louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05981196: Disparities Among Liver Transplant Patients
Official title: Individual and Structural-level Determinants Associated with Disparities Among Liver Transplant Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End Stage Liver DIsease
Keywords: Transplants
Transplantation
Healthcare Disparities
Minority Health
Communication
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects identified with end-stage liver receiving initial stage of transplant evaluation at Mayo Clinic Arizona.

Brief summary: The purpose of this study is to inform healthcare interventions to reduce the disparities in liver transplant listing and in transplantation.

Detailed description: Aim 1. Establish a longitudinal cohort of patients with end-stage liver dysfunction.

Aim 2. Examine interpersonal and structural factors associated with liver transplant evaluation and listing by patient characteristics (e.g., race, ethnicity, SES, gender).

Aim 3. Examine the use of stigmatizing language among patients undergoing liver transplant based on their demographic characteristics (e.g., race, ethnicity, SES, gender).

Eligibility criteria: Inclusion Criteria:

- Patients with end-stage liver, kidney, or cardiac dysfunction.

Exclusion Criteria:

* Patients with more than one system with end stage organ dysfunction, dementia, cognitive or sensory impairment, prior solid organ transplant.
* Patients with potential medical exclusions for transplant.

Primary outcomes:
measure: Liver transplant waiting list
timeFrame: Approximately one year
measure: Organ transplantation
timeFrame: Approximately one year
Secondary outcomes:
measure: Survival
timeFrame: Approximately one year post-transplant, or until you are removed from the transplant list
measure: Graft survival at six months
timeFrame: Six months post transplant
measure: Graft survival at one year
timeFrame: One year post transplant
Other outcomes:
measure: Mortality
timeFrame: Approximately one year post-transplant, or until you are removed from the transplant list
measure: Hospital length of stay
timeFrame: Approximately one year post-transplant, or until you are removed from the transplant list
measure: ICU length of stay
timeFrame: Approximately one year post-transplant, or until you are removed from the transplant list
measure: 30-day readmission
timeFrame: Approximately one year post-transplant, or until you are removed from the transplant list
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Adam Milam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00016796: Language Stimuli Screening in Children
Official title: Language Stimuli Screening in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Language Disorder
Healthy
Keywords: Reading
Naming
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2001-06-04
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: This study will determine baseline language skills in children 4 to 8 years old. The data will be used to design studies using functional magnetic resonance imaging (fMRI) to identify what areas of the brain in children are involved in understanding language. This information is important for children who require brain surgery to control seizures.

Healthy normal volunteers between the ages of 4 and 8 years who have an IQ of 70 or more; who have no history of neurologic, psychiatric or language disorder; who are performing at or above grade level, and who are native English speakers may be eligible for this study.

Participants will be asked to do the following:

* name pictures or read words that appear on a computer screen
* listen to stories and answer questions about them
* match pictures to a spoken word

The children's responses will be recorded.

Detailed description: We propose to study normal children to establish baseline data to use to develop novel sets of stimuli for functional imaging paradigms. Tasks using these stimuli will include object naming, sentence comprehension, and single word reading.

Eligibility criteria: INCLUSION CRITERIA:

Children will be between the ages 4 and 8 are eligible.

EXCLUSION CRITERIA:

Children who meet one of the following criteria are not eligible:

IQ below 70;

History of neurologic or psychiatric disorders;

History of an language disorder;

Performing below grade-level;

Non-native English speaker.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institute of Neurological Disorders and Stroke (NINDS)
state: Maryland
Study officials:
References:
citation: Hertz-Pannier L, Gaillard WD, Mott SH, Cuenod CA, Bookheimer SY, Weinstein S, Conry J, Papero PH, Schiff SJ, Le Bihan D, Theodore WH. Noninvasive assessment of language dominance in children and adolescents with functional MRI: a preliminary study. Neurology. 1997 Apr;48(4):1003-12. doi: 10.1212/wnl.48.4.1003.
citation: Devinsky O, Perrine K, Llinas R, Luciano DJ, Dogali M. Anterior temporal language areas in patients with early onset of temporal lobe epilepsy. Ann Neurol. 1993 Nov;34(5):727-32. doi: 10.1002/ana.410340517.
citation: Cycowicz YM, Friedman D, Rothstein M, Snodgrass JG. Picture naming by young children: norms for name agreement, familiarity, and visual complexity. J Exp Child Psychol. 1997 May;65(2):171-237. doi: 10.1006/jecp.1996.2356.
Clinical trial NCT06355596: Development and Validation of a Virtual Teaching Method for Minimally Invasive Surgery Skills
Official title: Development and Validation of a Virtual Teaching Method for Minimally Invasive Surgery Skills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Laparoscopic surgery skills
Medical education
Minimally invasive surgery
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Participants are randomly allocated to either face-to-face or virtual teaching groups
Primary purpose: OTHER

Brief summary: The goal of this observational study is to develop and evaluate a virtual teaching method for minimally invasive surgery (MIS) skills among novice learners, using widely available technology and incorporating objective assessments of proficiency. The main questions it aims to answer are:

Can MIS skills be effectively taught to novice learners through a virtual platform using widely available technology? How do virtual and face-to-face (F2F) teaching methods compare in terms of effectiveness, measured by performance in MIS tasks and cognitive workload parameters?

Participants in this study will:

Be randomly allocated to either F2F or virtual teaching groups. Undergo training and evaluation using validated laparoscopic assessments, namely the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task and the European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment.

Have their performance and cognitive workload parameters (SURG-TLX score, heart rate, and pupil metrics) evaluated during the tasks.


Eligibility criteria: Inclusion Criteria:

* Adult (age \> 18)
* Medical student, Foundation Year or Core Trainee level or equivalent

Exclusion Criteria:

* Specialty Registrar level
* Consultant level

Primary outcomes:
measure: McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) peg transfer task score
timeFrame: Two days
measure: European Academy laparoscopic 'Suturing Training and Testing' (SUTT) assessment score
timeFrame: Two days
Secondary outcomes:
measure: SURG-TLX score
timeFrame: Two days
measure: Heart rate
timeFrame: Two days
measure: Pupil metrics
timeFrame: Two days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Mary's Hospital
Study officials:
References:
Clinical trial NCT03469596: Evaluation by MRI of Anal Canal Cell Carcinoma: is There Predictive Factor?
Official title: Evaluation by MRI of Anal Canal Cell Carcinoma: is There Predictive Factor?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anal Carcinoma
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: every patient with anal canal cell carcinoma with an initial MRI in GHPS between 1st august 2009 and 24th april of 2015

Brief summary: Anal canal cell carcinoma is a very rare cancer but well treated. If the morphological test are well established in the initial evaluation, it's not the case of the follow up evaluation particularly by MRI.About 1/3 of patient decline with metastatic relapse during the follow up of these patients.It appears that clinical regression seen precociously is a predictive factor of survival without relapse. But there 's no study confirming that point.

This context takes us to evaluate if there is a predictive factor in MRI to final clinical result.


Eligibility criteria: Inclusion Criteria:

* patient with anal canal cell carcinoma histologically proved
* patient with initial MRI and follow up MRI in Hospital St Joseph's radiology yard.
* patient for whom a radio chemotherapy treatment decision was taken.

Exclusion Criteria:

* patients with already metastatic lesions

Primary outcomes:
measure: Distance with regard to the anal margin
timeFrame: maximum of 6 years after the initial MRI
measure: initial tumor size
timeFrame: maximum of 6 years after the initial MRI
measure: presence of nodal status
timeFrame: maximum of 6 years after the initial MRI
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT02135796: Echocardiography in Septic Shock
Official title: ICU Echocardiography in Resuscitation of Sepsis and Septic Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Septic Shock
Severe Sepsis
Keywords: Septic Shock
Severe Sepsis
ICU
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2014-05-12
Enrollment: 700
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to an Intensive Care Unit (ICU) with an initial diagnosis of severe sepsis or septic shock.

Brief summary: BACKGROUND: Echocardiography can provide evaluation of right or left ventricular dysfunction and volume status during resuscitation of patients with sepsis and septic shock and guide intravenous vasopressor and fluid therapy. While there are numerous echocardiographic studies regarding cardiac function and volume status in patients with established shock, there are none that describe these during the early resuscitation of septic shock.

The study objective is to correlate echocardiographic findings with clinical parameters and net fluid balance measured during the early resuscitation of critically ill patients with sepsis and septic shock.

Aim 1) correlate echocardiographic findings of cardiac function with physiologic markers in the early hours of resuscitation

Aim 2) correlate cardiac function and fluid status with clinical outcomes

Aim 3) evaluate the change in cardiac function over time in patients with sepsis and septic shock

Aim 4) evaluate long term clinical outcomes for patients with sepsis and septic shock.


Eligibility criteria: Inclusion Criteria:

- at least 13 years of age

SEPSIS PATIENTS:

Sepsis patients must have

1. Suspected or confirmed infection

   AND
2. Organ dysfunction as defined by a SOFA \>= 2 above baseline (if no baseline data available, SOFA assumed to be 0)

OR

SEPTIC SHOCK PATIENTS:

AFTER INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, Septic shock patients must have

1. Suspected or confirmed infection

   AND
2. Lactate \> 2 mmol/L

   AND
3. Receiving vasopressors

   * Enrollment of patients should occur within 8 hours of meeting criteria for severe sepsis or septic shock if it is required that a research only TTE be performed in the 0-6 hours after ICU admission. If a clinical TTE is performed in this timeframe, patients may be enrolled up to 24 hours after ICU admission.

Exclusion Criteria:

None.

Primary outcomes:
measure: Correlate echo findings and markers of resuscitation
timeFrame: Within 12 hours of Intensive Care Unit admission
Secondary outcomes:
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Michael Lanspa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00177996: Pharmacotherapy in Depression With Panic Spectrum
Official title: Pharmacotherapy in Depression With Panic Spectrum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Keywords: depression
anxiety
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 30
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 research study is being conducted to find out if certain individuals benefit from taking medication for their depression with a low dose of the antidepressant medication Zoloft.

Detailed description: Researchers at the University of Pittsburgh Medical Center Health System are currently recruiting men and women, ages 18 to 60, to examine the effectiveness of the FDA-approved medication sertraline (Zoloft) for major depression.

Participants will be randomly assigned to one of two groups. Each group will begin and continue taking Zoloft at different doses. A physician will follow eligible participants weekly for approximately 12 weeks

Eligibility criteria: Inclusion Criteria:

* Male or female ages 18-60;
* Current diagnosis of major depression, and a rating of ³15 on the HRS-D-25; - -Presence of significant, co-existing panic-agoraphobic spectrum symptoms,
* Absence of ongoing therapy with psychotropic medications (except for intermittent use of nonbenzodiazepine hypnotics) or willingness to be withdrawn from an ineffective ongoing antidepressant medications
* Physically healthy,
* Female participants of childbearing potential must be practicing a medically acceptable form of double-barrier birth control or using oral contraceptives such as birth control pills, implants, or injections;

Exclusion Criteria:

* Females who are pregnant or breast-feeding;
* History of suicide attempt in the 6 months prior to entry, active suicidal ideation, or significant suicide risk;
* History of hypersensitivity to or current use of sertraline;
* Unstable or untreated medical conditions,
* Participants who do not wish to discontinue current, ineffective antidepressant treatment;
* Participants who have recently begun psychotherapy (less than 3 months prior to study entry);
* Diagnosis of current panic disorder, psychosis, substance or alcohol abuse, anorexia, bulimia, dissociative, bipolar disorder, or any other psychiatric or medical illness that would interfere with the best treatment strategy for the potential participant.

Primary outcomes:
measure: Somatic Symptoms Scale (SSC)
timeFrame: 1 week
Secondary outcomes:
measure: Hamilton Rating Scale For Depression- 25 item (HRSD 25)
timeFrame: 1 week
measure: Global Assessment of Functioning (GAF)
timeFrame: past week
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Western Psychiatric Insititue and Clinic
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Andrea Fagiolini, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02888496: Lymphocyte and Cytokine Disturbances in Polymyalgia Rheumatica
Official title: Caractérisation Des Anomalies Immunologiques au Cours de la Pseudopolyarthrite rhizomélique et Effets du Traitement Par Tocilizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polymyalgia Rheumatica
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PMR patients included in the TENOR study (NCT01713842).

Brief summary: Pathophysiology of polymyalgia rheumatica (PMR) is ill defined. This study aims at characterizing immunological abnormalities in PMR patients, and to assess the effects of tocilizumab therapy on this abnormalities.

Detailed description: Comparison of PMR patients and matched control subjects.

Eligibility criteria: Inclusion Criteria:

* PMR patient included in the TENOR study with samples available

Exclusion Criteria:

* Patient not included in the TENOR study

Primary outcomes:
measure: Proportion of blood lymphocyte populations (T cells, B cells, NK cells)
timeFrame: 6 months
Secondary outcomes:
measure: Serum cytokine concentration measurement
timeFrame: 6 months
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Divi Cornec
role: STUDY_DIRECTOR
References:
citation: Devauchelle-Pensec V, Berthelot JM, Cornec D, Renaudineau Y, Marhadour T, Jousse-Joulin S, Querellou S, Garrigues F, De Bandt M, Gouillou M, Saraux A. Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study. Ann Rheum Dis. 2016 Aug;75(8):1506-10. doi: 10.1136/annrheumdis-2015-208742. Epub 2016 Feb 29.
Clinical trial NCT05470296: It's Native: Nudging Healthy Ways
Official title: It's Native: Nudging Towards Healthy Ways in Southeastern American Indian Country
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diet, Healthy
Physical Activity
Keywords: Native American
nutrition
physical activity
Lead sponsor: University of Southern Mississippi
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-/post design
Primary purpose: PREVENTION

Brief summary: Native Americans suffer disproportionately from chronic diseases that may be prevented by achieving a healthy diet, physical activity and weight. For this pilot study, the aim is to examine the effectiveness and feasibility of a standard lifestyle management program implemented in community based settings among Native Americans.

Detailed description: A pilot study will be implemented to establish comparison data for the delivery of a standard lifestyle management program among Southeastern Native Americans. The program addresses the physical and intellectual domains. The ultimate goal will be to use focus group data and this pilot pre-post clinical trial to inform further cultural and social adaptations that could advance the effectiveness of lifestyle management programs in Southeastern Native Americans.

Eligibility criteria: Inclusion Criteria:

* Not pregnant and more than 6 months postpartum
* Without complicated disease (ie. renal failure, cancer)
* Identify as Native American
* Resident of study area
* Adults 18-50 years

Exclusion Criteria:

* Pregnant or within 6 months postpartum
* Complicated diseases states that are contraindications for the program goals
* Not Native American
* Not permanent resident of study area
* Less than 18 years of age or older than 50 years of age

Primary outcomes:
measure: Added Sugar Intake
timeFrame: Change from Baseline Added Sugar Intake at 3 months
measure: Red and Processed Meat Consumption
timeFrame: Change from Baseline Red and Processed Meat Intake at 3 months
Secondary outcomes:
measure: Physical Activity
timeFrame: Change from Baseline Physical Activity at 3 months
measure: Body Mass Index
timeFrame: Change from Baseline Body Mass Index at 3 months
Other outcomes:
measure: Number of Participants who attend each session
timeFrame: up to 12 weeks
measure: Retention
timeFrame: at 12 weeks
Locations:
city: Hattiesburg
country: United States
facility: The University of Southern Mississippi
state: Mississippi
Study officials:
References:
Clinical trial NCT06199596: Alpha-s1 Casein Hydrolysate on Sleep
Official title: The Effect of Alpha-s1 Casein Hydrolysate for Patients With Chronic Insomnia: A Randomized Double-Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia
Polysomnography
Keywords: Alpha-s1 casein hydrolysate
Randomized controlled trial
insomnia
Polysomnography
Lead sponsor: Kuang Tien General Hospital
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigates the impact of Aalpha-s1 casein hydrolysate (ACH; Lactium®) on sleep quality in individuals with chronic insomnia, employing both subjective sleep profiles and objective polysomnography (PSG) recordings.

Detailed description: During the trial, the use of food or health products containing sedative or hypnotic ingredients or formulations is prohibited.

Eligibility criteria: Inclusion Criteria:

1. age between 20 and 80 who meet the diagnostic criteria for chronic insomnia according to the International Classification of Sleep Disorders (ICSD) (Third Edition);
2. PSQI score greater than 5;
3. participants must voluntarily agree to participate in the trial after explanation by a physician and complete the informed consent form.

Exclusion Criteria:

1. currently using tranquilizers, hypnotics, or stimulant-related medications or substances (such as coffee or energy drinks);
2. patients with a history of significant head trauma;
3. individuals with alcohol abuse within the past year;
4. those with other severe medical conditions (e.g., hepatic or renal dysfunction);
5. Pregnant women or breastfeeding mothers;
6. participants unable to comply with the trial schedule;
7. individuals on a vegetarian diet;
8. those with allergies to dairy products.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: 2nd and 4th week
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2nd and 4th week
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 2nd and 4th week
measure: General Sleep Disturbance Scale (GSDS)
timeFrame: 2nd and 4th week
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 2nd and 4th week
measure: Sleep quality
timeFrame: baseline and 4th week
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Kuang Tien General Hospital
Study officials:
References: