louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00370409: Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Late Postvitrectomy Diabetic Hemorrhage.
Keywords: Rebleeding
Diabetic vitreous hemorrhage
Cryotherapy
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-08-31
Enrollment: 112
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Late vitreous hemorrhage in postvitrectomized diabetic eyes may be due to fibrovascular tuft formation in sclerotomy sites. Cryotherapy of sclerotomy sites may prevent bleeding by regressing the fibrovascular tuft. This study will detect the safety and efficacy of cryotherapy of sclerotomy sites for prevention of late vitreous hemorrhage in vitrectomized diabetic eyes.


Eligibility criteria: Inclusion Criteria:

* Diabetic retinopathy cases undergoing vitrectomy

Exclusion Criteria:

* History of deep vitrectomy or cataract surgery
* Renal failure
* Silicone oil injection during surgery
* Early rebleeding
* History of antithrombotic drugs usage

Primary outcomes:
measure: Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes
timeFrame: 6 months
Secondary outcomes:
measure: Incidence of late vitreous hemorrhage in the cryo group.
timeFrame: 6 months
measure: Incidence of late vitreous hemorrhage in the control group.
timeFrame: 6 months
measure: Comparing incidence of late vitreous hemorrhage in both groups.
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Ophthalmic Research Center
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Morteza Entezari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05279209: Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma
Official title: Catheter-directed Sclerotherapy Versus Surgical Resecction: Randomized Controlled Trial Comparing Ovarian Function and Therapeutic Efficacy After Treatment of Ovarian Endometrioma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Endometrioma
Keywords: Endometrioma
resection
enucleation
sclerotherapy
ovarian function
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 98
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to compare residual ovarian function and therapeutic efficacy of surgical resection and catheter-directed sclerotherapy for ovarian endometrioma

Detailed description: Screening

* History, Physical examination
* Vital signs
* Laboratory test (Serum AMH, CA-125, HE-4) / EKG / MRI
* EHP-30

Intervention

* Surgical enucleation or catheter-directed sclerotherapy
* Laboratory test / EKG
* Adverse event monitoring

Follow-up visit #1 (1 month)

* Vital signs
* Lab test (AMH, CA-125) / Ultrasound
* Adverse event monitoring

Follow-up visit #2 (6 months)

* Vital signs
* Lab test (AMH, CA-125) / Ultrasound / Contrast-enhanced MRI
* EHP-30

Follow-up visit #3 (12months)

* Vital signs
* Lab test (AMH, CA-125) / Ultrasound
* EHP-30

Eligibility criteria: Inclusion Criteria:

1. Women with symptomatic fibroids (age: 20 - 60 years old)

Exclusion Criteria:

1. Gynecologic malignancy
2. Ongoing infection or inflammation
3. Coagulopathy (platelet \< 50,000 or INR \> 1.5)
4. Extraovarian endometriosis
5. Serum AMH of 5 or higher
6. Drug allergy
7. Illiteracy
8. Pregnancy

Primary outcomes:
measure: Serum AMH
timeFrame: Serum AMH at 1month after catheter-directed sclerotherapy
measure: Serum AMH
timeFrame: Serum AMH at 6months after catheter-directed sclerotherapy
measure: Serum AMH
timeFrame: Serum AMH at 12 months after catheter-directed sclerotherapy
Secondary outcomes:
measure: Recurrence
timeFrame: 1, 6, and 12 months
measure: hospital stay
timeFrame: duration of admission (days), up to 5 days
measure: serum CA-125
timeFrame: 1, 6, 12 months
measure: EHP-30 (Endometriosis Health Profile-30)
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References:
Clinical trial NCT03784209: Automatic Real-time Diagnosis of Gastric Mucosal Disease Using pCLE With Artificial Intelligence
Official title: Automatic Real-time Diagnosis of Gastric Mucosal Disease Using Probe-based Confocal Laser Endomicroscopy With Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Diseases
Artificial Intelligence
Confocal Laser Endomicroscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 951
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients who receive the upper gastrointestinal tract pCLE examination and screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study

Brief summary: Probe-based confocal laser endomicroscopy (pCLE) is an endoscopic technique that enables real-time histological evaluation of gastric mucosal disease during ongoing endoscopy examination. However this requires much experience, which limits the application of pCLE. The investigators designed a computer-aided diagnosis program using deep neural network to make diagnosis automatically in pCLE examination and contrast its performance with endoscopists.


Eligibility criteria: Inclusion Criteria:

* aged between 18 and 80;
* agree to give written informed consent.

Exclusion Criteria:

* Patients under conditions unsuitable for performing CLE including coagulopathy , impaired renal or hepatic function, pregnancy or breastfeeding, and known allergy to fluorescein sodium;
* Inability to provide informed consent

Primary outcomes:
measure: The diagnosis efficiency of Artificial Intelligence
timeFrame: 24 months
Secondary outcomes:
measure: Contrast the diagnosis efficiency of Artificial Intelligence with endoscopists
timeFrame: 24 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Endoscopic unit of Qilu Hospital Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanqing Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03572309: Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen
Official title: Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Hemorrhage
Coagulopathy
Keywords: trauma induced coagulopathy
multiple trauma
fibrinogen
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: Brno University Hospital
First posted: 2018-06-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult trauma patients with severe trauma admitted to emergency departement of university hospital who recieved fibrinogen during prehospital care.

Brief summary: The purpose of the study is to find out the incidence of trauma induced coagulopathy in patients with severe trauma who received fibrinogen prior admission to emergency department during prehospital care.

Detailed description: The study will commence following the Approval by The Ethics Research Committee. All patients admitted to emergency department during the study will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. After admission to emergency department the blood samples will be taken and blood tests and viscoelastic tests will be performed. All data and results will be entered in the study form. Statistical analysis will be performed and incidence of trauma induced coagulopathy estimated. In addition, 28-day mortality and the incidence of thromboembolic complications will be monitored.

Eligibility criteria: Inclusion Criteria:

* multiple trauma, injury severity score (ISS) ≥16
* administration of fibrinogen in prehospital care
* age 18-80 years

Exclusion Criteria:

* ISS 75
* pregnancy
* therapeutic anticoagulation
* therapeutic antiaggregation

Primary outcomes:
measure: Trauma induced coagulopathy
timeFrame: day of enrolment
Secondary outcomes:
measure: 28day mortality
timeFrame: 28 days after enrolment
measure: thromboembolic complications
timeFrame: 28 days after enrolment
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno and Masaryk University Brno
Study officials:
affiliation: Masaryk University
name: Roman Gal, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02614209: Blood Collection of Patient Presenting in the ED and Prescribed a BNP
Official title: A Blood Collection From Patients Presenting in the Emergency Department and Prescribed a Brain Natriuretic Peptide (BNP) Laboratory Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: ED
BNP
Lead sponsor: Fujirebio Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-25
Enrollment: 400
Sex: ALL
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 presenting to ED and prescribed a BNP with or without HF

Brief summary: Plasma specimen collected from patients presenting in the Emergency Department (ED) with or without Heart Failure (HF) and prescribed a BNP.

Detailed description: Plasma samples are collected from a minimum of 400 subjects. Specimens are used to confirm the currently accepted BNP cut off as and aid in the diagnosis and assessment of HF.

Stored specimens for future use in BNP assay development.

Eligibility criteria: Inclusion Criteria:

* Males and females \>21 years of age
* Able to understand and willing to provide informed consent
* Present in to ED
* BNP test requested

Exclusion Criteria:

* Males and females\< 21 years
* Unable to provide informed consent
* Not presenting to ED
* hemolyzed sample

Primary outcomes:
measure: Measure BNP
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Fujirebio Diagnostics, Inc.
name: Diana Dickson, RAC
role: STUDY_DIRECTOR
References:
Clinical trial NCT05223309: High Type Fistula in Ano, Use Staged Seton, Loose Thick Sutures
Official title: Loose Thick Seton Suture Stimulate Rapid Healing and Lower Recurrence Rate in the Treatment of High Type Fistula in Ano
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fistula in Ano
Keywords: High type
Seton
Loose thick sutures
Recurrance
Lead sponsor: Jabir Ibn Hayyan Medical University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Age distribution of patients showed that the highest rate of patients lies between the ages of 20-60 years adult population

Brief summary: Fistula in ano is a chronic problem for the patients. It causes distressing because of foul odor and soiling with recurrent infection and discharge. Recurrence and anal sphincter injury were the most critical complications following surgery. Loose, thick Seton placement was the most promising surgical operation. To reduce the time of Seton placement, therefore, decreasing the suffering of patients from soiling and multiple dressing.

Detailed description: Background: Fistula in ano is a chronic problem for the patients. It causes distressing because of foul odor and soiling with recurrent infection and discharge. Recurrence and anal sphincter injury were the most critical complications following surgery. Loose, thick Seton placement was the most promising surgical operation. To reduce the time of Seton placement, therefore, decreasing the suffering of patients from soiling and multiple dressing.

Patients and Methods: A retrospective study. One hundred patients with high type fistula in ano treated surgically in Al-Sader Medical city and Al-Najaf daily private clinic, Najaf city, Iraq from Feb 2018 to March 2019. Fistulography and magnetic resonance imaging have taken from all patients. After that, fistulectomy with loose, thick Seton suture placed for three months. Patients with the persistence of high fistula tract underwent a second surgery and third operation until complete healing.

Eligibility criteria: Inclusion Criteria:

* High type fistula in ano Recurrent high type fistula in ano Non abscess cases

Exclusion Criteria:

Low type fistula in ano below 16 years old

-

Primary outcomes:
measure: Rapid healing and less recurrent
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Najaf
country: Iraq
facility: Samer Al-Hakkak
state: An Najaf
Study officials:
affiliation: Jabir Ibn Hayyan Medical University
name: Samer Al-Hakkak, Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT03756909: Effect of Neutrophil Lymphocyte-platelet Lymphocyte Ratio on Complications in Pediatric Patients
Official title: The Effect of Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio on Intraoperative and Postoperative Complications in Pediatric Patients Undergoing Otolaryngology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Complication
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 127
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 2-10 years

Brief summary: The aim of this study was to investigate the relationship between NLR, PLR and postoperative complications in children undergoing adenotonsillectomy and adenoidectomy.

Detailed description: Between the dates of February 1, 2018 and June 30, 2018, patients between 2-10 years of age, ASA I-II, elective adenotonsillectomy and adenoidectomy under general anesthesia were planned to be included in the study. The number of neutrophils, lymphocytes and platelets will be taken from the hospital registry system taken preoperatively and the NLR and PLR ratios will be calculated.

All patients in the operating room will be started with routine monitoring and anesthesia. Hemodynamic data during surgery will be recorded. The entrance to the operating room (T1), 5 minutes after the start of anesthesia (T5), 15 minutes (T15), 30 minutes (T30) and 45 minutes (T45) will be recorded in the follow-up form of the anesthesia. The fasting period of the patients and the drugs and fluids applied during surgery will be recorded from the anesthesia form. At the end of the operation, the patients who were taken to the recovery room at the end of the surgery will be evaluated with 1 point, 15 minutes, 30 minutes, 1 hour and 4 hours and 6 hours vomiting using the 4 point nausea scale.

Introduction to recovery room using Modified Eastern Ontario Children's Hospital Pain Scale (mCHEOPS), postoperative pain at 15 min, 30 min, 1 hr and 4 hr. Analgesic requirement will be recorded. Bronchospasm, agitation, etc. will be recorded by evaluating whether there are complications.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective adenotonsillectomy and adenoidectomy under general anesthesia

Exclusion Criteria:

* Immunodeficiency
* Children of parents who do not want to participate in the study
* Use of anticoagulants
* Children with hematological disease

Primary outcomes:
measure: The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and adenoidectomy PAIN
timeFrame: Postoperative 6 hours
measure: The effect on postoperative complications of neutrophil lymphocyte ratio in adenotonsillectomy and/or adenoidectomy POVN
timeFrame: Postoperative 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University Training and Research Hospital
Study officials:
References:
Clinical trial NCT06226909: The Efficacy of Shear-wave Elastography-guided Biopsy for Diagnosis in Pleural Disease
Official title: The Efficacy of Shear-wave Elastography-guided Biopsy for Diagnosis in Pleural Disease: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pleural Diseases
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: To investigate the information from shear-wave elastography on pleural tissues will improve the diagnosis of pleural diseases, as to increase the diagnostic yield in ultrasound-guided transthoracic pleura biopsy.


Eligibility criteria: Inclusion Criteria:

* Patients with radiographic evidence of pleural disease

Exclusion Criteria:

* Age \< 18 y/o
* Patients who cannot hold their breath for 5 seconds

Primary outcomes:
measure: The diagnostic yield of the two groups
timeFrame: 6 months
Secondary outcomes:
measure: Procedure time
timeFrame: 1 day
measure: the rate of pneumothorax & hemothorax
timeFrame: 1 day
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yao-Wen Kuo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04707209: Sirolimus for Retinal Astrocytic Hamartoma
Official title: Intravitreal Injection of Sirolimus in the Treatment of Aggressive Retinal Astrocytic Hamartoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Astrocytic Hamartoma
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2021-01-13
Enrollment: 1
Sex: MALE
Minimum age (years): 15
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A single patient study using intravitreal Sirolimus to treat a patient with multiple retinal astrocytic hamartomas (RAH) of both eyes.

Detailed description: Retinal astrocytic hamartomas (RAH) are benign tumors of glial cells arising from astrocytes in the nerve-fiber layer of the retina. They are often associated with tuberous sclerosis complex (TSC) and, more rarely, neurofibromatosis type 1 (NF1). RAH may be caused by dysregulated tumor suppressors genes TSC1 or TSC2, which play a role in cell cycle regulation in retinal astrocytes via the PDGF-signalling pathway. Downregulation of TSC1 or TSC2 can result in hyperactivation of mTOR. Sirolimus is an inhibitor of mTOR, therefore inhibiting cell growth and proliferation of astrocytes. Systemic mTOR inhibitors (sirolimus and everolimus) have shown impressive reduction in the size of RAH in animal models and many human case series.

This single patient study is investigating the use of concurrent oral and intravitreal Sirolimus to treat a patient with multiple retinal astrocytic hamartomas (RAH) of both eyes to improve intraocular response and reduce duration of treatment. The patient has no other clinical features suggestive of neurofibromatosis and a presumed diagnosis of tuberous sclerosis is being considered, with only two hypopigmented skin lesions noted.

Eligibility criteria: Single case diagnosed with multiple retinal astrocytic hamartomas (RAH) of both eyes with imminent threat to vision.

Primary outcomes:
measure: Size of Retinal Astrocytic Hamartomas compared to baseline
timeFrame: 21 months
measure: Amount of retinal exudate compared to baseline
timeFrame: 21 months
measure: Retinal detachment progression/regression compared to baseline
timeFrame: 21 months
Secondary outcomes:
measure: Visual acuity compared to baseline
timeFrame: 21 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT02940509: Ketamine and Magnesium in Post-operative Pain Control in Patients Treated With Opioids
Official title: The Role of Ketamine and Magnesium in Post-operative Pain Control After Laparoscopic Surgery in Patients With Chronic Pelvic Pain Treated With Opioids: A Double-Blinded Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Pain
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this research proposal is to determine if the intraoperative administrative of Ketamine and Magnesium during laparoscopic gynecologic surgery improves postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain.

Detailed description: In this randomized control trial, patients' postoperative pain scores will be assessed as scored by the Numeric Rating Score (NRS) system. Intraoperative and postoperative narcotic usage, nausea scores and patients' perception of their quality of recovery via the QoR-40 survey will also be assessed.

The use of intraoperative Ketamine and Magnesium is predicted to decrease postoperative pain in patients on chronic opioid therapy for management of chronic pelvic pain and will overall improve patients' postoperative experience.

Eligibility criteria: Inclusion Criteria:

1. Subjects undergoing elective laparoscopic gynecologic surgery
2. Patients with chronic pelvic pain defined as pain that has persisted for more than 6 months in duration which is localized to the pelvis, anterior abdominal wall, lower back or buttocks and has leads to functional disability or medical care1
3. Patients requiring opioids daily for \>1 month
4. Consenting adults age 18-80
5. American Society of Anesthesiologists (ASA) Physical Status classification II to ASA III

Exclusion Criteria:

1. Patient refusal
2. Chronic Kidney disease (Creatinine\>2)
3. Patients treated with methadone
4. Known allergy or adverse effect of ketamine or magnesium
5. Patient unable to give informed consent
6. Patient with limited or no English fluency
7. Uncontrolled hypertension

Primary outcomes:
measure: Post-operative pain score using the Numeric Rating Scale (NRS)
timeFrame: 1st 24 hours post-op
Secondary outcomes:
measure: Post-operative opioid use
timeFrame: 24 hours post operative
measure: Recovery Questionnaire
timeFrame: 3-5 days post operative
measure: Intraoperative fentanyl use
timeFrame: Intraoperative
measure: Nausea Scores using PONV Impact Scale Score
timeFrame: 24 hours Post operative
measure: Length of Hospital Stay
timeFrame: 24 hours Post operative
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Stacey Duryea, DO
role: PRINCIPAL_INVESTIGATOR
References: