louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06659224: The Risk of Acute Myeloid Leukaemia in Patients with Ewing's Sarcoma
Official title: The Risk of Developing Acute Myeloid Leukaemia in Patients with Ewing's Sarcoma and Trend Analysis: a SEER-based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia (AML)
Ewing Sarcoma
Keywords: acute myeloid leukemia
Ewing sarcoma
SEER
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 2631
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with Ewing sarcoma between 2000 and 2021, followed up for more than 10 years after the initial diagnosis. Site record ICD-O-3/WHO 2008 restricted to bone and soft tissue; and histological type ICD-O-3 specified as Ewing sarcoma (9364)

Brief summary: Ewing's sarcoma is an uncommon yet vital malignancy of bone. It demonstrates a predilection for the pediatric and young adult population. Chemotherapy is considered an important treatment modality for Ewing's sarcoma. However, the development of therapy-related leukemia, especially acute myeloid leukemia following treatment, is attributed to the use of substances such as alkylating agents and topoisomerase inhibitors which are genotoxic. There is a very few studies elaborating on the incidence rates of such complications. So, our aim is to quantify the risk of developing acute myeloid leukemia in Ewing sarcoma patients and provide an updated evidence to the literature.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Ewing sarcoma
* Latency exclusion period of 6 months
* Sequence 0 or 1

Exclusion Criteria:

* patients lacking age documentation or age reported only on death certificates or autopsies

Primary outcomes:
measure: The standardized incidence ratio and excess risk of developing acute myeloid leukemia in Ewing's sarcoma patients
timeFrame: from Jan, 2000 till Dec, 2021
Secondary outcomes:
measure: The standardized incidence ratio and excess risk of second primary malignancies in Ewing's sarcoma patients across different racial groups
timeFrame: from Jan, 2000 till Dec, 2021
measure: The standardized incidence ratio and excess risk of second primary malignancies in Ewing's sarcoma patients between different stages
timeFrame: from Jan, 2000 till Dec, 2021
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
affiliation: Suez Canal University
name: Asmaa Ellaithy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03544424: A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices
Official title: A Study of Physical Activity paTTerns and Major Health Events in Older People With Implantable Cardiac Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Aging
Cardiac Disease
Lead sponsor: University of Manchester
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 183
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People 60 years or older with CIED in situ for at least 6 months

Brief summary: An observational study of physical activity patterns in 150 older adults with cardiac implantable electronic devices (CIED)

Detailed description: Study Type: observational, investigator led Study Design: observational model: cohort (retrospective) Population: 150 people over 60 years of age with a Medtronic CareLink® compatible CIED in situ recruited from the Manchester University NHS Foundation Trust, England, UK Data collection: daily PA measures, demographic details, co-morbidity status, physical frailty assessment, functional status, quality of life (QOL) and NEHA data Consent: for participation in the study, physical frailty assessment, additional collection of retrospective CIED data, and access to electronic patient records Data sources: CIED downloads, self-report questionnaire, physical measurements (height, weight, hand grip strength, gait speed), electronic hospital records, HES (hospital episode statistics) data Results analysis: data will be analysed to investigate: daily PA variability; the association between PA and NEHAs, and the impact of frailty on PA patterns

Eligibility criteria: Inclusion Criteria:

1. Age 60+ years
2. Functioning CIED in situ for at least 6 months
3. Medtronic manufactured device compatible with CareLink® Cardiac Compass application (platform which measures and stores physiological parameters)
4. Lives in the Greater Manchester area
5. Able and willing to given written, informed consent to enter the study

Exclusion Criteria:

1. Faulty or incompatible device
2. Immobile (unable to walk in upright position)
3. Active participant in a clinical trial which does not allow concurrent recruitment into this study
4. People unable to consent in the English language (including the understanding of study literature which is published in English only)

Primary outcomes:
measure: Non-elective Hospital Admissions
timeFrame: Retrospective: 12 months prior to enrolment (retrospective data spans 12 months prior to enrolment)
Secondary outcomes:
measure: Frailty
timeFrame: 30 days
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Heart Centre
Study officials:
affiliation: Manchester University
name: Adam Greenstein, MBChB, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02344524: Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain
Official title: Drainage of Traumatic Hemothorax and Pneumothorax: Small Bore Versus Large Bore Chest Drain- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Hemothorax and Pneumothorax
Lead sponsor: Delhi University
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the role of small bore chest drains in draining traumatic hemothorax and pneumothorax.

Detailed description: The precise role of small bore chest drains in treating post traumatic pleural collections, especially hemothorax is not well established. This trial is conducted to study the efficacy and safety profile of small bore chest drains in trauma patients with hemothorax and pneumothorax.

Eligibility criteria: Inclusion Criteria:

* Patients with traumatic hemothorax, pneumothorax and hemopneumothorax

Exclusion Criteria:

* Patients with tension pneumothorax
* Patients requiring emergency thoracotomy
* Patients who had undergone chest drain insertion elsewhere
* Patients lost to follow up

Primary outcomes:
measure: Success rate
timeFrame: 7 days (plus or minus 5 days)
Secondary outcomes:
measure: Procedure time
timeFrame: At the time of the intervention
measure: Iatrogenic injuries
timeFrame: At the time of the intervention
measure: Resolution time
timeFrame: 7 days (plus or minus 5 days)
measure: Wound healing time
timeFrame: 10 days (plus or minus 5 days)
measure: Catheter sepsis
timeFrame: 7 days (plus or minus 5 days)
Other outcomes:
Locations:
city: New Delhi
country: India
facility: University College of Medical Sciences & GTB Hospital
state: Delhi
Study officials:
affiliation: Delhi University
name: Sunil Kumar, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yi JH, Liu HB, Zhang M, Wu JS, Yang JX, Chen JM, Xu SX, Wang JA. Management of traumatic hemothorax by closed thoracic drainage using a central venous catheter. J Zhejiang Univ Sci B. 2012 Jan;13(1):43-8. doi: 10.1631/jzus.B1100161.
Clinical trial NCT02821624: First-in-Human Safety, PK, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Volunteers
Official title: First-in-Human Phase 1 Safety, Pharmacokinetic, and Food Effect Study of Single Ascending Doses of G1T38 in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: G1 Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-01
Enrollment: 76
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This first-in-human (FIH) study will provide the first safety and pharmacokinetic (PK) data for G1T38 in humans and will allow further development of G1T38 in patients with cancer.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers, 40-65 years of age; no clinically significant findings reported following detailed physical examination, medical history, vital signs, clinical laboratory tests, and ECGs as deemed by the PI
* Body mass index (BMI) in the range of 18 to 32 kg/m2 (inclusive) at screening, and weighing at least 50 kg
* Nonusers of nicotine-containing products for at least the previous 3 months prior to dosing or nonsmokers
* Agreement to use birth control during the study and 3 months post last visit.
* Able to comply with all protocol requirements and procedures

Exclusion Criteria:

* Clinically significant abnormalities found during physical examinations, medical history review, ECGs (QTcF interval \> 450 milliseconds for males and \>470 milliseconds for females), vital signs, and laboratory tests (including positive HIV, hepatitis B and C)
* Participated in in a previous clinical study with an investigational product in the last 60 days
* History of any serious allergic reaction to any medication
* Any blood or plasma donation or other loss of blood at a volume exceeding 500 mL within 3 months before dosing
* History of drug or alcohol abuse in the last 2 years
* Pregnant or lactating women
* Any other issues which, in the opinion of the PI, will make the subject ineligible for study participation

Primary outcomes:
measure: Number of Treatment Related Adverse Event, including Abnormal Laboratory Events
timeFrame: Up to Day 7
Secondary outcomes:
measure: Pharmacokinetics of G1T38: Maximum Plasma Concentration (Cmax)
timeFrame: Day 1, 2, 3, 4 and 5
measure: Pharmacokinetics of G1T38: Area under Curve - plasma concentration (AUC)
timeFrame: Day 1, 2, 3, 4 and 5
measure: Pharmacokinetics of G1T38: Plasma: terminal half life (T1/2)
timeFrame: Day 1, 2, 3, 4 and 5
measure: Pharmacokinetics of G1T38: Plasma - Volume of distribution
timeFrame: Day 1, 2, 3, 4 and 5
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Early Development Clinic
Study officials:
affiliation: PRA Early Development Clinic
name: Regner Tiessen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01942824: Adult Influenza Vaccination Text Message Reminders
Official title: Adult Influenza Vaccination Text Message Reminders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Vaccination
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 7250
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: Influenza infection leads to on average 24,0000 deaths and 150,000 hospitalizations annually. While vaccination is the cornerstone of preventing influenza infection, vaccination coverage in adults is low with only 35% vaccinated by end of November. Latino adults have the lowest coverage rates. Text message reminders have been used successfully for improving influenza vaccination for children. This study will assess the use of text messaging to improve influenza vaccination coverage rates in a largely minority, publicly insured adult population.


Eligibility criteria: Inclusion Criteria:

* \> or = 18 years of age,
* at least one visit to the AIM clinic during the previous year
* a cell phone number in the registration system
* fluent in English or Spanish. Exclusion criteria

Exclusion Criteria:

- Receipt of influenza vaccination during the 2013-2014 influenza season prior to randomization.

Primary outcomes:
measure: Timeliness of vaccination
timeFrame: 6 months
Secondary outcomes:
measure: Receipt of influenza vaccine dose
timeFrame: 15 weeks
measure: Receipt of Influenza vaccine dose, end of season
timeFrame: 28 weeks
Other outcomes:
Locations:
city: NY
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Melissa Stockwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Steven Shea, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04570124: STAMPP-HTN in a High-risk Rural Population of Women
Official title: Implementing the Systemic Treatment and Management of Postpartum Hypertension (STAMPP-HTN) Bundle in a High-risk Mississippi Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension in Pregnancy
Keywords: Hypertension
Blood Pressure
Post-Partum
Telemonitoring
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: University of Chicago
First posted: 2020-09-30
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine if monitored blood pressure paired with education reduces maternal mortality and morbidity during the post-partum period in a high-risk rural population of women.

Detailed description: Women with hypertension during pregnancy are at an increased risk of maternal mortality (death during or within 42 days of termination of pregnancy) and hypertension related morbidity. Black women, women with lower education and less access to health care resources also have increased maternal mortality and morbidity. This project will use Bluetooth enabled blood pressure devices to monitor blood pressure in a population of postpartum women at increased risk for maternal mortality and morbidity. We will compare the number of postpartum hypertensive incidences and severities to a population of women who did not have a postpartum blood pressure control intervention.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent in a postpartum woman between 18-45 years of age at the time of study enrollment
2. Hospitalized for delivery with a hypertensive disorder of pregnancy as defined by ACOG 2019 Guidelines (chronic hypertension, HELLP syndrome, eclampsia, preeclampsia, gestational hypertension or new onset postpartum hypertension).
3. Ability to understand English or Spanish
4. Reliable access to the Internet and a Bluetooth mobile device
5. Willingness to download Omron Connect App and ability to use blood pressure monitor

Exclusion Criteria:

1. Does not meet Inclusion criteria
2. Postpartum or operative complication that prolongs hospital stay beyond postpartum day 10.
3. Patients who are currently participating in another clinical trial to evaluate a therapeutic intervention for control of blood pressure.

Primary outcomes:
measure: Determine if HBPT decreases the severity of postpartum hypertension complication
timeFrame: 9 months
Secondary outcomes:
measure: Increase awareness and knowledge of postpartum blood pressure control in a group of high-risk women
timeFrame: 9 months
measure: Assess compliance using HBPT and adherence to blood pressure medication
timeFrame: 9 months
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of MS Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Kedra Wallace, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03691324: Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study
Official title: Could Training in Inhalation Technique During the Hospital Stay and Discharge Services From the Pharmacy Reduce the Rate of Readmissions for COPD Patients? - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Oslo University College
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Hospital Pharmacy Enterprise, South Eastern Norway
First posted: 2018-10-01
Enrollment: 40
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: Inhalation drugs are essential in the treatment of COPD, in controlling symptoms and preventing exacerbations. The aim of this pilot study is to collect data necessary for the planning of future efficacy trials. We plan to assess the value of providing training in inhalation technique to hospitalized COPD patients. Data on rehospitalizations will be collected from the hospital's medical records and from the National Patient Registry . The inhalation technique of all recruited patients will de assessed at baseline. The patients will then be randomised 1:1 to the intervention or standard care group. The intervention consists of a drug counselling, focusing on inhalation technique. In addition patients in the intervention group will have their medicines personally delivered from the hospital pharmacy at discharge (discharge service). Patients will be asked to fill in questionnaires evaluating the inhalation training and the discharge service


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the pulmonary ward, the Medical Department, Oslo University Hospital, Oslo, Norway

Exclusion Criteria:

Patients

* previously included to the study
* usually not administering their inhalation drugs themselves
* using nebulizer chamber with their drug
* who are contagious, thus restricting accessibility of personnel
* who are not able to provide informed consent

Primary outcomes:
measure: Time to first readmission
timeFrame: One year after discharge of the last patient
Secondary outcomes:
measure: Improvement in patient reported symptom score (CAT-score) from baseline to 2 months after discharge
timeFrame: 2 months after discharge
measure: Proportion of patients readmitted 3 months after discharge
timeFrame: 3 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Collage
name: Liv Mathiesen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kebede AT, Trapnes E, Lea M, Abrahamsen B, Mathiesen L. Effect of pharmacist-led inhaler technique assessment service on readmissions in hospitalized COPD patients: a randomized, controlled pilot study. BMC Pulm Med. 2022 May 27;22(1):210. doi: 10.1186/s12890-022-02004-z.
Clinical trial NCT06983496: Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome
Official title: Pharmacist-Intensivist Collaborative Telehealth for Post-Intensive Care Syndrome in Survivors of Critical Illness: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Intensive Care Syndrome (PICS)
Lead sponsor: Malcom Randall VA Medical Center
Sponsor class: FED
First posted: 2025-05-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this pilot randomized controlled trial is to determine if a randomized controlled trial of a collaborative pharmacist-intensivist telehealth follow-up after intensive care unit discharge can feasibly be performed in patients who have survived a critical illness.

The study intervention will be telehealth follow-up appointments provided by clinical pharmacists at approximately one and three months post-hospital discharge. The purpose of the follow-up appointments will be to assess for post-intensive care syndrome and provide recommend interventions aimed at improving recovery

Participants will randomized to receive the study intervention or standard of care.


Eligibility criteria: Inclusion Criteria:

* Adults 18-89 years of age
* Required admission to either medical or surgical ICU
* Respiratory failure requiring invasive mechanical ventilation of at least 24 hours during ICU stay; or ICU stay of at least 7 days
* Anticipated discharge to home after hospitalization
* Consent from patients themselves or a legally authorized representative if necessary

Exclusion Criteria:

* Pregnancy
* Incarceration/Imprisonment
* Life expectancy less than 6 months or enrolled in hospice/palliative care
* Anticipated discharge to skilled nursing facility, medical rehabilitation facility, or other long terms care facility
* Unable to participate in telehealth

Primary outcomes:
measure: Completion of Post-ICU follow-up
timeFrame: From enrollment to end of follow-up period at seven months
Secondary outcomes:
measure: Quality of life at 6 months using the Short Form Survey (SF-36)
timeFrame: From enrollment to 7 months
measure: Hospital or ICU re-admissions
timeFrame: Enrollment up to 7 months
measure: Emergency department visits
timeFrame: Enrollment up to 7 months
measure: Mortality
timeFrame: within 6 months post-hospital discharge
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05505396: Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury
Official title: Hyperglycaemia and Hyperlactataemia in Patients With Severe Acute Brain Injury in the Intensive Care Unit - a Prospective, Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Brain Injury
Hyperglycemia
Hyperlactatemia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 875
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include all patients with severe acute brain injury, admitted to the neuro intensive care department at Rigshospitalet, Denmark. Mainly, it will be patients with TBI, SAH, ICH or acute ischaemic stroke.

Brief summary: This is an observational study of patients with severe acute brain injury, which aims to characterize the development of hyperglycaemia and hyperlactataemia and the influence of these markers on clinical outcome.

Additionally, in a subgroup of patients undergoing advanced multimodal neuromonitoring on either clinical or research indication, the relationship between hyperglycaemia and brain glucose levels as well as systemic and microdialysis lactate will be examined.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Admission to the neurointensive care unit at Rigshospitalet
* Diagnosis of acute brain injury categorised as TBI, SAH, ICH, ischaemic stroke, or other conditions

Exclusion Criteria:

* Brain death before inclusion
* Closest relatives do not understand written and spoken Danish or English

Primary outcomes:
measure: Functional outcome at 6 months as evaluated by the modified Rankin Scale.
timeFrame: 6 months after admission.
Secondary outcomes:
measure: All-cause mortality at 6 months (dichotomous).
timeFrame: 6 months after admission.
measure: Length of stay in the neuro-ICU (continuous).
timeFrame: Day of discharge, typically 1-30 days after admission.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Neuroanesthesiology and Neurointensive Care, Rigshospitalet
Study officials:
References: