louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00319566: Heart and Estrogen-Progestin Replacement Study (HERS)
Official title: Heart and Estrogen-Progestin Replacement Study (HERS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Heart Disease
Keywords: Coronary Heart Disease
Hormone replacement therapy
Estrogen
Postmenopausal women
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2006-04-27
Enrollment: 2430
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to determine whether hormone replacement therapy in post menopausal women with coronary artery disease prevents future heart attacks or death from coronary heart disease.

Detailed description: A randomized, blinded trial in post menopausal women with cornaornary artery disease to test the hypothesis, among 2340 women who have a uterus, that those randomized to receive estrogen-progestin replacement therapy (Premanrin .625 mg daily plus medroxygrprogesterone acetate 2.5 mg daily) have the same frequency on new CHD events (myocardial infarction and CHD death) as those randomized to placebo.

Eligibility criteria: Inclusion Criteria:

* \<75 y.o.
* uterus present
* postmenopausal
* evidence of CHD
* signed consent

Exclusion Criteria:

* MI, CABG, mechanical revascularization within 6 months
* serum triglyceride \>300mg/dl
* used hormone therapy or estrogen vaginal cream in past 3 months
* history of DVT or pulmonary embolism
* history of breast cancer or mammogram suggestive of cancer
* history of endometrial cancer
* abnormal uterine bleeding
* pap smear abnormal
* SGOT more than 1.2 times normal
* Disease judged to be fatal within 4 yrs
* alcoholism, drug abuse
* NYHA Class IV congestive heart failure
* uncontrolled hypertension
* uncontrolled diabetes
* participation in any other investigational study

Primary outcomes:
measure: Myocardial Infarction
measure: CHD Death
Secondary outcomes:
measure: CABG, revascularization, angina
measure: serum lipids
measure: quality of life
measure: compliance
measure: incidence of uterine bleeding and endometrial hyperplasia
measure: incidencet and severity of vasomotor and genitourinary symptoms
measure: adverse effects
measure: thromboembolic events
measure: symptomatic gallbladder disease
measure: fractures
measure: cancer
measure: stroke
measure: peripheral arterial disease
measure: total mortality
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Stephen Hulley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06350266: Informing Low-acuity Emergency Department Patients of Non-emergent Resources
Official title: Informing Low-acuity Emergency Department Patients of Non-emergent Healthcare Resources Following Discharge to Decrease Emergency Department Utilization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergency Service, Hospital
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 6242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this campaign is to reduce unnecessary visits to a Geisinger emergency department (ED)/encourage patients with high acuity visits to follow up with an appropriate Geisinger provider. In this campaign, patients will be assigned to receive or not receive outreach following ED discharge that is aligned with the goal. Outreach will occur via a text message, as well as information added to the patient's after visit summary, and will includecalls to action to see their Geisinger CMSL PCP either in person or virtually. The study will assess whether ED use differs across patients in different outreach conditions. It will also examine whether patients follow through on the message-specific calls to action in the messages differently across conditions.


Eligibility criteria: Inclusion Criteria:

* \>= 18 years of age
* Geisinger ED visit rated as low acuity (L4 or L5)
* Discharged from Geisinger ED in past 24 hours

Exclusion Criteria:

* Cannot be contacted via the communication modality being used in the study (i.e., SMS), due to insufficient/missing contact information in the EHR or because the patient opted out
* Admitted to hospital
* Already included in intervention in past 365 days

Primary outcomes:
measure: Return to Geisinger ED
timeFrame: within 120 days following day of discharge
Secondary outcomes:
Other outcomes:
measure: PCP appointment made
timeFrame: within 60 days following day of discharge
measure: PCP visit
timeFrame: within 60 days following day of discharge
measure: Telehealth appointment made
timeFrame: within 60 days following day of discharge
measure: Telehealth appointment attended
timeFrame: within 60 days following day of discharge
measure: Call made to PCP
timeFrame: within 60 days following day of discharge
measure: Any of the suggested actions taken
timeFrame: within 60 days following day of discharge
measure: Urgent care visit
timeFrame: within 60 days following day of discharge
Locations:
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Amir Goren, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01113866: Biomarkers for Prognosis of Ambulatory Chronic Heart Failure Patients
Official title: Circulating Biomarkers as Prognostic Indicators of Death in Ambulatory Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: University of Parma
Sponsor class: OTHER
First posted: 2010-04-30
Enrollment: 124
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: heart failure patients with preserved or impaired systolic function

Brief summary: Biomarkers representing distinct biological domains including neurohormonal, inflammatory, metabolic-nutritional, oxidative-nitrosative and myocardial injury, might alone or in combination provide prognostic information on mortality in heart failure patients with preserved or impaired systolic function.

Detailed description: Upon enrollment in the study, Troponin I (cTn I), BNP, norepinephrine, plasma renin activity, aldosterone, high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), soluble receptor of interleukin 2 (sIL-2R), leptin, prealbumin, free malondialdehyde, 15-F2t-isoprostane and protein-bound nitrotyrosine were measured in stable ambulatory, non diabetic, elderly heart failure patients. Patients were followed up until death or study termination (31st January 2009).

Eligibility criteria: Inclusion Criteria:

* symptomatic congestive heart failure lasting at least six months
* reduced exercise tolerance
* impaired or preserved left ventricular ejection fraction
* cardiomegaly

Exclusion Criteria:

* acute infection
* rheumatoid or other autoimmune diseases
* primary cachectic states (cancer, thyroid disease, severe liver disease)
* severe chronic lung disease
* neuromuscular disorders
* myocardial infarction within the previous 20 weeks
* diabetes mellitus
* chronic renal failure (serum creatinine level \> 2.0 mg/dl, \>177 micromol/L)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Parma
country: Italy
facility: Università di Parma
Study officials:
affiliation: University of Parma
name: Aderville Cabassi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05692466: Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Molecular Testing Panel in the Community Setting ("DINOSAur")
Official title: Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Molecular Testing Panel in the Community Setting ("DINOSAur")
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stage III Solid Tumors
Stage IV Solid Tumors
Lead sponsor: Glendale Adventist Medical Center d/b/a Adventist Health Glendale
Sponsor class: OTHER
Collaborators: name: Caris Life Sciences
First posted: 2023-01-20
Enrollment: 572
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Newly diagnosed cancer patients at the pathology level.

Brief summary: To prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents from a comprehensive molecular test, for the purpose of selecting the most clinically appropriate treatment in a pragmatic two arm trial.


Eligibility criteria: Inclusion Criteria:

* Patients who have given informed consent in accordance with the methods and procedures of this study
* Diagnosis of cancer (stage 3 and stage 4; solid tumors only) requiring medical care
* Patients who have not received treatment related to his/her cancer
* Patients who are willing to sign a release of medical records to the research team
* Male and female patients ≥18 years of age
* Patients under oncology care of a participating site
* Sufficient clinical status for collection of biospecimen samples within usual care
* Patients who have insurance coverage for CMT

Exclusion Criteria:

* Patients considered minors in the jurisdiction where the protocol is conducted.
* Patients who are prisoners and pregnant women.
* Patients who cannot provide consent and did not sign a power of attorney.

Primary outcomes:
measure: European Organization for Research and Treatment of Cancer quality of life Questionnaire-C30 (QLQ-C30)
timeFrame: 2 years
Secondary outcomes:
measure: Compare the proportion of patients enrolling in clinical trials
timeFrame: 2 years
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Adventist Health Glendale
state: California
Study officials:
References:
Clinical trial NCT04831866: COVID-19 Surveillance and Exposure Testing in School Communities
Official title: Coronavirus Disease 2019 (COVID-19) Surveillance and Exposure Testing in School Communities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All students and staff who are members of participating school communities will be given the opportunity to consent to this study. Both children and adult school community members will be included in this study.

Brief summary: This is a prospective, observational study of COVID-19 surveillance and exposure testing in school communities. Participating school communities are providing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests to students and staff at their schools per school, local, and national guidelines. This study will combine data received from the schools with data collected directly from participants to guide analysis of the co-primary objectives. Participants will be grouped into two different cohorts, depending on each school's SARS-CoV-2 test administration practices.

Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff.

Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection.


Eligibility criteria: Inclusion Criteria:

* Data from all participating school communities will be included in this study (no inclusion/exclusion criteria will be assessed).

Exclusion Criteria:

* None

Primary outcomes:
measure: Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Surveillance Cohort.
timeFrame: 2 years
measure: Evaluate secondary transmission/prevalence of SARS-CoV-2 in Kindergarten through 12th grade schools in the Exposure Cohort.
timeFrame: 2 years
measure: Describe return to school outcomes in Kindergarten through 12th grade schools in Surveillance Cohort.
timeFrame: 2 years
measure: Describe return to school outcomes in Kindergarten through 12th grade schools in Exposure Cohort.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham Charter Schools
state: North Carolina
city: Statesville
country: United States
facility: Iredell-Statesville Schools
state: North Carolina
Study officials:
affiliation: Duke University
name: Kanecia Zimmerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05709366: Knowledge, Beliefs and Attitudes of Greek Physiotherapist About Pain Neuroscience Education
Official title: Knowledge, Beliefs and Attitudes of Greek Physiotherapist About the Using of Pain Neuroscience Education Program in Chronic Musculoskeletal Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Musculoskeletal Pain
Keywords: Pain Neuroscience Education
Chronic Musculoskeletal Pain
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Physiotherapists with chronic musculoskeletal experience and clinical practice in Greece

Brief summary: An e-survey study will be carried out based on Checklist for Reporting Results of 52 Internet E-Surveys (CHERRIES)". The purpose of this study is to investigate the knowledge, beliefs and behaviour of Greek physiotherapists regarding the pain neuroscience education program (PNE) as an intervention in patients with chronic musculoskeletal pain.

Detailed description: The main questions it aims to answer are:

What physiotherapists know about a PNE program; What physiotherapists believe about the using of a PNE program in patients with chronic musculoskeletal pain? Whether and how often they use a PNE program in patients with chronic musculoskeletal pain? What are the barriers of using PNE in patients with chronic musculoskeletal pain?

Eligibility criteria: Inclusion Criteria:

* Physiotherapists who are member of Panhellenic Association of Physiotherapist in Greece, with active clinical practice in Greece and clinical experience in musculoskeletal disorders (\>12 months).

Exclusion Criteria:

* None

Primary outcomes:
measure: Demographic characteristics
timeFrame: Baseline
measure: Knowledge related to Pain Neuroscience Education
timeFrame: Baseline
measure: Beliefs related to Pain Neuroscience Education
timeFrame: Baseline
measure: Attitudes related to Pain Neuroscience Education
timeFrame: Baseline
measure: Barriers related to Pain Neuroscience Education
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: University of Thessaly
Study officials:
affiliation: University of Thessaly
name: Eleni Kapreli, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00380666: The Utility of PET/CT in the Planning of Stereotactic Body Radiotherapy for Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Non-small Cell Lung Cancer
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: The Danish Medical Research Council
First posted: 2006-09-26
Enrollment: 0
Sex: ALL
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 trial evaluates the utility of 18FDG-PET/CT scan in the target definition process when SBRT is planned for stage I NSCLC.

Detailed description: The trial aims to evaluate the utility of 18FDG-PET/CT in SBRT planning for NSCLC with particular emphasis on the definition of macroscopic and microscopic boundaries of malignant growth. Studies indicate that the definition of the gross tumor volume may gain in quality when CT and 18FDG-PET are combined. In about 30-60% of NSCLC patients considered for radiotherapy, alteration of CT-based treatment volumes is the consequence of a supplementary 18FDG-PET scan. Studies examining the effect of combined PET/CT scans on the delineation of the GTV generally show reduced intra- and inter-clinician variability. Whether this higher degree of consistency is an actual improvement remains to be proven. Pathological specimens from operated NSCLC patients may serve as a gold standard in this respect. To meet the need for tight margins, the clinical target volume in SBRT planning is generally presumed to correspond to the GTV. Whether this clinical practice rests on firm ground is also an issue that can be addressed in a PET-CT-pathology correlation study.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or above
* Histologically or cytologically verified NSCLC
* Disease stage I (T1-2 N0 M0)
* Referred from the multi-disciplinary lung cancer conference at Aarhus University Hospital for operation at Skejby Hospital, Aarhus University Hospital
* Oral and written informed consent

Exclusion Criteria:

* Medically treated diabetes mellitus
* Fasting blood-glucoses above 6,7 mM
* Blood-creatinin above normal
* Allergies to intravenous contrast
* Detention according to the Danish laws on psychiatrics that does not comply with participation in a clinical trial
* Employment at the Dept. of Oncology, Aarhus University Hospital
* Pregnancy
* Lactation

Primary outcomes:
measure: Concordance indices between CT-based and PET/CT-based target definitions versus volumes of surgical specimens
timeFrame: 1 month
Secondary outcomes:
measure: Intra- and inter-individual variability of target definition
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University Hospital
name: Morten Hoyer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02182466: German Colon Capsule Registry
Official title: Documentation of Colon Capsule Endoscopies in a National Observational Study [Dokumentation Von Kolonkapsel-Endoskopien im Rahmen Einer Bundesweiten Studie]
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colon Cancer
Colon Polyp
Diarrhea
Inflammatory Bowel System
Ulcerative Colitis
Keywords: Colon capsule endoscopy
Colonoscopy
Screening colonoscopy
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2014-07-08
Enrollment: 120
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 indication for endoscopic investigation of the colon

Brief summary: Aim of the registry is to evaluate all colon capsule endoscopies performed in Germany. This is to investigate safety, quality assurance and quality control of colon capsule endoscopy.

Detailed description: Colon capsule endoscopy (CCE, Pill Cam Colon 2, (Given Imaging Ltd, Yoqneam, Israel and Given Imaging EMEA, Hamburg, Germany) provides direct visualization of the colon mucosa, enabling the investigator to diagnose colonic disease. CCE is a complementary means to flexible ileo-colonoscopy andt safety, quality assurance and quality control of CCE is not well understood. There are about 15 000 investigations performed worldwide until now, but systematic data on performance in a community based setting are lacking.

This study aims to investigate safety, quality assurance and quality control of colon capsule endoscopy.

Eligibility criteria: Inclusion Criteria:

* Indication for colon capsule endoscopy
* Age of 18 years or older
* Consent of the patient

Exclusion Criteria:

* Intestinal obstruction
* Dyphagia
* Pregnancy

Primary outcomes:
measure: Establishing a diagnosis from colon capsule endoscopy
timeFrame: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
Secondary outcomes:
measure: Technical success of colon capsule endoscopy
timeFrame: At presentation of the patient for performing colon capsule endoscopy until end of colon capsule endoscopy, an average of 24 hours
measure: Complications of colon capsule endoscopy, i.e. number of participants with Adverse Events and characterization of Adverse Events
timeFrame: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
measure: Cleansing level of colon capsule endoscopy
timeFrame: At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Frankfurt University Hospital
state: Hessen
Study officials:
affiliation: Frankfurt University Hospital Department of Internal Medicine I Theodor-Stern-Kai 7 D-60590 Frankfurt/Main Germany
name: Jörg G Albert, MD
role: PRINCIPAL_INVESTIGATOR
References: