louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01161069: A Study To Evaluate The Safety And Tolerability Of Different Doses Of PF-03049423 In Healthy Adult Volunteers And Healthy Older Volunteers
Official title: A Double Blind (3rd Party Open), Randomized, Placebo Controlled, Parallel Group, Multiple Dose Escalation Study To Evaluate The Safety, Toleration, Pharmacokinetics Of PF-03049423 In Healthy Young Adult Volunteers And Healthy Elderly Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: phase 1
healthy young adult volunteers
healthy elderly adult volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-07-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose this study is to evaluate the safety and toleration of PF-03049423 following multiple dose administration as an oral solution to healthy young adult volunteers and healthy elderly volunteers. The study will also evaluate the pharmacokinetics of PF-03049423 after multiple dose administration to healthy young adult volunteers and healthy elderly volunteers. The study will also explore the relationship between blood pressure (supine and standing) and PF-03049423 concentration.

Detailed description: The purpose of the investigation is to evaluate the safety and tolerability of an investigational new drug, PF-03049423, when dosed for two weeks in both healthy younger and healthy older subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy persons, male or female.
* For the healthy young adult cohort, subjects must be 18 to 50 years old, inclusive.
* For the healthy elderly adult cohort, subjects must be 51 to 99 years old, inclusive.
* Body Mass Index (BMI) of 18 to 35; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Subjects with clinically significant medical conditions.
* Women of non-child bearing potential.
* Subjects with a known medical history of hearing loss/disability or nonarteritic ischemic optic neuropathy.
* A positive urine drug screen.

Primary outcomes:
measure: Safety laboratory assessments, vital signs (including supine and standing blood pressure), physical examination, 12-lead ECGs and adverse events.
timeFrame: Days 1 through 14
measure: PK Parameters:Day 1: Area under concentration time curve from hour 0 to the last dosing interval (AUCtau), maximum observed concentration (Cmax), and time of maximum observed concentration (Tmax), for PF-03049423 in plasma.
timeFrame: Day 1
measure: PK Parameters: Day 14: Cmax at steady state, Tmax, AUCtau at steady state , t½, Cavg at steady state, Cmin at steady state, Cmax at steady state /Cmax sd, AUCtau at steady state/ AUCtau sd, Ae% and CLr.
timeFrame: Day 14
Secondary outcomes:
measure: Blood pressure
timeFrame: Days 1 to 14
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06991569: Evaluation for Healing of Iatrogenic Perforation After Non Surgical Repair
Official title: Retrospective Evaluation for Healing of Iatrogenic Perforation After Repair With Different Materials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Root Perforation at the Bifurcation Area
Strip Perforation
Lateral Perforation
Keywords: Root canal perforation
Endodontics
MTA
Perforation repair material
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2025-05-28
Enrollment: 88
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects were identified from among patients treated by endodontic specialist in his private clinic at Cairo, Egypt

Brief summary: The goal of this retrospective study is to evaluate the outcome of nonsurgical root perforation repair treated by specialized endodontist . The null hypothesis is:

MTA can be used successfully as perforation repair material with high success rate subjects of the study were identified from patients who had received endodontic treatment with non-surgical root perforation repair by an endodontic specialist in his private practice


Eligibility criteria: Inclusion Criteria:

* patients who had undergone nonsurgical endodontic perforation repair

Exclusion Criteria:

* Teeth that revealed root fracture, inadequate remaining tooth structure, or severe periodontitis
* Teeth that had undergone surgical perforation repair

Primary outcomes:
measure: Radiographic success in terms of Healing
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Advanced Endodontic clinic
Study officials:
References:
Clinical trial NCT05150769: Preferences of Vaccination for COVID-19 Among University Students and Staff: A Discrete Choice Experiment
Official title: Preferences of Vaccination for COVID-19 Among University Students and Staff: A Discrete Choice Experiment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preference, Patient
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 3423
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University students and staff working at university

Brief summary: From March 2021, COVID-19 vaccines have been made available to Hong Kong residents, first to priority groups including healthcare professionals and the elderly, and later to all adults and adolescents. Vaccinated individuals are generally exempted from mandatory regular out-of-pocket antigen testing. Vaccinated individuals of university halls and colleges of The University of Hong Kong (HKU) will also be exempted from mandatory weekly antigen testing. Freedom of choice is highly respected in the HKU community and as such, we would like to better understand the decision-making process among members of the HKU community. The anonymised results of this independent research study will help us understand preferences among the HKU community and inform on future vaccination planning policies.

Objectives: To elicit HKU staff and students' preferences and their willingness-to-pay (WTP) for COVID-19 vaccination in Hong Kong

Design: An online cross-sectional internet-based questionnaire with a discrete choice experiment (DCE) design distributed via email. All current students and staff from the University of Hong Kong are eligible to participate in the study

Main outcome measures: Preferences for the efficacy of protecting against infection, against severe disease manifestations, duration of protection, risk of adverse events, incentives, and out-of-pocket costs


Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Fluent in English
* Students and staff of The University of Hong Kong

Exclusion Criteria:

* Individuals who are younger than 18 years old
* Individuals who are unwilling to give consent

Primary outcomes:
measure: Preferences for efficacy of protection against infection
timeFrame: At baseline
measure: Preferences for efficacy of protection against severe disease manifestations
timeFrame: At baseline
measure: Preferences for duration of protection
timeFrame: At baseline
measure: Preferences for risk of adverse events
timeFrame: At baseline
measure: Preferences for incentives
timeFrame: At baseline
measure: Preferences for out-of-pocket cost
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
References:
Clinical trial NCT03081169: Timing of VTE Prophylaxis in TBI
Official title: Timing of Venous Thromboembolism Prophylaxis in Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: TBI (Traumatic Brain Injury)
VTE (Venous Thromboembolism)
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 0
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: This study compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients in both treatment groups will be monitored for development of VTE as well as complications from bleeding after commencement of VTE prophylaxis.

Detailed description: This a randomized prospective study that compares the efficacy and complication rates of early (24 hours) versus late (72 hours) VTE prophylaxis administration to TBI patients. Patients who are identified as having an intracranial injury will be randomized to early versus late VTE prophylaxis using a 1:1 random numbers allocation. Patients in both treatment groups will be monitored for development of VTE, primarily with scheduled duplex ultrasound studies of the lower extremities. Any clinical suspicion of VTE will also be investigated with duplex ultrasound and/or CT angiogram of the chest. Patients will be monitored for development of complications from bleeding post commencement of VTE prophylaxis. Intracranial bleeding complications will be monitored by physical examination and CT scanning of the head when indicated. Patients who undergo craniotomy or craniectomy will have VTE prophylaxis started 72 hours post-surgery and will undergo CT scan of the head (to assure bleeding stabilization) prior to administration of VTE prophylaxis.

Eligibility criteria: Inclusion Criteria:

* Traumatic brain injury
* Intracranial hemorrhage on CT scan

Exclusion Criteria:

* Under the age of 18
* Pregnant
* Die within 24 hours of admission
* Hospital stay less than 5 days
* Contraindications to enoxaparin or heparin
* Coagulopathy at 24 hours post-injury defined as INR\>1.6 aPTT\>2x normal, or platelet counts\<50k
* Known history of VTE

Primary outcomes:
measure: VTE
timeFrame: Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.
Secondary outcomes:
measure: Bleeding complications
timeFrame: Outcomes will be assessed until hospital discharge. Data will be presented at study completion with the expectation of approximately 2 years.
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT01878669: Effects of N-acetyl Cysteine During Percutaneous Coronary Intervention
Official title: Effects of N-acetyl Cysteine on Periprocedural Myocardial Infarction and Major Cardiac and Cerebral Events in Patients Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: n-acetyl cysteine
percutaneous coronary intervention
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the effects of N-acetyl cysteine on periprocedural myocardial infarction and major cardiac and cerebral events in patients undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old undergoing percutaneous coronary intervention and who have moderate to high risk for contrast induced nephropathy (Mehran Score ≥ 5)

Exclusion Criteria:

* Primary percutaneous coronary intervention
* Low risk for contrast induced nephropathy (Mehran Score \< 5)
* Use of nephrotoxic agents (NSAIDs, aminoglycosides,recent contrast injection...)
* Infection
* Pregnancy, Lactation
* Renal failure requiring dialysis
* Hepatic failure
* History allergy for NAC
* History of Asthma
* Chronic nitrate usage
* Malignancy
* Use of corticosteroids
* Leukocytosis,Thrombocytosis,Anemia
* Blood pressure of \>180/100mmHg despite anti-hypertensive therapy

Primary outcomes:
measure: periprocedural myocardial infarction
timeFrame: postprocedural 3-6 h
Secondary outcomes:
measure: NAC side effects (Asthma exacerbation, pruritus, dyspnea)
timeFrame: during hospitalization at 48 hours
measure: major cardiac and cerebral events
timeFrame: 1 year follow-up
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Suleyman Demirel University
state: Mediterranean Region
Study officials:
References:
Clinical trial NCT05336669: Coagulation Profile in Patients Undergoing Coronary Angiography and Percutaneous Coronary Intervention
Official title: Coagulation Profile in Patients Undergoing Coronary Intervention Measured With Activated Clotting Time, Global Thrombosis Test and Platelet Inhibition VerifyNow P2Y12 Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Coronary Insufficiency
Smoking
Keywords: coronary angiography
activated clotting time
platelet inhibition
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 patients, 20 smoking at least 10 cigarettes a day, 20 patients non-smoking (\<1 cigarette in last 30 days)

Brief summary: The activated clotting time (ACT), global thrombosis test (GTT-3), platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI).

Detailed description: The activated clotting time (ACT), global thrombosis test (GTT-3) and platelet inhibition P2Y12 (VerifyNow) test and serum coagulation factors will be measured in patients undergoing coronary angiography (CA) and percutaneous coronary intervention (PCI) - 20 smoking and 20 non-smoking.The measurements will take place: before coronary angiography (CA), 10 minutes after unfractionated heparin (HNF), 2h after CA, 6h after CA, 30 days after CA

Eligibility criteria: Inclusion Criteria:

* patients scheduled do CA \>18 years old

Exclusion Criteria:

* pregnancy
* previous treatment with P2Y12 inhibitors, novel oral anticoagulants (NOAC) or warfarin acenocoumarol in last 24 hours

Primary outcomes:
measure: ACT change
timeFrame: Baseline ACT , 10 minutes ACT, 2 hours ACT, 6 hours ACT, 30 days ACT
measure: GTT-3 change
timeFrame: Baseline GTT-3, 10 minutes GTT-3, 2 hours GTT-3, 6 hours GTT-3, 30 days ACT
measure: VerifyNow change
timeFrame: Baseline VerifyNow, 10 minutes VerifyNow, 2 hours VerifyNow, 6 hours VerifyNow, 30 days ACT
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Centre of Postgraduate Medical Education
name: Bogumił Ramotowski
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04656769: Analgesia aNd caNcer recUrrence Lung cAncer Resection
Official title: Impact of Analgesia on Cancer Recurrence and Mortality Within Five Years After Stage I Non-Small Cell Lung Cancer Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrence Tumor
Opioid Use, Unspecified
Analgesia
Thoracic Surgery
Keywords: Recurrence tumor
Opioid use
Analgesia
thoracic surgery
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012

Brief summary: The choice of analgesia after cancer surgery may play a role in the onset of recurrence, particularly opioids seem to play a role in the immune system by promoting cancer cell proliferation and migration. Based on this consideration, our aim was to assess the impact of perioperative analgesia's choice on cancer recurrence after curative surgery for Stage I Non-Small Cell Lung Cancer. The investigators retrospectively reviewed the records of patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012. Patients received analgesia either by peridural (PERI group) or, in case of patient refusal or failure in catheter positioning, intravenous analgesia with opioids (EV group). Follow-up was concluded in August 2019. The five-year cumulative incidence of recurrence and the overall survival were evaluated and adjusted with a propensity score matching methodology.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 yrs
* Patients who underwent lung resection for Stage I NSCLC between January 2005 and December 2012

Exclusion Criteria:

* Age\<18aa
* Pregnancy
* Day hospital patients

Primary outcomes:
measure: cumulative incidence of recurrence and the overall survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: AOU Città della Salute e della Scienza di Torino
Study officials:
affiliation: University of Torino
name: Luca Brazzi, Professor
role: STUDY_CHAIR
affiliation: A.O.U. Città della Salute e della Scienza
name: Giulio L Rosboch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Torino
name: Ilaria De Domenici, MD
role: STUDY_DIRECTOR
affiliation: A.O.U. Città della Salute e della Scienza
name: Edoardo Ceraolo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04355468: Opioid Free Anesthesia in Thoracic Surgery
Official title: Opioid-free Anaesthesia Effectiveness in Thoracic Surgery - Objective Measurement With a Skin Conductance Algesimeter: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Surgery
Analgesics, Opioid
Anesthesia, Conduction
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Proper assessment of pain and adequate analgesia in thoracic surgery is a challenging issue for medical practitioners. Basic aspects of thoracic anaesthesia are general anesthesia, intubation with double lumen tube and separation of lung ventilation, however proper analgesia needs to be standardized. Role of opioids in this clinical setting is reduced due to high risk of respiratory system complications. Instead, use of opioid free anaesthesia and regional anaesthesia is proposed. The aim of this study is to compare the use of opioid anaesthesia with opioid free anaesthesia and paravertebral block.


Eligibility criteria: Inclusion Criteria:

* body mass index between 19-30 kg/m2,
* American Society of Anesthesiology (ASA) physical status between 1 and 3

Exclusion Criteria:

* lack of consent
* significant coagulopathy,
* contraindication to drugs used in protocol
* history of chronic pain,
* chest wall neoplastic invasion,
* previous thoracic spine surgery,
* mental state preventing from effective use of PCA device,
* renal failure (GFR \<60 ml/min/1,73 m2)

Primary outcomes:
measure: Intraoperative pain related stress [oscillations per second]
timeFrame: Period before induction of anaesthesia to termination of anaesthesia
measure: Intraoperative opioid usage [mg]
timeFrame: Intraoperative period
measure: Intraoperative arterial blood pressure [mmHg]
timeFrame: Intraoperative period
measure: Intraoperative heart rate [bpm]
timeFrame: Intraoperative period
Secondary outcomes:
measure: Overall postoperative analgesia satisfaction
timeFrame: 48 hours
measure: Postoperative pain intensity (VAS)
timeFrame: 48 hours
measure: Postoperative pain intensity (PHHPS)
timeFrame: 48 hours
measure: Postoperative arterial blood pressure [mmHg]
timeFrame: 48 hours
measure: Postoperative heart rate [bmp]
timeFrame: 48 hours
measure: Postoperative sedation level
timeFrame: 48 hours
measure: Postoperative analgesic requirement [mg]
timeFrame: 48 hours
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1
state: Silesia
Study officials:
References:
Clinical trial NCT01689168: Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation
Official title: Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Smoking
Lead sponsor: Southern California University of Health Sciences
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tobacco use is the number one killer of Americans today. Most current smokers have tried and failed to quit at least once. Smokers are addicted to the nicotine in tobacco products, and withdrawal from smoking can lead to physical symptoms such as irritability, anxiety, nervousness, depression and insomnia.

This study will examine the effects of tobacco cessation counseling and chiropractic treatments on smokers who desire to quit.


Eligibility criteria: Inclusion Criteria:

* Adults 18 yrs and above
* Smokers with desire to quit smoking

Exclusion Criteria:

* Received chiropractic treatment or other manipulative therapies within the last month
* Have received any therapy for smoking cessation during the last month
* Visceral, systemic or joint inflammatory disease
* A history of low back surgery
* Osteoporosis
* Prolonged systemic corticosteroid medication
* Pregnancy
* Recent spinal fracture

Primary outcomes:
measure: Tobacco cessation
timeFrame: Smoking diary will be complete for 3 months
measure: Urinary cotinine
timeFrame: Baseline, 14, 30, 60 and 90 days
Secondary outcomes:
measure: Blood pressure
timeFrame: Baseline, 14, 30, 60 days
measure: Weight
timeFrame: Baseline, 14, 30, 60 days
Other outcomes:
Locations:
city: Whittier
country: United States
facility: University Health Center - Whittier
state: California
Study officials:
affiliation: Southern California University of Health Sciences
name: Kevin A Rose, DC, MPH
role: PRINCIPAL_INVESTIGATOR
References: