louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00967811: A Study of Different Formulations of the L-PPDS in Subjects With OH or OAG
Official title: An Open-Label, Phase 2 Study of Different Formulations (E1 and E2) of the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Mati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-28
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and preliminary efficacy of two formulations of the Latanoprost-PPDS in subjects with ocular hypertension or open-angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* Subjects over 18 years of age diagnosed with ocular hypertension or open-angle glaucoma
* Subjects who have a best corrected visual acuity of 20/100 or better

Exclusion Criteria:

* Subjects who wear contact lenses
* Subjects who have uncontrolled medical conditions
* Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic ocular topical medications
* Subjects who have a history of chronic or recurrent inflammatory eye disease

Primary outcomes:
measure: IOP change from baseline
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Menlo Park
country: United States
state: California
Study officials:
affiliation: QLT Inc.
name: Oscar Cuzzani, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00609011: Phase 1 Study of MPC-6827 and Temozolomide in Metastatic Melanoma
Official title: Dose Finding Phase 1 Study of the Treatment of Metastatic Melanoma With MPC-6827 in Combination With Temozolomide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metastatic Melanoma
Keywords: Melanoma
Metastatic
Lead sponsor: Myrexis Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, dose finding, multiple-dose study in subjects with metastatic melanoma. Three dose levels of MPC-6827 will be administered with temozolomide to three separate cohorts. Study endpoints will include determination of the maximum tolerated dose, determination of dose limiting toxicities, and evaluation of evidence of anti-tumor activity of MPC-6827 when given with temozolomide.


Eligibility criteria: Inclusion Criteria:

* Histologically proven melanoma
* For subjects with brain metastases that require radiation, therapy must have been completed at least 4 weeks prior to Day 1 of Study Drug
* Have unresectable melanoma with measurable metastases
* Be a minimum of 4 weeks since prior surgical resection or major surgical procedure and a minimum of 2 weeks since chemotherapy/ biochemotherapy
* Performance score of Karnofsky ≥ 60%, or Eastern Cooperative Oncology Group (ECOG) ≤ 2, or WHO ≤ 2
* If steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week

Exclusion Criteria:

* Hypersensitivity to Cremophor EL
* Have current/active intratumor hemorrhage by CT/MRI within 3 weeks prior to Day 1 of Study Drug confirmed by CT/MRI
* Have ocular melanoma
* Have primary intradural melanoma or leptomeningeal involvement
* Have cardiovascular disease (unstable angina or MI)
* Have cerebrovascular disease (stroke and/or TIA)
* Have uncontrolled hypertension
* Have a cardiac ejection fraction \< 50%
* Have Troponin-I elevated above the normal range

Primary outcomes:
measure: Safety and Tolerability; Maximum Tolerated Dose
timeFrame: After each cohort is enrolled
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: Cycle 1
measure: Antitumor Activity
timeFrame: Screening, end of each cycle, end of study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic
state: California
city: Ocoee
country: United States
facility: Cancer Centers of Florida
state: Florida
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute at the University of Utah
state: Utah
Study officials:
affiliation: Myrexis Inc.
name: Andrew P. Beelen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00546611: The Purpose of This Study is to Determine Whether Topical Application of PEP005 is Safe for the Treatment of Common Wart(s)
Official title: A Phase I, Single-Centre, Open-Label, Fixed-Dose Study of the Safety and Efficacy of up- to Three-Days Application of 0.05% PEP005 Topical Gel in the Treatment of Patients With Common Wart(s) (Verruca[e] Vulgaris) on the Dorsal Hand
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Warts
Keywords: PEP005
Common Wart(s)
Common warts (verruca[e] vulgaris)
Lead sponsor: Peplin
Sponsor class: INDUSTRY
First posted: 2007-10-19
Enrollment: 0
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: Verruca vulgaris, otherwise known as the common wart, is caused by the human papillomavirus (HPV). Common warts are generally located on the hands and feet, but can also occur elsewhere (e.g., any areas of frequent contact). Common warts have a characteristic cauliflower-like surface, are typically slightly raised above the surrounding skin and are generally diagnosed by visual inspection.The treatment of warts poses a therapeutic challenge for physicians. No single therapy has been proven effective at achieving complete remission in every patient.This study will aim to evaluate an up-to a three-day course of therapy with 0.05% PEP005 Topical Gel.


Eligibility criteria: Inclusion Criteria:

* Male and female patients at least 18 years of age.
* A clinically diagnosed, single common cutaneous viral wart (verruca vulgaris) on the dorsal hand.
* Written informed consent has been obtained.
* Agreement from the patient to allow photographs of the common wart(s) treatment area to be taken and used as part of the study package.

Primary outcomes:
measure: Safety
Secondary outcomes:
measure: Resolution of Common Wart(s)
Other outcomes:
Locations:
city: Carina Heights, Brisbane
country: Australia
facility: South East Dermatology, 1202 Creek Rd
state: Queensland
Study officials:
affiliation: Peplin Operations Pty Ltd
name: Angela Smith
role: STUDY_DIRECTOR
References:
Clinical trial NCT00549211: A First Time in Human Study in Healthy Male Volunteers for Compound GSK557296.
Official title: A Two-Part Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Oral Doses of GSK557296 in a Randomized, Single-Blind, Placebo-Controlled, Dose-Rising Design, and to Evaluate the Effect of Food on Single Oral Doses of GSK557296 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obstetric Labour, Premature
Premature Ejaculation
Keywords: Healthy Subjects,
Safety,
Tolerability,
Pharmacokinetics
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-25
Enrollment: 42
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study conducted on healthy volunteers to determine the safety, tolerability and affect on the human body by experimental drug GSK557296.


Eligibility criteria: Inclusion Criteria:

* Healthy males who are 18 to 45 years of age
* Body mass index between 19 and 30 with a body weight greater than 110 pounds and deemed healthy by a physician
* Non-smokers

Exclusion Criteria:

* Alcohol consumption averaging more than 7 drinks per week
* Positive for Hepatitis C antibody, Hepatitis B antigen or HIV
* Any use of prescription drugs or non prescription drugs

Primary outcomes:
measure: Safety tests up to 24 hrs after dose 12-lead ECG to look at the heart prior to dose and up to 24 hours after Dual-lead telemetry to monitor the heart rhythms for 20 hours prior to dosing and up to 12 hours after dosing Periodic vital signs
timeFrame: 24 Hours
Secondary outcomes:
measure: Blood tests to study how long the drug stays in your blood
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Evansville
country: United States
facility: GSK Investigational Site
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00393211: Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)
Official title: A Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial to Assess the Efficacy and Safety of MK0663 in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Recurrent Low Back Pain
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2006-10-27
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.


Eligibility criteria: Inclusion Criteria:

* Low back pain for previous 3 months and majority of days in last month
* Regular use of acetaminophen or NSAID to treat low back pain in past month
* Judged to be in otherwise good health

Exclusion Criteria:

* Low back pain that is due to secondary causes
* Radicular/myelopathic pain
* Surgery for low back pain within the past 6 months
* Active lawsuit or claim pertaining to their low back pain
* Disease that may confound the results of the study or pose risk to the patients
* Corticosteroid use in past month
* Previous participation in an MK0663 study

Primary outcomes:
measure: Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo
Secondary outcomes:
measure: Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Birbara CA, Puopolo AD, Munoz DR, Sheldon EA, Mangione A, Bohidar NR, Geba GP; Etoricoxib Protocol 042 Study Group. Treatment of chronic low back pain with etoricoxib, a new cyclo-oxygenase-2 selective inhibitor: improvement in pain and disability--a randomized, placebo-controlled, 3-month trial. J Pain. 2003 Aug;4(6):307-15. doi: 10.1016/s1526-5900(03)00633-3.
citation: Curtis SP, Ng J, Yu Q, Shingo S, Bergman G, McCormick CL, Reicin AS. Renal effects of etoricoxib and comparator nonsteroidal anti-inflammatory drugs in controlled clinical trials. Clin Ther. 2004 Jan;26(1):70-83. doi: 10.1016/s0149-2918(04)90007-0.
citation: Sheldon EA, Bird SR, Smugar SS, Tershakovec AM. Correlation of measures of pain, function, and overall response: results pooled from two identical studies of etoricoxib in chronic low back pain. Spine (Phila Pa 1976). 2008 Mar 1;33(5):533-8. doi: 10.1097/BRS.0b013e3181657d24.
Clinical trial NCT01616511: Pathway CH-1 Long-Term Follow-Up
Official title: Long-Term Follow-Up for the Pathway CH-1 Trial: Sphenopalatine Ganglion Stimulation for the Acute Treatment of Cluster Headache
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Cluster Headache
Lead sponsor: Autonomic Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2012-06-11
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial, who have completed the Pathway CH-1 trial, and who remain implanted with an ATI Neurostimulator.

Brief summary: The objective of the study is to demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for stimulation of the sphenopalatine ganglion (SPG) in cluster headache subjects.


Eligibility criteria: Inclusion Criteria:

* Subject has been implanted with an ATI Neurostimulator as a part of the Pathway CH-1 trial.
* Subject has completed the Pathway CH-1 Open Label Final office visit and remains implanted with an ATI Neurostimulator.
* Subject has the ability to read, comprehend and to reliably record information as required by the Protocol.
* Subject is able to provide written informed consent prior to participation in the study.

Exclusion Criteria:

* Subject has or requires a pacemaker/defibrillator or other implantable device having a sense amplifier that is programmed 'On.'
* Subject is not suitable for the study for any reason in the judgment of the Investigator.

Primary outcomes:
measure: Demonstrate the long-term safety and performance of the ATI Neurostimulation System when used for the stimulation of the SPG in CH Subjects.
timeFrame: Long-Term
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Headache Research Unit. University Department of Neurology, Citadelle Hospital
city: Glostrup, Copenhagen
country: Denmark
facility: Danish Headache Center & Department of Neurology, Glostrup Hospital, University of Copenhagen
city: Valencia
country: Spain
facility: Servicio de Neurologia, Hospital Clinico Universitario
Study officials:
affiliation: Citadelle Hospital
name: Jean Schoenen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00756093: Acute Comfort and Blurring Profile Evaluation of Marketed Lubricant Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry Eye, Artificial Tears,
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 20
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: To evaluate drop comfort, acceptability and blur profile between four marketed artificial tears in dry eye patients


Eligibility criteria: Inclusion Criteria:

* documented diagnosis of dry eye

Exclusion Criteria:

* use of topical ocular drops within 2 hours preceding enrollment

Primary outcomes:
measure: Drop Comfort
timeFrame: once upon instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center
state: Texas
Study officials:
References:
Clinical trial NCT00006393: Genetic Study of the FBN1 Gene and Fibrillin-1 Abnormalities in Choctaw Native Americans and Other Patients With Systemic Sclerosis
Official title: Genetic Study of the FBN1 Gene and Fibrillin-1 Abnormalities in Choctaw Native Americans and Other Patients With Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Keywords: arthritis & connective tissue diseases
rare disease
systemic sclerosis
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 2000-10-05
Enrollment: 80
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: OBJECTIVES: I. Determine whether defects in fibrillin-1 cellular processing are present in the tsk1 mouse model that carries a known FBN1 gene rearrangement and in a population of Choctaw Native American patients with systemic sclerosis who have a strong genetic predisposition to the disease.

II. Determine the ultrastructural features of fibrillin-1 in these patients. III. Screen the FBN1 gene for mutations beginning at the regions homologous to the tsk1 duplication and latent transforming growth factor binding proteins in these patients and in an unaffected Choctaw control group.

IV. Determine the correlation between fibrillin-1 abnormalities and clinical presentation, autoantibodies, and ethnicity.

Detailed description: PROTOCOL OUTLINE:

Patients undergo punch skin biopsy obtained from the upper arm or back. Studies of fibrillin-1 synthesis and cellular processing, and FBN1 mutational analysis, linkage analysis, and genetic mapping are performed on the tissue samples. Patients from all major US ethnic groups (Caucasian, Hispanic, African Americans) will be recruited for the study in the next 2 years.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of systemic sclerosis in accordance with the American College of Rheumatology preliminary criteria

Positive for systemic sclerosis antibodies (e.g., anticentromere, antitopo, antifibrillarin, or antiRNA polymerase)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas- Houston Medical School
state: Texas
Study officials:
affiliation: University of Texas
name: Filemon Tan, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02878993: Predicting Infant Extubation Using Diaphragm Surface Electromyography
Official title: Predicting Infant Extubation Using Diaphragm Surface Electromyography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Newborn, Disease
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: King's College Hospital NHS Trust
First posted: 2016-08-25
Enrollment: 72
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants mechanically ventilated on NICU without major congenital abnormalities

Brief summary: This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)

Detailed description: This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)

Eligibility criteria: Inclusion Criteria:

* intubated and mechanically ventilated on NICU

Exclusion Criteria:

* major congenital abnormalities

Primary outcomes:
measure: Magnitude of diaphragm EMG
timeFrame: One hour
measure: Ratio of diaphragm EMG to tidal volume
timeFrame: One hour
Secondary outcomes:
measure: Extubation success
timeFrame: 48 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: King's College London
name: Anne Greenough
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hunt KA, Hunt I, Ali K, Dassios T, Greenough A. Prediction of extubation success using the diaphragmatic electromyograph results in ventilated neonates. J Perinat Med. 2020 Jul 28;48(6):609-614. doi: 10.1515/jpm-2020-0129.
Clinical trial NCT00951093: Gastroesophageal Reflux Disease (GERD) Before and After Gastric Bypass
Official title: The Impact of Gastric Bypass on Gastroesophageal Reflux Disease in Patients With Morbid Obesity: a Prospective Study Based on Montreal Consensus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Morbid Obesity
Keywords: GERD
Gastric bypass
Lead sponsor: Clinica Gastrobese
Sponsor class: OTHER
First posted: 2009-08-04
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic patients

Brief summary: The hypothesis of this study was that gastric bypass (GBP) ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.

Detailed description: The investigators studied the impact of this surgical procedure on GERD in patients with morbid obesity.

Esophageal syndromes were evaluated according to the Montreal Consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy.

Esophageal acid exposure was determined through 24h pH monitoring. Increased acid exposure was characterized when total esophageal pH \< 4 for at least 4% of the total monitoring time.

Eligibility criteria: Inclusion Criteria:

* Morbid obesity
* Acceptance to undergo open gastric bypass

Exclusion Criteria:

* Prior gastroesophageal surgery
* Achalasia

Primary outcomes:
measure: Number of Participants Presenting Reflux Symptoms
timeFrame: Before GBP, 6 months after GBP and 39 months after GBP
measure: Number of Participants With Esophageal Injury
timeFrame: Before GBP, 6 months after GBP and 39 months after GBP
measure: Number of Participants With Gastroesophageal Reflux Disease (GERD)
timeFrame: Before GBP, 6 months after GBP and 39 months after GBP
measure: Total Esophageal Acid Exposure at 24h pH Monitoring
timeFrame: Before GBP, 6 months after GBP and 39 months after GBP
measure: Esophageal Acid Exposure at 24h pH Monitoring in Upright Position
timeFrame: Before GBP, 6 months after GBP and 39 months after GBP
measure: Esophageal Acid Exposure at 24h pH Monitoring in Supine Position
timeFrame: Before GBP, 6 months after GBP and 39 months after GBP
measure: Number of Participants With Increased Acid Exposure
timeFrame: Before GBP, 6 months after GBP and 39 months after GBP
Secondary outcomes:
Other outcomes:
Locations:
city: Passo Fundo
country: Brazil
facility: Clínica Gastrobese
state: RS
Study officials:
affiliation: Clinica Gastrobese
name: Carlos AS Madalosso, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madalosso CA, Gurski RR, Callegari-Jacques SM, Navarini D, Thiesen V, Fornari F. The impact of gastric bypass on gastroesophageal reflux disease in patients with morbid obesity: a prospective study based on the Montreal Consensus. Ann Surg. 2010 Feb;251(2):244-8. doi: 10.1097/SLA.0b013e3181bdff20.