louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06291493: Precision Study Measuring Potassium (K) in Capillary Specimens
Official title: Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Precision of Potassium (K) Test in Capillary Whole Blood
Lead sponsor: Abbott Point of Care
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Capillary precision analysis will be performed for Potassium K.
Primary purpose: DIAGNOSTIC

Brief summary: Assessing precision of i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer.

Detailed description: The objective of this study is to assess the precision of the i-STAT K test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer with investigational software using results from two (2) different fingerstick specimens from the same subject across the K measurement range.

Eligibility criteria: Inclusion Criteria:

* Signed and dated consent form (if required by the IRB)
* ≥ 18 years of age

Exclusion Criteria:

• Prior enrollment in the study

Primary outcomes:
measure: Precision for Potassium (K) Test
timeFrame: Up to 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore (UMD)
state: Maryland
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center (Hershey)
state: Pennsylvania
city: Redmond
country: United States
facility: Eastside Research Associates (ERA)
state: Washington
city: Ottawa
country: Canada
facility: Abbott Point of Care (APOC)
state: Ontario
Study officials:
affiliation: Abbott Point of Care
name: Manish Gupta, BS, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT05085093: Protective Efficacy of HPV Vaccination After Treatment of HPV Related Diseases
Official title: Protective Efficacy of HPV Vaccination After Treatment of HPV Related Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HPV Vaccination、HPV Related Diseases、Protective Efficacy
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 414
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with HPV related diseases

Brief summary: To understand the HPV infection status and subtype distribution of patients, and to study the protective effect of prophylactic HPV vaccination on the recurrence of HPV related diseases after treatment through a prospective cohort study. To provide data support for the primary prevention of HPV related diseases in Chinese women after treatment, and to analyze the related factors of HPV related disease recurrence and HPV continuous positive.


Eligibility criteria: Inclusion Criteria:

* 1. Women aged 18-45, of childbearing age or before perimenopause (patients without pregnancy plan within two years); 2. Patients diagnosed as condyloma acuminatum, vaginal intraepithelial lesions (high-grade and low-grade lesions), cervical intraepithelial lesions (high-grade and low-grade lesions), vulvar intraepithelial lesions (high-grade and low-grade lesions), cervical cancer (IA1-IIA2 stage) and treated within 3 months; 3. No surgical contraindications such as severe center of heart, lung and other organ dysfunction and abnormal hemagglutination; 4. Fully know the treatment method, sign informed consent, and actively cooperate with follow-up.

Exclusion Criteria:

* 1. Participating in other clinical trials; 2. Use immunoglobulin or blood products within 3 months before vaccination; 3. Hypersensitivity to vaccine active ingredients or any dressing ingredients; 4. Acute stage of moderate and severe diseases; 5. Acute stage of severe immune deficiency diseases and autoimmune diseases; 6. Pregnant women and lactating patients; 7. Patients with planned pregnancy within 2 years; 8. Less than 18 years old and more than 45 years old.

Primary outcomes:
measure: recurrence
timeFrame: 6 months after operation
measure: Persistent HPV infection
timeFrame: At least 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital, Air Force Medical University
state: Shaanxi
Study officials:
affiliation: The First Affiliated Hospital，Air Force Medical University,Xi'an, Shaanxi, China
name: hong Yang, professional
role: STUDY_CHAIR
References:
Clinical trial NCT00337493: Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.
Official title: A Study to Investigate the Impact of Pharmacogenetics on CellCept Use, in Patients Participating in a Study in Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-06-16
Enrollment: 155
Sex: ALL
Minimum age (years): 13
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine which, if any, allelic variants of mycophenolic acid (MPA) metabolizing enzymes, drug transporters and drug targets are associated with the observed variation in pharmacokinetic and pharmacodynamic outcomes observed with CellCept usage. Patients participating in study ML17225 will be eligible for this pharmacogenetic investigation, and will have one additional blood sample taken during the study. The anticipated time on study treatment in study ML17225 is 1-2 years, and the target sample size is 500+ individuals.


Eligibility criteria: Inclusion Criteria:

* patients participating in study ML17225.

Exclusion Criteria:

* N/A.

Primary outcomes:
measure: Correlation of allelic variants of MPA metabolizing genes, membrane transporter genes and target genes with AUC, transplant rejection, GER and drug side effects.
timeFrame: Throughout study
Secondary outcomes:
measure: Viral kinetics
timeFrame: Throughout study
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Gainesville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Shreveport
country: United States
state: Louisiana
city: Boston
country: United States
state: Massachusetts
city: Hackensack
country: United States
state: New Jersey
city: Livingston
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Madison
country: United States
state: Wisconsin
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02789293: Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients
Official title: Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Ultrasound
Ciliary body
Lead sponsor: EyeTechCare
Sponsor class: INDUSTRY
First posted: 2016-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.


Eligibility criteria: Inclusion Criteria:

* Open Angle Glaucoma patient (Primary Open Angle Glaucoma (POAG) including Pigmentary Glaucoma (PG) and PseudoExfoliative Glaucoma (PXF))
* Any patients without previous conventional glaucoma surgery failure (trabeculectomy, Deep Sclerectomy, Ahmed valve, drainage device implantation, cyclo cryotherapy, Diode laser cyclo-destruction)
* Subjects where the IOP is not adequately controlled with glaucoma medication, with IOP ≥ 21 mm Hg and \<30 mmHg
* No previous intraocular surgery or laser treatment during the 90 days before HIFU Day
* Age \> 18 years and \< 90 years
* Patient able and willing to complete postoperative follow-up requirements

Exclusion Criteria:

* Patient who has been diagnosed for normal tension glaucoma
* Ocular or retrobulbar tumor
* Ocular infection within 14 days prior to the HIFU procedure
* Ocular disease other than glaucoma that may affect assessment of visual acuity and/or IOP (choroidal hemorrhage or detachment, lens subluxation, thyroid ophthalmopathy, proliferative diabetic retinopathy, clinically significant macular edema...)

Primary outcomes:
measure: Efficacy endpoint : Reduction of intraocular pressure
timeFrame: 24 months
Secondary outcomes:
measure: Safety : rate of per and post-operative complications/adverse effects
timeFrame: 24 months
measure: Efficacy endpoint : Mean IOP (mmHg)
timeFrame: 24 months
measure: Efficacy Endpoint : Mean IOP variation (%)
timeFrame: 24 months
measure: Mean Number of ocular hypotensive medications
timeFrame: 24 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven - University Hospital
city: Tel Hashomer
country: Israel
facility: The Sam Rothberg Glaucoma Center, Goldschleger EyeInstitute, Sheba Medical Center
city: Pisa
country: Italy
facility: Cisanello Hospital
city: Lisboa
country: Portugal
facility: Santa Maria Hospital - Faculty of Medicine of Lisbon
Study officials:
References:
Clinical trial NCT02483793: Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Pain in the Pediatric Population
Official title: Randomized Prospective Trial Comparing Oxybutynin and Tamsulosin for Stent Discomfort in the Pediatric Population
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Disorder of Urinary Stent
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2015-06-29
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the efficacy and safety tamsulosin in reducing stent discomfort in the pediatric population in the peri-operative period. The secondary objective is to compare the efficacy of tamsulosin with that of oxybutynin in reducing stent discomfort.


Eligibility criteria: Inclusion Criteria:

* Patients aged 4-18 years will be enrolled in this study. We will include all patients who will have a ureteral stent placement after their procedure.

Exclusion Criteria:

* Patients with developmental delay or unable to verbalize their pain level will be excluded.

Primary outcomes:
measure: Number of doses of pain in medication used
timeFrame: 5 days post-op
measure: Pain scale based on the faces pain score
timeFrame: 5 days post-op
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01251393: Cocaine/Crack and Reduction of Compulsion With Biperiden
Official title: Cocaine/Crack Dependence: A Study of the Possible Reduction of Compulsion Under the Use of Biperiden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cocaine Dependence
Keywords: Cocaine
crack
treatment
dependence
biperiden
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Nacional Conseling of Scientific Development and Technology
First posted: 2010-12-01
Enrollment: 111
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence.

Detailed description: Cocaine consumption affects around 13.4 mi people or 0.3% of the world population between 15 and 64 years old. The drug dependence has been described by many authors as a dysfunction of the brain reward system. Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence. To accomplish this purpose 60 cocaine or crack male users between 18 and 50 years old will be study. This is a double-blind controlled and randomized placebo study. All the patients will be treated with brief intervention therapy (BIT), and half of them will receive biperiden (6mg/day) while the other half will receive placebo. The treatment efficacy will be evaluated through the comparison between the values obtained on the following measures before and after the treatment: Craving scale of Minnesota and Cocaine/crack consumption questionnaire, and the presence of the cocaine metabolite (benzoylecgonine) on urine.

Eligibility criteria: Inclusion Criteria:

* Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)

Exclusion Criteria:

* Being under treatment with psychoactive drugs
* Have been diagnosed for other Psychiatric Disorders
* Have dependence diagnosis for other drugs, except for tabacco

Primary outcomes:
measure: Compulsion
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: UDED - Drug Dependence Unit
Study officials:
affiliation: Universidade Federal de São Paulo
name: José C F. Galduróz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04735393: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
Official title: A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-03
Enrollment: 757
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 Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Clinical Trial Evaluating the Safety of 0.25% Reproxalap Ophthalmic Solution in Subjects with Dry Eye Disease


Eligibility criteria: Inclusion Criteria:

* 18 years of age (either gender and any race);
* Reported history of dry eye for at least 6 months prior to Visit 1;
* History of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1.

Exclusion Criteria:

* Clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Contact lens use within 7 days of Visit 1 or anticipate using contact lenses during the trial;
* Eye drop use within 2 hours of Visit 1;
* Previous laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Cyclosporine 0.05% or 0.09% or lifitegrast 5.0% ophthalmic solution within 90 days of Visit 1;
* Planned ocular and/or lid surgeries over the study period or any ocular surgery within 6 months of Visit 1;
* Temporary punctal plugs during the study that have not been stable within 30 days of Visit 1.

Primary outcomes:
measure: Ocular treatment emergent adverse events (TEAEs)
timeFrame: Safety assessment period (Day 1 through Day 28 or Day 1 through Day 360)
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT04436393: Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer
Official title: Guardant360® Related Clinical Outcomes in Patients Who Share Medical Records-Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Breast Cancer
Lead sponsor: Guardant Health, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-18
Enrollment: 109
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: Subjects located in the United States that have undergone Guardant360 testing as part of their routine clinical care.

Brief summary: The purpose of this study is to observe the routine clinical care of patients who have been diagnosed with breast cancer and have undergone Guardant360 testing.

Detailed description: Patients who have been diagnosed with breast cancer and have undergone Guardant360 testing will be approached regarding participation in the study. After being informed about the study and potential risks, all patients providing informed consent and access to their medical records, will provide a list of their health care providers related to their cancer treatment. Data related to their routine clinical care will be abstracted from medical records.

Eligibility criteria: Inclusion Criteria:

1. Adults (18 years of age and older) with a diagnosis of breast cancer
2. Guardant360 test results released to the patient's physician no less than 14 days prior to initial patient contact
3. Patient has previously provided contact information (either email or phone) to Guardant Health
4. Able and willing to complete the electronic informed consent process
5. Must have access to a computer terminal or personal computing device
6. Willingness to consent to the release of medical records

Exclusion Criteria:

1. Unable to understand English

Primary outcomes:
measure: Overall Survival
timeFrame: 18 months post Guardant360 testing
measure: Progression Events
timeFrame: 18 months post Guardant360 testing
measure: Subject Lost-to-Follow-Up
timeFrame: 18 months post Guardant360 testing
Secondary outcomes:
measure: Rate of biomarker discovery
timeFrame: 18 months post Guardant360 testing
measure: Time to Next Treatment
timeFrame: 18 months post Guardant360 testing
measure: Real-world Time to Tumor Progression
timeFrame: 18 months post Guardant360 testing
measure: Real-world Overall Survival
timeFrame: 18 months post Guardant360 testing
measure: Demographics
timeFrame: 18 months post Guardant360 testing
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Guardant Health
state: California
Study officials:
affiliation: Guardant Health, Inc.
name: Victoria M Raymond, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04503993: Healthy Planet Hepatitis B
Official title: Utilizing Electronic Health Systems to Enhance Screening and Linkage to Care for Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 5004
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This quality improvement project utilizes Epic Health Planet to increase screening for chronic hepatitis B through the creation of registries and ordering of hepatitis B laboratory panels.


Eligibility criteria: Inclusion Criteria:

- Asian ancestry as determined by ethnicity/race, primary language, surname as recorded in the electronic health record

Exclusion Criteria:

- previously completed hepatitis B screening tests

Primary outcomes:
measure: Completion of hepatitis B order panel
timeFrame: Within 1 year after placement of the order
Secondary outcomes:
measure: Linkage to care of those found to be infected with hepatitis B
timeFrame: Within 3 months after a positive HBsAg test
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Medical Center
state: California
Study officials:
References: