louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00773006: Canadian Anticoagulant Percutaneous Coronary Intervention Registry
Official title: Canadian Prospective, Observational Study on the Use of LMWH in the Setting of Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
percutaneous coronary intervention
anticoagulation
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 747
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: UA, STEMI and NSTEMI ACS patients treated prior to PCI with LMWH and/or patients treated with LMWH during PCI i.e. in catheterization laboratory.

Brief summary: Advances in mechanical intervention (PCI) and anticoagulation therapy have been the cornerstone of treatment of patients with coronary artery disease. However, the large diversity of approaches to anticoagulation during PCI introduces gaps in knowledge regarding management of cardiac patients. As such, we have initiated a national PCI registry to elucidate anticoagulant choice, dosing strategies, case selection dynamics, and clinical outcomes in the Canadian health care environment.


Eligibility criteria: Inclusion Criteria:

1. 18 or more years of age.
2. Undergoing PCI during treatment with LMWH
3. Provision of written and informed consent

Exclusion Criteria:

1. Language, medical, or psychiatric barriers that preclude understanding of informed consent process.
2. Patients in which the site investigator is unable to comply with completion of study documentation following PCI, i.e. patients with planned transfer to another hospital not participating in the registry.
3. Enrollment in a clinical trial involving another anticoagulant agent.

Primary outcomes:
measure: Description of anticoagulant management during PCI and current practices of participating centres will be undertaken
timeFrame: in-hospital
Secondary outcomes:
measure: In-hospital safety outcomes including - major, minor bleeding, requirement for transfusion, death, myocardial infarction (or re-MI), myocardial ischemia requiring urgent revascularization, and major bleeding
timeFrame: in-hospital
measure: In-hospital angiographic complications: no reflow, thrombus, occlusion of collateral branches, distal embolism, coronary dissection, acute closure of the culprit vessel
timeFrame: in-hospital
measure: PCI-related resources utilization during the study period, including cost of PCI and its treatment (e.g. duration of hospital stay, drug costs, costs related to bleeding such as transfusions)
timeFrame: in-hospital
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
References:
Clinical trial NCT04231006: Salvage HDR for Locally Recurrent Prostate Cancer
Official title: Salvage High Dose Rate Brachytherapy for Local Recurrence in Prostate Cancer: A Phase II Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study offers focal salvage brachytherapy for prostate cancer patients with a local recurrence after primary defintive radiotherapy

Detailed description: The aim of this study is to examine the efficacy and toxicity of focal salvage high dose rate brachytherapy (HDR BT) for patients with locally recurrent prostate cancer after definitive external beam radiotherapy. Furthermore, the investigators want to assess, whether it is feasible to perform salvage HDR BT as a focal treatment based on multiparametric (mp) pelvine MRI and PSMA PET/CT.

Eligibility criteria: Inclusion Criteria:

* Man ≥ 18 years, who had definitive EBRT or BT for prostate cancer T1-3b, N0-1, M0
* ≥ 2 years since the end of primary radiotherapy
* PSA recurrence Phoenix criteria (nadir + 2)
* No evidence of regional lymph nodes or distant metastases on PSMA PET/CT
* MRI guided biopsy-proven local recurrence of adenocarcinoma in the prostate gland or seminal vesicles
* GTV identifiable on mpMRI
* No current endocrine therapy
* Plasma testosterone ≥1.75 nm/l
* PSA doubling time ≥ 6 months and ≤ 24 months
* Performance status 0-1
* DAN PSS score ≤ 20
* Maximal urinary flow ≥ 10 ml/s
* Life expectancy \> 5 years
* PSA ≤ 10 ug/L at recurrence

Exclusion Criteria:

* Pubic arc interference or major calcifications within the prostate gland.
* Contraindication for spinal or general anaesthesia.
* Conditions indicating that the patient cannot go through the radiation therapy or follow-up, or a condition where the treating oncologist thinks the patient should not participate in the trial, for example due to language problems.
* Inflammatory bowel disease
* Contraindications to 3T MRI
* eGFR \< 30 ml/min
* ≥ Gr 3 urinary toxicity at baseline as assessed by CTCAE 4

Primary outcomes:
measure: Time to castration-resistant prostate cancer
timeFrame: 10 years
Secondary outcomes:
measure: Erectile dysfunction
timeFrame: 5 years
measure: Urinary symptoms
timeFrame: 5 years
measure: Bowel symptoms
timeFrame: 5 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Oncology
state: Region Midt
Study officials:
References:
Clinical trial NCT01575106: The Neurobiology of Expectancy and Pain Perception
Official title: A Brain Imaging Study of the Analgesic Effect of Lidocaine and the Hyperalgesic Effect of Capsaicin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-04-11
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will use using fMRI (functional Magnetic Resonance Imaging) to elucidate how contextual learning/expectation relieves or aggravates pain experience in the same cohort of subjects and the same study session.


Eligibility criteria: Inclusion Criteria:

* a) Healthy male and female adults aged 21-50
* b) No contraindications to fMRI scanning
* c) Right handed

Exclusion Criteria:

* a) Current or past history of major medical, neurological, or psychiatric illness
* b) Pregnancy or breast feeding, menopause, and irregular menstrual cycles (length of cycle must be within 26 to 32 days)
* c) Claustrophobia
* d) History of head trauma
* e) History of impaired elimination
* f) Instability of responses to experimental pain (see Study Procedures Section)
* g) Use of psychotropic drugs, hormone treatments (including hormonal birth control) within 1 year
* h) Non-fluent speaker of English

Primary outcomes:
measure: Subjective Response to Pain (0-20 Visual Analogue Scale)
timeFrame: Weeks 1-3
measure: fMRI Signal Changes in the Dorsal Anterior Cingulate Cortex
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jian Kong, MD,eq/MS/MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06450106: Study of STM-416p Administered to Patients Undergoing Radical Prostatectomy
Official title: A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: Intraoperative
Dose escalation
Open-label
STM-416
Resiquimod
Toll-like receptor 7/8
Radical prostatectomy
Robotic prostatectomy
Immunotherapy
STM-416p
PSA
R848
Hydrogel
Lead sponsor: SURGE Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-06-10
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: TREATMENT

Brief summary: A Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy

Detailed description: A Phase 1 Dose Escalation Study of STM-416p Administered Intraoperatively to Patients Undergoing Radical Prostatectomy

Eligibility criteria: Inclusion Criteria:

1. Males aged 18 years or older at time of informed consent.
2. Have a histologically confirmed diagnosis of prostate cancer, and are scheduled to undergo radical prostatectomy within 28 days of screening.
3. Grade Group 2-5.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 at Screening.
5. Have adequate organ and bone marrow function at screening.
6. Able to understand and be willing to sign an Institutional Review Board/Ethics Committee-approved written informed consent document

Exclusion Criteria:

1. Have an invasive malignancy, other than the disease under study.
2. Anticipated to require the use of a drain after radical prostatectomy.
3. Received any other anticancer therapy (e.g., including but not limited to chemotherapy, biologic therapy, immunotherapy, targeted therapy, endocrine therapy, radiation therapy, intravesical therapy ) within 28 days.
4. History of allergic reactions attributed to compounds of similar chemical or biologic composition as those used in the STM-416p formulation including poloxamer 407 and sodium hyaluronate.
5. History of allogeneic organ transplant.
6. History of primary immunodeficiency.
7. QTc interval \>470 msec at Screening.

Primary outcomes:
measure: Incidence of dose-limiting toxicities (DLTs) [Safety and Tolerability]
timeFrame: 21 Days
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Time on trial up to 90 days
Secondary outcomes:
measure: Pharmacokinetics of STM-416p
timeFrame: Day 0, post 24 hours, post 48 hour
measure: Pharmacodynamics of STM-416p in blood circulating cytokines
timeFrame: Day 0, post 24 hours, post 48 hours, post 21 days
measure: Assess surgical wound healing
timeFrame: Day 7, Day 21
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Urology Specialists
state: Arizona
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References:
Clinical trial NCT03695406: Mind Body Program for Fear of Recurrence
Official title: Mind Body Program for Fear of Recurrence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2018-10-04
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a pilot feasibility study of a group-based, mind body intervention for managing stress and fear of recurrence and promoting resiliency among adult cancer survivors.


Eligibility criteria: Inclusion Criteria:

1. Patients must have a history of breast, lung, colorectal, hematologic, prostate, melanoma, or gynecological cancer (by medical record and/or self-report)
2. Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy) between 3 to 30 months ago
3. Ages 18 and older (by medical record and/or self-report)

Exclusion Criteria:

1. Self-reported inability to speak and write in English
2. Concurrent participation in weekly, group-based psychosocial or mind-body programs
3. Serious mental illness (by medical record and/or self-report) as defined by history of suicidality, psychosis, and/or psychiatric hospitalization in the past year.
4. Inability to travel to necessary study visits
5. No e-mail address to access online assessments

Primary outcomes:
measure: Feasibility (i.e., retention at initial follow-up assessment)
timeFrame: Through study completion (approximately 5 months)
measure: Acceptability
timeFrame: During intervention group sessions (approximately 2 months)
Secondary outcomes:
measure: Fear of Cancer Recurrence
timeFrame: Baseline, 8 weeks (Post-intervention), 1 month follow-up, 3 months follow-up
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medial Center
state: Massachusetts
Study officials:
References:
citation: Hall DL, Park ER, Cheung T, Davis RB, Yeh GY. A Pilot Mind-Body Resiliency Intervention Targeting Fear of Recurrence among Cancer Survivors. J Psychosom Res. 2020 Aug 10;137:110215. doi: 10.1016/j.jpsychores.2020.110215. Online ahead of print.
Clinical trial NCT00081406: Individual and Family Therapy for Children With Anxiety Disorders
Official title: Child and Family Therapy for Anxiety-Disordered Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anxiety
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2004-04-12
Enrollment: 150
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare three treatments to determine which is most effective in reducing anxiety in children.

Detailed description: Children and their parents will complete a comprehensive diagnostic assessment to determine eligibility. The assessment will include an individual diagnostic interview with the child, interviews with the parents, and written observations of the child from family members and teachers. Participants will then be randomly assigned to receive individual cognitive behavioral therapy (ICBT), family CBT (FCBT), or education/support/attention (ESA) for 5 months. Children in the ICBT group will meet individually with a therapist. In the FCBT and ESA treatment groups, children and their parents will meet weekly with a therapist.

At the end of treatment and 1 year following treatment completion, families will complete another assessment to determine the effectiveness of each treatment at reducing short- and long-term anxiety symptoms in their children.

Eligibility criteria: Inclusion Criteria:

* Child with DSM-IV criteria for separation anxiety disorder, social phobia, or generalized anxiety disorder

Exclusion Criteria for Child Participants:

* IQ less than 80
* Current use of anti-anxiety or antidepressant medications
* Psychotic symptoms
* Child and/or parent is non-English speaking

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Child and Adolescent Anxiety Disorders Clinic
state: Pennsylvania
Study officials:
References:
citation: Kendall PC. Treating anxiety disorders in children: results of a randomized clinical trial. J Consult Clin Psychol. 1994 Feb;62(1):100-10. doi: 10.1037//0022-006x.62.1.100.
citation: Kendall PC, Flannery-Schroeder E, Panichelli-Mindel SM, Southam-Gerow M, Henin A, Warman M. Therapy for youths with anxiety disorders: a second randomized clinical trial. J Consult Clin Psychol. 1997 Jun;65(3):366-80. doi: 10.1037//0022-006x.65.3.366.
Clinical trial NCT01138306: Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia
Official title: Implications of s-SHIP Expression and SHIP Alterations in AML
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute myeloid leukemia/other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-06-07
Enrollment: 149
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of acute myeloid leukemia

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in samples from young patients with acute myeloid leukemia.

Detailed description: OBJECTIVES:

* Determine the extent and prognostic implications of variable s-SHIP expression and SHIP gene mutations in pediatric patients with acute myeloid leukemia.
* Determine the effects of aberrant s-SHIP expression on the PI3K/Akt pathway in these patients via electrochemiluminescence and phosphospecific flow cytometry assays.

OUTLINE: RNA samples are analyzed for variable s-SHIP expression and are screened for SHIP mutations. Cryopreserved cells (with known high- or low-s-SHIP expression) are analyzed for the levels of various components of the PI3K/Akt pathway via electrochemiluminescence and phosphospecific flow cytometry.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Event-free survival
Secondary outcomes:
measure: Overall survival
measure: Relapse rate
Other outcomes:
Locations:
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Phoenix Ho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01654406: Fractional CO2 Laser in the Treatment for Cesarian Scar
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cesarian Scar
Keywords: Cesarian scar
Fractional CO2 laser
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 8
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fractional CO2 laser can improve the Cesarian scar


Eligibility criteria: Inclusion Criteria:

* Female receiving Cesarean surgery for more than 1 month

Exclusion Criteria:

* Pregnancy
* Keloid
* Photosensitivity
* Wound
* Pacemaker
* Recent retinoid intake

Primary outcomes:
measure: change of Vancouver Scar Scale (VSS)
timeFrame: 1st, 5th, 7th month
Secondary outcomes:
measure: Quartile grading scale
timeFrame: 5th, 7th month
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wan Fang Hospital
Study officials:
References:
Clinical trial NCT01416506: Community-Acquired Pneumonia (CAP) Surveillance
Official title: Community-Acquired Pneumonia (CAP) Mycoplasma Surveillance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: Pneumonia, surveillance
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-15
Enrollment: 560
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: Chinese adult (male or female) \>/= 18 years old

Brief summary: Prospective, non-interventional, multi-center study. 7 investigative centers will involved in China. Around 560 CAP outpatients or inpatients will be screened until 56 M. pneumoniae isolates collected.


Eligibility criteria: Inclusion Criteria:

* Chinese adult (male or female) ≥18 years old
* Outpatients or inpatients who suffer from CAP

Exclusion Criteria:

-

Primary outcomes:
measure: In vitro Minimal Inhibitory Concentration Detection
timeFrame: Up to 27 months
Secondary outcomes:
measure: In vitro Gene Mutation Detection
timeFrame: Up to 15 months
Other outcomes:
Locations:
city: Many Locations
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04987606: Post COVID-19 Interstitial Lung Disease: A Study of Genetic and Environmental Interactions
Official title: POST COvid-19 Interstitial Lung DiseasE (POSTCODE) A Study of Genetic and Environmental Interactions: an Observational Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Fibrosis
COVID-19 Pneumonia
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with interstitial lung disease following COVID-19

Brief summary: This study aims to understand why some people who have had COVID-19 develop scarring of the lungs and why some people recover more quickly than others.

Detailed description: A large number of people diagnosed with COVID-19 suffer from long term symptoms, predominantly breathlessness and fatigue whether or not they were admitted to hospital. While there are a number of causes of long-term breathlessness following COVID-19 one of the most common, and potentially concerning with regards to long term prognosis is Interstitial Lung Disease.

The fibrogenic potential of SARS-CoV-2 is currently unknown but is predicted to be substantial based on the experience of previous coronavirus outbreaks and emerging data from this pandemic.

The investigators do not yet understand how scarring occurs following SARS-CoV-2, nor why there is resolution in some individuals and persistent or progressive disease in others. The investigators therefore plan to undertake bronchoscopy (camera test into the lungs) to examine for changes in the way the cells lining the lung behave, using genetics, and differences in the bacteria living in the airways in patients whom have developed scarring following COVID-19.

Eligibility criteria: Inclusion Criteria:

* Evidence of SARS-CoV-2 PCR/Seropositive
* Presence of interstitial lung disease on CT
* Participant is willing and able to give informed consent for participation in the study
* Aged 18 years or above

Exclusion Criteria:

* Confirmed ILD diagnosis prior to March 2020
* Patients with co-morbid disease that in the opinion of the investigators gives them an expected life expectancy of less than one year will be excluded from the study.
* Use of steroids at baseline visit

Primary outcomes:
measure: Differences in the bacterial burden and composition of the respiratory microbiome in post covid fibrosis compared to health
timeFrame: 2 years
Secondary outcomes:
measure: Change in bacterial burden over time in post covid fibrosis
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare Trust
city: Manchester
country: United Kingdom
facility: Manchester University NHS Trust
Study officials:
References: