louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02532894: Effects of E-smoke on Levels of Endothelial Progenitor Cells and Microparticles in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: endothelial dysfunction
microvesicles
endothelial progenitor cells
electronic cigarettes
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2015-08-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: We plan to investigate the acute effects of inhaling e-cigarette vapor on cell function measured by microvesicles and endothelial progenitor cells. Micro vesicles are released upon either activation or apoptosis from different cell types such as platelets, leucocytes and endothelial cell. Endothelial progenitor cells are a type of stem cells that circulate in the blood with the ability to differentiate to endothelial cells. Endothelial progenitor cells are inversely correlated to cardiovascular risk factors.

As a secondary endpoint we plan to investigate exhaled nitric oxide - a common inflammation marker used in asthmatic patients - after inhalation of electronic cigarette vapor.


Eligibility criteria: Inclusion Criteria:

* healthy subjects
* sporadic cigarette smoking (\<9 cigarettes per month)

Exclusion Criteria:

* Any form of cardiovascular disease
* Any form of pulmonary disease like asthma or COPD
* Any form of systemic or chronic disorder like rheumatologic or metabolic diseases.
* Active allergy within 4 weeks of the study
* Symptoms of infection or inflammation within 4 weeks of the study
* Pregnancy

Primary outcomes:
measure: Change in number of endothelial progenitor cells
timeFrame: 24 hours
measure: Change in number of micro vesicles
timeFrame: 24 hours
Secondary outcomes:
measure: Change in exhaled nitric oxide
timeFrame: 24 hours
Other outcomes:
Locations:
city: Danderyd
country: Sweden
facility: Institutionen för kliniska vetenskaper, Danderyds sjukhus
state: Stockholm
Study officials:
affiliation: Institutionen för kliniska vetenskaper, Danderyds sjukhus
name: Magnus Lundbäck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00840294: Randomized Trial of Ciprofloxacin Versus Observation for Men With Elevated Prostate Specific Antigen (PSA)
Official title: Randomized, Multi-Institution Trial of Ciprofloxacin Versus Observation for Men With an Elevated Prostate Specific Antigen (PSA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Elevated Prostate Specific Antigen
Keywords: Men with Elevated PSA
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 85
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the impact of an empiric course of antibiotics for men with an elevated prostate-specific antigen (PSA) level.

Detailed description: Study Objectives:

Primary Objective: To assess the impact of ciprofloxacin on the change in PSA from baseline/randomization to prostate biopsy

Secondary Objective: To assess the impact of ciprofloxacin on the overall infectious complications following prostate biopsy

The impact of observation versus ciprofloxacin on PSA levels will be assessed by PSA change from baseline. The first PSA measurement will be at the study entry and randomization. The second PSA measurement will be immediately prior to prostate biopsy, which will occur 21-45 days following randomization.

Eligibility criteria: Inclusion Criteria:

* Men 18 yrs. or older
* An elevated PSA (\>2.5 ng/ml) and normal digital rectal exam
* Have elected to proceed with a diagnostic 12-core prostate biopsy

Exclusion Criteria:

* Previous prostate biopsy
* History of prostate cancer
* Urinary tract infections or prostatitis within one year of study entry
* antibiotic use within one month prior to PSA level
* pyuria or bacteruria on urinalysis
* allergy to fluoroquinolones

Primary outcomes:
measure: Change in PSA Level From Baseline
timeFrame: At baseline and 21-45 days after randomization
Secondary outcomes:
measure: Overall Infectious Complication Rate Following Prostate Biopsy
timeFrame: Within 24 hours of biopsy
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Scott Eggener, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00302094: Image Fusion PET, CT and 3D-ultrasound Examinations
Official title: Image Fusion PET, CT and 3D-ultrasound Examinations in Treatment of Anal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2006-03-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with anal cancer

Brief summary: CT-examinations are used in computer programs which are used in the planning of external radiation of cancers in the anal canal. In CT the structures of the anal canal are hardly visible. 3D-ultrasound examinations offer a better visualisation of normal and pathological structures of the anal canal. The description of the tumour made from the 3D-ultrasound examination is used in the planning of the external radiation.

PET-CT is used to visualise tumour activity also in lymp nodes. The hypothesis of the study is that image fusion of PET, CT and 3D-ultrasound will offer better visualisation of tumour and hereby more accurate diagnostics and treatment.


Eligibility criteria: Inclusion Criteria:

* Histologically verified cancer of the anal canal

Exclusion Criteria:

* Pregnancy
* Unability to cooperate to radiation therapy

Primary outcomes:
measure: Program to fuse 3D ultrasound and PET/CT data
timeFrame: april 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Clinic of Radiology, Section of Ultrasound, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Michael B Nielsen, Dmsci, phd.
role: STUDY_DIRECTOR
affiliation: Rigshospitalet, Denmark
name: Caroline Ewertsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03610594: Effects of Kalaripayattu on Psychological Wellbeing and Behavior in Children
Official title: Effects of Kalaripayattu on Psychological Wellbeing and Behavior in Children: Randomised Wait- List Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological
Behavior
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Warwick Research Services
name: Swamigal Trust for Vedic Science, India
First posted: 2018-08-01
Enrollment: 70
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Kalaripayattu is an ancient martial art of India which has been practiced for centuries. It is mentioned in Vedic litrature of Ayurveda,Dhanurveda and Yoga. The main elements of Kalaripayattu include training in physical, combat, breathing exercises, higher form of meditation and specific class of medical treatments. The purpose of the experimental study is to determine the effect of kalaripayattu on psychological well-being and behaviour in children.


Eligibility criteria: Inclusion Criteria:

* Children from 8 years to 12 years of age
* Parents agreed to informed consent

Exclusion Criteria:

* Physical disabilities
* Diagnosed Mental or behavioural disorder
* Practicing other exercise, physical trainings or yoga

Primary outcomes:
measure: Psychological Well-being
timeFrame: Change from baseline to 12 weeks
Secondary outcomes:
measure: Behavior
timeFrame: Change from baseline to 12 weeks
Other outcomes:
Locations:
city: Jaipur
country: India
facility: NMP Medical Reserach Institute
state: Rajasthan
Study officials:
affiliation: Warwick Research Services
name: Neha sharma, PhD
role: STUDY_DIRECTOR
affiliation: Swamigal Trust for Vedic Studies
name: Ravishankar Ramanathan, BA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05435794: Long-term Benefits of CPAP or MAD Treatment on the Sleep of OSAS Patients
Official title: Long-term Benefits of Continuous Positive Pressure Therapy or Mandibular Advancement Devise on the Sleep of Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: OSA
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2022-06-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited based on scheduled appointments at the various centers that participate in the SunSAS clinical trial and are diagnosed and managed for their OSA in accordance with standard practice.

Brief summary: The REMAP study aims to follow a cohort of 400 patients in around ten sleep centers in France and to collect clinical routine data. The objectives of this study are to investigate the effects of one-year management of OSA by CPAP or MAD on sleep architecture defined by objective macro and micro sleep architecture parameters using a sleep test device. sleep connected at home, to assess the quality of sleep and the quality of life reported by patients. The study will also allow us to define predictive factors for improving sleep quality during OSA treatment.


Eligibility criteria: Inclusion Criteria:

* Patient already included in the SunSAS study (No. ID/RCB: 2021-A01827-34) or Patient who has undergone polygraphy or polysomnography eligible for treatment with CPAP or MAD in the context of OSA.
* Patient with a sleep test performed with the Sunrise device
* Men or Women from 18 to 80 years old
* Patient with OSAS eligible for CPAP or MAD therapy
* Affiliated patient or beneficiary of a social security scheme
* Signed informed consent

Exclusion Criteria:

* Patient previously treated for OSAS by CPAP or MAD during the last five years
* Patient with COPD or other respiratory diseases.
* Patient with contraindications to PPC or MAD therapy
* Patient with unstable heart disease or New York Heart Association class III or IV heart failure
* Patient unable to complete the study

Primary outcomes:
measure: To determine the evolution of deep slow-wave sleep at one year in OSA patients according to the treatment initiated by continuous positive pressure or mandibular advancement device (MAD).
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
city: Lyon
country: France
facility: CHU Lyon - Hôpital de la Croix-Rousse
city: Marseille
country: France
facility: Hopital Europeen Marseille
city: Paris
country: France
facility: APHP - Pitié-Salpêtrière University Hospital
city: Paris
country: France
facility: AP-HP Bichat
city: Reims
country: France
facility: CHU Reims
city: Rennes
country: France
facility: Polyclinique St Laurent
city: Saint-Martin-d'Hères
country: France
facility: Centre du Sommeil
Study officials:
References:
Clinical trial NCT04686994: Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase Ib Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC41 Tables in Overweight and Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight and Obesity
NAFLD
Hyperlipidemia
Keywords: Overweight and Obesity
NAFLD
Hyperlipidemia
LDL-C
NASH
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Hunan Provincial People's Hospital
First posted: 2020-12-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment 3:1 ratio
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and obese subjects who have elevated LDL-C .


Eligibility criteria: Key Inclusion Criteria:

* 23kg/m2 ≤ BMI \<40kg/m2.

Key Exclusion Criteria:

* A history of thyroid disease.
* A positive HBsAg, HCV Ab and/or HIV Ab.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Up to 28 days
Secondary outcomes:
measure: AUC of ASC41
timeFrame: Up to 28 days
measure: Cmax of ASC41
timeFrame: Up to 28 days
measure: t1/2 of ASC41
timeFrame: Up to 28 days
measure: CL/F of ASC41
timeFrame: Up to 28 days
measure: Vd/F of ASC41
timeFrame: Up to 28 days
measure: Tmax of ASC41
timeFrame: Up to 28 days
measure: LDL-C and other lipid parameters
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan provincial people's hospital
state: Hunan
Study officials:
References:
Clinical trial NCT03930394: Vascular Cardiotoxicity of Ponatinib
Official title: Vascular Cardiotoxicity of Ponatinib
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiotoxicity
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects diagnosed with CML or ALL who are to be treated with ponatinib.

Brief summary: Pre-clinical studies suggest that the third generation tyrosine kinase inhibitor ponatinib can result in microvascular angiopathy and acceleration of atherosclerosis. This study is intended to examine for myocardial microvascular angiopathy and changes in carotid plaque in patients receiving ponatinib as part of their clinical care.

Detailed description: In this study, we will perform serial echocardiography for ventricular function, myocardial contrast echocardiography for microvascular perfusion assessment, blood analysis for myocardial injury, and carotid US for plaque or IMT progression in subjects receiving ponatinib. This series of tests is intended to provide information on the presence of clinically-evident or subclinical microvascular angiopathy and plaque acceleration.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of CML or ALL
* Prescribed ponatinib

Exclusion Criteria:

* pregnancy or lactation
* major medical illness involving the heart or vasculature (CAD, PAD, DCM).
* hemodynamically unstable
* allergy to ultrasound contrast agents.

Primary outcomes:
measure: Presence versus absence of any myocardial perfusion defect assessed by visual analysis for any abnormalities of microvascular flux rate (beta function) or microvascular blood volume during an infusion of ultrasound microbubble contrast agents.
timeFrame: 6 months
measure: Presence versus absence of any myocardial perfusion defect assessed by visual analysis for any abnormalities of microvascular flux rate (beta function) or microvascular blood volume during an infusion of ultrasound microbubble contrast agents.
timeFrame: 12 months
measure: Carotid plaque size
timeFrame: 6 months
measure: Carotid plaque size
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon HSU
state: Oregon
Study officials:
References:
citation: Latifi Y, Moccetti F, Wu M, Xie A, Packwood W, Qi Y, Ozawa K, Shentu W, Brown E, Shirai T, McCarty OJ, Ruggeri Z, Moslehi J, Chen J, Druker BJ, Lopez JA, Lindner JR. Thrombotic microangiopathy as a cause of cardiovascular toxicity from the BCR-ABL1 tyrosine kinase inhibitor ponatinib. Blood. 2019 Apr 4;133(14):1597-1606. doi: 10.1182/blood-2018-10-881557. Epub 2019 Jan 28.
Clinical trial NCT05560594: Investigate Bladder and Prostate During Emptying With Intermittent Catheter
Official title: Explorative Study Investigating the Urinary Bladder and Prostate During Intermittent Catheterization in Healthy Male Adults by Use of MR-scanning.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Function
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2022-09-29
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Explore the behavior of the urinary bladder and prostate during emptying the bladder with an intermittent catheter.

By use of 3D scanning techniques and dynamic MRI, the objective is to investigate behavior of bladder emptying using an intermittent catheter compared to the voluntary bladder emptying.
Primary purpose: OTHER

Brief summary: Explorative study investigating the urinary bladder and prostate during intermittent catheterization in healthy male adults by use of MR-scanning.

Detailed description: 12 healthy male adults will be enrolled in the investigation. The study includes one study visit where MR-scans of the bladder and prostate will be performed during normal voiding as baseline measurement followed by measurements during emptying of the bladder with an intermittent catheter (SpeediCath CH12 standard male intermittent catheter).

Eligibility criteria: Inclusion Criteria:

* Male
* Has given written informed consent
* Be at least 18 years of age and have full legal capacity

Exclusion Criteria:

* Participate in any other clinical investigation
* Has symptoms of UTI (Investigator's judgement)
* Has known abnormalities and/or diseases in the bladder and/ or the lower urinary tract
* Has had previous disease or surgery in lower urinary tract
* Has any MR-scanning contraindication - according to "MR check list"

Primary outcomes:
measure: Bladder morphology
timeFrame: Within 1 year after termination
measure: Bladder behavior
timeFrame: Within 1 year after termination
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Per.bagi@regionh.dk /+45 35 45 83 10
name: Per Bagi, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06889194: Knowledge, Attitude and Barriers of Egyptian and Sudanese Dentists in Providing Oral Care to Geriatric Patients
Official title: Knowledge, Attitude and Barriers of Egyptian and Sudanese Dentists in Providing Oral Health Care to Geriatric Patients: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Knowledge, Attitude and Barriers of Egyptian and Sudanese Dentists in Providing Oral Health Care to Geriatric Patients
Keywords: knowledge, attitudes, and barriers of Egyptian and Sudanese dentists - Geriatric patient-
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Post graduated Sudanese and Egyptian Dentists currently practicing in Egypt and Sudan

* Experience: Dentists who have been practicing for at least 1 year to ensure they have enough experience to have formed opinions and practices regarding geriatric care.
* Age: 25-60 years

Brief summary: The goal of this observational study (Cross sectional study) is to assess the level of knowledge of Egyptian and Sudanese dentists about the oral health care needs of geriatric patients and to evaluate the attitude towards treating geriatric patients and barriers in providing care.

The data collection by validated questionnaires. The Dentists would fill out structured surveys addressing their knowledge, attitudes, and perceived barriers regarding geriatric dental care.


Eligibility criteria: Inclusion Criteria:

* Post graduated Sudanese and Egyptian Dentists currently practicing in Egypt and Sudan
* Experience: Dentists who have been practicing for at least 1 year to ensure they have enough experience to have formed opinions and practices regarding geriatric care.
* Age: 20-60 years

Exclusion Criteria:

* • Dentists Not Providing Geriatric Care: Dentists who exclusively work with Paediatric and do not treat elderly populations will be excluded.

Primary outcomes:
measure: Knowledge, Attitude and Barriers of Egyptian and Sudanese Dentists in Providing Oral Health Care to Geriatric Patients: A Cross-sectional Study
timeFrame: from April 2025 to December 2026
Secondary outcomes:
measure: Knowledge, Attitude and Barriers of Egyptian and Sudanese Dentists in Providing Oral Health Care to Geriatric Patients: A Cross-sectional Study
timeFrame: from April 2025 to December 2026
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00316394: Improving Preventive Service Delivery at Adult Complete Health Check-Ups
Official title: Improving Preventive Service Delivery at Adult Complete Health Check-Ups: the Preventive Health Evidence-Based Recommendation Form (PERFORM) Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preventive Health Care
Keywords: Preventive Health Care
Annual Health Check-up
Primary Care
Reminders
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2006-04-20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the effectiveness of a single checklist reminder form to improve the delivery of preventive health services at adult health check-ups in a family practice setting.


Eligibility criteria: Inclusion Criteria:

* Adults older than 21 years of age who had an complete health check-up completed at the clinic during the study period.

Exclusion Criteria:

* Charts were excluded if the patient was younger than 21, an investigator completed the assessment or the encounter was disease/illness specific.

Primary outcomes:
measure: Rates and relative risks (RR) of the performance of 13 preventive health maneuvers at baseline and post-intervention and the percentage of up-to-date preventive health services delivered per patient were compared between the two groups.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Vinita Dubey, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: