louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03822546: A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations
Official title: A Randomized, Open-label, Cross-over Clinical Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations in Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Fontem Ventures BV
Sponsor class: INDUSTRY
First posted: 2019-01-30
Enrollment: 15
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes. It was designed as a randomized, open-label, cross-over clinical study conducted in 15 healthy US adult smokers.


Eligibility criteria: Inclusion Criteria:

* Having smoked ≥10 manufactured cigarettes per day for at least the last year
* Expired carbon monoxide level of \>10 ppm at screening
* Tested positive for urinary cotinine (≥500 ng/mL)

Exclusion Criteria:

* Known or suspected hypersensitivity to any component of the e-liquid formulations
* Taking or receiving prescription smoking cessation medicines
* Willing or considering to stop smoking
* Smokers who draw smoke into their mouth and throat but do not inhale
* Relevant illness history
* Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2
* Breastfeeding women
* Women of child-bearing potential who were not using an accepted method of contraception

Primary outcomes:
measure: Nicotine pharmacokinetics Cmax
timeFrame: 30 minutes following the start of product use (12 measurements over the period)
measure: Nicotine pharmacokinetics Tmax
timeFrame: 30 minutes following the start of product use (12 measurements over the period)
measure: Nicotine pharmacokinetics AUC0-30
timeFrame: 30 minutes following the start of product use (12 measurements over the period)
Secondary outcomes:
measure: Subjective effects questionnaire
timeFrame: 20 minutes after the start of product use
measure: Incidence and nature of any adverse events (AE)
timeFrame: Through study completion, 6 days
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
References:
Clinical trial NCT00803946: Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 mg Tablets Under Fed Conditions
Official title: A Randomized, Single-Dose, Two-Way Crossover Relative Bioavailability Study of Ibuprofen Tablet Formulations in Normal, Healthy Men and Women Following Standard Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioequivalency
Keywords: bioequivalency
ibuprofen
Lead sponsor: Perrigo Company
Sponsor class: INDUSTRY
First posted: 2008-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the rate and extent of absorption of two oral formulations of Ibuprofen 800 mg Tablets, administered as a 1 x 800 mg tablet, under fed conditions.


Eligibility criteria: Inclusion Criteria:

* healthy men or women, 18 years of age or older
* body mass index between 19 and 30
* willing to participate and sign a copy of the informed consent form

Exclusion Criteria:

* history of allergy or hypersensitivity to ibuprofen
* recent history of drug or alcohol addiction or abuse
* pregnant or lactating women
* use of tobacco products during the past 3 months
* evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
* receipt of any drugs as part of a research study within 30 days prior to study dosing

Primary outcomes:
measure: Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01004146: Pre-op Use of Incentive Spirometry in Obese Patients
Official title: A Study on the Preoperative Use of Incentive Spirometry in Morbidly Obese Patients Undergoing General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Function
Bariatric Surgery
Keywords: incentive spirometry
bariatric surgery
obesity
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2009-10-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the use of preoperative incentive spirometry (IS) as an aid to improve postoperative lung function. The hypothesis is that application of a standardized protocol of preoperative respiratory care teaching and exercise will improve lung performance that will subsequently result in prevention of postoperative pulmonary complications and that increasing the duration of preoperative use better improves lung mechanics postoperatively. The investigators propose to compare a patient population that uses IS as currently prescribed in the routine course of care (only to be familiar with preoperatively, but use postoperatively) against a population that uses IS with a standardized regimen for at least 3 days prior to the operation in terms of preoperative IS volumes, intraoperative pulmonary mechanics, postoperative IS volumes, and incidence of postoperative pulmonary complications.


Eligibility criteria: Inclusion Criteria:

* morbid obesity
* bariatric surgery
* must be able to use incentive spirometer

Exclusion Criteria:

* BMI=\<40 kg/m2
* current symptoms of obstructive sleep apnea or actively using continuous positive airway pressure

Primary outcomes:
measure: Post Operative Incentive Spirometry Volume
timeFrame: 1 week before surgery to the day after
Secondary outcomes:
measure: Level of Compliance
timeFrame: 3 days to 2 weeks after clinic visit on the day of surgery
measure: Oxygen Saturation
timeFrame: one week prior to surgery up to one day after
measure: Heart Rate
timeFrame: one week prior to surgery to post operative day 1
measure: Respiratory Rate
timeFrame: one week prior to surgery to post operative day 1
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: University of Texas Medical School
name: Davide Cattano, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04755946: Possible Role of Roflumilast in Diabetic Nephropathy
Official title: Clinical Study Evaluating the Possible Efficacy and Safety of Roflumilast in Patients With Diabetic Nephropathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Nephropathies
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: adding roflumilast to the standard therapy for diabetic nephropathy and studying the progression of many outcomes including urinary albumin to creatinine ratio, estimated GFR, biomarkers of diabetic nephropathy


Eligibility criteria: Inclusion Criteria: diabetic patients with persistent micro- or macroalbuminuria despite treatment with the maximum tolerated dose of ACE inhibitors for at least 8 weeks before the screening and randomization

* Type I or II diabetic patient with stage 2 CKD (eGFR = 60 - 89 ml/min) ,stage 3 CKD (eGFR = 30 - 59 ml/min) or stage 4 (eGFR 15-29 ml/min)

Exclusion Criteria:

* moderate to severe hepatic disease (Child-Pugh B or C) severe renal disease (eGFR\<15 ml/min) body-mass index below 25 kg/m2 concomitant use of strong cytochrome P450 inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) known psychiatric illness, congestive heart disease patients with allergy for roflumilast pregnant and lactating women

Primary outcomes:
measure: Percent change in urinary albumin creatinine ratio (UACR)
timeFrame: Baseline and 3 months
measure: Absolute change in Estimated glomerular filtration rate (eGFR)
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in Urinary pro-inflammatory cytokine MCP-1
timeFrame: Baseline and 3 months
measure: Change in serum irisin level
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Pharm D
name: Hisham M Elnahhas, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03940846: CT-based Radiomic Signature Can Identify Adenocarcinoma Lung Tumor Histology
Official title: CT-based Radiomic Signature Can Identify Adenocarcinoma Lung Tumor Histology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nonsmall Cell Lung Cancer
Lead sponsor: Maastricht University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Radboud University Medical Center
First posted: 2019-05-07
Enrollment: 650
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with NSCLC, who further underwent tissue biopsy to determine tumor histology.

Brief summary: Lung cancer remains the leading cause of cancer related mortality worldwide, with more than 1.5 million related deaths annually. Lung cancer is divided into two main groups: Small Cell Lung Carcinoma (SCLC) and Non-Small Cell Lung Carcinoma (NSCLC), with prevalence of \~20% and 80% respectively. NSCLC is further subdivided into adenocarcinoma (the most common), squamous cell carcinoma (SCC), and large cell carcinoma. Furthermore, each subtype is likely to have specific mutations, which could be targeted for treatment.

Medical imaging and radiomics feature extraction represent a candidate alternative to conventional tissue biopsy, a theory that is investigated in this study.


Eligibility criteria: Inclusion Criteria:

* Availability of diagnostic non-contrast enhanced CT scan.
* Availability of histologic tumor analysis results

Exclusion Criteria:

-

Primary outcomes:
measure: Lung histology
timeFrame: December 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
state: Limburg
Study officials:
References:
Clinical trial NCT00858169: Assessment of Wrist Joint and Knee Joint Inflammation in Patients With Rheumatoid Arthritis by Quantitative Three Dimensional Power Doppler Ultrasonography
Official title: Taichung Veterans General Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: three-dimensional power Doppler ultrasonography
wrist
knee
rheumatoid arthritis
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2009-03-09
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 30 patients with RA who visit outpatient clinic of Rheumatology at Taichung Veterans General Hospital (TCVGH) will be enrolled consecutively at if they met the study inclusion criteria

Brief summary: The purpose of this study is to:

1. To investigate the wrist joint synovial blood flow intensity and model by quantitative three-dimensional (3D) power Doppler ultrasonography (PDUS) in patients with rheumatoid arthritis before and after initiation of a new medicine and compare these data with routinely used clinical data and laboratory findings, such as pain score, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)
2. To investigate the intra-observer and inter-observer agreement of quantitative 3D PDUS assessment of the vascularity in wrist joints and knee joints using automatic volume scan.


Eligibility criteria: Inclusion Criteria:

* Patients who fulfill the 1987 ARA criteria for RA
* Patients with at least one painful swollen wrist or knee joint observed by a rheumatologist
* Patients who will receive a new medicine, including oral corticosteroid, intravenous methylprednisolone pulse therapy, intraarticular injection with steroid or methotrexate, DMARDs, or biologic agent

Exclusion Criteria:

* Patients with active infection
* Patients with concurrent malignant disease
* Patients with a history of traumatic, septic, or cystal arthritis, previous joint surgery, or arthroscopic synovectomy of any wrist or kneejoint within the past 12 months before the study
* Patients who have severe wrist or knee joint deformity that makes the US assessment protocol unable to complete

Primary outcomes:
measure: Correlation between 2D- and 3D-PDUS quantification data and clinical data, including pain score, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)
timeFrame: cross-sectional
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01860469: Reducing Mesh Infections in Open Hernia Repairs
Official title: Does Soaking Synthetic Mesh in Vancomycin Solution Reduce Mesh Infections in Open Hernia Repairs?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Patients Undergoing Open Hernia Repair
Patients Undergoing Ventral or Inguinal Hernia Repair
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
First posted: 2013-05-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Soaking meshes in a vancomycin solution just prior to their use in open hernia repairs will decrease rates of mesh infection


Eligibility criteria: Inclusion Criteria:

* open ventral or inguinal hernia repair

Exclusion Criteria:

* laparoscopic hernia repair
* non ventral or inguinal hernia repairs

Primary outcomes:
measure: mesh infections
timeFrame: 6 months
Secondary outcomes:
measure: hernia recurrence
timeFrame: 6 months
measure: postoperative seroma formation
timeFrame: 6 months
Other outcomes:
Locations:
city: Moose Jaw
country: Canada
facility: Five Hills Health Region
state: Saskatchewan
Study officials:
References:
Clinical trial NCT03725969: Effect of Camel Milk on Insulin and Incretin Response
Official title: The Effect of Camel Milk on Insulin and Incretin Response to a Mixed-meal Challenge in People With Normal Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insulin Sensitivity
Glucose Tolerance
Lead sponsor: Imperial College London Diabetes Centre
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To examine the differential effect of camel and cow milk on the physiological response, to a liquid mixed-meal challenge, in people with normal glucose tolerance

Detailed description: Camel milk is used as a traditional remedy throughout the Middle East and Indian Subcontinent for conditions such as type 2 diabetes and dyslipidemia. It is currently unclear how such an effect could be mediated in vivo and studies are limited. We performed this study as a pilot experiment to assess the effects of camel milk on Insulin, Glucose, GLP-1, C-peptide and Lipid profile.

Eligibility criteria: Inclusion Criteria:

* Normal glucose tolerance
* BMI \< 30 kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus
* Type 2 diabetes mellitus
* Impaired fasting glucose or impaired glucose tolerance
* Lactose intolerance
* Weight loss / gain ≥ 5 kg in the preceding two months
* Use of estrogenic drugs or corticosteroids
* Known hypertriglyceridemia requiring treatment
* History of heart attack, angina or cardiovascular disorder
* History of malignant tumor
* Pregnant or lactating women
* Hemoglobin \< 12 for any reason
* Recent surgery or major hemorrhage
* History of bariatric or metabolic surgery

Primary outcomes:
measure: Glucose response to camel and cow milk
timeFrame: 5 months
measure: Response of glucose to camel and cow milk
timeFrame: 5 months
Secondary outcomes:
measure: Insulin response to camel and cow milk
timeFrame: 5 months
measure: Response of insulin to camel and cow milk
timeFrame: 5 months
measure: GLP-1 response to camel and cow milk
timeFrame: 5 months
measure: Response of GLP-1 to camel and cow milk
timeFrame: 5 months
measure: C-peptide response to camel and cow milk
timeFrame: 5 months
measure: Response of C-peptide to camel and cow milk
timeFrame: 5 months
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Imperial College London Diabetes Centre
Study officials:
affiliation: Imperial College London Diabetes Centre
name: Dr Nader Lessan, MBBS MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05783869: Study of Bronchiectasis and Associated Cardiovascular Comorbidities
Official title: Effect of Cardiovascular Comorbidities on Disease Severity and Quality of Life in Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiectasis
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Aliae AR Mohamed Hussein [ahussein
First posted: 2023-03-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: all patients at the study period attending the chest department at Assuit university

Brief summary: Effect of cardiovascular comorbidities on disease severity and quality of life in Patients with acute exacerbation of non-cystic fibrosis bronchiectasis

Detailed description: The study will include patients with bronchiectasis, and in an attempt to correlate the effect and burden of cardiovascular comorbidities in those patients, we will study the quality of life in those patients in comparison to the control group ( patients with bronchiectasis and without any other comorbidities) using SF-36 quality of life questionnaire. We will also study the inflammatory markers in both groups using D-dimer, BNP, and CRP and correlate them with the frequency of hospital admission, the severity of symptoms, and the general health state.

Eligibility criteria: Inclusion Criteria:

• Any Patients with Bronchiectasis had no comorbidities other than cardiovascular comorbidities during the study period.

Exclusion Criteria:

* Any Patients who refuse to participate in the study.
* Any other comorbidity or end-organ failure may affect the study's result.

Primary outcomes:
measure: assessment of BNP (Brain natriuretic peptide) pg/ml levels in patients with bronchiectasis and cardiovascular comorbidities.
timeFrame: March 2023 to September 2023
measure: Assessment of Quality of life in patients and control groups using The Short Form (36) Health Survey (SF-36)
timeFrame: March 2023 to September 2023
Secondary outcomes:
measure: Hospitalization frequency in patient group compared to control group.
timeFrame: March 2023 to September 2023
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut unviresty - Faculty of Medicine
Study officials:
affiliation: Assuit University Faculty of Medicine
name: Ahmad Shaddad
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University Faculty of Medicine
name: Ahmad Shaddad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03651869: Effects of Nicotine in Tobacco Smokers
Official title: Mechanisms Linking Obsessive-Compulsive Symptoms and Tobacco Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking, Tobacco
Smoking (Tobacco) Addiction
Keywords: Smoking
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Illinois Institute of Technology
First posted: 2018-08-29
Enrollment: 221
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will examine mechanisms linking Obsessive-Compulsive Disorder symptomatology to tobacco dependence.


Eligibility criteria: Inclusion Criteria:

* At least 21 years old
* Daily smoking at least 2 years

Exclusion Criteria:

* Currently pregnant or breastfeeding.

Primary outcomes:
measure: Smoking Urge
timeFrame: Throughout study completion, an average of two weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Adam M Leventhal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00611169: The Effects of Facilitated Percutaeous Coronary Intervention in Acute Myocardial Infarction
Official title: The Effects of Facilitated Percutaeous Coronary Intervention Compared to Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: Angioplasty, Transluminal, Percutaneous Coronary
tirofiban
Magnetic Resonance Imaging
Myocardial Infarction
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study to investigate whether the administration of high-dose tirofiban before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced magnetic resonance imaging.


Eligibility criteria: Inclusion Criteria:

* presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
* ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage

Exclusion Criteria:

* hemodynamic instability
* history of MI
* old age \> 80years
* Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)

Primary outcomes:
measure: Infarct size and its transmural extent using MRI
timeFrame: within the first 30 days after index procedure
Secondary outcomes:
measure: pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography
timeFrame: at 6 month after index procedure
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Hyeon-Cheol Gwon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: