louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03858426: Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis
Official title: Prospective Multicenter Nationwide Registry of Children With Eosinophilic Esophagitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophilic Esophagitis; PPIs, children, elimination diet, topical steroids
Lead sponsor: Sociedad Espanola de Gastroenterologia, Hepatologia y Nutricion Pediatrica
Sponsor class: OTHER
First posted: 2019-02-28
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis according to the recent European guidelines

Brief summary: 1. Registry of demographic, clinical, endoscopic and histological data at baseline.
2. Registry of patients treated with PPI:

   * Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
   * Clinical, endoscopic and histological response at 6 and 12 months weeks of maintenance treatment
3. Registry of patients treated with two foods elimination diet:

   * Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
   * Identification of food trigger: milk, gluten or milk and gluten
   * Clinical, endoscopic and histological response at one year elimination of food trigger
   * Registry of adverse events
4. Registry of patients treated with swallowed steroids (budesonide or fluticasone):

   * Clinical, endoscopic and histological response at 8-12 weeks of induction treatment
   * Clinical, endoscopic and histological response at 6 months of maintenance steroid treatment
   * Registry of adverse events


Eligibility criteria: Inclusion Criteria:

* Children from 1 month to 18 years with a new diagnosis of eosinophilic esophagitis (EoE) according to the recent European guidelines (symptoms of esophageal dysfunction + eosinophilic infiltrate of the esophagus \> 15 eos / CGA)
* And that they need to start treatment with any of the following options: PPI, diet excluding cow's milk and gluten, or swallowed corticosteroids .

Exclusion Criteria:

* Presence of pathological eosinophilia at the gastric or duodenal level (eosinophilic gastroenteritis)
* Simultaneous treatment with more than one treatment modality (PPI, empirical elimination diet, swallowed corticosteroids).

Primary outcomes:
measure: Complete histological remission
timeFrame: 12 weeks
Secondary outcomes:
measure: Partial histological remission
timeFrame: 12 weeks
measure: Clinical remission
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
Study officials:
References:
Clinical trial NCT03738826: Reducing Disparities in Medication Adherence in SLE
Official title: Reducing Disparities in Medication Adherence of Patients With Systemic Lupus Erythematosus (SLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: medication adherence
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: National Institutes of Health (NIH)
First posted: 2018-11-13
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot study to assess the feasibility of using Surescripts refill data during the clinical encounter to improve medication adherence in patients with systemic lupus erythematosus


Eligibility criteria: Inclusion Criteria

- All followup patients seen at the Duke Lupus clinic

Exclusion Criteria

* Patients not seen at the Duke Lupus Clinic
* New patients seen for the first time at the Duke Lupus Clinic
* Patients who are not prescribed any lupus medications

Primary outcomes:
measure: Feasibility as Measured by Number of Participants With EMR (Electronic Medical Record) Documentation of Adherence
timeFrame: 12 weeks
measure: Acceptability as Measured by Provider Survey
timeFrame: 12 weeks
Secondary outcomes:
measure: Medication Adherence as Determined by Self Report
timeFrame: 12 weeks
measure: Percentage of Adherent Participants as Determined by Medication Possession Ratio (MPR)
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Kai Sun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01683526: Safety and Efficacy of Endotracheal Intubation Using Glidescope Video-Laryngoscope
Official title: Safety and Efficacy of Endotracheal Intubation by Pulmonary Critical Care Physicians in Critically-Ill Patients Using Glidescope Video-Laryngoscope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Failure
Keywords: Urgent endotrachel intubation
Direct laryngoscopy
Video laryngoscopy
Glidescope
Critical Care
Lead sponsor: Beth Israel Medical Center
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 117
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 safety and efficacy of a video-laryngoscope as a primary intubation tool in urgent endotracheal intubation of critically-ill patients has not been well-described in the literature. This study will answer whether using a VL will impact on the efficacy and safety of intubation compared with a traditional direct laryngoscopy.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing urgent endotracheal intubation by a pulmonary critical care medicine physician

Exclusion Criteria:

* Difficult airway
* Oxygen saturation \< 92% despite adequate mask ventilation

Primary outcomes:
measure: First Pass Success Rate
timeFrame: From begining of intubation to verification. Less then 5 minutes approximatly
Secondary outcomes:
measure: Severe Desaturation
timeFrame: For 10 minutes post intubation
measure: Hypotension
timeFrame: For 10 minutes post intubation
measure: Cardiac Arrest
timeFrame: For 1 hour post intubation
measure: Complications of Intubation
timeFrame: For 10 minutes post intubation
Other outcomes:
Locations:
city: New York
country: United States
facility: Beth Isreal Medical Center
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Michael Silverberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06359626: Bioequivalence Study Between YHP2205 and YHR2401 in Healthy Volunteers
Official title: An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate Bioequivalence Between YHP2205 and YHR2401 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
Bioequivalence
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: two-way crossover
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers

Detailed description: 60 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "YHP2205" and "comparator" by cross-over design on day 1, 8

Subjects in group 2 will be administered "comparator" and "YHP2205" by cross-over design on day 1, 8.

Eligibility criteria: Inclusion Criteria:

* Those who are 19 years old or older at the screening visit
* Those whose weight is \> 60kg and their body mass index (BMI) shall be between 18.0 kg/m2 and 30.0 kg/m2
* Those without clinically significant congenital or chronic diseases at the screening visit and without any pathological symptom or opinion after an internal medicine examination
* Those who express their voluntary consent to participate in the trial by signing a written consent

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
* Others who are judged ineligible to participate in the trial by the principal investigator.
* Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.

Primary outcomes:
measure: Area under the plasma drug concentration-time curve [AUCt]
timeFrame: 0-36 hours
measure: Maximum plasma concentration [Cmax]
timeFrame: 0-36 hours
Secondary outcomes:
measure: Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
timeFrame: 0-36 hours
measure: Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
timeFrame: 0-36 hours
measure: Time of peak concentration [Tmax]
timeFrame: 0-36 hours
measure: Terminal phase of half-life [t1/2]
timeFrame: 0-36 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Bumin Hospital
Study officials:
affiliation: Bumin Hospital
name: Taegon Hong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00570726: Treatment of Failing Blebs With Ranibizumab
Official title: Effect of Needle Bleb Revision With Ranibizumab as a Primary Intervention in a Failing Bleb Following Trabeculectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glaucoma, Open-Angle
Failing Bleb Following Trabeculectomy
Lead sponsor: The New York Eye & Ear Infirmary
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-12-11
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the efficacy and safety in the use of Ranibizumab, an effective vascular endothelial growth factor (VGEF) inhibitor, in treating patients with a failing bleb, characterized by increased fibrosis and vascularization of the conjuctiva, following trabeculectomy. Six subjects from one site will be enrolled in this study.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age \> 40 years
* Patients with Open-angle Glaucoma who have had trabeculectomy
* Patients determined to have failing bleb with presence of superficial bleb vascularity and IOP increase on 3 successive visits without topical medication
* Patients whose intraocular pressure (IOP) is above goal IOP after suture lysis and digital compression have been attempted

Exclusion Criteria:

* Pregnancy (positive pregnancy test) or lactation.
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
* Current infection or inflammation in either eye
* Any abnormality preventing reliable applanation tonometry in either eye
* Other non-glaucomatous disease affecting visual field, (pituitary lesions, demyelinating disease, congenital optic nerve anomaly, prior retinal and optic nerve vascular occlusive disease, retinal dystrophy and degeneration, diabetes and HIV and AIDS infection)
* Strabismus, nystagmus, monocular patient
* Prior enrollment in the study
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Glaucoma Associates of New York
state: New York
Study officials:
affiliation: Robert Ritch, MD, LLC.
name: Jeffrey Liebmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04850326: Clinical Study to Evaluate the Short Time Efficacy of AP Green Tea Extract Affer High Fat, High Carbohydrate Diet
Official title: A Randomized, Cross-Over Clinical Study to Evaluate the Acute Efficacy of AP Green Tea Extract After a Meal Composed of High-Fat/High-Carbohydrate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose, High
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this clinical trial is to evaluate the short term effects of single dose AP green tea extracts in subjects with BMI (\< 30 kg/m2) and fasting glucose level of \> 100 mg/dL after high-fat/high-carbohydrate meal.


Eligibility criteria: Inclusion Criteria:

* Subjects aged 19 years or over
* BMI \< 30 kg/m2
* Fasting glucose level \> 100 mg/dL (who is not under medication)
* Subjects who voluntarily decide to participate in this clinical study and sign the informed consent form on their own or through their representatives

Exclusion Criteria:

* At the screening visit, subjects who were diagnosed with obesity, diabetes, dyslipidemia and undergoing medication
* Subjects who were diagnosed with ventricular associated disease, unstable and uncontrolled chronic medical disease, hyper/hypothyroidism, or active malignant tumor and undergoing medication within 4 weeks prior to the first administration of the investigational product
* Subjects who have renal failure, acute or chronic hepatitis or known liver cirrhosis
* In addition to the above, subjects who are determined to be ineligible to participate in the clinical study according to the investigator's medical opinion

Primary outcomes:
measure: Change of Blood glucose level
timeFrame: 0 - 300 minute
measure: Change of Insulin level
timeFrame: 0 - 300 minute
measure: Change of Triglyceride level
timeFrame: 0 - 300 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KangBuk Samsung Medical Center
Study officials:
References:
Clinical trial NCT02479126: Interstitial Lung Diseases in the Veterans Administration
Official title: Interstitial Lung Diseases in the Veterans Administration Health System - A Retrospective Description of Patient Characteristics, Management, and Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Lung Disease
Keywords: Interstitial Lung Disease
Idiopathic Pulmonary Fibrosis
Electronic Health Records
Computed Tomography
Mortality
Hospitalization
Acute care visits
Anti-inflammatory drug therapies
Lead sponsor: Durham VA Medical Center
Sponsor class: FED
Collaborators: name: Durham VA Medical Center
name: Boehringer Ingelheim
First posted: 2015-06-24
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults with encounters at any VISN6 healthcare facility during specified time period

Brief summary: The primary objective of this research project is to describe the characteristics, diagnosis, management, and outcomes of patients with Interstitial Lung Disease (ILD) who received care at the Veteran's Administration Veterans Integrated Service Network (VISN) 6 Mid-Atlantic Health Care Network (VISN6) (includes North Carolina, Virginia and West Virginia) for up to 5 years.


Eligibility criteria: Inclusion Criteria:

* Interstitial Lung Disease (ILD) ICD-9 code diagnosis 515.0 or 516.3

Exclusion Criteria:

* Inadequate documentation of patient receiving care for ILD in the health records

Primary outcomes:
measure: Prevalence of Interstitial Lung Disease in the VISN6 Veterans Administration Patient Population
timeFrame: up to 5 years
measure: Prevalence of Idiopathic Pulmonary Fibrosis in the VISN6 Veterans Administration Patient Population
timeFrame: up to 5 years
Secondary outcomes:
measure: Accuracy of ICD-9 Codes for diagnosis of Interstitial Lung Disease
timeFrame: up to 5 years
measure: Frequency of ICD-9 code diagnosis of Interstitial Lung Disease and clinic consultation with a pulmonary provider
timeFrame: up to 5 years
measure: Prevalence of Co-morbid Diabetes Mellitus with Interstitial Lung Disease
timeFrame: up to five years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Department of Medicine and Durham VA Medical Center
name: Robert M Tighe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01322126: Comparison of Safety And Efficacy of Neuraxial Anesthesia, Palpation Versus Ultrasound
Official title: Comparison of Safety And Efficacy of Neyraxial Anesthesia,Palpation Versus Ultrasound
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Regional Anesthesia
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether use of the ultrasound to locate the epidural space and assist with performing neuraxial anesthesia will decrease numbers of the attempts required for successful placement of epidural catheter.

Detailed description: It is known that ultrasound can be useful to assist placement of epidural analgesia among pregnant women.extenseve research on the usefulness of ultrasound imaging to facilitate the placement of neuraxial anesthesia in pregnant have been done.The potential advantages of successful placement among non-pregnant patients include increases the safety and comfort.

In our study all patients schedueld to receive an nueraxial anesthesia for non-obstetric surgery will be included.The investigator will request permission from the Helsinki committee of hadassah university hospital.Patients will be requesting for surgery and will be randomized to one of two study groups.One group will be passed neuraxial anesthesia on the standart technique and the secound group will be passed neuraxial anesthesia with the help of ultrasound.

Eligibility criteria: Inclusion Criteria:

* all patients scheduled for neuraxial anesthesia

Exclusion Criteria:

* previous spine surgery
* contraindication for neuraxial anesthesia
* refusing to sign the consent form

Primary outcomes:
measure: Number of epidural attempts made to succeed for placing epidural needle and catheter in epidural space
timeFrame: one year
Secondary outcomes:
measure: patient satisfaction as measured by VAS (0=not satisfied, 10 = most satisfied)
timeFrame: one year
Other outcomes:
Locations:
city: Jerusalem 91120
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Fayez T Saifi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03504657: Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis
Official title: Drug-coated Balloon Angioplasty for Patients With Symptomatic Vertebral Artery Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Vertebral Artery Stenosis
Keywords: Vertebral Artery Stenosis
Drug-coated balloon angioplasty
Stenting
Lead sponsor: The First Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 150
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: Posterior circulation stroke accounts for 20% of ischemic stroke. A quarter occurs in patients with stenosis in the vertebral and/or basilar arteries. Vertebral artery stenosis can be treated with stenting. However, in-stent restenosis rate have been reported as high as more than 30%, which may reduce the effect of stent therapy. Drug-coated balloon has shown good results in controlling neointimal hyperplasia in the femoral and popliteal arteries.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Patients presenting with posterior circulation transient ischemic attack or nondisabling stroke in the previous 6 months
* Vertebral artery origin stenosis resulting from presumed atheromatous disease with stenosis ≥50%
* Lesion length of the stenosis \>5mm.
* Angioplasty can be performed within two weeks after randomization
* Female subjects of childbearing potential have a negative pregnancy test.
* Signed informed consent prior to entering study

Exclusion Criteria:

* Potential cause of TIA or minor stroke other than stenosis in a vertebral artery (e.g. atrial fibrillation)
* Life expectancy shorter than 2 years
* Vertebral artery stenosis caused by dissection
* Vertebral stenting felt to be technically impracticable
* Previous stenting in randomized artery
* Pre-morbid modified Rankin scale score of greater than 3
* Currently participating or previously participated in any investigational drug or device study within 6 months.

Primary outcomes:
measure: Restenosis
timeFrame: 12 months
Secondary outcomes:
measure: The composite of vascular death, myocardial infarction, or any stroke
timeFrame: within 30 days after the start of treatment
measure: The composite of vascular death, myocardial infarction, or any stroke
timeFrame: within 12 months after the start of treatment
measure: Death resulting from any cause
timeFrame: 12 months
measure: Stroke in the supply territory of the symptomatic vertebral artery
timeFrame: 12 months
Other outcomes:
measure: Serious adverse events
timeFrame: 30 days
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanyang
country: China
facility: Nanyang City Center Hospital
Study officials:
References: