louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06275269: Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone to Treat Subglottic Stenosis
Official title: Comparison of the Safety and Economics of Translaryngeal Endoscopic Mucosal Injection Versus Ultrasound-Guided Injection of Triamcinolone for the Treatment of Subglottic Stenosis: a Multicenter, Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subglottic Stenosis
Keywords: Subglottic Stenosis
Triamcinolone
Translaryngeal Endoscopic Mucosal Injection
Ultrasound-Guided Injection
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study employs a multicenter, randomized controlled trial method, where patients meeting the inclusion criteria for subglottic stenosis are randomly divided into two groups. These groups are respectively undergoing translaryngeal endoscopic mucosal injection and ultrasound-guided injection of triamcinolone treatment. The comparison will focus on various indicators such as therapeutic effect, incidence of adverse reactions, treatment costs, and hospital resource utilization between the two groups. The safety and effectiveness will be compared to determine the relative merits of the two treatment methods.


Eligibility criteria: Inclusion Criteria:

* 1: "Diagnosed with subglottic stenosis through laryngoscopic examination or imaging studies such as CT."
* 2: "Experiencing symptoms related to subglottic stenosis, such as breathing difficulties, hoarseness, etc."

Exclusion Criteria:

* 1: "Severe cardiopulmonary dysfunction, patients extremely debilitated and unable to tolerate the procedure."
* 2: "Patients allergic to lidocaine, midazolam, triamcinolone, or any of their components."
* 3: "Pregnant or lactating women."
* 4: "Unstable angina, congestive heart failure, severe bronchial asthma."
* 5: "Severe hypertension and arrhythmias, hemodynamically unstable, and severe respiratory failure (PaO2 \<60mmHg after oxygen therapy or mechanical ventilation)."
* 6: "Known coagulation dysfunction, inability to stop anticoagulants, antiplatelet agents, aspirin, or nonsteroidal anti-inflammatory drugs before treatment."
* 7: "Patients do not agree to participate in this study."
* 8: "Participation in other studies within the last three months and not withdrawn or concluded, or having received triamcinolone treatment less than 1 month ago."
* 9: "Researchers believe there are any circumstances making the patient unsuitable for inclusion."

Primary outcomes:
measure: Incidence of Short-Term Postoperative Complications
timeFrame: one week after intervention
Secondary outcomes:
measure: Overall medical expenses incurred by patients
timeFrame: one week after intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04429269: A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis
Official title: A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer Diagnosis
Breast Cancer Screening
Keywords: Mammography
ultrasound
breast cancer screening
early diagnosis
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 6000
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese female subjects aged 35-70 years who were asymptomatic and able to undergo ultrasound and X-rays

Brief summary: Improving the early diagnosis of breast cancer can reduce mortality. With mammography as the main tool for screening early breast cancer, the characteristics of dense breast and young onset of disease in Chinese women lowers the efficiency. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.

Detailed description: Breast cancer has become the most common malignancy in women. Improving the early diagnosis of breast cancer can reduce mortality. Mammography is recommended as the main tool for screening and early diagnosis of breast cancer in the guidelines of European and American countries. However, the characteristics of dense breast and young onset of disease in Chinese women make the screening and early diagnosis strategies of Western countries, which are mainly based on mammography, unsuitable for Chinese women. The aim of this prospective study was to compare which method, x-ray or ultrasound, is more appropriate for screening and early diagnosis of breast cancer in Chinese women.

Eligibility criteria: Inclusion Criteria:

* Informed consent, subjects 35-70 years old, asymptomatic, able to undergo ultrasound and x-ray

Exclusion Criteria:

* Localized breast erythema and ulceration, pregnancy, lactation, after previous breast implantation, already pathologically definite breast cancer patients

Primary outcomes:
measure: screening yield
timeFrame: 3 years
Secondary outcomes:
measure: cost-effectiveness
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and PUMC, BJ, China
name: Songjie Shen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01565369: Evaluation of Physician Training Methods to Read Florbetapir-PET Scans
Official title: Evaluation of Physician Training for Interpretation of Florbetapir-PET Scans: Validation of Binary Image Rating Methodology Using Amyloid Histopathology at Autopsy as the Reference Standard.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Amyloid imaging
Positron Emission Tomography
18F-AV-45
florbetapir F 18
Diagnostic imaging
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is re-read of brain amyloid positron emission tomography (PET) scans acquired in previous florbetapir F 18 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had an autopsy to reveal the subject's true amyloid status.


Eligibility criteria: Inclusion Criteria (Study A07\[NCT00857415\]):

* Have a projected life expectancy of ≤ 6 months as determined by the principal investigator (e.g. terminal medical condition) or are already enrolled in a longitudinal study of aging with an autopsy component;
* Can tolerate a 10 minute PET scan; and
* Give informed consent for study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die.

Exclusion Criteria (Study A07\[NCT00857415\]):

* Have primary brain tumor, known metastases to the brain, central nervous system (CNS) lymphoma;
* Have any major, focal structural loss of brain matter;
* Are aggressively being treated with life sustaining measures (e.g. currently on respirator; receiving high dose chemotherapy);
* Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);
* Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
* Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, secretase inhibitor);
* Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
* Are females of childbearing potential who are pregnant or not using adequate contraception.

Primary outcomes:
measure: Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque
timeFrame: 50-60 min after injection
measure: Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque
timeFrame: 50-60 min after injection
Secondary outcomes:
measure: Inter-reader Agreement
timeFrame: 50-60 min after injection
Other outcomes:
Locations:
Study officials:
affiliation: Avid Radiopharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
Clinical trial NCT00143169: Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain
Official title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Of Morphine-Sparing Effect And Safety Of Parecoxib Administered Intravenously For The Treatment Of Postoperative Pain Following Orthopedic Or Gynecological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To validate the morphine-sparing effect and safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.


Eligibility criteria: Inclusion Criteria:

* Undergo gynecological or orthopedic surgery under epidural anesthesia

Exclusion Criteria:

* A previous history of intolerance or hypersensitivity to any NSAID, cyclooxygenase-2 selective inhibitors, sulphonamides, or any of the excipients of parecoxib.

Primary outcomes:
measure: To validate the morphine-sparing effect of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.
Secondary outcomes:
measure: To validate safety of parecoxib administered intravenously for the treatment of Chinese subjects with postoperative pain following gynecological or orthopedic surgery.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Shenyang
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Qingdao
country: China
facility: Pfizer Investigational Site
state: Shandong
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
city: Shanghai
country: China
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06796569: Systemic Immune Inflammatory Index in Systemic Lupus Erythematosus
Official title: Association of Systemic Immune Inflammatory Index with Disease Activity and Lupus Nephritis in Patients with Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Lupus Nephritis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients attending in rheumatology outpatient clinic, sohag university hospital

Brief summary: This study aims to investigate the association between the systemic immune-inflammation index and disease activity, as well as lupus nephritis in patients with systemic lupus erythematosus


Eligibility criteria: Inclusion Criteria:

* o Older than 16 years

  * In a patient with SLE, patients who fulfill the criteria of the American College of Rheumatology (ACR) and European League Against Rheumatism (EULAR).
  * In patients with LN, patients whose diagnosis is confirmed by kidney biopsy and pathohistological verification (WHO classification, and the International Society of Nephrology/Renal Pathology Society (ISN/RPS) classification.

Exclusion Criteria:

* Patients with other autoimmune rheumatological diseases, lymphoproliferative disorders, malignancies, liver diseases, end-stage kidney disease, diabetic nephropathy, active infections, recent history of blood transfusion and patients with deficiencies in vitamin B12, folate, and iron are excluded from the study.

Primary outcomes:
measure: association of systemic immune-inflammation index (SII) disease activity in systemic lupus erythematosus
timeFrame: baseline
measure: association of systemic immune-inflammation index (SII) and lupus nephritis in patients with systemic lupus erythematosus
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty
Study officials:
References:
Clinical trial NCT05994469: Prevention of Groin Injuries in Rink Hockey
Official title: Prevention of Groin Injuries in Rink Hockey: A One Season Natural Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Groin Injury
Groin Strain
Adductor Strain
Keywords: rink hockey
groin pain
injury prevention
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Natural experiment
Primary purpose: PREVENTION

Brief summary: Rink hockey teams from senior category (adults) will be recruited to implement a groin injury prevention program consisting on the Copenhagen Adduction Exercise (CAE) throughout the regular season, 0 times, once or twice per week (september 2023-march 2024)

Weekly team exposure to training sessions and games will be collected as well as cases of groin problems in the entire population

When the season ends, the number of groin problems will be compared between teams that used the prevention program once a week against twice a week or no sessions a week.

Detailed description: Rink hockey teams will be offered a prevention program consisting on the CAE to be performed during the season.

Teams will decide to implement the protocol once, twice or 0 times per week, depending on their schedule. No formal control group will be set, comparison of injuries will be performed between teams that used +80% of the total possible sessions and -80% (28 weeks equals a potential 42 CAE sessions throughout the season).

On a weekly basis, coaches will be contacted to report number of training sessions, games, and training sessions where they implemented CAE.

Bi-weekly, players will report any episode of groin problems (both leading to time-loss and those only affecting performance while not limiting participation).

Eligibility criteria: Inclusion Criteria:

* #1 Be part of a rink hockey team competing in senior league (either local (third division/lower) or national (first and second division))

  * 2 Accept participating in the study (signing the informed consent)

Exclusion Criteria:

* #1 not playing rink hockey in the previous season

  * 2 serious illness, injury or surgery in the previous 6 months that prevented rink hockey participation

Primary outcomes:
measure: Bi-Weekly prevalence of groin problems
timeFrame: Every 14 days throughout the entire study (which lasts 7 months)
Secondary outcomes:
measure: Adherence to the intervention
timeFrame: Every 7 days throughout the entire study (which lasts 7 months)
measure: hockey exposure
timeFrame: Every 7 days throughout the entire study (which lasts 7 months)
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hugo Olmedillas
state: Asturias
Study officials:
References:
Clinical trial NCT01772069: Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus:Focusing on Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Keywords: systemic lupus erythematosus, disease activity, sleep, quality of life
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2013-01-21
Enrollment: 300
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Patients : 150 women age 30 to 60 years with SLE
* Control subjects : age, sex matched control subject (150 subjects)
* Patients : First visit and second visit after an interval of six months
* Control subjects : baseline only

Brief summary: Systemic lupus erythematosus (SLE) patients show a high prevalence of fibromyalgia though rates vary considerably from one study to another (from 8.2% to 45%). Although fibromyalgia can bring out the disability in daily life, the majority of previous reports only ascertained no significant association between the presence of fibromyalgia and the severity of SLE.

It is necessary to make unremitting effort to reduce the mortality and life-threatening disease flare-up due to SLE disease itself. Additionally, we think that physicians need to pay more attention to improve health-related quality of life (HRQoL) in the patients with SLE. HRQoL could be influenced by various factors such as depression, fibromyalgia, disease duration, disease activity and etc. To improve the HRQoL in SLE patients, it might be the clinically important and constructive theme to investigate that which is the most important factor among the fibromyalgia, depression, sleep quality, SLE activity and SLE duration.

The objective of this study is to evaluate the degree of contribution of fibromyalgia for reduced HRQoL and to identify the status of managing fibromyalgia in Korean patients with SLE.


Eligibility criteria: Inclusion Criteria:

1. Woman between 30 and 60 years of age, inclusive
2. Have a diagnosis of Systemic lupus erythematosus according to the 1997 updated American college of Rheumatology criteria for classification of systemic lupus erythematosus

Exclusion Criteria:

1. Patients were excluded if they had had a history of head injury that led to unconsciousness
2. Have unstable disease necessitating an increase in prednisone dose or the addition of another immunosuppressive medication
3. Have a current malignancy
4. Have a history of or current evidence of substance abuse (drug or alcohol) problem within the previous 2 years

Primary outcomes:
measure: EuroQoL (EQ-5D)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00670969: Validation of Hand Held Indirect Calorimeter in Overweight and Obese Patients
Official title: Validation of Handheld Indirect Calorimeter in Overweight and Obese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2008-05-02
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major Inclusion \& Exclusion Criteria: Age at least 18 years (no upper limit). Able to fast overnight. Have a BMI no less than 25 kg/m2.

Method of Identification of Subjects/Samples/Medical Records: Participants will be recruited with a flyer. Interested individuals will contact the investigators who will ask basic eligibility questions. If eligible, pre-test requirements will be explained to the participant (12 hour fast, avoidance of physical activity and smoking for the same time period.)

Brief summary: The purpose of this study is to determine, in a group of overweight or obese volunteers, if a handheld indirect calorimeter can accurately measures oxygen consumption to determine resting metabolic rate compared to a portable indirect calorimeter.

Detailed description: 1. Background and Rationale: With the growing number of overweight and obese Americans, health professionals need accurate and convenient tools to help personalize weight loss programs. Portable indirect calorimetry measurements are more expensive than handheld devices and often limited to research setting only, making them impractical for clinical use. Additionally equations used to estimate resting metabolic rate may be significantly inaccurate in overweight patients. Several studies have been conducted to determine the accuracy of handheld devices, however none have been done in the overweight and obese populations. If handheld calorimeters can accurately measure resting metabolic rate in overweight and obese patients, these tests may be used to improve and personalize weight management programs.
2. Key Objectives: To determine in a group of overweight or obese volunteers if a handheld indirect calorimeter can accurately measures oxygen consumption to determine resting metabolic rate.

Eligibility criteria: Inclusion Criteria:

* Age at least 18 years (no upper limit).
* Able to fast overnight.
* Have a BMI no less than 25 kg/m2.

Exclusion Criteria:

* All others

Primary outcomes:
measure: Validate handheld calorimeter against a portable device
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Abigail E Schubert, MS, BA
role: PRINCIPAL_INVESTIGATOR
References: