louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03317223: A Phase 3 Study to Evaluate the Efficacy and Safety of Triple Therapy With CJ-12420 in H. Pylori Positive Patients
Official title: A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With CJ-12420, Amoxicillin and Clarithromycin in H. Pylori Positive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Infection
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2017-10-23
Enrollment: 350
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study is designed to demonstrate the non-inferiority of CJ-12420-based triple therapy (CJ-12420, amoxicillin and clarithromycin) versus lansoprazole-based triple therapy (lansoprazole, amoxicillin and clarithromycin) in H. pylori eradication rate and to evaluate the safety of CJ-12420 following oral administration of either triple therapy twice daily for 7 days in H. pylori positive patients.

Detailed description: This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (CJ-12420 50mg, lansoprazole 30mg). All subjects will be asked to take 5 tablets include clarithromycin, amoxicillin twice a day for 7 days.

After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.

Eligibility criteria: Inclusion Criteria:

* H. pylori-positive at screening
* Complain of gastric discomfort symptom

Exclusion Criteria:

* Having received prior therapy for eradication of H. pylori
* Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days
* Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days

Primary outcomes:
measure: H. pylori eradication rate
timeFrame: twice a day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Yong Chan Lee
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi YJ, Lee YC, Kim JM, Kim JI, Moon JS, Lim YJ, Baik GH, Son BK, Lee HL, Kim KO, Kim N, Ko KH, Jung HK, Shim KN, Chun HJ, Kim BW, Lee H, Kim JH, Chung H, Kim SG, Jang JY. Triple Therapy-Based on Tegoprazan, a New Potassium-Competitive Acid Blocker, for First-Line Treatment of Helicobacter pylori Infection: A Randomized, Double-Blind, Phase III, Clinical Trial. Gut Liver. 2022 Jul 15;16(4):535-546. doi: 10.5009/gnl220055. Epub 2022 Jul 6.
Clinical trial NCT02604823: A Study of Peginterferon Alfa-2a (Pegasys) in Participants With Hepatitis B E-Antigen (HBeAg)-Positive Chronic Hepatitis B Virus (HBV)
Official title: Efficacy and Safety of Peginterferon Alfa-2a (40 KD) (Pegasys®) in Patients With HBeAg-Positive Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-11-13
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study of the efficacy and safety of peginterferon alfa-2a (Pegasys) in naive, interferon- or lamivudine-pretreated participants with HBeAg-positive chronic HBV. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult participants between 18 to 65 years of age
* HBeAg-positive chronic HBV
* Treatment-naive, or have received and have not responded to or have relapsed on either conventional interferon or lamivudine therapy.

Exclusion Criteria:

* Antiviral or interferon-based therapy for chronic HBV within 6 months of enrollment
* Co-infection with active hepatitis A, C or D virus or with human immunodeficiency virus (HIV)
* Evidence of decompensated liver disease
* Medical condition associated with chronic liver disease other than viral hepatitis.

Primary outcomes:
measure: Percentage of participants with HBV deoxyribonucleic acid (DNA) less than (<) 100,000 copies per milliliters (copies/mL)
timeFrame: 72 weeks
measure: Percentage of participants with HBeAg seroconversion
timeFrame: 72 weeks
Secondary outcomes:
measure: Number of participants who achieved HBV DNA levels below limit of detection
timeFrame: Weeks 48 and 72
measure: Number of participants with HBsAg loss
timeFrame: Weeks 48 and 72
measure: Number of participants with both Hepatitis B Surface Antigen (HBsAg) loss and presence of Anti-HBs
timeFrame: Weeks 48 and 72
measure: Number of participants with alanine aminotransferase (ALT) normalization
timeFrame: Weeks 48 and 72
measure: Number of participants with combined response (HBV DNA <100,000 copies/mL, HBeAg loss, and ALT normalization)
timeFrame: Weeks 48 and 72
measure: Incidence of adverse events
timeFrame: up to 72 weeks
Other outcomes:
Locations:
city: Beijing
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT04448223: A Clinical Study to Evaluate the Efficacy and Safety of CKD-351
Official title: Multi Center, Randomized, Open-label, Active Controlled, Phase 2 Trial, Proof Of Concept Study to Evaluate the Efficacy and Safety of CKD-351 in Primary Open Angle Glaucoma or Ocular Hypertension Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Keywords: Primary Open-angle Glaucoma
Ocular Hypertension
CKD-351
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy and safety of CKD-351

Detailed description: Multi center, Randomized, Open-label, Active controlled, Phase 2 trial, Proof Of Concept Study to evaluate the efficacy and safety of CKD-351 in primary open angle glaucoma or ocular hypertension patients

Eligibility criteria: Inclusion Criteria:

1. More than the age of 19 years old
2. Subjects who has primary open-angle glaucoma or ocular hypertension
3. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

1. Subjects with intraocular pressure ≥ 35 mmHg at Visit 1 or Visit 2 (AM 09:00)
2. Subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at Visit 1 or Visit 2
3. Subjects who were diagnosed as below

   * Aphakia
   * Intraocular lens
   * Acute or Chronic Closed-Angle Glaucoma
   * Secondary Glaucoma
4. Subjects with ocular inflammation or infection within the last 3 months
5. Subjects with significant history of ocular trauma during the last 6 months or who underwent surgical opthalmic surgery
6. Subjects who received topical or systemic steroids within the last 1 month.

Primary outcomes:
measure: Change in mean intraocular pressure for efficacy measurement
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Change in mean intraocular pressure for efficacy measurement
timeFrame: Baseline, 2 weeks
measure: Changes in intraocular pressure for efficacy measurement
timeFrame: Baseline, 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: KiHo Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00076323: A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency
Official title: A New Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucosephosphate Dehydrogenase Deficiency
Favism
Keywords: G6PD
Favism
G6PD Deficiency
hemolysis
drug reaction
drug-induced hemolysis
Lead sponsor: Walter Reed Army Institute of Research (WRAIR)
Sponsor class: FED
First posted: 2004-01-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will evaluate a new and safe testing method for identifying medicines that can cause problems in glucose-6-phosphate dehydrogenase (G6PD) deficient individuals. We are looking for volunteers with G6PD deficiency who would be willing to donate blood samples.


Eligibility criteria: Inclusion:

* Normal clinical evaluation
* Willing and able to make all scheduled visits

Exclusion:

* pregnant or planning pregnancy
* Have taken any anti-malarial medication in past month
* Positive blood tests for HIV and specific types of hepatitis
* Allergic to primaquine

Primary outcomes:
measure: Difference in degree of hemolysis of G6PD(-) red blood cells in treated vs untreated matched samples.
Secondary outcomes:
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Walter Reed Army Institute of Research
state: Maryland
Study officials:
affiliation: WRAIR, Experimental Therapeutics
name: Shon A Remich
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615523: Executive Function in Preterm Born Children: An Integrative Approach From Genetics to Brain Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preterm Infants
Keywords: Executive functions
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents born preterm with their peers as controls

Brief summary: Hd-EEG and MRI measures are used to study the maturation of functional networks in order to identify the neural circuits underlying executive and memory processes in children born preterm. It will be determined whether children born preterm with executive function deficits will have an abnormal connectivity between basal ganglia and cortex due to WM injury. Moreover, the development of hd-EEG activity during sleep (coherence and travelling waves) and brain maturation of children and adolescents born preterm will be compared with the respective measures in healthy controls. This is of eminent importance as it helps to understand the nature of executive function and hence, it may help to develop neuroprotective strategies to prevent executive function deficits in these infants.


Eligibility criteria: Inclusion criteria:

* Schoolchildren between 10 and 12 or 14 and 16 (born between 1996 and 1998 or between 2000 and 2002)
* Preterm group: born \<32 weeks of gestation
* Control group: siblings or friends of preterm group in one of the two age groups

Exclusion criteria:

* Preterm Group: MDI \< 85 at 5 years of age; cerebral palsy
* Control Group: born \<37 weeks of gestation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Division of Neonatology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Division of Neonatology
name: Cornelia F Hagmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00524823: Early Detection of Prostate Cancer by FACS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Hyperplasia
Keywords: Prostate Cancer
Hyperplasia - BPH
FACS
Prostate Cancer, Hyperplasia - BPH, Malignancy
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2007-09-05
Enrollment: 40
Sex: MALE
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Early detection of prostrate cancer and development of metastases. The research will attempt to match the SCM test (structuredness of the cytoplasmic matrix) in lymphocytes as an early cancer detection test using Florescent Activated Cell Sorting (FACS) as a replacement for the CellScan instrument. The test is based on measurement of cellular changes in response to the specific prostate antigen, PSA.


Eligibility criteria: Inclusion Criteria:

Experimental group : Males between the ages of 60-90 years, with medical diagnosis of prostate cancer according to both clinical and hematological examinations, before receiving any medical treatment.

Control Group 1: Males between the ages of 60-90 years, with diagnosed benign prostate hyperplasia -BPH.

Control Group 2: Males between the ages of 60-90 years, medically diagnosed as healthy.

Control Group 3: Males between the ages of 60-90 years, medically diagnosed with another form of cancer, not prostate.

Exclusion Criteria:

Experimental group: Other known cancer or systemic infection. Control Group 1: Other known cancer or systemic infection. Control Group 2:Past hematological disorders nor cancer growth history. other known systemic infection, nor urinary tract infection. Patients hospitalized for orthopedic injuries of any type who are otherwise free of urinary tract infections.

Control Group 3:Other known systemic infection, nor urinary tract infection.

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Urology Department, Ziv Medical Center
Study officials:
affiliation: Ziv Medical Center
name: Nina Kucherski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klein O, Lin S, Embon O, Sazbon A, Zidan J, Kook AI. An approach for high sensitivity detection of prostate cancer by analysis of changes in structuredness of the cytoplasmic matrix of lymphocytes specifically induced by PSA-ACT. J Urol. 1999 Jun;161(6):1994-6.
citation: Altman, Roberta. The prostate Answer Book. Warner Books, lnc., 1993.
citation: American Cancer Society. National Cnference on Prostate Cancer. Philadelphia, Pennsylvania: September/October 1994.
citation: Rous, Stephen N., M.D.; The prostate Book. W.W. Norton & Co., 1992.
Clinical trial NCT06682923: MolecuLightDX Measurement Feature Clinical Validation
Official title: Evaluation of the MolecuLightDX Device in the Measurement of Surface Wounds in Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wounds
Wound of Skin
Lead sponsor: MolecuLight Inc.
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 72
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 22 years and older with surface wounds

Brief summary: This is a prospective, single-arm, paired clinical evaluation of the MolecuLightDX device in the measurement of surface wounds in patients.

Detailed description: The study compares the accuracy of wound measurements (area, length, and width) obtained using the ruler (standard of care) method and the MolecuLightDX device with a ground truth measurement (reference standard) derived from an expert panel.

Eligibility criteria: Inclusion Criteria:

* Willing to consent
* Willing to comply with all study procedures and availability for the duration of the study
* Male or female, aged over 22 years old
* Presented with diabetic foot ulcers, venous, arterial and pressure ulcers
* Wound size is greater than 0.5 cm2
* The wound has well-defined wound borders

Exclusion Criteria:

* Circumferential wound
* Wound without clearly defined wound borders
* Wound located in a difficult to reach/measure location
* Any contra-indication to routine wound care and/or monitoring
* Wounds with a length greater than 18.5cm or a width greater than 13.5cm.
* Tunneled or undermined wounds

Primary outcomes:
measure: Mean and SD of percent error for wound area by the MLI device in manual and automatic modes and by ruler
timeFrame: up to 6 months
Secondary outcomes:
measure: Mean and standard deviation of inter- and intra-user coefficient of variation (CV) for wound area measured by the MolecuLight device in manual and automaitc modes
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: The Mayer Institute
state: Ontario
city: Scarborough
country: Canada
facility: SHN Research Institute
state: Ontario
Study officials:
References:
Clinical trial NCT02990923: High-Flow Needleless Valve and DualCap Disinfection Devices Associate With Catheter-related Bloodstream Infection
Official title: The Effect of High-Flow Needleless Valve and DualCap Disinfection Devices on Incidence of Catheter-related Bloodstream Infection in Hemodialysis Patients: a Single Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Catheter-related Bloodstream Infection
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2016-12-13
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate whether the usage of High-Flow Needleless Valve and DualCap Disinfection Devices would reduce the incidence of catheter-related bloodstream infection in hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* Implanted non-tunneled cuff catheter for any reason and going on blood purified therapy in our centre
* Have signed information consent form

Exclusion Criteria:

* Have got bacteremia before catheter implantation
* Catheter changing in situ

Primary outcomes:
measure: Catheter-related bloodstream infection
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Number of participants with catheter withdraw for any reason
timeFrame: through study completion, an average of 1 year
measure: Number of participants with catheter dysfunction
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01702623: Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seizures
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-10-08
Enrollment: 64
Sex: ALL
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: The objective of this study was to prove the bioequivalence of Roxane Laboratories' Oxcarbazepine Suspension 600 mg under fasted conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to oxcarbazepine or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 10 Days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
state: Texas
Study officials:
affiliation: Worldwide Clinical Trials Drug Development Solutions (formerly CEDRA Clinical Research)
name: Cynthia Zamora, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00232323: Simulation Training as a Tool to Decrease Occupational Stress in ICU Personnel
Official title: Experimental Like Study of Stress Reduction in Intensive Care Teams by Use of Simulation Training
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Education, Health
Keywords: intensive care
stress
education
simulation
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2005-10-04
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: ECT

Brief summary: The purpose of the study is to check wether training mixed teams of physicians and nurses from intensive care units on patient simulators reduces stress in team members.

Detailed description: Patient safety and the prevention of medical error are primary goals of healthcare organizations. Stress reduction may reduce or ameliorate such errors. Simulation training, using advanced patient simulators, has been shown to improve diagnostic, resuscitation and technical skills amongst physicians and nurses.We intend to check wether stress during ICU shifts may be reduced by using specifically designed scenarios based on real life experience,in integrative multidisciplinary ICU teams.

Eligibility criteria: Inclusion Criteria:

* intensive care physicians and nurses working in respiratory ICU willing to participate in the study

Exclusion Criteria:

* unwilling to participate

Primary outcomes:
measure: reduction of stress parameters
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center and Medical Simulation Center
name: Asaph E Nini, MD
role: PRINCIPAL_INVESTIGATOR
References: