louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01976650: Safety and Efficacy of Dexamethasone (OZURDEX®) Intravitreal Implant in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vein Occlusion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-11-06
Enrollment: 724
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye treated with (OZURDEX®) in clinical practice.

Brief summary: This study is a Post-Market Surveillance study in Korea to evaluate the safety and efficacy of dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant used to treat Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients with Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye treated with (OZURDEX®) in clinical practice.

Exclusion Criteria:

* Patients with eye infections
* Patients with glaucoma.

Primary outcomes:
measure: Number of Patients With Adverse Events or Adverse Drug Reactions
timeFrame: 4 Years
Secondary outcomes:
measure: Percentage of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: 4 Years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Kim MS, Choi J, Lee HD, Woo SJ; Korea Ozurdex Post-Marketing Surveillance Study Group. Dexamethasone Intravitreal Implant for the Treatment of Macular Edema Following Retinal Vein Occlusion: Post Hoc Analysis of Post-Marketing Surveillance Data in the Real-World Setting in Korea. Clin Ophthalmol. 2021 Aug 27;15:3623-3636. doi: 10.2147/OPTH.S302014. eCollection 2021.
Clinical trial NCT02335008: The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity and Preference - Pilot
Official title: The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity and Preference - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impairment of Oral Perception
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to test the hypothesis that repeated consumption of artificial sweetener reduces sweet taste intensity.

Detailed description: Significant controversy surrounds the possibility that consumption of artificial sweeteners (AFS) leads to weight gain. Some studies have found correlations between AFS use and weight gain and/or diabetes \[1-4\] while others have indicated that AFSs may aid in weight loss \[5\] or have no effects on body mass index (BMI) \[6\]. In rats, exposure to AFS leads to reduced chow intake following a sweet preload \[7, 8\], higher body weight \[9, 10\] and increased glucose responses and decreased GLP1 release following an oral glucose tolerance test \[11\] compared to exposure to caloric sweeteners. Given that the five FDA approved AFSs are found in thousands of foods \[12\] this marks a clear and significant gap in knowledge. Our preliminary data demonstrate a 3-fold decrease in sweet taste sensitivity following consumption of a beverage sweetened with two packets of Splenda for just 10 days. These data provide strong evidence that repeated exposure to sucralose reduces perception of sweet taste intensity, most likely by down-regulation of the sweet taste receptor. Therefore, it is imperative that we gain a greater understanding of the consequences of AFS use, since alterations in sweet taste perception that occur in response to AFS exposure may promote weight gain.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Fluent in English

Exclusion Criteria:

* History of oral nerve damage,
* presence of known taste or smell disorder,
* food allergies or sensitivities (for example nuts, lactose, artificial sweeteners),
* history of CNS disease,
* diabetes,
* history of DSM-IV major psychiatric disorder, including alcohol and substance abuse, chronic use of medication that may affect taste,
* conditions that may interfere with gustatory or olfactory perception (colds, seasonal allergies, recent smoking history),
* aberrant stimulus ratings,
* contra-indication for fMRI,
* uncomfortable swallowing in supine position.

Primary outcomes:
measure: Ratings of taste sensitivity
timeFrame: up to one week after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: The John B Pierce Laboratory
state: Connecticut
Study officials:
affiliation: The John B Pierce Laboratory, Yale University
name: Dana M Small
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04871308: Dexmedetomidine and Myocardial Protection
Official title: Cardioprotective Effect of Dexmedetomidine in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass: a Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiac Surgery
Cardiopulmonary Bypass
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 224
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: Dexmedetomidine, an alpha-2 agonist, is a sedative that is widely used in various clinical settings because, compared to benzodiazepines, it preserves respiratory function better and its duration of action is short.

Recent experimental studies showed a possibility that dexmedetomidine may have an organoprotective effect from ischemic-reperfusion injury by reducing inflammatory response. Besides, dexmedetomidine is known to be related with attenuated sympathetic tone and improved microcirculation.

Taken together, it is plausible that dexmedetomidine exerts cardioprotection in patients undergoing cardiac surgery with cardiopulmonary bypass and aortic cross-clamp.

The aim of this trial is to test the effect of dexmedetomidine on postoperative cardiac troponin I measurements in patients undergoing cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* cardiac surgery utilizing cardiopulmonary bypass and aortic cross-clamp

Exclusion Criteria:

* Coronary artery bypass grafting
* Concomitant cryo-Maze procedure
* Myectomy
* Heart transplantation
* Concomitant major non-cardiac surgery
* Isolated complicated congenital heart surgery
* descending thoracic aorta surgery with partial cardiopulmonary bypass
* Emergency surgery
* Minimally invasive or robot-assisted surgery
* Estimated GFR \<30 ml/min/1.73 m2
* Documented end-stage renal disease
* Preoperative renal replacement therapy
* Preoperative history of percutaneous coronary intervention within 6 month before surgery
* Acute coronary syndrome within 4 weeks before surgery
* Preoperative mechanical circulatory support devices

Primary outcomes:
measure: cardiac troponin I
timeFrame: Three days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Karam Nam, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00784108: Optimizing Photodynamic Therapy of Cutaneous Neoplastic Diseases Via Structured Illumination and Real-time Dosimetry.
Official title: Non-contact Imaging Device (Camera) Can Help Improve Treatment for Patients With Basal Cell Carcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Cancer
Signs and Symptoms
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2008-11-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate native tissue optical properties and photosensitizer optical properties in vivo with a novel, non-contact optical imaging device call Modulated Imaging to help optimize the laser exposure in future photodynamic treatment for patients with skin cancer.

Photodynamic therapy involves the administration of a tumor-localizing photosensitizing agent that, when illuminated with the proper wavelength of light, can result in photochemical processes that cause irreversible damage to tumor tissues. Photodynamic therapy is non-invasive and has been shown to be effective in the treatment of skin cancer while producing excellent aesthetic appearance and psychological well-being in patients that normally would require invasive excisions.

Detailed description: The current standard of care for skin cancer is excision, curettage and electrodesiccation and/or cryosurgery.

The Modulated Imaging can measure tissue optical properties that effect the Photodynamic therapy treatment process can show spectral absorption and scattering coefficients, oxy- and deoxy-hemoglobin, water, melanin and use that information to provide customized laser light treatment.

The researchers can use an imaging system that can characterize the tissue and photosensitizer optical properties and use that information to drive a treatment light projection system that can spatially optimize the light irradiance for personalized treatment, thus improving outcomes.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Biopsy proven diagnosis of a basal cell carcinoma in a non-facial area

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Breast feeding.
* photosensitivity

Primary outcomes:
measure: Measure tissue optical properties
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical clinic
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Kristen M Kelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00429208: Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers
Official title: Effect Of Nicotine on Neurocognitive Performance of Cigarette Smokers: A Double-Blind, Within-Subjects, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nicotine Dependence
Smoking
Tobacco Use Disorder
Nicotine Use Disorder
Keywords: Nicotine Dependence
Smoking
Tobacco Use Disorder
Nicotine Use Disorder
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-01-31
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This research project addresses the hypothesis that a neurocognitive profile characterized by impairment of response inhibition and sustained attention may be a risk factor for smoking initiation and nicotine dependence among young women. Nicotine has short- term, facilitating effects on attention and response inhibition. Therefore, individuals who are impaired on cognitive functions such as these and initiate cigarette smoking may be more likely to maintain the habit and develop nicotine dependence. The research protocol specifically tests whether administration of nicotine to non-abstinent, regular cigarette smokers improves cognitive function in those domains where the participants had previously been shown to manifest performance deficits


Eligibility criteria: Inclusion Criteria:

* Reported smoking cigarettes on a daily basis at the time of the original study and continue to smoke currently
* Manifested poor performance on the MFFT (The neurocognitive test that yielded differences between smokers and non-smokers)
* Competent and willing to give written informed consent

Exclusion Criteria:

* Pregnancy, breast-feeding, non-use of contraception such that the possibility of pregnancy cannot be excluded
* Intake of any medication that may potentially interact with nicotine.
* Any current or past medical condition that represents a contra-indication to nicotine administration.

Primary outcomes:
measure: Neurocognitive functions
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Avi Yakir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yakir A, Rigbi A, Kanyas K, Pollak Y, Kahana G, Karni O, Eitan R, Kertzman S, Lerer B. Why do young women smoke? III. Attention and impulsivity as neurocognitive predisposing factors. Eur Neuropsychopharmacol. 2007 Apr;17(5):339-51. doi: 10.1016/j.euroneuro.2006.09.004. Epub 2006 Nov 30.
Clinical trial NCT05263908: A Study to Learn About PAXLOVID (a Commercial Medicine) In People With COVID-19
Official title: General Investigation for PAXLOVID PAC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Infection
Keywords: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
coronavirus disease 2019 (COVID-19)
Paxlovid
Nirmatrelvir
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-03-03
Enrollment: 3346
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects who have been treated with PAXLOVID PACK for the first time.

Brief summary: The purpose of this post marketing observational study is to learn about the safety and effects of the commercial medicine (called PAXLOVID) for the treatment of COVID-19. This study is intended to be registered with the participants who:

* Have taken PAXLOVID PACK and have no history of using this medicine.
* Are 12 years and older

All participants will receive PAXLOVID, a standard treatment for COVID-19. Participants will take PAXLOVID 2 times a day by mouth or as prescribed.

We will examine the experiences of people taking PAXLOVID. This will help us determine if PAXLOVID is safe and effective.

Participants will be followed up for 28 days after taking PAXLOVID. During this time, participants will be closely watched for the safety and effects of PAXLOVID.

Detailed description: This is a multicenter cohort study to be conducted in individuals with SARS-CoV-2 infection who are treated with this product, and the investigator will enter the information required in this study in the case report forms (CRFs) based on the information obtained through medical records.

Eligibility criteria: Inclusion Criteria:

* Subjects who are administered PAXLOVID PACK and have no history of using this drug.

Exclusion Criteria:

* There are no exclusion criteria for this study.

Primary outcomes:
measure: Incidence of adverse drug reactions
timeFrame: 34 days
Secondary outcomes:
measure: Ratio of subjects with worsening severity
timeFrame: 34 days
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Local County
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06449508: The Effectiveness of Probiotics in Neonatal Jaundice
Official title: Role of Probiotics Administered as an Adjuvant Therapy in Pathological Neonatal Unconjugated Hyperbilirubinemia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Jaundice, Neonatal
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 44
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hyperbilirubinemia is a prevalent problem in babies that necessitates medical attention. Probiotic administration as adjuvant therapy may have a positive impact on the pathological neonatal unconjugated hyperbilirubinemia.

Detailed description: Neonatal jaundice is a common health care issue that affects approximately 9% of newborns after birth. The percent of neonates who acquire jaundice in the first week of their birth is about 60%. while the percent of breasted neonates who develop jaundice during the first month of their birth is about 10%.

Phototherapy is the standard therapy for neonates who develop pathological jaundice, as it can alter bilirubin structure and increase its excretion.

Probiotics can also be used for the treatment of jaundice. The efficacy of probiotics depends on their ability to pass across the GIT and cause colonization in the intestinal lumen. Hence, it leads to a decrease in the bacterial growth in the small bowel, a reduction in the function of the gastrointestinal barrier, and a regulation of the immune system of the host.

Eligibility criteria: Inclusion Criteria:

* Neonate suffered from pathological unconjugated hyper-bilirubinemia with Total serum bilirubin (TSB) between 5-15mg/dl and need phototherapy.

Exclusion Criteria:

* neonates who have kernicterus.
* neonates who have ventilation problem.
* neonates who have heart failure.
* -neonates who have asphyxia.
* neonates who have history of Rh incompatibility

Primary outcomes:
measure: the change in the measured total bilirubin, direct bilirubin, and Indirect Bilirubin.
timeFrame: up to 4 weeks
Secondary outcomes:
measure: The change in serum concentration of the Human Tumor Necrosis Factor Alpha (TNFa)
timeFrame: up to 4weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00752908: Tissue Penetration of Antibiotics in Obesity
Official title: Tissue Penetration of Antibiotics in Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-09-16
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical Patients at BJH

Brief summary: The purpose of this study is to evaluate cefoxitin pharmacokinetics in obese surgical patients.


Eligibility criteria: Inclusion Criteria:

* BMI \<25 and \>40
* Scheduled for elective abdominal or pelvic surgery
* Surgical plan for intraoperative cefoxitin prophylaxis
* Able to provide informed consent

Exclusion Criteria:

* Allergy to Cefoxitin
* Renal or Hepatic insufficiency

Primary outcomes:
measure: Cefoxitin Plasma Concentrations
timeFrame: 8 hours
Secondary outcomes:
measure: Cefoxitin Tissue Concentrations
timeFrame: 8 hours
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Evan D Kharasch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05549908: Vaccine Prevention of Rabies Adopts 4-shot Immunization Method
Official title: Randomized, Blind, Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Freeze-dried Human Rabies Vaccine (Vero Cell) Inoculated in 4-dose Program (2-1-1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rabies Human
Antibody Titer
Lead sponsor: Changchun Zhuoyi Biological Co., Ltd
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 1800
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)

Detailed description: It is to prove that the freeze-dried human rabies vaccine (Vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination.

To compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and GMT 6 and 12 months after the test vaccine was vaccinated.

Eligibility criteria: Inclusion Criteria:

* The age is 10-60 years old;
* Underarm temperature ≤ 37.0 ℃.

Exclusion Criteria:

* Have a history of rabies vaccine immunization or use of rabies virus passive immunization agents；
* Has been diagnosed with congenital or acquired immunodeficiency disease；
* Pregnancy (including positive urine pregnancy test) or lactation, planned pregnancy preparation within 2 months.

Primary outcomes:
measure: Antibody positive conversion rate of experimental groups
timeFrame: 3 months
measure: Antibody positive conversion rate of 4 doses groups
timeFrame: 3 months
measure: Compare the GMT between two experimental groups
timeFrame: 3 months
measure: Geometric Mean Titer (GMT) of 4 doses groups
timeFrame: 3 months
measure: Safety within 30 minutes
timeFrame: 3 months
measure: Safety within 0-7 days
timeFrame: 3 months
measure: Safety within 6 months
timeFrame: 9months
Secondary outcomes:
measure: Antibody test of 7 days.
timeFrame: 3 months
measure: Antibody test after whole vaccination.
timeFrame: 3 months
measure: Persistent observation within 12 months
timeFrame: 16 months
Other outcomes:
Locations:
city: Changchun
country: China
facility: Changchun Zhuoyi Biological Co., Ltd
state: Jilin
Study officials:
affiliation: Changchun Zhuoyi Biological Co., Ltd
name: Li Miao, Dr
role: STUDY_DIRECTOR
References: