louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04329013: Position of EGD in Droplet Spreading
Official title: The Comparison of Left Lateral Versus Prone Position in Saliva Droplet Spreading During Upper Gastrointestinal Endoscopy; a Pilot Study of Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cotamination on Face Shield
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will randomize the patients who need EGD into 2 groups; left lateral and prone position by block of 4.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The association between position of upper gastrointestinal endoscopy (EGD) and saliva droplet spreading has never been studied. In the era of contagious viral spreading, this pilot study is aimed to assess adenosine triphosphate (ATP) at the face shield of endoscopist which can represent the saliva droplet spreading of patients in left lateral and prone position during EGD.


Eligibility criteria: Inclusion Criteria:

* Patients who have the indication for upper gastrointestinal endoscopy

Exclusion Criteria:

* Cannot be in prone position
* The endoscopist deny the assigned position in any reason.

Primary outcomes:
measure: The level of adenosine triphosphate (ATP) on face shield of endoscopist
timeFrame: immediately following the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
References:
Clinical trial NCT01508013: An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk
Official title: An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Keywords: Melanoma
Basal Cell Carcinoma
Squamous Cell Carcinoma
Lead sponsor: East Tennessee State University
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 443
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether a skin cancer prevention website is effective at reduce female teenagers' desire to use indoor tanning and ultimately their use of indoor tanning over an 18 month period.

Detailed description: The project is designed to improve the understanding of, and ability to affect UV risk behavior in teenage populations. The International Agency for Research in Cancer classifies indoor tanning as "carcinogenic to humans." There is evidence that female indoor tanning use increases dramatically from freshman to senior years of high school (e.g., 25-40% of older high school girls) making high school a critical time period for anti-tanning interventions to be carried out. This proposal assesses the effectiveness of a skin cancer prevention website for a nationally representative sample of high school teens in a randomized controlled trial. Teens exposed to the website will report reduced indoor tanning intentions, frequency and overall percentage of users while increasing sun protective behaviors at long-term (i.e 18 month) follow-up.

Eligibility criteria: Inclusion Criteria:

* Teenager between 12 and 18 years old; has either indoor tanned in the past year or has indicated their intentions to indoor tan in the coming year.

Exclusion Criteria:

* None other than not meeting inclusion criteria.

Primary outcomes:
measure: Indoor Tanning Behavior
timeFrame: 12 months
measure: Indoor Tanning Intentions
timeFrame: 12 months
measure: Indoor Tanning Willingness
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Johnson City
country: United States
facility: East Tennessee State University
state: Tennessee
Study officials:
affiliation: East Tennessee State University
name: Joel J Hillhouse, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06050213: Edentulous Maxilla Opposed by 2-implant Mandibular Overdenture?
Official title: Maxillary Overdenture Retained by Different Number of Implants Opposed by 2-implant Assisted Mandibular Overdenture. A Cross-over Study of Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Prosthesis Durability
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This within -subject study will be conducted to evaluate the proper number of unsplinted implants ;( three, four and five implants) for the edentulous maxilla opposed by mandibular two-implant overdentures.


Eligibility criteria: Inclusion Criteria:

* o Healthy and free from any systemic diseases that may interfere with the osseointegration of implants.

  * Patients have completely edentulous maxilla for at least 6 months after last extraction with opposing mandibular two-implant Overdentures.
  * The patients have angle class I maxillomandibular skeletal relation and sufficient interarch space not less than (10-12 mm) as detected by tentative jaw relation.
  * Maxillary and mandibular alveolar ridges covered with healthy, firm, relatively even thickness and even compressible mucosa as detected by palpation with the blunt end of the mirror and free from any signs of inflammation or flabbiness as detected by clinical examination.
  * Good quality and quantity of maxillary residual alveolar ridge, as detected by CBCT, available for implant width (3.7mm, 5mm for anterior and posterior implants respectively) and length (12mm, 10mm for anterior and posterior implants respectively) this was ascertained by CBCT.

Exclusion Criteria:

* o Any history of metabolic or systemic diseases that may affect integration of implant or connective tissue health surrounding implant.

  * History of irradiation in head-and-neck area.
  * Heavy smokers (more than 10 cigarettes per day)
  * Parafunctional habits such as bruxism.
  * Psychiatric disorders or unrealistic expectations.
  * Positive pregnancy test up to 5 days before surgery.
  * Severe thrombocytopenia and bleeding disorders.
  * Pathologic condition of soft tissue (bacterial and viral stomatitis, hyperplasia, cyst, fibrous lesions)
  * Patients with local contraindications for implant placement due to localized bone defects and poor bone quality (D5).
  * Patients with TMJ disorders or poor neuromuscular coordination.

Primary outcomes:
measure: Patient satisfaction
timeFrame: one year
measure: Bite force
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dakahlia
Study officials:
References:
Clinical trial NCT05661513: Inventory of the Management of Acute Community-acquired Pneumonia in Strasbourg University Hospitals
Official title: Inventory of the Management of Acute Community-acquired Pneumonia in the Pneumology Department of the Strasbourg University Hospitals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection, Lung Parenchyma
Keywords: Community-acquired Pneumonia
Infection, Lung parenchyma
Rhinovirus
Respiratory syncitial virus
Influenza virus
Streptococcus pneumoniae
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with acute community-acquired pneumonia (\< 48 hours after admission),

Brief summary: Acute community-acquired pneumonia (CAP) refers to an acute infection of the lung parenchyma, occurring within the first 48 hours of hospitalization. It is a frequent, serious pathology with a strong economic impact. Viruses (rhinovirus, respiratory syncitial virus, influenza virus for the most common) and Streptococcus pneumoniae are the most frequently encountered pathogens. However, more than half of the PACs have no microbiological documentation. The management of CAPs is based on national and international recommendations. Several studies have shown imperfect compliance by clinicians with recommendations with a prognostic impact.

The various published studies insist on the variability of the incidence, the type of pathogen, the severity and the economic impact, depending on the series. They also insist on the need to know the local epidemiology, in particular microbiological, in order to adapt the recommendations.

Detailed description: The objective of the study is to determine the epidemiological, clinical, biological and imaging characteristics of people admitted for acute community-acquired pneumonia.

Eligibility criteria: Inclusion criteria:

* Adult subject (≥ 18 years old),
* acute community-acquired pneumonia (\< 48 hours after admission),
* admitted from the Emergency Department, consultation or home.
* Subject not objecting to the reuse of their data for scientific research purposes

Exclusion criteria:

* Expressed refusal to reuse data for scientific research purposes.
* bronchitis, acute nosocomial pneumopathy, secondary infection due to bronchial dilation.

Primary outcomes:
measure: Retrospectively determine the epidemiological, clinical, biological and imaging characteristics of people admitted for acute community-acquired pneumonia
timeFrame: Files analysed retrospectively from January 01, 2015 to December 31, 2019 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Pneumologie - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00694213: Pandemic Influenza Plasmid DNA Vaccines (Needle-Free)
Official title: A Phase 1, Double-Blinded Study to Evaluate the Safety, Tolerability, and Immunogenicity of Pandemic Influenza Plasmid DNA Vaccines Administered With the Biojector® 2000 Needle-Free System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: Pandemic Influenza
Avian Influenza
DNA Vaccines
Antibody
T Cells
HA/NP/M2
Biojector
Lead sponsor: Vical
Sponsor class: INDUSTRY
First posted: 2008-06-10
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The trial will enroll up to 47 subjects. Qualified normal healthy volunteers will be enrolled in the study to receive the vaccine or placebo vaccine. Subjects will receive 2 vaccinations with the Biojector® 2000, and will be followed for 6 months to evaluate the safety of and the immune system's response to the vaccine. The safety and immune system's response will be studied throughout the trial.


Eligibility criteria: Inclusion Criteria:

* 18 to 45 years of age
* Able to provide informed consent and be followed for 6 months

Exclusion Criteria:

* No immunomodulatory therapy within the past 6 months
* No evidence of immunodeficiency or pregnancy
* No laboratory or evidence of clinically significant medical disease
* No history of previous pDNA immunization
* No influenza immunization within the past 30 days
* No blood donations within 30 days of screening visit
* No history of bleeding disorder
* No use of aspirin and/or anticoagulants within 2 weeks of the administration of the investigational vaccines

Primary outcomes:
measure: Safety and Tolerability of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000 in adult subjects.
timeFrame: 6 months
Secondary outcomes:
measure: Influenza-specific immunogenicity of VCL-IPT1 and VCL-IPM1 administered IM using the Biojector® 2000
timeFrame: 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Accelovance
state: California
city: Baltimore
country: United States
facility: SNBL
state: Maryland
city: Stony Brook
country: United States
facility: SUNY at Stonybrook, Stony Brook Medical Center
state: New York
Study officials:
affiliation: Vical
name: Don Guterwill, BS, MT
role: STUDY_CHAIR
References:
Clinical trial NCT06809413: Clinical Study on the Early Bactericidal Activity of Sitafloxacin Against Mycobacterium Abscessus Disease
Official title: Clinical Study on the Early Bactericidal Activity of Sitafloxacin Against Mycobacterium Abscessus Disease
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Fluoroquinolone
Mycobacterium
Keywords: Mycobacterium abscessus
Sitafloxacin
early bactericidal activity
Colony forming units
time to positivity
Lead sponsor: Beijing Chest Hospital
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single-center, open-label clinical trial designed to evaluate the early bactericidal activity (EBA) of sitafloxacin against Mycobacterium abscessus disease. Patients with Mycobacterium abscessus disease were enrolled and treated with sitafloxacin monotherapy for 14 days. Colony forming units (CFU) and time to positivity (TTP) in sputum cultures were analyzed and compared. By assessing the impact of sitafloxacin monotherapy on the bacteria in the sputum of patients with Mycobacterium abscessus disease, the early bactericidal activity of sitafloxacin was evaluated, providing a basis for the selection of new drugs for the treatment of Mycobacterium abscessus disease.

Detailed description: This study is a single-center, open-label clinical trial designed to evaluate the early bactericidal activity (EBA) of sitafloxacin against Mycobacterium abscessus disease. Patients with Mycobacterium abscessus disease were enrolled and treated with sitafloxacin monotherapy for 14 days. Colony forming units (CFU) and time to positivity (TTP) in sputum cultures were analyzed and compared. By assessing the impact of sitafloxacin monotherapy on the bacteria in the sputum of patients with Mycobacterium abscessus disease, the early bactericidal activity of sitafloxacin was evaluated, providing a basis for the selection of new drugs for the treatment of Mycobacterium abscessus disease.

Study medication: Sitafloxacin 100mg QD for 14 days.

Eligibility criteria: Inclusion Criteria:

* (1) Diagnosed or clinically diagnosed with Mycobacterium abscessus pulmonary disease within 6 months prior to enrollment; (2) Voluntarily participate in this study and sign the informed consent form; (3) Agree to use contraception voluntarily.

Exclusion Criteria:

* (1) Received glucocorticoids or immunosuppressants within 90 days prior to enrollment; (2) Pregnant women or postpartum lactating women; (3) Patients with evidence of fluoroquinolone resistance or allergy.

Primary outcomes:
measure: Early bactericidal activity
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute
state: Beijing
Study officials:
References:
Clinical trial NCT00800813: Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy
Official title: Assessing the Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate
Erectile function
Peyronie's Plaque
08-135
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-12-02
Enrollment: 121
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing open, laparoscopic, or robotic-assisted laparoscopic radical prostatectomy at MSKCC.

Brief summary: Some men complain of changes in the shape or dimensions of their penis after undergoing radical prostatectomy (removal of the prostate) for prostate cancer. Changes in penile dimensions include shortening or decreased girth. Changes in shape include a curvature or bending of the penis, and/or the appearance of indentation. These changes may be associated with formation of scar tissue involving the covering of the erection chambers, known as "plaque". The appearance of indurated plaque and a resultant curvature or indentation is a well described medical condition known as "Peyronie's Disease" and may occur in men who did or did not undergo radical prostatectomy. The purpose of this study is to evaluate these changes in penile shape and dimensions.


Eligibility criteria: Inclusion Criteria:

* Males, age 21 years or older (no maximum age limit)
* Ability and willingness to give informed consent
* Clinically localized prostate cancer
* Open, laparoscopic or robotic-assisted radical prostatectomy
* Must be sexually active (penetrative or non-penetrative sexual encounters, either with a partner or self-stimulation)

Exclusion Criteria:

* Preoperative / Postoperative pelvic radiation therapy
* Preoperative / Postoperative hormonal treatment
* Preoperative Peyronie's disease
* Preoperative presence of a penile implant

Primary outcomes:
measure: Assess the impact of radical retropubic prostatectomy on penile dimensions.
timeFrame: conclusion of the study
measure: Assess the impact of radical retropubic prostatectomy on the development of Peyronie's Disease.
timeFrame: conclusion of the study
Secondary outcomes:
measure: Assess the association between penile length change and erectile function.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: John Mulhall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02401113: Effect of Ursolic Acid of Loquat Extract on Function of Muscle
Official title: Effect of Ursolic Acid of Loquat Extract on Function of Muscle in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sarcopenia
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 54
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per day or a placebo for 12 weeks.

Detailed description: This randomized, placebo-controlled, double-blind study was designed to investigate the efficacy and tolerability of Ursolic Acid of Loquat Extract for treatment of muscle function improvement with relatively health adults. 54 subjects received 500 mg of Loquat Extract per day or a placebo for 12 weeks. Change over time in muscle fuction was evaluated by four outcomes: assessment of appendicular skeletal mass using DEXA (dual energy X-ray absorptiometry); quadriceps muscle power by Biodex; hand grib power; and Short Physical Performance Battery, SPPB.

Eligibility criteria: Inclusion Criteria:

* BMI 18.5-30KG/M2

Exclusion Criteria:

* \> SERUM creatinine 1.2mg/dL
* \> AST or ALT 60IU/L
* DM Patients

Primary outcomes:
measure: quadriceps muscle function
timeFrame: 12weeks
Secondary outcomes:
measure: ASM(appendicular skeletal mass) marker
timeFrame: 12weeks
measure: Short Physical Performance Battery, SPPB
timeFrame: 12weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: SANG YEOUP Lee, Pf.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prissadova N, Bozov P, Marinkov K, Badakov H, Kristev A. Effects of ursolic acid on contractile activity of gastric smooth muscles. Nat Prod Commun. 2015 Apr;10(4):565-6.
citation: Cho YH, Lee SY, Kim CM, Kim ND, Choe S, Lee CH, Shin JH. Effect of Loquat Leaf Extract on Muscle Strength, Muscle Mass, and Muscle Function in Healthy Adults: A Randomized, Double-Blinded, and Placebo-Controlled Trial. Evid Based Complement Alternat Med. 2016;2016:4301621. doi: 10.1155/2016/4301621. Epub 2016 Nov 24.
Clinical trial NCT05623813: Individual- and Group-based Postoperative Education for Patients Sternotomy
Official title: Individual- and Group-based Postoperative Education on Promoting Engagement in Daily Activities for Patients After Sternotomy: A Non-randomised Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-sternotomy
Keywords: patient education
individual and group delivery
engagement in daily activities
Lead sponsor: University of Western Sydney
Sponsor class: OTHER
Collaborators: name: Liverpool Hospital
First posted: 2022-11-21
Enrollment: 88
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 18 or above who had received cardiac surgery via sternotomy at Liverpool Hospital cardiothoracic ward.

Brief summary: Cardiac surgery via sternotomy is performed on more than one million people annually. Patient education may promote engagement in daily activities postoperatively. It is unknown if there is any difference in patients' feedback and outcomes when the education is delivered individually or in a group format.

The aim of this study is to collect participants' feedback and therapists' time spent on individual- and group-based Education in Daily Activities Engagement - Post-Sternotomy.

Detailed description: This single-site non-randomised controlled study was conducted at Liverpool Hospital, NSW, Australia. All patients aged 18 or above who had received cardiac surgery via sternotomy at Liverpool Hospital cardiothoracic ward were consecutively allocated to the individual- or group-based postoperative education. Outcomes included a survey to obtain participants' feedback, the time spent by therapists delivering the education per participant, and participants' length of postoperative hospital stay.

Eligibility criteria: Inclusion Criteria:

* over the age of 18
* had received cardiac surgery via sternotomy
* were medically ready for discharge

Exclusion Criteria:

* under the age of 18
* unable to provide consent
* did not speak English
* could not obtain a translator prior to discharge
* were infectious and required to isolate

Primary outcomes:
measure: Survey
timeFrame: Two to three days pre-discharge
measure: Survey
timeFrame: Four to six weeks post-discharge
Secondary outcomes:
measure: Time spent delivering education per participant
timeFrame: Post-discharge, up to six weeks
measure: Length of postoperative hospital stay
timeFrame: Post-discharge, up to six weeks
Other outcomes:
Locations:
Study officials:
References: