louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02855606: Acceptability of HIV Oral PrEP Among MSM and TGW
Official title: Acceptability of HIV Oral Pre-Exposure Prophylaxis (PrEP) Among Men Have Sex With Men (MSM) and Transgender Women (TGW)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Acceptance of Health Care
Keywords: Oral PrEP
TGW
Thai MSM
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 105
Sex: MALE
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: Thai MSM and TGW

Brief summary: The purpose of this study is to determine the factors associated with acceptability to oral HIV pre-exposure prophylaxis (PrEP) among Thai men who have sex with men (MSM) and transgender women (TGW).


Eligibility criteria: Inclusion Criteria:

* MSM or TGW at age18 years or older at enrollment
* Able to read and write effectively in Thai language
* Negative HIV testing (by assigned rapid tests) at enrollment
* Available to return for the study visits and willing to comply with study requirements
* Willing to provide reachable contact numbers and address
* Creatinine clearance ≥ 60 mL/min
* Negative urine protein
* Negative HBs Ag

Exclusion Criteria:

* Symptoms suggestive for acute HIV seroconversion
* Participating in any interventional HIV research
* Has any physical or mental condition(s) that, in the opinion of the investigator(s), complicate interpretation of study outcome data

Primary outcomes:
measure: Acceptability and factors affecting the decision to take oral PrEP
timeFrame: 1 year
Secondary outcomes:
measure: Adherence to PrEP by self-report
timeFrame: 1 year
measure: Adherence to PrEP by pill count
timeFrame: 1 year
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Piman Center
Study officials:
affiliation: Research Institute for Health Sciences (RIHES)
name: Suwat Chariyalertsak, MD. DrPH.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01148706: Effectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures
Official title: Phase IV Study of the ActiSight Needle Guidance System Which Assist in Guiding a Rigid Interventional Instrument Percutaneously, to a Designated Point Within the Body by Means of CT Visualization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Diseases
Liver Diseases
Keywords: thorax
abdomen
Lead sponsor: ActiViews Ltd.
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of CT visualization.

Detailed description: The ActiSight™ Needle Guidance System is an optical navigation system designed to assist physicians performing percutaneous interventions under CT guidance. The system allows the user to select an obstacle free path to a target lesion based on pre-procedure CT images, and then provides real-time information for guiding the interventional tool towards the target along the selected path.

The ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the CT image space, and thus, track the needle advance towards the target. CT scans are used as needed to verify the location of the needle.

The primary objective of this study is to demonstrate the effectiveness of the ActiSight™ Needle Guidance System in assisting in CT-guided percutaneous procedures.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects, 18 years of age or older at the time of enrollment.
* Subjects meeting all medical conditions for percutaneous CT guided. procedures in the chest, abdomen or pelvic, with safe path to lesion.
* Written informed consent to participate in the study.
* Ability to comply with the requirements of the study procedures.

Exclusion Criteria:

* Having co-morbidities that would clinically preclude them from an image guided procedure as determined by the operating physician.
* Significant coagulopathy that cannot be adequately corrected.
* Patients who have a medical contraindication to sedation (Lidocaine allergy).
* Pregnancy or lactation.
* Participation in an investigational trial within 30 days of enrollment.

Primary outcomes:
measure: Number of CT scans performed during the procedure, from needle insertion to final needle position in the target lesion
timeFrame: 1 Hour- During the procedure
Secondary outcomes:
measure: Procedure time (needle dwell time in the body)
timeFrame: 1 hour -duration of the procedure
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel MC
name: Natan Peled, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03431506: Vestibular Function and Vestibular Rehabilitation in SSHL With Vertigo
Official title: Vestibular Function and Vestibular Rehabilitation in Sudden Sensorneural Hearing Loss With Vertigo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vestibular Disorder
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural hearing loss(SSHL) with vertigo

Detailed description: Approximately 5-20 per 100,000 persons are afflicted with SSHL annually, and nearly 20-60% of SSHL patients complain of simultaneous vertigo.The aim of this study was to evaluate the prevalence of vestibulocochlear lesions in sudden sensorneural hearing loss(SSHL) with vertigo, as well as the role of vestibular rehabilitation in the prognosis of SSHL with vertigo.

Eligibility criteria: Inclusion Criteria:

1. A rapid onset sensorineural hearing loss of more than 30 dB for at least three contiguous audiometric frequencies within a period of 3 days, according to standard AAO - HNS;
2. Within 10 days from onset;
3. Without other virus infectious disease within three months.

Exclusion Criteria:

1. BPPV; Meniere's disease and vestibular migraine.
2. With certain Known etiology, including acoustic neuroma, heart cerebrovascular accident, injury, Hunt syndrome, etc

Primary outcomes:
measure: Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 1(before treatment)
timeFrame: before treatment
Secondary outcomes:
measure: Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 weeks after treatment)
timeFrame: 2 weeks after treatment
measure: Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 months after treatment)
timeFrame: 2 months after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
state: Shanghai
Study officials:
References:
Clinical trial NCT00576706: PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity
Official title: A Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Osteoarthritis
Ankylosing Spondylitis
Keywords: Patients with rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis or any other arthritis-like disease requiring continuous NSAIDs therapy
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2007-12-19
Enrollment: 396
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.


Eligibility criteria: Inclusion Criteria:

1. Signed written informed consent after being informed of the clinical trial
2. Males or females 19 years of age
3. Intake of any brand of NSAIDs in more than half of daily dose for at least the previous 4 weeks.

Exclusion Criteria:

1. Necessary to proceed in concomitant treatment with epileptic medications, anti-chollinergics, prokinetics, sucralfate
2. Presence or history of allergic drug reaction to the following medications; rebamipide, Misoprostol, NSAIDs designated to the protocol

Primary outcomes:
measure: Incidence rate of gastric ulcer on gastroendoscopy result at 12-week
timeFrame: 12 weeks
Secondary outcomes:
measure: Rate of Therapeutic failure
timeFrame: 12 weeks
measure: Severity of gastrointestinal symptoms
timeFrame: 12 weeks
measure: Antacid consumption
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
city: Chonju
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Jinju
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Suwon
country: Korea, Republic of
Study officials:
affiliation: Catholic University Hospital
name: Soo-Heon Park, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04029506: Medical Staff: Higher Risk for Gastrointestinal Polypoid Lesions
Official title: Medical Staffs Have Higher Risk for Gastrointestinal Polypoid Lesions: A Propensity Score-based Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: the Incidence of Gastrointestinal Diseases Diagnosed by Endoscopy in Physicians and General Population
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 878
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent gastroscopy and colonoscopy for physical examination in Qilu Hospital of Shandong University, China, from January 2017 to September 2018, were retrospectively reviewed. Subjects who had a history of gastrointestinal surgery or subjects who did not finish the endoscopic examination were excluded. All selected subjects were age- and sex- matched to form two groups: Group 1, medical staff from Qilu Hospital, and Group 2, general population.

Brief summary: This is a single center, retrospective, propensity score-matched analyzed study. Patients who underwent gastroscopy and colonoscopy for physical examination in Qilu Hospital of Shandong University, China, from January 2017 to September 2018, were retrospectively reviewed to compare the incidence of gastrointestinal diseases diagnosed by endoscopy between physicians and general population.

Detailed description: This is a single center, retrospective, propensity score-matched analyzed study. Patients who underwent gastroscopy and colonoscopy for physical examination in Qilu Hospital of Shandong University, China, from January 2017 to September 2018, were retrospectively reviewed.To compare the incidence of gastrointestinal diseases diagnosed by endoscopy between physicians and general population.

Eligibility criteria: Inclusion Criteria:

- Patients who underwent gastroscopy and colonoscopy for physical examination in Qilu Hospital from January 2017 to September 2018

Exclusion Criteria:

- Subjects who had a history of gastrointestinal surgery or subjects who did not finish the endoscopic examination were excluded

Primary outcomes:
measure: the incidence of gastrointestinal diseases diagnosed by endoscopy between physicians and general population.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References:
Clinical trial NCT03791606: Risk Factors,PREvention and OutComes for CI-AKI in PatientS undErgoing PCI at Intensive Care Unit(PRECISE-ICU)
Official title: Risk Factors,PREvention and outComes for Contrast-Induced Acute Kidney Injury in patientS undErgoing Percutaneous Coronary Intervention at Intensive Care Unit：a Single-center Cohort Study(PRECISE-ICU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CIN
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 755
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Critically ill patients undergoing PCI at ICU were enrolled

Brief summary: A retrospective, observational study included all consecutively critically ill patients undergoing percutaneous coronary intervention(PCI) at intensive care unit (ICU) in Fujian Provincial Hospital from January 1st 2012 to December 31st 2018. The aim was to determine the incidence,risk factors,prophylactic strategy and outcomes of CI-AKI in critically ill patients undergoing PCI.


Eligibility criteria: Inclusion Criteria:

* Critically ill patients undergoing PCI at ICU

Exclusion Criteria:

* pregnancy
* lactation
* end-stage renal disease (eGFR \<15 mL/min/1.73 m2)
* long-term dialysis treatment
* intravascular administration of contrast medium within the last 7 or 3 days postoperatively

Primary outcomes:
measure: CI-AKI
timeFrame: 1 year
Secondary outcomes:
measure: in-hospital adverse events
timeFrame: 1 year
Other outcomes:
measure: MACEs for long-term follow up
timeFrame: 1 year
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial
state: Fujian
Study officials:
References:
Clinical trial NCT00631306: Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease
Official title: Effects of Cranberry Juice on Risk Factors for Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Ocean Spray, Inc.
First posted: 2008-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mayo Clinic Patients

Brief summary: This study is being done to determine if the use of double strength cranberry juice in daily diet will improve endothelial function.

Detailed description: Study participants will be randomized assigned to drink either placebo (a drink that looks and tastes like cranberry juice, but does not contain cranberry juice) or a double strength Ocean Spray light cranberry juice cocktail for four months.

Eligibility criteria: Inclusion Criteria:

* Subjects over the age of 18 years old with known or suspected cardiovascular disease including documented CAD by cardiac catheterization, and multiple cardiovascular risk factors will be included, regardless of severity of endothelial dysfunction or previous history of cardiovascular events.
* Subjects with no known history of cardiac disease will also be eligible to participate.
* Subjects must demonstrate endothelial dysfunction via the RH-PAT test (an RH-PAT score of less than 2.0) to continue participating in this study.

Exclusion Criteria:

* Patients will be excluded if they have confounding factors including, but not limited to, history of renal or liver failure, or relevant food allergies (cranberries, etc.).

Primary outcomes:
measure: The current study was designed to test the hypothesis that the chronic administration of supplementation with double-strength cranberry juice will improve peripheral endothelial dysfunction.
timeFrame: baseline and 4 months post
Secondary outcomes:
measure: The current study was also designed to test the acute effect of double-strength cranberry juice on endothelial function.
timeFrame: 45 mins post consumption
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flammer AJ, Martin EA, Gossl M, Widmer RJ, Lennon RJ, Sexton JA, Loeffler D, Khosla S, Lerman LO, Lerman A. Polyphenol-rich cranberry juice has a neutral effect on endothelial function but decreases the fraction of osteocalcin-expressing endothelial progenitor cells. Eur J Nutr. 2013 Feb;52(1):289-96. doi: 10.1007/s00394-012-0334-4. Epub 2012 Mar 2.
Clinical trial NCT00211406: Treatment of Diabetic Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Diabetic Retinopathy
Lead sponsor: Manhattan Eye, Ear & Throat Hospital
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2005-09-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control diabetic retinopathy.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of patients with diabetic retinopathy.
2. Patients must be at least 18 years of age.
3. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
4. Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart

Exclusion Criteria:

1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
2. Patients who have undergone intraocular surgery within the last 2 months.
3. Patient participating in any other investigational drug study.
4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
5. Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access).
6. Patient with significant liver disease or uremia.
7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study
9. Patient has had insertion of scleral buckle in the study eye
10. Patient has received radiation treatment
11. Patient is on anticoagulant therapy with the exception of aspirin
12. Patient is pregnant or nursing.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Eye, Ear & Throat Hospital
state: New York
Study officials:
affiliation: Manhattan Eye, Ear & Throat Hospital
name: Lawrence Yannuzzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01198106: A Double-blind Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
Official title: A Double-blind Randomized Placebo Controlled Comparison of Scopolamine With Cinnarizin for Prevention of Simulator Sickness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Simulator Sickness
Keywords: simulator sickness
scopolamine
cinnarizine
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2010-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: BACKGROUND:flight simulator have become an important component in pilot training. However, they are known to be associated with motion sickness like symptoms defined as Simulator Sickness (SS). Prevention countermeasures against motion sickness have been studied extensively focusing on cholinergic blockers and antihistamines. Most comparataive studies emphasized the effectiveness of scopolamine over outher agents. Evidence, though, on prophylaxis against SS is sparse.

OBJECTIVE: to assess the effectiveness of oral scopolamine versus oral cinnarizine or placebo for SS prevention in helicopter pilots.

DESIGN: a prospective, placebo controlled double-blind.

SETTING: Israel Air Forse (IAF) Helicopter Aircaft vWeapon System Trainer.

PARTICIPANTS: IAF experienced helicopter pilots.

INTERVENTION: 0.6 mg oral scopolamine or 50 mg oral cinnarizine or placebo 1 hour before beginning of a 3 sortie simulator training


Eligibility criteria: Inclusion Criteria:

* age 21 to 50 years, qualified helicopter pilots
* history of average TS score in SSQ more than 7.48

Exclusion Criteria:

* known vestibular, visual or central nervous system pathology
* fever of more than 37.2 degrees
* any MS like symptom prior to simulator training
* any compromising acute health problem

Primary outcomes:
measure: Finding more effective treatment to the motion sickness symptoms during and after simulator training.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Yavne
country: Israel
facility: base 30 IAF
Study officials:
References:
Clinical trial NCT00942006: Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis
Official title: Doxycycline and Ceftriaxone in Patients With Suspected Early Lyme Neuroborreliosis and Normal CSF Cell Count.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suspected Early Lyme Neuroborreliosis
Keywords: Lyme neuroborreliosis
Lyme borreliosis
erythema migrans
doxycycline treatment
ceftriaxone treatment
outcome
subjective symptoms
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2009-07-20
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will compare doxycycline and ceftriaxone in treatment of patients with suspected early Lyme neuroborreliosis and normal CSF cell count. The study hypothesis is that the efficacy and adverse effects of both antibiotics are comparable.


Eligibility criteria: Inclusion Criteria:

* age \>15 years
* erythema migrans in 4 months period before neurologic symptoms
* normal CSF cell count
* absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy).

Exclusion Criteria:

* pregnancy
* lactation
* allergy on doxycycline and ceftriaxone
* immune deficiency.

Primary outcomes:
measure: Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days.
timeFrame: 1 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana, Department of Infectious Diseases
Study officials:
affiliation: UMC Ljubljana
name: Franc Strle, MD PhD
role: STUDY_CHAIR
References: