louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04719741: Drug and Dose Adjustment in Preventing Postoperative Nausea and Vomiting
Official title: Drug and Dosage Adjustment in Preventing Postoperative Nausea and Vomiting in Adult Patients Undergoing Elective Surgery Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Nausea and Vomiting
Keywords: nausea
vomiting
postoperative
dose adjustment
Lead sponsor: Jordan Hospital
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective surgery under general anesthesia

Brief summary: The aim is to evaluate the effectiveness of different regimens of prophylactic Ondansetron, Dexamethasone, or both, on the incidence and severity of post-operative nausea and vomiting.

Detailed description: Patients will be randomized to one of four arms: Ondansetron (4O-PE: 4 mg Ondansetron pre-emergence, 8O-PE: 8 mg Ondansetron pre-emergence, 4O-PI: 4 mg Ondansetron pre-incision, 8O-PI: 8 mg Ondansetron pre-incision), Dexamethasone (4D-PE: 4 mg Dexamethasone pre-emergence, 8D-PE: 8 mg Dexamethasone pre-emergence, or 4D-PI: 4 mg Dexamethasone pre-incision, or 8D-PI: 8 mg Dexamethasone pre-incision), Combination Therapy group (4O-PI+8D-PI: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-incision, 4O-PI+8D-PE: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-emergence, 4 O-PE+8D-PI: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction, 4 O-PE+8D-PE: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence), and Placebo group 2 ml Saline 0.9%. Primary outcome will be the incidence of PONV in the PACU prior to discharge.

Eligibility criteria: Inclusion Criteria:

* ASA grade I and II
* Aged 18-70 years
* Patients scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* All patients who received antiemetics or cortisone within 48 hr before surgery
* Pregnant, breast feeding ladies
* Any patient with BMI (Body Mass Index) \> 34 kg/m²
* Patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses were also excluded from the study protocol.

Primary outcomes:
measure: Presence of postoperative nausea and/or vomiting
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Jordan Hospital
Study officials:
affiliation: Anaesthesia Department, Jordan Hospital
name: AbdulRhman MA Ibnouf, MBBS
role: STUDY_DIRECTOR
References:
Clinical trial NCT03642041: Study of Smoking Trajectory in Newly Diagnosis Lung Cancer Patients
Official title: Smoking Trajectory in Newly Diagnosis Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newly Diagnosed Lung Cancer
Smoking, Cigarette
Survival
Quality of Life
Keywords: Smoking
Lung cancer
Survival
Quality of life
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 406
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed lung cancer patients

Brief summary: 1. Understanding the smoking change patterns among the newly diagnosis lung cancer patients after cancer diagnosis.
2. Explore the related factors of the smoking change patterns.
3. The type of smoking trajectory impact on survival and quality of life.

Detailed description: This was a prospective longitudinal design study. The investigators used the structure questionnaires to collect the data from a consecutive sample of newly diagnosed lung cancer patients.

Eligibility criteria: Inclusion Criteria:

* Over 20 years old
* Newly diagnosed lung cancer
* Conscious clear and able to communicate
* Agreed to participate the study

Exclusion Criteria:

* Consciously confused
* Cognitive or psychotic disorders

Primary outcomes:
measure: Changes From Baseline Smoking Behavior at 1,2,3,4,5,6 Months
timeFrame: baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
Secondary outcomes:
measure: Changes From Baseline Quality of Life at 1,2,3,4,5,6 Months
timeFrame: baseline, 1-month, 2-month, 3-month, 4-month, 5-month, 6-month
measure: Proportion of participants with Overall Survival up to 2 years
timeFrame: follow up to one or two years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04289441: Probiotics in Paediatric Asthma Management
Official title: "Randomized Controlled Double-blind Trial With Lactobacillus Salivarius LS01 (DSM 22775) and Bifidobacterium Breve B632 (DSM 24706) for Paediatric Asthma Management"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma in Children
Lead sponsor: Probiotical S.p.A.
Sponsor class: INDUSTRY
First posted: 2020-02-28
Enrollment: 46
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled double-blind trial
Primary purpose: TREATMENT

Brief summary: Randomized controlled double-blind trial in a child population with allergic asthma and recurring wheezing, undergoing probiotic treatment with Bifiasthm with the aim of assessing the reduction in asthma attacks.

Detailed description: Allergic disorders have dramatically increased in prevalence over the past decade, particularly in developed countries, and primary prevention of allergic disease has proved an elusive goal. There is increasing evidence that the airway microbiome influences the development of wheezing and childhood asthma. Probiotics are increasingly considered as a promising treatment for the correction of dysbiosis, reduction of systemic inflammation, and modulation of allergic diseases. The aim of this study is, therefore, to evaluate the efficacy of Bifidobacterium breve B632 (DSM 24706) and Lactobacillus salivarius LS01 (DSM 22775) in the prevention of asthmatic allergies in human subjects.

Eligibility criteria: Inclusion Criteria:

* The study will include all children aged 6 to 14, with slight and moderate persistent asthma according to GINA 2015 criteria (asthma classification did not change in GINA 2015 and 2016 guidelines), whether or not showing positive skin allergometric tests, as well as all children aged 2 yrs, 364 days to 5 years, 364 days, with recurring wheezing, whether or not diagnosed with asthma (positive and/or negative prick).

Exclusion Criteria:

* Severe persistent asthma
* Known congenital or acquired immunodeficiencies
* Cystic fibrosis
* Chronic pulmonary diseases (bronchodysplasia)
* Age \< 1 yr, 364d and 14 yrs

Primary outcomes:
measure: Reduction in Asthma episodes
timeFrame: 12 months
measure: Reduction in wheezing
timeFrame: 12 months
Secondary outcomes:
measure: Reduction of adminstrated drug quantity
timeFrame: 12 months
measure: Reduction in treatment time
timeFrame: 12 months
Other outcomes:
Locations:
city: Pozzuoli
country: Italy
facility: Primary Care Ambulatory
state: Naples
Study officials:
References:
citation: Ciprandi G, Schiavetti I, Cioffi L, Pane M, Drago L. The Probiotics in Pediatric Asthma Management (PROPAM) study: A Post Hoc analysis in allergic children. Ann Allergy Asthma Immunol. 2022 Jul;129(1):111-113. doi: 10.1016/j.anai.2022.04.026. Epub 2022 Apr 26. No abstract available.
Clinical trial NCT00249041: Enbrel Liquid Immunogenicity Protocol
Official title: Open-label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Enbrel liquid, antibodies
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Immunex Corporation
First posted: 2005-11-07
Enrollment: 447
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: The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis

Detailed description: The purpose of this study is to assess the rate of anti-etanercept antibody formation in a larger sample of subjects on liquid etanercept than the previous study, 20020378, in a minimum of 400 subjects receiving etanercept liquid for the first time, with and without concomitant MTX therapy. The rate of neutralizing antibodies to liquid etanercept will also be assessed.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Must be able to self-inject or have someone who can do so for them
* Should have Rheumatoid Arthritis per ARA criteria and screening lab results per predefined value

Exclusion Criteria:

* Any prior biologic therapy for inflammatory disease
* Any prior cyclophosphamide therapy
* Not using adequate contraception
* Pregnant or breast-feeding or any significant concurrent medical condition

Primary outcomes:
measure: Rates of anti-etanercept antibody formation to etanercept liquid with or without concomitant methotrexate (MTX) therapy at week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Rates of anti-etanercept antibody formation to etanercept liquid at week 12, and the rates of neutralizing antibodies at Weeks 12 and 24. Safety of etanercept liquid in RA subjects receiving 50 mg once weekly up to 24 weeks.
timeFrame: 12 weeks and 24 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Kavanaugh A, Lee SJ, Weng HH, Chon Y, Huang XY, Lin SL. Patient-derived joint counts are a potential alternative for determining Disease Activity Score. J Rheumatol. 2010 May;37(5):1035-41. doi: 10.3899/jrheum.090704. Epub 2010 Feb 15.
Clinical trial NCT06880341: Managing Transient Neurologic Episodes in Surgery for Moyamoya Disease
Official title: MagNETs- Managing Transient Neurologic Episodes in Surgery for Moyamoya Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moya Moya Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 88
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Moyamoya subject undergoing a standard of care direct and indirect extracranial-intracranial (ECIC) bypass.

Brief summary: The goal of this study is to study the incidence of post-operative Transient Neurologic Events (TNEs) within 30 days postoperatively, as assessed by clinical neurological scales, binned by week. Collect data on all interventions and assessments performed during the recovery post surgery up to 30 days, to understand what factors might cause Transient Neurologic Events (TNEs) and determine how these can be reduced in Moyamoya subjects post surgery.


Eligibility criteria: Inclusion Criteria:

* Moyamoya Disease (MMD) patients undergoing direct extracranial-intracranial (ECIC) bypass. Patients above the age of 3 years old are eligible for the study

Exclusion Criteria:

* Renal dysfunction, electrolyte disturbances neuromuscular disorders including Myaesthenia Gravis, heart block

Primary outcomes:
measure: Transient Neurologic Events (TNEs)
timeFrame: 30 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Hospital
state: California
Study officials:
References:
Clinical trial NCT06169241: Effect of Nitrate Supplementation on Blood Pressure and Microvascular Function of Resistant Hypertensive Patients
Official title: Effect of Nitrate Supplementation on Blood Pressure and Systemic Microvascular Function of Resistant Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Arterial Hypertension
Resistant Hypertension
Microvascular Function
Nitrate Supplementation
Keywords: microcirculation
capillary density
microvascular reactivity
systemic resistant hypertension
Lead sponsor: National Institute of Cardiology, Laranjeiras, Brazil
Sponsor class: OTHER_GOV
First posted: 2023-12-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Treatment with beetroot extract powder - nutritional supplementation
Primary purpose: TREATMENT

Brief summary: Arterial hypertension (AH) has been identified as an important public health problem and considered a new epidemic with high mortality and morbidity. High blood pressure (BP) levels increase the chances of coronary artery disease (CAD), heart failure (HF), stroke, chronic renal failure (CRF) and death. Beetroot powder may be an easier way to increase the availability of nitric oxide and consequently vasodilation in these patients. However, studies are needed to evaluate its benefits in patients with AH.


Eligibility criteria: Inclusion Criteria:

* Resistant hypertension, with a diagnosis described in the medical record, without changing medications or increasing doses in the last 30 days.

Exclusion Criteria:

* neoplasms
* heart failure
* use of medications with nitrate in their formula
* patients undergoing renal denervation

Primary outcomes:
measure: Assessment of blood pressure evolution
timeFrame: 60 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: National Institute of Cardiology
Study officials:
References:
Clinical trial NCT00548041: Rapid HIV Testing Program in the Emergency Department
Official title: Pilot Study to Evaluate a Rapid HIV Testing Program in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV
Emergency Department
HIV Seronegativity
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2007-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to evaluate the feasibility of a rapid HIV testing program in the Temple University Hospital(TUH)Emergency Department. We hypothesize that a rapid HIV testing program in the TUH Emergency Department is feasible. Patients presenting to the Adult TUH Emergency Department with certain conditions will be offered rapid HIV testing. Testing will be performed by oral swab using the OraQuick Advance test. Patients will receive post-test counseling.


Eligibility criteria: Inclusion Criteria:

One of the following conditions:

* Sexually transmitted disease evaluation or prior history of sexually transmitted disease
* Pregnancy
* Clinical condition that suggests possible immunodeficiency
* History of illicit drug use
* History of chronic viral hepatitis
* Patients with unexplained pneumonia or recurrent pneumonia
* Male patients who have a history of sex with men
* Abdominal pain in a sexually active woman or urethritis in a man
* Trauma.
* Age 18 years old or older.

Exclusion Criteria:

* Age less than 18 years.
* None of the above conditions.

Primary outcomes:
measure: Feasibility of Rapid HIV Testing in Emergency Department
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Ellen Tedaldi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00115141: Four Week Safety and Efficacy Study With a Topical Gel to Treat Common Warts in Adults
Official title: A Three-Stage, Modified-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 3 Times Per Week for 4 Weeks for the Treatment of Common Warts in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Warts
Keywords: Wart(s)
Adults
Common Wart(s)
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2005-06-22
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the effectiveness in adults, of four different strengths of resiquimod gel applied to common wart(s) three times a week for four weeks.

A second purpose is to evaluate the safety of the drug.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of common warts
* Two forms of birth control

Exclusion Criteria:

* Pregnant or breast feeding
* Other types of warts, ie. plantar
* Currently participating in another clinical study
* Chronic viral hepatitis B or C

Primary outcomes:
measure: Clearance of treated wart(s)
Secondary outcomes:
measure: Partial clearance of treated wart(s)
measure: Wart recurrence
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00759941: A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin
Official title: A Comparison of Brinzolamide Ophthalmic Suspension, 1% (Azopt) TID vs. Placebo TID Added to Latanoprost Ophthalmic Solution, 0.005% (Xalatan) in Patients With Elevated IOP on a Prostaglandin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 86
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to assess the efficacy of adding Azopt dosed three times a day to Xalatan as compared to that of adding placebo to Xalatan in patients with elevated intraocular pressure.


Eligibility criteria: Inclusion Criteria:

* Unilateral or bilateral primary open angle glaucoma, ocular hypertension or pseudoexfoliation syndrome.
* Intraocular pressure greater than 18 mmHg (mean diurnal) and less than 32 mmHg.
* Other protocol-defined inclusion criteria applied.

Exclusion:

* Previous intraocular surgery, except uncomplicated clear cornea phacoemulsification or argon laser trabeculoplasty.
* Argon laser trabeculoplasty or phacoemulsification within the last 3 months.
* Central corneal thickness outside the 500 - 600 (inclusive) micron range as measured by ultrasonic pachymetry.
* Ocular or periocular inflammation within 3 months prior to study (except blepharitis related or seasonal allergic conjunctivitis).
* History of uveitis or previous intraocular inflammation (other than post-operatively).
* Hypersensitivity to sulfa, or benzalkonium chloride.
* History of use of any steroids for over 1 week within 3 months of screening or likely need for any corticosteroids during the study (except inhaled, nasal or topical non-ocular).
* Other protocol-defined exclusion criteria applied.

Primary outcomes:
measure: Mean Change From Baseline in Intraocular Pressure, 8 AM, at 3 Months
timeFrame: Day 0, 3 months
measure: Mean Change From Baseline in Intraocular Pressure, 12 PM, at 3 Months
timeFrame: Day 0, 3 months
measure: Mean Change From Baseline in Intraocular Pressure, 4 PM, at 3 Months
timeFrame: Day 0, 3 months
measure: Mean Change From Baseline in Intraocular Pressure, Diurnal, at 3 Months
timeFrame: Day 0, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT02031341: Peripheral Insulin Uptake in Type 2 Diabetes Mellitus and in Non-Diabetic Individuals
Official title: Peripheral Insulin Uptake in Type 2 Diabetes Mellitus and in Non-Diabetic Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 50 subjects with T2DM and 50 nondiabetic individuals

Brief summary: Impaired uptake of glucose by skeletal muscle is a key feature of type 2 diabetes mellitus. It is unclear to what extent impaired insulin uptake from capillaries into skeletal muscle interstitium plays a role in this process.

We hypothesize that impaired uptake of insulin from capillaries into skeletal muscle interstitium is involved in impaired glucose uptake by skeletal muscle in type 2 diabetes mellitus.


Eligibility criteria: Inclusion criteria for all participants:

* written informed consent
* hemodynamically stable with a systolic blood pressure \> 100 mmHg
* medical need to undergo a CAG procedure as determined by cardiologist

Exclusion criteria for all participants:

* ongoing myocardial infarction as determined from elevated cardiac markers
* participation in an investigational trial within 90 days prior to present study
* donation of blood (\> 100 mL) within 90 days prior to present study
* serious mental impairment or language problems i.e. preventing to understand the study protocol/aim
* Use or recent use (within 3 months of study participation) of oral glucocorticoids

Inclusion criteria for non-diabetic individuals:

* 30 years ≤ age ≤ 80 years (extremes included)
* fasting glucose level of \< 7.0 mmol/L and HbA1C \< 6.5% (= \< 48 mmol/mol)

Exclusion criteria for non-diabetic individuals:

- known T2DM/use of glucose-lowering medication

Inclusion criteria for T2DM patients:

* 30 years ≤ age ≤ 80 years (extremes included)
* fasting glucose level of \> 7.0 mmol/L, or HbA1C \> 6.5 (= \> 48 mmol/mol) or known T2DM

Exclusion criteria for T2DM patients:

- treatment with insulin preparations

Primary outcomes:
measure: Fore-arm insulin uptake measured as ([A]-[V]) x F in pmol/min where A = arterial insulin concentrations, V= venous insulin concentrations, F = fore arm plasma flow;
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
Study officials:
References: