louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01226199: The Expression of TLR2 and TLR4 in the Lung of Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: The Expression of TLR2 and TLR4 in the Lung of COPD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smoking
COPD
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2010-10-22
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who will have lung resection for the therapeutic cause.

Brief summary: Smoking is the most important risk factor of COPD, but only a fourth of smokers had COPD in their life. There are also healthy smokers without evidence of COPD. Investigators hypothesize that innate immunity may affect this difference between COPD patients and healthy smokers, because TLR4 is the receptor of LPS, which is the one of important substance in cigarette. Investigators will measure TLR2 and TLR4 expression in lung tissue of patients whose lung will be resected. Investigators will compare the level of expression between COPD patients and healthy smokers.


Eligibility criteria: Inclusion Criteria:

* All patients who will have lung resection for the therapeutic cause.

Exclusion Criteria:

* Patients who do not agree with our study protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeongi
Study officials:
References:
Clinical trial NCT00143299: A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline
Official title: A 52-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety of Varenicline Tartrate ( CP-526,555) for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.


Eligibility criteria: Inclusion Criteria:

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects with clinically significant, recent cardiovascular disease.

Primary outcomes:
measure: Summarization of safety data in smokers treated with either varenicline or placebo.
Secondary outcomes:
measure: Information will be collected for the 7 day point prevalence of smoking cessation.
Other outcomes:
Locations:
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Milford
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Albuquerque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Syracuse
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Harleysville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Richmond
country: United States
facility: Pfizer Investigational Site
state: Virginia
city: Woodville South
country: Australia
facility: Pfizer Investigational Site
state: South Australia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Williams KE, Reeves KR, Billing CB Jr, Pennington AM, Gong J. A double-blind study evaluating the long-term safety of varenicline for smoking cessation. Curr Med Res Opin. 2007 Apr;23(4):793-801. doi: 10.1185/030079907x182185.
Clinical trial NCT05524142: Association Between ALDH2 Gene Polymorphism and Atrial Fibrillation
Official title: Association Between ALDH2 Gene Polymorphism and Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
ALDH2
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients diagnosed with atrial fibrillation in the Second Affiliated Hospital of Zhejiang University School of Medicine.

Brief summary: This study is a case-control study. In this study, 2ml of vein blood samples were collected from patients with atrial fibrillation undergoing radiofrequency ablation and those in the control group who underwent electrophysiological examination alone and confirmed no arrhythmia. The purpose of this study is to identify the relationship between the aldehyde dehydrogenase 2 (ALDH2) gene polymorphism and susceptibility to atrial fibrillation, and to explore the relationship between the genotype of ALDH2 SNP and the prognosis of patients with atrial fibrillation undergoing radiofrequency ablation.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent;

  * Age 18-85 years old, gender is not limited; ③ Case group: patients with clinical diagnosis of atrial fibrillation who underwent radiofrequency ablation; control group: patients with no arrhythmia confirmed by electrophysiological examination; ④ Able to communicate well with investigators and comply with the entire trial requirements.

Exclusion Criteria:

* Those who cannot understand or refuse to sign the informed consent or follow-up; ②Pregnant women, mentally retarded, mental/cognitive insufficiency and other possible vulnerable groups

Primary outcomes:
measure: atrial fibrillation recurrence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT05596942: Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic.
Official title: Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic: A Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sepsis
Keywords: sepsis
eNOS
NLR
PLR
Channa striata
albumin
inflammation
anti-oxidant
Lead sponsor: Universitas Sebelas Maret
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 42
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: Sepsis is an inflammation response produced by the host's immune system, which is agrravated by oxidative stress. One of the adjuvant therapy according to Surviving Sepsis Campaign Guideline is albumin, which has anti-inflammatory and anti-oxidant effects. However, human albumin is quite expensive, and other forms with similar potency and less costs are needed, one of which is Channa striata extract. Therefore, this study is conducted to compare albumin and human albumin, specifically their anti- inflammatory and anti-oxidant properties by assessing the eNOS marker, neutrophil/lymphocyte ratio (NLR) and platelet/lymphocyte ratio (PLR) in patient with sepsis.

Detailed description: In summary, this study showed that Channa striata extract has a better outcome in stabilizing eNOS level in patient with sepsis than human albumin 20%, and it has a potential benefit in stabilizing NLR values. However, further studies with a larger sample and a more advanced phase of sepsis are needed.

Eligibility criteria: Inclusion Criteria:

* patients sepsis who met the qSOFA criteria ≧ 2 \[two of which: unconsciousness (Glasgow Coma Scale ≤14)
* respiratory rate \> 22 and systolic blood pressure ≤ 100 mmHg\],
* aged ≧ 18 years
* admitted to intensive care unit and high care unit at Dr. Moewardi General Hospital

Exclusion Criteria:

* patients with severe trauma
* blood loss in stage three or higher
* stress ulcers
* a history of nephrotic syndrome
* refusal to participate

Primary outcomes:
measure: Endothelial Nitric Oxide Synthase
timeFrame: three days after treatment
Secondary outcomes:
measure: Neutrophil-Lymphocyte Ratio
timeFrame: three days after treatment
measure: Platelet-Lymphocyte Ratio
timeFrame: three days after treatment
Other outcomes:
Locations:
city: Sukoharjo
country: Indonesia
facility: Moewardi General Hospital
state: Central Jave
Study officials:
References:
Clinical trial NCT05746442: Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS
Official title: Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS (Project END-IT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
HIV
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: University of Oklahoma
name: M.D. Anderson Cancer Center
First posted: 2023-02-27
Enrollment: 800
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 goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.


Eligibility criteria: Inclusion Criteria:

* 1) being aged ≥18 years
* 2) being HIV-positive
* 3) self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes/day)
* 4) willing to set a date for a quit attempt within 2 weeks of study enrollment
* 5) being able to provide written informed consent to participate
* 6) being able to read Khmer (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form

Exclusion Criteria:

* 1) history of a medical condition that precludes use of nicotine replacement therapy
* 2) physician/clinician deemed ineligible to participate based on medical or psychiatric condition
* 3) enrolled in another cessation program or use of other cessation medications.

Primary outcomes:
measure: Self Reported 7 Day Abstinence Smoking Status
timeFrame: 12 Month Follow-Up
measure: Smoking Status by Expired Carbon Monoxide
timeFrame: 12 Month Follow-up
Secondary outcomes:
measure: Self Reported 7 Day Abstinence Smoking Status at 3 Months
timeFrame: At 3 Months
measure: Smoking Status by Expired Carbon Monoxide at 3 Months
timeFrame: At 3 Months
measure: Self Reported 7 Day Abstinence Smoking Status at 6 Months
timeFrame: At 6 Months
measure: Smoking Status by Expired Carbon Monoxide at 6 Months
timeFrame: At 6 Months
Other outcomes:
Locations:
city: Phnom Penh
country: Cambodia
facility: National AIDS Authority
city: Phnom Penh
country: Cambodia
facility: National Center for HIV/AIDS, Dermatology and STD
city: Phnom Penh
country: Cambodia
facility: National Institute of Public Health
Study officials:
affiliation: Moffitt Cancer Center
name: Damon Vidrine, Dr.PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Phnom Penh
name: Thanh Bui, Dr.PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02063542: CSF Cholinergic Biomarkers and Postoperative Cognitive Change
Official title: Cerebrospinal Fluid Cholinergic Biomarkers and Postoperative Cognitive Change in Aged Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrosis of Femoral Head
Knee Osteoarthritis
Fracture of Lower Limb
Keywords: Postoperative cognitive changes
Acetylcholine in CSF
Surgery
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 102
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Aged patients undergoing total knee replacement surgery.

Brief summary: Previous study demonstrated that the condition of central cholinergic nerve is important for the postoperative cognitive dysfunction. In present study investigators hypothesized that the acetylcholine concentration in the cerebral spinal fluid is associated to the postoperative cognitive changes in aged patients undergoing osteopathic surgery.


Eligibility criteria: Inclusion Criteria:

* Elder than 60 years old
* Spoke proficient Mandarin Chinese
* Agree to undergoing spinal plus general anesthesia
* Selected total knee replacement surgery

Exclusion Criteria:

* Patients with neurological and/or psychiatric diseases, including AD, stroke and psychosis
* Have contraindication for spinal anesthesia such as clotting disorder local infection in the puncture site
* Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
* Several audition or vision disorder
* Unwillingness to comply with the protocol or procedures.

Primary outcomes:
measure: Short-term postoperative cognitive dysfunction rate
timeFrame: The day before surgery and 7 days after surgery (or before leave hospital)
measure: Concentration of Acetylcholine in CSF
timeFrame: During spinal anesthesia
measure: Concentration of choline acetyltransferase in CSF
timeFrame: During spinal anesthesia
measure: Concentration of acetylcholinesterase in CSF
timeFrame: During spinal anesthesia
Secondary outcomes:
measure: Long-term postoperative cognitive dysfunction rate
timeFrame: Two months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Diansan Su, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT00909142: Bonefos and the Consumption of Analgesics
Official title: Bonefos and the Consumption of Analgesics. Influence of Clodronate on Analgesics Consumption Among Patients With Bone Metastasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Neoplasms
Keywords: Breast cancer
Prostate cancer
Multiple myeloma
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-05-27
Enrollment: 149
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: Random sample of cancer patients visting oncologist or urologist ambulance who are suitable for standard clodronate treatment.

Brief summary: The effect of Bonefos on consumption of analgesics (drugs used for pain treatment) in patients with proven bone metastases.


Eligibility criteria: Inclusion Criteria:

* Breast cancer or prostate cancer or multiple myeloma.
* Bone metastasis.
* Ability to use analgesics and clodronate 1600 mg/day.

Exclusion Criteria:

* Hypersensitivity to bisphosphonates.
* Clodronate in previous therapy.
* Concomitant use of other bisphosphonates.
* Serious renal insufficiency.

Primary outcomes:
measure: Analgesics consumption after 12 months of treatment with Bonefos in patients with bone metastases and breast or prostate cancer or multiple myeloma
timeFrame: 12 months
Secondary outcomes:
measure: Decrease in pain measured by VAS (Visual Analogue Scale)
timeFrame: 12 months
Other outcomes:
Locations:
city: Many locations
country: Czech Republic
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03219242: Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Using Caiman® Technology
Official title: Longitudinal Prospective Study on Primary Debulking Surgery Including Bowel Resection in Advanced Stage Ovarian Cancer Patients Using Caiman® Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Cancer
Keywords: Advanced ovarian cancer
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2017-07-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Longitudinal prospective study on primary debulking surgery including bowel resection in advanced stage ovarian cancer patients using Caiman® technology

Detailed description: Using CAIMAN® technology in primary surgery for advanced ovarian cancer including bowel resections.

Analyze potential time-sparing and the incidence of post-surgical complications.

Prospective, longitudinal, observational. 40 patients / year.

Eligibility criteria: Inclusion Criteria:

* Age ≤ 75 years
* Patients with advanced ovarian cancer (FIGO stage IIIC-IV).
* Bowel resection
* Class 0-2 according to the American Society of Anesthesiologists (i.e.: ASA score ≤ 2)
* Written informed consent to the study

Exclusion Criteria:

* Pregnant or chronic infections
* Previous pelvic radiotherapy

Primary outcomes:
measure: time-sparing for bowel resection
timeFrame: up to 1 hour
measure: Post surgical complications
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome,
country: Italy
facility: Catholic University of Sacred Heart Rome,
state: Rome
Study officials:
affiliation: Catholic University of Sacred Heart
name: Giovanni Scambia, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03128242: Oxytocin's Effect on Attention Training
Official title: An Eye-tracking Study to Investigate Oxytocin's Effect on Attentional Bias Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: oxytocin
attention bias
attention training
eye-tracking
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2017-04-25
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate oxytocin's effect on attentional bias training. Healthy participants will undergo a dot-probe task-based training to direct their attention away from negative stimuli (as compared to neutral). Effects of the training will be assessed using an eye-tracking anti-saccade task.

Detailed description: In this study, a dot-probe task will be used to examine if subjects show an attentional bias towards negative stimuli and whether the bias can be modified using a subsequent attentional bias training. During this training participants learn to direct their attention away from threatening stimuli. In a between-subject placebo controlled design participants will receive either intranasal oxytocin or placebo before the training to examine whether oxytocin could facilitate the effects of the attention training. Effects of the training and of oxytocin on the training will be assessed by means of an eye-tracking anti-saccade task. Based on previous studies showing the strongest effects of threat-attentional bias training in high anxious subjects, the study will recruit participants with an elevated trait anxiety.

Eligibility criteria: Inclusion Criteria:

* male participants with elevated trait anxiety (\> 45 scores as assessed with the State and Trait Anxiety Inventory, Spielberger, 1983)
* without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness
* smoking or drinking 24 hours before the experiment

Primary outcomes:
measure: Reaction time (RT) difference - oxytocin effects
timeFrame: Before drug administration (pre-treatment baseline) and 55 minutes after drug administration
measure: Reaction time (RT) difference - training effects
timeFrame: Before drug administration - 55-90 minutes after drug administration
measure: Saccade latency difference - training effects
timeFrame: Before drug administration - 55-90 minutes after drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Chendu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology of China
state: Sichuan
Study officials:
affiliation: School of Life Science and Technology, University of Electronic Science and Technology of China
name: Benjamin Becker, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05664542: Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries
Official title: Efficacy of Erector Spinae Block With Ropivacaine and Dexmedetomidine on Opioid Consumption After Lumar Spine Surgeries - A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Security Forces Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups, one with block and other with no block
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the role of 0.5 micrograms/kg of dexmedetomidine with 0.2 % ropivacaine in erector spinae block in reducing opioid consumption for patients undergoing lumbar spine surgeries. This study will help in understanding the role of adding dexmdetomidine to ropivacaine in erector spinae block in reducing opioid consumption after lumbar spine surgeries

Detailed description: A number of adjuvants have been used with local anesthetics including dexamethasone, nalbuphine and dexmedetomidine etc with the aim of improving quality and duration of peripheral nerve blocks. Dexmedetomidine is a potent alpha-2 agonist which can prolong the duration of regional anesthesia block when used in combination with local anesthetics. Although, there is no consensus on the dose of dexmedetomidine for peripheral nerve block considering the fact that it can lower heart rate and blood pressure intraoperatively. Investigators therefore, planned this randomised controlled trial to investigate the role of 0.5 micrograms/kg of dexmedetomidine with 0.2 % ropivacaine in erector spinae block for patients undergoing lumbar spine surgeries.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 70 years, scheduled to undergo lumbar spine surgeries with an ASA score of 1 to 3 will be included in the study

Exclusion Criteria:

* Patients who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with either contraindications for regional anesthesia, known allergy to local anesthetics or dexmedetomidine, bleeding diathesis, use of anticoagulants or corticosteroids, inability to operate patient controlled analgesia (PCA) system, psychiatric disorders or use of psychiatric medications will not be included in the study.

Primary outcomes:
measure: 24 hours opioid consumption
timeFrame: 24 hours
Secondary outcomes:
measure: pain score
timeFrame: 24 hours
measure: Occurrence of postoperative nausea and vomiting (PONV)
timeFrame: 24 hours
measure: Occurrence of drowsiness
timeFrame: 24 hours
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Security Forces Hospital
Study officials:
affiliation: Security Forces Hospital
name: Anwar ul Huda, FRCA
role: PRINCIPAL_INVESTIGATOR
References: