louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05175495: Influencing Factors of Coronary Heart Disease in Young People
Official title: To Study the Risk Factors of Youth Coronary Heart Disease From Inflammatory Cytokines，Lifestyle and Familial Inheritance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Heart Disease
Keywords: Coronary heart disease
Inflammatory cytokines
lifestyle
Familial inheritance
Myocardial infarction
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Nantong University
First posted: 2022-01-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed coronary heart disease

Brief summary: The incidence of coronary heart disease in young people is not uncommon and the investigators will explore the factors contributing to this outcome

Detailed description: Through the multi-center clinical research conducted by several units in Nantong city, the risk factors and aggregation of the incidence of CHD among young people in nantong city were obtained, so as to fill in the blank of domestic multi-center research and reduce the incidence of CHD among young people.The investigators will conduct a long-term follow-up study on the young patients with CHD to screen the factors contributing to the poor prognosis of CHD in young patients.The investigators will fill this gap and intervene early to improve patients' quality of life and prolong their survival

Eligibility criteria: Inclusion Criteria:

* Diagnosed coronary heart disease
* Confirmed by coronary angiography
* Diagnosed myocardial infarction
* Willing to sign an inform consent

Exclusion Criteria:

* Patients won't sign an inform consent or will not comply with the follow up.

Primary outcomes:
measure: Whether inflammatory factors are differentially expressed in young patients with coronary heart disease
timeFrame: Until April 2024
measure: The effect of gene activity on youth morbidity
timeFrame: Until April 2024
measure: Sedentary, high-fat diet, lack of exercise and other unhealthy lifestyle effects on young people
timeFrame: Until April 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Nantong
country: China
facility: shengHz
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: hzh sheng, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05586295: Vitamin B Complex Improved Exercise Performance and Anti-fatigue
Official title: The Functional Evaluation on Antifatigue and Improving Sports Performance by Vitamin B Complex of BULIKELAO Sugar-coated Tablet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Performance
Fatigue
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
Collaborators: name: Prince Pharmaceutical Co., Ltd
First posted: 2022-10-19
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to evaluate potential beneficial effects of TTFD® EX PLUS (Prince Pharmaceutical Co., Ltd., Yunlin County, Taiwan) on fatigue and ergogenic functions following physiological challenge. The test used a double-blind crossover design and supplementation for 28 days. 32 male and female 20-30 year-old subjects were divided into two groups in a balanced order according to each individual's initial maximal oxygen uptake and were assigned to receive a placebo with equal gender (non TTFD® EX PLUS with same color/day, n=16, 8 male and 8 female) or TTFD® EX PLUS (600mg/tablet/day, n=16, 8 male and 8 female) every morning. After the intervention, there were 28 days of wash-out, during which time the subjects did not receive further interventions.


Eligibility criteria: Inclusion Criteria:

* \>20 years old
* \>health

Exclusion Criteria:

* No smoking
* drinking habits
* no nutritional supplements or medications
* no food allergies
* normal liver and kidney function
* no diabetes and other chronic diseases

Primary outcomes:
measure: Exercise endurance exhaustion time
timeFrame: 28 days
measure: Clinical Biochemistry of lactate level
timeFrame: 28 days
measure: Clinical Biochemistry of ammonia level
timeFrame: 28 days
measure: Clinical Biochemistry of CK level
timeFrame: 28 days
measure: Clinical Biochemistry of glucose level
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Graduate Institute of Sports Science, National Taiwan Sport University
Study officials:
References:
Clinical trial NCT00391495: Inflammation in Children With Attention-Deficit/Hyperactivity Disorder
Official title: Inflammation in Children With Attention-Deficit/Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention-Deficit/Hyperactivity Disorder
Keywords: ADHD
Cytokines
CR-P
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-10-24
Enrollment: 45
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: The aim of this study is to investigate the inflammatory response in children with this disorder.

Detailed description: Attention deficit-hyperactivity disorder (ADHD) is a prevalent childhood neuropsychiatric disorder, characterized by age-inappropriate and impairing levels of inattention, hyperactivity and impulsiveness. Approximately 5-10% of school-age children are affected by ADHD, and in many cases, symptoms persist into adolescence and adulthood.

Cytokines are key mediators of immune function and can be either pro-inflammatory or anti-inflammatory. Recently few studies have suggested involvement of cytokine pathways in subjects with ADHD.

Polymorphism of IL-1 receptors antagonists' alleles have been suggested in families and subjects suffering from ADHD. Moreover, a new variant of inflammatory bowel disease, another immunological based disease, was recently suggested in children with ADHD and other developmental disorders. There are no other published reports on cytokine production in children who suffer from ADHD.

Eligibility criteria: Inclusion Criteria:

1. A defined condition of ADHD according to TOVA test (TOVA score \> (-1.8), Connor's questionnaire (Connor's score \> 15 points) and Achenbach's questionnaire;
2. A consent form signed by parents or legal guardianships;

Exclusion Criteria:

1. A history of any other neurological or major psychiatric disorder or other significant medical problems;
2. No current medications;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: The Unit of Clinical Nutrition
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Nachum Vaisman, Prof. (MD)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02208895: iSTAT Comparison Study, IRB3785
Official title: Correlation of In-lab Pleural Fluid Glucose Measurements With a Finger Stick Glucometer and Portable Point of Care Testing Device (i-STAT).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Effusions
Keywords: pleural
glucose
glucometer
i-STAT
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pleural effusions

Brief summary: Pleural fluid glucose levels measured with bed-side point of care methods such as finger stick glucometers and I-STAT device correlate with the traditional in-lab testing methods.

Detailed description: This is a prospective study which will identify patients in VAMC with a diagnosis of pleural effusion and undergoing diagnostic thoracentesis.The investigators plan to analyze the two bedside point-of-care fluid glucose testing methods (I- STAT device and finger stick glucometer) to measure pleural fluid glucose levels. The results obtained from these two methods will be compared to the traditionally in lab measured pleural fluid glucose levels.

Eligibility criteria: Inclusion Criteria:

* any patient 18 to 99 year old with a diagnosis of pleural effusion and undergoing a diagnostic thoracentesis.

Exclusion Criteria:

* Inability to provide informed consent by the patient or the surrogate to enroll for the planned study.

Primary outcomes:
measure: Correlation of pleural fluid glucose measured with a glucometer and the I-STAT with the pleural fluid glucose level measured in the Lab
timeFrame: <1 hour
Secondary outcomes:
measure: Intra assay precision of pleural fluid glucose measured with a glucometer and with an I-STAT device.
timeFrame: < 1hour
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: VAMC OKC
state: Oklahoma
Study officials:
affiliation: OUHSC
name: Houssein Youness, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00858195: A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules
Official title: A Relative Bioavailability Study of 75mg Indomethacin Extended-Release Capsules Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Inflammation
Keywords: Anti-inflammatory
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the bioequivalence of Indomethacin ER Capsules.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, medical history or clinical laboratory results on screening

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C
* No allergies to indomethacin or related drugs

Primary outcomes:
measure: Bioequivalence according to US FDA guidelines.
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: PRACS Institute, LTD.
name: Anthony R Godfrey, Pharm. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00200395: OSI-774 (Erlotinib, Tarceva) in Elderly Patients
Official title: Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2005-09-20
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to determine if OSI-774 (Tarceva) is effective in the treatment of non-small cell lung cancer and to further study its side effects. The investigators would also like to estimate disease-related symptom improvement rates using a questionnaire.

Detailed description: In recent years, it has been shown that the degree of improvement achievable with chemotherapy has plateaued with the use of chemotherapy doublets. The presence of co-morbid conditions and poor performance status may preclude the use of chemotherapy in many elderly patients, which even in the medically fit, has modest benefits. The advent of targeted cancer therapy with the discovery of tyrosine kinases as mediators of tumor growth, with its limited toxicity profile, offers a promising approach to the treatment of NSCLC, in particular to the elderly subset of patients. The encouraging results from the other trials provide a strong rationale to evaluate an oral EGFR-tyrosine kinase inhibitor OSI-774 in patients with advanced and inoperable NSCLC over the age of 70. In vitro and clinical data suggest a dose- dependent response with Tarceva (Genentech, data on file).

Eligibility criteria: Inclusion Criteria:

* Patients must have confirmed non-small cell lung cancer. Age \> 65 years Patients must have adequate organ and marrow function

Exclusion Criteria:

* Patients who have had prior chemotherapy will be excluded. Patients may not be receiving any other investigational agents.

Primary outcomes:
measure: Rate of Response
timeFrame: 1-3 years
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v2.0
timeFrame: 1-3 years
measure: Changes in Quality of Life (QOL): questionnaire
timeFrame: through study completion, an average of 3 years
measure: Rate of Progression free survival
timeFrame: 1-3 years
measure: Duration of stable disease
timeFrame: 1-3 years
measure: Overall Rate of Survival
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein Cancer Center
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center-
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Lakshmi Rajdev, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03402295: Superiority of VCD Versus CTD in Patients With Newly Diagnose Multiple Myeloma Eligible for Transplantation
Official title: Superiority of the Triple Combinations of Bortezomib, Cyclophosphamide and Dexamethasone (VCD) Versus Cyclophosphamide, Thalidomide and Dexamethasone (CTD) in Patients With Newly Diagnose Multiple Myeloma, Eligible for Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma
Effects of Chemotherapy
Lead sponsor: Grupo de Estudos Multicentricos em Onco-Hematologia
Sponsor class: NETWORK
First posted: 2018-01-18
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Retrospectively compared two different groups of treatments
Primary purpose: TREATMENT

Brief summary: This study compared two main different induction protocols used to treat myeloma eligible patients in Brazil. VCD against CTD.

Detailed description: The primary aim was observe response rate after 4 induction cycles.

Eligibility criteria: Inclusion Criteria:

* multiple myeloma newly diagnose elegible to autologous transplantation Patients submitted to ctd or vcd Myeloma patients newly diagnose \>18yo

Exclusion Criteria:

* other chemotherapy induction protocol

Primary outcomes:
measure: Response rate better than very good partial response after 4 induction cycles
timeFrame: Response rate after induction phase - at the end of cycle 4- (28 days each cycle)- time frame trough study completion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Bahia
name: Edvan Cusoe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05964595: Temporal Diffusion Spectroscopy MRI in Predicting the CPS of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy
Official title: Temporal Diffusion Spectroscopy MRI in Predicting the Comprehensive Positive Score of PD-L1 Expression and the Efficacy of Neoadjuvant Therapy in Head and Neck Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Squamous Cell Carcinoma
Magnetic Resonance Imaging
Neoadjuvant Therapy
Keywords: Head and neck squamous cell Carcinoma
Temporal diffusion spectroscopy imaging
Programmed death-ligand 1
Neoadjuvant therapy
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 136
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients first diagnosed with HNSCC by pathological biopsy and proposed to receive preoperative neoadjuvant therapy at Sun Yat-sen Memorial Hospital

Brief summary: The goal of this observational study is to explore the application of temporal diffusion spectroscopy MRI in head and neck squamous cell carcinoma (HNSCC).

The main questions it aims to answer are:

* If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the comprehensive positive score (CPS) of pathological PD-L1 expression in HNSCC?
* If the quantitative parameters of temporal diffusion spectroscopy MRI can predict the efficacy of neoadjuvant therapy in HNSCC? Participants will receive head and neck MRI, including T2WI, T1WI, diffusion-weighted imaging (DWI), oscillating gradient spin echo (OGSE) and pulsed gradient spin echo (PGSE) sequence before and after neoadjuvant therapy.

There is not a comparison group in our study.


Eligibility criteria: Inclusion Criteria:

* Patients first diagnosed with head and neck squamous cell carcinoma (HNSCC) by pathological biopsy
* Patients proposed to receive 2-3 courses of neoadjuvant chemotherapy and immunotherapy
* Patients without contraindications for MRI, such as nonremovable ferromagnetic metal foreign body, claustrophobia, renal insufficiency, and previous history of gadolinium contrast allergy

Exclusion Criteria:

* Less than 10mm in the maximum diameter of the baseline primary tumor
* Poor MRI image quality with obvious metal or motion artifacts
* The failure to complete the course of neoadjuvant therapy

Primary outcomes:
measure: Comprehensive positive score
timeFrame: 1 week before neoadjuvant therapy
measure: Pathological response
timeFrame: 1 month after the last neoadjuvant therapy
measure: Change from maximum transverse tumor diameter after neoadjuvant therapy
timeFrame: 1 week before the first neoadjuvant therapy and 1 month after the last neoadjuvant therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02204995: Surgical Treatment for Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4
Official title: Trapeziectomy With Ligament Reconstruction and Tendon Interposition or Simple Trapeziectomy for Treating Trapeziometacarpal Osteoarthritis Eaton & Glickel Stage 4: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trapeziometacarpal Osteoarthritis
Thumb Carpometacarpal Osteoarthritis
Keywords: Osteoarthritis
Thumb
LRTI
Trapeziectomy
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 62
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Trapeziometacarpal osteoarthritis is a common cause of pain and loss of hand function in postmenopausal women. Many surgical treatments have been described and recent literature has show that the relatively simple trapeziectomy gives equal results and less complications, when compared to other techniques such as ligament reconstructions and interpositions. These studies have been conducted predominantly in patients with stage 2 or 3 osteoarthritis. Stage 4 osteoarthritis is characterized by more cartilage and soft-tissue damage, which increases the chance for collapse of the first metacarpal bone and associated problems.

The investigators' hypothesis is that an LRTI can be of additional value in patients with stage 4 osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Women
* 40 years of age or more
* Symptomatic trapeziometacarpal osteoarthritis
* Eaton \& Glickel stage 4

Exclusion Criteria:

* An operation for trapeziometacarpal osteoarthritis on the same hand in the past.
* Participation in randomized clinical trial for trapeziometacarpal osteoarthritis with contralateral hand.
* Secondary trapeziometacarpal osteoarthritis as result of trauma, rheumatoid arthritis, systemic lupus or gout.
* Symptomatic carpal tunnel syndrome in same hand.
* Symptomatic Quervain's tenosynovitis in same hand.
* Neurological or other disorders of the affected side that can influence postoperative rehabilitation.
* Insufficient knowledge of Dutch language.

Primary outcomes:
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
timeFrame: 1 year after surgery
Secondary outcomes:
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
timeFrame: 5 years after surgery
measure: Michigan Hand Outcomes Questionnaire (MHOQ)
timeFrame: 1 and 5 years after surgery
measure: Disabilities of Arm Shoulder and Hand (DASH)
timeFrame: 1 and 5 years after surgery
measure: Grip strength
timeFrame: 1 and 5 years after surgery
measure: Thumb mobility
timeFrame: 1 and 5 years after surgery
measure: Complications
timeFrame: 1 and 5 years after surgery
measure: Return to work
timeFrame: 1 and 5 years after surgery
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Hospital
state: Overijssel
Study officials:
affiliation: Isala
name: Jeroen H. van Uchelen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04320095: Tonsillectomy Using BiZact Tonsilletomy Device
Official title: BiZact Versus Electrocautery in Tonsillectomy: A Single-Center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tonsillectomy
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 48
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe how Bizact Tonsillectomy Device might affect operative time and intraoperative blood loss in pediatric patients undergoing tonsillectomy, and compare these parameters to the standard technique in tonsillectomy at our institution, which is electrocautery.

Detailed description: It is a prospective, interventional, single-center study on the performance of Bizact tonsillectomy device on children undergoing tonsillectomy.The required parameters concerning operative time and intra operative blood loss will be obtained during the procedure.There will be no extra clinical visits for the participants.

Operative time will be assessed in 2 ways: 1). By using blade-tipped electrocautery on one tonsil and the BiZact device on the other tonsil for same patient; and 2). using electrocautery for removal of both tonsils and comparing the operative time to an equal number of cases wherein the BiZact device was used for removal of both tonsils.

With regard to intra operative bleeding, it will be quantified into one of 3 groups: 1). No blood in suction tubing, 2). blood in suction tubing but not in the suction canister, and 3). blood in the suction canister.

Eligibility criteria: Inclusion Criteria:

1. Children scheduled for tonsillectomy at Alberta Children Hospital
2. Tonsillectomy for either recurrent tonsillitis or sleep-disordered breathing.

Exclusion Criteria:

1. Craniofacial abnormalities
2. Bleeding disorders
3. Complex medical background

Primary outcomes:
measure: Operative time
timeFrame: during the procedure
Secondary outcomes:
measure: Intraoperative blood loss
timeFrame: during the procedure
Other outcomes:
Locations:
Study officials:
References: