louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03013816: Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention
Official title: Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Organ Donor Registration
Organ Donation Education
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2017-01-09
Enrollment: 611
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Four aims were pursued: (1) Evaluate the effectiveness of video messaging on adolescent donor designations in comparison to a regionally-matched historical comparison group of adolescents; (2) Compare the differential effectiveness of three commonly-used donation messaging strategies (informational, testimonial, and blended) on donor designations; (3) Examine the impact of donation messaging on changes in secondary outcomes (donation engagement, knowledge, attitudes, beliefs, likelihood of donor designation, discussion with a parent) before and after video intervention; and (4) Assess the commitment of parents to follow their adolescent's donation wishes in the event of death. Our central hypotheses were that integrating donation video messaging into driver education classes would generate a higher proportion of donor designations compared to a historical comparison group and that blended video messaging (informational + testimonials) would yield a higher proportion of donor designations and more change in secondary outcomes.


Eligibility criteria: Criteria for Classrooms:

Classroom eligibility criteria included: (a) driver education conducted in English, and (b) instructor agreement not to provide or discuss donation information beyond the study video.

Criteria for Adolescent Participants:

Inclusion Criteria:

* Enrolled in driving school class
* English speaking
* Adolescent assent
* Parental permission to participate

Exclusion Criteria:

* Prior participation in a driver's education class in which organ donation education was provided
* Parent permission form not signed

Primary outcomes:
measure: Organ Donation Registration
timeFrame: 6 months
Secondary outcomes:
measure: Organ Donation Knowledge and Attitudes
timeFrame: 1 week
measure: Parental Commitment
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: James Rodrigue, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rodrigue JR, Boger M, DuBay D, Fleishman A. Increasing Organ Donor Designation Rates in Adolescents: A Cluster Randomized Trial. Am J Public Health. 2019 Sep;109(9):1273-1279. doi: 10.2105/AJPH.2019.305178. Epub 2019 Jul 18.
Clinical trial NCT02853916: Efficacy of a Brown Seaweed Powder for Glycemic Control
Official title: Efficacy of a Brown Seaweed Powder for Glycemic Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: innoVactiv Inc.
First posted: 2016-08-03
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objectives of this trial are to confirm efficacy in human of a brown seaweed powder and explore dose-response relationship by comparing two different doses.

The primary endpoint is incremental area under the curve (iAUC, mmol\*min/L) for blood glucose.


Eligibility criteria: Inclusion Criteria:

* Males and females aged between 18-45 y
* Normoglycemic (fasting blood glucose \<5.6 mmol/L)
* Body mass index (BMI) 18.5-29.9 kg/m2
* Able to consume bread products

Exclusion Criteria

* Fasting blood glucose \> 5.6 mmol/L
* Systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg
* Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
* Presence of a gastrointestinal disorder within the past year
* Presence of major gastrointestinal surgeries
* Thyroid problems
* Smokers
* Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgement
* Women that are currently pregnant or lactating, or not using an appropriate contraception method
* Excessive alcohol intake (more than 2 drinks per day or more than 9 drinks per week)
* Allergic to shellfish (crab) or molluscs
* Weight gain or loss of at least 10lbs in previous three months

Primary outcomes:
measure: Incremental area under the curve (iAUC, mmol*min/L) of blood glucose
timeFrame: 0, 15, 30, 45, 60, 75, 90, 120, 150, 180 and 210 min
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Peter Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00070616: Pharmacokinetic Study of Palifermin in Subjects Receiving Radiation Therapy and Chemotherapy Followed by Blood Stem Cell Support
Official title: An Open-label Study of the Pharmacokinetics (PK) of Recombinant Human Keratinocyte Growth Factor (Palifermin; rHuKGF) in Subjects With Hematologic Malignancies Undergoing Total Body Irradiation and High-dose Chemotherapy Followed by Peripheral Blood Progenitor Cell (PBPC) Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia
Lymphoma
Myeloma
Keywords: mucositis
chemotherapy
radiation therapy
Lead sponsor: Swedish Orphan Biovitrum
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2003-10-08
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Open label palifermin will be administered to subjects who are at a risk of developing mucositis after radiotherapy and chemotherapy followed by blood stem cell support. The amount of palifermin in the blood following administration will be evaluated. The safety of palifermin administration and its effect on reducing mucositis will also be evaluated.

Detailed description: Mucositis is a common side effect to chemotherapy and radiotherapy involving the formation of erythema and ulcerative lesions in the mouth. Mucositis can be serious, resulting in pain requiring interventions such as analgesic medications and the use of parenteral feedings. Currently, no standard therapy is available to prevent or treat mucositis.

Eligibility criteria: * Patients diagnosed with Non-Hodgkin's Lymphoma, Hodgkin's Disease, Leukemia and Myeloma. - Eligible for treatment with radiation therapy and chemotherapy followed by blood stem cell support.

Primary outcomes:
measure: To characterize the PK profile of 3 daily intravenous (IV) doses of rHuKGF before total body irradiation (TBI) / high-dose chemotherapy conditioning treatment and after PBPC transplantation
Secondary outcomes:
measure: To assess the safety and tolerability of rHuKGF in subjects with hematologic malignancies undergoing TBI and high-dose chemotherapy followed by PBPC transplantation.
measure: To assess oral mucositis in subjects receiving rHuKGF.
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Zia-Amirhosseini P, Hurd DD, Salfi M, Cheah TC, Aycock J, Cesano A. Pharmacokinetics of palifermin administered as the standard dose and as a collapsed dose in patients with hematologic malignancies. Pharmacotherapy. 2007 Oct;27(10):1353-60. doi: 10.1592/phco.27.10.1353.
Clinical trial NCT05739916: Phamacokinetics and Safety Profiles of DA-1229_01 5/1000mg in Healthy Subjects at Fed State
Official title: An Open Label, Randomized, Single Dose, Cross-over ,Two-group Study to Evaluate the Pharmacokinetics and Safety of DA-1229_01 5/1000mg in Healthy Subjects at Fed State
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-22
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229_01(5/1000 mg x1 tablets) at fed state.


Eligibility criteria: Inclusive Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History

Primary outcomes:
measure: AUCt
timeFrame: pre-dose~48 hours post-dose
measure: Cmax
timeFrame: pre-dose~48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Metro Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT01503216: Safety and Bioefficacy of Vitamin D2 and Vitamin D3
Official title: Safety and Bioefficacy of Vitamin D2 and Vitamin D3: Randomized Trial With Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Keywords: randomized controlled trial
vitamin D
bioavailability
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
First posted: 2012-01-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to investigate the bioavailability of vitamin D2 and D3 as measured by the increase of the specific hydroxy forms in serum (25(OH)D2 and 25(OH)D3, respectively, and by total 25(OH)D.

Detailed description: Study design: Human volunteers will receive supplements containing either vitamin D2 or D3 for a period of 8 weeks. At baseline, after 4 weeks and after 8 weeks, 25(OH)D2, 25(OH)D3 and total 25(OH)D will be measured in serum as the main outcome variables. Additional outcome variables are the Ca concentration in serum, PTH concentration in serum, ambulatory blood pressure and heart rate, and renin expression in peripheral mononuclear cells.

Groups/Cohorts Assigned Interventions

1. Placebo group
2. Vitamin D2-group Daily treatment with vitamin d2-supplements (containing 2000 IU per capsule)
3. Vitamin D3-group Daily treatment with vitamin d3-supplements (containing 2000 IU per capsule)

Eligibility criteria: Inclusion Criteria:

* 18 years
* healthy

Exclusion Criteria:

* supplementation of vitamin d and calcium
* hypercalcemia
* hypercalciuria
* chronical illness (diabetes, kidney diseases, cardiovascular diseases)
* serum-creatinine above 115 mmol/l
* pregnancy or breastfeeding women

Primary outcomes:
measure: change of 25-hydroxvitamin D
timeFrame: after 4 and 8 weeks of supplementation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut für Agrar- und Ernährungswissenschaften
name: Jutta Dierkes, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Lehmann U, Hirche F, Stangl GI, Hinz K, Westphal S, Dierkes J. Bioavailability of vitamin D(2) and D(3) in healthy volunteers, a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Nov;98(11):4339-45. doi: 10.1210/jc.2012-4287. Epub 2013 Sep 3.
Clinical trial NCT00659516: Smart Capnography Respiratory Index in Post Anesthesia Patients
Official title: Smart Capnography Respiratory Index: Clinical Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients After Surgery and Anesthesia Monitored in the PACU
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2008-04-16
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the respiratory index evaluation will be performed on 40 patients (adult and pediatric) of which 30 will be non intubated

Brief summary: The smart capnography respiratory index is a software tool that constitutes a representation of 4 parameters: End Tidal CO2, respiratory rate, O2 saturation and heart rate already displayed on a monitor in the form of a single respiratory index integer value ranging from 1 to 10 with trend information. The index is to be used to identify and display status and changes in patient respiratory status in a simple manner based on the summary of changes in the 4-above mentioned parameters. the respiratory index is to be used in varied clinical environments and is intended for use in adult and pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Adult or pediatric patients after surgery and anesthesia, monitored in the PACU

Exclusion Criteria:

* none

Primary outcomes:
measure: To demonstrate that the displayed respiratory index values and their associated description match the clinical status of the patients
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical center Jerusalem, Israel
name: Yaacov Gozal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05630716: Non-Invasive Cardiac Output Monitor (NICOM) for Goal-directed Fluid Resuscitation for Inpatients With Hypotension and/or Septic Shock
Official title: Pilot Evaluation Using The Non-Invasive Cardiac Output Monitor (NICOM) for Goal-directed Fluid Resuscitation for Inpatients With Hypotension and/or Septic Shock
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Hypotension
Septic Shock
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 876
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Non-Invasive Cardiac Output Monitor (NICOM) is a non-invasive monitor capable of measuring cardiac output (CO) and cardiac index (CI), and stroke volume (SV) and stroke volume index (SVI) based on heart rate. Conceptually NICOM is a technology that utilizes a dynamic response characteristic in assessing the need for fluid administration, whereby SVI is measured before and after a fluid challenge with more fluid given only if SVI increases significantly with administered fluid. Dynamic response technologies are intended to replace older, "static" measures such as central venous pressure (CVP) and pulmonary capillary wedge pressures (PCWP) which are single point measurements utilized to assess the need to administer fluid.

The aim is to pilot and evaluate the effectiveness of using The Non-Invasive Cardiac Output Monitor (NICOM) technology for goal-directed fluid resuscitation in adult inpatients with sepsis associated acute hypotension and/or evidence of septic shock (Lactate \>= 4.0).


Eligibility criteria: Inclusion Criteria:

* All adult patients \> 18 years of age
* inpatients for \>/= 6 hours
* meeting criteria for sepsis as defined by hypotension related to sepsis (MAP \< 65 or SBP \< 90) or evidence of septic shock (Lactate ≥ 4.0).

Exclusion Criteria:

* Patients who die within 24 hours of hospital admission
* patients documented as "comfort cares" or enrolled in "general inpatient hospice" during the first 72 hours of hospitalization.
* opted out of having their medical information used in research, as noted in the EHR.

Primary outcomes:
measure: Hospital mortality
timeFrame: 18 months post-treatment
measure: Hospital length of stay
timeFrame: 18 months post-treatment
measure: ICU length of stay
timeFrame: 18 months post-treatment
Secondary outcomes:
measure: Hours of vasopressor use
timeFrame: 18 months post-treatment
measure: change from baseline serum creatinine
timeFrame: 18 months post-treatment
measure: Difference in positive fluid balance at 75 hours of ICU discharge
timeFrame: 75 hours post treatment ( ICU discharge)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jeffrey Dichter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03446716: Sleep Extension and Behavior of Young Children
Official title: Effects of Sleep Extension on Sleep Physiology and Behavior of Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-02-27
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to the ADHD or Typically Developing group based on diagnosis history. Each then completes the intervention (EXTENSION) either preceded or followed by a week of baseline sleep (CONTROL). The order is pseudo-randomized.
Primary purpose: TREATMENT

Brief summary: This pseudo-randomized intervention study examined change in inhibitory control following a sleep manipulation in which children with and without ADHD were instructed to advance their bedtime by 90 minutes for five days.

Detailed description: Objective: To evaluate the efficacy of a sleep extension intervention in young children with ADHD and determine whether sleep extension improves inhibitory control, a primary deficit in ADHD.

Design: Children with and without ADHD completed two 5-day assessments: a baseline condition in which children followed their normal bedtime routine and a sleep extension condition in which children were instructed to go to bed 90 minutes earlier than their habitual bedtime. Sleep was assessed with actigraphy and, on the final night, polysomnography. A Go/No-Go task was used to assess inhibitory control.

Setting: Participants slept in their home on nights 1-4 and in the sleep laboratory on night 5 of each condition.

Main Outcomes and Measures: Of interest is actigraph measurement of total sleep time for the baseline compared to the sleep extension condition. Polysomnography will be used to compared changes in sleep physiology. The primary behavioral outcome is inhibitory control, indexed by accuracy on No-Go trials in the Go/No-Go task.

Eligibility criteria: Inclusion Criteria:

* A subset of children were required to have an ADHD diagnosis

Exclusion Criteria:

* diagnosis of intellectual disabilities or developmental delay
* current diagnosis of history of sleep disorder
* uncorrected hearing or visual impairments

Primary outcomes:
measure: total sleep time
timeFrame: 5 days (actigraph watch is worn for 5 days in each condition and overnight sleep time is identified and averaged across these 5 days)
Secondary outcomes:
measure: inhibitory control
timeFrame: measured before and after sleep - about 12 hrs
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Amherst
name: Rebecca Spencer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00344916: Phase 1 Study of L-NMMA in Patients With Liver Cirrhosis
Official title: NO-Synthesis in Patients With Liver Cirrhosis: Effect of L-NMMA on Renal Hemodynamics, Sodium Excretion and Plasma Levels of Vasoactive Hormones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Cirrhosis
Keywords: Renal hemodynamics
Nitric oxide
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-06-27
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Phase 1 study of the effects of nitric oxide inhibition with L-NMMA in patients with liver cirrhosis and healthy controls. It is hypothesized that nitric oxide availability is increased in liver cirrhosis.

Detailed description: In a randomized, placebo controlled design the acute effects of Ng-monomethyl-L-arginine are studied on:

* renal hemodynamics (GFR and RPF)
* blood pressure and heart rate
* lithium clearance
* plasma levels of vasoactive hormones

Eligibility criteria: Inclusion Criteria:

Healthy controls

* Age 20 to 60 years
* Both men and women
* Weight below 100 kg
* Normal clinical examination and laboratory screening
* Fertile women only if using contraception
* Informed consent according to the regulations of the local ethics committee

Liver cirrhosis

* Biopsy verified liver cirrhosis or clinical and laboratory signs of liver cirrhosis including hypoalbuminaemia, increased prothrombin time in combination with esophagusvarices or ascites
* P-creatinine \< 250 µmol/L
* Age 20-60 years
* Both men and women
* Fertile women only if using contraception
* Body weight below 100 kg
* Informed consent according to the regulations of the local ethics committee

Exclusion Criteria:

Healthy controls

* History or clinical evidence of diseases of the heart and blood vessels, kidneys, liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction or cerebrovascular insult as evaluated by clinical examination and laboratory screening
* Current medication
* Drugs or alcohol abuse
* Pregnancy
* Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances
* Donation of blood less than 1 month before the experiments

Liver cirrhosis

* Apart from liver cirrhosis no history of diseases of the heart and blood vessels, endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic disease.
* Drugs or alcohol abuse
* Pregnancy
* Previously within one year received more than 0.2 mSV radioactive treatment or diagnostic substances

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
affiliation: Dept. of Medicine, Holstebro Hospital, 7500 Holstebro, Denmark
name: Jesper N Bech, MD, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References: