louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03156127: A Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet
Official title: A Randomized, Open-label, Single Dose, Two-way Crossover Study to Compare the Pharmacokinetics and Safety/Tolerability of BR-UPS (Ulipristal Acetate) 5 mg Tablet With Inisia (Ulipristal Acetate) 5 mg Tablet in Healthy Female Volunteers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Uterine Myoma
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2017-05-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
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 and Safety / Tolerability of BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in healthy female volunteers

Detailed description: This is a randomized, open-label, single dose, two-way crossover study to compare the pharmacokinetics and safety/tolerability of BR-UPS (Ulipristal acetate) 5 mg tablet with Inisia (Ulipristal acetate) 5 mg tablet in healthy female volunteers

Eligibility criteria: Inclusion Criteria:

* A subject provide written informed consent which he voluntarily confirms willingness to participate in a study, having been informed of the full details of the study and comply with the protocol.
* A Healthy female volunteers, aged 19-45 years
* BMI 18 \~ 27(kg/m2)

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease.
* History of gastrointestinal disease and resection
* History of clinically significant hypersensitivity to study drug, any other drug
* A subject with clinically significant genital bleeding
* Participation in any other study within 3 months
* Positive results for urine β-hCG in screening or lactating women
* A subject is using a method of hormone contraception and a Progesterone intrauterine device

Primary outcomes:
measure: Cmax(Maximum concentration of drug in plasma) of Ulipristal Acetate
timeFrame: 0~120 hours after medication
measure: AUClast(Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration) of Ulipristal Acetate
timeFrame: 0~120 hours after medication
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03542227: Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine
Official title: Study for the Development of Standard Operating Procedures for Anti-HPV Antibody Detection in First-void Urine: the AB-SOP Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papilloma Virus Infection
Keywords: Antibodies
Vaccination
Self-sampling
First-void urine
HPV
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 63
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In total 63 women are included in this trial. During their first two study visits, at day 0 and 7m post-vaccination, participants are asked to collect a first-void urine sample with the Colli-PeeTM device (n=63). During their third visit, the included women are asked to collect a third first-void urine sample with the Colli-PeeTM device (n = 58). Hereafter, a blood sample of 5-10 cc is collected. Following sample collection, women are asked to fill in a questionnaire (n=58).

Brief summary: The aim of the study is to develop and implement robust analytical protocols for first-void urine sample preparation and antibody assays to monitor vaccine induced immunity against HPV (Human Papillomavirus).

Detailed description: Participants of the HPV V503-004 study (Phase III Clinical trial vaccinating (young) adult women in Antwerp, EudraCT NUMBER: 2015-005093-38) will be asked if they are willing to provide two additional urine samples at day 1 and month 7 for biomedical research. Furthermore, they will be contacted again at approximately 3.5 years and asked if they are willing to provide an additional urine sample and a serum sample. At 3.5 years, they will also be asked to fill in a brief questionnaire. The collected urine will be used for the development and optimization of robust analytical protocols for sample preparation and antibody assays.

Eligibility criteria: Inclusion Criteria:

* Participant of the HPV V503-004 study at UA/UZA
* Willing to give informed consent (ICF) to the CEV research team

Primary outcomes:
measure: Concentration of HPV specific IgG (Immunoglobulin G) in FV urine.
timeFrame: Within 6 months after study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: university of Antwerp - centre for the evaluation of vaccination
state: Antwerp
Study officials:
affiliation: Universiteit Antwerpen
name: Pierre Van Damme, Prof, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiteit Antwerpen
name: Ilse De Coster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Wiebren A. A. Tjalma, Prof, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02382627: Choroidal Thickness in Optic Neuropathy
Official title: Choroidal Thickness in Optic Neuropathy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Optic Nerve Disorders
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 patients with optic neuropathy seen in the ophthalmology or neuro-ophthalmology clinics at the University of Colorado will be enrolled in this study.

Brief summary: This study plans to learn more about the thickness of the choroid in patients with optic neuropathy. The choroid is a layer of blood vessels that supplies oxygen and nourishment to the outer layers of the retina. Patients are being asked to be in this research study because they have optic neuropathy and are receiving care at the University of Colorado Hospital.


Eligibility criteria: Inclusion criteria:

* age greater than 18 years,
* diagnosis of optic neuropathy,
* willing and able to sign an informed consent.

Exclusion criteria:

* steroid use within the past 4 weeks,
* inability to cooperate with optical coherence tomography (OCT) testing,
* relevant ocular comorbidities in the affected or unaffected eye, such as

  * glaucoma,
  * uveitis,
  * optic nerve hypoplasia,
  * age related macular degeneration,
  * refractive error greater than 5 spherical diopters.

Primary outcomes:
measure: Difference of the subfoveal and parafoveal choroidal thickness in affected and unaffected eye of the same patient.
timeFrame: 1 time
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: 303-724-6450
name: Jeffrey Bennett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04582227: Using Ambu Aura-i Laryngeal Mask Airway in Cranial Surgery
Official title: The Effect of Using Ambu Aura-i Laryngeal Mask Airway Versus Endotracheal Tube on Emergence Hypertension in Supratentorial Cranial Surgery: A Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension, Malignant
Airway Management
Keywords: Hypertension
airway
Laryngeal Mask Airway
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients aged from 18 to 60 years presented with brain lesions undergoing craniotomies under general anaesthesia in supine position.

Brief summary: the investigators hypothesize that Ambu aura-i LMA can be used safely in patients undergoing craniotomies and are effective in reducing the incidence of emergence hypertension.

Detailed description: In this study the investigators want to assess the safety of using SGA devices in cranial surgery and comparing the effect of these devices with ETT regarding hemodynamics stability throughout the procedure and intracranial tension.

Eligibility criteria: Inclusion Criteria:

1. Study will be conducted on patients undergoing craniotomies under general anaesthesia in supine position.
2. Aged 18 to 60 years.
3. ASA 1 or 2.
4. GCS ≥ 13.

Exclusion Criteria:

1. Patients who are known hypertensive, history of cardiac diseases or chest diseases
2. Patients with risk of aspiration (Obesity with BMI ≥ 40, hiatal hernia, esophageal cancer and previous esophageal surgery).
3. Risk of difficult intubation
4. Extensive intracranial tumours that may affect recovery of patients.

Primary outcomes:
measure: Measure Mean blood pressure
timeFrame: UP TO 1 HOURE
Secondary outcomes:
measure: Measure Mean Heart rate
timeFrame: UP TO 1 HOURE
measure: successful placement of the airway device
timeFrame: UP TO 1 HOURE
measure: incidence of postoperative complication
timeFrame: up to 24 hours
measure: amount of fentanyl
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
affiliation: Cairo University
name: Amr s wahdan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02929927: Estimate the Effect of aPDT on Root Canal Disinfection
Official title: Acess the Clinical Effect of Antimicrobial Photodynamic Therapy (aPDT) on Root Canal Disinfection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Root Canal Disinfection
Keywords: Antimicrobial Photodynamic Therapy
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the clinical effect of traditional root canal disinfection and aPDT on root canal disinfection. And provide the reference for clinical application and experience.

Detailed description: The study of groups:

Group1: Calcium hydroxide-based antibacterial dressing - two session root canal treatment Group2: aPDT - one session root canal treatment Microbiological measurement. Filled with sterile PBS, the root canals were sampled immediately before and after the disinfection procedures.

Eligibility criteria: Inclusion Criteria:

Good general health, without syndromes or chronic systemic diseases; tooth with single root canal; a diagnosis of chronic periapical periodontitis; the lesions of the root tip was less than 6mm; recently (3months)did not take antibiotics.

Exclusion Criteria:

Refused to sign the informed consent document; systemic condition; uncooperative behavior; periodontal-endodontic lesions; allergic to photosensitizer; root apical absorption or destroy; A root canal anatomy of risk factors for the difficulty score ≧ 2

Primary outcomes:
measure: Quantification of bacteria by colony counting
timeFrame: 2 days after the sample taken
Secondary outcomes:
measure: tooth pain
timeFrame: 1 week and 3, 6, 12, 24 months after treatment
measure: change of the lesion
timeFrame: 3, 6, 12, 24 months after treatment
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: School and Hospital of stomatology,Fujian Medical University
state: Fujian
Study officials:
affiliation: School and Hospital of stomatology,Fujian Medical University
name: Xiaojing Huang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00994227: Clinicopathologic Findings for Macular Disease
Official title: Clinicopathologic Findings for Macular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Disease
Keywords: electron microscopy
internal limiting membrane
macular disease
optical coherence tomography
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: this study is to analyze and compare the ultrastructure of the retinal and vitreous plane of the epiretinal membrane and internal limiting membrane removed during macular surgery and to evaluate relation between the ultrastructure of the epiretinal membrane and internal limiting membrane and surgical outcomes.

Detailed description: prospective, interventional study and includes patients who underwent vitrectomy,peeling of an epiretinal membrane and internal limiting membrane excision with or without intraoperative intraocular ICG injection.

Excised specimens were placed on a Millipore filter, fixed in a paraformaldehyde solution, and examined by light and transmission electron microscopy. Ultrathin sections were stained with uranyl acetate-lead citrate and inspected in a Zeiss EM electron microscope. The assessment was done in a blinded, masked fashion so that the clinicians who reviewed the histologic specimens

Eligibility criteria: Inclusion Criteria:

* patients who underwent vitrectomy,peeling of an idiopathic MEM and ILM excision with or without intraoperative intraocular ICG injectio

Exclusion Criteria:

* the presence of macular hole or lamellar macular hole previous vitreoretinal surgery the presence of any other macular pathologic features potentially interfering with histologic results (such as diabetic retinopathy or age-related macular degeneration).

Primary outcomes:
measure: spectral domain optical coherence tomography
timeFrame: baseline, 1week, 1month, 3 month
measure: best corrected visual acuity
timeFrame: baseline, 1 month, 3 months
Secondary outcomes:
measure: electron microscopy finding of internal limiting membrane
timeFrame: during operation
measure: visual field
timeFrame: baseline, postoperative 1 months, 3 months
measure: preferential hyperacuity perimeter
timeFrame: baseline, postoperative 1 months, 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: JiWon Lim
Study officials:
References:
citation: Lim JW, Kim HK, Cho DY. Macular function and ultrastructure of the internal limiting membrane removed during surgery for idiopathic epiretinal membrane. Clin Exp Ophthalmol. 2011 Jan;39(1):9-14. doi: 10.1111/j.1442-9071.2010.02377.x.
Clinical trial NCT02656927: Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury (SCI)
Official title: Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Yoga
Psychological Flexibility
Mindfulness
Pain
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled study is to evaluate psychological variables, mindfulness, and pain in the context of a specialized yoga program for individuals with SCI. Participants will be randomized to either a wait-list control condition or to a specialized yoga program condition.


Eligibility criteria: Inclusion Criteria:

1. have an SCI or a spinal related condition,
2. be 18 years of age or older,
3. be able to speak and read English,
4. commit to two weekly, one hour yoga classes for six weeks,
5. be referred from a clinician on the inter-disciplinary team,
6. have a sitting tolerance of one hour,
7. be able to participate in gentle physical activity in that time,
8. be aware of and understand his/her health contraindications (is able to practice safely),
9. provide a note from their physician indicating that it is safe for them to participate in a physical activity intervention, such as yoga.

Exclusion Criteria:

1. are not medically stable,
2. have pre-existing medical contraindications,
3. have cognitive limitations or language comprehension issues that would impact participation (determined by care team),
4. have had a regular yoga practice in the last six months.

Primary outcomes:
measure: Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Change from Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from Baseline, 6 weeks, 12 weeks
measure: General Self-Efficacy Scale (GSES)
timeFrame: Change from Baseline, 6 weeks, 12 weeks
measure: Post-Traumatic Growth Inventory-SF (PTGI-SF)
timeFrame: Change from Baseline, 6 weeks, 12 weeks
measure: Connor-Davidson Resilience Scale-10 Item (CS-RISC-10)
timeFrame: Change from Baseline, 6 weeks, 12 weeks
measure: Five Facet Mindfulness Questionnaire-SF (FFMQ-SF)
timeFrame: Change from Baseline, 6 weeks, 12 weeks
measure: Self-Compassion Scale-SF (SCS-SF)
timeFrame: Change from Baseline, 6 weeks, 12 weeks
measure: Brief Pain Inventory-SF (BPI-SF)
timeFrame: Change from Baseline, 6 weeks, 12 weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Change from Baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University Health Network, University of Toronto
name: Sander L. Hitzig, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: York University
name: Kathryn J. Curtis, MA
role: STUDY_DIRECTOR
References:
Clinical trial NCT04007627: Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography
Official title: Dose Reduction and Acquisition Parameters Optimization for PEDiatric Digital Radiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pediatric Radiology
Keywords: ALADA
IQ
Pediatric Radiology
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric population

Brief summary: To reduce "As Low As Diagnostically Acceptable" (ALADA) the X ray exposure of pediatric radiology by using a new post treatment processing algorithm (S-Vue, Samsung table GC85A).

Detailed description: The study will investigate the minimum dose required to obtain acceptable image quality for different pediatric localizations (abdomen, thorax, pelvis, spine) by using a simulation tool of different dose levels. Three different radiologists blinded to the simulated dose level will score the images independently by using a dedicated image quality scoring grid.

Eligibility criteria: Inclusion Criteria:

* Children aged under 18 years and under 80 kg;
* Prior radiography perfomed within 6 months before the beginning of the study.

Exclusion Criteria:

- Refusal of parents to participate to the study.

Primary outcomes:
measure: Assesment of image quality by radiologists blinded to the simulated dose level
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Service de Radiologie Pédiatrique, C.H.U. Bicêtre, APHP
state: Île De France
Study officials:
affiliation: Faculté de Médecine Paris Sud, Service de Radiologie Pédiatrique, C.H.U. Bicêtre
name: Catherine Adamsbaum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Service de Radiologie Pédiatrique, C.H.U. Bicêtre
name: Joëlle Feghali, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT00159627: Dose Escalation Study of KW-3902 on Diuresis in Subjects With Congestive Heart Failure (CHF).
Official title: A Randomized, Double-Blind, Placebo Controlled, Dose Escalation Study of the Effects of KW-3902 on Diuresis in Patients With Congestive Heart Failure (CHF) Refractory to High Dose Diuretic Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure, Congestive
Keywords: heart failure, congestive
diuretic
Lead sponsor: NovaCardia, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2005-09-12
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of KW-3902IV compared to placebo and to determine the diuretic effect of KW-3902IV compared to placebo in patients hospitalized with volume overload due to CHF who are refractory to high dose diuretic therapy.


Eligibility criteria: Inclusion Criteria:

* History of CHF for greater than 3 months,
* Receiving oral/IV diuretic therapy
* Hospitalized for therapy for HF and edema that has not responded to diuretic therapy.
* Signs and symptoms of ongoing volume overload

Exclusion Criteria:

* Myocardial infarction in past 14 days
* Clinical evidence of acute coronary syndrome causing worsening of HF,
* Pregnant or breast-feeding,
* Severe, uncorrected primary valvular disease, constrictive pericarditis, restrictive or hypertrophic cardiomyopathy,
* Automated implanted cardiac defibrillator (AICD) or synchronization device implanted within the preceding 7 days,
* Require mechanical ventilation, ultrafiltration, or hemodialysis at the time of enrollment,
* Deterioration due to an acute or superimposed condition requiring therapy other than diuretics
* Symptomatic ventricular tachycardia,
* Severe concomitant primary hepatic disease,
* Severe pulmonary disease,
* Any other concomitant life-threatening disease,
* CVA in the preceding 6 months,
* Hypotension,
* Participated in another clinical trial within 30 days,
* Acute contrast nephropathy,
* Admitted for heart transplant surgery or have had a heart transplant.

Primary outcomes:
measure: Change in urine volume from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Sarasota
country: United States
state: Florida
city: Baltimore
country: United States
state: Maryland
city: Ayer
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Newark
country: United States
state: New Jersey
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Tullahoma
country: United States
state: Tennessee
Study officials:
References: