louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01474629: Probiotic Sport Study
Official title: Impact of Supplementation With Probiotics on Exercise-induced Oxidative Stress and Endotoxemia in Trained Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Inflammation
Endotoxemia
Keywords: oxidative stress
inflammation
endotoxemia
strenuous exercise
Lead sponsor: Green Beat
Sponsor class: OTHER
First posted: 2011-11-18
Enrollment: 24
Sex: MALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: We investigate the impact of a probiotic-based dietary supplement on oxidative stress and endotoxemia before and after strenuous exercise.

Hypotheses (H1):

* Supplementation has an influence on oxidative stress parameters before and post exercise
* Supplementation has an influence on parameters of endotoxemia and inflammation before and post exercise
* Strenuous exercise has an influence on parameters of oxidative stress, inflammation and endotoxemia


Eligibility criteria: Inclusion Criteria:

* trained men
* 30 - 45 years
* non-smokers
* 4wk wash out of all dietary supplements

Exclusion Criteria:

* untrained people (VO2max \< 55 ml x kg-1)
* female
* all people not matching this age group
* smokers
* all men taking dietary supplements
* all men that fail in ergometric exercise eligibility testing, refering to the standards in sports medicine (e.g.: significant ST-decrease or increase, blood pressure \> 240 mmHg, tachycardia, polymorphic extrasystolia, cyanosis, bradyarrhythmia..)
* all people that are not adjudged as "Healthy"

Primary outcomes:
measure: markers of oxidative stress, endotoxemia and inflammation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Medical University of Graz
name: Manfred Lamprecht, PhD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lamprecht M, Bogner S, Schippinger G, Steinbauer K, Fankhauser F, Hallstroem S, Schuetz B, Greilberger JF. Probiotic supplementation affects markers of intestinal barrier, oxidation, and inflammation in trained men; a randomized, double-blinded, placebo-controlled trial. J Int Soc Sports Nutr. 2012 Sep 20;9(1):45. doi: 10.1186/1550-2783-9-45.
Clinical trial NCT02748629: ProGrip Mesh Repair vs Lichtenstein Operation
Official title: Randomized Controlled Single-Center Trial: Self-Gripping ProGrip Mesh Repair vs Lichtenstein Operation of Inguinal Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: inguinal hernia
mesh
lichtenstein
hernia repair
selfgripping mesh
Lead sponsor: Regional Health Center in Kartuzy, Poland
Sponsor class: OTHER
Collaborators: name: Medical University of Gdansk
First posted: 2016-04-22
Enrollment: 143
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: The purpose of this trial is to compare clinical outcomes and to analyze cost-effectiveness following self-gripping, sutureless Parietex ProGrip Mesh to traditional Lichtenstein Operation with lightweight polypropylene mesh.

Detailed description: Single-center patient-blinded randomized clinical trial comparing self-gripping mesh (Parietex ProGrip) and standard Lichtenstein method using lightweight polypropylene mesh. Patients will be randomly allocated to the Lichtenstein Operation (L) and ProGrip Repair (R) group. Patients will be followed for one year. The primary outcome measure are: postoperative pain using the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS). Assessments will be made before the surgery, in the day of discharge, 1, 6 and 12 months postoperatively.

Secondary endpoints: recurrence rate, post-operative complications (short and long-term), foreign body sensation, incidence of surgical-site injury, costs, hospital stay, surgery duration, safety and patients satisfaction.

Eligibility criteria: Inclusion Criteria:

* All patients with primary inguinal hernia
* Signed consent

Exclusion Criteria:

* Recurrent hernia
* Emergency procedure
* Patient not willing to participate

Primary outcomes:
measure: Incidence of post-operative pain and its intensity using VAS Scale
timeFrame: 12 Months
Secondary outcomes:
measure: Rate of foreign body sensation - Subjective feeling of discomfort in the groin
timeFrame: 12 Months
measure: Hernia recurrence rate
timeFrame: 12 Months
measure: Post-operative complications
timeFrame: 12 Months
measure: Duration of surgery
timeFrame: Day of surgery
measure: Incidence of Treatment-Emergent Adverse Events [Safety]
timeFrame: 12 Months
Other outcomes:
Locations:
city: Kartuzy
country: Poland
facility: Regional Health Center in Kartuzy
Study officials:
affiliation: Regional Health Center in Kartuzy, Department of General Surgery
name: Mateusz T Zamkowski, MD
role: STUDY_CHAIR
References:
citation: Sanders DL, Nienhuijs S, Ziprin P, Miserez M, Gingell-Littlejohn M, Smeds S. Randomized clinical trial comparing self-gripping mesh with suture fixation of lightweight polypropylene mesh in open inguinal hernia repair. Br J Surg. 2014 Oct;101(11):1373-82; discussion 1382. doi: 10.1002/bjs.9598. Epub 2014 Aug 21.
Clinical trial NCT06233929: Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA)
Official title: Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rheumatoid Arthritis
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older and diagnosed with RA according to 1987 ACR or 2010 ACR / EULAR classification criteria will be consecutively recruited during 2023 and 2033 from the Department of Rheumatology, SunYat-sen Memorial Hospital (SYSMH), Sun Yat-sen University in Guangzhou, and Department of Rheumatology, ShenShan Medical center, Memorial Hospital of Sun Yat-sen University in ShanWei, China. The exclusion criteria are as follows: 1) diagnosis with tumors without control, or AIDS; 2) serious disease in cardiovascular, kidney and blood and endocrine system; and 3) history of schizophrenia or epilepsy

Brief summary: An ongoing long-term cohort study is conducted in the Sun Yat-sen Memorial Hospital of Sun Yat-sen University, that is dedicated to recruiting RA patients, to identify the development of clinical, neuroimaging, and biochemical biomarkers for the diagnosis and prognosis of RA, especially for those with sarcopenia/myopenia

To improve the prognosis of RA, this study includes the following objectives:

1. Construct a useful database to explore the secular dynamic progress of RA, especially the difference between early and lately RA, as well as to improve our understanding of the life-course factors affecting the process that will facilitate future research activities.
2. Identify the potential markers (clinical, biomedical and imaging) affecting/predicting the development process of sarcopenia/myopenia or other prognosis in RA patients.
3. Develop the related multi-modal prediction models with clinical, biomedical and imaging variables to improve the diagnosis and prognosis of RA.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older and diagnosed with RA according to 1987 ACR or 2010 ACR / EULAR classification criteria

Exclusion Criteria:

* Patients diagnosis with tumors without control, or AIDS
* Patients with serious disease in cardiovascular, kidney and blood and endocrine system; and 3) history of schizophrenia or epilepsy

Primary outcomes:
measure: Myopenia
timeFrame: 10 years
measure: CVDs
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00484029: Nasal Carbon Dioxide (CO2)for the Treatment of Temporomandibular Disorders (TMD)Related Pain
Official title: A Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Nasal CO2 in the Symptomatic Treatment of Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Temporomandibular Disorders
Pain
Headaches
Keywords: Temporomandibular Disorders
TMD
TMJ/TMD
Pain Management
Pain
Headaches
Lead sponsor: Capnia, Inc.
Sponsor class: INDUSTRY
First posted: 2007-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This purpose of this study is to evaluate the safety and efficacy of treatment with nasal CO2 in the treatment of pain and other symptoms related to temporomandibular disorder (TMD).

Detailed description: This is a randomized, controlled trial evaluating the safety and efficacy of nasal carbon dioxide for the treatment of pain and other symptoms related to temporomandibular disorders (TMD). Approximately 115 men and women ages 18 to 70 years old who have a history consistent with TMD-related pain for at least 3 months and meet all other eligibility criteria will be enrolled in this study. There may be up to two (2) visits to the clinic, screening and treatment. Screening and treatment may occur on the same day.

Eligibility criteria: Key Inclusion Criteria:

* Have a history consistent with TMD-related pain for at least 3 months prior to screening
* Agree not to use certain medications prior to randomization within the study specified
* Females of childbearing potential must commit to using an acceptable method of birth control and have a negative pregnancy test.

Key Exclusion Criteria:

* Have recent history of alcohol or drug abuse within 2 years prior to randomization
* Current major psychiatric disorder such as suicidal ideation, bipolar, panic disorder, schizophrenic, or psychoses
* History of asthma (other than mild or intermittent)
* Have an existing serious unstable systemic disease (such as severe emphysema, other respiratory diseases, heart disease, etc.) that precludes participation in the study
* Clinically significant nasal disorder (such as deviated septum, presence of polyps, evidence of significant congestion, rhinitis, or other nasal abnormalities)
* Current diagnosis of fibromyalgia
* History or clear clinical evidence of osteoarthritis of temporomandibular joint (TMJ)
* A TMD diagnosis of disc displacement without reduction, "locking"

Primary outcomes:
measure: Change in pain status from baseline over a 3 hour period
timeFrame: within 3 hours of the first dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington, Department of Oral Medicine, Box 356370, Health Sciences Building
state: Washington
Study officials:
affiliation: University of Washington School of Dentistry
name: Edward L. Truelove, DDS, MSD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03906929: Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures
Official title: Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Forearm Fracture
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Using of buried and exposed intramedullary k-wire in pediatric forearm fixation.
Primary purpose: SCREENING

Brief summary: Comparing the rate of complications between buried and exposed intramedullary implants after fixation of pediatric forearm fractures.

Detailed description: comparison between buried and exposed intramedullary k-wire in fixation of pediatric forearm fracture in rate of complications such as infection,malunion,nonunion and refracture.

Eligibility criteria: Inclusion Criteria:

1. Age: less than 10 years .
2. Diaphyseal forearm fracture.
3. closed fracture.
4. isolated or combined fracture of forearm.

Exclusion Criteria:

1. Patient age: more than 10 years old . 2-open fracture. 3- pathological fracture. 4-patient with medical history (immune compromized patient e.g D.M, cancer on chemotherapy and aplastic anemia).

5- neurovascular injury.

Primary outcomes:
measure: compare the rate of refracture in participants who fixed by buried and exposed K-wire.
timeFrame: 6 months
Secondary outcomes:
measure: compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.
timeFrame: 6 months
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assuit u. hospital
Study officials:
affiliation: professor of orthopedic and traumatology Assuit university
name: Mohamed K Hassan, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan LW, Siow HM. Exposed versus buried wires for fixation of lateral humeral condyle fractures in children: a comparison of safety and efficacy. J Child Orthop. 2011 Oct;5(5):329-33. doi: 10.1007/s11832-011-0358-y. Epub 2011 Jul 28.
citation: Tsukamoto N, Mae T, Yamashita A, Hamada T, Miura T, Iguchi T, Tokunaga M, Onizuka T, Momii K, Sadashima E, Nakashima Y. Refracture of pediatric both-bone diaphyseal forearm fracture following intramedullary fixation with Kirschner wires is likely to occur in the presence of immature radiographic healing. Eur J Orthop Surg Traumatol. 2020 Oct;30(7):1231-1241. doi: 10.1007/s00590-020-02689-0. Epub 2020 May 5.
citation: Lascombes P, Haumont T, Journeau P. Use and abuse of flexible intramedullary nailing in children and adolescents. J Pediatr Orthop. 2006 Nov-Dec;26(6):827-34. doi: 10.1097/01.bpo.0000235397.64783.d6.
Clinical trial NCT05699629: Prospective Coronary Heart Disease Cohort
Official title: A Prospective Longitudinal Multi-Omics Cohort of Patients With Coronary Heart Disease Undergoing Coronary Angiography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Heart Disease
Myocardial Infarction
Lead sponsor: Shandong First Medical University
Sponsor class: OTHER
Collaborators: name: Jinan Central Hospital
name: Shandong Provincial Hospital
name: The Second Affiliated Hospital of Shandong First Medical University
name: Qianfoshan Hospital
First posted: 2023-01-26
Enrollment: 50000
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: Patients with coronary heart diseases undergoing coronary angiography and healthy control subjects undergoing routine physical examination in physical examination department.

Brief summary: To evaluate the biomarkers for the prognosis of coronary heart disease, patients with coronary heart disease will be recruited and followed up for at least 2 years.

Detailed description: Patients with cardiovascular disease undergoing coronary angiography will be recruited and prospectively followed up for the incidence of major adverse cardiovascular events (MACE events), including all-cause mortality, cardiovascular mortality, ischemic stroke, heart failure and rehospitalization. Blood and fecal samples will be collected for further analysis. The basic and clinical information will be collected such as socio-demographic, diet, lifestyle, psychological status and medical history. The biomarkers for the incidence of coronary heart disease and the factors contributing to the poor prognosis of coronary heart disease will be investigated based on multi-omics analysis.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as coronary heart disease or with unexplained chest pain needed to undergo coronary angiography.
* Healthy subjects undergoing routine physical examination in the physical examination department and willing to sign informed consent will be recruited as control subjects.

Exclusion Criteria:

* With malignant tumors, infectious diseases and advanced liver diseases.
* Won't sign an inform consent.

Primary outcomes:
measure: major adverse cardiovascular events
timeFrame: 2-year outcome and long-term outcome
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong First Medical University
state: Shandong
Study officials:
affiliation: Shandong First Medical University
name: Tao Xu, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05892029: Develop a Risk Prediction Model for Phthalate-ester-induced Diseases
Official title: Using Machine Learning Algorithms to Develop a Risk Prediction Model for Phthalate-ester-induced Diseases and Suggestions for Improved Nursing Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plasticizers
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 1136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included 1337 subjects, with an average age of 48.98 years. Male subjects (51.8%) outnumbered the females. In addition, 75.1% of the subjects were married, 9.4% had drinking habits, 57.4% did not exercise regularly, 15.3% worked in the manufacturing industry, 47.4% were overweight according to BMI, 45.2% had a body fat percentage higher than normal, and 16.8% had bone density below 2.5. Table 1 shows the analysis results.

Brief summary: This exploratory study collected basic demographic and laboratory data from the Taiwan Biobank using artificial intelligence algorithms and applied data mining to identify the correlations between phthalate esters \[di(2-ethylhexyl) phthalate, DEHP\], lifestyle, and disease.

Detailed description: This study was designed as exploratory research. The Institutional Review Board and the Taiwan Biobank approved the study before it was conducted (Approval Number: TWBR11007-06). The data set included information from participants between 30 and 70 years old who were tested for PAEs between 2016 and 2022 (1337 cases). The data set includes (1) questionnaire responses, such as basic personal information, individual health behaviors, and female health issues; (2) physical examination results, such as body mass index (BMI), body fat percentage, waist circumference, hip circumference, waist-to-hip ratio, blood pressure, heart rate, pulmonary function, and bone mineral density; (3) blood and urine analyses results from blood tests, serology tests, hepatobiliary function tests, renal function tests, and urinalysis; and (4) data on PAE content of urine

Eligibility criteria: inclusion:

1. The target subjects of this study are individuals aged 30 to 70 years old
2. who were tested for PAEs from January 1, 2016 to December 31, 2020.

exclusion:

1who have not been tested for plasticizers

Primary outcomes:
measure: Risk assessment analysis of disease and PAEs
timeFrame: 2022
measure: Artificial intelligence prediction model for diseases and PAEs
timeFrame: 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
city: Taipei
country: Taiwan
facility: National Taipei university of nursing and health science
Study officials:
References:
Clinical trial NCT05868629: Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
Official title: Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors
Keywords: BRAF
v-raf murine sarcoma viral oncogene homolog B1
dabrafenib
trametinib
tumor agnostic
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants diagnosed with a rare BRAF V600E mutation-positive unresectable or metastatic solid tumor, 6 years and older excluding patients with melanoma, Non-Small Cell Lung Cancer, Colorectal Cancer, Anaplastic Thyroid Cancer, Biliary Tract Cancer and glioma, who will be treated with dabrafenib and trametinib.

Brief summary: This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (6 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.


Eligibility criteria: Inclusion Criteria:

* Study participant with a BRAF V600E mutation-positive solid tumor as confirmed by a local laboratory test;
* At least 1 measurable lesion as defined by RECIST v1.1 per local review;
* Study participant previously not treated with dabrafenib and/or trametinib. Study participants who received dabrafenib and trametinib in the past for the treatment of other malignancies are eligible if treatment has been discontinued for greater than 1 year;
* Ability to provide scans for central imaging review

Exclusion Criteria:

* Those with the following tumor types: melanoma, NSCLC, ATC, BTC, glioma and CRC;
* Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Approximately 4 years
Secondary outcomes:
measure: Duration of response (DOR)
timeFrame: Approximately 4 years
measure: Clinical benefit rate (CBR)
timeFrame: Approximately 4 years
Other outcomes:
Locations:
city: Washington
country: United States
facility: Johns Hopkins University
state: District of Columbia
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care Inc
state: Ohio
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: