louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03840876: SJOV With WNJ in Microlaryngeal Surgery
Official title: Supraglottic Jet Oxygenation and Ventilation Via Nasal Approach During Laser Microlaryngeal Surgery for Vocal Polyps Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Other Complications of Surgical and Medical Procedures
Keywords: Jet Ventilation
Supraglottic
Intranasal
Microlaryngeal Surgery
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The key to a successful microlaryngoscopy is adequate operative field exposure and illumination. A variety of airway control procedures has been developed to improve operative exposure. A small size endotracheal tube is commonly used. However, some surgeon may suggest a 'no-tube' technique to optimize the surgical field. This study aims to investigate effectiveness and safety of a novel technique by supraglottic jet oxygenation and ventilation (SJOV) via nasal approach to facilitate optimal visualization in laser microlaryngeal surgery for small vocal polyps resection.

Detailed description: The allocation sequence is generated by computer random number generation, and the allocation is placed in sequentially numbered opaque sealed envelopes by a non-investigator. Enrolment and data collection are performed by trained research staff who are not involved in the care of the patients. The treating clinicians are not possible to be blinded to the assignment group, but all other staff involved in both the collection and collation of data, and administration of neurocognitive testing, are blinded to group allocation.

The primary measurement is numerical rating scale (NRS) rated by surgeon according to surgical exposure and visualization. The secondary measurements are operation duration, and Intraoperative pulse oximetry (SpO2), PetCO2.

The continuous variables were expressed as means ± standard deviation (SD) whereas categorical variables were expressed as frequency and percentage for data description.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for laser laryngeal surgery under general anesthesia

Exclusion Criteria:

* Patients with cardiac, pulmonary, hepatic, or renal dysfunction. Patients with nasal disease. Patients with anticipated difficult airway.

Primary outcomes:
measure: Numerical rating scale (NRS) rated by surgeon
timeFrame: Immediately after surgery, the surgeons rated surgical exposure and visualization with NRS only once.
Secondary outcomes:
measure: Operation duration
timeFrame: Immediately after surgery, the duration of the operation was recorded by the investigator.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye, Ear, Nose and Throat Hospital
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: Wenxian Li, M.D. Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05005676: Evaluation of the New Acceleromyograph TOF 3D
Official title: Evaluation of the New Three-dimensional Acceleromyograph TOF 3D Compared With the Established TOF Watch SX.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Assessment of a New Acceleromyograph
Neuromuscular Block
Lead sponsor: Kreiskrankenhaus Dormagen
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The TOF 3D is a new acceleromyograph designed to assess the degree of a neuromuscular block during anesthesia. The study compares the new three-dimensional technique with the established TOF Watch SX.

Detailed description: The TOF 3D is a new acceleromyograph designed to assess the degree of a neuromuscular block during anesthesia. The study compares the new three-dimensional technique with the established TOF Watch SX. The time course of a neuromuscular block (onset, maximal block, time to recovery) is assessed simultaneously with both devices in 50 patients undergoing elective gynecologic surgery requiring neuromuscular block. The validity and reliability of the new technique is evaluated with a Bland-Altman- analysis.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective gynecologic surgery requiring general anesthesia and neuromuscular block

Exclusion Criteria:

* anticipated difficult airway
* Risk of pulmonary aspiration
* acute infection
* pregnancy
* renal or hepatic insufficiency
* neuromuscular disease
* chronic intake of drugs influencing neuromuscular block

Primary outcomes:
measure: TOF-R 90%
timeFrame: 12 months
Secondary outcomes:
measure: repeatability (precision)
timeFrame: 12 months
measure: bias and limits of agreement (Bland-Altman analysis)
timeFrame: 12 months
Other outcomes:
Locations:
city: Dormagen
country: Germany
facility: KKH Dormagen
Study officials:
References:
Clinical trial NCT00549276: Randomized Comparison of Curved Cutter Stapler and Linear Stapler
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Neoplasm
Surgical Stapler
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-10-25
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 patients were randomly assigned to either linear staplers or the CCS during low anterior resection for mid to low rectal cancers

Brief summary: This study aims to compare the safty and technical accessibility of linear stapler and curved cutter stapler during mid to low rectal cancer surgery.


Eligibility criteria: Inclusion Criteria:

* Biopsy proven adenocarcinoma of rectum.
* Preoperative stage I-III
* Patient who is expected to undergo low anterior resection at Samsung Medical Center.
* Age \> 19 years old

Exclusion Criteria:

* Patient with complicated rectal cancers(obstruction, perforation, abscess)
* Patient who needs to undergo emergency operation.
* Patient who can not undergo general anesthesia.
* Patient who does not agree with the informed consent or does not have the ability to understand content of the trial .

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center Sungkyunkwan University School of Medicine,
Study officials:
affiliation: Samsung Medical Center
name: Won-Suk Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03622476: Pharmacokinetic (PK)Research on Chinese Children of Hemophilia
Official title: Capital Characteristic Application: Pharmacokinetic（PK） Research on Chinese Children of Hemophilia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pharmacokinetics
Keywords: Hemophilia A，pharmacokinetics
Lead sponsor: Beijing Children's Hospital
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 155
Sex: MALE
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study start on June 30, 2018. The Severe(F Ⅷ\<1%) hemophilia A children without F Ⅷ inhibitor combining were recruited to Test the concentration of the drug in the blood to provide better treatment.

Detailed description: Through the integration of two technologies, pharmacokinetics and comprehensive evaluation system, we can improve the individualized prevention and treatment of hemophilia in Chinese children and achieve precise customization of treatment plans. Rational use of medical resources, but also fully achieve the prevention and treatment goals.

Eligibility criteria: Inclusion Criteria:

* FⅧ\<1% ,
* 1-14years old,
* There have been at least one history of bleeding in any joint of the knee, elbow, or ankle.
* A blood product containing FVIII is applied.
* There were no inhibitors at the time of enrollment, and there was no inhibitor-positive history and family history.
* Clinical visits are available on a regular basis and data is available, and preventive treatment is available prior to enrollment.
* The child was enrolled in the group and the guardian agreed.

Exclusion Criteria:

* Combining other disease researchers believes that it is not suitable for enrollment.
* FVIII inhibitor was found.
* Refuse to participate in research

Primary outcomes:
measure: Ultrasound evaluation
timeFrame: 3 years
measure: Imaging evaluation
timeFrame: 3 years
Secondary outcomes:
measure: Annualized Bleeding Rate
timeFrame: 3 years
measure: Annualized Joint Bleeding Rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02335476: Automatic Early Melanoma Detection by Ultrahigh Resolution Three Dimensional Optical Coherence Tomography
Official title: Automatic Early Melanoma Detection by Ultrahigh Resolution Three Dimensional Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma
Keywords: optical coherence tomography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are patients at out-patient clinics or ward of Department of Dermatology, National Taiwan University Hospital.

Brief summary: The investigators will use optical coherence tomography to detect the ex-vivo tissue image of surgical removed melanoma or other benign pigmented lesions of skin.

Detailed description: The investigators will use an advanced high resolution 3D optical coherence tomography (OCT) technology to observe skin tissue images in ex vivo culture. Parts of melanoma or benign pigmented lesions specimens derived from biopsy or surgical excision specimen will be observed by 3D optical tomography. A tiny tissue fragment of melanoma or benign pigmented lesions will be taken from surgical specimen without interference normal pathological evaluation. The location of melanocytic cells in melanoma or benign tissue fragments will be mapped by the 3D optical coherence tomography (OCT). The 3D optic tomography system utilize a Ce:YAG optical fiber as light source and also combined with confocal microscopy. Taken together, these features made the 3D optic tomography system have very high resolution and suitable for single cell imaging. This study will not interfere with the normal medical practice and had no impact on patient's safety and health. All of the materials will be destroyed once the experiments are done. The enrollment criteria will be dermatological patients who need to surgical intervention.

Eligibility criteria: Inclusion Criteria:

* Patients aged older than 20 years old
* Patients who had melanoma, melanoma in situ, and/or other benign pigmented lesions,
* Patients who had non-melanoma skin cancers (basal cell carcinoma, or squamous cell carcinoma).
* Patients who had precancerous skin lesions (Bowen's disease, actinicc keratosis)

Exclusion Criteria:

• Pregnant women.

Primary outcomes:
measure: Ex vivo Tissue image.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: JENGWEI TJIU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06834776: Evaluation of Neuromuscular Blockade Responses in Statin-Using and Non-Using Patients
Official title: Evaluation of Neuromuscular Blockade Responses in Statin-Using and Non-Using Patients Undergoing Elective Surgery Under General Anesthesia, Monitored by Train-of-Four (TOF)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neuromuscular Blockade
Statin-Associated Myopathy
Neuromuscular Monitoring
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Statin-Using and Non-Using Patients Undergoing Elective Surgery Under General Anesthesia

Brief summary: This study aims to compare the neuromuscular blockade responses in patients undergoing elective surgery under general anesthesia, with a focus on the use of statins. The study will assess the depth of neuromuscular blockade, recovery time, and postoperative residual curarization using Train-of-Four (TOF) monitoring, with the primary goal of determining whether statin use alters the neuromuscular blockade management.


Eligibility criteria: Inclusion Criteria:

* Age 18-75 years
* ASA classification I, II, III
* BMI 18-30
* Statin use for at least 3 months or no prior statin use
* Elective surgery requiring general anesthesia with endotracheal intubation
* Signed informed consent for participation in the study

Exclusion Criteria:

* ASA classification IV or higher
* BMI \<18 or \>30
* History of liver or renal insufficiency (creatinine \>1.6, liver function tests \>2x normal)
* Neuromuscular, psychiatric, or neurological disorders
* Pregnancy
* Use of drugs affecting neuromuscular function (e.g., anticonvulsants, aminoglycosides)
* History of malignant hyperthermia
* Respiratory disorders, including sleep apnea
* Allergy to anesthetic drugs used in the study

Primary outcomes:
measure: Time to reach TOF count 0
timeFrame: 0th minute
measure: Time to reach TOF 40
timeFrame: about 40th minute
measure: Time to reach TOF 90 (reversal of neuromuscular blockade)
timeFrame: about 60th minute
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Emine Emen, ass. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT01417676: DAPROCA Pelvic Lymph Node Irradiation to Prostate for High Risk Prostate Cancer: Phase I/II Study
Official title: Pelvic Lymph Node Irradiation With Simultaneous Integrated Boost to Prostate for High Risk Prostate Cancer Patients: A Phase I/II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate cancer
locally advanced
lymph node positive
radiation therapy
morbidity
early morbidity
late morbidity
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Denmark
name: Herlev Hospital
name: Odense University Hospital
name: Vejle Hospital
name: Aalborg University Hospital
name: Danish Center for Interventional Research in Radiation Oncology (CIRRO)
First posted: 2011-08-16
Enrollment: 87
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients are allocated for lymph node irradiation, either up front combined with prostate irradiation or lymph node irradiation after primary lymph adenectomy after combined with prostate irradiation.
Primary purpose: TREATMENT

Brief summary: This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study. The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation with simultaneous integrated boost to prostate in high risk prostate cancer patients.


Eligibility criteria: Inclusion Criteria:

* adenocarcinoma
* T3 tumor and either Gleason 8-10 and PSA ≤ 70,or PSA ≥ 30 and PSA ≤ 70, or T1-T3 and PSA ≤ 70 and N1
* no distant metastases

Exclusion Criteria:

* pelvic co-morbidity such as Crohns disease or ulcerative colitis
* uncontrolled heart or lung morbidity
* prior radiation treatment of pelvic region
* age \> 75 years

Primary outcomes:
measure: Incidence of late gastro-intestinal toxicity ≥ grade 2.
timeFrame: 3 years and beyond
Secondary outcomes:
measure: survival
timeFrame: 10 years
measure: recurrence
timeFrame: 10 years
measure: Incidence of late genito-urinary toxicity ≥ grade 2.
timeFrame: 3 years and beyond
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept. of Oncology, Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital, Daproca, CIRRO
name: Lise N Bentzen, MD., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02743676: A Retrospective, Observational Registry of Participants With Avian Influenza Infection
Official title: Avian/Pandemic Influenza Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Avian Influenza
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-04-19
Enrollment: 648
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective data are collected from participants with suspected or confirmed infection with avian influenza A H5N1.

Brief summary: This is a global, multi-center, observational registry of participants with suspected or confirmed infection with avian influenza A H5N1. Data are collected through retrospective abstraction, from detailed case reports that may be published and available in the public domain, or as incident cases received directly from the treating physician or other medical personnel.


Eligibility criteria: Inclusion Criteria:

* Participants who develop influenza-like symptoms and who are considered to be epidemiologically linked by time, place, and exposure to a probable or confirmed avian influenza or human case of H5N1 infection are eligible for inclusion in the Registry. Cases with atypical symptom presentation (e.g., non-respiratory) are also included, in keeping with evolving knowledge about the clinical presentation of avian influenza.
* Participants with documented positive serological test who either remain asymptomatic or experience mild illness only
* Participants with laboratory confirmation of infection with influenza A (H5N1) who survive long enough to present for medical care

Exclusion Criteria:

- There are no exclusion criteria in this study

Primary outcomes:
measure: Percentage of Participants with clinical outcome (death, recovery, or other overall clinical status) at the time of discharge from care
timeFrame: Up to 5 years
Secondary outcomes:
measure: Number of Participants with at least One Adverse Event (AE)
timeFrame: Up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05954676: Online Peri-operative Education Program for Patients Undergoing Major Head & Neck Surgery
Official title: Effects of Online Peri-operative Education Program for Patients Undergoing Major Head & Neck Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Head and Neck Neoplasms
Keywords: Head and neck cancer
CareOrbit
Peri-operative education
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: The Foundation for Barnes-Jewish Hospital
First posted: 2023-07-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This phase of the project will evaluate the utility and efficacy of a personalized online patient education platform developed from efforts in Phase 1 in 1) increasing patients' and caregivers' pre- and post-operative preparedness and satisfaction, and 2) reducing readmission, ED/Urgent care/unplanned clinic visits and telephone calls to clinic staff.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Have had or are undergoing free flap surgery and/or total laryngetomy
* Have internet access
* English speaking

Exclusion Criteria:

* Younger than 18 years of age
* No internet access
* Non-English speaking

Primary outcomes:
measure: 30-day readmission
timeFrame: At Day 30
Secondary outcomes:
measure: Number of emergency room/urgent care visits
timeFrame: Through 3 months post-operative
measure: Number of unplanned clinic visits
timeFrame: Through 3 months post-operative
measure: Number of telephone calls/electronic messages to clinic staff
timeFrame: Through 3 months post-operative
measure: Satisfaction of education
timeFrame: At pre-operative visit, 2 weeks post-operative, and 3 months post-operative
measure: Preparedness for head and neck surgery and post-operative care
timeFrame: At pre-operative visit, 2 weeks post-operative, and 3 months post-operative
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jason Rich, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01896076: The Caudal Space in Children: Ultrasound Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocele
Inguinal Hernia
Hypospadia
Cryptorchidism
Genitourinary Disease
Keywords: caudal space
children
ultrasound evaluation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-07-11
Enrollment: 300
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 0 - 84 months who were scheduled to undergo elective urological surgery. This investigation was conducted at a single tertiary medical center (Severance Hospital), Seoul, Republic of Korea.

Brief summary: Caudal anesthesia is commonly employed in pediatrics to produce postoperative analgesia in low abdominal or urologic surgery.

An exact understanding of the anatomy of the sacral area including sacral hiatus and surrounding structures is crucial to the success of caudal block.

The aim of this study is to evaluate the anatomy of the caudal space in pediatrics by ultrasound evaluation.


Eligibility criteria: Inclusion Criteria:

* Patients aged 0 - 84 months who were scheduled to undergo elective urological surgery.

Exclusion Criteria:

* Patients with any contraindication to caudal epidural block were excluded.

  * coagulopathy
  * allergy to local anesthetics
  * infection at the puncture site

Primary outcomes:
measure: ultrasound evaluation of caudal space
timeFrame: Right after induction of general anesthesia, the patients were placed in the lateral position. The ultrasound evaluation include transverse and longitudinal view.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References: