louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03076593: GAPcare Fall Prevention Pilot Survey
Official title: GAPcare: The Geriatric Acute and Post-acute Care Coordination Program - Pilot Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fall
Keywords: geriatric
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 82
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults presenting to the Emergency Department at Rhode Island Hospital for any indication

Brief summary: GAPcare (Geriatric Acute \& Post-acute Care Coordination Program for Fall Prevention) is an early stage investigation that surveys older adults who present to the Emergency Department for any illness to determine the feasibility of an Emergency Department (ED)-based multidisciplinary intervention for preventing recurrent falls in older adults. In this observational study, older adults will be approached during routine clinical care in the ED and asked about prior falls, prior experiences having falls treated in the inpatient and outpatient setting, and the investigators will solicit feedback on potential improvement to care in the ED setting for falls.


Eligibility criteria: Study inclusion criteria for GAPcare

* Adult 65 years-old or older
* Able to communicate in English
* No cognitive impairment (≥4 on SIS)

Exclusion criteria

• Unable to give informed consent due to intoxication or altered mental status

Primary outcomes:
measure: Feasibility of enrollment
timeFrame: at study enrollment
Secondary outcomes:
measure: Type of preventative services offered after a prior fall
timeFrame: at study enrollment
measure: Satisfaction with prior Emergency Department evaluations after a fall using a likert scale
timeFrame: at study enrollment
measure: Feedback on prior fall evaluations
timeFrame: at study enrollment
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital, Brown University
name: Elizabeth M Goldberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01871493: A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants
Official title: A Phase 1 Study to Evaluate the Pharmacokinetics of LY2605541 Injection and Insulin Lispro Injection Administered as Mixture or as Individual Components in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood. The study has two parts. Participants may enroll in only one part. Each part has four treatment periods in a fixed order. The study will last approximately 8 weeks, not including screening. Screening is required within 28 days prior to the start of the study.


Eligibility criteria: Inclusion Criteria:

* Are not of child-bearing potential
* Have a body mass index (BMI) between 18 and 29.9 kilograms per meter squared (kg/m\^2), inclusive
* Are nonsmokers or have not smoked for at least 2 months prior to entering the study

Exclusion Criteria:

* Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin
* Have a history of first-degree relatives known to have diabetes mellitus
* Have used systemic glucocorticoids within 3 months prior to entry into the study
* Have donated blood or had a blood loss of 450 milliliter (mL) within 1 month prior to study enrollment

Primary outcomes:
measure: Pharmacokinetics (PK): Time to Reach Peak Concentration (tmax) of LY2605541 and Insulin Lispro
timeFrame: Pre-dose up to 216 hours post-dose
measure: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY2605541 and Insulin Lispro
timeFrame: Pre-dose up to 216 hours post-dose
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC0-∞) of LY2605541 and Insulin Lispro
timeFrame: Pre-dose up to 216 hours post-dose
Secondary outcomes:
measure: Maximum Glucose Infusion Rate (Rmax)
timeFrame: Predose up to 32 hours post clamp procedure in all treatment periods
measure: Total Glucose Infused Over Clamp Duration (Gtot)
timeFrame: Predose up to 32 hours post clamp procedure in all treatment periods
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05170893: Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients
Official title: Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 36
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: All chronic kidney disease patients, whether on regular hemodialysis or not, are at high risk of cardiovascular diseases. This is mainly due to increased oxidative stress, reduced antioxidants and generalized inflammation. Coenzyme Q10 is a vitamin-like antioxidant synthesized in almost all body cells, and it is also available in many dietary sources. It was observed that chronic kidney disease patients have low plasma levels of Coenzyme Q10. Clinical benefits of Coenzyme Q10 supplementation have been documented for various cardiovascular and neurodegenerative disorders. The investigators believe that Coenzyme Q10 supplementation may have potential benefits in pediatric patients receiving hemodialysis; mainly due to its antioxidant activity and anti-inflammatory effects.


Eligibility criteria: Inclusion Criteria:

* Male or female patients with ages between 2 to 18 years old.
* Undergoing regular hemodialysis for at least 6 months.

Exclusion Criteria:

* Patients who weigh less than 10 kg.

Primary outcomes:
measure: Change in Malondialdehyde (MDA)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: El-Demerdash Children's Hospital
Study officials:
References:
Clinical trial NCT05144893: Brief Virtual Mindfulness-based Group Intervention with Social Support for Perinatal Individuals
Official title: CPO Pilot: Brief Virtual Mindfulness Based Group Intervention with Social Support
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Substance Use
Pregnancy Related
Mental Health
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: University of Oregon
First posted: 2021-12-03
Enrollment: 24
Sex: FEMALE
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: This is a feasibility and acceptability study for 4- week virtual mindfulness-based intervention with social support for perinatal individuals at higher risk for substance use. This study builds on the longitudinal collection of questionnaire data from pregnant and postpartum people during the COVID-19 pandemic. Each closed virtual support group will meet weekly for 4 weeks using a video conference platform. Groups will be focused on grounding, thinking patterns, self-compassion and self-care. This approach will foster increase awareness of wellbeing as well as social support between group participants. Primary outcomes include the feasibility and acceptability of this group-based intervention for perinatal individuals.


Eligibility criteria: Inclusion Criteria:

* Currently pregnant
* Have a single gestation pregnancy
* Fluently speak English
* A history of significant substance use or currently in treatment for a substance use disorder.

Exclusion Criteria:

* Inability to provide consent

Primary outcomes:
measure: Feasibility - Interest
timeFrame: at 1 week
measure: Feasibility - Attendance
timeFrame: up to 2 months
measure: Acceptability
timeFrame: up to 2 months
Secondary outcomes:
measure: Pregnancy-specific stress
timeFrame: up to 2 months
measure: Psychological Distress
timeFrame: up to 2 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Kristen Mackiewicz Seghete, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02569593: Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB
Official title: Evaluation of the Absorption Rate From Different Oral Fe-supplements in Obese Volunteers Pre- and Post-RYGB: an Interventional Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 15
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: Obese volunteers who have scheduled a gastric bypass (RYGB) in UZ Leuven will be asked to participate in a cross-over study using commercial available iron supplements. The aim of this study is to evaluate the absorption rate of different oral iron supplements in volunteers before and after RYGB (1, 3, 6 and 12 months post-RYGB).

Detailed description: Patients who met the criteria will be invited to come to the clinical research center at 10 occasions (two times before and 1, 3, 6 and 12 months after RYGB). During each visit the following information will be collected:

* General information concerning sociodemographic and medical background
* The medical history
* Anthropometric measures
* Physical activity by questionnaire
* Food frequency by questionnaire
* Information about menstrual blood loss.

Following an overnight fast, subjects will come to the clinical research center. An intravenous catheter will be inserted to collect blood samples. Before the oral administration, blood samples will be collected for the determination of the serum concentration of different iron status markers. The volunteers will receive first an iron(II)sulfate supplement, followed by a Fe-chelate supplement (at least 7 days between both supplements). After the administration of the supplement, blood samples will be taken at various time points to determine the amount of iron absorption and to investigate if there are any changes in the iron metabolism (at 15, 30, 60, 90 minutes and 2; 2.5; 3; 3.5; 4 and 5 hours after oral administration). There will be a one-week washout period between the tests with each iron supplement. The volunteers will be asked to repeat the test before surgery and 1, 3, 6 and 12 months after surgery for each iron supplement.

Eligibility criteria: Inclusion Criteria:

* Obese patients who have planned a RYGB surgery in the University Hospital Leuven
* Low iron status at the preoperative consultation (ferritin \< 30 µg/L and/or transferrin saturation \<20%)

Exclusion Criteria:

* Patients with a bariatric surgery history
* Smokers (\> 15 cigarettes/day)
* Pregnant women
* Lactating women
* Patients with a positive helicobacter pylori screening

Primary outcomes:
measure: The absorption rate from different oral Fe-supplements
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: KU Leuven
name: Bart Van der Schueren
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02902393: Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke
Official title: Interest of Thromboelastography (ROTEM) as a Biomarker of Revascularisation in Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Fibrinolysis
tPA
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients meeting the eligibility criteria will be invited to participate in the study . Patients will be recruited to emergencies CHU Caen and Saint Joseph Hospital. The goal is to recruit patients with neurological defect consistent with a neurovascular pathology eligible for thrombolysis with tPA.

With the admission of patients, blood samples are routinely made . For this study, the investigators will add one citrated 5 mL tube. An information letter and consent form will be given to the patient.

Brief summary: Revascularisation using recombinant tPA is the reference treatment of stroke. However, the efficacy of fibrinolysis is about 50%. Several factors, including the size of thrombus, have been associated with revascularisation efficacy.

The aim of this prospective study is to evaluate ex vivo the effect of tPA in patients with stroke with thromboelastography and to correlate results with the clinical outcome of patients. Results may predict revascularisation in patients with stroke.


Eligibility criteria: Inclusion Criteria:

* Patient (\> 18 years) with a neurological deficit compatible with a neurovascular pathology eligible for fibrinolysis rtPA and having a proximal occlusion of the middle cerebral artery (segment M1 / M2) or basilar trunk objectified brain imaging (MRI angiography or angio CT).

Exclusion Criteria:

* Any patient with major comorbidity, a pathology of hemostasis or anticoagulant treatment (vitamin K antagonist (VKA), direct oral anticoagulant).

Primary outcomes:
measure: Evaluation of revascularisation 24 hours after tPA injection using CT scan or MRI
timeFrame: 24 hours
Secondary outcomes:
measure: Clinical evaluation using NIHSS scale
timeFrame: 24 hours
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital
state: Calvados
Study officials:
affiliation: University Hospital, Caen
name: Richard MACREZ, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05681611: Effect of Rocuronium on BIS Values
Official title: Correlation Between Trend of Four Values and Bispectral Index Values During General Anaesthesia for Breast Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
General Anaesthesia
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fe-male patients undergoing breast oncologic surgery

Brief summary: Aim of this trial is to define if Trend of Four (TOF) values after a bolus of rocuronium is correlated with Bispectral Index BIS values during standard general anaesthesia for breast surgery.

Detailed description: Rocuronium. a curarizing agent, has been shown to decrease Bispectral Index (BIS) in awake volunteers.

However, correlation between Trend of Four (TOF) values after a bolus of rocuronium and BIS values during general anaesthesia for breast surgery has not been defined yet.

Investigators want to analyze this correlation during general anaesthesia conducted using Propofol and remifentanil. All of these drugs will be delivered with Targeted-Controlled Infusion pumps (in particular Eleveld for Propofol, Minto for Remifentanil), commonly used to deliver general anaesthesia. At stable anaesthesia maintenance, if requested for surgical (ie more muscle relaxation) or anesthesiological reasons (i.e. avoid air insufflation) a standard Rocuronium bolus (0.6 mg/kg) was given. In these case, with rocuronium bolus justified by clinical reasons, authors will observationally record the BIS values and the TOF values.

Eligibility criteria: Inclusion Criteria:

* Undergo General Anaesthesia with Propofol and Remifentanil, and necessity of curarization with Rocuronium for surgical or ventilatory reasons.

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Benzodiazepines praemedication
* Obesity

Primary outcomes:
measure: Correlation between Trend of Four (TOF) and Bispectral Index (BIS) values
timeFrame: 60 minutes after rocuronium bolus
Secondary outcomes:
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: ULSS2
Study officials:
References:
Clinical trial NCT06652711: Addressing the Mental Health and Emotional Well-being of Immigrants Through a Scalable Intervention
Official title: Addressing the Mental Health and Emotional Well-being of Immigrants Through a Scalable Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Well-being
Mental Health
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 2100
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: We will study the impacts of offering access to an emotional well-being phone app to Hispanic U.S. immigrants in psychological distress. Our primary outcome is participants' psychological well-being.


Eligibility criteria: The target population will be: immigrants to the U.S. of Hispanic origin whose native language is Spanish, who have been living in the U.S. (intermittently or continuously) for less than 10 years, who are over 18 years of age, who have a PHQ4 score that is three or more, who would be interested in using a well-being phone app, who do not have a graduate degree and have access to a smartphone.

Primary outcomes:
measure: Depression, anxiety, and stress
timeFrame: Up to six months since enrollment
measure: Anxiety
timeFrame: Up to six months since enrollment
measure: Stress
timeFrame: Up to six months since enrollment
measure: Self-efficacy
timeFrame: Up to six months since enrollment
measure: Locus of Control
timeFrame: Up to six months since enrollment
Secondary outcomes:
measure: Remittances
timeFrame: Up to six months since enrollment
measure: Social connectedness and Integration to the US
timeFrame: Up to six months since enrollment
Other outcomes:
measure: Perceptions and attitudes towards using mental health services
timeFrame: Up to six months since enrollment
measure: Parental expectations and aspirations about their youngest child under 18 educational attainment
timeFrame: Up to six months since enrollment
measure: Absenteeism
timeFrame: Up to six months since enrollment
measure: Uptake for the app
timeFrame: Up to six months since enrollment
measure: Use of the app
timeFrame: Up to six months since enrollment
measure: Demand for the app
timeFrame: Up to six months since enrollment
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT00564811: Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom)
Official title: Effect of Agaricus Blazei (Murrill) ss. Heinemann (Sun Mushroom) on the Nutritional State and Liver Biochemistry in Hepatitis C Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Nutritional Status
Hepatitis, Viral, Human
Keywords: Agaricus blazei (Murrill) ss. Heinemann,
Hepatitis C
Nutritional status
Liver Function Tests
Antiviral Agents
Lead sponsor: UPECLIN HC FM Botucatu Unesp
Sponsor class: OTHER
First posted: 2007-11-28
Enrollment: 10
Sex: ALL
Minimum age (years): 24
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study was to verify the influence of Agaricus blazei (Murrill) ss. Heinemann (A. blazei) on the evolution of nutritional state and liver function in hepatitis C patients.

Detailed description: Ten patients were studied (5 - GI - not taking A. blazei - and 5 - G2 - taking A. blazei), from both sexes, with positive Anti-VHC and a healthy nutritional state, admitted into in the viral hepatitis ward. Diagnosis and treatment for hepatitis C concurred with the regulations of the Ministry of Health and nutritional evaluation was performed in 3 moments according to anthropometrical, bioimpedance, biochemical and dietary standards, with duration of 6 months. The consumption of A. blazei (10g/day) in dehydrated powder was concomitant with antiviral therapy (conventional or pegylated interferon associated with ribavirin) with duration of 5 months.

Eligibility criteria: Inclusion Criteria:

* To have been informed and signed adequately the free and clarified assent
* Initiating the anti-viral treatment (interferon or pegylated interferon associate the ribavirin)
* Age: 24-70 years
* Gender :both the gender
* Race : all races
* To present serology positive to the anti-VHC ELISA
* To present genotype type 1,2,or 3
* Body mass index- \>18,5 e \< 35kg /m2
* Conditions full to the ORAL ingestion

Exclusion Criteria:

* Don't agree to the project or don't have signed the term of clarified free assent
* Restriction for oral ingestion
* The existence of surface of antigen of the hepatitis B virus(Ag HBs)
* The existence of antibody for the human immunodeficiency virus
* To be enclosed in another project of research or form of treatment
* Pregnant women
* Suckles
* Cirrhosis
* Patients with hepatitis auto-imune.

Primary outcomes:
measure: Measure: influence of Agaricus blazei (Murrill) ss. Heinemann on the evolution of nutritional state and liver function in hepatitis C patients. Time Frame: six months
timeFrame: Time Frame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Botucatu
country: Brazil
facility: Internal Medicine Department, Botucatu School of Medicine, São Paulo State University - UNESP
state: Sao Paulo
Study officials:
affiliation: Botucatu Medicine School - Sao Paulo State University
name: Caramori A Carlos, MD, PhD
role: STUDY_CHAIR
References: