louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00558649: A Pilot Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines
Official title: A Pilot, Controlled, Comparative and Single Blinded Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines Administered Intradermally Using Microneedle Injectors as Compared With Standard Dose Intramuscular Flu Vaccines as Reference.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza, Human
Lead sponsor: NanoPass Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2007-11-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective.

Detailed description: Influenza vaccination is the primary method for preventing influenza and its severe complications. Previous clinical studies demonstrated that delivery of vaccines intradermally (into the skin) can achieve good efficacy even with lower doses of the vaccine.

Comparison: Low dose flu vaccine delivered intradermally with a microneedle device compared to the standard dose flu vaccine delivered intramuscularly (into the muscle) with a regular needle.

Eligibility criteria: Inclusion Criteria:

* Signed an Informed Consent
* No previous immune-related disease

Important Exclusion Criteria:

* Significant illness within the previous 4 weeks
* Subjects who have received an influenza vaccine within the previous 6 months
* An active viral diseases
* Pregnant or nursing women
* Any known contraindication to the study vaccine or vaccine ingredients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Center for the Evaluation of Vaccination, University of Antwerp
name: Pierre Van Damme, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04513249: Effects of Therapeutic Plasmaexhange on Viscoelastic Tests in Non-coagulopathic Patients
Official title: Effects of Therapeutic Plasmaexhange on Viscoelastic Tests in Non-coagulopathic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transfusion Related Complication
Lead sponsor: Institutul Clinic Fundeni
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive patients undergoing therapeutic plasmaechange for autoimmune disease

Brief summary: Therapeutic plasma exchange is widely performed in patients with autoimmune disease. The exact effects of fresh frozen plasma on coagulation in this group of patients remains unknown. In order to investigate this issue the present study monitors periprocedural coagulation status with the aid of standard coagulation tests and rotational thromboelastometry. Four thromboelastometric tests will be performed: ExTEM, InTEM, FibTEM and ApTEM. The following parameters will be recorded from each test: CT (sec), CFT (sec) and MCF (mm) one hour before and one hour after plasmaechange was performed.


Eligibility criteria: Inclusion Criteria:

* patients undergoing therapeutic plasma exchange for autoimmune disease

Exclusion Criteria:

* previous coagulation disorders
* anticoagulant or antiplatelet therapy within the last 7 days

Primary outcomes:
measure: change in clotting time - CT (%)
timeFrame: one hour before compared to one hour after plasmaexchange
Secondary outcomes:
measure: change clot formation time - CFT (%)
timeFrame: one hour before compared to one hour after plasmaexchange
measure: change maximum clot firmness - MCF (%)
timeFrame: one hour before compared to one hour after plasmaexchange
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
Study officials:
affiliation: Fundeni Clinical Institute
name: Dana Tomescu, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT02594449: A Pharmacodynamic and Safety Study of BCS in Healthy Volunteers
Official title: A Pharmacodynamic and Safety Study of Benzalkonium Chloride Solution Clearing the Oral Colonized Bacterium in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Healthy Volunteers
Keywords: Pharmacodynamic Study of BCS
Lead sponsor: Lustre Pharmaceutical Lab Co., Ltd
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To compare pharmacodynamics among the different concentrations of BCS and NS.

Detailed description: 2 times mouthwash in the morning and at night. To collect bacterium samples to assess the pharmacodynamics among the different concentrations of BCS and NS: observe the changes of aerobic bacterial colonization in oropharyngeal over time during 24 hours, and assess the improvement of oral healthy status and the subjective feelings after 24 hours.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, males or females.
* Females with U-HCG negative.
* Signed ICFs, and could conduct this study with investigators.

Exclusion Criteria:

* History of mouthwash allergies, allergic rhinitis or dermatitis.
* Volunteers with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer.
* Volunteers with removable denture.
* Had received special oral clean.

Primary outcomes:
measure: The changes of aerobic bacterial colonization in oropharyngeal
timeFrame: 24 hours
Secondary outcomes:
measure: The improvement of oral healthy status
timeFrame: 24 hours
measure: The volunteers' feelings
timeFrame: 24 hours
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Shiyue Li, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03148249: A Trial of Patients With a Charles Bonnet Syndrome
Official title: A Randomized Control Trial of Patients With a Charles Bonnet Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevalence, Psychiatrist Intervention
Keywords: Randomized control trial
Charles Bonnet syndrome
visual hallucinations
age related macular degeneration
patient education
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 34
Sex: ALL
Minimum age (years): 55
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Charles Bonnet Syndrome (CBS) is defined by the occurence of visual hallucinations (VH) in the absence of any mental disorder. Elderly patients with reduced visual acuity due to ophthalmic diseases are most affected. Conditions are often associated with the syndrome of age-related macular degeneration, cataract or glaucoma. Existing data on the syndrome's prevalence in Europe reveal diverse results. Aim of this study was to assess the prevalence of CBS in patients with low visual acuity and to evaluate, if an additional therapeutic interview with and treatment by a psychiatrist is beneficial.

Detailed description: Patients with a visual acuity of 0.5 LogMAR or less in the better eye were screened for CBS. Instruments used were an interview asking for details of the hallucinations, a mental test and a scale concerning quality of life. Patients with CBS were randomized by minimization in two groups: in group 1, a patient-doctor interview by an ophthalmologist was performed and in group 2 an interview and if needed, a therapy by a psychiatrist. At the 3-months follow up, the psychological strain of patients was recorded again.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* visual acuity of 0.5 LogMAR or less at both eyes
* 55 years or older

Patients with CBS:

* have no mental pathologies such as dementia, psychosis or any other neurological diseases
* have a normal cognitive state
* are not able to control the VH
* know that the VH are not real
* are usually older
* have significantly reduced visual acuity due to an bilateral eye pathology

VH associated with CBS:

* disappear when the eyes are closed
* are repetitive
* are complex (eg. objects, geometrical patterns, faces, shapes, figures, scenes, animals or plants)

Exclusion Criteria:

* dopamine agonist medication
* temporal lobe epilepsy
* moderate to severe Alzheimer's dementia
* present chronic alcohol-/drug abuse
* bad cognitive state

There are no:

* auditory or olfactory hallucinations
* other abnormalities like delusions

Primary outcomes:
measure: Quality of life score between the two groups
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01268449: Evaluation of Low Dose Laser in Treatment of Tinnitus
Official title: Phase 1 Evaluation of Low Dose Laser in Treatment of Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Subjective Tinnitus
Keywords: Tinnitus
Low power laser
Lead sponsor: Islamic Azad University of Mashhad
Sponsor class: OTHER
First posted: 2010-12-30
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine wether low dose laser is effective on idiopathic subjective tinnitus.


Eligibility criteria: Inclusion Criteria:

* Adults older than 18 years old
* Idiopathic, subjective, unilateral tinnitus with at least 2 month duration

Exclusion Criteria:

* Patients with chronic otitis media
* Patients with tympan perforation with any underlying cause
* Patients with external otitis
* Patients with tinnitus related to a retrocochlear lesion or other known lesions of the ear

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05018949: Evaluation of Post-Angioplasty Outcomes
Official title: Evaluation of Post-Angioplasty Outcomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Limb Ischemia
Peripheral Arterial Disease
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that have successfully undergone lower limb angioplasty procedures

Brief summary: There is no hard and fast rule guiding the clinical decision between angioplasty and amputation. As such, this decision is greatly dependant on each clinician's experience and preference as to whether treatment should be conservative or aggressive.

Angioplasty can help restore blood flow and long-term patency of the blood vessels can help prevent major surgeries, such as amputation which affects patient's quality of life. However, some of these patients do not benefit from angioplasty and eventually had to undergo amputation. On the other hand, there are patients that undergo amputation, but may stand to benefit from angioplasty. Hence, it is essential to identify patients that will likely benefit from angioplasty to increase limb salvage rate. Many studies performed have also concluded that before amputations are performed, surgeons should consider angioplasty procedures.

Through a medical record review of patients that have undergone angioplasty to evaluate post-angioplasty outcomes, we hope to identify factors that potentially affects these outcomes. Ultimately with a better understanding of these factors and their impact on angioplasty outcomes, a predictive model or guideline can be developed to identify patients that stands to benefit from angioplasty. Such a model can help clinicians to better counsel patients on the risk and benefits, alternatives and prognosis. Patients can also make a better informed decision regarding their treatment


Eligibility criteria: Inclusion Criteria:

* All patients admitted into SGH Department of Vascular Surgery, and have successfully undergone angioplasty

Exclusion Criteria:

* Minors under age of 21

Primary outcomes:
measure: Amputation Free Survival
timeFrame: 12 months post-op
measure: Freedom from target lesion revascularization
timeFrame: 12 months post-op
measure: Primary Patency
timeFrame: 12 months
measure: Wound healing rates
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Tang Tjun Yip
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04566549: The Safety and Efficacy Evaluation of Hair Products Containing Probiotics
Official title: Testing of Hair Products Containing Probiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Problems
Keywords: Hair health
Scalp health
Probiotics
Scalp microbiota
Lead sponsor: GenMont Biotech Incorporation
Sponsor class: INDUSTRY
Collaborators: name: Chia Nan University of Pharmacy and Science
First posted: 2020-09-28
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Previous studies on skin health with Lactic acid bacteria (LAB) have been published for many years, including prevention of skin diseases and improvement of skin conditions. In this clinical study, the investigators researched the benefit effects of heat-killed Lactobacillus paracasei shampoo on scalp and hair healthcare.

Detailed description: To evaluate the safety and efficacy of hair products containing probiotics

Eligibility criteria: Inclusion Criteria:

- Healthy volunteers between the ages of 20-70.

Exclusion Criteria:

* Subjects are undergoing medical therapy for scalp, hair diseases or diabetes mellitus.
* Subjects with cosmetics allergy.
* Subjects had accepted the scalp surgery such as Follicular Unit Transpalnt, Follicular Unit Extraction in the past half year.
* Subjects with pregnancy or breast-feeding.

Primary outcomes:
measure: Skin Microbiota
timeFrame: Baseline, 4 weeks and 8 weeks
Secondary outcomes:
measure: The sebum on scalp
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks
measure: The scalp flakes (dandruff)
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks
measure: The hair density (hairs/scalp area)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, 20 weeks and 28 weeks
measure: Adverse Event
timeFrame: Baseline and 28 weeks
measure: Single application closed patch epicutaneous test under occlusion
timeFrame: 1 hour, 24 hours and 48 hour
measure: Repeated application closed patch epicutaneous test under occlusion
timeFrame: Day 1, 2, 3, 4 and 5
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chia Nan University of Pharmacy and Science
Study officials:
affiliation: Chia Nan University of Pharmacy ＆ Science
name: Ching-Gong Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01525849: Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up
Official title: Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Sinusitis
Lead sponsor: Entellus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-03
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.

Detailed description: This is a postmarket, multicenter, prospective, randomized clinical trial conducted at up to 15 US clinical sites comparing the efficacy of balloon sinus dilation with traditional endoscopic sinus surgery. The primary hypotheses were to demonstrate that: 1) long-term change in sinus symptoms after balloon dilation is not worse (non-inferior) than after FESS, and 2) balloon dilation is superior to FESS for a reduction in the number of postoperative debridements per patient. A minimum of 36 participants per arm is required to test the primary hypotheses. All participants will be followed through a minimum of 12 months post treatment.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* maxillary sinus disease
* chronic sinusitis

Exclusion Criteria:

* fungal disease
* Samter's triad
* hemophilia
* prior sinus surgery

Primary outcomes:
measure: Sinus Symptom Improvement
timeFrame: Baseline and 1-year
measure: Debridements
timeFrame: 1-year
Secondary outcomes:
measure: Revision Rate
timeFrame: 1-year
measure: Complication Rate
timeFrame: Duration of study (minimum of 12 months)
measure: Recovery Time
timeFrame: 6-months
Other outcomes:
Locations:
city: Plymouth
country: United States
facility: Entellus Medical
state: Minnesota
Study officials:
References:
citation: Cutler J, Bikhazi N, Light J, Truitt T, Schwartz M; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial. Am J Rhinol Allergy. 2013 Sep-Oct;27(5):416-22. doi: 10.2500/ajra.2013.27.3970. Epub 2013 Aug 5.
citation: Bikhazi N, Light J, Truitt T, Schwartz M, Cutler J; REMODEL Study Investigators. Standalone balloon dilation versus sinus surgery for chronic rhinosinusitis: a prospective, multicenter, randomized, controlled trial with 1-year follow-up. Am J Rhinol Allergy. 2014 Jul-Aug;28(4):323-9. doi: 10.2500/ajra.2014.28.4064. Epub 2014 May 12.
citation: Chandra RK, Kern RC, Cutler JL, Welch KC, Russell PT. REMODEL larger cohort with long-term outcomes and meta-analysis of standalone balloon dilation studies. Laryngoscope. 2016 Jan;126(1):44-50. doi: 10.1002/lary.25507. Epub 2015 Jul 30.
Clinical trial NCT04952649: The Ability of Peripheral Perfusion Index To Detect Changes of Hemodynamics in Patients With Pacemaker
Official title: The Ability of Peripheral Perfusion Index To Detect Changes of Hemodynamics in Patients With Pacemaker：a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pacemaker Dependence
Keywords: peripheral perfusion index
cardiac output
stroke volume
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pacemakers are widely used in post-cardiotomy patients, while it's common that some patients may be pacemaker dependent. We choose these patients who has been placed with temportary pacemaker during the cardic surgery

Brief summary: Pacemakers are widely used in postcardiotomy patients to avoid severe arrhythmia. The peripheral perfusion index (PI) has been considered as an effective parameter evaluating the circulation. In this study, investigators aim to avaluate the ability of peripheral perfusion index to detect changes of hemodynamics in postcardiotomy patients with pacemakers.

Detailed description: Pacemakers are widely used in postcardiotomy patients to avoid severe arrhythmia. The peripheral perfusion index (PI) has been considered as an effective parameter evaluating the circulation. In this study, investigators aim to evaluate the ability of peripheral perfusion index to detect changes of hemodynamics (cardiac output or storke volume,et al) in postcardiotomy patients with pacemakers.

Eligibility criteria: Inclusion Criteria:

* age \>=18 years old;
* postcardiotomy
* placement of temportary pacemaker during the surgery
* dependence of pacemaker (abscence of autonomic cardiac rhythm）

Exclusion Criteria:

* hemodynamic unstable （high dose of vasoactive drugs）
* fingers ischemia, cannot monitor the peripheral perfusion index

Primary outcomes:
measure: Cardiac output
timeFrame: During the study procedure
measure: stroke volume
timeFrame: During the study procedure
measure: Peripheral perfusion index
timeFrame: During the study procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhe Luo, MD PhD
role: STUDY_DIRECTOR
References:
citation: Bazaraa H, Roby S, Salah E, Algebaly H. Assessment of Tissue Perfusion Using the Peripheral Perfusion Index and Lactate Clearance in Shock in Pediatric Patients. Shock. 2021 Dec 1;56(6):933-938. doi: 10.1097/SHK.0000000000001811.
citation: Abdel-Ghaffar HS, Abdel-Wahab AH, Roushdy MM. Using the Perfusion Index to predict changes in the depth of anesthesia in children compared with the A-line Autoregression Index: an observational study. Braz J Anesthesiol. 2024 Sep-Oct;74(5):744169. doi: 10.1016/j.bjane.2021.04.030. Epub 2021 May 12.