louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00047762: Safety, Efficacy, and Pharmacokinetics Study of Tarceva to Treat Advanced Colorectal Cancer
Official title: Open-Label, Multicenter, Dose-Escalation Study in Subjects w/Advanced Colorectal Cancer to Evaluate the Safety, Efficacy, and Pharmacokinetics of Tarceva in Combination w/5-Fluorouracil, Leucovorin, and Irinotecan and of Bevacizumab in Combination w/Tarceva, 5-Fluorouracil, Leucovorin, and Irinotecan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2002-10-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is test the safety of Tarceva, find the best dose, and see what effects (good and bad) it has on you and your colorectal cancer. The effects of Tarceva will be evaluated in combination with 5-fluorouracil, leucovorin, and irinotecan, with or without Bevacizumab.


Eligibility criteria: Subjects must fulfill all of the following criteria to be eligible for study entry:

* Signed informed consent
* At least 18 years of age
* Histologically confirmed metastatic colorectal adenocarcinoma of the colon or rectum

Resected or biopsied primary tumors or metastatic site will serve as the basis for histologic confirmation.

* Measurable disease (defined as at least one dimension \>2 cm \[\>1 cm on spiral CT scans\])
* ECOG performance status of 0 or 1
* Life expectancy \>3 months
* Use of an effective means of contraception in men and in women of childbearing potential
* Ability to comply with study and follow-up procedures

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Cancer Pavilion
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Oncology Center
state: Maryland
city: Dallas
country: United States
facility: Mary Crowley Medical Research Center
state: Texas
Study officials:
References:
Clinical trial NCT04479462: The Establishment of Total Joint Arthroplasty Registry Database
Official title: The Establishment of Total Joint Arthroplasty Registry Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis Knee
Arthritis Hip
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 6000
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: The investigators will include the participants who will receive total joint arthroplasty in our institutte.

Brief summary: The purpose of this study will establish total joint arthroplasty registry database in Kaohsiung Chang Gung Memorial Hospital and collect patient-reported outcome.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing primary hip or knee arthroplasty
* Patients undergoing revision hip or knee arthroplasty
* Patients undergoing partial hip or knee arthroplasty

Exclusion Criteria:

* Incomplete patients' data
* Follow up less than 1 year after surgery
* Unwillingness to sign the informed consent

Primary outcomes:
measure: PROMIS Global--10 Score
timeFrame: From the pre-operative assessment until 3 years after the srugery
measure: Hip disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR)
timeFrame: From the pre-operative assessment until 3 years after the srugery
measure: Knee injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR)
timeFrame: From the pre-operative assessment until 3 years after the srugery
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT00848562: Nicorandil Study to Reduce Cardiac Death After Percutaneous Coronary Intervention (PCI) in Hemodialysis Patients
Official title: Oral Nicorandil to Reduce Cardiac Death After Coronary Revascularization in Hemodialysis Patients: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Congestive Heart Failure
Keywords: sudden cardiac death
Lead sponsor: Toujinkai Hospital
Sponsor class: OTHER
First posted: 2009-02-20
Enrollment: 129
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Survival after invasive coronary revascularization is worse in patients with chronic kidney disease than in those without it. The investigators aimed to examine whether oral administration of nicorandil, a hybrid of nitrate and adenosine triphosphate-sensitive potassium channel opener, could improve the survival of end-stage renal disease patients with coronary artery disease by inhibiting cardiac death after coronary revascularization.


Eligibility criteria: Inclusion Criteria:

* Hemodialysis patients with coronary artery disease who had undergone a successful first PCI with bare-metal stents between July 1, 2001 and December 31, 2003.

Exclusion Criteria:

* Subjects with moderate or worse cardiac valvular disease or old myocardial infarction at the point of first PCI.

Primary outcomes:
measure: Cardiac death (sudden cardiac death, deaths due to acute myocardial infarction or congestive heart failure)
timeFrame: Jan 1, 2002 to Dec 31, 2006
Secondary outcomes:
measure: All-cause mortality
timeFrame: Jan 1, 2002 to Dec 31, 2006
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Toujinkai Hospital
Study officials:
References:
Clinical trial NCT01662362: Abbott ESA Chagas Assay Post-Market Study
Official title: Abbott ESA Chagas Assay Post-Market Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chagas Disease
Keywords: Chagas Disease
Trypanosoma cruzi
American trypanosomiasis
South American trypanosomiasis
kissing bugs
reduviid bugs
Lead sponsor: Abbott Diagnostics Division
Sponsor class: INDUSTRY
First posted: 2012-08-10
Enrollment: 63
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The study is conducted to meet an FDA post market commitment to collect and report data on the performance of the ESA Chagas assay. A minimum of 50 donor specimens that are FDA-licensed ABBOTT PRISM Chagas repeatedly reactive (RR)will be tested with the ABBOTT ESA Chagas assay. In addition, minimum of 300 ABBOTT PRISM Chagas nonreactive (NR) unidentified donor specimens will be tested with ABBOTT ESA Chagas assay.

Detailed description: ABBOTT ESA Chagas testing will be performed at a minimum of two blood donor centers. Testing will be performed using the FDA-licensed ESA Chagas assay and will be performed in accordance with the ESA Chagas package insert. ABBOTT PRISM Chagas repeatedly reactive blood donor specimens identified by U.S. blood donor centers, as part of the routine blood donation process, will be tested with the FDA-licensed ESA Chagas. Specimens will also be tested with radioimmune precipitation assay (RIPA) for antibody to T. cruzi, a laboratory developed test, and the FDA-licensed ORTHO T. cruzi ELISA. The donor centers will contact the donors and request the donor to return to complete a questionnaire and provide a follow-up specimen.

In addition, a minimum of 300 blood donor specimens with ABBOTT PRISM Chagas nonreactive results will also be tested with ESA Chagas. These specimens will be unidentified, leftover specimens from routine donor testing and not individually identifiable. Specimens that are positive or indeterminate with ESA Chagas will be further tested with RIPA.

Eligibility criteria: PRISM Chagas Repeatedly Reactive Donor Specimens

Inclusion Criteria:

* Blood donor specimen documented as PRISM Chagas repeatedly reactive

Exclusion Criteria:

* None

Primary outcomes:
measure: ESA Chagas Testing of US Blood Donor Specimens Repeatedly Reactive by ABBOTT PRISM Chagas
timeFrame: Up to six months
Secondary outcomes:
measure: ESA Testing of Preselected Donor Specimens Nonreactive by ABBOTT PRISM Chagas
timeFrame: Up to six months
Other outcomes:
Locations:
city: Rosemont
country: United States
facility: LifeSource
state: Illinois
city: Gaithersburg
country: United States
facility: American Red Cross
state: Maryland
Study officials:
affiliation: American National Red Cross
name: Susan Stramer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: LifeSource
name: Sharon Gordon, MS, MBA, MT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02313662: Comparison of White Light, PDD and NBI in Detection of Flat Dysplasia and CIS at TURB - a Study of Trimodality
Official title: Trimodalitets-studie Hvidt Lys vs. NBI vs. PDD Ved Detektion af Flad Dysplasi og CIS Ved TURB
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Narrow Band Imaging and PDD in Cystoscopy
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: Hospitalsenheden Vest
name: Oslo University Hospital
First posted: 2014-12-10
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing PDD according to the Danish guidelines

Brief summary: All patients planned for PDD guided TURB can be included in this study. Two different optics with PDD and NBI are applied to the resectoscope in addition to regular WL.

First, a WL cystoscopy is made and any suspect areas are noted on the registration form, then NBI is used and any suspect areas are noted and finally the cystoscopy is made with PDD with registration of any additional findings. To adjust for bias introduced by photo bleaching, the second part of the study will be performed with PDD as the second modality. Any flat lesions will be biopsied if they appear suspicious in one of the modalities.

The registration form is completed by the surgeon, once the pathology results are known.

A total number of 152 patients is planned to be included.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing PDD according to the Danish guidelines

Exclusion Criteria:

* Patients not fulfilling the inclusion criteria

Primary outcomes:
measure: Detection of CIS
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Holstebro
country: Denmark
facility: Hospitalsenheden Vest
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: University of Aarhus
name: Jørgen Bjerggaard Jensen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01033162: Effectiveness of the CHESS eHealth Cancer Support Intervention in Population-based Care
Official title: Using Technology to Enhance Cancer Communication and Improve Clinical Outcome: Effectiveness of the CHESS Ehealth Cancer Support Intervention in Population-Based Care Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Breast Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-12-16
Enrollment: 368
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study's aim is to provide information about the clinical and business cases for comprehensive interactive cancer communication systems (ICCS) in the context of real world use for cancer care.

This study will be conducted within the Kaiser Permanente Northwest (KPNW) healthcare system. Outcomes for this study include amount of ICCS use and women's ratings of cancer information competence, perceived social support, and emotional well being. Secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits.


Eligibility criteria: Inclusion Criteria:

* All subjects must be within 2 months of their primary breast cancer diagnosis,
* All subjects must be at least 18 years of age

Exclusion Criteria:

* Illiterate
* Homeless

Primary outcomes:
measure: Amount of ICCS use and women's ratings of cancer information competence, perceived social support, and emotional well being. Secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Kaiser Permanente Northwest
state: Oregon
Study officials:
affiliation: University of Wisconsin, Madison
name: Timothy Baker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06458062: Pocket Colposcopy Using CARE Algorithm
Official title: Development and Validation of an Artificial-Intelligence-enabled Portable Colposcopy Device for Optimizing Triage Alternatives for HPV-based Cervical Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
HPV Infection
Keywords: HPV testing
colposcopy
cervical cancer screening
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: National Cancer Institute (NCI)
First posted: 2024-06-13
Enrollment: 1054
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Pocket colposcope has 510k FDA clearance and has been successfully used in \~2500 unique patients globally in Duke and non-Duke protocols to date. 1054 women who are HPV(+) and planned to undergo treatment at 4-6 Ministry of Health-supported outpatient clinics in Kisumu County will be recruited to the study. After providing informed consent, participants will be proceed with colposcopy using the POCKET colposcope.

Detailed description: Women undergo Pocket-Assisted VIA (PA-VIA) and green light imaging using the Pocket Colposcope. Women will have biopsies taken of any suspicious lesions, or two biopsies taken in random locations if no lesions are visible. The locations of the biopsies will be based on provider impression. After their study-exams and biopsies are taken, women who are eligible for ablative treatment will be immediately treated in the clinic. Those with larger lesions or lesions concerning for invasive cancer will be referred to the local hospital for an excisional procedure. Once we have obtained enough images to develop the CARE algorithm, it will also be used to assist the provider in diagnosis.

This record reflects Phase 1 of Aim 3 of the grant. Phase 2 of Aim 3 will be added once approved. Phase 1 of Aim 3 was previously included within NCT04998318.

Eligibility criteria: Inclusion Criteria:

1. Age \> 25 years old and \< 65 years old
2. Sex: Female
3. Positive HPV test within past 6 months

Exclusion Criteria:

1. Pregnant women (cannot perform a cervical biopsy on a patient who is pregnant unless absolutely indicated)
2. Women with a negative HPV test
3. Patients incapable of giving informed consent
4. Women with a history of cervical cancer
5. Pelvic exam concerning for cervical cancer or cervical infection

Primary outcomes:
measure: Sensitivity of the Pocket CARE in detecting pre-cancer
timeFrame: Day of imaging (Day 1)
measure: Specificity of the Pocket CARE in detecting pre-cancer
timeFrame: Day of imaging (Day 1)
measure: Positive Predictive Value (PPV) of the Pocket CARE in detecting pre-cancer
timeFrame: Day of imaging (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kenya Medical Research Institute
Study officials:
affiliation: Duke University
name: Megan Huchko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00195962: Risk Factors of Breastfeeding Study
Official title: Identification of Risk Factors Among Breast-Fed Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Breastfeeding
Post-partum mothers of healthy breast-fed newborns
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 1500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Mothers of healthy infants that are breastfeeding
* At least 24 hours post delivery
* Mother and baby will be dismissed from the hospital together.

Brief summary: The goal of this study is to identify infants who are at risk for developing problems related to being breast-fed.

Detailed description: The goal of this study is to identify infants who are at risk for developing problems related to being breast-fed. A previous study identified items that place an infant at a high risk for developing complications related to being breast-fed. The present study will use the same survey and collect data from more participants. These additional participants are necessary to provide statistical analysis for the survey. The survey being developed will assist health care professionals to identify those infants at risk for developing health problems related to being breast-fed and provide care that will minimize the chances of developing complications.

Eligibility criteria: Inclusion Criteria:

* Mothers of healthy infants that are breastfeeding
* At least 24 hours post delivery
* Mother and baby will be dismissed from the hospital together.

Exclusion Criteria:

* Mothers of newborns that are not breastfeeding
* Mothers of newborns that are ill and/or will not be dismissed from the hospital at the same time as the mother

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Kansas City
country: United States
facility: Truman Medical Center - Hospital Hill
state: Missouri
city: Lee's Summit
country: United States
facility: Truman Medical Center - Lakewood
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Anne Mercer, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall RT, Mercer AM, Teasley SL, McPherson DM, Simon SD, Santos SR, Meyers BM, Hipsh NE. A breast-feeding assessment score to evaluate the risk for cessation of breast-feeding by 7 to 10 days of age. J Pediatr. 2002 Nov;141(5):659-64. doi: 10.1067/mpd.2002.129081.
Clinical trial NCT00478062: Vaccine Therapy in Treating Patients Who Have Received First-Line Therapy for Hodgkin's Lymphoma
Official title: KGEL Vaccine After Initial Therapy of Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Lymphoma
Keywords: stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-05-24
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Vaccines made from a tumor antigen may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and how well vaccine therapy works in treating patients who have received first-line therapy for Hodgkin's lymphoma.

Detailed description: OBJECTIVES:

* Determine immunologic responses in patients who have completed first-line therapy for Hodgkin's lymphoma treated with Hodgkin's antigens-GM-CSF-expressing cell vaccine.
* Determine the durability of these immunologic responses in these patients.
* Determine the utility of an Epstein-Barr virus reporter system for monitoring cellular vaccine responses.
* Determine the safety and tolerability of this vaccine in these patients.

OUTLINE: Beginning 4-6 months after last chemotherapy, patients receive Hodgkin's antigens-GM-CSF-expressing cell vaccine on day 1. Treatment repeats every 3 weeks for up to 4 courses.

Immunologic responses are serially monitored along with disease status.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of classic Hodgkin's lymphoma
* Must have completed first-line therapy without evidence of disease progression

PATIENT CHARACTERISTICS:

* HIV negative

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No more than 6 months since prior chemotherapy or radiotherapy

Primary outcomes:
measure: Immunologic Response
timeFrame: 9 months
measure: Durability of Immunologic Response
timeFrame: 2 years
measure: Utility of Epstein-Barr Virus Reporter System for Monitoring Cellular Vaccine Responses
timeFrame: 2 years
measure: Safety and Tolerability
timeFrame: After administration of last vaccine at 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Yvette L. Kasamon, MD
role: STUDY_CHAIR
References: