louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00815191: Comparison of Vital HEAT (vH2) Temperature Management System to Upper-body Forced-air Warming
Official title: A Comparison Study of the Vital HEAT (vH2) Temperature Management System to Upper-body Forced-air Warming in Patients Undergoing Open Abdominal Surgery Under General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: temperature
surgery
heating device
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-12-29
Enrollment: 73
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: SUPPORTIVE_CARE

Brief summary: The primary objective of this study is to determine if the intraoperative distal esophageal (core) temperature with vitalHEAT warming is non-inferior to upper-body forced-air warming in patients undergoing open colectomy under general anesthesia. This is a randomized study.

Detailed description: Participants will be randomized into one of two groups. Patients assigned to vitalHEAT warming will have the circulating-water sleeve applied to an arm that will not require intravenous access. An esophageal temperature probe will be inserted and connected to the anesthesia machine monitoring system. Intravenous fluids will be warmed to 40-42°C.

As soon as practical after induction, the vitalHEAT warmer will be activated in the appropriate patients and set to "high" which is 42°C

An upper-body forced-air warmer will be positioned over the upper body and exposed arms on patients assigned to forced-air heating. The forced air blower will be set to "high" which is 43°C and activated as soon as practical, usually after prepping and draping.

Patients in both groups will be otherwise draped per surgical routine. Ambient temperature will be maintained near 20°C. Active warming will be maintained until just before extubation. The esophageal temperature probe will be removed, and the patient extubated after emergence from anesthesia. This will conclude the study and subsequent management will be at the discretion of the attending anesthesiologist

Eligibility criteria: Inclusion Criteria:

* Body-mass index 20-36 kg/m2;
* Age 18-75 yrs;
* ASA Physical Status 1-3.

Exclusion Criteria:

* Patient requires an intravenous or arterial catheter distal to the elbow on both arms;
* Serious skin lesions on the hands or arms;
* History of serious vascular disease in the arms;
* Pre-operative fever;
* Contraindication to sevoflurane endotracheal anesthesia.
* Pre-existing neuropathy

Primary outcomes:
measure: Intraoperative Distal Esophageal (Core) Temperature
timeFrame: at 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT01203891: Single Photon Emission Computed Tomography of the Normal Human Brain
Official title: Single Photon Emission Computed Tomography of the Normal Human Brain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Human Subjects
Keywords: SPECT
Imaging
Healthy brain
regional cerebral blood flow
Lead sponsor: Amen Clinics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 97
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study seeks to recruit 100 subjects between ages 10 and 90 for SPECT brain imaging.

Brief summary: The objective of the study is to acquire a database of Single Photon Emission Computed Tomographic (SPECT) studies of the brains of normal human subjects in resting and concentrating states. The database will provide a basis for subsequent investigation of meaningful brain differences between clinical and normal subject groups

Detailed description: See brief summary.

Eligibility criteria: Inclusion Criteria:

The study seeks to recruit 100 normal human subjects between ages 10 and 90 for SPECT brain imaging. Subjects will initially be screened for psychiatric and other major illnesses with a screening questionnaire; they will also be given a standard DSM-4 computer-administered questionnaire (The DISC for children and teens and the SCID for adults). They will also meet individually with a psychiatrist or psychological assistant for a screening interview.

Exclusion Criteria:

1. Suicidal thinking or behavior
2. Any psychiatric diagnosis assignable under contemporary DSM nosology
3. Unstable medical condition
4. epilepsy, serious head injury, or other significant neurological disorder or use of central nervous system medication.
5. Dementia, mental retardation, or coma
6. Substance abuse or alcoholism
7. Unreliability or inability to adhere to the requirements of the study
8. Inability to personally tolerate the requirements of the study
9. Significant exposure to occupational, diagnostic, or therapeutic radiation within the prior year
10. Pregnancy or breast-feeding
11. A first-degree relative meeting any of criteria 1 through 6.

Primary outcomes:
measure: Baseline SPECT image
timeFrame: 24 hour assessment and data may be presented up to 10 years later as part of a normative database
Secondary outcomes:
measure: Concentration SPECT image
timeFrame: 24 hour assessment and data may be presented up to 10 years later as part of a normative database
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Amen Clinics, Inc.
state: California
Study officials:
affiliation: Amen Clinics, Inc.
name: Daniel G Amen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05916391: Gene Therapy for Diabetic Macular Edema
Official title: An Open-label, Multy-center, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of FT-003 in Subjects With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Diabetic Macular Edema
Lead sponsor: Frontera Therapeutics
Sponsor class: INDUSTRY
Collaborators: name: Tianjin Medical University Eye Hospital
name: Peking Union Medical College Hospital
name: The First Affiliated Hospital of Zhengzhou University
First posted: 2023-06-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Central Involvement Diabetic Macular Edema
Primary purpose: TREATMENT

Brief summary: FT-003 is a gene therapy product developed for the treatment of central involvement diabetic macular edema (CI-DME). Diabetic retinopathy is one of the most common microvascular complications of diabetes mellitus, and diabetic macular edema is the main cause of vision loss in patients with diabetic retinopathy. In the latest guidelines, anti-VEGF therapy is preferred for CI-DME. Administration of FT-003 has the potential to treat CI-DME by providing intraocular protein which is durable expressed in therapeutic level. FT-003 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with CI-DME receiving anti-VEGF therapy in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Subjects that are willing and able to follow study procedures;
* Female or male patients ≥18 years old at the time of signing the ICF;
* Clinically diagnosed with CI-DME
* HbA1c≤10%
* The best corrected visual acuity (BCVA) of the studied eye is ≤ 73 letters

Exclusion Criteria:

* Presence of any other intraocular diseases other than CI-DME in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator

Primary outcomes:
measure: Safety and tolerability after FT-003 injection
timeFrame: Whthin 52 weeks after administration
Secondary outcomes:
measure: Preliminary effectiveness after FT-003 injection
timeFrame: Whthin 52 weeks after administration
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin,China
Study officials:
affiliation: Tianjin Medical University Eye Hospital
name: Xiaorong Li, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Hanyi Min, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Guangming Wan, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01521091: Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions
Official title: Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions Using Magnifying Colonoscopy With Narrow Band Imaging, Indigo Carmine, and Acetic Acid Staining
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: narrow band imaging（NBI）
indigo carmine
acetic acid
colorectal lesions
predicting histology
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 565
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive adult patients undergoing colonoscopy and find out more than one lesion ≧ 6mm from Jan 2009 to Dec 2010.

Brief summary: Chromoendoscopy (indigo carmine or acetic acid) and Narrow Band Imaging (NBI) could make accurate evaluation in predicting of invasive depth of colorectal neoplasia. NBI could be the first choice.

Detailed description: To compare the diagnostic accuracy of chromoendoscopy indigo carmine or acetic acid and NBI for differentiating neoplastic from non-neoplastic colorectal lesions, differentiating adenomas from carcinomas, and differentiating early carcinomas from invasive ones.

Included colorectal lesions consecutively distribute in a 1:1 ratio to 2 groups.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients with more than one lesion ≧ 6mm .

Exclusion Criteria:

* Patients with chronic inflammatory bowel disease, advanced cancer, insufficient bowel preparation, familial adenomatous polyposis (FAP)
* Lesions ≦ 5mm and submucosal tumor (SMT).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai, China
name: Xiaobo Li, MD. Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01016691: Safety and Efficacy of a Drug Delivery System in Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma
Ocular Hypertension
Lead sponsor: Vistakon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-11-19
Enrollment: 47
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: Evaluation of the ocular safety and efficacy of a drug delivery system in open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Man or woman 21 years of age or greater
* Open angle glaucoma or ocular hypertension
* Corrected visual acuity in each eye of 20/200 or better

Exclusion Criteria:

* Previous glaucoma intraocular surgery or refractive surgery
* Planned contact lens use during the study
* Clinically significant ocular or systemic disease that might interfere with the study
* Use of chronic corticosteroids by any route

Primary outcomes:
measure: Mean Change in Intraocular Pressure at Day 1
timeFrame: Baseline to Day 1
Secondary outcomes:
measure: Mean Change in Intraocular Pressure at Day 2
timeFrame: Baseline to Day 2
measure: Mean Change in Intraocular Pressure at Day 3
timeFrame: Baseline to Day 3
measure: Mean Change in Intraocular Pressure at Day 4
timeFrame: Baseline to Day 4
measure: Mean Change in Intraocular Pressure at Day 5
timeFrame: Day 4 to Day 5
Other outcomes:
Locations:
city: Miami
country: United States
state: Florida
city: Philadelphia
country: United States
state: Pennsylvania
city: Mount Pleasant
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Maryville
country: United States
state: Tennessee
Study officials:
References:
Clinical trial NCT00237991: Safety of GlaxoSmithKline (GSK) Biologicals Hepatitis A Vaccine in Korean Population
Official title: A Multicentric, Post-Marketing Surveillance to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals Hepatitis A Vaccine Administered in Korean Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis A
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-10-13
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: GlaxoSmithKline Korea has submitted a registration file for its hepatitis A vaccine. The present study will collect clinical data in the local target population as per the requirement of Korean Food and Drugs administration (FDA).

Detailed description: All subjects will be administered one dose of the hepatitis A vaccine.

Eligibility criteria: Inclusion criteria

* Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g. be reachable over the phone) should be enrolled in the study.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.
* Written informed consent is obtained from the subject/ subjects' parents or guardians.

Exclusion criteria

* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., Oral temperature \< 37.5°C (99.5°F) / Axillary temperature \< 37.5°C (99.5°F) / Rectal temperature \< 38°C (100.4°F) / Tympanic temperature on oral setting \< 37.5°C (99.5°F) / Tympanic temperature on rectal setting \< 38°C (100.4°F).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04925791: Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy
Official title: Does Limb Pre-Conditioning Reduce Pain After Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Injuries
Hip Dislocation
Hip Fractures
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if the utilization of Ischemic Pre-Conditioning 24-hours prior to hip arthroscopy decreases patient's post-operative pain and opioid consumption.

Detailed description: Subjects will be asked to take part in one of two treatment procedures 24 hours prior to their scheduled hip arthroscopy date. Subjects will be randomized into either the IPC or CON group.

These treatments consist of either 3 rounds of 5 minutes of occlusion alternating with 5 minutes of reperfusion or 3 rounds of 5 minutes of minimal occlusion alternating with 5 minutes of reperfusion. The treatment will last 30 minutes. Days 0-7 post-op will consist of self-reported pain scales and opioid consumption documentation in the morning and evening. This is a randomized single-blind research study.

This study has two study groups:

* The IPC group will get a standardized pre-conditioning treatment 24 hours prior to their hip arthroscopy. This consists of 3 rounds of 5 minutes of occlusion alternating with 5 minutes of reperfusion while seated.
* The CON group will get a controlled treatment of 20% of limb occlusion pressure 24 hours prior to their hip arthroscopy. This consists of 3 rounds of 5 minutes of minimal occlusion alternating with 5 minutes of reperfusion while seated.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a primary hip arthroscopy by the PI between the ages of 18 and 55.

Exclusion Criteria:

* Patients younger than 18 or older than 55 who have had a previous hip arthroscopy, venous thromboembolism, and/or who take medications and/or supplements known to increase the risk of blood clots.

Primary outcomes:
measure: Pain levels VAS score
timeFrame: 7 days post op
Secondary outcomes:
measure: number of days opioids were consumed post op
timeFrame: 7 days post op
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kerlan Jobe
state: California
Study officials:
affiliation: Cedar Sinai -Kerlan Jobe
name: Michael Banffy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06593691: Examining the Effectiveness of Multiwave Locked System Laser Treatment in Chronic Low Back Pain
Official title: Examining the Effectiveness of Multiwave Locked System Laser Treatment in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients who come to Tavşanlı Assoc. Prof. Dr. Mustafa Kalemli State Hospital, Physical Therapy, and Rehabilitation Department who have been diagnosed with Chronic Low Back Pain by a physician will be included. Patients will be divided into two groups by the physician: conservative treatment and patients whose treatment program is determined as multi-wave locked system laser treatment in addition to conservative treatment. Pain intensity will be measured with a numerical pain rating scale. The Roland-Morris disability questionnaire will be used to evaluate the functionality of the participants, and the esthesiometer will be used to assess tactile acuity. Pressure pain threshold will be evaluated with the MicroFET 2 device. The Turkish Form of the SF-12 Quality of Life Scale will be used to assess the participants' quality of life. Pittsburgh's sleep quality index will be used to evaluate sleep quality. Patient satisfaction will be evaluated with a numerical rating scale.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65
* Volunteering to participate in the study
* Having low back pain that has persisted for at least 3 months

Exclusion Criteria:

* History of surgery in the waist area
* Discopathy at a different level of the spine (Modic Type 3)
* Presence of tumor in the spine
* Infection in the discs
* Having an inflammatory disease
* Presence of neurological involvement
* Fracture
* Spondylosis
* Spinal Stenosis
* Spondylolisthesis
* Radiculopathy
* Having received treatment for low back pain in the last 3 months

Primary outcomes:
measure: pain intensity
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Functionality
timeFrame: Through study completion, an average of 1 year
measure: Tactile Acuity
timeFrame: Through study completion, an average of 1 year
measure: Pressure Pain Thereshold
timeFrame: Through study completion, an average of 1 year
measure: Assessment of Quality of life
timeFrame: Through study completion, an average of 1 year
measure: Sleep Quality
timeFrame: Through study completion, an average of 1 year
measure: Patient Satisfaction
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Meltem Işıntaş
role: STUDY_DIRECTOR
References:
Clinical trial NCT06337591: Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location
Official title: Diagnostic Performance of the Vesical Imaging-Reporting and Data System (VI-RADS) in Detecting Muscle-invasive Bladder Tumour (MIBC) in Clinical Practice: Comparison With Transurethral Resection of Bladder Cancer (TURB) and Evaluation of Diagnostic Accuracy According to Tumour Location
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: bladder cancer
TURB
VI-RADS
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected primary bladder cancer

Brief summary: VI-RADS was an observational, prospective, multicenter, no profit study. The aim of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.

Detailed description: The VI-RADS (bladder imaging-reporting and data system) scoring system is an imaging tool that can help distinguish non-muscle-invasive from muscle-invasive disease prior to transurethral resection (TURB). The VI-RADS consists of a five-point scoring system based on the assessment of tumour size, morphology, growth, degree of restriction and contrast capture to assess the likelihood of bladder wall invasion. VI-RADS was an observational, prospective, multicenter, no profit study. The aims of the study was to clarify the clinical validity of the Vesical Imaging-Reporting and Data System (VI-RADS) for the assessment of muscle invasion (MI) status in comparison with transurethral resection of bladder cancer (TURB) and to evaluate the diagnostic accuracy of the score according to the specific tumour location.

Eligibility criteria: Inclusion Criteria:

* patients with suspected primary bladder cancer at cystoscopy

Exclusion Criteria:

* Impaired renal function
* claustrophobia
* allergy to paramagnetic contrast agent

Primary outcomes:
measure: Sensitivity of Vescical Imaging-Reporting and Data System (VI-RADS) in predicting muscle-invasive bladder cancer after transurethral resection
timeFrame: up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: AOU Hospital
city: Ancona
country: Italy
facility: IRCCS INRCA Hospital
city: Jesi
country: Italy
facility: Carlo Urbani Hospital
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Sara Cecchini, MD
role: PRINCIPAL_INVESTIGATOR
References: