louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05597202: Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes
Official title: Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: diabetes mellitus
dotatate
bone marrow
semaglutide
vascular inflammation
glp1
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Dutch Heart Foundation
First posted: 2022-10-27
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To study the effect of type 2 diabetes (T2D) on vascular wall inflammation and hematopoietic stem cell composition in vivo, and whether these changes can be reversed with glucagon like peptide 1 receptor (GLP1R)-agonism.

Detailed description: We will use 68Ga-Dotatate PET/CT scans, bone marrow aspirations and peripheral blood analyses to determine the effect of type 2 diabetes on vascular wall inflammation, and hematopoietic stem cell composition, and whether these changes can be reversed using high dose semaglutide treatment, up to 2.0mg subcutaneously per week, for a period of six months.

Eligibility criteria: Inclusion Criteria:

* Age \>50 years old
* Diagnosed with type 2 diabetes
* HbA1c \>64mmol/mol

Exclusion Criteria:

1. (History of) malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator.
2. Chronic or recent infections and/or clinical signs of infection and/or a plasma C-reactive protein above 10ng/ml
3. Auto-immune diseases (including type 1 diabetes)
4. Recent or chronic immunosuppressant or antibiotic usage
5. Use of any GLP1R-agonist at baseline or prior intolerance to use of GLP1R-agonists.
6. Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.
7. Uncontrolled hypertension (systolic blood pressure \> 180mmHg, diastolic blood pressure \> 100mmHg)
8. Uncontrolled chronic inflammatory conditions, including gout.
9. Women of childbearing age who are not using effective contraceptives.
10. Heart failure New York Heart Association (NYHA) class IV at screening visit.
11. Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) ≥ 2 times the upper limit of normal (ULN) at screening visit.
12. Pancreatitis in medical history.

Primary outcomes:
measure: Difference in coronary 68Ga-Dotatate uptake after treatment.
timeFrame: 6 months
Secondary outcomes:
measure: Difference in bone marrow aspirates after treatment.
timeFrame: 6 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AMC
state: Noord-Holland
Study officials:
References:
Clinical trial NCT03426202: The Effect of Modafinil on Affective and Cognitive Processing
Official title: The Effect of Modafinil on Neural Processing During the Interference and Feedback Based Learning Task
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: modafinil
emotion
cognitive processing
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to examine whether a single dose of modafinil (200mg, p.o.) can affect feedback-based learning and interference processing in healthy male subjects.

Detailed description: Based on previous animal and human research suggesting a catecholamine-mediated, potentially pro-cognitive, mechanism of action of modafinil, the present study seeks to explore effects of modafinil on feedback-based learning and interference processing in healthy subjects. To this end, the present randomized double-blind, between-subject, placebo-controlled pharmaco-fMRI experiment plans to determine the behavioral and neural effects of a single dose of p.o.modafinil (200mg) versus placebo on validated feedback-based learning and emotional/non-emotional cognitive conflict paradigms. To control for potential effects of pre-medication personality traits as well as effects of modafinil on subjective task performance, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of meta-cognitive confidence estimation.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders
* Non-smokers
* Right-handedness

Exclusion Criteria:

* Medical or psychiatric illness
* Allergy against medications or general strong allergies
* Sleep disorders
* High blood pressure, general cardio-vascular alterations
* History of head injury
* Visual or motor impairments

Primary outcomes:
measure: Neural processing during the interference processing
timeFrame: 4h after treatment
measure: Neural processing during feedback based learning
timeFrame: 4h after treatment
Secondary outcomes:
measure: Behavioral interference performance - Response Time
timeFrame: 4h after treatment
measure: Behavioral interference performance - Accuracy
timeFrame: 4h after treatment
measure: Behavioral learning performance - Reaction time
timeFrame: 4h after treatment
measure: Behavioral learning performance - Accuracy
timeFrame: 4h after treatment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technology
state: Sichuan
Study officials:
References:
Clinical trial NCT01720121: Digital Videos Disc and Printed Guidelines and Improve the Knowledge of Patients Undergoing Cardiac Catheterization
Official title: Digital Videos Disc and Printed Guidelines and Improve the Knowledge of Patients Undergoing Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2012-11-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: This study is randomized clinical trial to verify the effect of nursing guidelines for patients undergoing left cardiac catheterization on an outpatient basis. Comparing three approaches to direct guidelines about the procedure:

* printed,
* digital video disc (DVD)
* conventional guidelines provide by nursing team

Detailed description: This study is randomized clinical trial to verify the effect of nursing guidelines for patients undergoing left cardiac catheterization on an outpatient basis. Comparing three approaches to direct guidelines about the procedure:

* guidelines printed, (GOI) with informative material
* guidelines through a digital video disc (GDVD) six minutes
* conventional guidelines provide by nursing team

Eligibility criteria: Inclusion Criteria:

* Patients undergoing the procedure were included, with age equal or superior to 18 years

Exclusion Criteria:

* patients who had already undergone previous procedures similar severe comorbidities, illiterate and who came to the facility to urgently

Primary outcomes:
measure: improvement of knowledge about the procedure after orientation
timeFrame: four months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Eneida R Rabelo da Silva, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02136121: Prospective Investigation of Robotic Single-port System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate and Kidney Cancer
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2014-05-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: To determine the feasibility of representative urologic procedures as measured by the rate of conversions


Eligibility criteria: Inclusion Criteria:

* Prostatectomy:
* Patients age 18-75 years
* BMI \<=35 kg/m2
* Confirmed localized adenocarcinoma of the prostate
* Suitable for minimally invasive prostate cancer surgery

Nephrectomy:

* Patient age 18-75 years
* BMI \<=35 kg/m2
* Kidney disease amenable to nephrectomy or partial nephrectomy
* Suitable for minimally invasive kidney surgery

Exclusion Criteria:

Untreated active infection (includes local kidney infection)

* Vulnerable population (ex: prisoners, mentally disabled)
* Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (i.e., cancer)
* Anatomy unsuitable for endoscopic visualization or minimally invasive surgery
* Patient with second primary cancer
* Extensive previous abdominal surgery
* Prior radiation treatment for prostate or kidney cancer
* Patient with distant metastasis
* Complex renal vascular anatomy
* Patient with kidney cancer - stage T3 or N+ M+ \*\*
* Horseshoe kidney\*\*
* Previous ipsilateral kidney surgery \*\*- specific to kidney surgery -

Primary outcomes:
measure: To determine the feasibility as measured by the rate of conversions
timeFrame: Intra Operative
Secondary outcomes:
measure: Perioperative surgical outcomes
timeFrame: From admission to discharge from the hospital for the primary procedure typically up to 7 days
measure: Perioperative Surgical outcomes
timeFrame: Intra-operative
measure: Perioperative Surgical Outcomes
timeFrame: 30 day, 1 year , 2 year and 3 year follow up
measure: Post-operative - Continence
timeFrame: 1 year, 2 year and 3 year follow up
measure: Perioperative Surgical Outcome- potency
timeFrame: 1 , 2 and 3 year follow up
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital HURIEZ, CHRU
Study officials:
affiliation: Hôpital HURIEZ, CHRU
name: Arnold Villers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Jihad Kaouk, MD
role: STUDY_CHAIR
References:
citation: Kaouk JH, Haber GP, Autorino R, Crouzet S, Ouzzane A, Flamand V, Villers A. A novel robotic system for single-port urologic surgery: first clinical investigation. Eur Urol. 2014 Dec;66(6):1033-43. doi: 10.1016/j.eururo.2014.06.039. Epub 2014 Jul 17.
Clinical trial NCT06917521: VAP Identification by AI
Official title: EARLY IDENTIFICATION OF VENTILATOR ASSOCIATED PNEUMONIA USING MACHINE LEARNING TECHNIQUES: A PROSPECTIVE COHORT
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ventilator Associated Pneumonia ( VAP)
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 76
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: All consecutive adult patients admitted to our ICU requiring invasive respiratory support for at least 48 hours will be enrolled

Brief summary: Ventilator-associated pneumonia (VAP) is the most frequent infection in the intensive care setting. For VAP there is currently no reliable diagnostic criteria. We aimed with the present study, using data from the mechanical ventilator to identify early this infection using artificial intelligence methods .

Detailed description: Ventilator-associated pneumonia (VAP) is defined as a hospital-acquired pneumonia occurring in patients submitted to invasive mechanical ventilation (MV) for at least 48 hours. VAP represents the most prevalent nosocomial infection in the intensive care setting. VAP is burdened by prolonged duration of MV and hospital length of stay and consequently increases hospital costs. Moreover, mortality and antibiotic use are also significantly affected. Unfortunately, there is currently no valid, accurate diagnostic criteria of VAP because even the most widely used ones are neither sensitive nor specific.. The insufficient sensitivity of these criteria to rule out VAP carries the risk of antibiotic overuse with the consequently emerging of antibiotic resistance and superinfections. On the other hand, the insufficient specificity to rule in VAP carries the risk of delayed administration of antimicrobial therapy leading to increased mortality. Ventilator-associated event surveillance failed to accurately identify VAP, too . The purpose of the present study is to develop different AI-algorithms using data continuously recorded form the mechanical ventilator in supporting clinicians for the early detection of VAP. An accurate AI-algorithm for early VAP identification has the potential to reduce morbidity, mortality, exposure to broad-spectrum and/or unnecessary antibiotics and finally to reduce costs.

Eligibility criteria: Inclusion Criteria:

* adult patients admitted to our ICU requiring invasive respiratory support for at least 48 hours

Exclusion Criteria:

* previuos pneumonia

Primary outcomes:
measure: Early identification of VAP
timeFrame: From July 2023 to Mars 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Ospedale civico Lugano
state: Ticino
Study officials:
References:
Clinical trial NCT01223521: Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion.
Official title: Systematic Provision of Intrauterine Contraception After First Trimester Abortion - Effects on Quality of Life and Risk of Repeat Abortion. A Randomized, Prospective Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Contraception
Abortion
First trimester
Intrauterine device
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: City of Helsinki
First posted: 2010-10-19
Enrollment: 748
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A randomized prospective study on the effects of immediate provision of intrauterine contraception after first trimester induced abortion - effects on repeat abortions and quality of life.


Eligibility criteria: Inclusion Criteria:

* Duration of pregnancy \< 12 weeks.
* Age ≥18 years

Exclusion Criteria:

* Contraindication for spiral insertion: uterine anomaly, infection, copper allergy (Cu-IUD).

Primary outcomes:
measure: Number of repeat abortions
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Dept Obstetrics and Gynecology, Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Oskari Heikinheimo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: City of Helsinki
name: Satu P Suhonen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Pohjoranta E, Mentula M, Gissler M, Suhonen S, Heikinheimo O. Provision of intrauterine contraception in association with first trimester induced abortion reduces the need of repeat abortion: first-year results of a randomized controlled trial. Hum Reprod. 2015 Nov;30(11):2539-46. doi: 10.1093/humrep/dev233. Epub 2015 Sep 14.
citation: Toffol E, Pohjoranta E, Suhonen S, Hurskainen R, Partonen T, Mentula M, Heikinheimo O. Anxiety and quality of life after first-trimester termination of pregnancy: a prospective study. Acta Obstet Gynecol Scand. 2016 Oct;95(10):1171-80. doi: 10.1111/aogs.12959.
citation: Pohjoranta E, Suhonen S, Mentula M, Heikinheimo O. Intrauterine contraception after medical abortion: factors affecting success of early insertion. Contraception. 2017 Mar;95(3):257-262. doi: 10.1016/j.contraception.2016.10.012. Epub 2016 Nov 9.
citation: Pohjoranta E, Suhonen S, Gissler M, Ikonen P, Mentula M, Heikinheimo O. Early provision of intrauterine contraception as part of abortion care-5-year results of a randomised controlled trial. Hum Reprod. 2020 Apr 28;35(4):796-804. doi: 10.1093/humrep/deaa031.
citation: Pohjoranta E, Mentula M, Suhonen SP, Heikinheimo O. Predicting poor compliance with follow-up and intrauterine contraception services after medical termination of pregnancy. BMJ Sex Reprod Health. 2018 Sep 15:bmjsrh-2018-200098. doi: 10.1136/bmjsrh-2018-200098. Online ahead of print.
Clinical trial NCT00375921: Evaluating Taste and Smell Function and Food and Taste Preferences of Head and Neck Cancer Patients During Radiation Therapy/Chemotherapy
Official title: Evaluation of Chemosensory Function and Taste Preference of Head and Neck Cancer Patients Prior to, On Completion of and Six Weeks After Oncology Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: diet
food
taste
smell
head and neck
radiation
chemotherapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2006-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, hypopharynx, larynx and thyroid

Brief summary: Changes to taste and smell have been reported in head and neck cancer patients who undergo radiation and chemotherapy. This may cause food to be unappealing and can lead to a reduced food intake. Thsi study will increase our understanding of taste and smell changes and how it relates to food and taste preferences.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* diagnosed with head and neck cancer including the lip, oral cavity, salivary glands, paranasal sinuses, oropharynx, hypopharynx, larynx and thyroid
* all histologic types of cancer
* all tumour stages according to American Joint Committee for Cancer (AJCC) Staging
* all forms of RT including standard or investigational and/or concurrent standard or investigational chemotherapy for head and neck cancers
* alert and mentally competent
* English speaking

Exclusion Criteria:

* unable to swallow
* unwilling to participate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Cathy Kubrak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05440721: Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
Official title: Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Nicotine Addiction
Drug Addiction
Drug Dependence
Substance Use Disorder
Tobacco Dependence
Keywords: Smoking
Cigarette Smoking
Tobacco Smoking
Nicotine
Drug
Addiction
Tobacco
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.

Detailed description: The overarching study aim is to recruit a population of current smokers who are motivated to quit with the assistance of a mobile solution, enroll them into a study testing apps to help them quit, and randomize them into one of two arms. The core study period will consist of 8 weeks of usage of Treatment A or Treatment B. At the end of this period, users will receive notifications to link them to an online survey, which will record their responses in a secure database.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 65
2. Smokes at least 5 cigarettes daily
3. Is interested in quitting in the next 30 days
4. Owns an iPhone with iOS 9 or higher or Android with OS 4.1 or higher
5. Willing and able to receive SMS text messages
6. Able to comprehend the English-language and the informed consent form
7. Lives in the United States
8. One half of the study sample will be recruited from the general population of smokers via social media advertisements
9. One half of the study sample will be recruited via mail from a Magellan Behavioral Health value-based care network

Exclusion Criteria:

1. Prior use of Clickotine or QuitGuide
2. Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)

Primary outcomes:
measure: Primary Outcome Measure:
timeFrame: [Time Frame: 8 week core study]
Secondary outcomes:
measure: Secondary Outcome Measure
timeFrame: [Time Frame: 8 week core study]
measure: Secondary Outcome Measure
timeFrame: [Time Frame: 8 week core study]
measure: Secondary Outcome Measure
timeFrame: [Time Frame: 8 week core study]
Other outcomes:
Locations:
city: New York
country: United States
facility: Click Therapeutics
state: New York
Study officials:
affiliation: Click Therapeutics
name: Shaheen Lakhan, MDPhD, FAAN
role: STUDY_CHAIR
References:
Clinical trial NCT02147821: Necessity of Using Pleural Drainage Tubes After IMA Harvesting During Cardiac Surgery
Official title: Necessity of Using Pleural Drainage Tubes After IMA Harvesting During Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusions Post Coronary Artery Bypass Graft
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This prospective randomized controlled trial will examine the efficacy of reducing the number of chest tubes used in the postoperative cardiac surgery patient. Typically used are three chest tubes - two in the mediastinum and one in the pleural space, if opened. The investigators propose that removal of the pleural tube will not impact the rates of clinically significant pleural effusions post cardiac surgery. Patients will be randomized into two groups - one receiving the standard three chest tubes (standard), and the other receiving only mediastinal drains (experimental). The primary outcome will be rates of post-operative pleural effusions as determined by defined interventions, including insertion of a chest tube, thoracentesis, or return to the operating room for primary evacuation of pleural effusion or hemothorax. Secondary outcomes include length of hospital stay, length of mechanical ventilation, postoperative respiratory status, and presence/size of pleural effusions, as well as readmission for pleural effusion.


Eligibility criteria: Inclusion Criteria:

* patients must be undergoing CABG at our institution with the attempted harvest of a LIMA and/or RIMA
* pleura must be entered in order for patients to be included.

Exclusion Criteria:

* cardiac surgery where the pleura is not entered
* previous surgery where the pleura was entered
* other pre-existing pleural diseases or fibrosis
* Patients currently participating in other studies
* Patients presenting with emergent need for bypass

Primary outcomes:
measure: Pleural Effusion
timeFrame: 6 weeks
Secondary outcomes:
measure: Postoperative Respiratory Status
timeFrame: 1 week after CABG
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Center
state: Alberta
Study officials:
References: