louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01006187: Comparison of Different Methods for Reducing Pain From Influenza Vaccine Injections
Official title: Comparison of Different Analgesic Methods for Reducing Pain From Adult Intramuscular Influenza Virus Vaccine Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Anxiety
Keywords: Analgesics
Influenza
Vapocoolant
vaccination
pain
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2009-11-01
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare four different analgesic strategies in adults undergoing routine influenza immunization

Detailed description: In this study, we will compare relative effectiveness of 4 analgesic strategies (i.e., topical local anesthetics, vapocoolant spray, tactile stimulation and distraction) in adults undergoing routine immunization in order to provide further evidence of the effectiveness of each intervention and to determine if one method is superior to another. We are not including a 'no treatment' group because we do not wish to subject participants to unnecessary pain when there are available analgesic treatments. Moreover, in the presence of a 'no treatment' group, we cannot rule out a placebo effect for all treatment groups unless we provide a matched placebo for each intervention, which is not feasible. In future studies, we plan to address the added benefit of combining analgesic interventions (i.e., evaluating the effect of a multimodal approach).

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged \>18 years of age undergoing voluntary immunization with influenza virus vaccine

Exclusion Criteria:

* Pre-medication with any of the analgesic interventions in this study,
* Chronic pain syndromes/conditions
* Receiving systemic analgesics and sedatives
* Abnormal circulation (e.g., Raynaud's phenomenon)
* Allergy/hypersensitivity to amide local anesthetics
* Allergy to influenza virus vaccine or constituents
* Prior participation in the trial
* Inability to understand the VAS
* If suspected to be pregnant, pregnant or breastfeeding (due to possible treatment with liposomal lidocaine).

Primary outcomes:
measure: Pain from adult intramuscular influenza virus injection
timeFrame: 1 day
Secondary outcomes:
measure: Adverse Events
timeFrame: 1 day
measure: Anxiety
timeFrame: 1 hour
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taddio A, Lord A, Hogan ME, Kikuta A, Yiu A, Darra E, Bruinse B, Keogh T, Stephens D. A randomized controlled trial of analgesia during vaccination in adults. Vaccine. 2010 Jul 19;28(32):5365-9. doi: 10.1016/j.vaccine.2010.05.015. Epub 2010 May 16.
Clinical trial NCT02657187: The Neuromuscular Effect of Rocuronium in Patient
Official title: The Neuromuscular Effect of Rocuronium in Patient Measuring Muscle Mass by Bioelectrical Impedance Analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2016-01-15
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. The purpose of this study is to find 50% effective dose and 95% effective dose of rocuronium according to muscle mass.

Detailed description: Rocuronium block neuromuscular transmission at the neuromuscular junction, causing paralysis of the affected skeletal muscles. There have been several studies reported positive relationship between muscle mass and amount of neuromuscular junction. Until now, dose of rocuronium has been judged by patient's weight and height. When the rocuronium was developed, 50% effective dose and 95% effective dose of rocuronium was calculated by patient corrected body weight which used weight and height. However, height and weight do not represent exact muscle mass. The purpose of this study is to find 50% effective dose and 95% effective dose of rocuronium according to muscle mass. Measurement of muscle mass will be obtained using bioelectrical impedence analysis.

Eligibility criteria: Inclusion Criteria:

* All patient who undergo general anesthesia

Exclusion Criteria:

* Liver and kidney disease
* Any types of muscle disorder.
* Metal materials or pacemaker in body

Primary outcomes:
measure: percentage of neuromuscular block
timeFrame: ten minutes
Secondary outcomes:
measure: onset time
timeFrame: ten minutes
Other outcomes:
measure: lag time
timeFrame: ten minutes
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea university anam hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Go eun Bae, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04509687: Training Endoscopists to Perform On-site Rapid Cytological Evaluation for EUS-FNA of Solid Pancreatic Lesions
Official title: Feasibility Study of Training Endoscopists to Perform On-site Rapid Cytological Evaluation for Endoscopic Ultrasound-guided Fine-needle Aspiration of Solid Pancreatic Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We plan to involve 60 patients with solid pancreatic lesion, with trained endoscopists performing ROSE in the procedure of EUS-FNA

Brief summary: In China, there is a serious shortage of pathologists who can perform on-site cytological diagnosis. As a result, there are few centers that can conduct ROSE in China, which limits the diagnostic accuracy of EUS-FNA to a certain extent. Previous research reports on whether endoscopists could be trained for ROSE were controversial, which may be related to the lack of standardization of the training of endoscopists. There is no training program for training endoscopists to systematically process pathological specimens, operate microscopes, read the adequacy of cytological specimens, and evaluate the atypia of cytological specimens in China. Therefore, our center intends to carry out a training for endoscopists to compare the improvement of endoscopists' ROSE operating ability before and after the training, and to evaluate the practice of each endoscopist to perform on-site rapid cytology specimens of solid pancreatic lesions.


Eligibility criteria: Inclusion Criteria:

1. age ≥18 years
2. diagnosis or suspected of solid pancreatic mass based on previous imaging examination;
3. EUS-FNA is achievable.
4. signed informed consent letter

Exclusion Criteria:

1. pregnant female
2. pancreatic cystic lesions
3. anticoagulant/antiplatelet therapy cannot be suspended
4. unable or refuse to provide informed consent
5. coagulopathy (platelet count \<50 ×103/uL, international normalized ration \>1.5）
6. severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia
7. with history of mental disease
8. other medical conditions that are not suitable for EUS-FNA

Primary outcomes:
measure: Accuracy of endoscopists for interpretation of cytologic specimen adequacy and primary diagnosis of malignancy
timeFrame: 10 months
Secondary outcomes:
measure: The results of standard specimens-processing, microscope-operating training on endoscopists
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT02901587: Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
Official title: Interventional, Randomised, Double-blind, Parallel-group, Active-control, Multiple-dose Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2016-09-15
Enrollment: 119
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or schizoaffective disorder after 6 weeks of treatment


Eligibility criteria: Inclusion Criteria:

* The patient is able by her/himself to provide informed consent to participate in the study
* The patient has a primary diagnosis of schizophrenia or schizoaffective disorder (DSM-5™ criteria)
* The patient has BMI ≤35 kg/m2
* The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill)
* PANSS total score ≤ 80 and a score ≤4 (moderate) on the PANSS items, P7 (hostility) and G8 (uncooperativeness)
* The patient is willing to be hospitalized for up to 8 weeks
* The patient is generally healthy based on medical history, physical examination, vital signs, ECG, and laboratory tests.
* The patient agrees to protocol-defined use of effective contraception

Exclusion Criteria:´

* The patient experienced acute exacerbation of psychosis requiring hospitalization within the last 3 months or required change in medication due to exacerbation of psychosis within the last 8 weeks
* The patient has met moderate or severe co-morbid Substance Abuse Disorder DSM-5™ criteria in the last 3 months
* The patient is at significant risk of harming her/himself or others in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS)
* The patient has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)

Other protocol defined inclusion and exclusion criteria may apply

Primary outcomes:
measure: Change from time-matched baseline on day 1, 21, and 42 in QTcF
timeFrame: Before dose to 10 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: US1104
state: California
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT02488187: Comparison of Preoperative ABUS and MRI in Newly Diagnosed Breast Cancer Patients
Official title: Comparison of Preoperative Automated Breast Ultrasound (ABUS) and Magnetic Resonance Imaging (MRI) in Newly Diagnosed Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
MRI
Mammogram
Whole Breast Sonogram
ABUS
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2015-07-02
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of Preoperative Automated Breast Ultrasound (ABUS) and magnetic resonance imaging (MRI) in Newly Diagnosed Breast Cancer Patients.

Detailed description: This is a prospective pilot study investigating the use of Automated Breast Ultrasound in the preoperative evaluation of newly diagnosed breast cancer patients. The Investigator intends to demonstrate that preoperative automated breast ultrasound (ABUS) will provide a relatively inexpensive and well-tolerated alternative to MRI for detection of occult breast cancer missed by mammography and hand-held ultrasound in women with newly diagnosed breast cancer. The research will take place at the University of Kansas Medical Center (KUMC). The research study will be open to newly diagnosed breast cancer patients who present to KUMC with a recommendation for preoperative MRI and who fit all inclusion criteria and have none of the exclusion criteria.

Eligibility criteria: Inclusion Criteria:

* Women (age 18-100) undergoing preoperative evaluation at the University of Kansas Cancer Center (KUCC) for a new diagnosis of breast cancer
* Patients with a diagnosis of breast cancer by either core needle biopsy or excisional biopsy.
* Bilateral mammography and hand-held ultrasound (if clinically indicated) performed prior to the MRI and ABUS.
* If a breast MRI is advised and there is no contraindication to MRI, a breast MRI and ABUS will performed at KUCC (Study Arm 1).
* If a breast MRI is not performed, an ABUS exam without MRI will be performed (Study Arm 2).
* The MRI and ABUS exam must be obtained within 2 weeks of each other.

Exclusion Criteria:

* Males
* Pregnant women
* Lactating women
* Patients \< 18 and \> 100 years of age
* Patients with breast implants

Primary outcomes:
measure: Measure rate of detection of occult breast cancer by ABUS that was not detected by standard imaging
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
Study officials:
References:
Clinical trial NCT01052987: Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia
Official title: A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Allopurinol Compared With Tranilast Alone and Allopurinol Alone in Healthy Subjects With Hyperuricemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gout
Hyperuricemia
Keywords: Gout
Hyperuricemia
Lead sponsor: Nuon Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-21
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period 2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of allopurinol on tranilast PK and PD as measured by reduction in serum uric acid levels.


Eligibility criteria: Inclusion Criteria:

* Male or female, aged 21 to 70
* Subjects with hyperuricemia who are otherwise healthy

Exclusion Criteria:

* Pregnant or nursing
* Known history of gout unless approved by the Investigator or Sponsor
* Clinically significant infection at Screening
* Known sensitivity to tranilast or allopurinol

Primary outcomes:
measure: Mean percent decrease in serum uric acid levels
timeFrame: Seven days
Secondary outcomes:
measure: Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination
timeFrame: Seven days
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Nuon Investigative Site
state: Hawaii
city: Evansville
country: United States
facility: Nuon Investigative Site
state: Indiana
city: Dallas
country: United States
facility: Nuon Investigative Site
state: Texas
Study officials:
affiliation: Nuon Therapeutics, Inc.
name: Director, Nuon Clinical Trials Group
role: STUDY_DIRECTOR
References:
Clinical trial NCT05560087: Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)
Official title: Association of PeRiODontal Disease and gUt Microbiome With Coronary artEry Disease (PRODUCE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Coronary Heart Disease
Human Microbiome
Dysbiosis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 450
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity in single tertiary hospital

Brief summary: The purpose of this study is to explore the relationship between periodontal disease and coronary artery disease through changes in the gut microbiome. In addition, the investigators aim to find possible periodontal pathogens that have association with cardiovascular disease.

Detailed description: The previous studies have reported the associations among cardiovascular disease, periodontitis, and gut microbiome dysbiosis. However, there is a lack of evidences about the axis of association from oral-gut-cardiovascular disease. The investigators hypothesized that periodontal disease might induce dysbiosis of gut microbiome and dysbiosis might have a role in cardiovascular disease (as called "oro-gut-vascular axis"). The investigators aim to prove this hypothesis through this case-control, cross-sectional study.

Eligibility criteria: Inclusion Criteria:

-Patients aged from 19 to 80 years who underwent invasive coronary angiography for clinical necessity, with informed consent

Exclusion Criteria:

* Patients with prosthetic valve
* pregnancy
* active malignancy
* active autoimmune disease
* active inflammatory bowel disease
* chronic kidney disease (eGFR\<30, or on dialysis)
* Active liver disease or liver cirrhosis
* consistent use of probiotics
* prior gastrointestinal surgery within 1 year

Primary outcomes:
measure: The association between periodontal disease and cardiovascular disease
timeFrame: within 3 years after enrollment (until the completion of dataset)
Secondary outcomes:
measure: The associations among periodontitis, gut microbiome and biomarkers
timeFrame: within 3 years after enrollment (until the completion of dataset)
measure: The associations between periodontitis and cognitive function
timeFrame: within 3 years after enrollment (until the completion of dataset)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Jong-Won Ha
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06741787: Microbial Study of Sublingual Immunotherapy Spray in Patients With Allergic Rhinitis
Official title: Microbial Characterization in Patients With Allergic Rhinitis Before and After Sublingual Immunotherapy Spray
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Rhinitis, Allergic
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with allergic rhinitis in the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and selected sublingual spray desensitization.

Brief summary: The incidence of allergic rhinitis (AR) in Chinese adults was reported to be as high as 24.1% and 16.8% in children. The current symptomatic treatment has the disadvantage of poor efficacy and cannot change the natural course of the disease. Allergen immunotherapy (AIT) is the only causative treatment approved by the WHO, bringing a new option to patients with allergic diseases. The quality of allergen preparations is critical to the diagnosis and treatment of the disease, emphasizing the need for standardized preparations, and AIT treatment in the early stages of the disease may change the long-term progression of the disease. Recent studies have reported that the microbiome of patients with different efficacy of desensitization therapy is different and may be correlated with the clinical symptoms of patients, but no prospective studies have been reported.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18-65 years).
* Patients with canis familiari/felis domesticus/alternaria alternata allergic rhinitis were diagnosed based on clinical history and positive dust mite sensitization tests (skin prick test and/or specific IgE).
* Patients who visited the Department of Otolaryngology of the First Affiliated Hospital of Nanjing Medical University and selected sublingual spray desensitization.

Exclusion Criteria:

* Patients who refused to accept specimen and questionnaire collection.
* Patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.

Primary outcomes:
measure: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
timeFrame: 2024.2-2026.7
measure: Visual analogue scale (VAS)
timeFrame: 2024.2-2026.7
measure: Total Nasal Symptom Score (TNSS)
timeFrame: 2024.2-2026.7
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Lei Cheng, PhD
role: STUDY_DIRECTOR
References: