louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00663377: Effects of Losartan on Insulin Resistance in Patients With Heart Failure
Official title: Losartan Improved Insulin Resistance and Decreased Inflammatory Cytokines in Patients With Chronic Heart Failure Treated With Angiotensin Converting Enzyme Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure
Keywords: Heart Failure
Insulin Resistance
Losartan
ACE inhibitor
Inflammatory cytokine
Lead sponsor: Tottori University Hospital
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of losartan, an ARB, on glucose metabolism and inflammatory cytokines in CHF patients treated with ACE inhibitors.

Detailed description: Chronic heart failure (CHF) is associated with marked insulin resistance, characterized by both fasting and stimulated hyperinsulinemia. Furthermore, insulin resistance is a predictor of CHF and associated with more severe disease and a worse prognosis in patients with CHF. In CHF patients, therefore, insulin resistance is not merely a function of adiposity and may have implications in the pathophysiology of CHF disease progression. Angiotensin II negatively modulates insulin-mediated actions by regulating multiple levels of the insulin signaling cascade such as the insulin receptor, IRS, and PI3-kinase. Furthermore, both ACE inhibitors and angiotensin II receptor blockers (ARB) improve glycemic status not only in patients with type II diabetes but also in patients with hypertension and the metabolic syndrome. On the other hand, it is well known that some cytokines, such as TNF-α, are involved with pathophysiology of insulin resistance and CHF. However, it is still unclear whether the ARB improves insulin resistance in CHF patients already treated with ACE inhibitors and whether there is the relationship between insulin resistance and inflammatory cytokines in CHF patients already treated with ACE inhibitors. Therefore, the purpose of this study is to evaluate the effects of losartan, an ARB, on glucose metabolism and inflammatory cytokines in CHF patients treated with ACE inhibitors.

Eligibility criteria: Inclusion Criteria:

* chronic stable heart failure

Exclusion Criteria:

* renal dysfunction or under treatment with antidiabetic agents

Primary outcomes:
measure: insulin resistance
timeFrame: 16 weeks
Secondary outcomes:
measure: inflammatory cytokines
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Ogino K, Kato M, Furuse Y, Kinugasa Y, Kaetsu Y, Mizuta E, Sugihara S, Ishida K, Yanagihara K, Hisatome I, Shigemasa C. Addition of losartan to angiotensin-converting enzyme inhibitors improves insulin resistance in patients with chronic heart failure treated without beta-blockers. Circ J. 2010 Nov;74(11):2346-52. doi: 10.1253/circj.cj-10-0395. Epub 2010 Sep 4.
Clinical trial NCT00855777: Etoricoxib Versus Ibuprofen in Third Molar Extraction Pain
Official title: Evaluation of Analgesic Efficacy of Etoricoxib Compared With Ibuprofen in Third Molar Extraction Pain.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dental Extraction
Keywords: third molar extraction
etoricoxib
ibuprofen
analgesic efficacy
pain
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 110
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 aim of this study is to evaluate the analgesic efficacy of etoricoxib compared with a well known and widely used non-steroid antinflammatory drug, ibuprofen, in third molar extraction pain. At this time, there are no data about the efficacy of etoricoxib for reducing pain following dental extraction.

This will be a single center, randomized, double-blind study, in which patients with moderate to severe pain following third molar extraction will be randomized to receive etoricoxib (120 mg in a single dose + 2 dose of placebo pro day for 3 days) or ibuprofen (1800 mg in 3 doses pro day for 3 days). Paracetamol plus codeine will be used as rescue medication. Pain assessment will be performed using a 11-point pain intensity scale (0 = no pain and 10 = worster pain) during the first 3 days after dental extraction. Patients will be enrolled 15 days before the dental extraction. During enrollment visit a complete clinical evaluation with particular attention for potential exclusion criteria (e.g. hypertension and cardiovascular risk factors) as well as blood analyses will be performed. A follow-up visit will be performed 15 days after the dental extraction. Tolerability will be assessed through recording of adverse events.


Eligibility criteria: Inclusion Criteria:

* subjects with age \> 18 years
* in good health status (assessed in occasion of enrollment visit) without any major systemic illness
* candidate to third molar extraction and presenting local pain within 2 hours after dental extraction

Exclusion Criteria:

* patients with any major systemic illness
* patients with a clinical history of drug abuse
* patients with hypertension and/or a condition of increased cardiovascular risk
* pregnant or lactating women
* patients with a history of hypersensitivity/allergy to analgesic drugs, including classical NSAID or coxibs
* patients with either high levels of liver enzymes (major of 1.5x the upper limit of reference interval) or of creatinine(major of 1.2x the upper limit of reference interval)
* patients with either a history of peptic ulcer or of haemorrhagic diathesis
* patients who can not ensure an adequate compliance for the study

Primary outcomes:
measure: analgesic efficacy
timeFrame: 3 days
Secondary outcomes:
measure: side effects
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
affiliation: Universita di Verona
name: Roberto Corrocher, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00980577: Stimulating Catheter With or Without Ultrasound Guidance
Official title: Phase 2 Study of Stimulating Catheter for Continuous Femoral Nerve Block in Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2009-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study whether the combination of ultrasound guidance and stimulating catheter could reduce the time for needle and catheter insertion compared with using stimulating catheter alone. Secondary outcomes: analgesic effects after the surgery.


Eligibility criteria: Inclusion Criteria:

* Elective primary total knee replacement surgery under neuraxial anesthesia ASA\<=4
* Able to give informed consent
* Able to cooperate with sensory and motor testing of lower limb function

Exclusion Criteria:

* coagulopathy
* Allergy to local anaesthetic or postanalgesic rescue regimen
* Signs, symptoms or laboratory evidence of local infection or systemic sepsis
* No pre-existing neurological deficit (sensory or motor) affecting lower limb
* Patients with lower limb amputations

Primary outcomes:
measure: time and number of attempts to perform block, the efficacy of the block
timeFrame: during the block procedure
Secondary outcomes:
measure: postoperative analgesic effect
timeFrame: pod 1-3
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hosptial
Study officials:
References:
Clinical trial NCT05533177: Effect Analysis of Physical Therapy Based on Electronic Medical Record
Official title: Effect Analysis of Physical Therapy Based on Electronic Medical Record
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Physical Therapy
Keywords: rTMS
big data analysis
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Qingdao Mental Health Center
First posted: 2022-09-08
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are patients in Shanghai Mental Health Center and Qingdao Mental Health Center; meet ICD-10 diagnosis criteria of ICD-10 F20-F48 and its subtype (mental examination was conducted by three levels of doctors including at least one attending physician and one chief physician in psychiatric); available relevant HIS system biochemical data; have been treated with physical therapy; age and gender is not limited

Brief summary: WHO has reported the heavy disease burden of psychiatric disorders. Due to the unsatisfactory effect of pharmacotherapy, physical therapy has attracted extensive attention as a complementary therapy. However, few large sample real-world studies are exploring its efficacy. This study intends to explore the efficacy of physical therapy in different types of mental disorders, which is meaningful for the formulation of personalized treatment plans.


Eligibility criteria: Inclusion Criteria:

* age is not limited
* gender is not limited
* meets the diagnostic criteria of ICD-10 F20-F48 and its sub-categories
* has relevant HIS system data that can be utilized.
* have been treated with physical therapy

Exclusion Criteria:

* patients who did not meet the appeal diagnosis
* patients who met the above three diagnoses but had severe data loss (missing value ≥ estimated data value of 30%)

Primary outcomes:
measure: Times of outpatients visit of patients with different types of mental disorders treated with rTMS
timeFrame: At December 2022
measure: Thyroid hormones changes of biochemical parameters after rTMS in patients with mental disorders
timeFrame: At March 2023
measure: Liver function related indexes changes of biochemical parameters after rTMS in patients with mental
timeFrame: At March 2023
measure: Duration of the whole outpatients visit of patients with different types of mental disorders treated with rTMS
timeFrame: At December 2022
measure: Changes of status description of patients with different types of mental disorders treated with rTMS
timeFrame: At December 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Yiru Fang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06099977: Binaural Sound for Remimazolam Induction
Official title: The Effect of Preoperative Binaural Sound on Remimazolam Dose Required for Induction of General Anesthesia: a Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: General Anesthesia
Prostate Cancer
Uterine Myoma
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is important to decrease the time-to-loss of consciousness and anesthetics dose of remimazolam for general anesthesia induction. We will evaluate the effect of binaural sound for general anestheia induction using remimazolam infusion.


Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for generla anesthesia
2. Patients aged 20-60
3. Patients with American Society of Anesthesiologist physical status classification 1-2
4. Patients with ideal body weight 50-80 kg

Exclusion Criteria:

1. Patients with hearing disability
2. Patients using opioids or sedatives in 1 week
3. Patients who are dependent for alcoholics or drugs
4. Patients with hypersensitivities to remimazolam
5. Patients with arrhythmia, cardiovascular disease, heart failure, or hypovolemia
6. Patients with liver failure

Primary outcomes:
measure: Remimazolam dose for no response to voice
timeFrame: At anesthesia day 0
Secondary outcomes:
measure: Remimazolam dose for no eye lash reflex
timeFrame: At anesthesia day 0
measure: Remimazolam dose for patient state index 50
timeFrame: At anesthesia day 0
measure: Anxiety level
timeFrame: At anesthesia day 0
measure: Patient state index electroencephalography
timeFrame: At anesthesia day 0
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: GangnamSeveranceHospital
Study officials:
References:
Clinical trial NCT05629377: Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health (ARCH)
Official title: Hypothalamic Amenorrhea as a Fertility Status Marker for Cardiovascular Health
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypothalamic Amenorrhea
Keywords: Functional Hypothalamic Amenorrhea
Amenorrhea
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-11-29
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal women with hypothalamic amenorrhea at Mayo Clinic Florida.

Brief summary: Hypothalamic amenorrhea (HA) occurs during reproductive years and results in stopped menstrual cycles and infertility which can be prolonged from months to years and is characterized by varying combinations of psychosocial stress, anxiety, high levels of physical activity, and/or weight loss. Data from our group indicates that one-third of women with HA (mean age: 27 yrs) have preclinical cardiovascular disease (CVD) measured noninvasively as vascular dysfunction and vascular inflammation. This study will use HA as a marker of fertility status for cardiovascular health and perform dense-phenotyping using remote patient monitoring (FitBit) and patient reported outcomes (questionnaires) to determine which HA phenotypes are related to preclinical CVD and inflammation.


Eligibility criteria: Inclusion Criteria:

* Secondary amenorrhea of 3 or more consecutive months duration
* Include the screening hormones (eg, estradiol (E2) \< 50 pg/ml, Follicle-Stimulating Hormone (FSH) \<10 mIU/ml, and Luteinizing Hormone (LH) \< 10mIU/ml and other HA-defining hormones); or clinical diagnosis of HA by medical providers.
* Pre-menopause status.
* Able to give informed consent.

Exclusion Criteria:

* A diagnosis for secondary amenorrhea including prolactinoma, Polycystic Ovary Syndrome (PCOS), premature ovarian insufficiency, pituitary surgery, infection or infarction
* Pregnancy
* Psychotropic/illicit drug use
* Mental/neurological/major psychological disorders (other than depression and anxiety).
* Parturition/lactating in the last 6-12 months.

Primary outcomes:
measure: Hypothalamic Amenorrhea (HA) duration
timeFrame: 3 months
measure: Vascular dysfunction
timeFrame: 3 months
measure: Psychosocial stress
timeFrame: 3 months
measure: Perceived stress
timeFrame: 3 months
measure: Step count
timeFrame: 3 months
measure: Physical activity level
timeFrame: 3 months
measure: Heart Rate
timeFrame: 3 months
measure: Caloric intake and nutrition
timeFrame: 3 days
measure: Vascular inflammation
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Chrisandra Shufelt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04036877: Mood Disorders Bladder Cancer
Official title: Evaluation of Mood Disorders in Bladder Cancer Patients and Their Primary Caregivers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-07-30
Enrollment: 358
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 and caregivers of patients with a diagnosis of bladder cancer who have received treatment at the University of Kansas Health System

Brief summary: This is a cross-sectional study evaluating mood disorders in bladder cancer patients and their caregivers across the bladder cancer trajectory


Eligibility criteria: Inclusion Criteria:

* Patients or caregiver of patient with a histologic diagnosis of bladder cancer of the following subtypes, urothelial carcinoma, adenocarcinoma, or squamous cell carcinoma, within 24 months of survey administration and received treatment at the University of Kansas Health System
* ≥ 18 years of age
* Have a patient-designated primary informal/family caregiver
* Able to speak and read English
* Willing and able to provide informed consent
* Functioning telephone number or access to one

Exclusion Criteria:

* Patients or caregivers of patients with metastatic bladder cancer
* Patients who are unable to designate a primary caregiver
* Patients and caregivers who do not both consent to study participation

Primary outcomes:
measure: Severity of depression in bladder cancer patients and their caregivers: Patient-Health Questionnaire-9
timeFrame: Data will be assessed through study completion, on average one year
measure: Severity of anxiety in bladder cancer patients and their caregivers: Generalized Anxiety Disorder-7
timeFrame: Data will be assessed through study completion, on average one year
measure: Health-related quality of life in bladder cancer patients and their caregivers: Short Form-12
timeFrame: Data will be assessed through study completion, on average one year
measure: Financial Toxicity in bladder cancer patients and their caregivers
timeFrame: Data will be assessed through study completion, on average one year
Secondary outcomes:
Other outcomes:
measure: Assess the correlation between caregiver depression, anxiety, and HRQOL and four primary domains of caregiver needs (accessing health services, psychological and emotional needs, work and social needs, and informational needs)
timeFrame: Data will be assessed through study completion, on average one year
Locations:
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Elizabeth Wulff-Burchfield, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06710977: To Compare the Safety and Efficacy of Intracameral Levofloxacin and Intracameral Cefazolin in Reducing Rates of Endophthalmitis Following Cataract Surgery.
Official title: A Double-blind, Randomized Controlled Pilot Study Comparing the Safety and Efficacy of Intracameral Levofloxacin and Intracameral Cefazolin in Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cataract
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with senile cataracts undergoing phacoemulsification were assigned to receive intracameral levofloxacin (0.1ml/0.5mg) or intracameral cefazolin (0.1ml/1mg). The primary endpoint was the occurrence of endophthalmitis during the 3 month follow-up period. Secondary endpoints included best-corrected visual acuity (BVCA), the presence of anterior chamber (AC) inflammation with grading of AC cells and presence of flare, along with intraocular pressure (IOP), corneal cell thickness (CCT), central foveal thickness (CFT) and cell density.


Eligibility criteria: Inclusion Criteria:

* Aged ≥50 to \<80 years
* Undergoing cataract surgery under the care of one of three study investigators, all of whom were consultant level cataract surgeons
* Only those with senile cataracts, assessed using the Lens Opacities Classification System III scale (LOCS III) and without features of complex cataracts were included

Exclusion Criteria:

* \<50 or \>80 years old
* Prior ocular trauma, pregnant, previous history of refractive, corneal or intraocular surgery, cornea endothelial cell count \<1500/sqmm², concomitant ocular disease, allergy to penicillin, fluoroquinolone or cephalosporin, and abnormal biometric measurements

Primary outcomes:
measure: Number of Participants with Treatment related adverse events to Intracameral Cefazolin versus Levofloxacin
timeFrame: From cataract surgery through to study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: Ang Mo Kio Specialist Center
Study officials:
References:
citation: Cruz FM, Uy HS, Rubio CJ, Chan PS. Postoperative Safety Outcomes in Patients Undergoing Routine Phacoemulsification Cataract Surgery with Intraoperative Intracameral Injection of Preservative-Free Moxifloxacin versus Levofloxacin. Philippine Journal of Ophthalmology. 2022;47(1)
citation: Espiritu CRG, Bolinao JG. Prophylactic intracameral levofloxacin in cataract surgery - an evaluation of safety. Clin Ophthalmol. 2017 Dec 12;11:2199-2204. doi: 10.2147/OPTH.S144625. eCollection 2017.
Clinical trial NCT01565577: Evaluation of Immune Response Against the Strain of Neisseria Meningitidis B: 14, P1-7, 16 Patients Vaccinated With MenBVac® (Extension MenbVac)
Official title: Phase 3, Vaccinal Activity Assessment of MenBVac Against Nesseiria Menigitidis B:14,P1.7,16 Strain in Child Vaccinated With MenBVac®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vaccination With MenbVac
Keywords: Neisseria meningitidis B:14, P1-7, 16
Serum bactericidal activity
Menbvac
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Direction Générale de la Santé, France
name: Institut Pasteur
name: Dieppe
First posted: 2012-03-28
Enrollment: 117
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to estimate the vaccinal immunity four years after four doses of MenbVac in children aged 4-8 years.


Eligibility criteria: Inclusion Criteria:

* children born between 01/01/2000 and 06/23/2005, living in Dieppe-Est, Dieppe-Ouest and Offranville, vaccinated with four doses of MenBVac in the first MenbVac clinical trial study,
* parental authority(ies)assent.

Exclusion Criteria:

* no parental authority(ies)assent,
* no parental authority(ies)assent,
* no blood sample during the third vaccination,
* impossibility of third vaccination.

Primary outcomes:
measure: vaccine Immunity
timeFrame: two and a half years after the fouth vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen,
country: France
facility: UH-rouen
state: Seine Maritime
Study officials:
affiliation: CHU - Hôpitaux de Rouen
name: François Caron, Professor
role: PRINCIPAL_INVESTIGATOR
References: