louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03440021: Single-dose Novel Selective alpha2c Antagonist Pharmaco-MRI Study in Healthy Volunteers
Official title: The Effects of Single-dose Administration of a Novel Selective alpha2c Antagonist on Emotional and Cognitive Processing in Healthy Volunteers: an fMRI Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Noradrenalin Agents
Physiological Effects of Drugs
Mood disorders
Behavioral Symptoms
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: Orion Corporation, Orion Pharma
name: University of Oxford
First posted: 2018-02-20
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: High-dosage (60mg), Low-dosage (10mg), Placebo
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to investigate changes in neural activity (BOLD signal), as measured using fMRI, in brain areas associated with emotional and working memory during task performance after single-dose administration of a novel selective alpha2c adrenoceptor antagonist (ORM-12741) in healthy volunteers. Further, it will be explored whether ORM-12741 affects connectivity between brain areas in rest, as measured using fMRI, and cognitive performance in the sample under investigation.


Eligibility criteria: Inclusion Criteria:

* good command of English language
* right handedness
* normal or corrected-to-normal vision

Exclusion Criteria:

* personal history or active presence of psychiatric conditions
* usage of psychotropic medication within the past 3 months
* pregnancy or breast-feeding status
* systolic blood pressure \< 90 mmHg or \> 140 mmHg at screening visit
* diastolic blood pressure \< 50 mmHg or \> 90 mmHg at screening visit
* resting heart rate \< 45 beats/minute or \> 100 beats/minute at screening visit
* active presence of medical condition at physical examination
* history of major traumatic brain injury
* any other contraindication to MRI of the brain
* use of psychoactive substances incl. alcohol in 24 hours prior to test session

Primary outcomes:
measure: Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with emotional memory
timeFrame: 1-1.5 hours post medication intake
measure: Effect of ORM-12741 on BOLD signal in fMRI of the brain areas associated with working memory
timeFrame: 1-1.5 hours post medication intake
Secondary outcomes:
measure: Effect of ORM-12741 on connectivity measures between brain areas as measured with BOLD signal in fMRI obtained in a resting state
timeFrame: 1.5-2 hours post medication intake
measure: Effect of ORM-12741 on memory task performance (as measured by accuracy and response latency)
timeFrame: 1-3 hours post medication intake
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: UCT Dept. Psychiatry & Mental Health / CUBIC
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Dan J. Stein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03371121: Clinical and Radiographic Outcomes After AMIC Treatment for Talus Osteochondral Lesion Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC
Official title: Valutazione Dell'Epidemiologia e Dei Risultati Radiografici e Clinici Nel Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Talar Osteochondral Defect of Ankle
Pain
Arthroscopy
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the study is to evaluate clinical and radiographic outcomes in patients undergone all-arthroscopic autologous matrix induced chondrogenesis for symptomatic osteochondral talar lesions


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* males and females
* patients underwent arthroscopic cartilage reconstruction surgery with AMIC technique for osteochondral lesions of the talus

Exclusion Criteria:

* age \<18 years at the time of surgery
* patients with previous surgery on the affected ankle

Primary outcomes:
measure: Radiologic reduction of the lesion
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Federico Usuelli
Study officials:
affiliation: IRCCS Istituto Ortopedico Galeazzi
name: Federico G Usuelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00847184: Comparison of Airtraq Versus MacIntosh Intubation Via Nasal Approach
Official title: Comparison of Airtraq vs. MacIntosh Intubation Via Nasal Approach
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tracheal Intubation
Keywords: nasal intubation
Aitraq
difficult intubation
Lead sponsor: Kliniken Essen-Mitte
Sponsor class: OTHER
First posted: 2009-02-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Time, success rate, and number of optimising maneuvers for tracheal intubation via the nasal approach are not different when Aitraq technique is used compared to a standard MacIntosh blade.

Detailed description: One hundred adult patients with an expected easy intubation and 100 patients with an expected difficult intubation are enrolled. Intubations are performed by two experienced fully boarded anesthesiologists. The design of the study is prospective and randomised.

Eligibility criteria: Inclusion Criteria:

* Scheduled for nasal intubation
* Adult

Exclusion Criteria:

* Age under 18 years

Primary outcomes:
measure: Time for intubation
timeFrame: 10 month
Secondary outcomes:
measure: Success rate for intubation
timeFrame: 10 month
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Prof. Dr. Harald Groeben
Study officials:
affiliation: Kliniken Essen-Mitte
name: Harald Groeben, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maharaj CH, Higgins BD, Harte BH, Laffey JG. Evaluation of intubation using the Airtraq or Macintosh laryngoscope by anaesthetists in easy and simulated difficult laryngoscopy--a manikin study. Anaesthesia. 2006 May;61(5):469-77. doi: 10.1111/j.1365-2044.2006.04547.x.
Clinical trial NCT06352684: Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast
Official title: Multi-Reader Multi-Case, Retrospective Study to Evaluate Effectiveness of CadAI-B for Breast
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Lead sponsor: BeamWorks Inc.
Sponsor class: INDUSTRY
Collaborators: name: Severance Hospital
First posted: 2024-04-08
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mainly recruited from a tertiary hospital but no limitation of enrollment

Brief summary: The purpose of this study is to evaluate the effectiveness of lesion detection and diagnosis-aiding software (CadAI-B for Breast) during ultrasound (US) examination

Detailed description: CadAI-B for Breast is a real-time AI diagnosis system designed to assist healthcare professionals in lesion detection and differential diagnosis during breast US examinations. The primary objective of the study is to evaluate the effectiveness of CadAI-B in the assistance of detection and diagnosis of breast cancer by comparing the clinical performance of physicians before and after using CadAI-B in their ultrasound reading. The secondary objective of this study is to evaluate the sensitivity and specificity using CadAI-B for US examinations.

Eligibility criteria: Inclusion Criteria:

* Women who underwent breast US examination
* Women with breast cancer (DCIS or invasive cancer) diagnosed via biopsy
* Women who had been followed for more than 2 years after initial US examination

Exclusion Criteria:

* women who had breast implants
* women who had US images containing artifacts affecting the review of images

Primary outcomes:
measure: Area Under the LROC Curve
timeFrame: 6 weeks
Secondary outcomes:
measure: Lesion detection sensitivity and specificity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
Study officials:
References:
Clinical trial NCT00320502: A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Determine the Effects of BXT-51072 on CK-MB in High-Risk Type 2 Diabetic Patients Undergoing Elective Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Type 2 Diabetes
Lead sponsor: Synvista Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
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 determine the safety and feasibility of BXT-51072 as a cardioprotective agent in diabetics undergoing elective angioplasty / percutaneous intervention (PCI), a procedure to "open" coronary arteries.

BXT-51072 belongs to a class of drugs called "glutathione peroxidase mimics." BXT-51072 works by imitating a substance produced in various tissues in the body, which prevents damage of the heart and blood vessels.

Detailed description: Following screening, baseline measurements and informed consent, patients will receive BXT-51072 40 mg or placebo in a 2:1 ratio, 30 minutes before their scheduled PCI and then three times per day for 2 days. There will be 5 treatment visits and 3 follow-up visits.

Blood samples will be obtained for CK-MB, troponin and routine chemistry. A 24-hour continuous electrocardiogram will be obtained following the PCI and regular electrocardiograms will be obtained during the study and follow-up period.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Scheduled for elective angioplasty with acute coronary syndrome within 72- hours or MI within 7 days

Exclusion Criteria:

* CK-MB above normal
* Elevated troponin not showing a decreasing value
* Congestive heart failure
* Atrial fibrillation or left bundle branch block
* Uncontrolled diabetes

Primary outcomes:
measure: Change in CK-MB
measure: Safety
Secondary outcomes:
measure: Change in troponin
measure: Myocardial ischemia by 24-hour continuous 12-lead ECG
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Nahariya
country: Israel
facility: Western Galilee Hospital
city: Safed
country: Israel
facility: Rivka Sieff Hospital
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Sourasky Medical Center, Tel Aviv, Israel
name: Shmuel Banai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Medical Center, Haifa, Israel
name: Ariel Roguin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04060602: Personalized Feedback Intervention to Reduce Risky Cannabis Use.
Official title: Personalized Feedback Intervention to Reduce Risky Cannabis Use: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2019-08-19
Enrollment: 747
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to determine whether participants who receive a personalized feedback report and educational materials about risky cannabis use will be less likely to report risky cannabis use at follow-up compared to participants who only received educational materials.

Detailed description: This project aims to reduce risky cannabis use among those with less severe cannabis use, most of whom will never seek formal treatment. All of the participants will receive educational material regarding risky cannabis use and its prevention. Half of the participants will also be assigned by chance to receive a personalized feedback report.

The investigators hypothesize that:

1. Participants who receive the full personalized feedback intervention will be less likely to report risky cannabis use at 3- and 6-month follow-ups compared to participants who receive educational materials only (Primary Hypothesis).
2. Participants who receive the full personalized feedback intervention will report greater reductions in their perceptions of how much others use cannabis at a 3-month follow-up compared to participants who receive educational materials only.
3. Reductions in perceptions of how much others use cannabis at 3-month follow-up will be positively associated with reduction in the participant's risky cannabis use at 6-month follow-up.

A 2-arm parallel group randomized controlled trial will be conducted to test these hypotheses with follow-ups occurring at 3 and 6 months after randomization. Online media advertisements will be used to recruit people currently using cannabis. The advertisements will be placed across Canada using locations found successful in previous trials to rapidly recruit participants (e.g. Google AdWords).

Eligibility criteria: Inclusion Criteria:

* Score of 4 or more on the Alcohol, Smoking, and Substance Involvement Screening Test, Cannabis subscale (ASSIST)

Exclusion Criteria:

* Being under 18 years of age

Primary outcomes:
measure: Cannabis Use in the last 30 days
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST, cannabis subscale)
timeFrame: Baseline, 3 and 6 months
measure: Perceptions of Cannabis Use by Peers in the past 3 months
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: John A Cunningham, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03935802: Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy
Official title: Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Keywords: Radiotherapy
CETC
CTC
breast cancer
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2019-05-02
Enrollment: 161
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary non-metastatic breast cancer

Brief summary: The aim of this study was to investigate the systemic effect of radiotherapy on patients with primary non-metastatic breast cancer using CETC and to analyze possible changes in CETC quantity under adjuvant radiotherapy.

Detailed description: In cooperation with the Women's Hospital of the Friedrich Schiller University in Jena, a total of 161 patients with clinically proven, primarily non-metastatic breast cancer were sampled and examined before and after radiotherapy over a period from 09/2002 to 09/2012. The MAINTRAC method was used to quantitatively determine the amount of CETC in the blood and to observe its peritherapeutic course.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed invasive breast carcinoma
* age \>= 18 years
* exclusive treatment at the Jena University Hospital
* complete curative-intended adjuvant or definite radiotherapy
* at least 2 blood collections (before the start of therapy, after the end of the RT)

Exclusion Criteria:

* presence of metastases
* recurrence
* DCIS, inflammatory breast cancer
* second malignancy \<10 years before diagnosis of breast cancer
* radiotherapeutic pretreatment

Primary outcomes:
measure: Overall survival
timeFrame: up to 10 years
Secondary outcomes:
measure: Disease free survival
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Department of Radiooncology, Jena
Study officials:
References:
Clinical trial NCT05416502: Prospective Relationship Between the Rates of Spontaneous Passage of Distal Ureteral Stones and the Distal Lumen
Official title: Prospective Observational Evaluation of the Relationship Between the Rates of Spontaneous Passage of Distal Ureteral Stones and the Diameter of the Most Narrow Part of the Distal Ureter
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ureter Stone
Lead sponsor: Hiram's Healthcare and Education Company
Sponsor class: INDUSTRY
Collaborators: name: Ataturk University
First posted: 2022-06-13
Enrollment: 1000
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 ureter stones

Brief summary: Patients (female, male, or queer) with ureteral stones (smaller than 1 cm at the widest diameter of the stone) without pyonephrosis, urinary sepsis, or untraceable pain will be enrolled into the study. Ureteral width at the smallest area of the ureter (in most cases UV junction) will be noted during regular ultrasound scans. The ratio of ureteral width to the stone diameter will be correlated with the spontaneous stone passage.


Eligibility criteria: Inclusion Criteria:

Ureteral Stone smaller than 1 cm Volunteer to be enrolled

Exclusion Criteria:

Pyonephrosis Urinary Sepsis Untraceable Pain

Primary outcomes:
measure: Passage
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
Clinical trial NCT02020902: Post Marketing Surveillance for Contac Bien Z in Japan
Official title: Contac Bien Z Adverse Effect Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Seasonal Allergic Rhinitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-12-25
Enrollment: 1552
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants who purchase the marketed cetrizine hydrochloride formulation from pharmacy stores in Japan.

Brief summary: This is a post-marketing surveillance study on a marketed cetrizine hydrochloride formulation.


Eligibility criteria: Inclusion Criteria:

* Male and female participants, between 15-65 years of age, who purchase the marketed cetrizine hydrochloride formulation

Exclusion Criteria:

* Who have ever experienced allergic symptoms by taking this medication or any component of this medication, piperazine derivative (including levocetirizine, hydroxizine)
* Those who have been under 15en diagnosed with kidney disease
* Children under 15 years of age

Primary outcomes:
measure: Adverse events after having cetrizine hydrochloride
timeFrame: At baseline
Secondary outcomes:
measure: Efficacy of the marketed cetrizine hydrochloride formulation
timeFrame: At baseline
Other outcomes:
Locations:
city: Saitama
country: Japan
facility: Drug Store Seki
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02492802: Effect of Inflammation on Pharmacokinetics of Posaconazole
Official title: Effect of Inflammation on Pharmacokinetics of Posaconazole
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mycoses
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 64
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 hematological malignancies
* immunocompromised patients

Brief summary: Posaconazole plasma concentration and inflammatory markers will be determined in all samples available from routine analysis.

Detailed description: A prospective observational study will be performed at the University Medical Center Groningen, the Netherlands using longitudinal data collection. The design of the study will be that patients starting on posaconazole treatment will be evaluated. After informed consent is obtained medical data will be collected from the medical chart. Posaconazole plasma concentration (trough levels) and inflammatory markers (e.g. C-reactive protein) will be determined in all samples available from routine analysis (often daily). This will result in a detailed data set capturing day to day variations in inflammation and drug concentrations.

Eligibility criteria: Inclusion Criteria:

* \>18 yrs
* receiving posaconazole
* Written informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: C Reactive Protein Levels in mg/L (CRP) on Posaconazole Concentrations in mg/L
timeFrame: 6 months after start of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: UMCG
name: Jan-Willem Alffenaar, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: