louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04598061: IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants
Official title: IV Dexmedetomidine as Spinal Anesthesia Adjuvant in Infants : RACHI_dex
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Newborns
Infant
Spinal Anesthesia
Keywords: less than 7 kg
undergoing an infra-umbilical surgery
Spinal anesthesia
Dexmedetomidine
respiratory complications
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 210
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour

Brief summary: * Spinal anesthesia in newborns is one of " Gold standard " techniques in short subumbilical surgeries (less than 30 minutes) with advantage of avoiding the risks inherent to general anesthesia.
* Spinal anesthesia of the newborn remains a complex technical procedure with a failure rate of up to 16%. The child's movements and certain degrees of discomfort may also interfere with the successful completion of the procedure.
* The second major issue of spinal anesthesia is the limitation of the motor block duration and the need for general anesthesia to complete the surgery
* Spinal anesthesia duration can be prolonged by the addition of differents adjuvant such as opioid or alpha 2 adrenergic agonist.
* Since 2018, dexmedetomidine, an alpha 2 adrenergic agonist with sedative, analgesic and anxiolytic properties, is being used as a current and standard practice in our anesthesia department. Intravenous administrationis performed ten to twenty minutes before spinal anesthesia placement in all children weighing less than 7 kg undergoing an infra-umbilical surgery of expected duration of less than 1 hour. This strategy ensures the child's comfort and allows the procedure to be performed under optimal conditions for practitionner.
* The objective of this study is to review our practices and to evaluate the impact of the use of dexmedetomidine during spinal anesthesia of newborns and infants.


Eligibility criteria: Inclusion criteria:

* Newborns or Infants
* less than 7 kg
* Infra-umbilical surgery less than 1 hour
* Spinal anesthesia

Exclusion criteria:

* parental refusal
* Contraindication to spinal anaesthesia (coagulation disorder, ongoing sepsis, spinal malformation...).
* Contraindication to Dexmedetomidine (intracardiac conduction disorder, uncontrolled hemodynamic instability, alertness disorder)

Primary outcomes:
measure: duration of motor block
timeFrame: immediately after procedure in the recovery room
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital
state: Hérault
Study officials:
affiliation: UH Montpellier
name: Chrystelle SOLA, PH
role: STUDY_DIRECTOR
References:
Clinical trial NCT05807061: Reducing Children's Racial Biases Via a Parent-Led Intervention
Official title: Reducing Children's Racial Biases Via a Parent-Led Intervention
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Racial Bias
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-04-10
Enrollment: 648
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to test a parent-led program for reducing children's racial biases in White families. The main question it aims to answer is: With training, can parents effectively address their children's racial biases? Parent will receive training and tools for addressing their children's racial biases. Researchers will study effects on both parents' and children's racial biases.


Eligibility criteria: Inclusion Criteria:

* The child is 5.00 to 7.99 years of age
* The child participant and their parent are both non-Hispanic White

Exclusion criteria are:

* Non-proficiency in English on the part of the parent or the child
* The parent is \<18 years old
* The child or parent identifies with another racial/ethnic identity in addition to White

Primary outcomes:
measure: Change in Likelihood of Child's Racial Bias
timeFrame: Baseline, Post-Test 1 (up to 4 weeks on study), Post-Test 2 (up to 16 weeks on study)
measure: Change in Concern about Children's Racial Bias
timeFrame: Baseline, Post-Test 1 (up to 4 weeks on study), Post-Test 2 (up to 16 weeks on study)
measure: Change in Concern about Own Child's Bias
timeFrame: Baseline, Post-Test 1 (up to 4 weeks on study), Post-Test 2 (up to 16 weeks on study)
measure: Change in Motivation to Regulate Children's Bias
timeFrame: Baseline, Post-Test 1 (up to 4 weeks on study), Post-Test 2 (up to 16 weeks on study)
measure: Change in Self-Efficacy for Addressing Children's Bias
timeFrame: Baseline, Post-Test 1 (up to 4 weeks on study), Post-Test 2 (up to 16 weeks on study)
measure: Change in Intergroup Liking
timeFrame: Baseline, Post-Test 1 (up to 4 weeks on study), Post-Test 2 (up to 16 weeks on study)
measure: Change in Diversity Preference
timeFrame: Baseline, Post-Test 1 (up to 4 weeks on study), Post-Test 2 (up to 16 weeks on study)
measure: Change in Reactions to Discrimination: Evaluation
timeFrame: Baseline, Post-Test 1 (up to 4 weeks on study), Post-Test 2 (up to 16 weeks on study)
measure: Change in Reactions to Discrimination: Confrontation
timeFrame: Baseline, Post-Test 1 (up to 4 weeks on study), Post-Test 2 (up to 16 weeks on study)
measure: Change in Predicting Parents' Attitudes
timeFrame: Post-Test 1 (up to 4 weeks on study), Post-Test 2 (up to 16 weeks on study)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Waisman Center at UW-Madison
state: Wisconsin
Study officials:
References:
Clinical trial NCT04299061: Effect of the Physical Activity Courses on the Physical Activity Level at University Students
Official title: The Effect of the Physical Activity and Healthy Living Elective Courses on Physical Activity Level and Awareness Among University Students Educating in Different Departments
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Physical Activity Level
Physical Activity Awareness
Lead sponsor: Istanbul Kültür University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of our study is to evaluate the level of physical activity and awareness of physical activity among university students studying in a department other than health sciences and who have taken courses on "physical activity, exercise, healthy life".

According to the results of the study, the perceptions of students from different departments on physical activity and exercise will be compared and the effects of the courses they have taken on students' attitudes of daily physical activity will be examined.

Our hypothesizes are:

1 . A course such as an exercise, physical activity or wellness increases the awareness and physical activity level of students studying in different branches.

2. Stress and sleep problems are less common among students who do regular physical activity.


Eligibility criteria: Inclusion Criteria:

* Volunteer to participate in the study
* Being a student in departments of lawyer, engineering and architecture in university
* Participation in courses is compulsory
* For the study group; having taken physical activity, exercise, wellness classes as compulsory or optional in their university
* For the control group; not taking physical activity, exercise, wellness lessons in their university

Exclusion Criteria:

* Being a student in other departments

Primary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: Baseline of the study
measure: Physical Activity Awareness Questionnaire - prepared by the researcher
timeFrame: Baseline of the study
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline of the study
measure: Perceived Stress Scale
timeFrame: Baseline of the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05134961: Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma
Official title: Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duodenal Cancer
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients subjected to resection of primary duodenal adenocarcinoma

Brief summary: The aim of this study is to examine the long-term outcomes after curatively intended resection of duodenal adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients subjected to resection of primary duodenal adenocarcinoma

Exclusion Criteria:

* None.

Primary outcomes:
measure: 3-year survival
timeFrame: Three years
Secondary outcomes:
measure: Duodenal cancer recurrence
timeFrame: 5 years
Other outcomes:
Locations:
city: Copenhagen NV
country: Denmark
facility: Kristian Schaumburg Kiim
state: Copenhagen
Study officials:
References:
Clinical trial NCT03078361: Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)
Official title: Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening) Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Colorectal Carcinoma
Keywords: cancer screening
colon
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
name: Bankhead-Coley Cancer Research Program
First posted: 2017-03-13
Enrollment: 159
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After completion of baseline assessments, participants will be randomized so that the study personnel are unaware of the intervention assignment at the time of the baseline assessment.
Primary purpose: SCREENING

Brief summary: The purpose of this study is to conduct 4 focus groups and recruit for 12 participants per focus group to explore community members' views about colorectal cancer screening (CRCS) processes and perceived benefits and impediments, what information they believe should be communicated, communication preferences (style, tone) and perceptions of screenings.


Eligibility criteria: Inclusion Criteria:

* Men and women, age 50-75 years
* Self-identify as Hispanic/Latino
* Able to understand, read, and speak Spanish
* Prefer to receive health information in Spanish
* Previously screened or not screened

Primary outcomes:
measure: Rate of Feedback from Community Advisory Board
timeFrame: Up to 4 months
Secondary outcomes:
measure: Rate of Receipt of I-FOBT from Participants
timeFrame: Up to 4 months
measure: Rate of Receipt of Assessments from Participants
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Clement Gwede, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chavarria EA, Christy SM, Feng H, Miao H, Abdulla R, Gutierrez L, Lopez D, Sanchez J, Gwede CK, Meade CD. Online Health Information Seeking and eHealth Literacy Among Spanish Language-Dominant Latino Adults Receiving Care in a Community Clinic: Secondary Analysis of Pilot Randomized Controlled Trial Data. JMIR Form Res. 2022 Oct 13;6(10):e37687. doi: 10.2196/37687.
citation: Christy SM, Cousin LA, Sutton SK, Chavarria EA, Abdulla R, Gutierrez L, Sanchez J, Lopez D, Gwede CK, Meade CD. Characterizing Health Literacy Among Spanish Language-Preferring Latinos Ages 50-75. Nurs Res. 2021 Set/Oct 01;70(5):344-353. doi: 10.1097/NNR.0000000000000519.
Clinical trial NCT00168961: Enteral Nutrition in Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Cirrhosis
Keywords: liver cirrhosis Child B or C
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2005-09-15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Malnutrition is frequently occurring in patients with liver cirrhosis and is associated with a poorer outcome, as it determines life quality and affects both morbidity and mortality.

Long term prognosis after liver transplantation also depends on the nutritional status.

Therefore, the early diagnosis and intervention for malnutrition is an important issue in the clinical management of liver cirrhosis. However, oral intake has been shown to be insufficient due to disease related anorexia or concomitant drowsiness and confusion.

Specific aims: To investigate the effect of early nutritional intervention via tube feeding on nutritional status, functional status (hand grip strength and peak flow), life quality and disease related complications such as intestinal permeability, and oxidative stress, as well as liver function.


Eligibility criteria: Inclusion Criteria:

* Liver cirrhosis (Child B or Child C)

Exclusion Criteria:

* Malignant comorbidity
* Encephalopathy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Klinik für Gastroenterologie
Study officials:
affiliation: Charite Universitätsmedizin CCM Klinik für Gastroenterologie
name: Matthias Pirlich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02528461: Macrophage Activation Markers During Sofosbuvir-based Treatment Regimes of Chronic Hepatitis C
Official title: Measuring Inflammation Cells (CD163 and CD206) With the Purpose of Examining Reduction of Fibrosis in the Liver of Chronic Hepatitis C Patients Following Treatment With the Medication Sofosbuvir
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Sofosbuvir
Direct acting anti-viral treatment
liver cirrhosis
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2015-08-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis C initiating sofosbuvir-based direct-acting antiviral treatment.

Brief summary: The purpose of the study is to investigate how the liver is affected with regard to inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C.

In order to examine how the liver heals, we want to use blood samples to check for the occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of ultrasound examination) and also preferably with extraction of a small tissue sample. We want to examine how the liver function as inflammation and scar tissue decrease, especially concerning the liver's ability to produce proteins. Furthermore, we want to examine with a gastroscopy, if the circulation of blood in the liver is improved after successful treatment with the expected result that potential varicose veins in the esophagus vanish.


Eligibility criteria: Inclusion Criteria:

* Hepatitis C and initiation of sofosbuvir-based direct-acting antiviral treatment

Exclusion Criteria:

* HIV or Hepatitis B Virus

Primary outcomes:
measure: Changes in the macrophage activation markers sCD163 and sCD206
timeFrame: 1 year
Secondary outcomes:
measure: Changes in liver fibrosis with fibroscan
timeFrame: 1 year
measure: Changes in histological liver fibrosis
timeFrame: 1 year
measure: Changes in clinical status
timeFrame: 1 year
measure: Changes in hepatic venous pressure
timeFrame: 1 year
measure: Changes in metabolic liver function determined by the galactose elimination capacity (GEC) test
timeFrame: 1 year
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Henning Grønbæk, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00061061: Tobacco Cessation in Postmenopausal Women (Part I) - 1
Official title: The Effects of ERT on Appetitive Behavior and Withdrawal in Short-term Smoking Cessation Compared to Smoking ad Lib in Postmenopausal Female Smokers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Use Disorder
Keywords: Tobacco Cessation
Postmenopausal Women
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2003-05-22
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation compared to smoking ad lib in postmenopausal female smokers.

Detailed description: Female subjects were screened and randomized. Following two weeks of medication monitoring, all participants continued smoking as usual for one week, at which time baseline measurements were taken. For the remaining two weeks (the experimental period), participants were randomized to a continued smoking or smoking abstinence condition. The abstinent group was provided with cessation counseling and monitored for abstinence. For all participants, data were collected during five clinic visits on all dependent measures: MNWS, QSU, Beck Depression Inventory (BDI), Profile of Mood States, Motor Speed Tasks and Reaction Time Tests. Question of interest was whether hormone replacement therapy would improve these dependent measures as manifested during short-term smoking cessation.

Eligibility criteria: Inclusion Criteria:

Female smokers ages 40-79, smoking at least 15 cigarettes per day for at least one year, have natural menopause, have a transvaginal ultrasound to confirm loss of follicular activitiy, have a normal baseline mammogram, a normal chemistry at baseline, willing to take hormone replacement therapy for the duration of the study, normal thyroid function, and have a normal TSH.

Exclusion Criteria:

Women who have had formal dieting with or without pharmacological methods within the last three months; a weight change greater than or equal to 10 pounds within the last three months, BMI greater than or equal to 40, severe menopausal symptoms, active medical problems, alcohol or drug abuse, other forms of nicotine use.

Primary outcomes:
measure: Smoking Cessation Outcomes
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sharon Allen, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000261: Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13
Official title: Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol-Related Disorders
Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
sevoflurane
ethanol
subjective effects
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to evaluate the effects of alcohol history on the subjective and reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. All subjects underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of intervention.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Mood
timeFrame: Baseline, inhalation, recovery
measure: Psychomotor performance
timeFrame: Baseline, inhalation, recovery
measure: Choice of drug vs placebo
timeFrame: After placebo and drug in each session
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00730561: Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy
Official title: Autologous Hematopoietic Stem Cell Transplantation for the Treatment of Limb Ischemia and Diabetic Neuropathy in Patients With Diabetes Mellitus Type 2:A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Limb Ischemia
Diabetic Neuropathy
Keywords: nerve conduction velocity
hematopoietic stem cell transplantation
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2008-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several pathophysiological theories have been proposed for the development of diabetic chronic complications. In recent years, the use of stem cells (totipotential, hematopoietic or endothelial lineages) has been reported as an adjunctive modality of treatment for ischemia models in animals and humans. Nevertheless, there are no reports in the use of stem cells for the treatment of human sensorimotor peripheral diabetic neuropathy. We performed this study to evaluate the effect of autologous hematopoietic CD34+ cell transplantation on nerve conduction velocity in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Ambulatory patients with type 2 diabetes mellitus and ischemia of one or both lower limbs, defined as lack of limb improvement with conventional care (medications, debridements) after a recent amputation or a patient graded III or IV in the Leriche-Fontaine functional classification.

Exclusion Criteria:

* Patients older than 75 years
* Hypercoagulable states
* Cardiac ejection fraction \< 30%
* Active vasculopathy in brain, kidneys or heart
* Neoplastic disease
* Active infection
* Diabetic ketoacidosis or hyperosmolar hyperglycemic state
* Gangrene of the extremity requiring immediate surgery.

Primary outcomes:
measure: Change in nerve conduction velocity
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario "José E. González"
state: Nuevo León
Study officials:
affiliation: Departamento de Endocrinología del Hospital Universitario "José E. González"
name: Fernando J Lavalle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang P, Li S, Han M, Xiao Z, Yang R, Han ZC. Autologous transplantation of granulocyte colony-stimulating factor-mobilized peripheral blood mononuclear cells improves critical limb ischemia in diabetes. Diabetes Care. 2005 Sep;28(9):2155-60. doi: 10.2337/diacare.28.9.2155.