louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02593149: Product Evaluation for the Effectiveness of the ClearGuard® HD End Cap
Official title: Product Evaluation for the Effectiveness of the ClearGuard® HD End Cap
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease (ESRD)
Lead sponsor: Pursuit Vascular, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Davita Clinical Research
First posted: 2015-10-30
Enrollment: 1902
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: To assess blood stream infections in participants using two FDA-cleared devices: ClearGuard HD end caps compared to the Tego® connector with the CurosTM for Tego disinfecting port protector.

Detailed description: Prospective, cluster-randomized, open-label, post market, comparative effectiveness evaluation with facilities participating for up to 13 months.

Eligibility criteria: Inclusion Criteria:

* All patients dialyzing with a central venous catheter

Exclusion Criteria:

* Known allergy to chlorhexidine

Primary outcomes:
measure: Positive Blood Cultures (PBC's) Per 1,000 Central Venous Catheter (CVC)-Days
timeFrame: Through the 13-month intervention period.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
Study officials:
affiliation: DaVita Clinical Research / DaVita HealthCare Partners
name: Steven M Brunelli, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunelli SM, Van Wyck DB, Njord L, Ziebol RJ, Lynch LE, Killion DP. Cluster-Randomized Trial of Devices to Prevent Catheter-Related Bloodstream Infection. J Am Soc Nephrol. 2018 Apr;29(4):1336-1343. doi: 10.1681/ASN.2017080870. Epub 2018 Feb 22.
Clinical trial NCT00069849: A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease
Official title: A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2003-10-02
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of 2 mg, 4 mg, and 20 mg of ABT-089 BID to placebo in adults with Alzheimer's disease.


Eligibility criteria: INCLUSION CRITERIA:

* Current diagnosis of probable Alzheimer's disease.
* ADAS-cog score of at least 12 and MMSE score of 10 to 26.
* Non-smoker
* Must have legally authorized representative and a reliable caregiver. The caregiver and legally authorized representative may be the same person.
* Fluent in English.

EXCLUSION CRITERIA:

* Use of cholinesterase inhibitors or any other drugs to treat Alzheimer's disease in the last 6 weeks.
* Has clinically significant or uncontrolled medical condition other than Alzheimer's disease.
* Nursing home resident.

Primary outcomes:
measure: MMSE
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
state: California
city: San Diego
country: United States
state: California
city: Orlando
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Florence
country: United States
state: Kentucky
city: Portland
country: United States
state: Oregon
city: Salt Lake City
country: United States
state: Utah
city: Bennington
country: United States
state: Vermont
Study officials:
affiliation: Abbott
name: Katherine A Tracy, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01577849: Safety and Pharmacokinetic Characteristics of DP-R206(Vitamin D3) in Healthy Adult Volunteers
Official title: Randomized, Open-label Crossover Study to Evaluate Comparative Pharmacokinetics of Vitamin D3 Between DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 Tablet) and a 24,000 IU Vitamin D3 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2012-04-16
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to compare the pharmacokinetic characteristics of DP-R206 (150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) and Vitamin D3 (24,000 IU Vitamin D3 , qd) after oral administration in healthy adult volunteers.

Detailed description: The number of patient is thirty-six. Patients were randomly assigned either a Vitamin D3 tablet(24,000 IU Vitamin D3, qd) first, DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) Second or DP-R206(150mg Ibandronate / 24,000 IU Vitamin D3 complex tablet, qd) first, Vitamin D3 tablet(24,000 IU Vitamin D3 , qd) second.

Eligibility criteria: Inclusion Criteria:

* 20 to 55 years of healthy volunteers

Exclusion Criteria:

* Hypersensitivity Reaction about Ibandronate or other drugs(aspirin, antibiotics)

Primary outcomes:
measure: Composite of pharmacokinetics
timeFrame: 24, -18, -12, -6, 0(predose), 1, 4, 6, 8, 10, 16, 24, 36, 48, 72, 96, 120 hours post-dose
Secondary outcomes:
measure: Composite of pharmacokinetics
timeFrame: 24, -18, -12, -6, 0(predose), 1, 4, 6, 8, 10, 16, 24, 36, 48, 72, 96, 120 hours post-dose
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Chonbuk national University Hospital
state: Chonbuk
Study officials:
affiliation: Chonbuk National University Hospital
name: Min Gul KIM, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jeon JY, Lee SY, Im YJ, Kim EY, Kim Y, Park TS, Chae SW, Lee JW, Jun H, Lee TW, Kim MG. Comparison of the pharmacokinetics, safety, and tolerability of vitamin D3 in DP-R206 (150-mg ibandronate/24,000-IU vitamin D3 tablet) and as monotherapy (24,000 iu) in healthy male Korean adults. Clin Ther. 2014 Jan 1;36(1):48-57. doi: 10.1016/j.clinthera.2013.12.001. Epub 2013 Dec 28.
Clinical trial NCT01876849: An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus
Official title: An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
exenatide
Byetta
Amylin
Lilly
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2013-06-13
Enrollment: 275
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the long-term safety of exenatide in patients with type 2 diabetes who were treated with exenatide in Study H8O-MC-GWAA (6-month study) or Study H8O-MC-GWAD (12-month study). Study H8O-MC-GWAN serves as an open-ended extension to Studies H8O-MC-GWAA and H8O-MC-GWAD.


Eligibility criteria: Inclusion Criteria:

* Patients received exenatide therapy in Study H8O-MC-GWAA or Study H8O-MC-GWAD and completed the respective study.

Exclusion Criteria:

* Patients were excluded or discontinued early from Study H8O-MC-GWAA or Study H8O-MC-GWAD.
* Patients have received treatment within the last 30 days with a drug, not including exenatide, that has not received regulatory approval for any indication at the time of study entry.

Primary outcomes:
measure: Long-term safety of twice-daily exenatide treatment, as defined by the occurrence of adverse events.
timeFrame: 128 weeks (average treatment period)
Secondary outcomes:
Other outcomes:
Locations:
city: Renton
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: Chief Medical Officer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05336149: Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation
Official title: Demineralized Whole-tooth vs Demineralized Particulate Dentin Grafts in Alveolar Ridge Preservation. a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alveolar Bone Loss
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to compare whole-tooth vs particulate dentin for their effects in alveolar ridge preservation.

Detailed description: Extraction of the teeth is still one of the most commonly undertaken procedures in dental practices due to various reasons that render the teeth non-restorable. Following extraction, replacing the lost teeth with a prosthetic alternative that provides for both optimal esthetics and function can be challenging due to the inevitable events of socket healing that results in the reduction in alveolar bone height and width. To overcome these limitations and provide for adequate ridge volume, different bone preservation or augmentation techniques can be utilized with different clinical applications.

Alveolar ridge preservation is a procedure that attempts to reduce bone dimensional changes that naturally take place following tooth extraction. To overcome this problem, various approaches using various grafting materials and/or covering membranes have been proposed with varied success. The extracted tooth is no longer considered as clinical waste, it has been explored as an appropriate source for autogenous graft substitute. This idea emerged due to the shared embryonic origin of bone and teeth as well as the similarities in chemical structure as dentin is composed of 30-35% organic part and 65-70% inorganic part in comparison to alveolar bone, with inorganic and organic parts of 35% and 65% respectively. Both whole-tooth and particulate forms has been utilized for alveolar ridge preservation or augmentation but the superiority of one form over the other is not yet clear.

Eligibility criteria: Inclusion Criteria:

* Non-restorable tooth indicated for extraction
* single-rooted teeth
* Patients at least 18 years or older
* Motivated patients, agree to sign informed consent and complete the follow-up period

Exclusion Criteria:

* Pregnant females
* active infection at extraction site
* Smokers
* systemic conditions affecting healing (e.g. diabetes, medications as bisphosphonates...)

Primary outcomes:
measure: Alveolar bone width change in mm
timeFrame: 6 months
Secondary outcomes:
measure: Alveolar bone height change in mm
timeFrame: 6 months
measure: Histological assessment
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT05596149: Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa
Official title: Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: DNA Damage
Keywords: Fluoride
Toothpaste
Cytotoxicity
Genotoxicity
Buccal mucosa
DNA damage
Lead sponsor: University of Zagreb
Sponsor class: OTHER
Collaborators: name: University of Split, School of Medicine
First posted: 2022-10-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The remarkable therapeutic anticaries effect of fluoride is well recognized, but in recent years, toxic effects on the oral mucosa have been discussed. So far, many in vivo studies examining the genotoxic and cytotoxic effect of fluoride in human cells (lymphocytes, bone marrow, germ cells) have been carried out, but there are no studies examining the effect of fluoride on cells of the buccal mucosa. In vitro studies have shown that sodium fluoride can be toxic to fibroblasts of the oral mucosa by inhibiting protein synthesis, suppressing mitochondrial function and consequently reducing the amount of intracellular ATP.

The study would include 80 participants, aged between 18 and 75. All subjects would use the same toothpaste without fluoride for the first month, and then they would be randomly divided into four groups, where three groups would receive a toothpaste with fluoride with one of the active substances (sodium fluoride, sodium monofluorophosphate, amine fluoride) for the next 60 days, while the control group would continue to use the toothpaste without fluorine. Swabs of the buccal mucosa would be taken at 0 (before the start of use) and 30, 45 and 60 days after the start of using the tested toothpastes.

The aim of this research would be to examine the cytotoxic and genotoxic effect of toothpastes containing fluoride with different active substances and to compare their effect. As a measure of genotoxicity and cytotoxicity in cells, the micronucleus test will be used.


Eligibility criteria: Inclusion Criteria:

* age of 18 and older
* good oral and general health
* non smokers

Exclusion Criteria:

* subjects suffering from infectious diseases or chronic inflammatory diseases
* use of antibiotics, corticosteroids and anti-inflammatory drugs in the last six months
* damage to the mucous membrane of the oral cavity
* subjects who have fixed-prosthetic works and orthodontic braces

Primary outcomes:
measure: Number of patients with cytotoxic and genotoxic effect of fluoridated toothpastes in buccal cells, assessed by micronucleus test
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: School of Dental Medicine, University of Zagreb
Study officials:
References:
Clinical trial NCT02138149: Is the Nerve Growth Factor (NGF) a Useful Biomarker in Neurogenic Bladder Dysfunction After Spinal Cord Injury?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Neurogenic Detrusor Overactivity
Neurogenic Lower Urinary Tract Dysfunction
Keywords: spinal cord injury
neurogenic lower urinary tract dysfunction
nerve growth factor
neurogenic detrusor overactivity
urodynamics
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2014-05-14
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: individuals suffering from neurogenic lower urinary tract dysfunction, namely neurogenic detrusor overactivity

Brief summary: Spinal cord injury (SCI) almost always affects bladder function as well. As a result of this bladder dysfunction, individuals with SCI have to undergo regular invasive examination of their bladder function (urodynamic examination).

The nerve growth factor (NGF) is released from smooth muscle cells of the bladder, and there are reports, that the concentration of NGF is elevated in the urine of patients with bladder dysfunction. The NGF concentration can also be measured in the blood. The concentration of NGF in the blood and urine of SCI individuals has not yet been investigated. These concentrations may correlate with the severity of bladder dysfunction, and may thus be used to replace or at least reduce the number of the more invasive urodynamic examinations.

The hypothesis that urine and blood NGF concentrations in individuals with SCI are higher compared to individuals with healthy bladder function will be tested.


Eligibility criteria: Control Group

Inclusion Criteria:

* physiologic bladder function

Exclusion Criteria:

* no signed consent form
* age \<18 / \>80 years
* urinary tract infection
* bladder surgery
* radiation therapy of the pelvic area
* pregnancy
* bleeding disorder

Study Group

Inclusion Criteria:

* neurogenic detrusor overactivity
* presentation for urodynamic examination

Exclusion Criteria:

* no signed consent form
* age \<18 / \>80 years
* urinary tract infection
* bladder augmentation
* bladder evacuation by permanent catheterization
* radiation therapy of the pelvic area
* pregnancy
* bleeding disorder

Primary outcomes:
measure: urinary concentration of nerve growth factor
timeFrame: day 0
Secondary outcomes:
measure: serum concentration of nerve growth factor
timeFrame: day 0
measure: demographics
timeFrame: day 0
measure: urodynamics
timeFrame: day 0
measure: International Prostate Symptom Score (I-PSS)
timeFrame: day 0
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
References:
Clinical trial NCT00099749: Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
Official title: Safety and Efficacy of FTY720 in Adult Patients Who Receive a Kidney Transplant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Kidney Transplantation
Keywords: Kidney, immunosuppression, transplant, rejection
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-12-20
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The efficacy and safety of FTY720 is being evaluated in patients who receive a kidney transplant.


Eligibility criteria: Inclusion Criteria:

* Male and Female
* Between 18 to 65 years old

Exclusion Criteria:

* Patients in need of multiple organ transplants

Primary outcomes:
measure: Biopsy-proven acute rejection (BPAR), graft loss, death and study discontinuation, within 6 months post transplantation.
Secondary outcomes:
measure: Safety/tolerability based on adverse event reporting.
measure: BPAR, graft loss, death and study discontinuation, within 6 and 12 months post transplantation.
measure: Efficacy parameters between the 3 treatment groups within 6 and 12 months post-transplantation.
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Springfield
country: United States
facility: SIU School of Medicine
state: Illinois
city: Livingston
country: United States
facility: St. Barnabas Medical Center
state: New Jersey
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Tedesco-Silva H, Szakaly P, Shoker A, Sommerer C, Yoshimura N, Schena FP, Cremer M, Hmissi A, Mayer H, Lang P; FTY720 2218 Clinical Study Group. FTY720 versus mycophenolate mofetil in de novo renal transplantation: six-month results of a double-blind study. Transplantation. 2007 Oct 15;84(7):885-92. doi: 10.1097/01.tp.0000281385.26500.3b.
Clinical trial NCT06962449: Real-World Assessment of Therapeutic Strategies and Survival Outcomes Following First-Line Tislelizumab Therapy in Advanced Non-Small Cell Lung Cancer
Official title: Analysis of Treatment Patterns and Clinical Outcomes After First-Line Treatment With Tislelizumab in Advanced NSCLC: A Real-World Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Non-Small-Cell Lung Cancer
Non-Small-Cell Lung Cancer Stage IV
Keywords: advanced non-small-cell Lung cancer
real-world study
Tislelizumab
progression
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced NSCLC who progressed after first-line treatment with Tislelizumab

Brief summary: This study is an observational study evaluating the treatment patterns and clinical outcomes after progression on first-line Tislelizumab treatment in advanced NSCLC. Based on the inclusion and exclusion criteria, patients with advanced NSCLC who received first-line Tislelizumab treatment and progressed will be retrospectively screened and collected from January 1, 2020, to the study initiation date, and followed up for observation.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC based on the 8th edition of the AJCC staging system.
* Previously received first-line treatment with Tislelizumab for advanced NSCLC.
* Medical records of disease progression after first-line treatment.

Exclusion Criteria:

* Patients with incomplete key baseline and treatment information，including clinical stage, pathological type, treatment regimen, tumor assessment record after treatment ect.
* Patients included in anti-tumor drug intervention or unblinded clinical trials, in which the treatment being administered is unknown.

Primary outcomes:
measure: real-world progression-free survival
timeFrame: the time from the start of treatment to the first recorded progression event in the medical information system or death from any cause, whichever occurs first, excluding events within 14 days after the start of treament.
measure: overall survival (OS)
timeFrame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
References: