louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02051647: Copeptin as a Stress Marker During a Written Examination
Official title: Copeptin as a Stress Marker During a Written Examination - the CoEXAM
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: medical students
Basel University
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 42 healthy voluntary medical students studying in the 4th year at Basel University

Brief summary: To investigate whether copeptin levels increase upon a psychological stress (i.e. written examination) and whether copeptin levels measured immediately before the written examination predict success of the examination.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Member of 4th year in medical course at Basel University

Exclusion Criteria:

* Intake of any medication (except birth control pill)
* BMI over 30kg/m2
* Evidence of acute disease
* History of chronic illness, including chronic psychiatric disease
* Anamnestic certain or assumed pregnancy
* Regularly smoking students

Primary outcomes:
measure: Change in copeptin levels upon examination stress comparing copeptin levels prior and after examination
timeFrame: 4 hours
Secondary outcomes:
measure: Correlation between copeptin levels prior to an exam and exam success
timeFrame: 4 hours
measure: Correlation to cortisol as the classical stress marker
timeFrame: 4 hours
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hopsital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Mirjam Christ-Crain, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Urwyler SA, Schuetz P, Sailer C, Christ-Crain M. Copeptin as a stress marker prior and after a written examination--the CoEXAM study. Stress. 2015 Jan;18(1):134-7. doi: 10.3109/10253890.2014.993966. Epub 2015 Jan 8.
Clinical trial NCT04503447: COVID-19 Seroprevalence Study in ITM Staff
Official title: Severe Acute Respiratory Syndrome Coronavirus (CoV) 2 (SARS-CoV-2) Seroprevalence Study in Institute of Tropical Medicine (ITM) Staff
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: humans
COVID-19
pandemics
SARS virus
cross-sectional studies
seroepidemiological studies
Belgium
risk factors
seroprevalence
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 330
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Active ITM staff members

Brief summary: In Belgium, the corona virus disease 2019 (COVID-19) epidemic is in the growing phase of its second wave.

The Belgian crisis cell is balancing between allowing the economy to recover and minimize the disease spread. To decide which containment measures should be maintained, reinstalled or suspended, information on what proportion of people has been infected and on possible risk factors for virus transmission can be helpful.

This study will be conducted on staff members of the ITM. All staff members will be invited to participate. Participants will be asked to have a blood sample drawn for detections of antibodies against SARS-CoV-2 (using one of these two commercial assays: Anti-SARS-CoV-2 ELISA (EUROIMMUN) or WANTAI SARS-CoV-2 Ab ELISA (WANTAI SARS-CoV-2 Diagnostics)) and to complete a questionnaire about their exposure, both within and outside the ITM, to the SARS-CoV-2, and about their health and symptoms. The primary objective is to estimate the occurrence rate of anti-SARS-CoV-2 antibodies or seroprevalence in ITM staff. Secondary objective is to estimate the SARS-CoV-2 seroprevalence in ITM staff member groups, stratified by variables obtained through the questionnaire, such as age, gender, symptoms, exposure to COVID-19 patients/samples, comorbidities, adherence to containment measures.

Detailed description: The study is observational and will be conducted on ITM staff members. All members will be invited to participate.

Eligibility criteria: Inclusion Criteria:

* Be an active ITM staff member
* Be willing and able to complete the questionnaire
* Be willing and able to provide informed consent

Exclusion Criteria:

* Doctor of Philosophy (PhD) students, Master students and interns of the ITM

Primary outcomes:
measure: SARS-CoV-2 seroprevalence ITM staff
timeFrame: Sample is drawn once, within 7 days after recruitment
Secondary outcomes:
measure: SARS-CoV-2 seroprevalence in ITM staff, stratified by variables
timeFrame: Questionnaire is completed once, at recruitment
Other outcomes:
measure: Risk or protective factors for SARS-CoV-2 seropositivity
timeFrame: Questionnaire is completed once, at recruitment
Locations:
city: Antwerp
country: Belgium
facility: Institute of Tropical Medicine
Study officials:
affiliation: Institute of Tropical Medicine, Belgium
name: Marjan Van Esbroeck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195247: Study Evaluating TTI-237 in Advanced Malignant Solid Tumors
Official title: A Phase 1 Dose Escalation Study of TTI-237 Administered Intravenously Every 3 Weeks in Subjects With Advanced Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Tumors
Advanced malignant solid tumors
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD) of TTI-237 for the treatment of subjects with advanced malignant solid tumors.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of malignant solid tumor with measurable disease
* Life expectancy of at least 12 weeks
* ECOG performance status of 0, 1, or 2

Exclusion Criteria:

* Recent major surgery, radiation therapy or anti-cancer treatment
* History of any other prior malignancy within the last 5 years

Primary outcomes:
measure: Primary purpose is to address the safety and tolerability of TTI-237. Patient will be assessed on an ongoing basis during their participation on the trial.
Secondary outcomes:
measure: Preliminary pharmacokinetics (cycle 1 only) and anti-tumor activity of TTI-237 (approximately every 8 weeks).
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Baltimore
country: United States
state: Maryland
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04325347: VR in Diabetic Polyneuropathy
Official title: Reducing Awakenings and Increasing Sleep Efficiency With Virtual Reality in Patients Suffering From Diabetic Polyneuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Polyneuropathy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is an experimental single centre study investigating the effect of VR on overall sleep quality and number of awakenings in patients with diabetic polyneuropathy.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70 years old
* Able to speak Dutch/French
* Continuing usual care regarding medication use 3 weeks prior and during study participation
* Diagnosis of DPN for 6 months or longer, confirmed on EMG

Exclusion Criteria:

* History of seizures/epilepsia
* Susceptibility to motion sickness or cyber-sickness, susceptibility to claustrophobia
* shift workers

Primary outcomes:
measure: Change in sleep efficiency between experimental and control intervention.
timeFrame: Evaluated during two time periods of two weeks.
measure: Change in number of awakenings during the night between experimental and control intervention.
timeFrame: Evaluated during two time periods of two weeks.
Secondary outcomes:
measure: Change in subjective sleep quality between experimental and control intervention.
timeFrame: Evaluated during two time periods of two weeks.
measure: Change in pain intensity reporting between experimental and control intervention.
timeFrame: Evaluated during two time periods of two weeks.
measure: Pain catastrophizing
timeFrame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
measure: Anxiety and depressive symptoms
timeFrame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
measure: Change in clinical status
timeFrame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
measure: Any side effects of the experimental intervention
timeFrame: Evaluated at the end of the experimental intervention namely after the two-week period.
measure: Nature, severity and impact of insomnia
timeFrame: Evaluated at the end of the experimental and control intervention namely after the two-week periods.
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
References:
Clinical trial NCT06574347: Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
Official title: A Phase II Study of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Keywords: NSCLC
Lung Cancer
MET Amplification
EGFR L858R
EGFR Exon 19 Deletion
EGFR
Lead sponsor: Avistone Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-27
Enrollment: 120
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: Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.

Detailed description: A Multicenter,Randomized,open-label,Phase II Study to Evaluate the Efficacy and Safety of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients with EGFRm+(exon 19 deletion or exon 21 L858R)/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.

Eligibility criteria: Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document.
2. Aged at least 18 years old.
3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB\~IV).
4. Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) .
5. At least one measurable lesion as defined by RECIST V1.1.
6. ECOG performance status 0 to 1.

Exclusion Criteria:

1. There are mutations of ALK or ROS1.
2. Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.
3. Pregnant or nursing women.

Primary outcomes:
measure: The objective response rate of the tumor (ORR)
timeFrame: 2 Years
Secondary outcomes:
measure: The disease control rate (DCR)
timeFrame: 2 Years
measure: Duration of Response (DoR)
timeFrame: 2 Years
measure: Progression-free survival (PFS)
timeFrame: 2 Years
measure: Time to Response (TTR)
timeFrame: 2 Years
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 2 Years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yi long Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01223547: Study of the Effects of Carbohydrate Counting
Official title: The Effect of Carbohydrate Counting and Bolus Calculation Using an Electronic Calculator in Carbohydrate Counting-naïve Persons With Non-optimally Treated Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Carbohydrate counting
Insulin bolus calculation
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Council for Strategic Research
name: Medtronic
name: Roche Pharma AG
name: Novo Nordisk A/S
First posted: 2010-10-19
Enrollment: 64
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: The investigators hypothesize that non-optimally treated carbohydrate counting-naïve patients with type 1 diabetes can achieve better metabolic control by counting carbohydrates and that the metabolic control can be further improved with concurrent use of an integrated glucose meter and bolus calculator. The investigators want to test the hypothesis in this study.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Diabetes duration at least 12 months
* MDI therapy
* HbA1c 8-10,5% (both included)

Exclusion Criteria:

* Gastroparesis
* Present or former practice of carbohydrate counting
* Pregnancy or nursing

Primary outcomes:
measure: Change in HbA1c
timeFrame: 4 months
Secondary outcomes:
measure: Variation in blood glucose
timeFrame: 4 months
measure: Number of hypoglycemic events
timeFrame: 4 months
measure: Treatment satisfaction
timeFrame: 4 months
measure: Total daily insulin dose
timeFrame: 4 months
measure: Weight
timeFrame: 4 months
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Signe Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt S, Meldgaard M, Serifovski N, Storm C, Christensen TM, Gade-Rasmussen B, Norgaard K. Use of an automated bolus calculator in MDI-treated type 1 diabetes: the BolusCal Study, a randomized controlled pilot study. Diabetes Care. 2012 May;35(5):984-90. doi: 10.2337/dc11-2044. Epub 2012 Feb 16.
Clinical trial NCT05962047: Augmented Reality for Behavior and Executive Function of Children With Autism Spectrum Disorder
Official title: Use of Augmented Reality for Restricted and Repetitive Behavior and Executive Function of Children With Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Augmented Reality
Behaviour
Executive function
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 18
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the effects of usage of augmented reality for Restricted and repetitive behavior and executive function of children with autism spectrum disorder

Detailed description: Augmented Reality allows children to see a representation of imaginary content and pretend play overlaid on the real-world environment. Today, technology can be a safe and motivating way of engaging children with autism in social interaction activities. Current research in therapeutic technology for autism is aimed toward improving behavior and psychomotor activities that impact social communication. The aim of this research project is to help teachers, parents, practitioners, and researchers to understand the unique strengths of their children with autism along with technology based educational and therapeutic activities for home and classroom.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with autism spectrum disorder in the age range of 5-12 years at verbal imitation and 1-step command following.

Exclusion Criteria:

* Sensory issues and patients on medication

Primary outcomes:
measure: Developmental Behaviour Checklist (DBC)
timeFrame: After 8 weeks
Secondary outcomes:
measure: Repetitive Behaviors Scale-Revised (RBS-R)
timeFrame: After 8 weeks
measure: The flexibility Scale
timeFrame: After 8 weeks
measure: Digital span memory test
timeFrame: After 8 weeks
measure: The Stroop test
timeFrame: After 8 weeks
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Child Development Center - Riphah International University
state: AL
Study officials:
affiliation: Riphah International University
name: Suman Sheraz, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berenguer C, Baixauli I, Gomez S, Andres MEP, De Stasio S. Exploring the Impact of Augmented Reality in Children and Adolescents with Autism Spectrum Disorder: A Systematic Review. Int J Environ Res Public Health. 2020 Aug 24;17(17):6143. doi: 10.3390/ijerph17176143.
citation: Dechsling A, Orm S, Kalandadze T, Sutterlin S, Oien RA, Shic F, Nordahl-Hansen A. Virtual and Augmented Reality in Social Skills Interventions for Individuals with Autism Spectrum Disorder: A Scoping Review. J Autism Dev Disord. 2022 Nov;52(11):4692-4707. doi: 10.1007/s10803-021-05338-5. Epub 2021 Nov 16.
Clinical trial NCT01711047: Benefit of CFAE Ablation
Official title: A Study to Investigate the Benefit Of Complex Fractionated Atrial Electrogram (CFAE) Ablation in Addition to Circumferential Pulmonary Vein and Linear Ablations in the Treatment of Persistent Atrial Fibrillation. (BOCA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: catheter ablation
atrial fibrillation
pulmonary vein isolation
linear ablation
CFAE ablation
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
First posted: 2012-10-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The optimal strategy for catheter ablation of persistent atrial fibrillation is not clearly defined. This study investigates if Complex Fractionated Atrial Electrogram (CFAE) ablation in addition to pulmonary vein isolation and linear ablations improves single procedural success rate over a 12 month follow up period.


Eligibility criteria: Inclusion Criteria:

* persistent atrial fibrillation

Exclusion Criteria:

* previous catheter or surgical ablation for atrial fibrillation
* pregnancy

Primary outcomes:
measure: Single procedural success rate (free from AF off anti-arrhythmic drugs)
timeFrame: 12 MONTHS
Secondary outcomes:
measure: Multiple procedure success rate
timeFrame: 12 months after last ablation
measure: Complication rate
timeFrame: 30 days of procedure
measure: Percentage of AF termination
timeFrame: Time 0
measure: recurrence of atrial fibrillation or organised atrial tachycardia
timeFrame: 12 months after the last procedure
measure: Ablation time
timeFrame: Time 0
measure: Procedure time
timeFrame: Time 0
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
Study officials:
References:
citation: Wong KC, Paisey JR, Sopher M, Balasubramaniam R, Jones M, Qureshi N, Hayes CR, Ginks MR, Rajappan K, Bashir Y, Betts TR. No Benefit of Complex Fractionated Atrial Electrogram Ablation in Addition to Circumferential Pulmonary Vein Ablation and Linear Ablation: Benefit of Complex Ablation Study. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1316-24. doi: 10.1161/CIRCEP.114.002504. Epub 2015 Aug 17.
Clinical trial NCT00252447: Preop Conformal Radiotherapy - Prostate
Official title: A Pilot Study of Pre-Operative Conformal Radiotherapy in Patients With Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostatic Neoplasm
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2005-11-11
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Radical prostatectomy and radical radiation therapy remain the standard treatment approaches for patients with clinically localized prostate cancer (T1, T2).Radical prostatectomy is most effective when the disease is organ confined at the time of surgery. However, in many series up to 60% of patients have positive resection margins at the time of surgery and there is evidence to suggest that these patients may not be curable by surgery alone. A number of preoperative clinical variables including clinical stage, serum Prostate Specific Antigen (PSA) and Gleason scorea re helpful in determining the probability of finding organ confined disease at the time of syrgery.


Eligibility criteria: * Histologically confirmed carcinoma of the prostate
* High risk localized disease defined as clinical T1 or T2 plus \[ (i) Gleason ¡Ý7, PSA\>10 ng/ml and \<35 ng/ml OR (ii) PSA \>15 ng/ml and less \<35 ng/ml (any Gleason) \]
* No evidence of pelvic lymph node metastases on CT scan within 4 months of surgery
* No evidence of distant metastases on bone scan within 4 months of surgery
* No contraindication to pelvic radiation therapy

Primary outcomes:
measure: To document the feasibility of pre-operative conformal radiation therapy in patients undergoing radical prostatectomy for localized prostate cancer who are at high risk for having local extra-prostatic disease at time of surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Princess Margaret Hospital, Canada
name: Padraig Warde, MD
role: PRINCIPAL_INVESTIGATOR
References: