louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00433940: Immune Suppression Of Infants Treated With Steroids
Official title: Immune Suppression of Infants Treated With Oral Corticosteroids for Infantile Hemangiomas: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemangioma
Keywords: Hemangioma
Corticosteroid
Prednisone
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2007-02-12
Enrollment: 16
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects were recruited from a hospital based pediatric dermatology clinic.

Brief summary: The goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas.

Detailed description: Infants with large or complicated hemangiomas are often treated systemically with oral steroids. The side effects of the drug on young infants has not been studied. The goal of this study is to clarify the degree of immune suppression in infants requiring therapy and to create guidelines for evaluation and prevention of infection in infants on oral steroids for hemangiomas. Prednisone will be started according to established standard of care. Visits will occur every four weeks for follow-up. There will be six blood draws from baseline to completion of study. Approximately up to 1 ½ teaspoons per blood sample will be drawn to test the strength of the infant's immune system. Participation in this study will last up to 14 months or until stabilization of the hemangioma. Evaluation will occur 12 weeks after discontinuing the steroid for its long-term effects on the immune system.

Eligibility criteria: Inclusion Criteria:

* Infants \< 6 months of age with infantile hemangiomas requiring treatment with oral corticosteroids
* Infant must be enrolled prior to initiation of steroid therapy

Exclusion Criteria:

* Infants \> 6 months of age
* Infants already receiving oral corticosteroid treatment prior to the start of this study
* Infants with know immunodeficiencies
* Infants receiving other oral medications for the treatment of hemangiomas

Primary outcomes:
measure: Lymphocyte Subtest of Complete Blood Count Analysis (Primary Immunodeficiency)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Beth A Drolet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03261440: Cardiac, Pulmonary and Diaphragm Sonography for the Early Diagnosis of the Different Etiologies Underlying Failure of Weaning From Mechanical Ventilation
Official title: Combined Cardiac, Pulmonary and Diaphragm Sonography for the Evaluation of Failure in Ventilation Weaning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mechanical Ventilation
Following Heart or Abdominal Surgery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on post-operative mechanical ventilation following heart or abdominal surgery

Brief summary: Weaning patients off ventilation in an ICU is sometimes difficult, because of three major inter-related etiologies: impaired lung, heart and diaphragm function. In this context, ultrasonography during tests to wean patients off ventilation could make it possible to diagnose cardiac dysfunction, a loss of pulmonary aeration or diaphragm dysfunction and thus reduce the number of failures at extubation.

The study will be carried out in 100 patients on mechanical ventilation following abdominal or heart surgery, who will have echocardiography, and pulmonary and diaphragm ultrasonography.


Eligibility criteria: Inclusion Criteria:

* Patients on mechanical ventilation for at least 48 hours
* Age ≥ 60 years
* Patients who have undergone abdominal or heart surgery

Exclusion Criteria:

* Patients with a known neuromuscular disease
* Patients younger than 60 years
* Duration of mechanical ventilation \<48h
* Non-surgical patients
* Patients with severe COPD

Primary outcomes:
measure: Echocardiography
timeFrame: At baseline
measure: Lung ultrasonography
timeFrame: At baseline
measure: Diaphragm ultrasonography
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
citation: Bouhemad B, Mojoli F, Nowobilski N, Hussain A, Rouquette I, Guinot PG, Mongodi S. Use of combined cardiac and lung ultrasound to predict weaning failure in elderly, high-risk cardiac patients: a pilot study. Intensive Care Med. 2020 Mar;46(3):475-484. doi: 10.1007/s00134-019-05902-9. Epub 2020 Jan 8.
Clinical trial NCT01962740: Serial Evaluation of Drug-Eluting Stents Using OCT (STRUT-OCT)
Official title: Serial Evaluation of Drug-Eluting Stents Using OCT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Drug Eluting Stents (DES)
Percutaneous Coronary Intervention (PCI)
Uncovered and Malapposed Stent Struts
Optical Coherence Tomography (OCT)
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2013-10-14
Enrollment: 3
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: DIAGNOSTIC

Brief summary: The study is proposed as a 48-patient randomized-controlled pilot study that will use Optical Coherence Tomography (OCT) imaging to compare stent strut coverage and malapposition of three second-generation Drug Eluting Stents (DES) \[Xience EES (Abbott Vascular, Santa Clara, CA), Resolute Integrity ZES (Medtronic, Minneapolis, MN) and Promus Element EES (Boston Scientific, Natick, MA)\] at 6 weeks post implantation.

Study Hypothesis is that the rates of stent strut coverage and malapposition of the Xience EES, Promus EES and will be similar to each other and improved (higher rates of stent strut coverage and lower rates of malapposition) compared to the Resolute ZES at 6 weeks post-implantation.


Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 18 years
2. Clinical need for percutaneous coronary intervention using either a Xience, Promus Element, or Resolute Integrity drug-eluting stent using optical coherence tomography optimization
3. Native coronary artery de novo lesion with ≥70% angiographic percent diameter stenosis by visual estimation
4. Target vessel reference diameter between 2.5 and 4.0 mm by visual estimate
5. Target lesion ≤28 mm in length by visual estimate
6. Agree to participate and provide informed consent

Exclusion Criteria:

1.Presentation with acute ST-elevation myocardial infarction (defined as electrocardiographic (ECG) ST-elevation ≥ 2 mm in 2 or more contiguous ECG leads along with symptoms compatible with ischemia)

Primary outcomes:
measure: Stent Strut Coverage
timeFrame: 6 weeks post-implantation
measure: Stent Strut Malapposition
timeFrame: 6 weeks post-implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
Study officials:
affiliation: North Texas Veterans Healthcare System
name: Shuaib Abdullah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02113540: Assessment of the Effect of Atorvastatin on Prevention of CIN in Patients Undergoing Coronary Angiography
Official title: Atorvastatin and Prevention of Contrast Induced Nephropathy Following Coronary Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Contrast Induced Nephropathy
Keywords: coronary angiography
chronic stable angina
CIN
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-04-14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: As the effect of statin use before the angiography to prevent contrast induced nephropathy (CIN) is not well-known, the aim of the current study is to assess the effect of atorvastatin on prevention of CIN in patients undergoing coronary angiography.


Eligibility criteria: Inclusion Criteria:

* having chronic stable angina who were referred for coronary angiography
* non-pregnant female subjects
* no history of diabetes mellitus
* no history of renal failure
* no history of single kidney
* no history of cardiogenic shock
* no history of unstable angina
* no history of myocardial infarction
* no history of hypersensitivity to statins
* no history of previous intravascular contrast injection during one month before admission

Exclusion Criteria:

* glomerular filtration rate (GFR) \<60
* cardiogenic shock

Primary outcomes:
measure: Contrast induced nephropathy (CIN) incidence
timeFrame: 48 hours after the procedure
Secondary outcomes:
measure: serum creatinine (Cr) level
timeFrame: 48 hours after the procedure
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
Study officials:
References:
Clinical trial NCT05669040: mHealth to Improve the Experience, Adherence to Drug Treatment and Positive Mental Health
Official title: mHealth to Improve the Experience, Adherence to Drug Treatment and Positive Mental Health of Patients Diagnosed With Femur Fracture: Protocol for a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture of Femur
Keywords: education
patient experience
adherence medication
mental health
mobile health
nurse
mHealth
protocol
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Amgen
name: University of Barcelona
First posted: 2022-12-30
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study aims to evaluate the effectiveness of a pharmacological nursing educational intervention (EFE) with "Myplan Aplication" about the patient's experience, adherence to pharmacological treatment, and positive mental health of patients with femur fracture.

Detailed description: Once the informed consent has been obtained, the investigators will explain to the patient the pharmacological treatment with the support of an aplication (what it is for, how the medication should be taken, possible adverse effects), also the investigators will share time with the patient during the 4 face-to-face training sessions. The investigators will accompany during their hospital stay, offering to pacients telematic support upon discharge with the treatment and until the end of the study. This is a quasi-experimental non-randomized study with 3 phases of data collection. Possible adverse reactions, if any, will be recorded.

Eligibility criteria: Inclusion Criteria:

* diagnosis of femur fracture
* knowledge of the Spanish language
* 24-hour admission to the traumatology unit
* level of consciousness on the Glasgow scale of 15
* have access to a mobile device
* ability to participate in the pilot study
* be able to provide written informed consent or obtain consent from a legal representative.

Exclusion Criteria:

* presence of psychological pathologies or cognitive impairment
* isolation in hospital admission

Primary outcomes:
measure: Patient experience questionnaire-15. Changes in outcomes are assessed at three time points.
timeFrame: at 1rst day (before intervention), at 7th day (at discharge after intervention), and 25th day (after discharge)
measure: Morinski-Green Questionnaire. Changes in outcomes are assessed at three time points.
timeFrame: at 1rst day, at 7th day and 25th day.
measure: Positive Mental Health Questionnaire. Changes in outcomes are assessed at three time points.
timeFrame: at 1rst day, at 7th day and 25th day.
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: UB
name: Carmen Moreno Arroyo
role: STUDY_DIRECTOR
References:
Clinical trial NCT03642340: A Post-marketing Surveillance to Assess Safety and Efficacy of Besivo
Official title: A Post-marketing Surveillance to Assess Safety and Efficacy of Besivo
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis b
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 3000

Brief summary: This study is a post-marketing surveillance of Besivo in participants with chronic hepatitis B.

Detailed description: This post-marketing surveillance required by Korea MFDS regulation. The objectives of this study are to monitor adverse events and effectiveness of Besivo.

Eligibility criteria: Inclusion Criteria:

* The patient diagnosed with chronic hepatitis B.
* The patient who is first prescribed and administered Besivo.

Exclusion Criteria:

* The patients who are overreacting to this drug or its components
* Medium to severe Renal function disorder
* The patient under 19
* The Patient who are taboo with L-Carnitine

Primary outcomes:
measure: Incidence of adverse event after this drug administration in general medical practice.
timeFrame: 48weeks
measure: Incidence of serious adverse event after this drug administration in general medical practice.
timeFrame: 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: PV
name: Ildong Ildong
role: STUDY_DIRECTOR
References:
Clinical trial NCT06874140: Proteomic Study of Chuanhong Zhongfeng Capsule in the Treatment of ACI
Official title: Biomarkers and Potential Mechanisms of Chinese Medicine Compound (Chuanhong Zhongfeng Capsule) in the Treatment of Acute Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Ischemic Stroke
Lead sponsor: Affiliated Hospital of Changchun University of Chinese Medicine
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Acute cerebral infarction is characterized by high disability rate and high recurrence rate, which poses a great threat to the life and health of the nation. Proteomics technology is a holistic and comprehensive understanding of disease mechanism, cell metabolism and other processes at the protein level. The correlation between acute cerebral infarction and proteomics has become a hot spot of clinical and basic research in recent years. Chuanhong Zhongfeng capsule was developed by Ren Jixue, a master of national medicine, and clinical studies have confirmed that it not only promotes the recovery of neurological function in patients with cerebral infarction, reduces the disability rate, but also improves the long-term prognosis, but its mechanism of action and its target are still unclear. In the present study, we applied 4D Label-free proteomics technology and PRM technology to study for the first time the mechanism of action and potential targets of Chuanhong Zhongfeng Capsule in the treatment of acute cerebral infarction, which will provide a direction for the study of traditional Chinese medicine compounding for the prevention and treatment of cerebral infarction.


Eligibility criteria: Inclusion Criteria:

1. Meet the diagnostic criteria for ischemic stroke in the Chinese Guidelines for Diagnosis and Treatment of Ischemic Stroke in the Acute Phase 2018.
2. Meet the diagnostic criteria for ischemic stroke in Chinese medicine.
3. Within 2 weeks of acute onset of ischemic stroke.
4. 4 ≤ NIHSS score \<15.
5. Age 40-80 years old. -

Exclusion Criteria:

1. Diagnosis of hemorrhage or other pathological brain disorders based on head CT or MRI;
2. Allergic individuals, those who are allergic to the test medication or the associated medicinal flavors or components thereof;
3. Age \<40 years or \>80 years;
4. Those with severe liver or kidney function impairment. -

Primary outcomes:
measure: Explore protein expression levels, post-translational modifications, protein-protein interactions, and obtain protein-level insights into disease mechanisms and disease biomarkers.
timeFrame: 14 day
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
Study officials:
References:
Clinical trial NCT00509340: Cognitive Behavioral Therapy to Help HIV Infected Adults With Depression to Adhere to Antiretroviral Therapy
Official title: Cognitive Behavioral Adherence Intervention for Depressed HIV Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Depression
HIV Infection
Keywords: antiretroviral
adherence
poor antiretroviral adherence
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-07-31
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the effectiveness of a cognitive behavioral intervention versus usual clinic care in helping HIV infected adults with depression to take their HIV medications on schedule.

Detailed description: Antiretroviral therapy (ART) is a type of medication treatment for HIV that impairs the virus's ability to multiply. When used properly, it has been shown to be successful in reducing HIV-related deaths. A high adherence rate to ART is required to adequately suppress the virus, limit drug resistance, and reduce transmission. HIV infected people who are depressed often experience increased difficulty with adhering to their ART regimen. This study will compare the effectiveness of a cognitive behavioral intervention that targets both depression and adherence versus usual care practices which may or may not include mental health intervention with the goal of improving ART adherence among HIV infected adults with depression who are experiencing difficulty with adhering to their medication regimen.

This study will last 24 weeks. Participants will be randomly assigned to receive the cognitive behavioral intervention or usual care. Study visits for all participants will occur at baseline and Weeks 4, 8, 16, and 24. Those receiving the intervention will also have visits at Weeks 1 and 2. Participants receiving the intervention will attend five individual treatment sessions followed by one to three booster treatment sessions; these sessions will coincide with the study visits.

Eligibility criteria: Inclusion Criteria:

* reports significant depressive symptoms as indicated by score of 10 or greater on PHQ-9
* Currently taking ART for HIV infection
* Less than 90% adherence rate to ART regimen
* Capable of walking and in stable health
* Speaks fluent English

Exclusion Criteria:

* Depression therapy is needed immediately
* Meets criteria for current drug dependency
* Current diagnosis of psychotic disorder or bipolar depression

Primary outcomes:
measure: Microelectronic medication adherence
timeFrame: Measured at Weeks 16 and 24
Secondary outcomes:
measure: Self-reported depression
timeFrame: Measured at Weeks 16 and 24
Other outcomes:
Locations:
city: Torrance
country: United States
facility: LA Biomedical Institute at Harbor-UCLA
state: California
Study officials:
affiliation: RAND
name: Glenn J. Wagner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00719940: Tinnitus Treatment by Structured Cognitive Behavioral Therapy
Official title: Randomized Controlled Clinical Trial of Efficacy and Safety of Individual Cognitive Behavioral Therapy (CBT) Within the Setting of the Structured Therapy Program sTCP (Structured Tinnitus Care Program) in Patients With Tinnitus Aurium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tinnitus
Keywords: tinnitus, cognitive behavioral therapy, CBT
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2008-07-22
Enrollment: 286
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Test of hypothesis that in contrast to non-treatment tinnitus specific cognitive behavioral therapy intervention procedures that are manualized and structured within the disease management program TCP are effective.

Detailed description: Intervention:

Individual application of structured and tinnitus specific cognitive behavioral therapy intervention procedures in the clinical setting of the structured therapy program "tinnitus care program (TCP)"

Duration of intervention per patient: 1-15 treatment sessions plus self treatment up to 16 weeks

Control intervention: Waiting group (16 weeks)

Eligibility criteria: Key Inclusion Criteria:

* Persistent and stable tinnitus of more than 11 weeks
* Gap between audiometric tinnitus matching and subjective tinnitus loudness rating scale

Key Exclusion Criteria:

* Psychiatric or neurological comorbidity
* Tinnitus as concomitant symptom of an otherwise treatable disease
* Drug treatment for tinnitus 24 hrs. prior or during therapy

Primary outcomes:
measure: Validated tinnitus questionaire (TF Goebel and Hiller 1992); validated tinnitus change rating scale (TC, Zenner and de Maddalena 2005)
timeFrame: Last session
Secondary outcomes:
measure: Tinnitus loudness (TL), validated 6-point numeric verbal rating scale; tinnitus annoyance (TA), validated 8-point numeric verbal rating scale
timeFrame: last therapy session
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Tinnitus Care Center
city: Frankfurt
country: Germany
facility: Tinnitus Care Center
city: Tuebingen
country: Germany
facility: Dept. ORL, University of Tuebingen
city: Tuebingen
country: Germany
facility: Private Practice
Study officials:
affiliation: Universität Tübingen
name: Hans P. Zenner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zenner HP, De Maddalena H. Validity and reliability study of three tinnitus self-assessment scales: loudness, annoyance and change. Acta Otolaryngol. 2005 Nov;125(11):1184-8. doi: 10.1080/00016480510012282.
citation: Zenner HP, Vonthein R, Zenner B, Leuchtweis R, Plontke SK, Torka W, Pogge S, Birbaumer N. Standardized tinnitus-specific individual cognitive-behavioral therapy: a controlled outcome study with 286 tinnitus patients. Hear Res. 2013 Apr;298:117-25. doi: 10.1016/j.heares.2012.11.013. Epub 2012 Dec 31.