louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04539652: Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients
Official title: A Multicenter, Single-Arm, Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of TenofoBell® Tablet in Chronic Hepatitis B Patients in Treatment of Oral Antiviral Therapy for Hepatitis B Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-09-07
Enrollment: 78
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate the rate of subjects with HBV DNA less than 20 IU/mL after taking TenofoBell® tablet for 48 weeks


Eligibility criteria: 1. Inclusion Criteria:

1. Patients who show positive HBsAg
2. Patients who show positive or negative HBeAg

2. Exclusion Criteria:

1. Patients who have hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV)
2. Patients with a history of allergic reaction to Tenofovir
3. Patients who are unable to participate in clinical trials based on investigator's decision.

Primary outcomes:
measure: Rate of subjects with HBV DNA less than 20 IU/mL
timeFrame: change after 48 weeks compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Daegu Chatholic University Medical center
Study officials:
References:
Clinical trial NCT04648852: The HUNT for Heart Failure" Risk Score
Official title: Heart Failure Burden and Heart Failure Risk in the General Population in Norway: "The HUNT for Heart Failure" Risk Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: risk factor
population
diagnosis
prognosis
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: Norwegian University of Science and Technology
name: Vestre Viken Hospital Trust
First posted: 2020-12-02
Enrollment: 36511
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population

Brief summary: In this population study aim is to evaluate risk factors for heart failure and combine these into a new heart failure risk score.

Secondly, the heart failure risk score will be internally and externally validated, and compared with established heart failure risk scores. Additionally, the prevalence of heart failure as well as the distribution of the heart failure risk score in the general population will be evaluated.

Detailed description: Explore which clinical risk factors or patient characteristics in a general population that are associated with increased risk for heart failure events and combine these into a new population-based heart failure risk score ("The HUNT for heart failure risk score") for predicting heart failure risk

Validate the newly developed heart failure risk score internally in the HUNT2 database

Compare the predictive ability of the new heart failure risk score with established heart failure risk scores (the ABC Health HF risk score, the Framingham HF risk score) and an established Norwegian cardiovascular risk score (NORRISK 2)

Estimate the prevalence of likely ("undiagnosed") heart failure , i.e., patients at high risk of HF, in a general population by using both the established heart failure risk scores and the newly developed heart failure risk score, and compare the heart failure event rate between those at high risk of heart failure and those with established heart failure.

Eligibility criteria: Inclusion Criteria:

* Participation in the third or second wave of the HUNT study

Exclusion Criteria:

* Not willing to participate
* Missing vital data

Primary outcomes:
measure: Time to incident heart failure event
timeFrame: 10 years
Secondary outcomes:
measure: Time to death from any cause
timeFrame: 10 years
measure: Time to first heart failure event or death from any cause
timeFrame: 10 years
measure: Validity of heart failure risk score
timeFrame: 10 years
Other outcomes:
measure: Prevalence of heart failure
timeFrame: 0 days
measure: Distribution of heart failure risk score categories
timeFrame: 0 days
Locations:
city: Levanger
country: Norway
facility: Levanger hospital
state: Norge
Study officials:
affiliation: Helse Nord-Trøndelag HF
name: Håvard Dalen, MSc, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01531452: The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer
Official title: a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Keywords: Stomach Neoplasms
drug therapy
oxaliplatin
s1
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2012-02-13
Enrollment: 43
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 purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.

Detailed description: There was no evidence of standard chemotherapy for advanced gastric cancer (AGC) in China. Fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of AGC. Capecitabine/cisplatin combination therapy showed an overall response rate (ORR) of 41- 55%, a median time to progression/progression free survival (TTP/PFS) of 5.6-6.3 months, and a median overall survival (OS) of 10.1-10.5 months. Though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both S-1 and capecitabine appear to be comparable in terms of efficacy and safety. The investigators conducted a phase II trial of oxaliplatin combined with S-1 in the treatment of first-line AGC.

Eligibility criteria: Inclusion Criteria:

* Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma
* Measurable lesion and/or non-measurable lesion defined by RECIST
* ECOG performance status ≦ 1
* Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
* Creatine ≦ upper normal limit (UNL)
* Total bilirubin ≦ 1.5 X UNL
* AST, ALT and ALP ≦ 2.5 x UNL
* Subjects must be able to take orally
* No prior chemotherapy
* Life expectancy estimated than 3 months
* Written informed consent

Exclusion Criteria:

* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
* Known brain metastases
* History of hypersensitivity to fluoropyrimidines, oxaliplatin
* Active double cancer
* Treatment with any investigational product during the last 4 weeks prior to study entry
* Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0
* Any previous chemotherapy or radiotherapy for AGC

Primary outcomes:
measure: Progression Free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Response Rate
timeFrame: 2 years
measure: overall survival
timeFrame: 2 years
measure: number of participants with adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: cancer hospital & Institute,Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: cancer hospital&institute,Chinese Academy of Medical Sciences
name: Jinwan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01878552: Energy Load in Patients With Acute Respiratory Distress Syndrome (ARDS)
Official title: Energy Load During Mechanical Ventilation in Patients With Acute Respiratory Distress Syndrome (ARDS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 20
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: ARDS patients

Brief summary: The investigator would assess if there is an incremental energy load during mechanical ventilation in Acute Respiratory Distress Syndrome (ARDS) patients.

Detailed description: The investigator would study the inspiratory and expiratory pressure volume curve in ARDS patients and investigate if there is a correlation between the energy loss (hysteresis curve) and the severity of disease.

Eligibility criteria: Inclusion Criteria:

* ARDS patients

Exclusion Criteria:

* pediatric population
* Chronic Obstructive Pulmonary Disease (COPD)
* patients with hemodynamic instability

Primary outcomes:
measure: Mortality
timeFrame: Two weeks (average ICU stay)
Secondary outcomes:
Other outcomes:
Locations:
city: Mialn
country: Italy
facility: Policlinico hospital
Study officials:
References:
Clinical trial NCT04850352: Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea Extracts
Official title: A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Blood Triglyceride Decreasing Effect and Safety of Korean Post-Fermented Tea(Heukcha) Extracts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Triglycerides High
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-20
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study was conducted to investigate the effects of daily supplementation of Korean Post-Fermented Tea(Heukcha) Extracts on improvement of Blood Triglyceride Level.

Detailed description: This study was a 8 week, randomized, multicenter, double-blind, placebo-controlled, parallel-design human trial.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects older than 19 years old
* Who has fasting blood triglyceride levels ≥ 150 mg/dL
* Who voluntarily agreed to participate in the study and signed an informed consent form

Exclusion Criteria:

* Those who are taking functional food designed for dyslipidemia reduction within 4 weeks before study participation
* Those who have been diagnosed and are on medication with dyslipidemia, cardiovascular disease, kidney disease, liver disease or thyroid disease within 4 weeks before study participation
* Fasting plasma glucose \>126 mg/dL or treatment with medications including oral hypoglycemic agents or insulin
* Who has used or is expected to inevitably use prohibited concomitant medications during the study
* Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives
* Who has dosed other study medications within 30 days before screening
* Who is determined ineligible for study participation by investigators for any other reasons

Primary outcomes:
measure: Change in fasting triglycerides
timeFrame: Baseline, Week 4 and Week 8
Secondary outcomes:
measure: Change in total cholesterol, LDL-C, HDL-C
timeFrame: Baseline, Week 4 and Week 8
measure: Change in BMI (kg/m2)
timeFrame: Baseline, Week 4 and Week 8
measure: Change in Waist circumference (cm)
timeFrame: Baseline, Week 4 and Week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KangBuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital, College of Medicine, The Catholic University of Korea
Study officials:
affiliation: Seoul National University
name: Belong Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02163252: Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies: Study 5
Official title: Does Early Intervention Improve Weight Loss Outcomes Among Individuals Enrolled in an Internet-based Weight Loss Program?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 examine whether providing additional intervention support to individuals with lower than expected weight loss within the initial stages of an internet-based behavioral weight loss program improves weight loss outcomes at Week 12, compared to the internet program alone.


Eligibility criteria: Inclusion Criteria:

* age 18-70 years
* BMI \>=25 kg/m2
* No health problems that make weight loss or unsupervised exercise unsafe
* English speaking
* Access to computer/internet

Exclusion Criteria:

* report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire 62 (PAR-Q; items 1-4).
* Individuals endorsing joint problems, prescription medication use or other medical conditions that could limit exercise will be required to obtain written consent to participate from a health care provider
* are currently pregnant or intend to become pregnant in the next 12 months
* are planning to move outside of the state within the next 4 months

Primary outcomes:
measure: Change in weight
timeFrame: 12-week
Secondary outcomes:
measure: frequency of self-monitoring
timeFrame: 12 weeks
measure: exercise minutes
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital's Weight Control and Diabetes Research Center
state: Rhode Island
Study officials:
References:
Clinical trial NCT00625352: Study of Developing an Optimal Gemcitabine Based Regimen to Treat Elderly Patients With Advanced Non-Small Cell Carcinoma
Official title: Prospective Phase II Trial of a Combination of Gemcitabine and UFT as First-Line Treatment in Elderly Patients With Advanced Non-Small Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma, Non-Small-Cell Lung
Aged
Gemcitabine
UFT
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
Collaborators: name: Jeil Pharmaceutical Co., Ltd.
First posted: 2008-02-28
Enrollment: 48
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cares for elderly patients with advanced non-small cell lung cancer(NSCLC) become one of the common clinical practices oncologist are now facing. So, we need to seek adequate regimens for them. Gemcitabine is well known to be one of active third generation agents in terms of both efficacy and tolerability. Gemcitabine alone have been recommended as first line treatment for elderly NSCLC patients, especially in the aspect of tolerability. However, gemcitabine alone is suggested to be suboptimal to control their disease. Therefore, we plan to make an optimal regimen containing gemcitabine for the elderly patients.


Eligibility criteria: Inclusion Criteria:

* Histologically- or cytologically- confirmed Non-Small-Cell Lung Cancer Stage IIIB/IV
* No prior chemotherapy
* Existence of measurable disease. The measurable disease should not have been irradiated
* Life expectancy of more than 3 months
* Age ≥ 70 years
* Performance status (ECOG):1 or 2
* Adequate bone marrow function (Absolute neutrophil count \>1500/mm\^3, Platelet count\>100000/mm\^3, Hemoglobin\>9gr/mm\^3)
* Adequate liver (Bilirubin\<2 times upper limit of normal and SGOT/SGPT\<3 times upper limit of normal) and renal function (creatinine\<1.5mg/dl)
* Informed consent

Exclusion Criteria:

* Psychiatric illness or social situation that would preclude study compliance.
* Other concurrent uncontrolled illness.
* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
* Currently/recently taken warfarin, phenprocoumon or phenytoin
* Hypersensitivity history to any drug

Primary outcomes:
measure: overall response rate
timeFrame: every two cycles
Secondary outcomes:
measure: toxicity, response duration, progression free survival, overall survival
timeFrame: according to protocol
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References:
Clinical trial NCT05588752: Transverse Abdominal Plane Block for Caesarean
Official title: Efficacy of Transverse Abdominal Plane Block (TAP Block) With Bupivacaine and Dexamethasone for the Management of Post-cesarean Pain at the CHU Sourô Sanou (CHUSS) in Bobo-Dioulasso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caesarean Section; Pain
Keywords: Caesarean, TAP-block, Postoperative pain
Lead sponsor: Université NAZI BONI
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients admitted for caesarean under spinal anesthesia were randomized according to the sealed envelope method into two groups. Group 1 received 100 µg of morphine intrathecally at induction and group 2 a bilateral TAP block at the end of cesarean section with 20 ml of bupivacaine 0.25% and dexamethasone 4 mg in the same syringe on each side.
Primary purpose: OTHER

Brief summary: Cesarean sectionis a commonly performed major surgical procedure that results in significant postoperative pain. The objective of this study was to evaluate the effectiveness in the management of post-cesarean pain at the CHU Souro Sanou of Bobo-Dioulasso


Eligibility criteria: Inclusion Criteria:

* Adult parturients (≥ 18 years old) awaiting caesarean section under spinal anesthesia
* ASAI, ASAII

Exclusion Criteria:

* Lack of informed consent,
* Parturients with cognitive disorders,
* Parturients with notion of chronic pain,
* Allergy to local anesthetics,
* Morphine allergy
* Parturients not understanding pain assessment scores

Primary outcomes:
measure: Proportion of mild pain on mobilization in the first 24 postoperative hours
timeFrame: Hours 24 postoperative
Secondary outcomes:
measure: Proportion of mild pain at rest in the first 24 postoperative hours
timeFrame: Hours 24 postoperative
measure: Proportion of mild pain on mobilization in the first 48 postoperative hours
timeFrame: Hours 48 postoperative
measure: Proportion of nausea-vomiting postoperative during the first 48 hours
timeFrame: Hours 48 postoperative
measure: Proportion of maternal satisfaction during the first 48 hours postoperatively
timeFrame: Hours 48 postoperative
Other outcomes:
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: CHU Souro Sanou
state: Houet
Study officials:
References:
Clinical trial NCT01833052: CLaret Embolic Protection ANd TAVI - Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frequency of Cerebral Perfusion Defects After TAVI
Size of Cerebral Perfusion Defects After TAVI
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2013-04-16
Enrollment: 100
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 prospective, randomized study was designed to investigate the benefit of using a Filter-Protection-Device (Claret MontageTM Dual Filter System) during transcatheter aortic valve implantation (TAVI) with a Medtronic CoreValve®.


Eligibility criteria: Inclusion Criteria:

* Subject must be scheduled to undergo an endovascular aortic valve prosthesis (Medtronic CoreValve®) implant procedure with the femoral artery as the intended access site for the valve delivery system.

Exclusion Criteria:

* Patient is unsuitable for TAVI
* Prior Stroke or TIA in the last 12 month
* Carotic stenosis \>70%
* Relevant stenosis of the brachiocephalic trunc or the right subclavian artery
* Expected Non-compliance for follow-ups
* Pregnancy
* Patient is already recruited for another study

Primary outcomes:
measure: Rate and Size of Cerebral Embolism
timeFrame: 2 days after Intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Leipzig Herzzentrum
Study officials:
References:
citation: Haussig S, Mangner N, Dwyer MG, Lehmkuhl L, Lucke C, Woitek F, Holzhey DM, Mohr FW, Gutberlet M, Zivadinov R, Schuler G, Linke A. Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial. JAMA. 2016 Aug 9;316(6):592-601. doi: 10.1001/jama.2016.10302.
Clinical trial NCT02463552: Naproxen on Tooth Sensitivity Caused by In-office Bleaching
Official title: Rior Use of Naproxen on Tooth Sensitivity Reduction After In-office Bleaching: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toothache
Tooth Bleaching
Lead sponsor: Universidade Federal de Sergipe
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the effects of prior use of non-steroidal anti-inflammatory Naproxen on risk and level of tooth sensitivity caused by in-office bleaching procedures.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old patients of both genders presenting good general/oral health;
* All maxillary anterior teeth presenting shade equal or darker than 2M2 at Vita bleachguide guide (Vita-Zahnfabrik, Germany);
* Signed the form accepting to participate of this study.

Exclusion Criteria:

* Presence of caries lesions, restorations and/or endodontic treatment at any maxillary anterior teeth.
* Undergone tooth-whitening procedures;
* Pregnant/lactating;
* Presence of periodontal diseases;
* Presence of severe tooth discoloration by tetracycline stains or fluorosis;
* Any kind of medicine, bruxism habits or any other pathology that can cause sensitivity (such as recession, dentin exposure);
* Continuous use of drugs with anti-inflammatory actions;
* Presence of tooth hypersensitivity at baseline measurement;
* Any known adverse effects caused by Naproxen;
* Non-attendance to any session of evaluation or bleaching.

Primary outcomes:
measure: Risk to Tooth sensitivity - during procedure
timeFrame: During the bleaching procedure
Secondary outcomes:
measure: Level of tooth sensitivity - during procedure
timeFrame: During the bleaching procedure
measure: Risk of tooth sensitivity - after procedure
timeFrame: 24 hours after bleaching prcedure
measure: Level of tooth sensitivity - after procedure
timeFrame: 24 hours after bleaching prcedure
Other outcomes:
measure: Efficacy of bleaching
timeFrame: 7 days after bleaching procedure
Locations:
city: Aracaju
country: Brazil
facility: Universidade Federal de Sergipe
state: SE
Study officials:
References: