louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00735839: V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Single Dose of Merck S. Aureus Vaccine (V710) in Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Staphylococcal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-15
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.


Eligibility criteria: Inclusion Criteria:

* Generally Good Physical Health

Exclusion Criteria:

* Received V710 Vaccine, Any Other Investigational S. Aureus Vaccine, Or Investigational S. Aureus Antibodies Before
* Temperature Of Equal/Greater Than 100.4 Degrees F(38 Degrees C) Within The Past 48 Hours

Primary outcomes:
measure: Geometric Mean Fold Rise (GMFR) From Baseline in Antibody Level
timeFrame: Baseline (Day 1) to Day 14 postvaccination
measure: Number of Participants With Vaccine-related Serious Adverse Experiences
timeFrame: Baseline (Day 1) to Day 84 postvaccination
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05092139: Endovascular treatmenT for Acute Ischemic Stroke in China (DETECT2-China)
Official title: enDovascular trEatmenT for acutE isChemic sTroke in China (DETECT2-China): a Prospective, National, Multi-center, Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: acute ischemic stroke with large vessel oclussion

Brief summary: This is a prospective real world registry study, aiming to explore the effectiveness and safety of endovascular treatment of acute ischemic stroke in a Chinese population.


Eligibility criteria: Inclusion Criteria:

* Age: ≥ 18;
* Ischemic stroke confirmed by head CT or MRI;
* Patients receiving endovascular treatment;
* First ever stroke or pre-stroke mRS≤2;
* signed informed consent.

Exclusion Criteria:

* Prestroke mRS≥3;
* Other serious illness that would confound the clinical outcome at 90 days;
* Unavailable neuroimaging data;
* Other unsuitable conditions judged by the investigator

Primary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 2
timeFrame: Day 90
Secondary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 1
timeFrame: Day 90
measure: Distribution of modified Rankin Score
timeFrame: Day 90
measure: Changes in National Institute of Health stroke scale (NIHSS)
timeFrame: 24 hours, 48 hours, and 2 weeks
measure: Proportion of symptomatic intracranial hemorrhage (sICH)
timeFrame: 48 hours
measure: Proportion of death
timeFrame: 7 days
Other outcomes:
measure: neuroimaging associated with clinical outcome
timeFrame: 48 hours
measure: changes in serum biomarkers
timeFrame: 48 hours
measure: dynamic changes of TCD data associated
timeFrame: 24 hours
measure: dynamic changes of cortical blood oxygen saturation by near infrared spectroscopy
timeFrame: 24 hours
Locations:
city: ShenYang
country: China
facility: Hui-Sheng Chen
state: Liaoning
Study officials:
References:
Clinical trial NCT04893239: Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
Official title: Exploratory Study to Assess Delivery of LMN-201 Components Via Enteric Capsules in the Gut of Individuals With Ostomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: C. Diff. Infections
Lead sponsor: Lumen Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-19
Enrollment: 12
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a Phase 1, single-site, open label, exploratory study to assess delivery of LMN-201 components via enteric capsules in the gut of individuals with ostomies.


Eligibility criteria: Inclusion Criteria:

* Willing to participate in the clinical trial
* Able and willing to provide informed consent
* Stable ostomy (no revisions in the last 6 months)
* At least 19 years old
* Medically stable, but may be on medications for chronic conditions

Exclusion Criteria:

* Unable or unwilling to provide adequate informed consent
* Non-English speakers
* Clinically significant disease
* Women who are pregnant, intending to become pregnant, or breastfeeding
* Use of anti-diarrheal medicine
* Suffer gastroparesis
* Opioid use

Primary outcomes:
measure: Number of Participants With Presence of Capsules and/or Transit Markers in Ostomy Fluid by Visual Observation
timeFrame: Arrival (baseline), Predose (immediately before dosing), and up to 12 hours post dose.
Secondary outcomes:
Other outcomes:
Locations:
city: Auchenflower
country: Australia
facility: Wesley Medical Research Limited
state: Queensland
city: Maroochydore
country: Australia
facility: Coastal Digestive Health
state: Queensland
city: North Mackay
country: Australia
facility: Coral Sea Clinical Research Institute
state: Queensland
Study officials:
affiliation: Lumen Bioscience, Inc.
name: Carl Mason
role: STUDY_DIRECTOR
References:
Clinical trial NCT06233539: A Study on Diagnosis and Treatment Strategies for Atlantoaxial Dislocation
Official title: A Study on Diagnosis and Treatment Strategies for Atlantoaxial Dislocation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atlantoaxial Dislocation
Treatment
Diagnostic
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with atlantoaxial dislocation and treated with surgery

Brief summary: The most effective treatment for atlantoaxial dislocation is surgical treatment, with the principle of achieving reduction, reconstruction, and fusion of the atlantoaxial joint. The surgical strategies mainly include simple anterior approach, simple posterior approach, and combined anterior posterior approach. The investigators have summarized 904 cases of atlantoaxial instability or dislocation from 1998 to 2010 and preliminarily published the diagnosis and treatment strategy tree of the Third Hospital of Beijing Medical University. This strategy is divided into four types based on the severity of atlantoaxial dislocation: unstable, reversible, difficult to recover, and skeletal, and enters different surgical treatment processes. With the increase in the number of cases, accumulation of experience, and technological improvements in the past decade, spinal surgery colleagues have updated their classification diagnosis, diagnosis and treatment processes, and surgical techniques for atlantoaxial instability or dislocation.

However, the selection of treatment strategies for atlantoaxial dislocation is mostly based on the surgeon's own experience, and there is a lack of standardized, large-scale, and high-level evidence-based medical research on the safety and effectiveness of current empirical strategies. Based on this, this study intends to adopt a multicenter, retrospective, and prospective study to construct a high-quality clinical cohort of atlantoaxial dislocation, update the classification and diagnosis and treatment strategies of atlantoaxial dislocation. And conduct long-term follow-up on patients to evaluate their safety and effectiveness, guide the surgical treatment of atlantoaxial dislocation, and thus form a recognized diagnostic and treatment standard for atlantoaxial dislocation.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with atlantoaxial dislocation and treated with surgery

Exclusion Criteria:

* Disagree to participate in this study.

Primary outcomes:
measure: The incidence of special attention adverse events in patients within 12 months after surgery
timeFrame: 12 month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Shenglin Wang
state: Beijing
Study officials:
References:
Clinical trial NCT06640439: LED Therapy for Third Molar Surgery
Official title: LED Therapy Using 830 Nm in the Mandibular Third Molar Surgery: Double-blind Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Molar, Third
Photobiomodulation
Photobiomodulation Therapy
Third Molar Surgery
Keywords: photobiomodulation
LED
830 nm
third molar surgery
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who underwent mandibular third molar extraction
Primary purpose: TREATMENT

Brief summary: LED Therapy for third molar surgery

Detailed description: LED Therapy using 830 nm in the mandibular third molar surgery

Eligibility criteria: Inclusion Criteria:

1. Healthy Asians;
2. 20-55 years old;
3. Having mandibular third molars that are inappropriately erupted and need to be extracted due to caries, orthodontic reasons and/or periodontal disease;

Exclusion Criteria:

1. Underlying diseases: diabetes, cardiovascular disease, coagulation disorder, osteoporosis, hypertension, neurological disease, psychological disorder, tumor, systemic infection or cyst at the extraction site;
2. Women who are preparing for pregnancy, pregnant or breastfeeding;
3. Medication history: use of analgesics, anti-inflammatory drugs and/or antibacterial drugs 2 weeks before tooth extraction, need for systemic medication other than acetaminophen after surgery, allergy to acetaminophen, use of anticoagulants, bisphosphonates;
4. Bad habits, such as addicted to smoking, drinking, etc.;
5. Volunteers who have recently participated in other clinical trials;

Primary outcomes:
measure: Pain
timeFrame: Day 7
measure: Swelling
timeFrame: Day 3; Day 7
measure: Trismus
timeFrame: Day 3; Day 7
Secondary outcomes:
measure: Quality of life score
timeFrame: Day 3; Day 7
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital Affiliated to Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT04163939: Collar Use for Cervical Radicular Pain
Official title: A Randomized Controlled Trial of Collar Use for Cervical Radicular Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: Neck pain
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Synovation Medical Group
First posted: 2019-11-15
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To evaluate the effectiveness of treatment with Vista Therapy Collar for indication of cervical radicular pain, defined as pain radiating into one or both upper extremities compared to standard care.
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of treatment in subjects with cervical radicular pain with Vista Therapy Collar, using a Visual Analog Scale, a Neck Disability Index and the SF-36 quality of life survey.

Detailed description: To evaluate the effective of treatment with Vista Therapy Collar for indication of cervical radicular pain, defined as pain radiating into one or both upper extremities compared to a 'wait and see' approach.

Eligibility criteria: Inclusion Criteria:

1. Age greater than 18 years
2. Cervical radicular pain as defined by neck pain radiating to one arm with at least one of the following:

   * Provocation by neck movements or sensory changes in one or more adjacent dermatomes or diminished deep tendon reflexes in the affected arm.
   * Muscle weakness in one or more adjacent myotomes.
3. Neck Disability Index (NDI) score \>= 10 points
4. VAS for neck pain \>= 40
5. Subject has signed and dated the Patient Informed Consent /Patient Information Sheet prior to any study-related activities being conducted
6. Subject is willing and able to attend visits as scheduled and to comply with the study protocol

Exclusion Criteria:

1. Serious somatic or psychiatric disorder
2. Previous Neck Surgery
3. Whiplash as the primary incident
4. History of spinal tumor or infection
5. Cervical Instability per opinion of PI
6. Morbid Obesity (BMI\>40)
7. TMJ issues
8. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study
9. Subject is involved in current litigation regarding neck pain or injuries associated with neck pain
10. Subject is involved in Worker's Compensation litigation
11. Non-English speaking

Primary outcomes:
measure: Neck Disability Index (NDI)
timeFrame: 90 days
measure: SF-36 Quality of Life Survey
timeFrame: 90 days
measure: Visual Analog Scale (VAS)
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Comprehensive Spine Center, Rhode Island Hospital
state: Rhode Island
Study officials:
References:
Clinical trial NCT05279339: Subjective and Objective Changes in Muscle-stiffness
Official title: The Relationship Between Subjective and Objective Changes in Muscle-stiffness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Muscle Soreness
Lead sponsor: Aalborg University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate muscle stiffness in relation to delayed on-set muscle soreness following exercise and to investigate how well the change in muscle stiffness correlates with the subjective experienced degree of stiffness.


Eligibility criteria: Inclusion Criteria:

* Healthy participants aged 18-80
* Able to speak, read and understand Danish and/or English

Exclusion Criteria:

* Have performed resistance training on a regular basis during the past month
* Experience of delayed onset muscle soreness (DOMS) during the last two weeks leading up to the first test session
* Current use of analgesics
* Any current neurological, musculoskeletal or mental illnesses that could interfere with the results.
* Pregnancy
* Lack of ability to cooperate

Primary outcomes:
measure: Muscle stiffness (change) - Shear wave
timeFrame: Day1,Day 2 and Day7
Secondary outcomes:
measure: Muscle stiffness (change) - Self-reported
timeFrame: Day1,Day 2 and Day7
measure: Muscle stiffness (change) - Myotonometry
timeFrame: Day1,Day 2 and Day7
measure: Muscle stiffness (change)- Palpation
timeFrame: Day1,Day 2 and Day7
Other outcomes:
measure: Muscle thickness
timeFrame: Day1,Day 2 and Day7
measure: Muscle soreness
timeFrame: Day1,Day 2 and Day7
measure: Neck disability
timeFrame: Day1,Day 2 and Day7
measure: Shoulder disability
timeFrame: Day1,Day 2 and Day7
Locations:
city: Aalborg
country: Denmark
facility: Dept. Of Health Science and Technology, Aalborg University
Study officials:
affiliation: Aalborg University
name: Steffan WM Christensen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01852539: Dexmedetomidine for Laryngeal Mask Airway Insertion
Official title: Optimal Dose of Dexmedetomidine for Laryngeal Mask Airway Insertion During Propofol Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Drug Usage
Keywords: LMA insertion
dexmedetomidine
propofol
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2013-05-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators attempted to determine the optimal dose of dexmedetomidine required for the successful insertion of LMA during propofol induction without a neuromuscular blocking agent.

Detailed description: After a predetermined bolus dose of dexmedetomidine was injected over 2 min, anesthesia was induced with propofol 2.0 mg/kg. After confirming the loss of eyelash reflex and the bispectral index (BIS) score decreased below 60, the insertion of LMA was attempted.

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients undergoing general anesthesia for short elective surgery (\<1 hr)

Exclusion Criteria:

* G-E reflux
* obesity (BMI\>30)
* anticipated difficult airway

Primary outcomes:
measure: successful insertion of LMA
timeFrame: from baseline to 2 min after insertion of LMA (participants will be followed for the duration of anesthetic induction, an expected average of 10 min).
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
Study officials:
affiliation: Ajou University School of Medicine
name: Jong Yeop Kim, MD
role: STUDY_DIRECTOR
References:
citation: Uzumcugil F, Canbay O, Celebi N, Karagoz AH, Ozgen S. Comparison of dexmedetomidine-propofol vs. fentanyl-propofol for laryngeal mask insertion. Eur J Anaesthesiol. 2008 Aug;25(8):675-80. doi: 10.1017/S0265021508004213. Epub 2008 Apr 10.
Clinical trial NCT06550739: Comprehensive Prognostic Model: The Study Introduces a Novel Prognostic Model That Incorporates a Wide Range of Clinical and Laboratory Variables, Providing a More Holistic Approach to Predicting Overall Survival in HCC Patients
Official title: Development and Validation of a New Prognostic System for Patients With Hepatocellular Carcinoma: A Cohort Study in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 1053
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The data used in the retrospective cohort study were obtained from 958 patients with HCC from the Chongqing University Cancer Hospital tumor database between Jan 1, 2019, and Dec 12, 2020.

Brief summary: Background: Hepatocellular carcinoma (HCC) is a significant health problem in China, with high incidence and mortality rates. This study aimed to identify the prognostic factors of elderly HCC patients in southwest China and construct a new prognostic model for predicting overall survival (OS).

Methods: This retrospective cohort study collected clinical data from 958 patients with liver cancer on January 1, 2019, and December 12, 2020. The Cox regression model was used to test the significance of all available variables as prognostic factors of OS. Independent prognostic factors were identified based on multivariable analysis to model nomograms. The concordance index (C-index), the area under the receiver operating characteristic (AUC), the Time-dependent C-index, the Time-dependent AUC, the calibration curve, and decision curve analysis (DCA) were measured to assess the model performance of the nomogram.

Conclusions: The comprehensive risk prediction model for OS in HCC patients developed through this retrospective cohort study offers a promising avenue for improving clinical outcomes and patient care.


Eligibility criteria: Inclusion Criteria:

* (1) age ≥ 18 years; (2) had pathologically confirmed primary liver cancer; (3) received the main treatment in our hospital; (4) provided baseline clinical information and follow-up information; (5) completed the entire course of radiotherapy, chemotherapy and targeted therapy.

Exclusion Criteria:

* no follow-up records and a history of cancer treatments.

Primary outcomes:
measure: Survival status
timeFrame: April 31, 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
Study officials:
References:
Clinical trial NCT05549739: Evaluation of Respiratory Parameters and Functional Capacity in Coronary Artery Patients
Official title: Evaluation of Respiratory Parameters and Functional Capacity in Coronary Artery Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: respiratory function test
physical functional performance
coronary artery disease
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 41
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are more than 40 years old and diagnosed with coronary artery disease.

Brief summary: The purpose of this study is to evaluate respiratory parameters and functional capacity in coronary artery patients.

Detailed description: Decreased pulmonary function as measured by forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), or peak expiratory flow (PEF) has been associated with an increased risk of cardiovascular mortality and morbidity. A low MIP value may generally indicate weak muscle strength and therefore be an indicator of general poor health. Respiratory muscle weakness and decreased respiratory muscle endurance affect exercise tolerance in individuals with chronic disease, including cardiovascular disease. Studies have supported the association of grip strength with frailty, physical activity, diabetes, functional limitation, nutritional status, metabolic syndrome, and mortality.

The study will evaluate respiratory parameters and functional capacity in coronary artery patients.

Eligibility criteria: Inclusion Criteria:

* Patients with coronary artery disease
* Volunteering to participate in the research

Exclusion Criteria:

* Having a musculoskeletal problem
* Having unstable cardiac disease
* Having chronic heart failure (NYHA III-IV)
* A history of acute coronary syndrome or surgical revascularization less than 3 months ago
* Having arrhythmia
* Having the last stage of kidney disease
* Having active myocarditis or pericarditis

Primary outcomes:
measure: Six-minute-step test
timeFrame: Day 1
measure: Respiratory muscle strength
timeFrame: Day 1
measure: Respiratory muscle endurance
timeFrame: Day 1
Secondary outcomes:
measure: Pulmonary functions
timeFrame: Day 1
measure: Hand grip strength
timeFrame: Day 1
measure: Functional Capasity
timeFrame: Day 1
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Naciye Vardar-Yagli, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Hikmet Yorgun, PhD
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Ahmet Hakan Ates, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Dilara Saklica, MSc
role: PRINCIPAL_INVESTIGATOR
References: