louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03518424: Injury Epidemiology Within Scottish Professional Football
Official title: Scottish Football Injury Study (S-FIS): Epidemiology of Injuries in Scottish Professional Football - A Multi-club, One Season Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Injury;Sports
Keywords: Association football
Soccer
Injury
Epidemiology
Lead sponsor: Heriot-Watt University
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 200
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Scottish Professional Football League (SPFL) club contracted football players

Brief summary: The aim of the present study is to establish the injury incidence, severity and burden typically observed within Scottish professional football clubs. In line with the well-established model of sports injury prevention research proffered by van Mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden. Such a multi-club study has never been conducted within Scotland despite a thriving professional game.


Eligibility criteria: Inclusion Criteria:

* Professional football player contracted to an SPFL club

Exclusion Criteria:

* Loss of professional status as a footballer

Primary outcomes:
measure: Injury incidence
timeFrame: 1 year
measure: Injury type
timeFrame: 1 year
measure: Injury burden
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Oriam: Scotland's Sports Performance Centre
Study officials:
affiliation: Oriam: Scotland's Sports Performance Centre
name: Robert McCunn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06423924: Second Primary Cancer and Early-onset Colorectal Cancer
Official title: Risk Factors, Cancer Types and Prognostic Significance of Second Primary Cancer Based on the Early-onset and Late-onset Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Cancer
Second Primary Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients retrieved from the database of Fudan University Shanghai Cancer Center. These patients were diagnosed with CRC primary tumors between January 2008 and December 2018.

Brief summary: The objective of this study was to analyze the pathological factors influencing the occurrence and prognosis of SPC in CRC patients of varying ages and compare the differences in the patterns of SPC occurrence and prognosis among patients of different age groups.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing radical surgery for colorectal cancer at Fudan University Shanghai Cancer Center between January 2008 and December 2018.
* Stage Ⅰ-Ⅳ colorectal cancer confirmed by clear pathological information

Exclusion Criteria:

* Previous history of other cancers before surgery
* Patients under 18 years old or over 80 years old

Primary outcomes:
measure: overall survival
timeFrame: The duration from the date of surgery to death for any reason or the last recorded follow-up, whichever comes first. Up to 100 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00157924: Ezetimibe (+) Simvastatin vs. Atorvastatin Comparative Study in DM or Metabolic Syndrome Patients (0653A-093)
Official title: A Multicenter, Randomized, Open-label Study to Evaluate the Lipid-Altering Efficacy and Safety of Ezetimibe (+) Simvastatin Versus Atorvastatin in Hypercholesterolemic Patients With Diabetes Mellitus or Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An efficacy and safety study of ezetimibe (+) simvastatin compared to atorvastatin at week 6 in diabetics or metabolic syndrome patients in Korea.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hypercholesterolemia
* Drug naive or statin treated but inadequately controlled patients against NCEP ATP III guideline goal

Exclusion Criteria:

* Hypersensitivity to HMG-CoA inhibitor or Ezetimibe

Primary outcomes:
measure: LDL-C lowering efficacy
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01945424: Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry
Official title: Sanofi Pasteur Quadrivalent Influenza Vaccine Pregnancy Registry Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Influenza
Keywords: Quadrivalent Influenza Vaccine
Pregnancy Registry
Influenza
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-09-18
Enrollment: 244
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV)

Brief summary: The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.

Detailed description: Pregnant women will be enrolled in the registry prospectively (after exposure to QIV in routine clinical settings but before knowledge of the pregnancy outcome). Women exposed to QIV with or without adverse events will be recorded in the Global Pharmacovigilance Database and medically reviewed. Pregnancy outcomes will be sought via questionnaires sent to the reporter at enrollment, estimated time of delivery, and six months after delivery. Descriptive statistical methods will be the primary approach for summarizing data.

No vaccine products will be provided or administered as part of this registry protocol.

Eligibility criteria: Inclusion Criteria:

* Pregnant women will be enrolled in the registry prospectively (after exposure to Quadrivalent Influenza Vaccine (QIV) but before the conduct of any prenatal tests that could provide knowledge of the outcome of pregnancy). If the condition of the fetus has already been assessed through prenatal testing (e.g., targeted ultrasound, amniocentesis, etc.), such reports will be considered retrospective reports. Retrospective reports are also eligible for the registry but they will be analyzed separately from prospective reports.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Number of cases and outcomes of pregnancies following exposure to QIV vaccine
timeFrame: Up to six years
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Albany
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Harrisburg
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Ledlie S, Gandhi-Banga S, Shrestha A, Mallett Moore T, Khromava A. Exposure to quadrivalent influenza vaccine during pregnancy: Results from a global pregnancy registry. Influenza Other Respir Viruses. 2022 Jan;16(1):90-100. doi: 10.1111/irv.12897. Epub 2021 Sep 14.
Clinical trial NCT02606734: DyeVert Pilot Trial
Official title: DyeVert Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Angiography
Lead sponsor: Osprey Medical, Inc
Sponsor class: INDUSTRY
First posted: 2015-11-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the usability characteristics of DyeVert™ during normal clinical use and to understand the amount of contrast media (CM) diverted from the subject and saved over a total angiographic procedure.


Eligibility criteria: Inclusion Criteria:

1. The subject is indicated for a coronary angiogram or percutaneous coronary procedure
2. The subject is ≥ 18 years of age
3. The subject (or subject's legal representative) is willing and able to provide appropriate informed consent.

Exclusion Criteria:

1. Subject is undergoing a STEMI procedure
2. The subject is female and currently pregnant
3. In the investigator's opinion, the subject is not considered to be a suitable candidate

Primary outcomes:
measure: Volume (Percentage) of Contrast Media (CM) Diverted (Saved) in a Total Procedure
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Clayton
country: Australia
facility: Monash Health
state: Victoria
city: Lübeck
country: Germany
facility: University Hospital of Schleswig-Holstein
Study officials:
References:
Clinical trial NCT02401334: Antimicrobial Hernia Repair Device Clinical Study
Official title: Feasibility Study of the Antimicrobial Hernia Repair Device for Repair of Ventral or Incisional Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Incisional Hernia
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2015-03-27
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective clinical study will evaluate the safety and efficacy of the Cook® Antimicrobial Hernia Repair Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected (i.e., Class II, Class III, and Class IV) surgical fields. Up to 30 patients will be treated with the Cook® Antimicrobial Hernia Repair Device and patients will be followed for 12 months.


Eligibility criteria: Inclusion Criteria:

* Patient presents with a ventral or incisional hernia that is to be surgically corrected using open repair technique

Exclusion Criteria:

* Body Mass Index (BMI) \< 25.
* Body weight \< 45 kg
* Glycosylated Hemoglobin (Hgb A1c) \> 10%
* Albumin \< 2.5 g/dL or pre-albumin \< 5.0 mg/dL
* Renal insufficiency, as determined by an estimated glomerular filtration rate (GFR) \< 60 mL/min/1.73 m2
* Known allergies to study device components
* Other relevant exclusion criteria apply

Primary outcomes:
measure: Incidence of Surgical Site Infection
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of procedural or post-operative adverse events related to the study device or procedure (i.e., Permanence of hernia repair, as determined by hernia recurrence).
timeFrame: 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Salford
country: United Kingdom
facility: Salford Royal Hospital
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Hospital
Study officials:
References:
citation: Minor S, Brown CJ, Rooney PS, Hodde JP, Julien L, Scott TM, Karimuddin AA, Raval MJ, Phang PT. Single-stage repair of contaminated hernias using a novel antibiotic-impregnated biologic porcine submucosa tissue matrix. BMC Surg. 2020 Mar 30;20(1):58. doi: 10.1186/s12893-020-00715-w.
Clinical trial NCT06667934: Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis
Official title: Clinical Trial of Zuoqing SAN in Treating Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Ulcerative Colitis (UC)
Lead sponsor: The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 60
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: The exact efficacy of Zuoqing SAN enema in the treatment of Ulcerative colitis (UC) has been clinically verified. In this study, Zuoqing SAN was used to treat UC patients with large intestine damp-heat syndrome, and the traditional chinese medicine (TCM) syndrome type was large intestine damp-heat syndrome. The changes of symptoms and signs of patients before and after treatment were observed and compared, and the clinical efficacy of Zuoqing SAN in the treatment of UC large intestine damp-heat syndrome was evaluated by combining the changes of patients' symptoms, related blood indicators, improved Mayo total score, overall syndrome efficacy, clinical comprehensive efficacy and other aspects. By replicating the rat UC model, the effects of Zuoqing SAN on general survival state, colonic gross appearance and histopathological changes, related inflammatory factors, peroxisome proliferator-activated receptor γ (PPAR-γ) /nuclear factor kappa-B（NF-κB) /signal transducerand activator of transcription 1 (STAT1) pathway, macrophage M1, M2 phenotype and microangiogenesis were observed in UC rats. Thus, the specific mechanism of Zuoqing SAN in the treatment of UC was revealed. In this study, the therapeutic effect of Zuoqing Powder on UC was investigated through clinical and animal experiments, and the specific mechanism of action was studied.


Eligibility criteria: Inclusion Criteria:① Clinically diagnosed UC; ② The severity of UC is mild to moderate.

-

Exclusion Criteria:① The severity of UC is severe; ②patient with Severe liver, kidney, heart and brain diseases; ③ Patients with Chinese medicine allergy; ④ Pregnant or lactation patients.

-

Primary outcomes:
measure: Symptoms: frequency of stool
timeFrame: Follow-up for 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04126434: Intervention of Air Pollution and Acute Coronary Syndrome
Official title: Intervention of Air Pollution and Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the effect of intervention of ambient air pollution on acute coronary syndrome patients.

Detailed description: To investgate the effect of wearing facemasks to decreasing levels of exposure to ambient air on acute coronary syndrome patients.

Eligibility criteria: Inclusion Criteria:

1. Non-smoker of any type during past six months and living in a non-smoking household.
2. A diagnosis of myocardial infarction or unstable angina 7-90 days prior to signed informed consent.

Exclusion Criteria:

1. Unstable CV disorders including uncompensated heart failure, refractory angina, uncontrolled arrhythmias, critical valvular heart disease and severe hypertension.
2. A history of infection with human immunodeficiency virus.
3. History of malignancy including leukemia and lymphoma AND/OR any severe, life-threatening disease AND/OR history of drug abuse within the last 2 years.
4. Pregnancy or intent to get pregnant during the study period.

Primary outcomes:
measure: vascular function
timeFrame: six months
measure: autonomic nervous function
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University ,School of Public Health
state: Beijing
Study officials:
affiliation: Peking University Health Science Center
name: Wei Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00674934: Far Infrared Irradiation for Managing and Treating Multiple Sclerosis (MS)
Official title: Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation for Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: MS (Multiple Sclerosis)
Multiple Sclerosis, Acute Fulminating
Sclerosis, Disseminated
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2008-05-08
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multiple sclerosis (abbreviated MS) is an autoimmune condition in which the immune system attacks the central nervous system (CNS), leading to demyelination. This study will investigate the use of far infrared radiation for MS control, management and treatment.

Detailed description: MS a demyelinating disease, is any disease of the nervous system in which the myelin sheath of neurons is damaged. This impairs the conduction of signals in the affected nerves, causing impairment in sensation, movement, cognition, or other functions depending on which nerves are involved.

MS affects the areas of the brain and spinal cord known as the white matter. White matter cells carry signals between the grey matter areas, where the processing is done, and the rest of the body. More specifically, MS destroys oligodendrocytes which are the cells responsible for creating and maintaining a fatty layer, known as the myelin sheath, which helps the neurons carry electrical signals.

Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly lead to complete rehabilitation of people who have MS.

Eligibility criteria: Inclusion Criteria:

* Patients with MS

Exclusion Criteria:

* None

Primary outcomes:
measure: Treatment of MS
timeFrame: 2 years
Secondary outcomes:
measure: Rehabilitation of MS Patients
timeFrame: 2 Years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01833234: Epilepsy Impact Scale
Official title: Questionnaire Development for a Comprehensive Scale to Measure the Impact of Epilepsy on Life.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: epilepsy
quality of life
seizure severity
antiepileptic drug side effects
questionnaire
patient reported outcomes
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: James & Carrie Anderson Fund for Research in Epilepsy
First posted: 2013-04-16
Enrollment: 51
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 in the Stanford Epilepsy Center who have had a seizure in the past year and agree to participate.

Brief summary: The investigators are developing a questionnaire that can quickly measure the impact that epilepsy has on a person's life. This questionnaire will be useful in following whether the impact of epilepsy increases, decreases or stays the same over time. The results also may point out areas that would benefit from discussion or attention in visits with your doctor.

Detailed description: The investigators have used a set of broad open-ended questions about the impact of epilepsy on a person's life to formulate a long list of questions to characterize the impact the seizures, medications, and comorbidities that you are having. In the future, this will be boiled down to a short list of questions.

Eligibility criteria: Inclusion Criteria:

1. Age 18 or more.
2. Patient has had at least 1 seizure in the past 365 days.
3. Patient can speak and understand English.

Exclusion Criteria:

1. Patients suspected of having one of the imitators of epilepsy, for example, syncope, sleep disorder, psychogenic nonepileptic seizures, will be excluded, even if they also have epileptic seizures.
2. Patients unwilling to spend the time doing the questionnaire.

Primary outcomes:
measure: Validation of a concise question set
timeFrame: Up to 1 year for question set validation, data presentation within up to 1.5 years
Secondary outcomes:
measure: Correlation of subscales
timeFrame: Up to 1.5 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Robert S Fisher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02913534: Hypofractionated Stereotactic Radiation Therapy of Brain Metastases: Evaluation of Whole-brain Radiotherapy
Official title: Hypofractionated Stereotactic Radiation Therapy of Brain Metastases: Evaluation of Whole-brain Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Metastasis
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients records would be extracted from the electronic health record system of Institut de Cancérologie de Lorraine.

Brief summary: The aim is to identify in patients with brain metastases the predictive factors of overall survival, survival without local recurrence and survival with progression-free brain metastases after complementary whole brain radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients with one to three brain metastases treated in our department with hypofractionated stereotactic radiotherapy (SRT) from March 2008 to February 2013.

Exclusion Criteria:

* A patient record captured after February 2013.

Primary outcomes:
measure: Overall survival
timeFrame: 72 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre-les-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: PHILIPPE ROYER, MD
role: PRINCIPAL_INVESTIGATOR
References: