louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06784492: Incorporating Healthy Living Strategies to Aid in Recovery After Acute Pulmonary Embolism
Official title: Recovery After Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pulmonary Embolism
Keywords: Recovery acute pulmonary embolism
Six minute walk
Cardiac Effort
actigraphy
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-01-20
Enrollment: 100
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 purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. Specifically, Investigators will compare changes in Cardiac Effort (#heart beats used during the 6-minute walk test/walk distance) measured after an 8-week program.


Eligibility criteria: Inclusion Criteria:

1. English speaking (\>18 years old). Daily messages will be sent in English.
2. Acute PE with at least one of the following:

   1. any right ventricular enlargement or dysfunction on echocardiogram;
   2. CT Angiogram reporting any right ventricular enlargement; or
   3. elevated cardiac biomarker (NT-pro BNP or troponin above baseline). Criteria for enrollment will be included on source document.
3. Rate controlled atrial arrythmias (resting heart rate \<110 beats/m) are eligible for enrollment. This includes atrial fibrillations. This is standard of care management for atrial fibrillation.
4. Subjects do need to take prescribed anticoagulation.

Exclusion Criteria:

1. Pregnancy.
2. Cardiac Effort \>3.5 beats/m during 6MWT.
3. Resting tachycardia \>110 beats/m at hospital discharge.
4. Chronic Thromboembolic Pulmonary Hypertension
5. Systolic blood pressure \>180 mmHg at hospital discharge.
6. Inability to walk.
7. Estimated prognosis \<12 months at the time of discharge due to underlying co-morbidities (e.g., cancer).
8. Advanced neurologic disease and would not be able to comply with the messages.
9. Lack of access to email or text messaging 10. Inability or unwillingness to follow daily instructions.

Primary outcomes:
measure: Mean change in cardiac effort
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Mean number of health care visits (Health Care Utilization)
timeFrame: 3 months
measure: Mean change in Pulmonary Embolism Quality of Life Questionnaire (PEQOL) Score
timeFrame: baseline and 3 months
measure: Mean change in 6 minute walk distance
timeFrame: baseline and 3 months
measure: Mean change in activity as measured by Actigraph
timeFrame: baseline and 3 months
measure: mean change in diagnoses
timeFrame: baseline and month 3
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01094392: Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)
Official title: Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Keywords: ALL
PEG-asparaginase
prolonged treatment
Thrombosis
Central venous line
Echocardiography
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and young adults (age 1-17.9 years) newly diagnosed with ALL in the Nordic Countries and treated according to the Nordic ALL-protocol NOPHO ALL-2008.

Written informed consent has been obtained

Brief summary: Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but severe side effects to the treatment is thrombosis in or outside the central nervous system.

The aim of this study is to investigate and describe the influence on the coagulation parameters during prolonged treatment with asparaginase.

Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it possible to prevent these.


Eligibility criteria: Inclusion Criteria:

* Childhood ALL, eligible to receive standard risk or intermediate risk therapy as described in the protocol, written informed consent has been obtained

Exclusion Criteria:

* No allergic reactions to PEG-asparaginase

Primary outcomes:
measure: Description of the coagulation parameters
timeFrame: December 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Aarhus
country: Denmark
facility: Department of Pediatrics, Skejby Hospital
city: Copenhagen
country: Denmark
facility: Department of Pediatrics, Rigshospitalet
city: Odense
country: Denmark
facility: University Hospital in Odense
Study officials:
affiliation: Department of Pediatrics, Skejby Hospital, Aarhus, Denmark
name: Birgitte K Albertsen, Ph.D. M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02110992: Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
Official title: A Phase I Pilot Study of SBRT and Concurrent Docetaxel for Reirradiation of Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Head and Neck Cancer
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 7
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 purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.


Eligibility criteria: Inclusion Criteria:

* Recurrent or second primary squamous cell head and neck cancer
* Defined area of recurrence on imaging
* Previous head and neck radiation (RT) to \>/= 50 Gy
* Performance status score 0-1
* Time interval from previous RT \>/= 9 months
* Volume of disease appropriate for protocol treatment
* Minimum estimated survival of \>/= 3 months
* Age \>/= 18
* Adequate labs

Exclusion Criteria:

* Primary tumors of the salivary gland
* Original pathology report and radiation therapy records not available
* Prior spinal cord dose \> 45 Gy
* Surgery or chemotherapy within 4 weeks
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers are permitted

Primary outcomes:
measure: Number of acute dose limiting toxicities
timeFrame: 3 months
Secondary outcomes:
measure: Locoregional control
timeFrame: 2 years
measure: Disease-free survival
timeFrame: 2 years
measure: overall survival
timeFrame: 2 years
measure: Number of late effect dose limiting toxicities
timeFrame: 2 years
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Institute
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Brad Huth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04387292: Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
Official title: Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID19
Ophthalmopathy
Keywords: COVID19
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2020-05-13
Enrollment: 34
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: Ophthalmologic damages secondary to COVID-19 coronavirus infection are little described. The ocular involvement is probably multiple, ranging from pathologies of the anterior segment such as conjunctivitis and anterior uveitis to disorders that threaten vision such as retinitis or optic neuropathy. On the other hand, in addition to this impairment, when patients are hospitalized for acute respiratory failure, complications related to possible resuscitation, medication prescriptions, positioning and oxygenation.

COVID-19 itself, has several components:

* An apoptotic action of the viral attack which will generate cellular destruction, whether pulmonary, cardiac or renal or maybe ocular
* A secondary autoimmune action with the development of major vascular inflammation, possibly reaching the retinal, choroidal, and optic nerve vessels. A secondary "hyper" inflammatory syndrome with flashing hypercytokinemia and multi-organ decompensation is described in 3,7% to 4 ,3% of severe cases.
* A thromboembolic action

Detailed description: Upon discharge from hospital for COVID-19 infection (or during a telephone call for patients already discharged at the start of the study), patients will be informed of the study. An ophthalmology appointment will be given to them between 4 and 6 months after their discharge.

During the ophthalmology appointment, the patient's clinical data will be collected during an interview (medical and treatment history, blood group). The patient will benefit from a full ophthalmological examination.

Eligibility criteria: Inclusion Criteria:

* Patients having been hospitalized for a confirmed COVID-19 infection (CT-scanner or PCR- Polymerase chain reaction)

Exclusion Criteria:

* Pregnant or breastfeeding woman

Primary outcomes:
measure: Description of the ophthalmological problems observed
timeFrame: 6 months after discharge of hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A de Rothschild
Study officials:
affiliation: Fondation A. de Rothschild
name: Martine MAUGET FAYSSE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01583192: Chloridehexidine Versus Povidine Jodine Both Soluted in Alcohol in Forefoot Surgery
Official title: Prospective Study of Chloridehexidine/Alcohol Versus Jodine/Povidine in Forefoot Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hallux Valgus
Arthritis of the First Metatarsophalangeal Joint
Keywords: infection
skin preparation
fore-foot surgery
chloride-hexidine
povidine-jodine
alcohol
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2012-04-23
Enrollment: 52
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: The study will prospectively compare the efficacy and safety of chloride hexidine soluted in alcohol with povidine-jodine soluted in alcohol in forefoot surgery.

Detailed description: It will be a comparative study in which we will swab cultures before skin preparation directly after skin preparation and at the and of the operation (hallux valgus correction and arthrodesis of the first metatarsophalangeal joint.

There will be a quantitative and quality analysis of the swabs. We will also measure allergic reactions. During the post-operative period of 6 weeks we will measure the wound infections stated by Prezies.

Eligibility criteria: Inclusion Criteria:

* age above 18 years
* written informed consent
* indication for hallux valgus correction or arthrodesis of the first metatarsophalageal joint

Exclusion Criteria:

* allergic for jodine-povidine and/or chloride-hexidine
* active infection
* skin defect
* blood clotting or coagulation disorder

Primary outcomes:
measure: number of positive swab cultures
timeFrame: From start surgery week until 48 hours post-operatively
measure: wound infection
timeFrame: until 6 weeks postoperatively
Secondary outcomes:
measure: Allergic events
timeFrame: Until 6 weeks postoperatively
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius Hospital
state: Utrecht
Study officials:
affiliation: St. Antonius Hospital
name: Mario Speth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03518892: Assessing Dietary Requirements in Relation to Resting Metabolic Rate in Spinal Cord Injury
Official title: Assessing Dietary Requirements in Relation to Resting Metabolic Rate in Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Dietary Habits
Keywords: Resting Metabolic Rate
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spinal Cord Injury subjects and healthy controls across central Pennsylvania.

Brief summary: Assess the relationship between body composition, metabolism, and dietary needs in people with spinal cord injury compared to their healthy controls that are age and sex matched.

Detailed description: This study will quantify body composition and resting metabolic rate and then compare these parameters to results from a nutritional analysis. Participants will have two study visits that include physical exam, blood draws, resting metabolic rate, Dual Energy X-ray Absorptiometry (DXA) scan, and dietary assessments.

Eligibility criteria: Inclusion Criteria:

1. C4-L2 motor complete (AIS A \& B) Spinal Cord injury for duration greater than 12 months.

4. \<5% change in body in body weight over the past 12 months 5. Fluent in written and spoken English

Exclusion Criteria:

1. \<22% body fat
2. Coronary artery disease
3. Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus (fasting glucose\>126 or HgbA1c\>7.0)
4. Hypothyroidism, and/or renal disease
5. Decisional impairment
6. Prisoner

Primary outcomes:
measure: Percentage of Body fat
timeFrame: Week 2
measure: Fat Free Mass
timeFrame: Week 2
measure: Fat Mass
timeFrame: Week 2
measure: Resting Metabolic Rate
timeFrame: Week 2
measure: Dietary Assessment Using Self-Reported Diary Questionaire
timeFrame: Week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: David Gater, MD, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00340392: Isolation and Characterization of Mammary Stem Cells
Official title: Isolation and Characterization of Mammary Stem Cells
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stem Cells
Keywords: Mammary Stem Cells
Breast Cancer
Cancer Stem Cells
Gene Expression Profiling
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Institutes of Health (NIH)
First posted: 2006-06-21
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Background:

* Cancer stem cells in breast cancer have been identified as a small population of tumor cells whose self-renewal mechanism is highly deregulated. This deregulation seems to be necessary for cancer to develop.
* These cells can be identified by certain surface markers that overlap with markers associated with normal embryonic stem cells.

Objective: To isolate tumor stem cells using the same methods generally used to isolate human embryonic stem cells.

Eligibility:

* Tissue samples will be obtained from the human cooperative network.
* Samples will include normal tissues from individuals who have no opportunistic diseases and from individuals with cancer.

Design: Breast cancer stem cells will be isolated, grown in the laboratory and characterized.

Detailed description: Cancers are composed of heterogeneous populations of cells with varying degrees of proliferative capacity and ability to reconstitute tumors when transplanted into nude or SCID mice.

Recently, cancer stem cells have been identified as a small population of tumor cells which possess the stem cell properties in that their self-renewal pathway is highly deregulated. This deregulation seems to be the prerequisite for the development of cancer.

Eligibility criteria: * INCLUSION CRITERIA:

The tissue samples will come from the human cooperative network. They have their own set of criteria. We are requesting tissue samples from individuals that are normal as well as those who have cancer.

EXCLUSION CRITERIA:

The tissue samples will come from the human cooperative tissue network and we are asking for normal samples from individuals who don't have any opportunistic diseases.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Cancer Institute (NCI), 9000 Rockville Pike
state: Maryland
Study officials:
References:
Clinical trial NCT04383392: QoL Between CIEDs With and Without Rate Adaptive Pacing
Official title: A Cross-over Randomized Controlled Trial of Quality of Life Between Cardiovascular Implantable Electronic Device With and Without Rate Adaptive Pacing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pacemaker DDD
Quality of Life
Keywords: rate adaptive
pacemaker
quality of life
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Clinical implantable electronic devices, such as permanent pacemaker, implantable cardioverter defibrillator and cardiac resynchronization therapy are used in current daily practice for patients with bradycardia, ventricular arrhythmia, or heart failure. The rapid progress of permanent pacemaker function is growing to replace human's degenerating electrophysiology of heart.

The ability of physical work is an important cornerstone of quality of life. In daily activities, rate response to higher rate is importance for patients with bradycardia who can not accelerate their heart rate. And rate-adapting pacing of permanent pacemaker is a design to increase heart rate pacing according to physical activity or emotional activity. Patients with rate-adaptive pacing will get more cardiac output and overcome the physical activity such as stair climbing. But there are few studies to evaluate whether the rate-adaptive pacing of permanent pacemaker will improve the quality of life in people with bradycardia. The aim of this study is to compare turn-on with turn-off this function (DDDR vs DDD) whether rate-adaptive pacing will improve quality of life in patients with permanent pacemakers.


Eligibility criteria: Inclusion Criteria:

* sick sinus syndrome for permanent dual-chamber pacing
* pacemakers are implanted for ≥30 days with no complications.

Exclusion Criteria:

* (1) patient or legal representative could not provide written informed consent
* (2) unwillingness or inability to return for follow-up visits or reason to believe that adherence to follow-up visits wound be irregular,
* (3) current or scheduled enrollment in other, conflicting studies,
* (4) concomitant disease or other medical condition likely to result in death within 6 months, and

Primary outcomes:
measure: Short-Form 36 Questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: 6 minute walking test
timeFrame: 3 months
measure: NYHA functional class
timeFrame: 3 months
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital Hsinchu Branch
Study officials:
References:
Clinical trial NCT05189392: Efficacy of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty
Official title: Effect of PICO Compared to Opsite Post-Op Visible on Surgical Wound in Patients at High Risk of Local Complications, Undergoing Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Evaluate Postsurgical Hematoma
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 42
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 21 patients with visible opsite patch and 21 patients with PICO
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of the PICO medical device, compared to the Opsite Post-Op Visible medical device, in reducing the formation of postsurgical hematoma in the surgical wound of patients at high risk of local complications, undergoing hip arthroplasty


Eligibility criteria: Inclusion Criteria:

* aged between 55 and 85 years inclusive,
* Patients with BMI ≥ 30 + ASA 3 + Diabetes mellitus
* Patients suffering from coxarthrosis candidates for hip arthroplasty surgery or revision of hip arthroplasty

Exclusion Criteria:

* Age\> 85 years, \<55 years
* Patients who are unable to understand and want.
* Patients with severe neurological disorders or with severe disabilities.
* Oncological patients and patients with malignant tumor at the edge of the wound
* Patients who have undergone radiotherapy treatment
* Patients with bleeding disorders
* Patients on anticoagulant treatment with warfarin or NAO
* Previously confirmed osteomyelitis
* Patients with liver cirrhosis
* Patients with non-enteric fistulas
* Patients with necrotic tissue with the presence of eschar at the intervention site
* Patients with autoimmune thrombocytopenia.

Primary outcomes:
measure: By ultrasound examination at 7 +/- 1 days after hip replacement surgery, underestimating the effect of PICO compared to Opsite Post-Op Visible in the 70% reduction of post-surgical hematoma formation
timeFrame: 8 day
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
state: MI
Study officials:
References: