louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01118156: Suicide Classification System
Official title: Suicide Classification System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide and Self-harm
Keywords: Suicide Nomenclature
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
First posted: 2010-05-06
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mental Health professionals at the Denver and Grand Junction VA Medical Centers

Brief summary: The purpose of this study is to evaluate whether a new standardized language for categorizing suicidal and self-injury related thoughts and behaviors can be readily adopted for use by mental health clinicians. Efforts also include developing a measure that can be used to help clinicians identify appropriate terms (e.g., behaviors) for specific patients.

Detailed description: In recent years, suicide prevention has received increased focus within the VA. This is in part related to concerns regarding the mental health and associated suicide risk of Operation Enduring Freedom/Operation Iraqi Freedom military personnel, and a recent study highlighting the increased risk of death by suicide for members of the veteran population. Suicide prevention initiatives could be greatly enhanced if a clinically feasible uniform language regarding suicidality and self-injury was readily available and adopted throughout the VA system. With this goal in mind, the Self-Directed Violence Classification System (SDVCS) and Clinical Tool were developed based upon the Centers for Disease Control and Prevention (CDC) nomenclature and VA VISN-19 MIRECC's work in this area. The purpose of this study is to evaluate whether a new standardized language for categorizing suicidal and self-injury related thoughts and behaviors can be readily adopted for use by mental health clinicians. Efforts also include developing a measure that can be used to help clinicians identify appropriate terms (e.g., behaviors) for specific patients.

Eligibility criteria: Inclusion Criteria:

* Suicide Prevention Coordinator team members at Denver or Grand Junction VA Medical Center
* Mental Health leadership at Denver or Grand Junction VA Medical Center
* Mental Health professionals at Denver or Grand Junction VA Medical Center

Exclusion Criteria:

* Failure to sign appropriate informed consent
* MIRECC staff members

Primary outcomes:
measure: Proportion of clinicians utilizing nomenclature
timeFrame: 6 months
Secondary outcomes:
measure: Analysis of qualitative focus group data
timeFrame: 6 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: Grand Junction
country: United States
facility: Grand Junction VA Medical Center
state: Colorado
Study officials:
affiliation: VA ECHCS VISN 19 MIRECC
name: Lisa Brenner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03719209: Using Virtual Reality for Patients With Gastrointestinal Disease
Official title: Using Virtual Reality to Foster Engagement, Understanding, and Knowledge in Patients With Gastrointestinal Disease and Their Families
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Disease
Inflammatory Bowel Diseases
Keywords: Crohns disease
Patient Education
Ulcerative Colitis
Celiac
Ulcer
Polyp
Gastrointestinal bleeding
Inflammatory Bowel Disease
Virtual Reality
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Klick Health
First posted: 2018-10-25
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary aim of this study is to evaluate the effect and impact of a technology which creates a virtual reality (VR), personalized representation of a patient's endoscopic findings in comparison our standard practice (SP). Our study will compare the level of knowledge, understanding and satisfaction the patient and family have between those receiving SP and those receiving both SP and VR.


Eligibility criteria: Inclusion Criteria:

* Patients aged 8-25 years of age who are willing and able to participate
* Patients who recently had an endoscopic procedure at Boston Children's Hospital

Exclusion Criteria:

* Patients who are unable to provide consent due to age or developmental status

Primary outcomes:
measure: Patient and family knowledge, understanding, and satisfaction
timeFrame: 1 month
Secondary outcomes:
measure: Longitudinal Medication Adherence
timeFrame: up to 5 years
measure: Longitudinal Readmission Rate
timeFrame: up to 5 years
measure: Patient Satisfaction Scale
timeFrame: 1 month
measure: Client Satisfaction Questionnaire
timeFrame: 1 month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
citation: Palanica A, Leier M, Lee A, Fossat Y, Docktor MJ. Enhancing the Patient Experience for Individuals Undergoing Endoscopic Procedures Using Virtual Reality. J Pediatr Gastroenterol Nutr. 2020 Mar;70(3):341-343. doi: 10.1097/MPG.0000000000002577.
Clinical trial NCT03118609: Understanding Needs
Official title: Understanding the Needs of Informal Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers
Keywords: Caregivers
Chronic Pain
Lead sponsor: Colorado State University
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single focus group.

A single group will be analyzed based on survey results
Primary purpose: SUPPORTIVE_CARE

Brief summary: The "Understanding Needs" Project is designed to gain an understanding of the needs of informal caregivers. Researchers have designed a survey to highlight activities of daily living involved in the caregiving role, pain related to caregiver, and potential services desired. The initial phase of the study will consist of a focus group of informal caregivers to discuss current needs. The survey will then be refined based on knowledge gained from the focus group, and feedback from expert researchers. The refined survey will then be disseminated to caregivers throughout the country.

Please click on the following anonymous link to participate: https://chhscolostate.co1.qualtrics.com/jfe/form/SV_54j83BQSItMuoUB

Detailed description: The "Understanding Needs" Project highlights the needs of informal caregivers. An informal caregiver is defined as a person who regularly provides unpaid care to another adult. The survey will ask about pain intensity, pain interference, and relation of pain to the caregiving role. The survey will also address which activities the caregiver assists with, and activities now lacking since becoming a caregiver. One focus group will be completed to refine the contents of the survey prior to dissemination. The results will be analyzed by an occupational therapist, with a focus on how pain may connect to assistance with daily living activities provided to the care recipient. The needs of caregivers within the community will be compiled to inform future involvement in remediation of needs.

Eligibility criteria: Inclusion Criteria:

* At least 18 years old
* Informal caregivers (unpaid)
* have been a caregiver for \> 6 months
* provide at least 8 hours of care/week
* able to read english

Exclusion Criteria:

* Less than 18 years old
* paid caregivers
* not able to read english
* Caregiver or care recipient has a terminal diagnosis with a life expectancy of less than one year

Primary outcomes:
measure: PEG: Three Item Pain Measure
timeFrame: Self-report, up to one year for analyses when all surveys are returned
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Colorado State University
state: Colorado
Study officials:
References:
Clinical trial NCT01871909: Validation of Lower Body Negative Pressure (LBNP) Model of Human Hemorrhage in Trauma Patients
Official title: Validation of LBNP Model of Human Hemorrhage in Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Trauma
Keywords: Physical trauma
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2013-06-07
Enrollment: 50
Sex: ALL
Minimum age (years): 31
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Trauma patients

Brief summary: Lower body negative pressure (LBNP) is a laboratory model used to study hemorrhage in humans. The investigators hypothesize that the physiologic changes that occur with application of LBNP mimic those observed in bleeding and hemodynamically unstable trauma patients, and that LBNP is a truly valid model of human hemorrhage.

Detailed description: Specific aims:

1. Compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from LBNP subjects.
2. Determine the accuracy of LBNP in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.

Eligibility criteria: Inclusion Criteria:

* age: 31 days - 89 years
* patients cared for in the Emergency Department (ED), Operating Room (OR), or the Intensive Care Unit (ICU) at Denver Health Medical Center, Children's Hospital Colorado and San Antonio Military Medical Center
* Patients with report of physical trauma within 24 hours of presentation at the hospital.

Exclusion Criteria:

* pregnant patients
* incarcerated patients
* patients who object at any time to participating in the study

Primary outcomes:
measure: Waveform data comparison
timeFrame: Up to 12 months
measure: Approximation accuracy
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
city: San Antonio
country: United States
facility: San Antonio Military Medical Center
state: Texas
Study officials:
affiliation: Children's Hospital Colorado
name: Steve Moulton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00891709: LEO 29102 Single and Multiple Dose Study by Dermal Application
Official title: A Phase 1, First in Man, Safety, Tolerability and Pharmacokinetic Study of Single Ascending and Multiple Cutaneous Doses of LEO 29102 2.5 mg/g Cream or LEO 29102 Cream Vehicle in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2009-05-01
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The principal aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 29102 is administered cutaneously as single and multiple doses to healthy male subjects.

The study is divided into one single dose part followed by a multiple dose part.


Eligibility criteria: Inclusion Criteria:

* Male adults between the age of 18 and 55 years (both inclusive) and with a BMI between 19 and 30 kg/m2 (both inclusive).
* Subjects must be healthy as determined by medical history, physical examination, electrocardiogram (ECG), blood pressuer and heart rate, and clinical laboratory evaluation.

Exclusion Criteria:

* Subjects who show signs of eczema or other skin lesions.
* Subjects who have any clinical signs of allergic diseases (excluding non active hay fever).

Primary outcomes:
measure: To determine the safety and tolerability
Secondary outcomes:
measure: To determine the pharmacokinetics
Other outcomes:
Locations:
city: Bourn
country: United Kingdom
facility: LCG Bioscience
state: Cambridgeshire
Study officials:
affiliation: LCG Bioscience, Bourn Hall, Bourn, Cambridgeshire, CB23 2TN, UK
name: Anthony Priestley, MBChB MFPM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05992909: Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy: A Prospective Observational Study
Official title: Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lymphadenectomy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: M D Anderson Cancer Center

Brief summary: To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery rather than after a patient has already developed the disease.

Detailed description: Primary Objectives:

The objective of this study is to evaluate the protective benefit to performing LVB surgery at the time of ILND. In the secondary objective, we will compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed.

Eligibility criteria: Eligibility Criteria:

1. Patients greater than or equal to 18 years of age.
2. Patients willing to participate.
3. Patients able to complete informed consent.
4. Patients undergoing ILND.

Exclusion Criteria:

1. Patients taking anticoagulants within 7 days prior to surgery.
2. Patients that are known to be pregnant at the time of surgery.
3. Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period.
4. Patients with BMI greater than 50.0.

Primary outcomes:
measure: Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
timeFrame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Ashleigh Francis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01364909: Exercise in Critically Ill Patients With Sepsis
Official title: Early Intervention With Exercise in Critically Ill Patients With Sepsis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis Syndromes
Keywords: Sepsis
Severe sepsis
Septic shock
Septicaemia
Bacteremia
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Royal Brisbane and Women's Hospital
First posted: 2011-06-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate whether early exercise in critically ill patients will decrease inflammatory markers, increase pro-inflammatory markers and prevent loss of muscle mass.

Detailed description: This study will investigate the effects of an early targeted rehabilitation program on inflammatory markers and muscle mass in patients with sepsis syndromes in intensive care.

The Primary Hypothesis is that an early targeted rehabilitation ICU patients with sepsis syndromes over 7 days will Prevent loss of lean muscle mass by within 7 days of recruitment to the study. Decrease pro-inflammatory and increase anti-inflammatory cytokines within 7 days of recruitment to the study.

Eligibility criteria: Inclusion Criteria:

* Systemic inflammatory response syndrome with a proven or suspected infectious etiology.
* 18 years and over
* Relatives willing to give consent
* Admitted to intensive care and likely to remain ventilated for \> 48 hours

Exclusion Criteria:

* Patients with septic shock unresponsive to maximal treatment or who are moribund or have an expected mortality within 48 hours
* Head injuries
* Burn injury
* Multiple lower limb fractures

Primary outcomes:
measure: Fat free mass ie muscle mass (lean tissue)
timeFrame: Change from baseline to one week, then change from baseline to two weeks
Secondary outcomes:
measure: Interleukin 6
timeFrame: Change from baseline to measurements taken daily for 7 days
measure: Tumour necrosis factor alpha (TNF-alpha)
timeFrame: Change from baseline to measurements taken daily for 7 days
measure: Interleukin 10
timeFrame: Change from baseline to measurements taken daily for 7 days
measure: Vital signs - observation only
timeFrame: Fifteen minutes pre and post every exercise session recorded every 10 seconds
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane & Womens Hospital
state: Queensland
Study officials:
References:
Clinical trial NCT03043209: Genomic Sequencing in Patients With HCM Undergoing Septal Myectomy
Official title: Genomic Sequencing in Patients With Hypertrophic Cardiomyopathy Undergoing Septal Myectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Genetic Disease
Gene Product Sequence Variation
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 years and older, scheduled for septal myectomy and no family history of HCM

Brief summary: Investigators aim to use comparative exome and/or genome sequencing to discover causative molecular lesions for phenotypes hypothesized to be caused by somatic mutations. For this study, investigators have targeted hypertrophic cardiomyopathy.

Detailed description: The hypothesis is that sporadic or simplex occurrences of what are typically autosomal dominantly inherited diseases can instead be caused my mosaic mutations, specifically, mutations in the heart itself.

This hypothesis mandates that investigators sequence both affected and unaffected tissues, which in this case, investigators will construe to be peripheral blood DNA and discarded myocardium from cardiac procedures.

Eligible individuals will first undergo informed consent to be part of the study prior to their scheduled myomectomy. The study participants will also have phlebotomy for research samples.

The NIH Intramural Sequencing Center (NISC) will perform paired exome or genome sequencing and we will first screen for germline mutations in known cardiomyopathy genes that meet ACMG standards of likely pathogenic or pathogenic.

Then, if this is negative, investigators will screen for sequence variants that are present in cardiac tissue but absent in the blood DNA. Investigators will also screen blood DNA for secondary findings in genes recommended for annotation and results return by the ACMG and sequence variants deemed clinically relevant in this gene set will be validated in a CLIA-certified laboratory and the results returned to that participant.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 years and older has a clinical diagnosis of hypertrophic cardiomyopathy.
* Patient scheduled for clinically-indicated myomectomy.
* Patient has a negative family history of hypertrophic cardiomyopathy
* Patient is willing to receive results of secondary variant screen

Exclusion Criteria:

* Pregnant
* Inability to give informed consent

Primary outcomes:
measure: Genetic causes of HCM in patients without a strong family history of the condition
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Milind Desai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00956709: Regional Anesthesia for Major Surgery of the Foot. Levobupivacaïne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Through médiofémorale
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Nerve Block
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ropivacaine 0.5% and 0.5% in levobupivacaïne are used in regional anesthesia for major surgery of the foot. The literature does not highlight a significant difference in terms of onset of action between these two molecules to block the sciatic nerve \[4\]. Our hypothesis is that this lack of difference is due to the use of a neurostimulator for locating the injection site (indiscriminate nature of the anatomical approach to the sciatic nerve). Indeed, the sensitivity of neurostimulation is low compared with ultrasound \[58\] and ultrasound, for accurate visualization of the deposit of the local anesthetic around the nerve to improve the quality of the block and reduce the onset of action of local anesthetic \[46, 47\].

The investigators propose to make a comparative trial between levobupivacaïne 0.5% ropivacaine and 0.5% under the control of the ultrasound as part of a sciatic nerve block. The use of ultrasound will reduce the variability of results because the changes would be linked exclusively to the local anesthetic. The investigators test the hypothesis that levobupivacaïne gives better results in terms of onset of action than ropivacaine.


Eligibility criteria: Inclusion Criteria:

* Patients with unilateral major surgery of the foot: hallux valgus (not ambulatory), claw toes, fusion-Astragalo calcaneum, complex syntheses of tarsus-aged over 18 years .
* Male and female
* ASA 1 or 2
* Insured Social
* Informed Consent

Exclusion Criteria:

* Diabetes
* Intoxication-alcoholic chronic
* Allergy to local anesthetics
* Hemostasis disorders
* Hepatic failure
* Chronic pain syndrome

Primary outcomes:
measure: Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot
timeFrame: 72 hours
Secondary outcomes:
measure: Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve.
timeFrame: 72 hours
measure: Duration of Motor Sciatic Block (h)
timeFrame: 72 hours
measure: Duration of Sensory Sciatic Block (h)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References: