louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01626404: Screening for Advanced Heart Failure Treatment (SEE-HF)
Official title: Screening for Advanced Heart Failure Treatment (SEE-HF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Heart Failure
CRT and/or ICD
Keywords: Thoratec Corporation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Thoratec Europe Ltd
First posted: 2012-06-22
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients with CRT and/or ICD, EF \</= 40% and in NYHA III-IV

Brief summary: Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with CRT and/or ICD who are candidates for advanced heart failure treatment and obtain insights into patient and physician decisions regarding referral for advanced heart failure therapy.


Eligibility criteria: Inclusion Criteria:

* CRT and or ICD device in place.
* NYHA class III - IV heart failure
* EF \</= 40%
* Patient is an out-patient
* Patient is on optimal medical management as tolerated and as defined by primary care physician.
* Patient has signed an informed consent for data collection.

Exclusion Criteria:

* Age \<18 years or \>80 years
* CRT device that has been implanted \< 3 months prior to enrollment
* Coronary revascularization within 3 months prior to enrollment
* Patient only has ICD but has CRT planned
* Non-cardiac disease resulting in life expectancy \< 2 yrs
* Patient is hospitalized or will be hospitalized at this time
* Known diagnosis of dementia
* Patient is currently on dialysis
* Oxygen dependent lung disease
* Previously or currently treated with LVAD or heart transplantation

Primary outcomes:
measure: Proportion of patients
timeFrame: 12 months
Secondary outcomes:
measure: Reasons for non-referral
timeFrame: 12 months
measure: Patient's reasons
timeFrame: 12 months
measure: Actual and predicted 12 month survival
timeFrame: 12 months
measure: Simple clinical parameters for referral
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Nantes
country: France
facility: CHU of Nantes
city: Hannover
country: Germany
facility: Hannover Medical Center
city: Tuebingen
country: Germany
facility: University Clinical Center Tuebingen
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester NHS Trust
Study officials:
affiliation: Thoratec Europe Limited
name: Pooja Chatterjee
role: STUDY_DIRECTOR
References:
Clinical trial NCT05834504: Exploring the Intervals in Distributed Laparoscopic Skills Training
Official title: Exploring the Intervals in Distributed Laparoscopic Skills Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skills Acquisition
Simulation
Laparoscopy
Lead sponsor: Copenhagen Academy for Medical Education and Simulation
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of this trial is to investigate if short intervals (1-2 days) between training sessions are more efficient than practicing with longer intervals (6-8 days) between sessions during proficiency-based laparoscopic simulator training. Our hypothesis is that just 1-2 days of break between sessions is optimal for the acquisition of laparoscopic skills and that a shorter interval between sessions is optimal for training.


Eligibility criteria: Inclusion Criteria:

- Master's degree medical students, enrolled at a Danish University.

Exclusion Criteria:

* Medical students that have participated in prior studies or similar involving laparoscopic training.
* Performing laparoscopy surgery between the intervention and the retention test 3-5 weeks after.
* No informed consent.
* Does not speak Danish on a conversational level.
* Any disability or injury regarding eyesight and mobility.

Primary outcomes:
measure: Time to proficiency
timeFrame: 6 months
Secondary outcomes:
measure: Retention test
timeFrame: 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Academy For Medical Education and Simulation (Cames)
state: Capital Region
Study officials:
affiliation: Copenhagen Academy for Medical Education and Simulation
name: Flemming Bjerrum, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03566004: Performances of a H. Pylori Stool PCR Test
Official title: Performance of a Non-invasive Test for the Detection of Helicobacter Pylori and Its Resistance to Clarithromycin in Stool by Real-Time PCR Amplidiag H. Pylori + ClariR (Mobidiag)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-06-21
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Performance of a non-invasive test for the detection of Helicobacter pylori and its resistance to clarithromycin in stool by Real-Time PCR Amplidiag H. pylori + ClariR (Mobidiag).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* indication of endoscopy with biopsies for H. pylori infection
* Free subject, without tutorship or curatorship or subordination
* Patients benefiting from a social security scheme or benefiting through a third party
* Consent informed and signed by the patient after clear and fair information about the study

Exclusion Criteria:

* Age \<18 years
* Contraindications to fibroscopy (suspicion of oesophageal perforation)
* Antibiotic intake less than 4 weeks old
* Diarrheal patients during sampling
* Patients who do not benefit from a social security scheme or who do not benefit from it through a third party
* Persons enjoying enhanced protection, namely minors, pregnant women, breastfeeding, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergency situation.
* Pregnant or lactating women, women of childbearing potential who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy )

Primary outcomes:
measure: Detection of H. pylori by culture or glmM real-time PCR
timeFrame: Day 2
measure: Detection of H. pylori by culture or glmM real-time PCR
timeFrame: Day30
measure: Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
timeFrame: Day 2
measure: Detection of clarithromycin resistance by E-test or Scorpion PCR from gastric biopsies.
timeFrame: Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU DE Poitiers
Study officials:
affiliation: Poitiers University Hospital
name: Christophe BURUCOA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02619604: A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia
Official title: A Quality Improvement Approach to the Management of Chronic Lymphocytic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Med-IQ
name: Gilead Sciences
name: Genentech, Inc.
First posted: 2015-12-02
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This project addresses the need to improve physician knowledge and clinical practice patterns related to quality of life (QoL) concerns for patients with chronic lymphocytic leukemia (CLL).

Detailed description: This multifaceted initiative will include evaluating patient perspectives on their QoL, evaluating provider perspectives on managing QoL, and providing education to the whole CLL care team (hematologists/oncologists, nurse practitioners, physician assistants, and nurses) on contemporary approaches for individualized, patient-centered management of CLL. Providers, including physicians, nurse practitioners, and physician assistants will participate in educational initiatives geared towards enhancing their knowledge and confidence with managing QoL concerns for patients with CLL. Pre and post surveys will be conducted with providers to evaluate change in these areas. The project aims to train this team on how to enhance communication with patients and caregivers as a means to increase patient engagement in care and QoL in this population.

Eligibility criteria: Inclusion Criteria: Clinician

* Participant must be a hematologist, oncologist, nurse practitioner, or physician assistant who practices medicine in the Duke Cancer Network
* Participant treats patients with CLL
* Participant is willing to participate in the educational component of this project

Inclusion Criteria: Patient

* Patient has a diagnosis of Chronic Lymphocytic Leukemia
* Patient is over the age of 18
* Patient is being treated at a Duke Cancer Network affiliate site,
* Patient is expected to see their physician or another member of their care team at least 3 times annually.
* Signed informed consent

Exclusion Criteria: Clinician

* None

Exclusion Criteria: Patient

* Patient is Non-English speaking
* Patient diagnosed with CLL \< 60 days ago

Primary outcomes:
measure: Change in provider knowledge with management of Quality of Life Concerns for CLL patients, as measured by survey
timeFrame: Baseline, 6 months
measure: Change in provider confidence with management of Quality of Life Concerns for CLL patients, as measured by survey
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Network
state: North Carolina
Study officials:
affiliation: Duke University
name: Linda Sutton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06969404: Prognostic Value of Capillary Lactatemia in Potentially Severe Polytrauma Patients
Official title: Prognostic Value of Capillary Lactatemia in Potentially Severe Polytrauma in Pre-hospital Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Polytrauma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 550
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: Nowadays, the tools available to assess the severity of a polytrauma patient in the pre-hospital setting (vital parameters, shock index, MGAP score, Vittel criteria) have their limitations and are sometimes subjective. To date, there are no objective, practical and reproducible tools for triaging these patients. Venous lactataemia also appears to be predictive of poor outcome in severe trauma. However, there are no studies in the literature on capillary lactataemia, which would indicate the potential severity of a polytrauma patient in the pre-hospital setting. However, it is an easily performed, risk-free assay, the results of which can be obtained rapidly at the scene of the accident. The aim of this project is to confirm that, like venous lactataemia, capillary lactataemia can be useful in the pre-hospital phase for predicting a patient's poor outcome. Incorporating this assay into the assessment of potentially severe polytrauma patients in the pre-hospital phase could improve the predictive value of clinical and contextual data and thus enable better referral and management of these patients.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age
* Presenting a potentially serious pre-hospital trauma defined by:

  o A road accident or a fall of more than 2 metres
* Requiring the dispatch of a SMUR 06 team (mobile emergency and resuscitation service)
* And transferred to an emergency facility in the Alpes Maritimes with medical assistance.
* Consent signed (by the patient or a relative) after the event if it is not possible to sign immediately.
* Pregnant women may also take part in the study without any risk to themselves or their child.

Exclusion Criteria:

* Patients with isolated peripheral limb trauma (wrist, elbow, knee, ankle, shoulder)
* Patients under legal protection (guardianship, curatorship)
* Patients in cardiorespiratory arrest when taken into care by the SMUR (emergency medical services)

Primary outcomes:
measure: lactemie value H0
timeFrame: at inclusion
measure: lactemie value H6
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Antibes
country: France
facility: Antibes Hospital
city: Cannes
country: France
facility: Cannes hospital
city: Nice
country: France
facility: Nice University Hospital
Study officials:
References:
Clinical trial NCT02990104: First Report, Five Years Experience of the Acute Leukemia Work Group
Official title: Diagnostic and Treatment in Acute Lymphoblastic Leukemia Adults: A Multicenter Study of Five Years Experience, Retrospective in Acute Lymphoblastic Leukemia Adults Patients, Mexico City: First Report of the Acute Leukemia Work Group (GTLA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Leukemia (Category)
Lead sponsor: Mexican Agrupation for Hematology Study
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2016-12-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Lymphoblastic Leukemia

Brief summary: The purpose of this study is to describe the incidence, clinic characteristics, biological and suvirval in Lymphoblastic Leukemia patients in Mexico City reference hospitals.

Detailed description: Multicenter and retrospective revision of clinical files with Acute Lymphoblastic Leukemia diagnostic between 2009 and 2013 in Mexico City reference hospitals, in five hospitals with 50 and 100 new cases Acute Lymphoblastic Leukemia per year. With a expected sample between 500 and 1000 patients it will descriptive statistics of variables. The data collection with necessary variables for survival analysis study and risk factors with Kaplan-Meier curve and risk proportional method Cox.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Acute Lymphoblastic Leukemia

Exclusion Criteria none

Primary outcomes:
measure: Get the incidence of Acute Lymphoblastic Leukemia in Mexico City reference hospitals
timeFrame: 5 years
Secondary outcomes:
measure: Clinic characteristics, biological and survival in Acute Lymphoblastic Leukemia patients in Mexico City reference hospitals
timeFrame: 5 years
Other outcomes:
Locations:
city: Mexico Distrito Federal
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Study officials:
affiliation: Regional Hospital High Speciality, Tamaulipas Cd. Victoria
name: Dr. Erick Crespo, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01610804: Choroidal Thickness Measurements During Central Serous Chorioretinopathy (CSCR) Treatment
Official title: Choroidal Thickness Measurements During CSCR Treatment Applying EDI-OCT Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choroidal Thickness
Lead sponsor: University Hospital Regensburg
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with reduction of vision due to Central Serous Chorioretinopathy

Brief summary: The purpose of this study is to determine changes in choroidal thickness in patients with Central Serous Chorioretinopathy (CSCR) during the first 3 months after initial diagnosis via Enhanced-Depth-Imaging-Spectral-Domain-Optical-Coherence-Tomography (EDI-OCT).

Study hypothesis: Since exudative changes in the choroid seem to constitute the primary pathology of CSCR, changes in choroidal thickness compared to healthy eyes should be present and be visible using EDI-OCT.


Eligibility criteria: Inclusion Criteria:

* Patients with initial diagnosis of CSCR and no treatment so far

Exclusion Criteria:

* Therapy (drugs/laser) due to CSCR

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University Hospital Regensburg
state: Bavaria
Study officials:
affiliation: University Hospital Regensburg
name: Maria A Gamulescu, PD Dr. med.
role: STUDY_CHAIR
References:
citation: Imamura Y, Fujiwara T, Margolis R, Spaide RF. Enhanced depth imaging optical coherence tomography of the choroid in central serous chorioretinopathy. Retina. 2009 Nov-Dec;29(10):1469-73. doi: 10.1097/IAE.0b013e3181be0a83.
citation: Margolis R, Spaide RF. A pilot study of enhanced depth imaging optical coherence tomography of the choroid in normal eyes. Am J Ophthalmol. 2009 May;147(5):811-5. doi: 10.1016/j.ajo.2008.12.008. Epub 2009 Feb 20.
Clinical trial NCT01954004: Open Registry Measuring Impact of Genomic Testing on Treatment of Prostate Cancer Patients
Official title: An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2013-10-01
Enrollment: 1270
Sex: MALE
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: Recently diagnosed treatment-naïve patients with early stage localized prostate cancer

Brief summary: This registry is intended to evaluate the impact of genomic test results towards selecting a first-line therapy option for newly diagnosed localized prostate cancer patients.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed (≤6 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics.
* Clinically localized (no evidence on clinical or imaging studies of advanced disease).
* No hormonal therapy including LHRH (luteinizing hormone-releasing hormone) agonist or antagonist, anti-androgen, estrogens or exogenous androgens, when applicable.
* Sufficient amount of tissue remains from biopsy to perform genomic testing.

Exclusion Criteria:

* Patients with a known history of hypogonadism

Primary outcomes:
measure: Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option implemented following results of genomic risk assessment testing (Prolaris®).
timeFrame: 4 months
Secondary outcomes:
measure: Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following review of the genomic test results (prior to patient consultation)
timeFrame: 1 month
measure: Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient.
timeFrame: 2 months
Other outcomes:
measure: • The mean change in the physician's likelihood of recommending non-interventional therapy (watchful waiting or active surveillance) post-genomic testing compared to pre-genomic testing.
timeFrame: 4 months
Locations:
city: Salt Lake City
country: United States
state: Utah
Study officials:
affiliation: Myriad Genetic Laboratories, Inc.
name: Richard Wenstrup, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00249704: Randomized Study Of Exercise And Vitamin D In Frail Elderly Subjects
Official title: Evaluation of the Effect of a 4-Month Intervention of Exercise and/or Vitamin D on Mobility Function and Strength in Frail Elderly Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Elderly, Frail
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-07
Enrollment: 64
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will explore multiple mobility function tests as well as functional and neuropsychological tests in elderly subjects at risk for falls and disability, before and after 4-month exercise and/or Vitamin D intervention.

Detailed description: The study was terminated on 10Jan2008. This was a strategic decision not related to safety, efficacy, or feasibility of trial.

Eligibility criteria: Inclusion Criteria:

* Elderly subjects with moderate frailty residing in assisted living facilities.

Exclusion Criteria:

* Presence of progressive, unstable chronic disease; hyperparathyroidism, hypercalcemia.

Primary outcomes:
measure: Characterization of effect of 4-month exercise and/or Vitamin D intervention on mobility function and strength in frail elderly subjects.
timeFrame: Throughout trial
Secondary outcomes:
measure: Evaluation of utility and variability of mobility function tests and biomarkers, as well as explore the predictors for the exercise and/or Vitamin D intervention response in frail elderly subjects.
timeFrame: throughout trial
Other outcomes:
Locations:
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Hyattsville
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Roslindale
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: