louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00815230: Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level
Official title: Effect of Cardiac Computed Tomography Angiography on the Blood Reactive Oxygen Species Level
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Radiation Injury
Keywords: radiation injury
computed tomography
reactive oxygen species
free radicals
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study subjects will be OPD patients who are arranged for cardiac CTA examination because of suspect coronary artery disease.

Brief summary: The clinically widely used X-ray computed tomography examination has a low-grade radiation effect and recently has attracted much attention concerning the possible adverse effects of radiation on human body \[ref. 1-5\]. The radiation is harmful to human tissues and cells mainly because it can interact with water (which makes up to 80% of cells) to generate reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we can reach, there is no report concerning the relation between X-ray computed tomography examination and the blood ROS level. Therefore, we wish to conduct this study to clarify if the cardiac computed tomography angiography (cardiac CTA) may induce a higher level of ROS in the peripheral blood.

Study subjects will be OPD patients who are arranged for cardiac CTA examination because of suspect coronary artery disease (CAD). In total, twenty cases will be enrolled for the study. The formal consent will be delivered and explained to the patients and families after the arrangement of cardiac CTA. It then will be retrieved just before the performance of cardiac CTA.

For each enrolled case, peripheral blood will be sampled three times (once before and twice after the performance of cardiac CTA). Totally 60 blood samples will be collected from 20 study subjects within 3 months (January 1 \~ March 31, 2009). ROS level in the collected blood samples will be then measured, compared, and analyzed.


Eligibility criteria: Inclusion Criteria:

* subjects who are arranged for cardiac CTA examination because of suspect coronary artery disease.

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
References:
Clinical trial NCT06472830: Prevalence of Monoclonal Gammopathy of Undetermined Significance (MGUS) / Multiple Myeloma (MM) Among Unique Populations of Black People
Official title: Monoclonal Gammopathy of Undetermined Significance (MGUS) /Myeloma Awareness and Genetic Insights Campaign (MAGIC) Screening Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Monoclonal Gammopathy of Undetermined Significance
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who self-report east African ancestry without a diagnosis of multiple myeloma

Brief summary: This study is being done to screen for monoclonal gammopathies in people of East African descent. Monoclonal gammopathy is a condition where abnormal proteins are found in the blood, most commonly called monoclonal gammopathy of undetermined significance or MGUS. There is little information on the presence of this condition in people of East African descent. This study is being done to determine how this condition affects this population in order to better treat and/or prevent this condition in the future.

Detailed description: PRIMARY OBJECTIVE:

I. To determine the prevalence of monoclonal gammopathies (MGUS, Smoldering and Multiple Myeloma) in people of East African descent in Minnesota.

OUTLINE: This is an observational study.

Participants undergo medical chart review and blood sample collection, as well as complete a questionnaire on study. Participants who test positive for MGUS are notified, along with their primary care physician, so that the necessary follow up and referral is provided as clinically indicated.

Eligibility criteria: Inclusion Criteria:

* Adults ≥ 40 years
* Self-reported east African ancestry (including individuals of mixed east African descent)
* Willing and able to review, understand, and provide consent before starting any study-specific procedures

Exclusion Criteria:

* Pregnant women

Primary outcomes:
measure: Prevalence of MGUS in people of east African descent
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Joselle M. Cook, M.B.B.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01201330: DPBRN Retrospective Cohort Study of Osteonecrosis of the Jaw
Official title: Retrospective Cohort Study of ONJ
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteonecrosis of the Jaw
Keywords: ONJ
Lead sponsor: Dental Practice-Based Research Network
Sponsor class: NETWORK
Collaborators: name: HealthPartners Institute
name: Kaiser Permanente
name: Permanente Dental Associates Group, Oregon
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2010-09-14
Enrollment: 572606
Sex: ALL
Minimum age (years): 41
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients older than 40 with a history of jaw osteonecrosis and control patients with exposure to biphosphonates were included.

Brief summary: The purpose of this study was to determine the prevalence of ONJ in the patient population of 2 large HMOs and study the risk factors associated with the development of this condition.

Detailed description: The electronic database from Kaiser Permanente and HealthParnters of Minnesota were used to identify all ONJ cases that occured between 1994 and 2006 and then demographic, social and medical risk factors possibly associated with the disease were abstracted and analyzed.

Eligibility criteria: Inclusion Criteria:

* ONJ sufferers and control biphosphonate users older than 40, of any gender, race and ethnic origin

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Gregg H. Gilbert, DDS, MBA
state: Alabama
Study officials:
affiliation: Kaiser Permanente
name: Jeffrey Fellows, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Andrei Barasch, DMD,MDSc
role: PRINCIPAL_INVESTIGATOR
affiliation: HealthPartners of Minnesota
name: Brad Rindal, DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama School of Dentistry
name: Gregg H Gilbert, DDS, MBA
role: STUDY_CHAIR
References:
Clinical trial NCT06721130: Role of 18F-FDG PET/CT in the Evaluation of Cavernous Sinus Syndrome: a Pilot Study
Official title: Role of 18F-FDG PET/CT in the Evaluation of Cavernous Sinus Syndrome: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cavernous Sinus Syndrome
Cavernous Sinus Meningioma
Cavernous Sinus Lesions
Keywords: Cavernous Sinus Syndromes
Ophthalmoplegia
Positron Emission Tomography Computed Tomography
Fluorodeoxyglucose F18
Cavernous Sinus
Lead sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive treatment naive patients of either sex with signs and symptoms of cavernous sinus syndrome attending the outpatient clinic in the Department of Neurology, Postgraduate Institute of medical Education \& Research, Chandigarh.

Case definition for CSS- involvement of two or more cranial nerves (which pass through CS) or oculosympathetic fibers on the same side, or involvement of only cranial nerve in combination with a radiologically confirmed cavernous sinus lesion.

Brief summary: Cavernous sinus syndrome (CSS) can be caused by a wide range of inflammatory, malignant, benign, vascular and miscellaneous disorders. Even after modern advances, reaching the final etiological diagnosis remains a challenge in CSS. This study is planned to determine the role and incremental value of 18F-FDG PET/CT in characterising different cavernous sinus pathologies based on their metabolic activity and detecting extracranial involvement.


Eligibility criteria: Inclusion Criteria:

1. Patients with age greater than or equal to 18 years,
2. with newly diagnosed CSS,
3. lesion seen on MRI in the CS, and
4. willing to give written informed consent.

Exclusion Criteria:

1. Pregnant and lactating patients
2. Patients already being treated (including steroids)

Primary outcomes:
measure: SUVmax of the cavernous sinus lesions on FDG PET/CT
timeFrame: From enrollment to the establishment of final diagnosis upto a period of three months
measure: Number of patients with extracranial sites of involvement on FDG PET/CT
timeFrame: From enrollment to the establishment of final diagnosis upto 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
Study officials:
References:
Clinical trial NCT02299830: Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture
Official title: Prospective, Open, Multicenter Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Obstruction
Keywords: neoplasm
central airway
obstruction
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: Xinqiao Hospital of Chongqing
name: China Meitan General Hospital
name: Micro-Tech (Nanjing) Co., Ltd.
First posted: 2014-11-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of malignant central airway stricture.

The four techniques are：

* cryotherapy
* argon plasma coagulation
* stent
* snare


Eligibility criteria: Inclusion Criteria:

* malignant neoplasm caused central airway stenosis
* the degree of stenosis is above 50%
* estimated survival duration is longer than 3 months
* received no treatment one month before
* can understand the statement informed consent
* agree to enroll in the study

Exclusion Criteria:

* older than 70 years or younger than 18 years
* not malignant neoplasm caused central airway stenosis
* not central airway stenosis
* existence of lumina collapse or twisting
* severe arrhythmia, myocardial ischemia or hypertensive crisis
* coagulation disorders
* existence of severe organ disfunction
* allergic to anesthesia drugs
* refuse to participate the study

Primary outcomes:
measure: percentage of the cases that got Ⅰand Ⅱlevel remission
timeFrame: the next day after the treatment
Secondary outcomes:
measure: the values of dyspnea index
timeFrame: the next day after the treatment
measure: Karnofsky Physical scales
timeFrame: the next day after the treatment
Other outcomes:
measure: adverse event during the treatment
timeFrame: from the beginning of the treatment to 48 hours after the treatment
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Faguang Jin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00130130: Testing the Effects of an Algorithm for Neuropathic Pain on Patient and System Outcomes
Official title: Testing the Effects of an Algorithm for Neuropathic Pain on Patient and System Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2005-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients experiencing NP from a variety of causes

Brief summary: The overall purpose of this project is to improve nurse skills regarding neuropathic pain (NP) assessment, treatment and referral practices through implementation of an evidence-based algorithm and to improve selected patient outcomes as a result of algorithm use.

Detailed description: Neuropathic pain (NP) is defined as pain that arises from injury, disease or dysfunction of the central or peripheral nervous system. For the patient focused phase of the project NP treatment will be guided via the Peripheral Neuropathy Treatment Algorithm. Patients will receive algorithm-specific treatment for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Cancer patients experiencing NP from a variety of causes
* NP Visual Analogue Scale (VAS) score equal to or \> 4 with 12 week estimated duration
* Karnofsky Performance Status (KPS) 60% or greater
* Age greater than 18

Exclusion Criteria:

* Patients undergoing anticancer or invasive pain procedures specifically intended to palliate NP are ineligible

Primary outcomes:
measure: To implement an evidence based screening, assessment, treatment, and referral guideline for hematology/oncology patients with NP receiving care
timeFrame: outcome measures will consist of the NPVAS, and a PPCPS adapted rom the original project. Adequate satisfaction will be defined as 25% or mor of all patients reporting being very or completely satisfied as measured by PPCPS
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Ellen Lavoie-Smith, ARNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06194630: Application of 68Ga-labeled ACE2 Targeting Probe PET/CT Imaging in Tracing ACE2 Expression and Diagnosis of Lung Cancer
Official title: Application of 68Ga-labeled ACE2 Targeting Probe PET/CT Imaging in Tracing ACE2 Expression and Diagnosis of Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Lung Cancer
Healthy Human
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In the past three years, as the key protein suggested to be involved in host cell entry of SARS-CoV-2, studies of ACE2 aroused people's attention again. Tracking the expression of ACE2 in vivo is crucial to further understanding of COVID-19, dynamically monitoring the effect of antiviral therapy and the development of related vaccines. It is also expected to further conduct in-depth research on the physiological effects of ACE2 and RAAS, and the mechanism of ACEI/ARB (32). With the development of both molecular imaging agents and related equipment, several ACE2-targeting PET imaging agents have been investigated based on different strategies while some of them were tested in clinical trials. The aim of this study was to intercept key ACE2-binding sites from coronavirus RBD and test their potential as ACE2-targeting PET agents.


Eligibility criteria: Inclusion Criteria:

* the ability to provide informed written consent
* a medical history without any ACE2-related comorbidities

Exclusion Criteria:

* liver and renal function dysfunction,
* pregnancy or current lactation

Primary outcomes:
measure: standardized uptake value (SUV)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Diagnostic performance
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Nuclear Medicine, Peking Union Medical College Hopital, Chinese Academy of Medical Science
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT05036330: ProvoxLife Adoption Trends for Heat-Moisture Exchanger
Official title: ProvoxLife® Adoption Trends for Heat-Moisture Exchanger (HME): The PATH Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Malignant Head and Neck Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-09-05
Enrollment: 130
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: Patients using or planning to use HME as part of standard care

Brief summary: This study examines factors that affect how often patients who have a total laryngectomy use a ProvoxLife heat-moisture exchanger (HME) system to help improve their lung function. ProvoxLife HMEs are single use heat- and moisture exchangers for patients breathing through a tracheostoma. Information from this study may help doctors learn more about factors associated with patterns of use and how often patients use the ProvoxLife HME system.

Detailed description: PRIMARY OBJECTIVE:

I. To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy.

SECONDARY OBJECTIVES:

I. To explore outcomes associated with patterns of ProvoxLife HME system. II. To explore factors associated with post-laryngectomy outcomes.

OUTLINE:

Patients undergo speech and swallow evaluation by speech pathologist or study staff member and examination of tracheoesophageal puncture (TEP) and laryngectomy stoma. Patients also complete questionnaires over 30 minutes about use the ProvoxLife HME system, symptoms, ability to communicate, exercise and physical activity levels, and quality of life at baseline and 3 months post-ProvoxLife.

Eligibility criteria: Inclusion Criteria:

* Adults \>= 18 years of age planned for or status post total laryngectomy
* Using or ready for fit of HME system

Exclusion Criteria:

* Active malignancy if post-total laryngectomy (TL) at the time of enrollment
* Unable to complete questionnaires in English language

  * The primary endpoint derives from a study specific questionnaire, due to limited resources, is only available in English language
* Cognitive or other limitations that preclude independent self-care or completion of questionnaires

  * Cognitive or other limitations that preclude independent self-care or completion of questionnaires will be assessed in the screening interview by the clinical or research team

Primary outcomes:
measure: To determine clinical and patient factors associated with patterns of use of the ProvoxLife HME system for pulmonary rehabilitation after total laryngectomy.
timeFrame: Up to 3 months post-ProvoxLife HME
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Katherine A Hutcheson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05825430: Direct Versus US Guided PECS Block on Controlling Postmastectomy Pain
Official title: Direct Versus Ultrasound Guided PECS Block Effect on Controlling Postmastectomy Pain: A Prospective, Randomized, Single Blinded, Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmastectomy Pain
Keywords: Ultrasound guided pecs block
Direct pecs
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2023-04-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Perioperative analgesia for surgery in carcinoma breast utilizes significant quantities of opioids as compared to cosmetic breast surgeries. Regional anesthesia reduces the need for perioperative opioids and thus may improve the outcome. The investigators decided to perform the modified pectoral nerve block ( Pec II) under vision after resection of tumor, without ultrasound and compare the postoperative analgesic and opioid sparing effects of the nerve block with ultrasound guided modified pectoral nerve block (Pec) in patients undergoing modified radical mastectomy.


Eligibility criteria: Inclusion Criteria:

* 20 - 50 years
* ASA I or II undergo elective simple mastectomy

Exclusion Criteria:

* patients with diabetes mellitus i
* Intradialytic hypotension,
* chronic kidney disease and Bronchial Asthma

Primary outcomes:
measure: Total morphine consumption
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: postoperative visual analogue scale (VAS)
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Haney Baumey
city: Tanta
country: Egypt
facility: Neveen Kohaf
Study officials:
References: