louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04271358: Peer Coaching Intervention in Young Adults With Congenital Heart Disease
Official title: Peer Coaching Adaptive Self-Management Interventions for Young Adults With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease
Congenital Heart Defect
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Adult Congenital Heart Association
First posted: 2020-02-17
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Once enrolled, participants will be randomly assigned to the intervention or control group (1:1 ratio)
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to evaluate a peer coaching intervention in young adults with congenital heart disease.

Detailed description: Our research team has developed a peer coaching intervention that has been deployed to promote activated self-management for AYAs with several conditions, and this has been modified adolescents and young adults (AYA) with with congenital heart disease (CHD). This study will be conducted over two years and pair AYA with CHD with a peer coach who also has CHD has successfully navigated the transition to adult medical care and over six months will work to promote the motivation for self-care as well as the development of self-management skills. This pilot study will test feasibility and acceptability, as well as preliminary efficacy and long-term effects on successful transfer to adult cardiology.

Eligibility criteria: Inclusion Criteria:

* Age 18-26
* Diagnosis of congenital heart disease
* Patient at a Duke pediatric cardiology clinic
* Access to a smart phone

Exclusion Criteria:

* Cognitive delay
* Patient at an adult cardiology clinic

Primary outcomes:
measure: Evaluate number of participants enrolled
timeFrame: Up to 2 months after recruitment closes
measure: Evaluate completion of study
timeFrame: Up to 8 months after enrollment of each participant
measure: Measure impact on health
timeFrame: Up to 8 months after enrollment of each participant
measure: Determine change in patient activation
timeFrame: baseline, 3 months, 6 months
measure: Determine change in self-management
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Determine change in transition readiness
timeFrame: baseline, 3 months, 6 months
measure: Determine change in health related quality of life
timeFrame: baseline, 3 months, 6 months
measure: Determine change in emotional health
timeFrame: baseline, 3 months, 6 months
measure: Evaluate successful transfer of participants from pediatric to adult cardiology care
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Health
state: North Carolina
Study officials:
affiliation: Duke University
name: Richard A Krasuski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Gary Maslow, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00696358: Excimer Lamp Versus Excimer Laser in Vitiligo Treatment
Official title: Comparative Study of 308nm Excimer Lamp and 308nm Excimer Laser in the Treatment of Vitiligo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitiligo
Keywords: Vitiligo
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2008-06-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: 308 nm excimer lamp and 308 nm excimer laser have both provide interesting results in treating vitiligo. They have the same wavelength but the type of emission of the photons is different. To date there is no direct comparative data concerning these two devices in this indication.

The aim of the study is to make an intra-individual prospective comparison between these two phototherapies.


Eligibility criteria: Inclusion Criteria:

* patient above 18
* vitiligo for more than 3 months
* at least 2 vitiligo symmetric patches more than 10cm²
* to read and understand the inform consent
* to have a social security number
* non pregnant for women

Exclusion Criteria:

* pregnant women
* keloids
* history of radiotherapy or skin cancer in the treated areas
* treatment for vitiligo in the past 4 weeks
* phototherapy in the past 12 weeks; history of photodermatosis
* treatment inducing photosensibilization
* immunosuppression
* patient who participated in a study in the past 3 months

Primary outcomes:
measure: Repigmentation rate in the treated areas
timeFrame: 12 weeks
Secondary outcomes:
measure: Tolerance and safety of the treatments
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nice
country: France
facility: Department of Dermatology, University Hospital of Nice
Study officials:
References:
Clinical trial NCT05594758: Named Patient Program for Olverembatinib (HQP1351)
Official title: Named Patient Program for Providing Access to Olverembatinib (HQP1351) to Countries Where the Drug is Not Available
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Keywords: Named Patient Program
Lead sponsor: Ascentage Pharma Group Inc.
Sponsor class: INDUSTRY
Collaborators: name: Tanner Pharma Group
First posted: 2022-10-26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT

Brief summary: This program will allow eligible patients access to Ascentage Pharma's novel drug candidate Olverembatinib (approved in China) on a named patient basis in over 100 countries ( with the exception of the USA and China) and regions where the drug is not available.

Detailed description: Olverembatinib is a novel third generation BCR-ABL inhibitor that can effectively target a spectrum of BCR-ABL mutants, including the T315I mutation. Olverembatinib is approved in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation as confirmed by a validated diagnostic test1.

Eligibility criteria: Inclusion Criteria:

• Patients who are suitable to receive Olverembatinib and for whom there is reasonable expectation that Olverembatinib may provide clinical benefit based on the medical judgment of their prescribing physician.

Exclusion Criteria:

* Existing risks of serious Arterial occlusive events (AOE), including myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and recent revascularization procedures
* Existing risks of serious Venous thromboembolic events (VTEs), including deep venous thrombosis, pulmonary embolism, and retinal vein thrombosis
* Existing serious heart conditions, including acute/chronic heart failure, coronary artery disease
* Existing conditions of severe liver malfunction
* Existing conditions of severe myelosuppression
* Existing conditions of severe hemorrhage
* Pregnant or baby feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00360958: Treatment of Severe Heart Failure by Ultrafiltration
Official title: Ultrafiltration for the Chronic Treatment of Severe Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Severe Congestive Heart Failure
Keywords: ultrafiltration
heart failure
fluid overload
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
First posted: 2006-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with severe congestive heart failure show increased fluid body content which is often resistant to conventional diuretic therapy. Therefore, chronic heart failure patients have frequent access to the emergency room and hospital for hemodynamic instability. Ultrafiltration is a simple renal replacement therapy which reduces fluid overload. The purpose of this study is to determine whether periodic ultrafiltration sessions maintain patients in stable clinical condition and reduce hospitalisations as well as access to emergency heart failure treatment.

Detailed description: Patients with severe heart failure (New York Heart Association \[NYHA\] III-IV) and fluid overload will be randomized to ultrafiltration (UF group) or conventional medical treatment (Control group). Patients follow-up at least monthly visit for one year. Ultrafiltration will be repeated during follow-up in case of body weight gain due to fluid accumulation. Ultrafiltration will be performed during short term hospitalization.

Eligibility criteria: Inclusion Criteria:

* Severe heart failure (NYHA III-IV) with fluid overload
* Ejection fraction \< 40%
* Estimated fluid overload \> 4 kg

Exclusion Criteria:

* Severe renal insufficiency
* Acute pulmonary edema and/or cardiogenic shock

Primary outcomes:
measure: number of hospitalizations for heart failure
timeFrame: End of study
Secondary outcomes:
measure: long term major adverse clinical events including death
timeFrame: End of study
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
Study officials:
affiliation: Centro Cardiologico Monzino
name: Piergiuseppe Agostoni, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marenzi G, Muratori M, Cosentino ER, Rinaldi ER, Donghi V, Milazzo V, Ferramosca E, Borghi C, Santoro A, Agostoni P. Continuous ultrafiltration for congestive heart failure: the CUORE trial. J Card Fail. 2014 Jan;20(1):9-17. doi: 10.1016/j.cardfail.2013.11.004. Epub 2013 Nov 20.
Clinical trial NCT06140758: Evaluation of the Anticaries Efficacy of Dentifrice Formulations Using an In-situ Model
Official title: Evaluation of the Anticaries Efficacy of Various Dentifrice Formulations Using an In-situ Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2023-11-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective is to compare the remineralization and demineralization inhibition potential of early subsurface carious lesions in enamel in situ after rinsing with six different aqueous slurries of toothpaste formulations.


Eligibility criteria: Inclusion Criteria:

* Be 18-75 years of age.
* Provide written informed consent prior to participation and be given a signed copy of the informed consent form.
* Be in good general health based on medical/dental history and oral exam.
* Have no history of adverse or allergic reactions to tin or tin-containing products.
* Agree not to participate in any other oral study for the study duration.
* Have a reasonable functional dentition as determined by the oral examiner and sufficient teeth to support the fabricated dental appliance.
* Be willing to participate in the study, able to follow the study directions, successfully tolerate/perform all study procedures, and willing to return for all specified visits at their appointed time.
* Be willing to refrain from using non-study dentifrice, mouth rinse, chewing gum, and other non-study oral care products during the study.
* Be willing to postpone all elective dental procedures until the study has been completed.
* Be willing to refrain from using calcium chews while using the test products.
* Be willing and able to refrain from wearing a nightguard (occlusal splint) for the entire course of the study (for nightguard wearers only).
* Ability to understand, and ability to read and sign, the informed consent form.
* Have at least 22 natural teeth.
* Have a gum-stimulated whole salivary flow rate ≥ 1.0 ml/minute and unstimulated whole salivary flow rate ≥ 0.2 ml/minute.

Exclusion Criteria:

-

Primary outcomes:
measure: Mineral Density
timeFrame: 14 days
measure: Scanning Electron Microscopy (SEM)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: University of Melbourne
Study officials:
References:
Clinical trial NCT06212258: Pneumoperitoneum Increases Mean Expiratory Flow Rate: an Observational Study in Healthy-lung Patients
Official title: Pneumoperitoneum Increases Mean Expiratory Flow Rate: an Observational Study in Healthy-lung Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pneumoperitoneum Increases Mean Expiratory Flow Rate
Keywords: mechanical ventilation; body mass index; chest compliance; pneumoperitoneum; expiratory flow rate, intraabdominal pressure, laparoscopic surgery
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Helthy lung patients, over age 18 years, males and femailes together.

Brief summary: Upon introducing pneumoperitoneum our research team noticed a reduction in expiration time displayed on the screen of the anesthesia machine. Since most respirators do not directly indicate the length of expiratory time and the average expiratory flow rate, we decided to investigate whether pneumoperitoneum really accelerates expiratory flow rate and thus shortens expiratory time.

Detailed description: Furthermore we also intended to investigate which ventilation parameters these changes can be correlated with, elucidating the factors contributing to the acceleration of expiration..

This study aims to uncover the physiological mechanisms behind alterations in respiratory dynamics during and after pneumoperitoneum, offering valuable insights that may aid in refining ventilation strategies in the context of laparoscopic procedures.

Eligibility criteria: Inclusion Criteria:

* elective laparoscopic abdominal surgery, healthy lung patients, age over 18 years. Obrained, written informed consent to partake in the research.

Exclusion Criteria:

chronic obstructive pulmonary disease, bronchial asthma, silicosis, and those with a history of previous lung surgery, patients under 18 years of age, those who had not provided consent, and pregnant individuals were excluded from the study.

-

Primary outcomes:
measure: Pneumoperitoneum increases mean expiratory flow rate
timeFrame: during surgery
measure: Expiration time would be shortened, resulting in a potentially higher flow rate
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Pécs
country: Hungary
facility: Department of Anaesthesia and Intensive Care, Medical School, University of Pécs
state: Baranya
Study officials:
References:
Clinical trial NCT04257058: Education Tools to Support Pediatric Survivor Care
Official title: Predicting Childhood Cancer Survivors' Transition Readiness & Transfer Outcomes (SURV Transfer Outcomes) (Administrative Supplement to R01CA218389)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Pediatric Cancer
Keywords: Behavioral study
Social study
Pediatric cancer
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-02-05
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the impact of electronic educational materials on adolescent and young adult (AYA) survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.

Detailed description: Despite increased risk for morbidity and mortality related to cancer treatment, over half of young adult survivors of childhood cancer do not engage in the recommended healthcare designed to detect late effects and secondary cancers. There is a scarcity of data on adherence to survivor-focused healthcare, particularly at the critical transition from pediatrics to adult care. In order to improve transition outcomes, the investigators need to create media to educate survivors about need for adherence to adult survivor healthcare.

This study aims to evaluate the impact of electronic educational materials on AYA survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.

Eligibility criteria: Inclusion Criteria:

* Patients must be 18-25 years of age,
* Diagnosed with cancer at ≤ 18 years of age,
* ≥ 2 years since the last cancer treatment,
* seen at least once in the Aflac Cancer Survivor Program (CSP) in the past 2 years or transitioned out of the Aflac CSP to adult survivor care since 2013.

Exclusion Criteria:

* Patients will be excluded from participation in the study if the participant is non-English speaking.
* Young adult survivors who are cognitively impaired and unable to complete the questionnaires.
* Participants that do not consent to the recording of their interviews.

Primary outcomes:
measure: Survivor Care Knowledge Scale
timeFrame: Baseline, 2 weeks post-intervention
Secondary outcomes:
measure: Benefits for Survivor Care
timeFrame: Baseline, 2 weeks post-intervention
measure: Barriers for Survivor Care
timeFrame: Baseline, 2 weeks post-intervention
measure: Perceived Susceptibility for Late Effects
timeFrame: Baseline, 2 weeks post-intervention
measure: Intentions for Survivor Care
timeFrame: Baseline, 2 weeks post-intervention
measure: Change in Perceived Health Competence Scale (PHCS)
timeFrame: Baseline, 2 weeks post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Emory University
name: Jordan Marchak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06940258: Caval Aorta Index for Fluid Optimization in Traumatic Brain Injury
Official title: Efficacy of Caval Aorta Index for Fluid Optimization in Critically Ill Patients With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fluid Balance
Keywords: caval aorta index
traumatic brain injury
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After enrollment, patients will be randomly allocated using block into two groups of 46 patients in each group; ultrasound-guided ﬂuid management (US group) or standard care (C group)
Primary purpose: TREATMENT

Brief summary: Traumatic brain injury is a leading cause of death and disability in trauma patients. As the primary injury cannot be reversed; management strategies must focus on preventing secondary injury by avoiding hypotension and hypoxia besides, maintaining appropriate cerebral perfusion pressure, which is a surrogate for cerebral blood flow.

Detailed description: The caval aorta index is an ultrasound element, relatively new, used to assess volume status. Technically, the sonographic assessment of the inferior vena cava /aorta diameter ratio is an easy test to perform and can be performed effectively by doctors who are not experienced in the field of sonography (Kusumastuti et al .2021).

In this study; the caval aorta index will be used to guide fluid dosage in critically ill patients with traumatic brain injury.

Eligibility criteria: Inclusion Criteria:

Traumatic brain injury diagnosed by computed tomography scan Glasgow coma score ≥ 4

Exclusion Criteria:

Inability to get consent. Pregnant and lactating women Traumatic subarachnoid hemorrhage Spinal cord injury Increased intra-abdominal pressure Abdominal aortic aneurysm Inferior vena cava (IVC) thrombus Portal hypertension Acute corpulmonale Congestive heart failure chronic hemodialysis Surgical intervention other than neurological one within the first 7 days Mechanical ventilation need during first 7 days Cardiac arrest during the first 7 days

Primary outcomes:
measure: fluid balance
timeFrame: after 96 hours from the admission
Secondary outcomes:
measure: Urine output
timeFrame: Daily for 7 weeks
measure: Central Venous Pressure (CVP) measurements
timeFrame: Daily every 6 hours for 7 days
measure: Frequency and duration of hypotension
timeFrame: within first 7 days
measure: Glasgow Coma Scale
timeFrame: daily within first 7 days
measure: Central capillary refill
timeFrame: Daily for 7 days
measure: incidence of pulmonary edema
timeFrame: Daily within first 7 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01484158: Gait Speed for Predicting Cardiovascular Events After Myocardial Infarction
Official title: Gait Speed for Predicting Cardiovascular Events After Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: Myocardial Infarction
Lead sponsor: Yokohama City University Medical Center
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 450
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute myocardial infarction.

Brief summary: There are growing evidences that gait speed is inversely associated with all causes mortality especially cardiovascular mortality among the elderly. The purpose of this study is to evaluate the predictive value of gait speed for cardiovascular events in patients after ST-segment elevation myocardial infarction (STEMI).

Detailed description: The investigators will enroll patients capable of walking with STEMI. All patients will receive successful reperfusion therapy within 12-hour from onset. Gait speed during cardiac rehabilitation is measured. Cardiovascular events were defined as a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, for an average follow-up period.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ST-segment elevation acute myocardial infarction
* Must be treated within 12 hours after symptom onset
* Must be able to walk
* Must receive successful primary percutaneous coronary intervention

Exclusion Criteria:

* History of prior myocardial infarction
* Cerebrovascular disease with residual hemiplegia
* Severe peripheral arterial disease

Primary outcomes:
measure: Cardiovascular Events
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Matsuzawa Y, Konishi M, Akiyama E, Suzuki H, Nakayama N, Kiyokuni M, Sumita S, Ebina T, Kosuge M, Hibi K, Tsukahara K, Iwahashi N, Endo M, Maejima N, Saka K, Hashiba K, Okada K, Taguri M, Morita S, Sugiyama S, Ogawa H, Sashika H, Umemura S, Kimura K. Association between gait speed as a measure of frailty and risk of cardiovascular events after myocardial infarction. J Am Coll Cardiol. 2013 May 14;61(19):1964-72. doi: 10.1016/j.jacc.2013.02.020. Epub 2013 Mar 14.