louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00846599: Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men
Official title: Postprandial Endothelial Dysfunction After a High-Fat Meal in HIV-infected Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Cardiovascular Risk
HIV Infections
Keywords: brachial artery ultrasound
brachial artery reactivity
HIV
human immunodeficiency virus
cardiovascular risk
omega three
saturated fat
sustiva
atripla
kaletra
treatment naive
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: HIV-infected white males who have identified themselves with concerns about diet or cardiovascular disease.

Brief summary: The purpose of this study is to examine the postprandial (anytime after a meal) effect of different dietary fats on endothelial function in HIV-infected and HIV-uninfected men.

Detailed description: This study requires two visits. Once determined eligible by the study criteria, during the first visit the participant will be randomly placed to receive one of two high-fat meals. The participant will receive the other study meal during the second visit. At each visit, brachial artery ultrasounds will be performed before and 3 hours after the meal is eaten. The sample size is 50 subjects. This study will be conducted at the Clinical Research Center at Tufts Medical Center.

Eligibility criteria: Inclusion Criteria:

* HIV-positive white male aged \>18 years
* Under one of the following treatment categories:

  * Treatment naive or have never taken any HIV medications
  * Taking Kaletra
  * Taking Sustiva
  * Taking Atripla

Exclusion Criteria:

* Smoker
* Pre-existing diagnosis or treatment for the following:

  * Lipid disorder
  * Cardiovascular disease
  * High blood pressure
  * Diabetes
* Acute opportunistic infection or malignancy within last 3 months or current therapy for either
* Active IV drug use

Primary outcomes:
measure: To measure flow-mediated dilation before and after eating the two study meals.
timeFrame: Study visit 1 and 2
Secondary outcomes:
measure: To compare the effect of different dietary fats on endothelial function.
timeFrame: Study visit 1 and 2
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts University School of Medicine
name: Alexandra Mangili, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03512899: Comparison Between Internal Jugular Vein Versus Axillary Vein for Implantable Ports
Official title: Internal Jugular Vein Versus Axillary Vein With Single-incision for Implantable Ports: a Prospective and Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Complications
Cancer
Keywords: implantable port
Lead sponsor: AC Camargo Cancer Center
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison between internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 6 months.
Primary purpose: TREATMENT

Brief summary: Comparison between internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 12 months.

Detailed description: Prospective and randomized trial comparing internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. Investigators are recruiting 240 patients and randomizing 120 for each arm in a single center study at AC Camargo Cancer Center. Every surgery is assisted by ultrasound and radioscopic and the catheter is districath®, 8.5 French. Clinical assessment will be at 10 days and every 3 months after surgery. Primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. The follow-up is 12 months.

Eligibility criteria: Inclusion Criteria:

* Catheter due to chemotherapy.
* Cancer patients.
* ECOG (performance status) from 0 to 2.
* Signed informed consent form.

Exclusion Criteria:

* Non compliance.
* Anticoagulant therapy.
* Coagulopathy (platelet count below 50,000 and/or protrombin time above 18s).
* Death within 30 days after the procedure.
* Another catheter in superior vena cava.
* Previous long term catheter in superior vena cava.
* Obesity (IBM\>40 Kg/m2).

Primary outcomes:
measure: Early complications.
timeFrame: 30 days
Secondary outcomes:
measure: Late complications
timeFrame: 30 to 180 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: AC Camargo Cancer Center
Study officials:
affiliation: Vascular and Endovascular Surgery Department
name: Bruno S Pignataro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01184599: A Prospective Study of the Kidney Protective Effect of Aliskiren in Hypertensive Patients With IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Glomerulonephritis, IGA
Hypertension
Keywords: Aliskiren
Albuminuria
Angiotensinogen
collagen type IV
Transforming Growth Factor beta
aldosterone
renin
prorenin receptor
des-angiotensin I renin substrate
oxidative stress
advanced glycosylation end-product receptor
N,N-dimethylarginine
Lead sponsor: Kagawa University
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin inhibitor, on renal function and progress of renal disease in hypertensive patients with IgA nephropathy.


Eligibility criteria: Inclusion Criteria:

* IgA nephropathy confirmed by renal biopsy
* Hypertension (\<= 125/75 mmHg)

Exclusion Criteria:

* Patients who have been treated with angiotensin type 1 receptor blocker or angiotensin-converting enzyme inhibitor within 4 weeks
* Severe hypertension (\<= 180/110 mmHg) or secondary hypertension
* Patients with history of allergy or adverse effect for aliskiren
* Renal dysfunction (estimated Glomerular Filtration Rate \< 60 mL/min/1.73m2)
* Pregnancy
* Patient treated with cyclosporine
* Hyperkalemia (serum potassium \>= 5.6 mmol/L)
* Autoimmune disease including systemic lupus erythematosus
* Patients inadequate for the study

Primary outcomes:
measure: Renal function (Creatinine clearance)
timeFrame: One year (every 6 months)
measure: Urinary protein
timeFrame: One year (every 6 months)
Secondary outcomes:
measure: Urinary angiotensinogen
timeFrame: One year (every 6 months)
measure: Urinary type 4 collagen
timeFrame: One year (every 6 months)
measure: Urinary Transforming growth factor-beta
timeFrame: One year (every 6 months)
measure: High-sensitivity C-reactive protein
timeFrame: One year (every 6 months)
measure: Plasma Rennin Activity
timeFrame: One year (every 12 months)
measure: Aldosterone
timeFrame: One year (every 12 months)
measure: Asymmetric dimethylarginine
timeFrame: One year (every 12 months)
measure: Advanced glycation end product
timeFrame: One year (every 12 months)
measure: (Pro)renin receptor
timeFrame: One year (every 12 months)
measure: Oxidative stress
timeFrame: One year (every 12 months)
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Kurume University, School of Medicine
city: Osaka
country: Japan
facility: Department of Internal Medicine, Osaka City General Hospital
city: Osaka
country: Japan
facility: Ohno memorial Hospital
city: Osaka
country: Japan
facility: Kinki University, Faculty of Medicine
Study officials:
affiliation: Osaka City General Hospital
name: Masahito Imanishi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06943599: Strategies for Improving Linkage-to-Care After Eye Disease Screening
Official title: Village Integrated Eye Worker II Linkage-to-Care Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Age Related Macular Degeneration
Diabetic Retinopathy
Glaucoma
Keywords: Eye Diseases
mass screening
patient compliance
retention in care
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Seva Foundation
name: National Eye Institute (NEI)
First posted: 2025-04-24
Enrollment: 3000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this randomized, parallel-group, controlled trial is to compare methods of enhancing linkage-to-care for participants in the Village Integrated Eye Worker II (VIEW II) trial who are referred to the eye hospital following eye disease screening. Participants who are referred to the hospital at an eye screening visit will be randomized to three different linkage-to-care interventions: (1) text message reminders, (2) reminders from community health workers, or (3) no intervention. The primary outcome of the trial will be whether or not the participant presented to the eye hospital for a referral visit by 21 days following screening.


Eligibility criteria: Inclusion Criteria:

- Participant of the VIEW II study referred to the eye hospital at their eye screening visit.

Exclusion Criteria:

* Residence in a community without reliable mobile connectivity

Primary outcomes:
measure: Referral Visit Attendance
timeFrame: 21 days after screening
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jeremy Keenan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06661499: An Observational Clinical Study on the Construction of an Artificial Neural Network Model for ICU Pneumonia
Official title: An Observational Clinical Study on the Construction of an Artificial Neural Network Model for Rapid Intelligent Diagnosis of Microorganisms in ICU Pneumonia Based on Species-specific Rapid Detection of Pathogenic Bacteria
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pneumonia
Keywords: pneumonia
colonization
infection
artificial neural network model
intensive care unit
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2024-10-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pneumonia patients who admitted to Nanjing Drum Tower Hospital from Jan 1,2025 to Dec 31,2027 and meet the inclusion criteria.

Brief summary: To achieve rapid, intelligent and accurate microbiological diagnosis and treatment for ICU pneumonia, an artificial neural network model for microbiological diagnosis is established, which depends on many clinical cases and machine deep learning from clinical experts' judgements according to species-specific rapid detection of pathogenic bacteria and other clinical parameter variables of patients.

Detailed description: This study is a prospective single-centre observational study, 600 ICU pneumonia patients are expected to be selected as the observation object, and the lower respiratory secretions of patients on d1, d3 and d7 after enrollment are collected for species-specific rapid detection and microbial culture, while the general information of the patients and the clinical information of the corresponding time points on d1, d3 and d7 are collected. Two experienced senior physicians were organized to determine whether the microbial results were colonized or infected, and an artificial neural network model for rapid and intelligent diagnosis of pathogenic microorganisms in ICU pneumonia will be established and validated through multi-dimensional machine learning.

Eligibility criteria: Inclusion Criteria:

1. aged ≥18 years;
2. agreed to obtain lower respiratory specimens for rapid testing of pathogenic bacteria;
3. all were enrolled by an experienced physician who dynamically determined that the microorganisms were in a colonised or infected state;
4. signed an informed consent form.

Exclusion Criteria:

1. pregnant women;
2. lactating women;
3. patients who could not obtain lower respiratory specimens;

Primary outcomes:
measure: clinical evaluation of each microbial detected whether in colonization or infection
timeFrame: day1,day3 and day7 after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Drum Tower Hosptial
name: Yan Wang, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05364099: Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
Official title: Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Shoulder Pain
Keywords: Overuse Shoulder Syndrome
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of using suprascapular nerve block for individuals with chronic spinal cord injury who have chronic shoulder pain.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 18-70 years of age, inclusive. 2 Neurological impairment secondary to SCI that occurred at least twelve (12) months prior to the Screening Visit; neurological level of injury between C6 and L5, inclusive.

3. Non-ambulatory, except for exercise or therapy purposes. 4. Uses a manual wheelchair. 5 History of chronic shoulder pain for ≥6 months that has been unresponsive to conservative treatment (e.g. physical therapy, pharmacological agents), and is rated as ≥4 out of 10 on an 11-point Numeric Rating Scale (NRS) (0 = "no pain"; 10 = "most intense pain imaginable") for average shoulder pain intensity during the week leading up to the Screening Visit.

6. Able and willing to comply with the protocol. 7. Able to give voluntary informed consent prior to the performance of any study-specific procedures.

Exclusion Criteria:

1. Contra-indications to the procedure (e.g. infection, coagulopathy)
2. History of active cancer within 5 years
3. Adhesive capsulitis
4. Prior history of regenerative medicine intervention
5. Glucocorticoid injection within the past four weeks
6. Any medical condition, including psychiatric illness, which would interfere with the interpretation of the study results or the conduct of the study

Primary outcomes:
measure: Number of participants at each Global Satisfaction Rating (GSR)
timeFrame: 1 month post procedure
measure: Number of participants reporting treatment related adverse events
timeFrame: Up to 12 months
Secondary outcomes:
measure: Number of participants at each Global Satisfaction Rating
timeFrame: Up to 12 months post procedure
measure: Change in NRS scores
timeFrame: Baseline, 12 months
measure: Change in DASH Questionnaire scores
timeFrame: Baseline, 12 months
measure: Change in BPI-I scores
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Timothy Tiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01080599: Comparison of the Success Rate of Two Approaches for Obturator Nerve Block in TURB (Conventional Pubic Approach [Labat Technique] and Inguinal Approach)
Official title: Comparison of the Success Rate of Two Approaches for Obturator Nerve Block in TURB (Conventional Pubic Approach [Labat Technique] and Inguinal Approach)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Keywords: obturator nerve block in TURB
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the success rate of two approaches for obturator nerve block in TURB (conventional pubic approach \[Labat technique\] and inguinal approach.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergoing transurethral resection of bladder tumor during combined spinal anesthesia and obturator nerve block were included in the clinical study

Exclusion Criteria:

* Patients with advanced cardiac and respiratory insufficiency
* Allergy to local anesthetics
* Preexisting neurologic deficits
* Prior operation involving the hip and the inguinal region and bleeding tendency were excluded.

Primary outcomes:
measure: Assessment of obturator sign during using nerve stimulator and operation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01986699: Laparascopic Assisted Colonoscopic Polypectomy
Official title: Randomized Controlled Trial-Laparoscopic Assisted Colonoscopic Polypectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Polyps
Keywords: polypectomy
laparoscopic
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: GI clinic

Brief summary: Study Objective: To compare the hospital costs between the standard surgical procedure and the Laparascopic Assisted Colonoscopic Polypectomy (LACP) technique for patients with advanced polyps in the colon.

Detailed description: All patients being referred for possible LACP to the Division of Colorectal Surgery at Stony Brook University Medical Center will be randomized in a 1:1 fashion using a computer generated system to undergo either partial colectomy (performed by means of laparoscopy when possible), or LACP for the treatment of advanced polyp(s). Our research assistant will be present in the operating room to record the data.Patients will then undergo standard clinical management while hospitalized at Stony Brook according to the procedure performed.

Eligibility criteria: Inclusion Criteria:

* Polyp spanning 2 or more colonic folds
* Polyp \> 20mm
* Polyp spanning greater than 50% of the colonic circumference
* Positive "lift sign" following submucosal injection of saline beneath the polyp
* Difficult location or position of the polyp, thus preventing assurance of complete endoscopic resection.

Exclusion Criteria:

* Polyps with histological evidence of adenocarcinoma
* Polyps in the rectum (\<15cm from anal verge)
* Patients with known inflammatory bowel disease (IBD).
* Patients with known familiar adenomatous polyposis (FAP) syndrome
* Polyps without known histology (i.e. not previously biopsied)
* Polyps with large ulcerations, or those that demonstrate a "non-lift sign" during submucosal injection at the time of colonoscopy; as these are indicators of adenocarcinoma .
* Severe cardio-pulmonary disease, or irreversible coagulopathy, preventing abdominal surgery at an acceptable risk.
* POSSUM predicted mortality score greater than 2%
* Inability to obtain informed consent
* Patients under the age of 18
* Pregnant patients

Primary outcomes:
measure: hospital cost
timeFrame: 1-3 days
Secondary outcomes:
measure: complication rates
timeFrame: 1-3 days
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
Study officials:
affiliation: Stonybrook University
name: Roberto C Bergamaschi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04285099: Frequency Effect of STN-DBS Through the Dual System on FOG in PD
Official title: Frequency Effect of Subthalamic Nucleus Deep Brain Stimulation Through the Dual System on Freezing of Gait in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease, Freezing of Gait, Deep Brain Stimulation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We aim to confirm the effect for FOG by changing the frequency through the dual-system approach in PD patients after STN-DBS.

Detailed description: The investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. After four weeks, the investigators will check the UPDRS part I, II, IV, FOG-Q, and PDQ-39 values at each frequency, including the proportion of use of two frequencies.

Eligibility criteria: Inclusion Criteria:

* patients with PD who are aged 30 years or older
* patients with bilateral STN-DBS
* patients who have a FOG at their med "off" state in outpatient clinic or hospitalization, or UPDRS part II FOG subscore above 1

Exclusion Criteria:

* patients without FOG
* patients who have undergone DBS
* patients who have had previous brain surgery
* patients who have undergone reoperation of DBS
* patients who underwent unilateral DBS
* patients with cognitive impairment (MMSE \<18)

Primary outcomes:
measure: Stimulation frequency ratio in 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part I score in 130 and 60Hz at the fourth week
timeFrame: 4 weeks
measure: Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part II score in 130 and 60Hz at the fourth week
timeFrame: 4 weeks
measure: Comparison of Movement Disorder Society Unified Parkinson's Disease Rating Scale Part IV score in 130 and 60Hz at the fourth week
timeFrame: 4 weeks
measure: Comparison of Freezing of Gait Questionnaire score in 130 and 60Hz at the fourth week
timeFrame: 4 weeks
measure: Comparison of Parkinson's Disease Questionnaire-39 score in 130 and 60Hz at the fourth week
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Beom S Jeon
Study officials:
References: