been no studies to clearly demonstrate that the "anesthetic dilating gel" is as effective at dilating the pupil and reducing sensitivity of the cornea during surgery than the traditional methods of drops and gel. It is possible that the dilating gel is less effective due to slower diffusion of drugs into the eye. The study will compare the effectiveness of the anesthetic dilating gel with the standard pre-operative pharmacologic regimen for cataract surgery. Stability (maintaining effectiveness over time) and contamination of the study gel will also be assessed. If the dilating gel is shown to be as effective in regards to pupil dilation and corneal anesthesia, while maintaining stability and sterility over time, hospitals can be encouraged to use such a anesthetic dilating gel routinely during pre-operative procedures before cataract surgery.


Eligibility criteria: Inclusion Criteria:

* scheduled for first cataract surgery (i.e., first eye)

Exclusion Criteria:

* previous ocular surgery,
* pseudoexfoliation syndrome,
* diabetes,
* herpetic eye disease,
* posterior synechiae,
* previous uveitis

Primary outcomes:
measure: Pupil dilation
measure: Corneal anesthesia
Secondary outcomes:
measure: Gel stability
measure: Gel sterility
measure: Patient comfort
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
Study officials:
affiliation: Hotel Dieu Hospital, Kingston General Hospital, Queen's University
name: Sherif El-Defrawy, MD PhD FRCSC
role: PRINCIPAL_INVESTIGATOR
References: