louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00675922: Study of the Treatment of Burn Wounds With Antimicrobial Topical Soaks
Official title: Comparing the Use of Sulfamylon 5%, Dakins 0.025%, Cerium, Silver Nitrate 5% and/or Other Topical Antimicrobial Products for the Treatment of Excised and/or Grafted Burn Wounds
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Burn
Keywords: Burn
Wounds
Wound infection
Topical antimicrobials
Cerium
Dakins
Sulfamylon Soaks
Silver Nitrate
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2008-05-12
Enrollment: 98
Sex: ALL
Minimum age (years): 1
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Determine effectiveness of various antimicrobial solutions on burn wounds (infections, wound healing, length of hospital stay).

Detailed description: Patients were treated with both Sulfamylon soaks and Silver nitrate soaks on different burn areas. These two areas were then compared for incidence (percentage) of infections.

Eligibility criteria: Inclusion Criteria:

* Burn Injury requiring excisional therapy
* Hospitalization required until wounds are closed

Exclusion Criteria:

* Known hypersensitivity to products
* Outpatient treatment for burn injury

Primary outcomes:
measure: Infection Rate
timeFrame: Acute hospitalization following burn injury: admission to discharge (1-20 weeks)
Secondary outcomes:
measure: Length of Hospital Stay With Various Antimicrobial Solutions for Burn Patients
timeFrame: Admission to burn unit to discharge
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: David N Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03278522: Ramosetron Pre-treatment for PONV and QT Prolongation
Official title: Comparison of Ramosetron Pre-treatment Time for Postoperative Nausea and Vomiting (PONV) and QTc Prolongation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: PONV
Prolonged QTc Interval
Keywords: ramosetron
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 64
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ramosetron is commonly used to prevent postoperative nausea and vomiting (PONV) in the Eastern Asia. The prolongation of QTc interval is a main side effect. In this study, the pre-treatment time of ramosetron to decrease PONV, and QTc prolongation is compared.

Detailed description: This prospective study evaluate 42 female patients who underwent laparoscopic gynecologic surgery under general anesthesia. Group I (n=21) receive 0.6mg of ramosetron at anesthesia induction. Group R (n=21) received the same at the end of surgery. PONV is evaluated at arrival to post-anesthetic care unit (PACU), before induction, discharge from PACU, 24-, 48-, and 72- after discharge from PACU. The QTc interval is checked before anesthesia, at arrival to PACU, and 24-h after discharge from PACU.

Forty two subjects are needed with an α value of 0.05, a power of 0.8, and effect size difference of 0.9.

Eligibility criteria: Inclusion Criteria:

* patients who underwent laparoscopic gynecologic surgery

Exclusion Criteria:

* preoperative bradyarrhythmia in ECG

Primary outcomes:
measure: QTc interval change
timeFrame: within 10 min after arrival at PACU, and 24 hour after discharge from PACU
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Lee Sung Ho
Study officials:
affiliation: Konkuk University Medical Center
name: Ka Young Rhee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02290522: Copenhagen Prospective Personalized Oncology (CoPPO)
Official title: A Prospective Study Using Genomic Screening to Select Patients for Targeted Molecular Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Patients with advanced solid tumors referred to the Phase 1 Unit are offered mapping of GA for identification of pts who could benefit from a personalized treatment.

Detailed description: Two ultrasound-guided biopsies obtained to be stored in RNAlater® for DNA and RNA purification. A 3rd biopsy for histology is paraffin embedded. SNP-array (Affymetrix Cytoscan HD) from DNA (tumor) is performed to identify copy number changes. Whole exome sequencing (WES) from DNA (tumor and blood) will be performed using sequence capture, SureSelect v5 (Agilent) and Illumina HiSeq2500 to call tumor specific mutations. Expression levels of therapeutic targets are revealed by expression Array from tumor RNA. In addition to the expression array, RNA-seq (Nugens Ovation RNA-seq system v2) is performed to investigate whether chromosomal translocations were the reason for tumor specific expression of an oncogene. Results will be reviewed by a tumor board. Patients with specific genetic profiles that can be targeted with marketed drugs or drugs under development are offered such treatment. PFS from the treatment is compared to PFS of the most recent standard treatment (PFS ratio).

Eligibility criteria: Inclusion Criteria:

* Solid tumor
* No standard treatment option
* PS 0-1
* Lesion assessable for biopsy
* Measurable disease
* Informed consent

Exclusion Criteria:

* Life expectancy \< 3 months
* Bone marrow suppression
* Abnormal renal or hepatic function
* Serious concurrent medical conditions

Primary outcomes:
measure: Median progression free survival (PFS)
timeFrame: Median time from date of randomization to date of progression or death, assessed up to 100 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Ulrik Lassen, MD, PH.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tuxen IV, Rohrberg KS, Oestrup O, Ahlborn LB, Schmidt AY, Spanggaard I, Hasselby JP, Santoni-Rugiu E, Yde CW, Mau-Sorensen M, Nielsen FC, Lassen U. Copenhagen Prospective Personalized Oncology (CoPPO)-Clinical Utility of Using Molecular Profiling to Select Patients to Phase I Trials. Clin Cancer Res. 2019 Feb 15;25(4):1239-1247. doi: 10.1158/1078-0432.CCR-18-1780. Epub 2018 Oct 1.
Clinical trial NCT02502422: Relationship Between Optimal Laryngeal Mask Airway Cuff Volume and Physical Examination of Head and Neck
Official title: Prediction of Optimal Laryngeal Mask Airway Cuff Volume From Parameters of Physical Examination of Head and Neck
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Laryngeal mask airway
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2015-07-20
Enrollment: 170
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Overinflation of laryngeal mask airway cuff increase side effect like hoarseness, vocal cord paralysis, sorethroat. The investigators will study correlation between laryngeal mask airway cuff volume and pressure and physical examination of head and neck.

Detailed description: Overinflation of laryngeal mask airway cuff can induce side effects like hoarseness, vocal cord paralysis, sorethroat. Some study revealed that 60cmH2O of intracuff pressure is maximum pressure which is not increase side effect.

The manufacturer recommends that the cuff is inflated with the minimum volume of air required to provide an effective seal(max volume - size 3, 20 ml; size 4, 30 ml; size 5, 40).

The investigators will measure anatomical structure (neck circumference, neck length, thyroid-mental distance, etc.) which can influence cuff volume and pressure and find correlation between cuff volume and physical figure measured.

Eligibility criteria: Inclusion Criteria:

* Adult (age 19-65)
* American Society of Anesthesiology Classification I-III

Exclusion Criteria:

* cardiovascular disease, cerebrovascular disease, pulmonary disease
* patient who have operation history for airway
* patient who expected difficult intubation
* patient who have risk of aspiration

Primary outcomes:
measure: optimal laryngeal mask airway cuff volume
timeFrame: 20minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea university anam hospital
Study officials:
affiliation: Department of anesthesiology and pain medicine, Korea University Anam Hospital
name: Hye-Won Shin, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05885022: Feasibility Clinical Evaluation of the Calibreye System
Official title: Feasibility Clinical Evaluation of the Calibreye System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma, Open-Angle
Lead sponsor: Myra Vision Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and feasibility of the Calibreye System in patients with open angle glaucoma.

Detailed description: This is a prospective, nonrandomized, open-label feasibility clinical trial, to evaluate the surgical procedure, safety and effectiveness of the Calibreye System in reducing intraocular pressure in subjects with open angle glaucoma.

Eligibility criteria: Inclusion Criteria:

* Open angle, pseudoexfoliative or pigmentary glaucoma
* IOP at preoperative visit of ≥ 18mmHg and ≤ 45mmHg
* Visual field mean deviation score of -3dB or worse
* Area of healthy, free and mobile conjunctiva in the target quadrant
* Shaffer angle grade ≥ 3 in the target quadrant

Exclusion Criteria:

* Angle closure glaucoma
* Congenital, neovascular or other secondary glaucomas
* Previous intraocular surgery (with the exception of laser trabeculoplasty or uncomplicated phacoemulsification with IOL occurring \> 3 months prior to the preoperative visit)
* Previous glaucoma shunt/valve in the target quadrant
* Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit
* History of corneal surgery, corneal opacities or corneal disease
* Active diabetic retinopathy

Primary outcomes:
measure: Intraocular Pressure
timeFrame: 12 Months
measure: Adverse Events
timeFrame: 12 Months
Secondary outcomes:
measure: Glaucoma Medication Usage
timeFrame: 12 Months
Other outcomes:
Locations:
city: Chennai
country: India
facility: Dr. Agarwal's Eye Hospital Ltd.
city: Chihuahua
country: Mexico
facility: Centro Oftalmologico de Chihuahua
city: Puebla
country: Mexico
facility: Oftalmología Láser de Puebla S.C.
city: Panama City
country: Panama
facility: Panama Eye Center
Study officials:
affiliation: Moorfields Eye Hospital NHS Foundation Trust
name: Keith Barton, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03833622: Shared Decision Making to Improve Goals of Care in the ED
Official title: Shared Decision Making to Improve Goals of Care Discussions in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Goals
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 230
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project will develop and refine a shared decision making (SDM) intervention (decision aid tool) to improve and normalize high quality end of life discussions in the Emergency Department (ED) setting.

Detailed description: Develop a shared decision making (SDM) intervention informed by insights elicited from patients and clinicians to improve goals of care discussions.

The process of decision aid design involves: (1) review and synthesis of the evidence; (2) an analysis of usual practice through observation of clinical encounters; (3) development of an initial decision aid prototype; (4) field testing in the context of clinical care to gain insights on both intended and unintended effects of its use in practice to facilitate patient centered goals of care discussions; and (5) successive iterations of the decision aid until thematic saturation is reached and it is ready for testing in a clinical trial.

Eligibility criteria: Inclusion:

1. Patients presenting to Mayo Clinic Rochester, Saint Marys' Emergency Department,
2. Patients at high risk for critical illness as determined by an Elderly Risk Assessment (ERA) score ≥ 16 or as determined by provider discretion,
3. ≥ 60 years of age,
4. Ability to provide informed consent,
5. Medically stable at the time of enrollment,
6. Able to participate without causing a delay in care.

Exclusion:

1. GCS scores \< 15,
2. Signs of altered mental status,
3. Known to be pregnant,
4. Incarcerated or in Police Custody,
5. Communication barriers such as visual or hearing impairment that may preclude use of the decision aid.

Primary outcomes:
measure: Patient and physician feedback survey for tool development and iterative refinement
timeFrame: 1 year
Secondary outcomes:
measure: Patient and physician satisfaction questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Laura E Walker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05530122: Prognosis in UC After First Biological
Official title: The Long-term Outcome of Patients With Ulcerative Colitis Treated With First Trial of Biological.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: infliximab
adalimumab
golimumab
ustekinumab
vedolizumab
tofacitinib
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 192
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All patients treated in Tampere University Hospital for UC between January 2009 and January 2020 were identified from the digital patient records. Patients at the age of 16 years or over with biological treatment initiated for treatment of moderate to severe UC were included.

Brief summary: To study the long-term clinical outcome of patients with ulcerative colitis treated with first trial of biological therapy.

Detailed description: UC patients treated with at least one biological in Tampere University Hospital between January 2009 and January 2020 were identified and reviewed from patient records.

Eligibility criteria: Inclusion Criteria:

* Patients treated for ulcerative colitis for the first trial of biological

Exclusion Criteria:

* Age under 16 years

Primary outcomes:
measure: Response to treatment
timeFrame: within 5 years
measure: Side-effects
timeFrame: within 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tampere University Hospital
name: Pekka Collin, PhD
role: STUDY_DIRECTOR
affiliation: Central Hospital of Kanta-Häme
name: Heli Eronen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01531322: A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
Official title: A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumococcal Infection
Keywords: 13vPnC
Healthy subjects
China
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-02-10
Enrollment: 72
Sex: ALL
Minimum age (years): 42
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months.


Eligibility criteria: Inclusion Criteria:

1. Age at the time of enrollment is:

   * 18 through 55 years (before the fifty sixth birthday) for Group 1.
   * 3 through 5 years (before the sixth birthday) for Group 2.
   * 42 to 98 days for Group 3.
2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

* Previous vaccination with licensed or investigational pneumococcal vaccine.
* Previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination with pneumococcal vaccine.

Primary outcomes:
measure: Number of participants reporting Adverse Events
timeFrame: Baseline to Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Huaian
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Nanjing
country: China
facility: Pfizer Investigational Site
state: Jiangsu
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Zhu F, Hu Y, Liang Q, Young M Jr, Zhou X, Chen Z, Liang JZ, Gruber WC, Scott DA. Safety and tolerability of 13-valent pneumococcal conjugate vaccine in healthy Chinese adults, children and infants. Ther Adv Drug Saf. 2015 Dec;6(6):206-11. doi: 10.1177/2042098615613985.
Clinical trial NCT04955522: Multimodal Imaging Analysis of Spinal Tumors
Official title: Multimodal Imaging Analysis of Spinal Tumors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Tumor
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 242
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spinal tumor patients in Peking University Third Hospital from January 2006 to October 2019

Brief summary: In this study, we retrospectively analyzed the imaging data of spinal tumors to find out more imaging features of spinal tumors, in order to provide more accurate reference for the diagnosis of spinal tumors.

Detailed description: Bone tumors account for 1-2% of total body tumors, and spinal tumors only account for 6.5% of total body tumors. Because of the low incidence rate, the number of patients and the attention in this field are far lower than other tumors, so far, all the researches on spinal tumors are relatively lacking. Because the diagnosis of bone tumor needs the combination of clinical, imaging and pathological to make a more accurate diagnosis, so the imaging diagnosis of spinal tumor is very important. In this study, through retrospective analysis of a variety of imaging data of patients with spinal tumor, measurement and recording of spinal tumor image related parameters, and statistical analysis, in order to find out more imaging characteristics of patients with spinal tumor, more accurate diagnosis of lesions, and provide more help for clinical decision-making.

Eligibility criteria: Inclusion Criteria:

* Complete and accurate clinical and pathological data are available；Imaging examination was performed in our hospital

Exclusion Criteria:

* Patients with missing image data and unclear image

Primary outcomes:
measure: radiomics features
timeFrame: 2020.12.1-2020.12.25
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Huishu Yuan
role: STUDY_CHAIR
References:
Clinical trial NCT04204122: Vigamox Treatment for Ocular Graft-Versus-Host Disease
Official title: Evaluation of Topical Vigamox in the Initial Management of Ocular Graft-Versus-Host Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ocular Graft-versus-host Disease
Keywords: GVHD
Graft-Versus-Host Disease
Ocular Surface
Ocular Surface Microbiome
Vigamox
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The eyes of each enrolled participant will be randomized such that one eye is treated with Vigamox and the other eye is treated with a placebo eye drop.
Primary purpose: TREATMENT

Brief summary: In this study the investigators seek to prospectively measure the response of ocular graft-versus-host disease (GVHD) patients to treatment with topical Vigamox. The investigators will accomplish this by enrolling patients with bilateral ocular GVHD and treating one eye with topical Vigamox and the other eye with a placebo eye drop. By assessing the response to treatment with Vigamox, the investigators hope to identify a role for topical antibiotic treatment in ocular GVHD.


Eligibility criteria: Inclusion Criteria:

-Participants will be adults with a history of allogeneic hematopoietic stem cell transplantation, signs of either acute or chronic GVHD per the hematologist, signs and symptoms consistent with ocular GVHD + within 4 months of developing symptoms of ocular GVHD

Exclusion Criteria:

* Treated with antibiotic eye drops in the month prior to enrollment
* History of fluoroquinolone allergy
* Asymmetric ocular disease
* Pregnant
* Nursing

Primary outcomes:
measure: Change in Ocular comfort
timeFrame: First clinic visit through second clinic visit (estimated to be 9-14 days)
Secondary outcomes:
measure: Change in Ocular Surface Disease Index (OSDI) score
timeFrame: First clinic visit through second clinic visit (estimated to be 9-14 days)
measure: Change in Visual acuity
timeFrame: First clinic visit through second clinic visit (estimated to be 9-14 days)
measure: Change in the Degree of Conjunctival injection
timeFrame: First clinic visit through second clinic visit (estimated to be 9-14 days)
measure: Change in Corneal/conjunctival punctate epithelial erosions
timeFrame: First clinic visit through second clinic visit (estimated to be 9-14 days)
measure: Change in Culture results
timeFrame: First clinic visit through second clinic visit (estimated to be 9-14 days)
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Todd Margolis, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: