louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04738019: A Multicenter, Prospective Observational Study to Evaluate the Incidence of Delayed-onset Nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 Injected Into the Facial Skin Layer.
Official title: A Multicenter, Prospective Observational Study to Evaluate the Incidence of Delayed-onset Nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 Injected Into the Facial Skin Layer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Condition
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 1022
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any healthy male and female whose filler injection on facial area is already planned for volume enhancement and anti-wrinkle treatment.

Brief summary: This is an observational study to evaluate the incidence of delayed-onset nodules of YVOIRE Y-Solution 360, YVOIRE Y-Solution 540 or YVOIRE Y-Solution 720 injected into the facial skin layer.


Eligibility criteria: Inclusion Criteria:

* Planned for YVOIRE Y-Solution 360 or 540 or 720 filler injection in facial area (except middle of the forehead, lips) for the volume enhancement or anti-wrinkle treatment.
* Male and female of 19 years or above age.
* Informed consent to participate in the study.
* Able to participate throughout the study period.

Exclusion Criteria:

* Prohibited in the Product Label.
* Have active or infectious skin disease in injection area.
* Autoimmune disease or HIV infected patient.
* Received immunosuppressive therapy within 2 weeks.
* Previously experienced Delayed-onset nodule after filler injection in facial area.
* Previously experienced Hypertrophic scar or Keloid.
* Have participated in an interventional clinical investigation within 30 days or plan to participate one during the study period.
* Ineligible for this clinical investigation as per Investigator's discretion.

Primary outcomes:
measure: Delayed-onset nodule.
timeFrame: 1 year.
measure: Other adverse events.
timeFrame: 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Dong Yeop Shin
state: Gangseo-gu
Study officials:
References:
Clinical trial NCT00585819: Validation of a Novel Thoracic Neoplasm Radiotherapy Image Guidance Technique: A Pilot Study
Official title: Validation of a Novel Thoracic Neoplasm Radiotherapy Image Guidance Technique: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2008-01-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The overall, broad objective of this study is to pilot the BSD technique. The specific purpose of this particular study is to generate pilot data to validate several crucial steps of the BSD technique, in particular steps 1, 2, and 4. Radiation treatments will proceed per standard of care, and will not be modified in any way during this protocol. This study is a non-treatment protocol.


Eligibility criteria: Inclusion Criteria:

* Any thoracic neoplasm scheduled to undergo radiation therapy
* 18 years or older
* Must be treated with radiation as part of standard of care
* Able to tolerate the mouthpiece for spirometry and video glasses
* Ability to provide written informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Reproducibility of the guided breathing cycle
timeFrame: 6 weeks
Secondary outcomes:
measure: Stability of motion envelope derived from initial 4D imaging compared to CT's obtained throughout the course of therapy
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Minesh Mehta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06832319: IMPACT of KNOWLEDGE and SKILLS in MANAGEMENT of BLEEDING DURING PREGNANCY
Official title: EFFECT of PERSONALIZED FEEDBACK USED in SIMULATION TECHNIQUE on KNOWLEDGE and SKILLS in MANAGEMENT of BLEEDING DURING PREGNANCY
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bleeding Management
Lead sponsor: Burdur Mehmet Akif Ersoy University
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Simulation training motivates participants to interact and collaborate, and studies on interdisciplinary groups show that it improves soft skills such as communication and teamwork. Midwifery students' skills are the ability to apply knowledge and use their knowledge to perform tasks and solve problems. They are cognitive in nature and include logical, intuitive and creative thinking. Practical experiences such as the application of skills and methods, materials, tools and equipment further develop these skills. Skills represent the application of learned abilities and the result of practical experience that emerges both cognitively and practically. In addition, feedback is included in the methods used as an important part of clinical education


Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the research, Continuing their sophomore year in the 2024-2025 Spring semester,

Exclusion Criteria:

* Students who do not participate in theoretical explanation

Primary outcomes:
measure: Scale for Evaluating Simulation-Based Learning
timeFrame: 1 HOUR
measure: Student Satisfaction and Self-Confidence Scale in Learning
timeFrame: 1 HOUR
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05984719: New Daily Persistent Headache Survey
Official title: New Daily Persistent Headache Patient Experience Survey
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: New Daily Persistent Headache (NDPH)
New Daily Persistent Headache
Keywords: Constant headache
Refractory headache disorder
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-08-09
Enrollment: 10000
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is participants with a diagnosis of NDPH. The NDPH diagnosis must come from a physician and will be further assessed with disease-specific survey questions.

Brief summary: Purpose: to explore headache characteristics and treatment effects of patient with new daily persistent headache (NDPH) through an online survey.

Research design: Online survey of patients with new daily persistent headache.

Risks: Risks include a breach of confidentiality as well as fatigue from taking the survey online.

Importance of knowledge that may recently be expected to result: The study aims to discover new information in a very understudied disease. This information could, in future studies, help change the diagnostic criteria or lead to new treatment options.


Eligibility criteria: Inclusion Criteria:

* Patients with NDPH that have been diagnosed by a health care professional (no documentation is needed, participant must simply state that he or she has been diagnosed)

Exclusion Criteria:

* Unable to speak English (the survey is only in English)
* Unable to use a computer to take the online survey

Primary outcomes:
measure: Survey data
timeFrame: At study completion, expected to be in 6-12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UTHealth Houston
state: Texas
Study officials:
References:
Clinical trial NCT05070819: Atrial Natriuretic Peptide in Assessing Fluid Status
Official title: Role of Atrial Natriuretic Peptide in Assessing of Fluid Status in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Overload
Fluid Loss
Volume Overload
Cardiac Disease
Cardiac Output, Low
Cardiac Output, High
Keywords: fluid responsiveness
fluid status
cardiac surgery
volemic status
pro-ANP
hemodynamic monitoring
functional test
teboul test
stroke volume variation
cardiac output
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2021-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Biomarkers can play a significant role in fluid status assessment intraoperatively.

Detailed description: Routinely intraoperatively the fluid status assessment is based on central venous pressure and other parameters. Nevertheless, the minority of anesthesiologists use continous dynamic parameters like pulse pressure variation, stroke volume variation and other to manage fluid status. There's a fast acting biomarker that can help anesthesiologist to diagnose and manage the volemic status and possibly guide the infusion therapy better.

Pro-ANP is a biomarker that reacts on atria strain and can be used in volemic status assessment in cardiac surgery patients.

Eligibility criteria: Inclusion Criteria:

CABG, one-, two valve repair/replacement, ascending aorta, aortic arch replacement, ASD/AVD closure, septal myectomy

Exclusion Criteria:

1. Atrial fibrillation, atrial flutter, frequent ventricular and supraventricular arrythmias
2. EFLV \< 50%
3. Pulmonary hypertension \> 2 st
4. CKD \> C3 (GFR \< 30)
5. Redo surgery
6. Left atrium volume \> 150 ml
7. LV EDV \> 250 ml

Primary outcomes:
measure: Number of Patients With Pro-ANP Twofold Raise by the End of Surgery
timeFrame: intraoperatively
measure: Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver
timeFrame: intraoperative
measure: Number of Patients With Cardiac Index Rise > 10% After Passive Leg Raising Maneuver
timeFrame: 10 minutes of PLR test
measure: Number of Patients With Pro-ANP Increase > 10% by the PLR Maneuver at the End of Surgery
timeFrame: 10 minutes of PLR test
Secondary outcomes:
measure: Postoperative Complications
timeFrame: up to 10 days
measure: Mortality
timeFrame: up to 10 days
measure: Multiorgan Failure
timeFrame: up to 10 days
measure: Respiratory Failure
timeFrame: up to 10 days
measure: Renal Failure
timeFrame: up to 10 days
measure: Heart Failure
timeFrame: up to 10 days
measure: Circulatory Insufficiency
timeFrame: up to 10 days
measure: Infection Rate
timeFrame: up to 10 days
measure: Length of Intensive Care Stay
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky Research National Centre of Surgery (Petrovsky NRCS)
Study officials:
affiliation: Petrovsky NRCS
name: Boris Akselrod, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01571219: An Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 3.1
Official title: An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-Administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab(Remicade or CP-P13) in Study CT-P13 3.1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: RA
Biosimilar
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2012-04-05
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: CT-P13 (Infliximab) is a monoclonal antibody currently being developed by CELLTRION, Inc. This open-label, single-arm, multicenter, multiple single dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 3 Study CT-P13 3.1 is designed to assess the long-term efficacy and safety of multiple doses of CT-P13.


Eligibility criteria: Inclusion Criteria:

* Patient who has completed the scheduled visits, including the End-of-Study Visit, in Study CT-P13 3.1
* Patient who has not had any major protocol violation in Study CT-P13 3.1
* Patient is permitted to enter the extension study if, in the option of their general practitioner or the investigator, the patient will continue to gain benefit from treatment in the extension study. Local guidelines for patient treatment will be followed

Exclusion Criteria:

* Patient who has been withdrawn from Study CT-P13 3.1 for any reason
* Patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events (SAEs) or intolerance issues that mean continuation in this extension study could be detrimental to their health, in the opinion of the investigator
* Patient who plans to participate in a study with an investigational drug during the period of this extension study

Primary outcomes:
measure: Long term efficacy evaluated by American College of Rheumatology(ACR) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test
timeFrame: Up to week 40
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
Study officials:
affiliation: Hanyang University
name: Dae Hyun Yoo, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04549519: Lumbopelvic Control in Baseball Batting
Official title: Influence of Lumbopelvic Control on Batting Mechanics and Bat-swing Velocity in Baseball Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletes
Keywords: Batting mechanics
Bat-swing velocity
Lumbopelvic control
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 44
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: College baseball batters in the area of Tainan City

Brief summary: Baseball batting is important to winning the games. Baseball batting is achieved by proximal-to-distal sequencing of body movements and controlled by the neuromuscular system. Poor lumbopelvic control could influence production and transfer of energy in the kinetic chain. This study aims to investigate the impact of lumbopelvic control in hitting mechanics and bat swing velocity in high school baseball players.


Eligibility criteria: Inclusion Criteria:

* Sport specialization in baseball batting
* Active players on college baseball teams

Exclusion Criteria:

* History of surgery in the lumbar area
* Severe musculoskeletal or neurological symptoms that interfere with participation in competition, training and test

Primary outcomes:
measure: Ratio of angular displacement of lumbar spine and hip joint
timeFrame: 1 week after enrolled
measure: Bat-swing velocity
timeFrame: 1 week after enrolled
measure: Ratio of angular displacement of thoracic spine and lumbar spine
timeFrame: 1 week after enrolled
measure: Timing of maximal angular velocity of hip joint
timeFrame: 1 week after enrolled
measure: Timing of maximal angular velocity of lumbar joint
timeFrame: 1 week after enrolled
measure: Timing of maximal angular velocity of thoracic joint
timeFrame: 1 week after enrolled
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
References:
Clinical trial NCT04484519: Recovery of Biographical Memories Associated With a Melody: a Functional Magnetic Resonance Imaging Study
Official title: Recovery of Biographical Memories Associated With a Melody: a Functional Magnetic Resonance Imaging Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cognitively unimpaied, 20-50 years old

Brief summary: This study aims to validate a functional MRI paradigm to determine the regions involved in the retrieve of music-linked memories


Eligibility criteria: Inclusion Criteria:

* Adult men or women (aged 20 - 50)
* Signature of the study's informed consent form, accepting to not receive information with regards to any research results that are not clinically relevant.
* Persons that accept the study's procedure: magnetic resonance imaging.

Exclusion Criteria:

* Contraindication to MRI scanning or conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
* Persons with severe or profound hearing loss or deafness

Primary outcomes:
measure: fMRI paradigm
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: BarcelonaBeta Brain Research Center
Study officials:
References:
Clinical trial NCT04004819: Rituximab for HTLV-1-associated Myelopathy
Official title: Rituximab Therapy for the Patients With HTLV-1-associated Myelopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: HTLV-1-associated Myelopathy
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental: Rituximab group Drug: Rituximab will be administered as 100 mg IV, once per week for 3 consecutive weeks. Continued dosage was dependent on the percentage of circulating CD19 B-cell counts from patients . Whenever it reached 1% of total lymphocyte population, rituximab 100 mg was reinfused

Placebo Comparator: Control group Patients will receive usual care and drug use.
Primary purpose: TREATMENT

Brief summary: Neuroprotective or anti-inflammatory strategies are invaluable in HTLV-1-associated myelopathy due to its rapid progression. We evaluated the efficacy of rituximab in patients with HTLV-1-associated myelopathy.


Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Patients HTLV-1-associated myelopathy (tropical spastic paraparesis)

Exclusion Criteria:

* Anticipated survival of at least 3 years
* Inability to undergo neuroimaging with Magnetic Resonance
* Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs \>2x normal, coagulopathy as described)
* Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome
* Pregnancy
* Malignancy (history of or active)
* Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies

Primary outcomes:
measure: The improvement of pyramidal or bowel-bladder function score in EDSS during 12 month treatment
timeFrame: up to 360 days
Secondary outcomes:
measure: Change in immunology function
timeFrame: up to 360 days
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology ,First Affiliated Hospital Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT00724919: A Post-Intervention Surveillance Study Regarding the Acquisition Rate of ESBL-KP, Ecoli
Official title: Association of Antibiotic Utilization Measures and Control of Extended-Spectrum β-Lactamases (ESBLs) (A Post-Intervention Surveillance Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection
Keywords: ESBL
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted to ICU/burn unit

Brief summary: To determine the acquisition rate of ESBL producing E. coli or K. pneumoniae, post- intervention in the selected medical centres

Detailed description: This is post-interventional study to follow the acquisition rate of ESBP producing E. coli or K. pneumoniae at the sites involved in a previous interventional study.

Eligibility criteria: Inclusion

1. All patients admitted or transferred to ICU/burn unit.
2. Patients of either sex, 18 years of age or older. Exclusion

Patients were excluded if they had underlying conditions or diseases that were ultimately fatal within 48 hours

Primary outcomes:
measure: The acquisition rate of ESBL producing E. coli or K. pneumoniae at the end of surveillance phase
timeFrame: 48hours
Secondary outcomes:
measure: The infection rate due to ESBL producing E. coli, or due to K. pneumoniae at the end of surveillance phase
timeFrame: 48hours
Other outcomes:
Locations:
city: Miaoli County
country: Taiwan
city: Taichung
country: Taiwan
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01698619: Hemodynamic Changes in Altitude Adaptation
Official title: Hemodynamic Changes in Altitude Adaptation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Mountain Sickness
High Altitude Pulmonary Edema
High Altitude Cerebral Edema
Lead sponsor: Goethe University
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers taking part in an expedition to Mount Aconcagua

Brief summary: We use a new technology (Nexfin from BMEYE-Inventive Hemodynamics) to monitor Cardiac Output, Blood Pressure, Fluid Responsiveness, Pulse Oximetry, Hemoglobin Concentration, Oxygen Delivery in Climbers during their process of acclimatization on a expedition to Mount Aconcagua.

Detailed description: Several parameters will be recorded to analyze their influence on the adaptation to high altitude. Such as, food composition, dietary supplements, water intake and output.

Eligibility criteria: Inclusion Criteria:

* No acute or chronic disease
* Body mass index : 20 - 30

Exclusion Criteria:

* Any preexisting disease that has a potential impact on physical performance such as:

  * pulmonary
  * cerebral
  * muscular
  * cardiac
  * vascular - diseases

Primary outcomes:
measure: Changes from baseline in Oxygen Delivery
timeFrame: daily, up to 18 days
Secondary outcomes:
measure: Changes from baseline in Hemoglobin Concentration
timeFrame: daily, up to 18 days
Other outcomes:
measure: Changes from baseline in Blood pressure, Fluid Responsiveness, Oxygen Saturation, Cardiac Output
timeFrame: daily, up to 18 days
Locations:
city: Frankfurt
country: Germany
facility: Goethe University
state: Hessen
Study officials:
References: