louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02035410: Decrease Implantation Site INFECTION (DISINFECTION I): a Randomized Controlled Trial
Official title: Phase 1 Study of Prevention of Cardiac Device Implantation Site Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Keywords: cardiac devices
prevention
infection
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 352
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cardiovascular implantable electronic device (CIED) infections have been increasing out of proportion to the number of devices implanted We investigated recent trends and possible causes of the increasing numbers of Cardiovascular implantable electronic device infections.

Detailed description: There are many studies on the preventive use of Antibiotics or povidone iodine to Cardiovascular implantable electronic device (CIED) infections.

But, studies of prophylactic use of hydrogen peroxide is still limited.

We had planned research on effects of preventive using hydrogen peroxide before cardiac devices insertion.

Eligibility criteria: Inclusion Criteria:

* scheduled for cardiac devices Implantation

Exclusion Criteria:

* under the age of 18
* Hydrogen peroxide allergy
* take an antibiotic
* History of infection within 30 days

Primary outcomes:
measure: freedom of cardiac device-related infection
timeFrame: 1 year after precedure
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
state: Seo Ch-gu
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Yong Seog Oh, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT03221010: Use of the Motivational Interviewing in the Treatment of Smokers in Groups in Primary Health Care
Official title: Evaluation of the Effectiveness of the Motivational Interviewing in the Cessation of Smoking in Groups in Primary Health Care Services: a Community Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Tobacco
Smoking Cessation
Keywords: Smoking
Smoking cessation
Motivational Interviewing
Primary health care
Randomized clinical trial
Lead sponsor: Hospital Nossa Senhora da Conceicao
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2017-07-18
Enrollment: 600
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: The objective of this study is to evaluate the efficacy of Motivational Interview (MI) on the smoking cessation rates of the smoking groups performed by the primary care teams of the Conceição Hospitalar Group, Porto Alegre, Brasil, and also whether there is an increase in the completion rate of the groups.

Detailed description: Smoking is the leading cause of preventable death and a major public health problem worldwide. Primary health care is a strategic setting in the treatment of this problem. The objective of this study is to evaluate the efficacy of Motivational Interview (MI) on the smoking cessation rates of the smoking groups performed by the primary care teams of the Conceição Hospitalar Group, Porto Alegre, Brasil, and also whether there is an increase in the completion rate of the groups. Methodology: A randomized community trial was carried out in the 12 units of this service, starting in July 2016, with randomization by cluster, where the intervention group received an 8-hour training in MI in order to associate the technique with the conventional approach, while the units of the control group used only the conventional approach.

Eligibility criteria: Inclusion Criteria:

* Smokers.
* Participate in group smoking treatment.

Exclusion Criteria:

* Missing more than two sessions of the smoking group.

Primary outcomes:
measure: Smoking cessation
timeFrame: thirty days
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Nossa Senhora da Conceição Hospital
state: RS
Study officials:
References:
Clinical trial NCT05138510: Sexual Health in Breast Cancer Patients
Official title: Sexuality and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-12-01
Enrollment: 130
Sex: FEMALE
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: All patients diagnosed with ductal carcinoma in situ or invasive breast cancer, seen in the breast center between 9/1/2019 to present, will potentially be recruited to participate. Patients less than 18 years of age and those with non-cancer diagnoses or prior history of breast cancer will be excluded.

Brief summary: In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment.

Detailed description: In the present study, we propose a mixed methods approach to characterize and address the sexual health needs among women with breast cancer at the time of diagnosis and throughout treatment. The objectives are as follows:

1. To characterize the sexual well-being of women longitudinally throughout the continuum of care, from initial diagnosis into survivorship.

   We predict that treatment will adversely affect sexual well-being, and that patient factors, clinical factors, and treatment choices will influence changes in sexual well-being.
2. To identify gaps is sexual health education provided at the time of diagnosis or during treatment and to determine the appropriate timing of sexual health education delivery.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ductal carcinoma in situ or invasive breast cancer, seen in the breast center between 09/01/2019 to present, will potentially be recruited to participate.

Exclusion Criteria:

* Patients less than 18 years of age and those with non-cancer diagnoses or prior history of breast cancer will be excluded.

Primary outcomes:
measure: Determine changes in sexual well-being for women with breast cancer
timeFrame: 1 year
measure: Determine educational resources currently used for sexual health information
timeFrame: 1 year
measure: Determine educational resources currently used for sexual health information
timeFrame: 1 year
measure: Determine patients preferred type of education for sexual health
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: Colorado Research Center
name: Sarah Tevis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000210: Treatment Efficacy for Drug Abuse and AIDS Prevention - 1
Official title: Treatment Efficacy for Drug Abuse and AIDS Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Heroin Dependence
Keywords: opioid addiction
cocaine addiction
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Mclean Hospital
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 26
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of buprenorphine for treatment of concurrent intravenous heroin and cocaine dependence.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital, Dept. of Psychiatry
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Jack Mendelson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01094210: Evaluation of a Low-fluoride Anticaries Toothpaste
Official title: Evaluation of a Low-fluoride Anticaries Toothpaste Containing an Innovative Calcium Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tooth Abnormality
Keywords: Anti-erosion dental benefits
Lead sponsor: Indiana Nanotech, LLC
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center at San Antonio
First posted: 2010-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This in situ study will recruit 30 adult subjects (between 18-50 years of age). No potential subject will be excluded from this study, regardless of their gender or racial/ethnic origins. However, it is expected that about 18 (60%) of the 30 subjects in the trial will be women. This distribution will allow for meaningful comparisons between gender groups. We will recruit patients attending the clinics of UTHSCSA dental school clinics, which reflect the ethnic mix of the area the clinics serve. However, majority of subjects will be Hispanic due to the high Hispanic prevalence (57.8%) in San Antonio. Thus, minorities will be included at a similar rate to that in the general population attending for dental care,

Brief summary: The purpose of this trial is to evaluate the anticaries remineralizing potential of a toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model, whereby approved human participants will wear an orthodontic appliance fitted with an enamel specimen for the duration of a leg (28 days). There will be two test legs.


Eligibility criteria: Inclusion Criteria:

* 30 adult subjects (between 18-50 years of age)

Primary outcomes:
measure: Surface Microhardness
timeFrame: 30 days
measure: Transverse Microradiography
timeFrame: 30 days
measure: Cross-Sectional Microhardness
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Dental Diagnostic Clinic within the University of Texas Health Science Center
state: Texas
Study officials:
References:
Clinical trial NCT02334410: Early Intervention to Reduce Bone Loss After Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injury
Osteoporosis
Keywords: fractures
immobilisation
paraplegia
tetraplegia
Lead sponsor: University of Strathclyde
Sponsor class: OTHER
Collaborators: name: Queen Elizabeth National Spinal Injuries Unit, Glasgow
First posted: 2015-01-08
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: After a complete spinal cord injury (SCI), the patient becomes wheelchair-dependent, and the associated lack of weight-bearing and inactivity of paralysed muscles can lead to extensive bone loss in the long bones of the legs. It has been documented that the most rapid phase of bone loss is during the first year, but bone loss can continue for a number of years post-injury, leading to an increased risk of fracture in chronic SCI. Through a previous longitudinal study, in which we described rates of bone loss in the first year of SCI using peripheral Quantitative Computed Tomography (pQCT), we showed that there is a subset of patients who suffer from extremely rapid bone loss, losing up to 50% of their bone mineral density (BMD) in the first 12 months post-SCI. As a result of this work, we now know that, by performing repeat bone scans within months of injury, we are able to detect and "red-flag" those patients at highest risk of rapidly weakening bones. We propose that, once these patients have been identified, there is an opportunity to intervene with bone-stimulating interventions within months of injury, before BMD reaches dangerously low values. In this new phase of the research, therefore, we are introducing an intervention phase to the longitudinal pQCT study. For this, we aim to trial a physical intervention, Whole Body Vibration (WBV), that could potentially reduce rates of further bone loss in fast bone losers. Vibration would achieve this by acting as a mechanical stimulus for bone cells, to encourage bone formation. If shown to be successful as an early bone-stimulating intervention, it may prove to be a tool for reducing future fracture risk in patients with SCI.


Eligibility criteria: Inclusion Criteria:

* Motor-complete spinal cord injury (SCI)
* SCI at neurological levels C4 and below
* Within six weeks of SCI

Exclusion Criteria:

* Recent bilateral fractures in tibia and/or femur
* Previously diagnosed osteoporosis
* Pregnancy

Primary outcomes:
measure: Rate of change of bone mineral density (BMD) based on peripheral Quantitative Computed Tomography (pQCT) bone scans
timeFrame: 12 months
measure: Rate of change of calcium and bone profiles based on blood samples
timeFrame: 12 months
Secondary outcomes:
measure: Correlation between imaging and biochemical markers of bone health
timeFrame: 12 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth National Spinal Injuries Unit
Study officials:
References:
Clinical trial NCT01711710: Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant
Official title: Clinical Trial to Evaluate the Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) in Women Aged 22 and Over With Breast Reconstruction or Augmentation Mammoplasty.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Breast cancer
reconstruction
augmentation
cohesive silicone gel
breast implant
rupture
capsular contracture
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: HansBiomed Co.,Ltd.
First posted: 2012-10-22
Enrollment: 103
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or augmentation


Eligibility criteria: Inclusion Criteria:

* Over 22 years of age
* Subjects who want breast augmentation reconstruction following breast cancer, congenital or accidental unbalanced breast size
* Negative pregnancy test in fertile women
* Subjects who voluntarily decided the participation of the study and signed the informed consent
* Subjects who can understand and comply with the instructions and participate during the entire period of the trial

Exclusion Criteria:

* previous breast reconstruction or augmentation history
* self -immune disease
* uncontrolled active infectious disease
* unable to insert beast implant due to radiotherapy
* Patients who have recurrent breast cancer or do not treat effectively their cancer
* Keloid
* Abnormal blood test or ECG result for general anesthesia
* Patients who cannot MRI scan due to having Metallic substance in the body or Claustrophobia
* Aesthetic addiction, drug abuse, alcohol abuse
* Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator

Primary outcomes:
measure: a rate of rupture of 1%
timeFrame: 2 years
measure: a rate of capsular contracture of 5%
timeFrame: 2 years
Secondary outcomes:
measure: a rate of connective tissue disease
timeFrame: 2 years
measure: Changes in bust girth and actual measured bra-cup size
timeFrame: 2 years
measure: Change in life satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Chanyeong Heo, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06417710: Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis
Official title: Standardized Clinical Assessment of Patients With Leptomeningeal Metastasis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Leptomeningeal Metastasis
Leptomeningeal Disease
Leptomeningeal Neoplasms
Leptomeningeal Cancer
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
name: The Netherlands Cancer Institute
First posted: 2024-05-16
Enrollment: 200
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 leptomeningeal metastases from various extra-central nervous system (CNS) solid primary tumors for whom a tumor-specific treatment is planned

Brief summary: The goal of this project is to develop and validate a reproducible scorecard for the neurological assessment of patients with leptomeningeal metastases that can be used in clinical trials including such patients, as well as in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18 years or more), female or male
* Histologically confirmed diagnosis of extra-CNS primary solid cancer
* Diagnosis of leptomeningeal metastases confirmed or probable per EANO ESMO criteria
* Performance status compatible with enrolment into clinical trials
* Ability to consent
* Signed informed consent form from patient
* Participation in a parallel clinical trial is allowed in this non-interventional study

Exclusion Criteria:

* Inability to give informed consent
* Inability to adhere to recommended follow-up according to the treating physician

Vulnerable participants will not be included.

Primary outcomes:
measure: inter-observer agreement of response assessment of the overall clinical assessment - per center and among all raters
timeFrame: December 2026
Secondary outcomes:
measure: inter-observer reproducibility (agreement) for each item - per center and among all raters
timeFrame: December 2026
measure: association between items
timeFrame: December 2026
measure: variability of the interobserver agreement
timeFrame: December 2026
measure: description of clinical neurological symptoms and signs
timeFrame: December 2026
measure: association of clinical response with imaging and CSF cytology response and the overall global clinical/MRI/CSF response
timeFrame: December 2026
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Amsterdam
country: Netherlands
facility: Netherlands Cancer Institute
city: Zurich
country: Switzerland
facility: University Hospital Zurich
Study officials:
References:
Clinical trial NCT06512610: ELN 2022 in MENAFC ( Middle Eastern or North Coast of Africa ) Patients With Newly AML
Official title: Validation of the Use of the "ELN 2022" Risk Stratification System in HLA MENAFC Patients Newly Diagnosed With Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Leukemia, Myeloid
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HLA, Middle Eastern or North Coast of Africa, acute myeloid leukemia patients

Brief summary: "In daily clinical practice, 2022 ELN guidelines were used to predict response to conventional treatment and to guide the need for allogenic stem cell transplantation. But, the team has to underline that ELN guidelines are mainly reflective of relatively young Caucasian patients. Few studies have compared 2017 and 2022 ELN in ethnicity cohorts to evaluate the potential prognostic value of this new criteria in these types of population. For example, with the 2022 ELN guidelines, the disease-free surviva) and the overall survival of African American \< 60 y.o were not statistically different between intermediate and adverse groups (p=0.30, p=0,46). There were not a significant difference between favorable and intermediate groups in DFS (p=0.42, p=0.42) respectively in African American and Hispanic patients or in OS (p=0.67) in Hispanic patients. Is the 2022 ELN applicable to all ethnic subgroups? To date, no studies have examined and validated its applicability in Middle Eastern or North Coast of Africa (MENAFC) patients."


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed AML
* At least 18 yo
* MENAFC (Middle East ern of North Coast of Africa) patients with HLA HLA \> 50%
* ECOG performance status of 0,1,2,3"

Exclusion Criteria:

* Acute promyelocytic leukemia
* Patients alive at the start of the study who did not receive study information or who objected to the collection of data"

Primary outcomes:
measure: Overall survival according to ELN 2022 genetic-risk group in comparison to ELN 2017
timeFrame: Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025
Secondary outcomes:
measure: Relapse free survival before alloHSCT
timeFrame: Time from date of complete remission to date of relapse or death from any cause, assessed up to 01/01/2025
measure: Risk group according to 2017 and 2022 ELN
timeFrame: At the diagnosis
measure: Complete remission rates
timeFrame: Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025
measure: Safety and tolerance
timeFrame: Time from first administration of induction chemotherapy to death from any cause, assessed up to 01/01/2025
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NICE
state: Alpes Maritimes
Study officials:
References: