louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00781105: Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
Official title: An Open-label, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Keywords: Chronic hepatitis B
Adult
HBV DNA suppression
Telbivudine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-10-28
Enrollment: 2200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52.


Eligibility criteria: Inclusion Criteria:

* Male or female 16 to 65 year of age
* Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
* Willing and able to comply with the study drug regimen
* Written informed consent before any assessment

Exclusion Criteria:

* Patient has a history of/or clinical signs/symptoms of hepatic decompensation
* Patient has a history of HCC or findings suggestive of possible HCC
* Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
* History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
* Patient has received IFN or other immunomodulatory treatment with 12 months before screening
* Previous treatment history with NRTIs

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: HBV DNA PCR negativity rate
timeFrame: at 52 weeks
Secondary outcomes:
measure: HBV DNA PCR negativity rate
timeFrame: at week 24
measure: DNA reduction
timeFrame: from baseline to Weeks 12, 24, 36, 52
measure: HBeAg loss rate
timeFrame: at week 52
measure: HBeAg seroconversion rate
timeFrame: at week 52
measure: ALT normalization rate
timeFrame: at weeks 24 and 52
measure: Incidence of AE (SAE,etc), Graded lab abnormalities
timeFrame: at week 52
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Beijing Friendship Hospital
name: Jia Jidong, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01107405: Loteprednol Ophthalmic Base Compared to Loteprednol Ophthalmic Suspension vs Placebo in an Allergen Challenge
Official title: Efficacy of Loteprednol Etabonate Ophthalmic Base Compared to Loteprednol Etabonate Ophthalmic Suspension vs Placebo in a Modified Conjunctival Allergen Challenge(CAC) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-04-21
Enrollment: 101
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the efficacy of loteprednol etabonate ophthalmic base, compared to loteprednol etabonate ophthalmic suspension, and vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in a modified Conjunctival Allergen Challenge model and in an environmental model during pollen season. Comparisons will be made following 2 weeks of dosing.


Eligibility criteria: Inclusion Criteria:

* Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
* Calculated best-corrected visual acuity of 0.70 logMAR or better in each eye as measured using the ETDRS chart.
* Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
* Positive bilateral CAC reaction in 1 out of 3 time points for the initial and re-challenge at visit 2.

Exclusion Criteria:

* Known contraindications or sensitivities to the study medication or its components.
* Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
* Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Primary outcomes:
measure: Ocular Itching
timeFrame: Visit 4 (8 hr re-challenge)
measure: Conjunctival Redness
timeFrame: Visit 4 (8 hr re-challenge)
Secondary outcomes:
measure: Ocular Itching
timeFrame: Visit 3 (initial challenge)
measure: Conjunctival Redness
timeFrame: Visit 3 (initial challenge)
measure: Ocular Itching
timeFrame: Visit 4 (initial challenge)
measure: Conjunctival Redness
timeFrame: Visit 4 (initial challenge)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Tuyen Ong, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04266405: Efficacy Testing of Collagen and Zhuyin Drinks
Official title: Efficacy Testing of Collagen and Zhuyin Drinks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess collagen and zhuyin drink on skin \& body condition improvement


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
* Vegetarian
* Subjects who have large spots (area \>3 square centimeter) or abnormal acne.

Primary outcomes:
measure: The change of skin moisture
timeFrame: Change from Baseline skin moisture at 4 weeks
measure: The change of skin wrinkles
timeFrame: Change from Baseline skin wrinkles at 4 weeks
measure: The change of skin collagen density
timeFrame: Change from Baseline skin collagen density at 4 weeks
measure: The change of TEWL
timeFrame: Change from Baseline TEWL at 4 weeks
measure: The change of skin brightness
timeFrame: Change from Baseline skin brightness at 4 weeks
measure: The change of interleukin-6
timeFrame: Change from Baseline skin brightness at 4 weeks
measure: The change of interleukin-8
timeFrame: Change from Baseline skin brightness at 4 weeks
measure: The change of Tumor necrosis factor
timeFrame: Change from Baseline skin brightness at 4 weeks
measure: The change of Matrix metalloproteinase-1
timeFrame: Change from Baseline skin brightness at 4 weeks
measure: The change of metallopeptidase inhibitor 1
timeFrame: Change from Baseline skin brightness at 4 weeks
Secondary outcomes:
measure: The change of skin texture
timeFrame: Change from Baseline skin texture at 4 weeks
measure: The change of skin pores
timeFrame: Change from Baseline skin pores at 4 weeks
measure: The change of skin spots
timeFrame: Change from Baseline skin spots at 4 weeks
measure: The change of red areas
timeFrame: Change from Baseline red areas at 4 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chia Nan University of Pharmacy ＆ Science
Study officials:
References:
Clinical trial NCT03401905: Effects of Low Versus High Frequency Percutaneous Electrical Nerve Stimulation on Chronic Neck Pain Patients.
Official title: Comparison and Effects of Low and High Frequency Percutaneous Electrical Nerve Stimulation on Myofascial Chronic Neck Pain Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Chronic Pain
Myofascial Pain Syndrome
Keywords: Percutaneous electrical nerve stimulation
Myofascial trigger point
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind randomized control trial.
Primary purpose: TREATMENT

Brief summary: Comparison between high and low frequency percutaneous electrical nerve stimulation as treatment of myofascial chronic neck pain. The main hypothesis is that low frequency treatment will have more hypoalgesic effects than high frequency, and low frequency effects will last longer.


Eligibility criteria: Inclusion Criteria:

* Neck pain of more than 6 months of evolution.
* Pain level of more than 30 millimeter on the VAS scale.
* Active myofascial frigger points on upper trapezius muscle.

Exclusion Criteria:

* Upper limb radiculopathy.
* Recent whiplash.
* Cervicogenic dizziness.
* Migraine.
* Previous cervical surgery.

Primary outcomes:
measure: Pain
timeFrame: Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.
Secondary outcomes:
measure: Pressure pain threshold
timeFrame: Changes on pain will be assessed during one month follow up. Baseline will be measured on the first day and one month later pain score will be reassessed.
measure: Neck disability index.
timeFrame: Pre treatment at the beginning of the study and one month later, on the last of the follow up period.
measure: kinesiofobia
timeFrame: Pre treatment at the beginning of the study and one month later, on the last of the follow up period.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU La Salle
Study officials:
affiliation: CSEU La Salle
name: Jose V León Hernández, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03817905: Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach
Official title: Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Positive FIT or Stool DNA Testing Follow up
Keywords: Colonoscopy
Fecal Immunochemical Testing
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study seeks to determine whether a patient navigator can help improve follow up care after a stool test shows the presence of blood or other abnormal markers.

Detailed description: Participants who recently had a stool test that had abnormal results will be asked to participate in this study in order to determine whether the use of a navigator can increase the use of colonoscopy, which is the recommended follow up to an abnormal stool test. A navigator is an individual trained to help patients access necessary health care services and understand the test results and next steps. Participants will be asked to meet the navigator at their colonoscopy appointment and discuss any problems that are experienced in getting the colonoscopy done. This will take about 10 minutes to complete. Participants will tell him or her in their own words how the experience was and whether they faced any barriers to scheduling and colonoscopy completion. Study personnel will also look at participants' electronic medical record to see what testing participants had done that prompted the need for colonoscopy.The study will include about 30 people.

Eligibility criteria: Inclusion Criteria:

• Positive test for FIT or sDNA

Exclusion Criteria:

• Does not understand English

Primary outcomes:
measure: Number of participants completing a follow-up colonoscopy procedure
timeFrame: Up to 6 months from start of study
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Gregory Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00275405: Effect of Garlic on Inflammatory Mediators
Official title: Effect of Garlic Oil Macerate on Inflammatory Mediators in Healthy Normal Weight and Obese Subjects.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Healthy
Keywords: Effects of Garlic
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2006-01-12
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research will investigate the effect of garlic oil extract when added to daily diet on inflammatory mediators and blood clotting activation.

Detailed description: To investigate the pharmacokinetics of one of the garlic oil macerate, Ajoene, the anti-inflammatory effect of garlic oil macerate on the pro-inflammatory transcription factor NF-kB, it's activating proteins, including IkB, IkB Kinases a and B (IKKa and IKKB) and the pro-inflammatory NF-kB-regulated proteins, c-reactive protein (CRP), tumor necrosis factor-alpha (TNF-a), soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), matrix metalloproteinase-9 (MMP-9), plasminogen activated protein-1 (PAI-1)and the effect of garlic oil macerate intake on platelet activation in normal subjects.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Normal subjects with BMI \<25, obese subjects with BMI \>30
* Subjects who have consented to adhere to the diet, regular weekly visits, and blood draws.

Exclusion Criteria:

* Subjects on any antioxidant medication.
* Patient on non-steroidal anti-inflammatory drug.
* On any agent with antioxidant properties.
* History of drug or alcohol abuse.
* Any life threatening disease.
* On any agent with significant antioxidant properties.
* Taking garlic extracts in the diet regularly.

Primary outcomes:
measure: 1. To examine the pharmacokinetics of the garlic oil macerate.
Secondary outcomes:
measure: 2. To examine the effect of garlic oil macerate on inflammatory mechanisms at the cellular and molecular level.
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Albany Medical College
name: Howard S Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albany College of Pharmacy
name: Shaker A Mousa, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albany College of Pharmacy
name: Ahmad Aljada, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06550505: Management of the Patient at High Risk Hemorrhagic in Cardiac Surgery by Monitoring Viscoelastic Hemostasis.
Official title: Evaluation and Follow-up of a Protocol for the Management of the Patient at High Risk Hemorrhagic in Cardiac Surgery by Monitoring Viscoelastic Hemostasis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 30
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: Adult patients. Elective or non-elective heart surgery. High risk of bleeding.

Brief summary: Evaluation and following of a protocol using viscoelastic test for the management of high risk patients in cardiac surgery

Detailed description: Haemorragy is a frequent issue in cardiac surgery due to multiple contributing factors. Excessive bleeding as well as transfusion are associated with increased morbidity and mortality.

Haemostatic blood products (Fibrinogen, fresh frozen plasma, platelets) transfusion had historically been guided by routine coagulation tests (aPTT, PT, platelets and fibrinogen). However, the delay (Up to 60 minutes) often leads to an empirical use of blood products in a context where clinical judgment is unreliable due to the multiples mechanisms contributing to haemostatic failure.

Using viscoelastic tests (VET) in this context has several advantages :

* A quicker response (with first results from 10 minutes)
* An overall evaluation of haemostatic from the clot formation to its dissolution.

The use of VET has mainly been evaluated in cardiac surgery, with several recent meta-analysis : The use of transfusion algorithms based on VET is associated with less transfusions of red blood cell concentrates, plasma and platelets and also with less mortality, less re-interventions due to excessive bleeding and less post operative renal failure.

These data led the international society for the study of hemostasis and thrombosis (ISTH) to recommend their use of VET in cardiac surgery. In France, the proposals of the peri operative hemostatis group of interest (GIHP) also support their use, specifying that there is no unique consensual algorithm.

Considering this, the investigator established a transfusion algorithm based on the Quantra, a viscoelastic device using sonorrheometry, to guide transfusion in high-risk of bleeding cardiac surgery patients.

Eligibility criteria: Inclusion Criteria :

* Adult patients
* Elective or non-elective high risk of bleeding heart surgery
* Non-opposition

Exclusion Criteria:

* Pregnant women
* Age \< 18 years
* Patients under guardianship
* Opposition

Primary outcomes:
measure: fresh frozen plasma transfusion
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU BREST, Hôpital de la Cavale Blanche
Study officials:
References:
Clinical trial NCT03567005: Clinical Validation of DACP Digital Design
Official title: Clinical Validation of DACP Digital Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2018-06-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.


Eligibility criteria: Inclusion Criteria:

* Willing and able to sign an IRB/IEC approved Informed Consent form;
* Current wearer of DACP spherical contact lenses (at least 2 months in current correction), with a minimum wearing time of 5 days per week and 8 hours per day;
* Experiencing symptoms of eye strain from using technology;
* Willing to wear study lenses each day;
* Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
* Willing to NOT use rewetting/lubricating drops at any time during the study;
* Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
* Willing to NOT use any near aid (e.g. reading glasses) at any time during the study.

Exclusion Criteria:

* Conditions, use of medications, injury, or surgery, as specified in the protocol;
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
* Monocular (only one eye with functional vision);
* Pregnant.

Primary outcomes:
measure: Distance Visual Acuity (VA) (logMAR, OU)
timeFrame: Day 7, each product
Secondary outcomes:
measure: Overall Vision
timeFrame: Day 7, each product
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Alcon Investigative Site
state: Illinois
city: Powell
country: United States
facility: Alcon Investigative Site
state: Ohio
city: Brentwood
country: United States
facility: Alcon Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
Study officials:
affiliation: Alcon Research
name: Alcon Research
role: STUDY_DIRECTOR
References:
Clinical trial NCT04991805: Descriptive Study of the Incidence of Malignancy in Severe Asthma Patients Receiving Benralizumab and Other Biologic Therapy, a Post Authorization Safety Study
Official title: Descriptive Study of the Incidence of Malignancy in Severe Asthma Patients Receiving Benralizumab and Other Biologic Therapy, a Post Authorization Safety Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Neoplasms
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-08-05
Enrollment: 14000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients with severe asthma recruited into ISAR and CHRONICLE. Severe asthma patients are defined as those receiving treatment consistent with Global Initiative for Asthma (GINA) Step 5 or who are uncontrolled on GINA Step 4 treatment regimens. The three main study groups are: severe asthma patients who receive benralizumab, who receive non-benralizumab biologics, and those who do not receive any biologics.

Brief summary: This is a real-world, observational, prospective cohort study in patients with severe asthma recruited into the International Severe Asthma Registry (ISAR) and the US severe asthma registry (CHRONICLE) and followed-up for occurrence of new malignancies. The primary objective is to measure the incidence of malignancy in the overall severe asthma population as well as its relevant subgroups, including patients receiving benralizumab, patients receiving non-benralizumab biologics, and patients not receiving biologics. The secondary objective is to describe the clinical characteristics of new malignancy cases that develop in severe asthma patients and relevant subgroups.


Eligibility criteria: Inclusion Criteria:

* The study population includes patients with severe asthma recruited into ISAR and CHRONICLE. Severe asthma patients are defined as those receiving treatment consistent with Global Initiative for Asthma (GINA) Step 5 or who are uncontrolled on GINA Step 4 treatment regimens.

Exclusion Criteria:

- Patients who are not willing and able to sign written informed consent

Primary outcomes:
measure: Neoplasm
timeFrame: Annually, up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Research Site
city: Norwich
country: United Kingdom
facility: Research Site
state: Norfolk
Study officials:
affiliation: AstraZeneca
name: Adrian P.J. Rabe, DHPeD, MSc, MD, FRSPH
role: PRINCIPAL_INVESTIGATOR
References: