louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06350357: Conventional Clipping Versus Punching Closure
Official title: Conventional Clipping Versus Punching Closure for Defect Closure After ESD：a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: the Rate of Complete Closure
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Endoscopic submucosal dissection (ESD) is an important minimally invasive treatment method for early digestive tract tumors, with a high cure rate, and it is widely used in clinical practice. And wound closure after ESD is a great challenge, which is closely related to postoperative perforation bleeding. Clip closure is one of the most commonly used closure methods. However, when the wound is large or when the wound is located more difficult to operate, conventional closure may lead to delayed perforation, and postoperative clips may be prone to early spontaneous shedding. The authors have recently reported a method that may be able to close larger and difficult wounds because the grooves can better fix the metal clips. The latest study suggests that this approach may be safe and effective, but the study has a small sample size and has no controls. Therefore, high-quality clinical study evidence related to punch closure is required in the strategy of defect closure after ESD, in order to better evaluate the feasibility and safety of this new endoscopic closure method.


Eligibility criteria: Inclusion Criteria:

* 1. Patients undergoing gastrointestinal ESD wound closure in the First Affiliated Hospital of Ningbo University from April 20, 2024 to December 31, 2025; 2. Age 18-75 years old; 3. Patients who voluntarily agreed to participate in this study and signed informed consent.

Exclusion Criteria:

* 1. Persons under the age of 18 2. Unwilling or unable to provide informed consent 3. Treatment or radiotherapy for malignant diseases, severe chronic heart or lung diseases, coronary or cerebrovascular events requiring hospitalization within the last 3 months 4.. Severe abdominal pain, bloating, nausea and other abdominal symptoms 5.. Patients with lifelong anticoagulant therapy or severe bleeding disorders, and patients who have recently taken anticoagulant or antiplatelet drugs 6. Pregnant or lactating 7. Patients with aggressive lesions and recurrent or residual tumors

Primary outcomes:
measure: Completely closed
timeFrame: 4 weeks
Secondary outcomes:
measure: delayed hemorrhage
timeFrame: 2 weeks and 4 weeks
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo first hospital
state: Zhejiang
Study officials:
References:
Clinical trial NCT05089357: Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin
Official title: A Prospective, Non-interventional Study to Collect Subject and Physician Satisfaction During Long Term Treatment of Glabellar Lines With Dysport® in Subjects of Chinese Origin in Real Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glabellar Lines
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female adult subjects up to 65 years of age with moderate to severe glabellar lines (GL)

Brief summary: This is a prospective, longitudinal, non-interventional, multi-center study to collect subject and physician satisfaction, and treatment experience with Dysport in real clinical practice in subjects of Chinese origin.

Detailed description: Approximately 250 subjects are planned to be included in the study.

Eligibility criteria: Inclusion Criteria:

* Adult male or female up to 65 years of age, and of Chinese origin.
* Moderate (grade 2) or severe (grade 3) glabellar lines at max frown.
* Prior to and independent of study, subject is seeking long term treatment of their glabellar lines.
* Prior to and independent of the study participation, physician intended to treat the subject with Dysport.
* Time and ability to complete the study and comply with instructions.
* Understands the study requirements and signed the informed consent form (ICF)

Exclusion Criteria:

* Hypersensitive to Dysport or its excipients.
* Presence of contraindications to Dysport treatment as specified in the approved leaflet in China.
* Subject is at risk for precautions, warnings, and/or contraindications to Dysport as specified in the approved leaflet in China.

Primary outcomes:
measure: Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire
timeFrame: Month 14
Secondary outcomes:
measure: Percentage of Participants in Each Response Category for Overall Physician Satisfaction at Visit 6, Assessed by the Physician Satisfaction Questionnaire
timeFrame: Month 14
measure: Percentage of Participants Satisfied With the Treatment Assessed Using a Subject Satisfaction Questionnaire
timeFrame: Month 20
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou Yanshuyuerong medical cosmetology clinic
state: Zhejiang
Study officials:
affiliation: Hangzhou Yanshuyuerong medical cosmetology clinic
name: Weiming Song
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04872348: An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0)
Official title: An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Lead sponsor: Sight Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects treated with OMNI® Surgical System as a standalone procedure in pseudophakic eye with mild to moderate primary open angle glaucoma

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of the OMNI® Surgical System in subjects who have undergone canaloplasty and trabeculotomy using OMNI® Surgical System without any concomitant surgery in pseudophakic eyes with mild to moderate primary open angle glaucoma (POAG) at least 150 days prior to enrollment.


Eligibility criteria: Inclusion Criteria:

* Treated with OMNI® Surgical System as a standalone procedure in pseudophakic eye with mild to moderate primary open angle glaucoma at least 150 days prior to enrollment.

Exclusion Criteria:

* Systemic disease that, in the opinion of the Investigator, would put the subject's health at risk and/or prevent completion of required study visits.
* Ocular pathology which, in the Investigator's judgment, would either place the subject at increased risk of complications or contraindicate washout, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol (e.g., returning to Investigator's office for follow-up visits).

Primary outcomes:
measure: Change in Intraocular Pressure (IOP)
timeFrame: 18 months
measure: Change in Number of Medications
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Eye Specialists of Georgia
state: Georgia
city: Wichita
country: United States
facility: Grene Vision Group
state: Kansas
city: Bloomington
country: United States
facility: Minnesota Eye Consultants
state: Minnesota
city: Orange
country: United States
facility: Northern New Jersey Eye Institute
state: New Jersey
city: Oklahoma City
country: United States
facility: Oklahoma Eye Surgeons
state: Oklahoma
city: Maryville
country: United States
facility: University Eye Specialists
state: Tennessee
city: El Paso
country: United States
facility: El Paso Eye Surgeons
state: Texas
city: Fort Worth
country: United States
facility: Ophthalmology Associates - Fort Worth
state: Texas
city: Ogden
country: United States
facility: Utah Eye Centers
state: Utah
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
References:
Clinical trial NCT03413748: Peritoneal Irrigation at Elective Cesarean Section
Official title: Comparative Study Between Intraabdominal Irrigation and Non Irrigation During Elective Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Recovery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: All participants will be randomized at elective cesarean section to either irrigation with 500 to 1000 ml of warm normal saline after closure of visceral peritoneum or non irrigation

Detailed description: All participants will be randomized at elective cesarean section to either irrigation with 500 to 1000 ml of warm normal saline after closure of visceral peritoneum or non irrigation during the procedure of elective lower segment cesarean section

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Gestational age 36 - 40 weeks
* Elective Cesarean section
* Under spinal anaesthesia

Exclusion Criteria:

* Chronic diseases as Diabetes and hypertension
* Intestinal diseases as Crohn's disease
* Psychological and neurological conditions affecting pain sensation
* women with ferbrile morbidity before the operation
* The need for general anesthesia

Primary outcomes:
measure: Intestinal recovery
timeFrame: 24 hours after operation
Secondary outcomes:
measure: Temperature
timeFrame: every hour for 16 hours after the operation
measure: postoperative pain
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: professor
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01279148: Electromagnetic Tracking of Devices During Interventional Procedures
Official title: Electromagnetic Tracking of Devices During Interventional Procedures
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Biopsy or Ablation Procedures
Keywords: biopsy guidance
tracking device
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2011-01-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitals and Out-patient Clinics

Brief summary: This prospective, randomized, controlled, parallel-design trial will compare the use of electromagnetic tracking and image guidance during biopsy/ablation procedures verses the typical standard or conventional image guided procedure alone (control). "US" ultrasound-guided biopsies/ablations with or without "CT" computed tomography- imaging will be used to complete the procedures in either the CT suite or a procedure room, at the discretion of the physician, and according to normal local practice patterns.

Detailed description: The study will consist of approximately 300 patients from 1 sites. Each site will have a study group, where the physician will use the electromagnetic tracking system along with "US" ultrasound or "CT" computed tomography to complete the procedure and a control group, where the electromagnetic tracking system will be used, but the physician will be blinded to it and use only the typical, standard, conventional protocol, using US or CT, to complete the procedure. The expected completion time for enrollment is 12 months, but will depend on the ability of each Clinic to enroll patients.

Data and observations will be collected at a total of 2 scheduled appointments (screening and 1 study visit) or based on the current hospital workflow, which may combine these into one patient encounter.

Eligibility criteria: Inclusion Criteria:

* Has had a pre-operative CT scan performed and will be undergoing a biopsy or ablation procedure of the chest, abdomen and/or pelvis;
* Is over the age of 18;
* Has the ability to understand and the willingness to sign a written informed consent form, and complies with the protocol;
* Has the ability to follow procedural instructions, including, but not limited to, holding their breath and remaining reasonably motionless during the procedure.

Exclusion Criteria:

* Was precluded from a biopsy/ablation procedure based on standard exclusions;
* Has an adhesive allergy (due to the application of active fiducials with adhesive backing);
* Has a pacemaker or automatic implantable cardiac defibrillator;
* Has a gross body weight above the procedural table limit (typically \> 170 kg);
* Is pregnant

Primary outcomes:
measure: Target Registration Error
timeFrame: Day 1
Secondary outcomes:
measure: Success of ablation as determined by imaging
timeFrame: 3 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT05612048: A Study of Tooth Erosion in People With Esophagogastric Cancer
Official title: Pilot Study of Dental Erosion as a Non-invasive Biomarker of Esophagogastric Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophagogastric Cancer
Keywords: Tooth erosion
GERD
Loss of tooth enamel
22-370
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will complete a questionnaire and undergo imaging by the intra-oral camera of their teeth.
Primary purpose: DIAGNOSTIC

Brief summary: The researchers are doing this study to find out more about what may lead to the loss of tooth enamel (the thin outer covering of the tooth) and how often it happens in people with esophagogastric cancer, colorectal cancer, pancreatic cancer, breast cancer, head and neck cancer, or non-small cell lung cancer, or a healthy volunteer.


Eligibility criteria: Inclusion Criteria:

* Subject is willing and able to provide written informed consent.
* Patients with a history of esophagogastric, HNSCC, PDAC, CRC, or NSCLC or healthy controls
* Patients must be able to fully comprehend and complete the survey and be willing to have pictures taken of their teeth with a camera or intra-oral camera.
* Patients must be able to understand English language or have access to adequate translation services.
* Age ≥ 18 years old.

Exclusion Criteria:

* Subjects without evaluable molars or with significant molar dental work precluding dentists from assessing enamel status, Note: evaluable is defined as having bilateral assessable mandibular molars, or erosions present in the remaining assessable quadrants.
* For healthy controls only, patients cannot have a non-skin cancer history nor presenting for a procedure evaluating reflux symptoms.

Primary outcomes:
measure: The incidence of dental erosions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Steven Maron, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04522648: Prospective Surveillance for Breast Cancer-Related Lymphedema
Official title: Prospective Surveillance for Breast Cancer-Related Lymphedema: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: lymphedema
Prospective surveillance
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Odense University Hospital
name: Zealand University Hospital
name: Herlev Hospital
First posted: 2020-08-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized trial will test the effect of a prospective surveillance program for early detection and subclinical management of breast cancer-related lymphedema on the prevalence of chronic lymphedema.

Detailed description: Design and setting: This trial is a multi-center single-blind trial involving five hospitals in Denmark.

Procedure: All women booked for surgery for breast cancer at one of the study sites will be invited to participate. Women, who provide written informed consent, will have BIS measurements, and perform self-measurements of arm circumference. Further, participants will complete a sociodemographic questionnaire which will be used to ensure recruitment of a representable sample. This data will be collected at the hospital of surgery at pre-treatment. After surgery, women who had \>6 lymph nodes removed and have planned radiation therapy will be randomized 1:1 into intervention or control.

Eligibility criteria: Inclusion Criteria:

* female;
* ≥18 years;
* surgery for breast cancer (unilateral and bilateral) including ALDN with \>6 lymph nodes removed;
* can effectively communicate verbally in Danish;

Exclusion Criteria:

* surgery for breast cancer with SLNB or \< 6 nodes removed;
* pre-existing lymphedema (primary or secondary);
* previous treatment for breast cancer;
* pace maker;
* conditions known to cause swelling (pregnancy, congestive heart failure, chronic/acute renal disease, cor pulmonale, nephrotic syndrome, nephrosis, liver failure or cirrhosis, pulmonary edema, and thrombophlebitis or deep vein thrombosis in the arms).

Primary outcomes:
measure: Prevalence of chronic lymphedema
timeFrame: At 24 months post-surgery
Secondary outcomes:
measure: Time-to-treatment
timeFrame: INT group: will be collected throughtout the study period. CON group: at 6, 12, 18 and 24 months post-surgery
measure: Health-related quality of life
timeFrame: pre-treatment, 6, 12, 18 and 24 months post-surgery
measure: Arm function
timeFrame: pre-treatment, 6, 12, 18 and 24 months post-surgery
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT03169348: The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia
Official title: The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Autoimmune thrombocytopenic purpura is an immunological disorder characterized by increased platelet destruction due to presence of anti-platelet antibodies. Hepatitis C virus infection, which is one of the most common chronic viral infections worldwide, may cause secondary chronic immune thrombocytopenic purpura. It seemed to play a pathogenic role in autoimmune thrombocytopenic purpura. Moreover, the successful response (negative hepatitis C virus - ribonucleic acid) to tapered steroids and antiviral therapy was useful to revert thrombocytopenia


Eligibility criteria: Inclusion Criteria:

* Hepatitis C virus infection and thrombocytopenia before treatment

Exclusion Criteria:

* Infection Hepatitis B virus
* Hypersplenism
* Diseases affecting Bone marrow
* Major clotting factors abnormalities eg. Disseminated intravascular coagulopathy, severe Prothrombin deficiency

Primary outcomes:
measure: the mean difference on the platelet count
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT05708248: Effect of Pentoxifylline on Anemia in Hemodialysis Patients
Official title: Effect of Pentoxifylline on Anemia in Hemodialysis Patients: Role of Hypoxia Inducible Factor-2 Alpha
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis Complication
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-02-01
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this clinical trial is to evaluate the promoting effect of pentoxifylline on anemia correction in hemodialysis patients, and involvement of the hypoxia-inducible factor-2 alpha. While, the secondary aim is to evaluate the effect of pentoxifylline on inflammation, hepcidin and other markers of iron homeostasis in these patients. Participants in this trial will be selected to be age and sex ratio matched and will be randomly assigned into two groups. Patients in group I will receive their regular doses of erythropoietin stimulating agents and other routine treatments plus 400 mg pentoxifylline tablets twice daily with meals for 6 months. While, patients in group II will receive their regular doses of erythropoietin stimulating agents and other routine treatments.


Eligibility criteria: Inclusion Criteria:

* Both sexes of HD patients
* Age \>20 years
* Patients who have adequate hemodialysis for at least 6 months
* Hb level ≤ 10.5 g/dl

Exclusion Criteria:

* Recently dialyzed patients (less than 6 months)
* Patients with known sensitivity to theophylline or other xanthine derivatives
* Severe iron deficiency with serum ferritin \< 100 µg/dL and/or TSAT \< 20%
* Planning for pregnancy, pregnancy, or lactation
* Patients with severe liver disease or other organ failure
* Previous renal transplantation, noncompliance with medication or HD prescription, or inability to oral drug administration
* Malignancy within last 3 months

Primary outcomes:
measure: Variation in Hemoglobin (Hb) levels
timeFrame: 6 months
measure: Variation in Hypoxia inducible factor-2 alpha (HIF-2α) levels
timeFrame: 6 months
measure: Variation in Transforming growth factor β1 (TGF-β1) levels
timeFrame: 6 months
measure: Variation in erythropoietin stimulating agents' (ESAs) doses
timeFrame: 6 months
measure: Variation in ESA resistance index (ESA Dose/kg/Week/Hb)
timeFrame: 6 months
Secondary outcomes:
measure: Variation in different inflammatory markers levels
timeFrame: 6 months
measure: Variation in hepcidin hormone levels
timeFrame: 6 months
measure: Variation in different parameters for iron status evaluation
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
Study officials:
References: