louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00756678: Efficacy and Acceptability of Two Lubricant Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-09-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Efficacy and acceptability of two new artificial tears following two weeks of treatment in patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then crossover to the alternate treatment for 7 days.


Eligibility criteria: Inclusion Criteria:

* Male or Female
* At least 18 years of age
* Current use of artificial tears

Exclusion Criteria:

* Any uncontrolled systemic disease
* Pregnancy or planning a pregnancy
* Contact lens wear

Primary outcomes:
measure: Mean Frequency of Eye Drop Use Over 1 Week
timeFrame: 1 week
Secondary outcomes:
measure: Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16
timeFrame: Baseline, Day 16
measure: Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16
timeFrame: Day 16
measure: Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16
timeFrame: Day 16
Other outcomes:
Locations:
city: Chevy Chase
country: United States
state: Maryland
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00559078: Qualitative Research on Women With Congenital Adrenal Hyperplasia
Official title: Health-related Quality of Life, Mental Health and Psychotherapeutic Considerations for Women Diagnosed With a Disorder of Sexual Development: Congenital Adrenal Hyperplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Adrenal Hyperplasia
Keywords: Adrenal Hyperplasia, Congenital
Psychosexual Development
Sexual Development
Intersex
Qualitative
CAH
Interview
Disorder of Sex Development
Telephone
Quality of Life
Mental Health
Counseling
Lead sponsor: Lehigh University
Sponsor class: OTHER
First posted: 2007-11-16
Enrollment: 16
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with CAH (either simple-virilizing or salt-losing types) living in the United States

Brief summary: This qualitative interview-based study will investigate the impact that living with congenital adrenal hyperplasia has for women in the following areas: health-related quality of life (HRQL), psychological health, and health-seeking behaviors.

Detailed description: Congenital Adrenal Hyperplasia is a chronic-illness requiring life-long treatment and is caused by an inherited enzyme deficiency that leads to an overproduction of hormones produced by the adrenal glands, which in turn, masculinizes the female genitalia before birth. While the mechanisms by which CAH influences physiological development are understood, the impact of this hormonal elevation on health-related quality of life (HRQL), psychological health, and health-seeking behaviors is less clear. This study is guided by three research questions: (1) how does CAH influence HRQL domains (physical, functional, emotional and interpersonally), (2) how does CAH influence the mental health of women diagnosed with CAH, and (3) how does CAH influence decisions to seek help from a counselor? Semi-structured qualitative interviews will be conducted with women with CAH. Interviews will be analyzed through the Consensual Qualitative Research (CQR) methodology.

Eligibility criteria: Inclusion Criteria:

* 46XX, Females
* Diagnosed by a physician with CAH (either simple-virilizing or salt-losing types)
* Willing to complete a brief demographic questionnaire and participate in an hour long telephone interview

Exclusion Criteria:

* Non-classical or late-onset CAH

Primary outcomes:
measure: Telephone interview consisting of approximately 7 open ended questions addressing domains of HRQL, Mental Health and Support
timeFrame: 1 hour
Secondary outcomes:
measure: Demographic Questionnaire
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: Lehigh University
state: Pennsylvania
Study officials:
affiliation: Lehigh University Counseling Psychology
name: Matthew A Malouf, BA
role: STUDY_DIRECTOR
affiliation: Lehigh University Counseling Psychology
name: Arpana G Inman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00711178: A Randomized Multicenter Study of Daylight Mediated Photodynamic Therapy (PDT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Actinic Keratoses
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2008-07-08
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: A randomised, multi-center study of daylight mediated photodynamic therapy (PDT) with Metvix in patients with multiple actinic keratosis on the face and/or scalp.


Eligibility criteria: Inclusion Criteria:

* 18 years and older, 5 AK in face and scalp

Exclusion Criteria:

* immunosuppression

Primary outcomes:
measure: response rate
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Hans Christian Wulf, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01680978: A Study to Evaluate the Effect of Aleglitazar on Cardiac Energetics and Function in Patients With Type 2 Diabetes Mellitus and no History of Coronary Artery Disease
Official title: A SINGLE CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, CROSSOVER, PHASE II STUDY TO ASSESS THE EFFECT OF ALEGLITAZAR ON CARDIAC ENERGETICS AND FUNCTION IN PATIENTS WITH UNCOMPLICATED TYPE 2 DIABETES MELLITUS AND NO HISTORY OF CORONARY ARTERY DISEASE WHO ARE DRUG-NAÏVE OR TREATED WITH STABLE METFORMIN MONOTHERAPY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER

Brief summary: A single center, double-blind, placebo-controlled, randomized, crossover, phase II study to assess the effect of aleglitazar on cardiac energetics and function in patients with uncomplicated type 2 diabetes mellitus and no history of coronary artery disease who are drug-naïve or treated with stable metformin. Eligible patients will receive either 150 mcg aleglitazar or placebo orally daily for 6 weeks. After a washout period of 6 weeks, patients will cross over to the treatment not yet received.


Eligibility criteria: Inclusion Criteria:

* Adult patients, 40 to 70 years of age (inclusive) at screening
* Patients with Type 2 diabetes mellitus diagnosed at least 12 weeks before screening and either drug-naïve or treated with stable metformin monotherapy for at least 12 weeks prior to screening
* HbA1c \>/= 7 % and \</= 9% at screening
* Absence of history of coronary artery disease

Exclusion Criteria:

* Diagnosis or history of Type 1 diabetes mellitus, diabetes resulting from pancreatic injury, or secondary forms of diabetes
* Current treatment with fibrates, thiazolidinediones, or insulin
* Prior intolerance to thiazolidinediones and/or fibrates
* Clinically significant liver disease or impaired liver function
* Know chronic diabetic complications (i.e. retinopathy, neuropathy, nephropathy)
* Symptomatic congestive heart failure classified as NYHA class II-IV
* Diagnosed and/or treated malignancy within the past 5 years, except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer
* Contraindications to MRI, or inability to tolerate MRI scanning

Primary outcomes:
measure: Cardiac energetics: Change in PCr/ATP ratio using phosphorus magnetic resonance spectroscopy (MRS)
timeFrame: from baseline to Week 6
Secondary outcomes:
measure: Change in left ventricular diastolic function measured by mitral inflow, tissue Doppler Imaging and magnetic resonance imaging (MRI)
timeFrame: from baseline to Week 6
measure: Change in cardiac/hepatic triglyceride content assessed my MRS
timeFrame: from baseline to Week 6
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05925478: Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage
Official title: Pterygopalatine Fossa Block in Aneurysmal Subarachnoid Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Subarachnoid Hemorrhage, Aneurysmal
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aneurysmal subarachnoid hemorrhage (aSAH) can cause a severe headache (HA) that is famously treatment-resistant. Current pain regimens are too reliant on opioids, which results in long-term opioid dependence and can obfuscate the neurological examination, which is critical to detect vasospasm and delayed cerebral ischemia. This study will gather the initial evidence of whether the pterygopalatine fossa (PPF) regional anesthesia nerve block can treat aSAH-related HA and reduce opioid consumption in patients with aSAH.


Eligibility criteria: Inclusion Criteria:

* Aneurysmal subarachnoid hemorrhage with secured aneurysm
* Age greater than or equal to 18 years
* Able to communicate pain level

Exclusion Criteria:

* Documented allergy to local anesthetics (e.g. bupivicaine)
* Patients with unsecured aneurysms
* Patients who are unable to communicate pain level (e.g. sedation/mechanical ventilation/delirium, etc)
* Medical treatment for vasospasm including blood pressure/inotropic augmentation
* Angiographic treatment for vasospasm within 48 hours

Primary outcomes:
measure: Opioid consumption
timeFrame: 3 days
measure: Pain Rating Scale
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
References:
Clinical trial NCT00798278: Urokinase Versus Video-assisted Thoracoscopic to Treat Complicated Parapneumonic Empyema in Childhood
Official title: Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Empyema
Pneumonia
Keywords: Empyema
Urokinase
Thoracoscopic
Childhood
Lead sponsor: Spanish Society of Pediatric Surgery
Sponsor class: OTHER
First posted: 2008-11-26
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A great controversy exists about which is the best method to perform the evacuation of the collection. The purpose of this study is to evaluate which is the best initial treatment to drain complicated parapneumonic empyema (stages II and III) in children: the present study raises a hypothesis of equivalence between both arms of treatment (chest drainage plus intrapleural urokinase or videothoracoscopic debridement).


Eligibility criteria: Inclusion Criteria:

* Patients less than 15 years of age with pneumonia and persistent fever, and complicated parapneumonic empyema (septation or loculation seen on ultrasound or Rx thorax)stages II and III requiring an intervention to drain

Exclusion Criteria:

* Existing contraindications or other previous conditions, hypertension, pneumothorax

Primary outcomes:
measure: duration of the hospital stay after the treatment
timeFrame: 3 months
Secondary outcomes:
measure: complications of the treatment and complications of the disease
timeFrame: 3 months
measure: total duration of the hospital stay
timeFrame: 3 months
measure: number of days carrying the chest drain
timeFrame: 3 months
measure: duration of the fever once the empyema has been drained
timeFrame: 3 months
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: San Sebastián
country: Spain
facility: Hospital de Donostia
state: Donostia
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Infantil La Paz
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
References:
Clinical trial NCT05168878: Safety Education in the Emergency Department: A Pilot Study
Official title: Safety Education in the Emergency Department (SEED): A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Firearm Injury
Keywords: Injury prevention
anticipatory guidance
firearm counseling
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical & Translational Sciences Institute
name: Emergency Medicine Foundation
name: American Foundation for Firearm Injury Reduction in Medicine
First posted: 2021-12-23
Enrollment: 407
Sex: ALL
Minimum age (years): 30
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study is to assess the feasibility and acceptability of video-based safe firearm storage education in the Pediatric Emergency Department.


Eligibility criteria: Inclusion criteria:

* Children \> 30 days and \< 18 years old presenting to the CHCO ED
* Parent/guardian who is ≥ 18 and ≤ 85 years old
* Arms 1 \& 2 will include a subset of patients ≥10 years and \< 18 years old with a firearm in the home.

Exclusion criteria:

* Child is in an emergent/acute medical condition
* Patient seen in our fast track area or other room without a television
* Parent/guardian is non-English speaking.

Primary outcomes:
measure: Acceptability of Intervention
timeFrame: At baseline
measure: Feasibility of Follow up
timeFrame: Through study completion, an average of three months
measure: Safe Firearm Storage
timeFrame: At baseline
measure: Safe Firearm Storage at Three Months
timeFrame: Three month follow up
measure: Knowledge About Temporary Firearm Transfer at Baseline
timeFrame: At baseline
measure: Knowledge About Temporary Firearm Transfer at Follow up
timeFrame: At study follow-up, an average of three months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Maya Haasz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04564378: Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure
Official title: Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fuchs Dystrophy
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2020-09-25
Enrollment: 43
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with mild or severe Fuchs Dystrophy

Brief summary: This study is being done to discover if there is a link between estrogen exposure and the severity of Fuchs Endothelial Corneal Disease. We are trying to understand if the decrease in estrogen levels in post-menopausal women may be a reason why FECD is seen more often in women than men.


Eligibility criteria: Inclusion Criteria:

1. Individuals with FECD grade 1-2/7 (mild) or 5-6/7 (severe) in one or both eyes
2. Age ≥ 55
3. Phakic and pseudophakic individuals will be included. Pseudophakic patients must have evidence of routine cataract surgery (posterior chamber intraocular lens in-the-bag without clinical evidence of damage to any intraocular structures).

Exclusion Criteria:

1. Females are excluded if not post-menopause.
2. Pseudophakic patients with a history of complex cataract surgery or other intraocular surgery (e.g. have an anterior chamber lens, sulcus lens, or poorly positioned posterior chamber lens, aphakia, iris damage, glaucoma surgery) will be excluded due to risk of iatrogenic damage to the corneal endothelium.

Primary outcomes:
measure: Association Between Fuchs endothelial Corneal Dystophy Severity and Estrogen Exposure
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: The Ira G. Ross Eye Institute
state: New York
Study officials:
affiliation: The Ross Eye Institute
name: Sagita Patel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04200378: Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair
Official title: Invasive Hemodynamic Response to Transcatheter Edge-to-Edge Mitral Valve Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 22
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: Patients receiving a standard of care TMVR with Transcatheter edge to edge repair device for mitral regurgitation symptom alleviation.

Brief summary: Studying the effects of Trans-catheter Mitral Valve Repair (TMVr) on the hemodynamics and biomarkers in patients with severe mitral valve regurgitation.


Eligibility criteria: Inclusion Criteria:

* Adults (age ≥ 18 years) with severe, symptomatic primary mitral regurgitation identified by Doppler transthoracic echocardiogram
* Heart team (cardiologist and cardiac surgeon) agree that patient would be eligible for TMVR with Transcatheter edge to edge repair device.
* TMVR procedure will be performed in the cardiac catheterization laboratory for hemodynamic data recording

Exclusion Criteria:

* Women who are pregnant or believe they could be pregnant

Primary outcomes:
measure: Change in stroke volume index
timeFrame: Baseline, approximately 10 mins after valve repair
measure: Change in cardiac index
timeFrame: Baseline, approximately 10 mins after valve repair
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mackram Eleid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00551278: Validation Study Using the GeneSearch BLN Assay to Test Sentinel Lymph Nodes From Patients With Breast Cancer
Official title: GeneSearch™ Breast Lymph Node (BLN) Assay for Molecular Testing Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: sentinel lymph node
metastasis
molecular pathology
Lead sponsor: Janssen Diagnostics, LLC
Sponsor class: INDUSTRY
First posted: 2007-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a previous diagnosis of breast cancer scheduled for sentinel lymph node dissection.

Brief summary: The purpose of this trial is to show adequate assay performance on clinical samples tested in real time at the clinical site.

Detailed description: This study will determine the sensitivity, specificity, negative predictive value, and positive predictive value of the GeneSearch™ BLN Assay in patient samples by comparing its performance to that of the current methods -- permanent section Hematoxylin and Eosin (H\&E) staining with IHC. Additional marker testing using probes associated with nodal metastases may be used in the assay performance calculations. The observed performance measures will be compared to those obtained in the larger U.S. registration trial to show that there are no differences in the assay's performance.

Eligibility criteria: Inclusion Criteria:

* Previous diagnosis of carcinoma of the breast
* Patient scheduled for sentinel lymph node dissection as per standard of care at the clinical site
* 18 years or older
* Female or male, and
* Able and willing to give consent to participate in the study

Exclusion Criteria:

* Patients taking part in other research studies that would interfere with their full participation in this study

Primary outcomes:
measure: The study will determine the sensitivity, specificity, negative predictive value and positive predictive value of the GeneSearch™ BLN Assay by comparing its performance to permanent section Hematoxylin and Eosin (H&E) staining with IHC.
timeFrame: 1 month
Secondary outcomes:
measure: A secondary objective will assess the timing and logistical aspects of introducing a real time molecular test within the pathology lab.
timeFrame: 1 day
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University Cancer Pavilion
name: Robert J. Goulet, MD
role: PRINCIPAL_INVESTIGATOR
References: