louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05505071: DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease
Official title: DANTE SPACE for Evaluation of Subjects With Intracranial Vascular Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Intracranial Vascular Disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Purpose: The purpose of this study is to evaluate the Delay Alternating with Nutation for Tailored Excitation (DANTE) SPACE sequence in clinical studies to determine whether it can provide more useful information for clinical diagnosis.

Participants: 100 participants with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI will be recruited.

Procedures (methods): Patients with concern for intracranial vascular disease scheduled to undergo a clinical vessel wall MRI who will have an additional non-FDA approved sequence (DANTE SPACE) added to their clinical scan. The investigational sequence requires less than 15 minutes and will be added following the standard MRI sequence.


Eligibility criteria: Inclusion Criteria:

* Ages 18 and older
* Concern for intracranial vascular disease
* Scheduled to undergo a clinical vessel wall MRI

Exclusion Criteria:

* Claustrophobia
* Implanted metallic devices, parts, vascular clips, or other foreign bodies.
* Known hypersensitivity to gadolinium contrast or to any component of gadolinium contrast refractory to standard medications (antihistamines, steroids)
* Impaired kidney function (serum creatinine level \> 1.8 mg/dL or a glomerular filtration rate \< 60 as approximated using serum creatinine levels) unless anuric and on dialysis.
* Any woman who is pregnant or has reason to believe she is pregnant via self report

Primary outcomes:
measure: Clinical Utility for Visualizing Pathology
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Mahmud Mossa-Basha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06015971: Omega-3 Fatty Acids and Nutritional Support in Gastrointestinal Cancer
Official title: Omega-3 Enriched Supplements in the Nutritional Support of Patients With Gastrointestinal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: cancer
nutritional support
omega-3 enriched nutritional supplements
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sarcopenia is a frequent complication in patients with cancer and chronic diseases, it is characterized by decreased muscle strength and fatigue due to reduced skeletal muscle mass, which is accompanied by atrophy and decreased quality of muscle tissue. In all cases, it negatively impacts treatment tolerance, clinical outcomes and survival, in consequence, quality of life of these patients decreases while morbidity, mortality and costs increase. In this context, appropriate nutritional screening and early nutrition support are extremely recommended, to this aim, in some cases, oral nutritional supplements (ONS) are necessary; ONS could have a standard formula or be enriched with specific nutrients (arginine, glutamine, branched chain amino acids, n-3 fatty acids, and nucleotides), which can modulate the activity of the immune system and provide an additional benefit beyond the nutritional support, this intervention type is called immunonutrition. Despite these possible benefits, their utility has been proven in few clinical scenarios, for example in with patients with upper gastrointestinal cancer undergoing surgical resection; based on this, current guidelines recommend that patients should receive oral/enteral nutritional support with an specific formula enriched in immunonutrients (with arginine, n-3 fatty acids or nucleotides) , but there is a lack of evidence for supporting its use in other clinical conditions including patients with cancer that receive systemic treatment


Eligibility criteria: Inclusion Criteria:

* - Patients with Gastrointestinal tumor undergoing systemic treatment (chemo-radio-immuno therapy or their combination)
* Body weight loss \>5% in the previous three months or \>10% in the previous six months
* Both sexes
* Age between 18-85 y-old.

Exclusion Criteria:

* Life expectancy \< 2 weeks
* MDRD \< 15 mL/min
* End-stage liver disease
* Any musculoskeletal, cardiovascular and/or neurological disorders that could affect exercising.

Primary outcomes:
measure: Muscle mass
timeFrame: 12 weeks
measure: Functionality
timeFrame: 12 weeks
Secondary outcomes:
measure: Albumin
timeFrame: 12 weeks
measure: C-RP
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cordoba
country: Spain
facility: IMIBIC
Study officials:
References:
Clinical trial NCT00844571: Effect E-learning Program About Child Maltreatment
Official title: The Effectiveness of an E-learning Program About Child Maltreatment for Nurses on an A&E Department: a Randomised Controlled Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Child Abuse
Keywords: child abuse and neglect
child maltreatment
non accidental injury
training
educational program
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: a private, non-commercial foundation that wishes to not be named
First posted: 2009-02-16
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nurses working at the A\&E department of UMC-Utrecht

Brief summary: The purpose of this study is to determine whether the e-learning program about the recognition of child maltreatment is effective in nurses on the A\&E department compared to a control group.

Detailed description: Child abuse and neglect represents an international problem with high prevalence and unacceptable levels of morbidity and mortality. Many children are seen each day in the accident and emergency departement of an hospital. Therefore the A\&E departement have an important role in the identification of child maltreatment. The lack of an effective teaching program together with the failures in the child protection process has encouraged the development of a clinical-practice-oriented e-learning program on detecting child maltreatment. We will investigate the effect of this e-learning program.

Eligibility criteria: Inclusion Criteria:

* Working at the A\&E department of the UMC-Utrecht.

Exclusion Criteria:

* Absent during one of the two measurement periods.

Primary outcomes:
measure: Clinical behaviour on the A&E department, self-efficacy of the nurse in the detection of child abuse and assessment of the individual performance on screening child abuse.
timeFrame: 2-3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UMC Utrecht
name: Keetie Smeekens, Drs.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walsh K, Eggins E, Hine L, Mathews B, Kenny MC, Howard S, Ayling N, Dallaston E, Pink E, Vagenas D. Child protection training for professionals to improve reporting of child abuse and neglect. Cochrane Database Syst Rev. 2022 Jul 5;7(7):CD011775. doi: 10.1002/14651858.CD011775.pub2.
citation: Smeekens AE, Broekhuijsen-van Henten DM, Sittig JS, Russel IM, ten Cate OT, Turner NM, van de Putte EM. Successful e-learning programme on the detection of child abuse in emergency departments: a randomised controlled trial. Arch Dis Child. 2011 Apr;96(4):330-4. doi: 10.1136/adc.2010.190801. Epub 2011 Jan 12.
Clinical trial NCT04107571: A Registry Study on Serumal Biomarkers About Adverse Events in Patients Undergoing Coronary Artery Bypass Grafting.
Official title: A Chinese Registry to Determine the Serumal Biomarkers for Prognosis of Adverse Events in Patients Undergoing Coronary Artery Bypass Grafting.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Surgery
Keywords: Coronary artery bypass graft
Biomarker
Prognosis
Lead sponsor: Beijing Institute of Heart, Lung and Blood Vessel Diseases
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group consists of patients who underwent coronary artery bypass grafting in Beijing Anzhen Hospital.

Brief summary: This is a national registry study to determine the serumal biomarkers for prognosis of adverse events in patients undergoing coronary artery bypass grafting.


Eligibility criteria: Inclusion Criteria:

1. Subject undergoing coronary artery bypass grafting;
2. Age is more than 18 and less than 80 years old;
3. Male and non pregnancy female;
4. Subject who understands study requirements and agrees to sign an informed consent from prior to study procedures.

Exclusion Criteria:

1. Pregnancy female;
2. Participate in other clinical trial in the last 1 month.
3. Subject who doesn't agree to sign an informed consent from prior to study procedures.
4. Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.

Primary outcomes:
measure: All-cause death and cardiac death
timeFrame: These data is collected during follow-up visit at in-hospital/1 year after discharge
Secondary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: These data is collected during follow-up visit at in-hospital/1 year after discharge
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
Study officials:
affiliation: Beijing Anzhen Hospital
name: Jie Du, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05415371: Persistent Poverty Counties Pregnant Women With Medicaid
Official title: Monetary Incentives to Promote Engagement With the Oklahoma Tobacco Helpline Among Pregnant Women With Medicaid
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Tobacco Cessation
Tobacco Use
Tobacco Smoking
Smoking Cessation Financial Incentives
Socioeconomic Status
Contingency Management
Pregnancy
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although many women initially quit smoking during pregnancy, most will return to smoking by the end of pregnancy or during the first 6 months postpartum. The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation coaching and biochemically-verified smoking abstinence at follow-up among pregnant women with Medicaid insurance who contact the Oklahoma Tobacco Helpline (OTH). The study will enroll 100 pregnant women who will be randomly assigned to OTH care or OTH plus escalating incentives (OTH+I) for completing up to 5 coaching calls over the first 8 weeks after enrolling (prepartum) and for biochemically-verified smoking abstinence at 9 weeks post-enrollment (assessed remotely via smartphone). In addition, participants will be incentivized for completing a postpartum coaching call by 8 weeks postpartum. Feasibility outcomes for the incentives based intervention will focus on coaching call completion, rates of prepartum and postpartum follow-up, biochemically-verified smoking cessation, and perceptions of the intervention. Potential effectiveness will be evaluated by comparing biochemically-verified smoking abstinence rates in OTH+I relative to OTH alone at 12 weeks post-enrollment (prepartum) and 12 weeks postpartum.


Eligibility criteria: Inclusion Criteria

* contact the Oklahoma Tobacco Helpline seeking smoking cessation treatment, and enroll in the multiple call program
* are a female ≤ 25 weeks pregnant
* report smoking ≥ 5 cigarettes per day
* are ≥ 18 years of age
* are able to provide a copy/photo of their ID/driver's license or other documentation of identity
* are able to read, speak, and understand English

Exclusion Criteria

• participants will be excluded if they do not meet the inclusion criteria

Primary outcomes:
measure: Biochemically verified abstinence 12 weeks post enrollment
timeFrame: 12 weeks post enrollment
measure: Self-reported abstinence 12 weeks postpartum
timeFrame: 12 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: TSET Health Promotion Research Center
state: Oklahoma
Study officials:
References:
Clinical trial NCT04572971: Reliability and Validity of iOS in IPF
Official title: Reliability and Validity of iOS in IPF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with IPF

Brief summary: Idiopathic pulmonary fibrosis (IPF) is a condition where scar tissue (called fibrosis) builds up in the lungs. It usually gets worse over time. Fibrosis causes the lungs to become stiff, and reduces the amount of oxygen that the lungs can take up. People with IPF complain of worsening breathlessness, which limits their day to day activities.

Lung function tests are breathing tests that measure how well the lungs are working, and are used by doctors to decide whether to start or stop medicines in people with IPF. However, people with IPF tell us that lung function tests require a lot of effort, can make them cough and feel very short of breath. About 1 in 5 people with IPF are unable to perform lung function results accurately.

Impulse oscillometry (iOS) is a new type of breathing test. It uses sound waves to measure the stiffness of the lung. The test is very quick (30 seconds), does not require any effort from the patient, and only requires a patient to breathe in their usual way. iOS has been used successfully in children who are unable to perform normal lung function tests.

The investigators will assess whether people with IPF can perform iOS tests accurately and to compare their experiences of having iOS tests with their experience of performing current lung function tests. The investigators will also compare whether there is a relationship between iOS tests and the information gathered from the tests currently used by doctors to measure the impact of IPF (lung function tests, exercise tests, lung scans and questionnaires that measure quality of life).


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of idiopathic pulmonary fibrosis made by specialist multidisciplinary team according to international standards
2. Able to provide written informed consent

Exclusion Criteria:

1. Contraindication to performing conventional lung function tests, e.g untreated TB, haemoptysis, pneumothorax, unstable cardiovascular status, recent eye, thoracic or abdominal surgery, thoracic, abdominal or cerebral aneurysm, acute illness (including diarrhoea and vomiting)
2. Unable to create seal on mouthpiece

Primary outcomes:
measure: iOS measurements of reactance
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton and Harefield hospitals
state: Gb-lnd
Study officials:
References:
Clinical trial NCT02244671: Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)
Official title: Botulinum-assisted Orbital Fat Augmentation With PRP (Platelet-rich-plasma)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orbital Atrophy
Lead sponsor: Fox, Donald Munro, M.D., P.C.
Sponsor class: INDIV
First posted: 2014-09-19
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: immobilization of yoked extra-ocular muscles in the anophthalmic orbit, in conjunction with platelet-rich-plasma, will improve integration of viable adipocytes injected into orbital fat

Detailed description: Immobilization of tissue (graft, graft bed) is a prerequisite for tissue integration. Since yoked extra-ocular muscles continue to be stimulated by movements of the seeing eye after fat injection into the anophthalmic orbit, the use of botulinum toxin(s) can be used to prevent movement of the orbital tissue bed(s) and improve anchoring of injected fat. Platelet rich plasma may also improve fat cell anchoring by the action of fibrin on the adhesion process. This innovation builds on the results of IRB protocols 10.27 and 12.01 as registered with Clinical Trials.gov

Eligibility criteria: Inclusion Criteria:

* anophthalmic enophthalmos in subjects within a 50 mile radius of New York City, grade 0-1 anesthesia risk, ages 21-75

Exclusion Criteria:

* radiated orbits

Primary outcomes:
measure: Orbital volume
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
Study officials:
affiliation: New York Eye and Ear Infirmary
name: Donald M Fox, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05228171: Mobile Food Record on Recall Effects
Official title: Use of a Mobile Food Record, Enhanced by a Novel Artificial Intelligence-Based Informatics Framework to Expand Capture of Dietary Intake
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Mobile food record
nutrition
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: Human dietary habits remain challenging to measure. Even the "gold-standard" interviewer-administered 24 hour dietary recall has established underreporting issues especially in high-risk populations, such as patients with obesity. Performance of precision nutrition research requires state of the art tools to capture individual dietary patterns. Given the widespread availability of smart phones, mobile-phone based food records present a prime opportunity to capture "in the field" dietary intake. Mobile food records, however, are not yet widely used in nutrition research. Several reasons exist. First, the mobile food record needs to be validated relative to the "gold standard" of dietary intake, the 24-hour dietary recall. Second, many available mobile food records are commercially based, with caveats about data availability and meeting research-quality data security practices (HIPAA compliance).

In response, this study includes using a freely available, research-focused, HIPAA compliant, mobile food record (mCC: my Circadian Clock app) actively used in research studies (including our own ongoing work) to test the hypothesis that a mobile food record can expand capture of dietary intake. The proposed aims include the following: Using a randomized, cross-over design, evaluation of augmenting interviewer-administered 24-hour dietary recalls by a mobile food record (Augmented Recall) results in less energy intake underreporting than a standard (un-augmented) interviewer administered 24-hour dietary recall (Standard Recall).


Eligibility criteria: Inclusion Criteria:

* Adults between 18-65 years old
* BMI ≥30 kg/m2
* Without a 4 year (BS/BA) college degree
* Owns a smart phone
* Able to read and speak English

Exclusion Criteria:

• Pregnant or lactating women

Primary outcomes:
measure: Caloric intake
timeFrame: 60 days from intervention
Secondary outcomes:
measure: Energy intake
timeFrame: 24 hours following food intake
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: UMN
name: Lisa Chow, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01182571: Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients
Official title: Exploration of Fatigue ,Uncertainty ,Depression and Quality of Life in Heart Transplantation Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Transplantation
Keywords: Heart Transplantation
Symptom Distress
Fatigue
Depression
Quality Of Life.
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The outpatients who undergone heart transplantation were recruited from the Department of Cardiac Surgery

Brief summary: The purpose of this study is to explore the fatigue, uncertainty, depression and quality of life in heart transplant recipients, and associated factors of quality of life .

Detailed description: The purpose of this study is to explore the symptom distress, fatigue, depression, uncertainty, and quality of life in heart transplant recipients, and associated factors of quality of life (QOL). The eligible patients are (1)who undergone heart transplantation were recruited from the Department of Cardiac Surgery, Nation Taiwan University Hospital,(2)18 year old or older. A set of questionnaire with the Transplant Symptom Frequency and Symptom Distress Scale, Hospital Anxiety and Depression Scale (HADS) , Fatigue Symptom Inventory (FSI), Mishel's Uncertainty Scale, and 12-item Short-Form Health Survey (SF-12) were used to collected symptom distress, fatigue, depression, uncertainty, and QOL .

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of heart transplantation
* Adults 18 years of age

Exclusion Criteria:

* The woman who are pregnant

Primary outcomes:
measure: The SF12 Health survey
timeFrame: 1 month
measure: Transplant Symptom Frequency and Symptom Distress Scale
timeFrame: 1 week
measure: Fatigue Symptom Inventory
timeFrame: 1 week
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 1month
measure: Illness Uncertainty Scale
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Shiow-Ching Shun, PhD
role: PRINCIPAL_INVESTIGATOR
References: