louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01037036: A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG
Official title: An Open-Label, Phase 2 Study of the Latanoprost Punctal Plug Delivery System (L-PPDS) With Adjunctive Xalatan® Eye Drops in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Hypertension
Open-Angle Glaucoma
Keywords: Ocular Hypertension
Open-Angle Glaucoma
Xalatan
IOP
Lead sponsor: Mati Therapeutics Inc.
Sponsor class: INDUSTRY
Collaborators: name: QLT Inc.
First posted: 2009-12-21
Enrollment: 15
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: The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.


Eligibility criteria: Inclusion Criteria:

* Over 18 years
* Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
* Currently on prostaglandin therapy

Exclusion Criteria:

* Uncontrolled medical conditions
* Subjects who wear contact lenses
* Subjects requiring chronic topical artificial tears, lubricants, and /or - requiring any other chronic topical medications

Primary outcomes:
measure: Change from baseline in IOP measurements
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Menlo Park
country: United States
facility: Menlo Park
state: California
Study officials:
affiliation: QLT Inc.
name: Oscar Cuzanni, MD, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT00866736: A Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
Official title: A Phase II Study of Dasatinib in Patients With Imatinib Resistant or Intolerant Chronic Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Myeloid Leukemia
Keywords: chronic myeloid leukemia
dasatinib
chronic phase myeloid leukemia
Lead sponsor: Kanto CML Study Group
Sponsor class: OTHER
Collaborators: name: Epidemiological and Clinical Research Information Network
First posted: 2009-03-20
Enrollment: 65
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and the safety of dasatinib in subject with chronic phase chronic myeloid leukemia(CML) who are either resistant to or intolerant of imatinib mesylate.


Eligibility criteria: Inclusion Criteria:

* Signed Written Informed Consent
* Subjects with chronic phase chronic myeloid leukemia (CML)
* Subjects resistant/intolerant to imatinib
* Subjects presenting:

  1. ECOG performance status (PS) score 0-2
  2. Adequate hepatic function
  3. Adequate renal function
  4. Adequate lung function

Exclusion Criteria:

* Concurrent malignancy other than CML
* Women who are pregnant or breastfeeding
* Concurrent pleural effusion
* Uncontrolled or significant cardiovascular disease
* A serious uncontrolled medical disorder that would impair the ability of the subjects to receive protocol therapy.
* Prior therapy with dasatinib
* Subjects with T315I and/or F317L BCR-ABL point mutations

Primary outcomes:
measure: rate of Major Molecular Responses (MMR) in chronic phase chronic myeloid leukemia subjects
timeFrame: at 12 months
Secondary outcomes:
measure: safety after treatment with dasatinib
timeFrame: 2 year
measure: rate of Complete Cytogenetic Response(CCyR)
timeFrame: 2 year
measure: rate of Complete Hematologic Response (CHR)
timeFrame: 2 year
measure: efficacy on patients with BCR-ABL point mutations
timeFrame: 2 year
measure: progression free survival
timeFrame: 2 year
Other outcomes:
Locations:
city: Bunkyo-ku
country: Japan
facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
state: Tokyo
Study officials:
affiliation: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
name: Hisashi Sakamaki, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Inokuchi K, Kumagai T, Matsuki E, Ohashi K, Shinagawa A, Hatta Y, Takeuchi J, Yoshida C, Wakita H, Kozai Y, Shirasugi Y, Fujisawa S, Iwase O, Yano S, Okamoto S, Oba K, Sakamoto J, Sakamaki H. Efficacy of molecular response at 1 or 3 months after the initiation of dasatinib treatment can predict an improved response to dasatinib in imatinib-resistant or imatinib-intolerant Japanese patients with chronic myelogenous leukemia during the chronic phase. J Clin Exp Hematop. 2014;54(3):197-204. doi: 10.3960/jslrt.54.197.
Clinical trial NCT05041036: Individual Patient Compassionate Use of Nirogacestat
Official title: Individual Patient Compassionate Use of Nirogacestat
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Desmoid Tumor
NOTCH Gene Mutation Positive Tumors
Keywords: desmoid tumor
aggressive fibromatosis
desmoid fibromatosis
Notch-positive tumors
Lead sponsor: SpringWorks Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee, and applicable competent authority approval.


Eligibility criteria: Inclusion Criteria:

* Patient has a serious, debilitating or life-threatening medical condition that cannot be treated satisfactorily with an authorized medicinal product or other available standard treatment options, or all other treatment options have been exhausted.
* Patient does not qualify to participate in an ongoing clinical trial.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00185536: Effects of Advertising on Young Children's Perception of Taste
Official title: Effects of Advertising on Young Children's Perception of Taste
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Taste
preschool children
fast food
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2005-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: To test whether young children's actual taste preferences are influenced by the natural marketing environment in which they live. To do so, we tested whether preschool children would like the taste of a food more if they thought it was from a heavily marketed source. We asked preschool children to taste identical foods in packaging from this heavily marketed source and plain packaging, and to tell us if they tasted the same or if one tasted better. We hypothesized that, even among a sample of 3-5 year olds participating in Head Start, a federally-sponsored preschool program for low-income families, young children would prefer the taste of foods perceived to be from the heavily marketed source.


Eligibility criteria: Inclusion Criteria:

* enrolled at participating head start sites

Exclusion Criteria:

* unable to complete the study procedures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Thomas N. Robinson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Robinson TN, Borzekowski DL, Matheson DM, Kraemer HC. Effects of fast food branding on young children's taste preferences. Arch Pediatr Adolesc Med. 2007 Aug;161(8):792-7. doi: 10.1001/archpedi.161.8.792.
Clinical trial NCT04478136: Can Blood Panels Provide Early Warning of Bleeding in Patients on ECMO?
Official title: Can Blood Panels Provide Early Warning of Bleeding in Patients on ECMO?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: ECMO
Bleeding
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 0
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: The population in this prospective cohort study will include sixty (60) adults 18 - 70 years who are anticoagulation (AC) with bivalirudin and placed on ECMO for cardiac and/or respiratory failure.

Brief summary: This is a prospective, observational study of 60 adult patients anticoagulated with bivalirudin for extracorporeal membrane oxygenation (ECMO). The study aims to identify the most precise early warning blood test or panel of blood tests to predict bleeding in patients on bivalirudin/ECMO. The project will involve comparing currently used blood tests with an extended panel of coagulation and metabolic blood tests with the aim of early warning of impending bleeding to allow intervention in the form of adjusted bivalirudin dose, modification of other risk factors, or transfusion with hemostatic products targeted to documented coagulation test abnormalities.


Eligibility criteria: Inclusion Criteria:

* adults 18 - 70 years who are anticoagulation (AC) with bivalirudin and placed on ECMO for cardiac and/or respiratory failure. Surgical and non-surgical patients will be included.

Exclusion Criteria:

* known pre-existing bleeding disorder (due to a factor deficiency that requires factor replacement, or platelet disorder), or a creatinine \> 2.0.

Primary outcomes:
measure: Number of participants with changes in extended blood panel (EBP) for each of the bleeding and non-bleeding patient groups.
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Number of participants designated as major bleeders (MB)
timeFrame: Up to 2 weeks
measure: Number of participants designated as non-major bleeders (NMB)
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Albert Einstein College
name: Kiri Mackersey, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04584736: To Evaluate the Efficacy and Safety in Patients With Primary Hypercholesterolemia
Official title: To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 283
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia.

Detailed description: A Multi-center, Randomized, Double-blinded, Active-controlled, Factorial Design Phase 3 Clinical Trial

Eligibility criteria: Inclusion Criteria:

* Patients with primary hypercholesterolemia

Exclusion Criteria:

* The subject not meet the specified LDL-C level

Primary outcomes:
measure: % change in LDL-C level from baseline at Week 8
timeFrame: Week 8
Secondary outcomes:
measure: Change in LDL-C level from baseline at Week 4 and Week 8
timeFrame: Week 4 and Week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangdong Sacred Heart Hospital
state: Korea
Study officials:
affiliation: +82-2-840-6982
name: dongryeong lee, Manager
role: STUDY_CHAIR
References:
citation: Jeong HS, Hong SJ, Cho JM, Han KH, Cha DH, Jo SH, Kang HJ, Choi SY, Choi CU, Cho EJ, Jeong YH, Gwon HC, Kim BK, Lee SY, Kim SH, Ahn JC, Hong YJ, Kim WS, Woo SI, Park TH, Han KR. A Multicenter, Randomized, Double-blind, Active-controlled, Factorial Design, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of Pitavastatin and Ezetimibe Versus Monotherapy of Pitavastatin in Patients With Primary Hypercholesterolemia. Clin Ther. 2022 Oct;44(10):1310-1325. doi: 10.1016/j.clinthera.2022.09.001. Epub 2022 Oct 12.
Clinical trial NCT06463236: Clinical Validation of the Management Process for Renal Anemia in Maintenance Hemodialysis Patients
Official title: Clinical Validation of the Management Process for Renal Anemia in Maintenance Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anemia of Chronic Kidney Disease
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 1296
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: This test aims to verify that the management process of renal anemia in maintenance hemodialysis patients can improve the hemoglobin compliance rate better than that of anemia management by primary doctors, and promote the system at the grassroots level to guide primary doctors in anemia management and improve the management standard of renal anemia in maintenance hemodialysis patients through prospective randomized controlled trials. To improve the anemia compliance rate of maintenance hemodialysis patients, and to improve the basic doctors' grasp of the anemia management guidelines, consensus and standard operating procedures.


Eligibility criteria: Inclusion Criteria:

① Age over 18 years old; ② Receive regular hemodialysis at least twice a week for at least 3 months, and have no plans to stop hemodialysis within 6 months since the start of the trial; ③ The patient voluntarily participated in this study.

Exclusion Criteria:

* Patients who have planned to undergo kidney transplantation or terminate hemodialysis during the study period; ② Previous history of bone marrow hematopoietic system diseases, such as combined myelodysplastic syndrome, multiple myeloma, and other diseases; ③ Any known hereditary blood disease, such as thalassemia, sickle cell anemia, pure red blood cell aplasia, etc.; ④ Active or chronic gastrointestinal bleeding; ⑤ There was a severe infection within one week prior to screening.

Primary outcomes:
measure: Changes in the one-year compliance rate of renal anemia
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
References:
Clinical trial NCT02547636: Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel
Official title: Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evaluation of Test Panel
Lead sponsor: BioFire Diagnostics, LLC
Sponsor class: INDUSTRY
Collaborators: name: BioFire Defense LLC
First posted: 2015-09-11
Enrollment: 1822
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with fever will be prospectively enrolled, and whole blood will be collected. Additional residual specimens left-over from standard of care laboratory testing will also be enrolled.

Brief summary: This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.


Eligibility criteria: Inclusion Criteria:

* Whole blood (prospectively collected via informed consent):
* Adult subject has a recorded or self-reported fever within the previous 24 hours
* Subject provides informed consent prior to enrollment and specimen collection
* Subject has not previously provided a whole blood specimen for this study

Whole blood (residual)

* Whole blood (in EDTA) submitted to laboratory for standard of care testing
* Specimen is not from an individual with a specimen previously enrolled in the study

Positive Blood Culture:

* Culture was detected as positive by an automated blood culture system
* Culture is not from a patient previously enrolled in the study

Negative Blood Culture:

* Culture not detected as positive by an automated blood culture system
* Culture is not from a patient previously enrolled in the study

Sputum:

* Specimen was accepted for testing by the respective site's microbiology laboratory
* Specimen is not from an individual that has a sputum already enrolled in the study

Primary outcomes:
measure: Clinical specificity of the FilmArray NGDS Warrior Panel
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Navy Medical Center San Diego/Naval Health Research Center
state: California
city: Honolulu
country: United States
facility: Tripler Army Medical Center
state: Hawaii
city: St. Louis
country: United States
facility: Washington University/Barnes Jewish Hospital
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
References:
Clinical trial NCT01421836: Prospective Study Comparing EUS vs ERCP Stent Insertion for Malignant Biliary Obstruction
Official title: Prospective Study Comparing EUS Guided Biliary Drainage and ERCP With Stent Placement for Malignant Biliary Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Tumor Appearance of Biliary System Obstruction
Keywords: stent patency
EUS guided insertion
ERCP guided insertion
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 1. Purpose of the study

   -To compare stent patency and complication rate between endoscopic ultrasound (EUS) guided stent insertion and endoscopic retrograde cholangiopancreatography (ERCP) guided stent insertion for malignant biliary obstruction
2. Subjects of the study

   -Patients who have biliary obstruction owing to malignant tumors
3. Methods of the study

   * Prospective randomized controlled study
   * Patients were enrolled randomly in two groups, EUS guided stent insertion group or ERCP guided stent insertion group
   * Patients will get assigned procedure (EUS guided stent insertion or ERCP guided stent insertion)for decompression of malignant biliary obstruction
   * After the procedure, regular follow up, blood test,and imaging test will be done to check sufficient biliary decompression,stent patency and complications.

Detailed description: 1. Inclusion criteria 1) age: 18 - 80 2) a patients who had common bile duct dilatation because of malignant distal common bile duct obstruction in radiologically 3) Hyperbilirubinemia (total bilirubin \>= 1.5 mg/dl) 4) inoperable state 5) a patients who agree to join this study
2. Exclusion criteria 1) a patients who can not endure sedation 2) a patients with bleeding tendency (PT \> 1.5 INR, PLT \< 50,000) 3) a patients with systemic infection 4) a patients who had hilar obstruction

Eligibility criteria: Inclusion Criteria:

* distal biliary obstruction due to malignant tumor
* unresectable tumor
* Jaundice

Exclusion Criteria:

* Children
* Hilar obstruction
* Active infection
* Bleeding tendency

Primary outcomes:
measure: stent patency (days)
timeFrame: six months
Secondary outcomes:
measure: complication rate
timeFrame: six months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Irwon-dong, Gangnam-gu
Study officials:
affiliation: Division of Gastroenterology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Kwanghyuck Lee, MD, phD
role: STUDY_DIRECTOR
References:
citation: Park JK, Woo YS, Noh DH, Yang JI, Bae SY, Yun HS, Lee JK, Lee KT, Lee KH. Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study. Gastrointest Endosc. 2018 Aug;88(2):277-282. doi: 10.1016/j.gie.2018.03.015. Epub 2018 Mar 30.
Clinical trial NCT03576118: Moderate vs Deep Neuromuscular Block on Biotrauma During Laparoscopy
Official title: The Effects of Moderate Versus Deep Neuromuscular Block on Respiratory Mechanics and Biotrauma in Patients With Intraoperative Protective Lung Ventilation for Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pneumoperitoneum
Keywords: biotrauma
laparoscopic surgery
neuromuscular block
sugammadex
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 74
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purposes of this study is to investigate the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy.

Detailed description: Mechanical ventilation results in the disruption of the alveolar-capillary barrier and increased permeability, a hallmark of experimental ventilator-induced lung injury. These mechanical forces also induce an increase in the concentrations of inflammatory cytokines.

The benefits of deep neuromuscular blocks for laparoscopic procedures are controversial and most of the studies undertaken have only sought to improve surgical conditions. Theoretically, deep neuromuscular block permits a lower abdominal insufflation pressure, which leads to better respiratory mechanics and gas exchange. The investigators examined the effects of moderate vs. deep neuromuscular block on respiratory mechanics and biotrauma in patients with intraoperative protective lung ventilation for laparoscopy. The investigators hypothesized that deep neuromuscular block (PTC 1 or 2) and low pressure pneumoperitoneum (8 mmHg) would improve respiratory mechanics and reduce inflammatory processes associated with biotrama during mechanical ventilation compared with moderate neuromuscular block (TOF count 1 or 2 ) and standard pressure pneumoperitoneum (12-15 mmHg).

Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II, aged 25 to 80 years, scheduled for laparoscopic surgery with trendelenburg position

Exclusion Criteria:

* cerebrovascular disease
* uncontrolled hypertension, asthma, COPD
* neuromuscular disorder
* patients who have had abdominal surgery
* morbid obesity (body mass index \> 35 kg/m2)

Primary outcomes:
measure: Change of Cytokine
timeFrame: baseline, end of pneumoperitoneum, 24 hr after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
Study officials:
affiliation: Ajou University Hospital, Suwon, Gyeongki-do, Korea,
name: Jong Yeop Kim
role: PRINCIPAL_INVESTIGATOR
References: