louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05907460: EXecution of Trans-Esophagus Echo Cardiogram in CardioPulmonary Resuscitation for Patients With Out-of-hospital Cardiac Arrest
Official title: EXecution of Trans-Esophagus Echo Cardiogram in CardioPulmonary Resuscitation for Patients With Out-of-hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: Out-Of-Hospital Cardiac Arrest
Chest compression site
transesophageal echocardiography
end-tidal CO2
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this single center, randomized clinical control trial is to determine that changing chest compression site during cardiopulmonary resuscitation according to the examination of the TEE could increase the level of end-tidal CO2, which represents the quality of cardiopulmonary resuscitation, or not in adult patients with non-traumatic out-of-hospital cardiac arrest while comparing to those who don't receive examination of transesophageal echocardiography during cardiopulmonary resuscitation.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 20 years-old
2. Out-of-hospital cardiac arrest
3. Non-trauma

Exclusion Criteria:

1. Obvious signs of death appears, such as separation of head and body, rigor mortis, livor mortis, cankered corpse......etc.
2. Family members clearly express the willing of do not attempt resuscitation or patients who have registered advance care planning not to attempt resuscitation.
3. Patients not suitable for transesophageal ultrasound, such as patients with esophageal tumor, those whose probe cannot be placed......etc.
4. Received Extracorporeal CPR.
5. Achieving sustained ROSC before ED arrival

Primary outcomes:
measure: Rate of sustained return of spontaneous circulation (ROSC)
timeFrame: 20 minutes after ROSC
Secondary outcomes:
measure: Rate of any return of spontaneous circulation
timeFrame: 1 minutes after ROSC
measure: Rate of survival to ICU admission
timeFrame: 48 hours after ROSC
measure: Rate of survival to discharge
timeFrame: 6 months after ROSC
measure: Rate of discharge with favorable neurological outcomes
timeFrame: 6 months after ROSC
measure: end-tidal carbon dioxide (EtCO2)
timeFrame: During resuscitation
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Far Eastern Memorial Hospital
state: New Taipei City
Study officials:
affiliation: Attending physician of emergency medicine department
name: Jun-Tang Sun, MD, Msc
role: STUDY_CHAIR
References:
Clinical trial NCT03433560: An Observational Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®)
Official title: An Observational, Prospective, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of Pegfilgrastim (Neulasta®) as Secondary Prophylaxis to Decrease the Incidence of Febrile Neutropenia in Korean Female Patients With Breast Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Breast Neoplasm Female
Keywords: febrile neutropenia
neutropenia
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 1300
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Please refer to the inclusion criteria

Brief summary: The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. This is a prospective, observational, open-label trial with a target enrollment of 1400 subjects.

Primary endpoint The primary aim of this study is to determine the incidence of febrile neutropenia.

Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%


Eligibility criteria: Inclusion Criteria:

* ≥ 19 years old, and ≤ 64 years old, and
* Female patients with breast cancer receiving chemotherapy recently covered under national health insurance (only chemotherapy regimens in the table below), and
* Patients with neutropenic events (febrile neutropenia or grade 4 neutropenia) in any previous cycle that did not use G-CSF for the prevention of neutropenia

Exclusion Criteria:

Patients with any of the followings are excluded.

* Patients with a history of allergic reactions to E-coli derived proteins, human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim
* Uses for off-label indications such as chronic myelogenous leukemia, myelodysplastic syndrome

Primary outcomes:
measure: The incidence of febrile neutropenia after secondary prophylaxis with pegfilgrastim
timeFrame: From the cycle of chemotherapy before administration of next cycle of chemotherapy (approximately 3weeks)
Secondary outcomes:
measure: The incidence of bone pain, or percentage of patients with relative dose intensity (RDI) or all adverse events as assessed by CTCAE
timeFrame: During the study period (~ 1months follow-up)
Other outcomes:
Locations:
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon
city: Bucheon
country: Korea, Republic of
facility: Bucheon Soonchunhyang University Hospital
state: Kyounggi
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Kyoungsang
Study officials:
References:
Clinical trial NCT04928560: Diagnosis of Superficial Lymphadenopathy
Official title: SMI and CEUS in the Diagnosis of Superficial Lymphadenopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphadenopathy
ULTRASOUND
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with lymphadenopathy

Brief summary: The purpose of this study is to study the application of CEUS and SMI technology in superficial lymph node lesions (metastasis, lymphoma, inflammation, etc.), and to provide some diagnostic ideas for non-invasive diagnosis of lymph node lesions.

Detailed description: CEUS and SMI technology were used to evaluated the superficial lymph node lesions (metastasis, lymphoma, inflammation, etc.), and to provide some diagnostic ideas for non-invasive diagnosis of lymph node lesions.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old and ≤ 80 years old;
2. Patients with enlarged lymph nodes detected by ultrasound;
3. No contraindications such as hypersensitivity to contrast-enhanced ultrasound;
4. Voluntarily enrolled in this research project

Exclusion Criteria:

* The patient's position cannot be matched during ultrasound examination

  * Treatment history of lesion area: operation, radiotherapy, intervention, etc ③ Patients without informed consent ④ Lack of clinical data (no effective images such as two-dimensional ultrasound, color Doppler, contrast-enhanced ultrasound, micro blood flow imaging, or poor image quality, unable to analyze, unknown pathological results, etc.) ⑤ Lack of follow up information

Primary outcomes:
measure: PATHOLOGY
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: ZJU
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: pintong Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05760560: Incidence of Postoperative Residual Neuromuscular Blockade in the Era of Sugammadex
Official title: Incidence of Postoperative Residual Neuromuscular Blockade in the Era of Sugammadex
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Residual Curarization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 52
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective surgery under general anesthesia will be screened and included in this study.

Brief summary: This study is a prospective observational study. A total 52 patients will be included in this study. We will observe the incidence of postoperative residual neuromuscular blockade in patients receiving sugammadex.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective surgery under general anesthesia.
* American Society of Anesthesiologists grade 1, 2, or 3.
* Aged \>18 years

Exclusion Criteria:

* Refusal to participate in the study
* Body Mass Index \< 18.5 kg/m2 or \> 35 kg/m2
* History of neuromuscular disease.
* History of allergy to neuromuscular blockade
* Scheduled to transfer to the intensive care unit

Primary outcomes:
measure: Postoperative residual neuromuscular blockade
timeFrame: On the arrival of PACU
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chang-Hoon Koo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03674060: Study to Compare Pharmacokinetic Property of SYO-1644 Tab. and Nexavar Tab. in Healthy Male Volunteers
Official title: A Dose-block Randomized, Active-controlled, Open-label Clinical Study to Compare Pharmacokinetic Property of SYO-1644 Tab and Nexavar Tab in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy, Male
Keywords: Healthy Male Volunteers
Evaluation of the Pharmacokinetic Property
A Dose-block Randomized, Active-controlled, Open-label
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Hospital
First posted: 2018-09-17
Enrollment: 32
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the pharmacokinetics characteristics ,tolerability, and safety after orally administrating SYO-1644 to healthy male volunteers in randomized, active-controlled, open-label clinical study.

Detailed description: After orally administrating SYO-1644 and Nexavar 200 mg to healthy male participants , the safety, tolerability, and pharmacokinetic characteristics are to be compared while testing pharmacokinetic characteristics based on the dosage.

Eligibility criteria: Inclusion Criteria:

1. Healthy male age between 19 and 50 years old at the time of screening
2. Healthy male more than or equal to 50 kg or less than or equal to 90 kg with BMI of 18\~27

   * BMI(kg/m2) = Weight(kg) / {Height(m)}2
3. Agreement with written informed consent

Exclusion Criteria:

1. Participants with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary, psychiatric disorders or history
2. Participants with history of gastrointestinal ulcers, gastritis, gastric ulcer, gastroesophageal reflux disease, Crohn's disease, etc, that may affect the safety and pharmacokinetic evaluation of the test drug, except simple appendectomy and hernia surgery)
3. Participants with hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs including sorafenib and allogeneic drugs, and other drugs (aspirin, antibiotics, etc.)

Primary outcomes:
measure: Evaluation of pharmacokinetic properties
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168 hours
measure: Evaluation of pharmacokinetic properties
timeFrame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 168 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03168360: Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient
Official title: Effect of Intensive Cognitive Rehabilitation in Subacute Stroke Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Rehabilitation
Cognitive Function
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. However, there was no consensus of proper amount of cognitive rehabilitation in stroke patients. In this study, the investigators assess the effects of the intensive cognitive rehabilitation during subacute phase to improve cognitive function at 6 months after onset in patients with first-ever strokes.

Detailed description: Intensive cognitive rehabilitation group

* cognitive therapy for 1 hours on every working day for 4 weeks

Conventional cognitive rehabilitation group

* cognitive therapy for 30 minutes on every working day for 4 weeks

Eligibility criteria: Inclusion Criteria:

* Acute first-ever stroke
* Korean Mini-Mental State Examination: 11\~24 at 7 days after stroke onset

Exclusion Criteria:

* Transient ischemic stroke

Primary outcomes:
measure: Korean-Montreal Cognitive Assessment (K-MoCA)
timeFrame: Change of K-MoCa after intensive cognitive rehabilitation for 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang WH, Sohn MK, Lee J, Kim DY, Lee SG, Shin YI, Oh GJ, Lee YS, Joo MC, Han EY, Kim YH. Korean Stroke Cohort for functioning and rehabilitation (KOSCO): study rationale and protocol of a multi-centre prospective cohort study. BMC Neurol. 2015 Mar 25;15:42. doi: 10.1186/s12883-015-0293-5.
citation: Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
citation: Longley V, Hazelton C, Heal C, Pollock A, Woodward-Nutt K, Mitchell C, Pobric G, Vail A, Bowen A. Non-pharmacological interventions for spatial neglect or inattention following stroke and other non-progressive brain injury. Cochrane Database Syst Rev. 2021 Jul 1;7(7):CD003586. doi: 10.1002/14651858.CD003586.pub4.
Clinical trial NCT00421980: An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
Official title: An Open-Label, Multicentre, Long-Term Extension Study of Etanercept in Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ankylosing Spondylitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study was to determine the long-term safety of etanercept in adults with AS who had completed study 0881A3-311-EU.

Detailed description: This was an open-label, multicenter extension study that was conducted to evaluate the safety and efficacy of etanercept in the treatment of adult subjects with AS who had completed study 0881A3-311-EU. The study consisted of an open-label treatment period of up to approximately 96 weeks.

Eligibility criteria: 1. Completed the entire 12 weeks of therapy in study 0881A3-311-EU, or completed at least 8 weeks of therapy and returned for the week 12 visit in study 0881A3-311-EU.
2. Negative serum β-HCG pregnancy test at baseline (all women of childbearing potential).
3. Sexually active women of childbearing potential had to use a medically acceptable form of contraception. Medically acceptable forms of contraception included oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms was suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
4. Sexually active men had to agree to use a medically accepted form of contraception during the study.
5. Able to reconstitute and self-inject test article or have a designee who can do so.
6. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol-specific procedures were performed.
7. Able to store injectable test article at 2°C to 8°C.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Dijkmans B, Emery P, Hakala M, Leirisalo-Repo M, Mola EM, Paolozzi L, Salvarani C, Sanmarti R, Sibilia J, Sieper J, Van Den Bosch F, van der Heijde D, van der Linden S, Wajdula J. Etanercept in the longterm treatment of patients with ankylosing spondylitis. J Rheumatol. 2009 Jun;36(6):1256-64. doi: 10.3899/jrheum.081033. Epub 2009 May 1.
Clinical trial NCT04882280: Dose-dependent Impact of Daytime Lighting on Evening Responses to Light
Official title: Dose-dependent Impact of Daytime Lighting on Evening Responses to Light
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep
Lead sponsor: VA Palo Alto Health Care System
Sponsor class: FED
First posted: 2021-05-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to systematically examine the impact of different intensities of daytime light and the subsequent impact that such exposure has on non-image forming responses to light in the evening.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-65
2. Good health
3. Male or female
4. Normal color vision

Exclusion Criteria:

1. Sleep disorders
2. Extreme chronotypes
3. Routine smoker
4. Significant hearing loss
5. Depressed
6. Alcohol use disorder
7. Use of illegal drugs

Primary outcomes:
measure: Suppression of melatonin production
timeFrame: 4 hours
measure: Phase shift in the timing of melatonin onset
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
References:
Clinical trial NCT02336360: Augmenting Flortaucipir Dosimetry Estimates
Official title: A Multicenter Study to Obtain Data to Assist in Radiation Dosimetry Calculations From Subjects Enrolled in Human Studies Employing 18F-AV-1451
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-01-13
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will obtain data from urine in subjects administered flortaucipir in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates.


Eligibility criteria: Inclusion Criteria:

* Subjects who passed screening in an Avid-sponsored study in which flortaucipir will be administered

Exclusion Criteria:

* Subjects who have withdrawn informed consent
* Investigator or sponsor believes it is in the best interest of the subject to be removed from the trials

Primary outcomes:
measure: Urine Analysis - Total Integrated Radioactivity Excreted in Urine
timeFrame: 0-360 minutes post injection
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Molecular NeuroImaging
state: Connecticut
Study officials:
References:
Clinical trial NCT01376960: Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures
Official title: Ankle Block Versus Popliteal Fossa Block as Primary Anesthesia for Forefoot Surgical Procedures: A Prospective Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Forefoot Surgery
Keywords: forefoot surgery
Ankle Block
Popliteal Fossa Block
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2011-06-20
Enrollment: 202
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare, for the first time ever, single shot popliteal fossa blocks to ankle blocks as primary anesthesia for patients undergoing forefoot procedures. The primary outcome variable for this study is the percentage of patients that convert to general anesthesia following either a single shot popliteal fossa block or ankle block.

H0: There is no difference in the percentage of patients that convert to general anesthesia between single shot popliteal fossa blocks and ankle blocks.

HA: There will be a lower percentage of patients receiving a single shot popliteal fossa block that convert to general anesthesia compared to patients receiving an ankle block.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective forefoot surgery, including both soft-tissue and osseous procedures

Exclusion Criteria:

* Diabetes
* Any form of Peripheral neuropathy
* Known allergy to local anesthesia
* Active infection

Primary outcomes:
measure: Conversion to general anesthesia following either a single shot popliteal fossa block or ankle block
timeFrame: Participants will be followed for the duration of the surgery, an expected average of 2 hours
Secondary outcomes:
measure: Visual Analog Pain Scale (VAS)
timeFrame: 24 hours postoperatively
measure: Patient Satisfaction
timeFrame: 48 hours postoperative
measure: Length of Post Anesthesia Care Unit (PACU) stay
timeFrame: Up to 6 hours postoperative
measure: Narcotic Use
timeFrame: Up to 30 days postoperative
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina, PA
state: North Carolina
Study officials:
affiliation: OrthoCarolina, PA
name: Bruce E Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: