louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05993026: A School-based Intervention to Promote Mental Health and Self-efficacy Among Students in 7th to 10th Grade
Official title: Evaluation of a School-based Intervention to Promote Mental Health and Self-efficacy Among Students in 7th to 10th Grade in Denmark: A Single-group Pre- and Post-test Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Self Efficacy
Keywords: Mental Health
Self Efficacy
Schools
Students
Teachers
Teaching Materials
Denmark
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Committee for Health Education
name: Ole Kirks Fond
First posted: 2023-08-15
Enrollment: 3966
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The present study is an evaluation of school-based intervention. The intervention aims to strengthen students' well-being and increase their mental health through training in tools that increase self-efficacy and ability to understand themselves and others. The Danish Committee for Health Education is responsible for developing and implementing the intervention and for recruiting schools, while the the Danish National Institute of Public Health at University of Southern Denmark is responsible for the evaluation of the intervention, including data collection, analysis and reporting.


Eligibility criteria: Inclusion Criteria: Student classes in grade 7 to grade 10. This corresponds to students who are typically ages between 12 and 16 years old.

Exclusion Criteria: None

Primary outcomes:
measure: Mental wellbeing measured by the short version of the Warwick-Edinburgh Mental Well-being Scale (SWEMWBS)
timeFrame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
measure: Self-efficacy measured by two items used in the Danish Health Behaviour in School-aged Children (HBSC) study
timeFrame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
Secondary outcomes:
measure: Social and emotional competence
timeFrame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
measure: Student relationships
timeFrame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
measure: Teacher support
timeFrame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
measure: General school engagement
timeFrame: Measurements at baseline (one week before treatment) and follow-up (approximately 4 months after baseline)
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Danish Committee for Health Education
Study officials:
affiliation: University of Southern Denmark
name: Maj Britt Nielsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02960126: Efficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk
Official title: Comparison of Efficacy and Safety Between Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Atrial Fibrillation
Lead sponsor: Chuncheon Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 1500
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed in order to evaluate and compare the efficacy and safety between aspirin and clopidogrel in the patient with low stroke risk Atrial Fibrillation (AF).

Detailed description: Efficacy outcome will be evaluated the major cerebro-cardiovascular event including stroke, cardiovascular death, and myocardial infarction during 1 year-medication period. In addition, safety outcome will be evaluated the gastrointestinal responses including peptic ulcer and upper gastrointestinal bleeding events to both study drugs by repeated gastroenteroscopic examinations before and after medication by GI specialist.

Eligibility criteria: Inclusion Criteria:

1. Man or Women \> 20 years old
2. newly detected AF (CHA2DS2VASc index score: 1)
3. Patient who needs antiplatelet therapy using aspirin clopidogrel for stroke prevention
4. volunteer only
5. childbearing aged women who takes proper oral contraceptive

Exclusion Criteria:

1. No specific contraindication or any history of hypersensitivity of Clopidogrel or aspirin
2. Patient with active GI bleeding or bleeding tendency or major bleeding history
3. less than 1 year of residual expected life
4. Pregnant or breast-feeding women
5. Other causes, determined by charged physician
6. Patient with definite GERD who needs special treatment
7. Patient who needs to take NSAID (Non-Steroidal Anti-Inflammatory Drug) for more than 2 weeks

Primary outcomes:
measure: Major Cerebrovascular and cardiac events including stroke, CV death, MI
timeFrame: 1 year after randomization
measure: Major gastrointestinal event including peptic ulcer disease and bleeding
timeFrame: 1 year after randomization
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Park SM, Jeong H, Jung MH, Hong KS, Hong MK, Bang CS, Kim CY. Rationale and Design for a Randomized Comparison of Efficacy and Safety between Aspirin and Clopidogrel in Atrial Fibrillation Patients with Low Stroke Risk: CESAC-AF trial. Contemp Clin Trials. 2017 Sep;60:51-55. doi: 10.1016/j.cct.2017.06.011. Epub 2017 Jun 19.
Clinical trial NCT04017026: Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function
Official title: Survival and Success Rates of 6mm Implants With a Micro-rough Surface After 4.5 - 18.2 Years in Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Jaw, Edentulous, Partially
Dental Implant Failed
Implant Complication
Keywords: Short dental implant
Partially edentulous jaw
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2019-07-12
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated with a 6mm short implant at the University of Bern were recalled for a clinical and radiographic follow-up examination.

Brief summary: In this retrospective study, approximately 60 patients treated with 6mm short implants (Straumann, SLA (sandblasted, large-grit, acid-etched surface), SLActive (sandblasted, large-grit, acid-etched, hydrophilic surface), 4.1 or 4.8 mm in diameter) will be followed for 4.5-18.2 years. Clinical and radiographic parameters will be assessed in a follow-up examination.


Eligibility criteria: Inclusion Criteria:

* Partially or fully edentulous jaw
* Written informed consent

Exclusion Criteria:

* Pregnant women/lactating women

Primary outcomes:
measure: Implant survival rates
timeFrame: 5-18 years
Secondary outcomes:
measure: Radiographic: Annual bone loss
timeFrame: 5-18 years
measure: Clinically: modifying risk factors on implant survival and success
timeFrame: 5-18 years
measure: Clinically: modifying risk factors on implant survival and success
timeFrame: 5-18 years
measure: Clinically: modifying risk factors on implant survival and success
timeFrame: 5-18 years
measure: Clinically: modifying risk factors on implant survival and success
timeFrame: 5-18 years
measure: Clinically: modifying risk factors on implant survival and success
timeFrame: 5-18 years
measure: Clinically: modifying risk factors on implant survival and success
timeFrame: 5-18 years
measure: Patient reported outcome measures
timeFrame: 5-18 years
measure: Patient reported outcome measures
timeFrame: 5-18 years
measure: Implant success rates
timeFrame: 5-18 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department for oral surgery of the zmk Bern, University of Bern
Study officials:
affiliation: University of Bern
name: Vivianne Chappuis, DMD
role: STUDY_CHAIR
References:
Clinical trial NCT00903526: Prevalence and Epidemiology of Nosocomial Candidaemia and Antifungal Susceptibility Patterns in an Italian Tertiary-Care Hospital
Official title: Prevalence and Epidemiology of Nosocomial Candidaemia and Antifungal Susceptibility Patterns in an Italian Tertiary-Care Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Candidemia
Keywords: fungal susceptibility
Lead sponsor: University of Modena and Reggio Emilia
Sponsor class: OTHER
First posted: 2009-05-18
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with a nosocomial candidaemia at the University Hospital of Modena, Italy, between January 1998 and March 2008

Brief summary: During the past two decades, the frequency of invasive fungal infections has increased dramatically in hospitalised patients throughout the world, and Candida has now emerged as one of the leading causes of bloodstream infections (BSIs). Risk-factors for invasive candidiasis include improvements in intensive care strategies (i.e., central venous catheters, mechanical ventilation, hyper-alimentation), prolonged stays in intensive care units (ICUs), the development of more aggressive surgical techniques, and the prolongation of survival of critically-ill patients. Two other important factors, observed mainly in cancer patients, are colonization of mucous membranes by yeasts, and neutropenia, resulting from increased use of antibiotics and anti-neoplastic agents, respectively. The crude mortality rate of candidaemia is high (38-75%), and the attributable mortality has been estimated at 25-38%. During the past 15 years, the prevalence of infections caused by non-albicans Candida spp. has increased exponentially, so that these organisms now account for \> 50% of episodes of fungaemia in various surveys. The increase in invasive fungal infections, the associated high mortality rate, and the emergence of antifungal resistance, have all driven the search for more potent antifungal drugs. The aims of the present study are to investigate the prevalence and the epidemiology of candidaemia and to determine the antifungal susceptibility patterns of Candida spp. isolates from a tertiary-care hospital in Italy.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with a nosocomial candidaemia at the University Hospital of Modena, Italy, between January 1998 and March 2008

Primary outcomes:
measure: The aims of the present study are to investigate the prevalence and the epidemiology of candidaemia and to determine the antifungal susceptibility patterns of Candida spp. isolates from a tertiary-care hospital in Italy.
timeFrame: 2009
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03754426: A Prospective, Pilot Evaluation of Device Equivalence
Official title: Validation of MolecuLight Phoenix Prototypes in Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound
Lead sponsor: MolecuLight Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-27
Enrollment: 50
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: patients with chronic wounds

Brief summary: Patients with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.

Detailed description: Patients (n = 50) with chronic wounds will be imaged using 3 imaging devices. Two types of images will be acquired with each device, as standard photograph (ST-image) and a fluorescence image (FL-image). The images captured with the 3 imaging devices will be compared off-line by 5 interpreters to assess for any differences in the images that would alter a clinical decision.

Eligibility criteria: Inclusion Criteria:

* Subjects (inpatient/outpatient) presenting with a wound
* Wound size less than 15 cm in length
* 18 years or older

Exclusion Criteria:

* Treatment with an investigational drug within 1 month before study enrolment
* Subjects with recent (\<30 days) biopsy or curettage of target wound
* Subjects with wounds that cannot be completely imaged by study device due to anatomic location
* Unable or unwilling to consent

Primary outcomes:
measure: Concordance
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: North York
country: Canada
facility: Judy Dan Research and Treatment Centre
state: Ontario
Study officials:
affiliation: Judy Dan Research and Treatment Centre
name: Ron Linden, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01411826: Online Programs to Promote Colon Cancer Screening
Official title: Online Programs to Promote Colon Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer Screening
Keywords: Colon cancer screening
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2011-08-08
Enrollment: 306
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To evaluate online peer support and colorectal cancer screening behavior among individuals who are not currently meeting colorectal cancer screening guidelines. This is a randomized controlled trial.

Detailed description: Participants in the control group will view standard online information about colon cancer screening. Participants in the intervention group will view the same information and also will be invited to sign on to the online website and interact with peer supporters at their convenience. They will have 6 months to communicate with peer supporters. Peer supporters are encouraged to address comments and concerns of the study participants.

About 300 study participants, majority white, female. Inclusion criteria: age 50-75, not currently meeting colorectal cancer screening guidelines, no previous colorectal cancer.

The study will also include 15 previously identified peer supporters.

Recruitment: Administrators of the SparkPeople.com weight loss community will send study recruitment emails to members at least 50 years of age. Interested individuals will pass an eligibility screening and provide informed consent.

Eligibility criteria: Inclusion Criteria:

1. Age 50-75
2. Not currently meeting colorectal cancer screening guidelines
3. No previous colorectal cancer.

Primary outcomes:
measure: Feasibility
timeFrame: 6 months
Secondary outcomes:
measure: Colon cancer screening attitudes
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Kevin Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hwang KO, Ottenbacher AJ, Graham AL, Thomas EJ, Street RL Jr, Vernon SW. Online narratives and peer support for colorectal cancer screening: a pilot randomized trial. Am J Prev Med. 2013 Jul;45(1):98-107. doi: 10.1016/j.amepre.2013.02.024.
Clinical trial NCT03480126: Herbal Teas on Bone Health in an Osteopenic Population
Official title: Assessing the Efficacy of Herbal Teas on Bone Health in an Osteopenic Population: OsTea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Lead sponsor: Duquesne University
Sponsor class: OTHER
Collaborators: name: Duquesne University
First posted: 2018-03-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The project goal is to identify if herbal teas consumed three times per day over a period of three months can improve these markers of bone health as well as improve quality of life (QOL) compared to women taking placebo by increasing osteoblast activity, decreasing osteoclast activity, increasing nocturnal melatonin levels and by decreasing C-reactive protein (CRP) and cortisol levels. Our central hypothesis is that these herbal teas will improve both objective and subjective measures of bone health in a population with osteopenia not taking this regimen by reducing osteoclast activity and increasing osteoblast activity and by reducing stress and anxiety.


Eligibility criteria: Inclusion Criteria:

* male or female with osteopenia (T-score between -1.0 and -2.5)
* at least 18 years of age
* must be willing to drink tea three times a day for 3 months
* must also be willing to come to the study location on 4 occasions (baseline, end of month 1, end of month 2, and end of month 3),
* must also be willing to come to the study location to provide urinary, salivary and fecal samples on 2 occasions (baseline and at the end of month 3),
* must also be willing to come to the study location to have their blood pressure taken on 4 occasions (baseline, end of month 1, end of month 2, and end of month 3)
* must be willing to come to the study location to complete questionnaires on 2 occasions (baseline and at the end of month 3)
* must be willing to maintain daily diary for 4 months.

Exclusion Criteria:

* Women or men with osteoporosis
* Women or men with osteopenia due to hyperparathyroidism, multiple myeloma, metastatic bone disease, chronic steroid use
* Women or men who are on any bone therapies (i.e. bisphosphonates, selective estrogen receptor modulators, hormone therapy, teriparatide, and denosumab)
* Women or men with chronic obstructive pulmonary disease (COPD)
* Women or men who smoke

Primary outcomes:
measure: The Effect of 3 month Herbal Tea on Changes in Human Type 1 Collagen C-telopeptide (CTx) levels
timeFrame: 3 months
measure: The Effect of 3 month Herbal Tea on Changes in Human Procollagen Type 1 Intact N-terminal Propeptide (Total P1NP) levels
timeFrame: 3 months
measure: The Effect of 3 month Herbal Tea on Changes in the Ratio of CTx:P1NP
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Duquesne University
state: Pennsylvania
Study officials:
affiliation: Duquesne University
name: Paula A Witt-Enderby, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00400426: DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer
Official title: DAHANCA 20 Palliative Radiotherapy for Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Neoplasms
Recurrence
Neoplasms, Second Primary
Keywords: Palliative radiotherapy
Recurrent
Head and neck Neoplasm
Quality of life
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Head and Neck Cancer Group
First posted: 2006-11-16
Enrollment: 100
Sex: ALL
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: Palliative radiotherapy for head and neck cancer is widely used but the effect and side effects are largely unknown. We will study the effect of short hypofractionated palliative radiotherapy (20 Gy in 4 fractions) on symptom intensity and -frequency as weel as side effects


Eligibility criteria: Inclusion Criteria:

* Incurable primary or second primary head and neck cancer
* Speaks and reads Danish
* Capable of filling out questionnaires for at leas two months after radiotherapy
* Age\>=18 years
* Expected survival\> 3months

Primary outcomes:
measure: Frequency and intensity of symptoms before and after radiotherapy (EORTC C30 and H&N35 questionnaires and CTC AE 3.0 toxicity scores)
timeFrame: 11 mths
Secondary outcomes:
measure: Survival
timeFrame: 11 mths
measure: Side effects
timeFrame: 2 mths
measure: Other treatments
timeFrame: 11 mths
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Oncology
Study officials:
affiliation: DAHANCA (Danish Head and Neck Cancer Group)
name: Kenneth Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00487526: Duodenal Jejunal Bypass for Type 2 Diabetes (DJBD)
Official title: Clinical Evaluation of the Effect of Duodenal Jejunal Bypass on Type Two Diabetes in Non Obese Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Diabetes Mellitus
Keywords: Bypass
Duodenal jejunal
type 2 diabetes
non-obese adults
Lead sponsor: Ferzli, George S., M.D. F.A.C.S.
Sponsor class: INDIV
First posted: 2007-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study the effect of Duodenal jejunal bypass on human adults with type 2 diabetes.

Detailed description: Adults non obese ( BMI less than 34 ) will undergo duodenal jejunal bypass. The Outcome measures: Blood Sugar, Insulin,HbA1c, CCK,Gastrin, GIP1and 2, Ghrelin, Cholesterol, Triglycerides,FFA, C-Peptide.

Eligibility criteria: Inclusion Criteria:

* Adults age 20-65
* Clinical diagnosis of type 2 diabetes
* Non obese with BMI less than 34.
* Oral agents or insulin to control T2DM.
* Inadequate control of diabetes as defined as HbA1c\>/7.5
* Understanding of the mechanisms of action of the treatment

Exclusion Criteria:

* Children with type 1 diabetes
* Obese with BMI over 34
* Coagulopathy
* Liver cirrhosis
* Unable to comply with study requirements, follow-up or give valid consent
* Currently pregnant
* Previous upper abdominal surgery
* Inabilty to tolerate general anesthesia

Primary outcomes:
measure: control of type 2 diabetes in non obese adults
timeFrame: two years
Secondary outcomes:
measure: CCK FFA,Cholesterol,Ghrelin,C-peptide,HbA1c,Gastrin,GIP,Triglycerides,Insulin
timeFrame: 2 years
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Center for Advance Medicine Abel Gonzalez
Study officials:
affiliation: SUNY Downstate
name: George S Ferzli, MD F.A.C.S
role: PRINCIPAL_INVESTIGATOR
References: