louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02152397: Safety and Health Intervention Project
Official title: Developing a Prescription Opioid Overdose Prevention Intervention in Addictions Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Overdose
Opioid Related Disorders
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-06-02
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Use of opioid medications for treatment of pain has increased greatly in the U.S., with the average quantity of prescribed opioids increasing 700% in a decade, from \~100 morphine milligram equivalents (MME) per person to \~700 MME per person from 1997 to 2007. There have been concurrent increases in opioid-related adverse outcomes, such as extramedical use, opioid use disorders, and overdose. As a result, there were more unintentional poisoning deaths than deaths due to motor vehicle crashes among adults in 2010 (32,723 vs. 32,640). Additionally, the number of Americans seeking treatment for opioid use disorders has increased; in SAMHSA's Treatment Episode Data Set, prescription opioids were the primary substance of abuse for 142,782 individuals in 2009, compared to 22,637 in 1999, a 530% increase.

The specific aims of this project are to: (1) Refine a motivational enhancement prevention intervention for prescription opioid overdose risk reduction and improved witnessed overdose response for at-risk patients in addictions treatment; (2) Conduct a pilot randomized controlled trial comparing the prescription opioid overdose prevention intervention to a supportive educational control condition for patients in addictions treatment in order to: (a) obtain information about the feasibility of randomized controlled procedures; and (b) determine the distribution and variability of the primary (overdose risk behaviors) and mediating/secondary (witnessed overdose response, self-efficacy to reduce overdose risk, knowledge of overdose risk factors and symptom recognition) outcomes; and (3) Determine the distribution and variability in changes in HIV risk behaviors (e.g., reductions in injection of prescription opioids) over follow-up.


Eligibility criteria: Inclusion Criteria:

* Patients 18 and older in treatment at CPI
* able to provide informed consent.

Exclusion Criteria:

* acute suicidality
* psychiatric condition that precludes participation in the intervention
* inability to speak and understand English
* inability to give informed, voluntary, written consent for any reason

Primary outcomes:
measure: Overdose risk behavior
timeFrame: Change over time (3- and 6-month post-baseline)
measure: HIV risk behavor
timeFrame: Change over time (3- and 6-months post-baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Waterford
country: United States
facility: Community Programs, Inc.
state: Michigan
Study officials:
affiliation: University of Michigan
name: Amy Bohnert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00736697: Study Evaluating The Effect Of High-Fat Meal On Bioavailability And Pharmacokinetics Of Single Dose Of Moxidectin
Official title: An Open-Label, Randomized, Single-Dose, Parallel-Group Study to Determine the Effect of a High-Fat Meal on the Relative Bioavailability and Pharmacokinetics of a Single Dose of Moxidectin Administered Orally to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infection
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary objective of this study is to assess the effect of a high-fat meal (breakfast) on the concentrations of moxidectin measured in the blood after a single oral administration in healthy subjects.


Eligibility criteria: Inclusion Criteria

* Men or women of non childbearing potential aged 18 to 50 years inclusive at screening.
* Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight greater than or equal to 50 kg.

Exclusion criteria

* Any clinical important deviation from normal limits in physical examination findings, vital sign measurements, electrocardiograms or clinical laboratory test results.
* Presence or history of any disorder that may prevent the successful completion of the study.

Primary outcomes:
measure: Blood samples
timeFrame: 4 months
Secondary outcomes:
measure: Electrocardiograms
timeFrame: 4 months
Other outcomes:
Locations:
city: Poitiers
country: France
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02040597: A Study to Investigate the Pharmacokinetics, Safety and Tolerability of CHF 5993 pMDI in Subjects With Renal Impairment.
Official title: Open-label, Non-randomized, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability of a Single Dose of CHF 5993 pMDI in Subjects With Mild, Moderate and Severe Renal Impairment in Comparison With Matched Healthy Control Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with different level of renal impairment in comparison with matching healthy volunteers. Moreover, the safety and tolerability of the study drug will be also evaluated.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers and
* Subjects with mild, moderate and severe renal impairment

Exclusion Criteria:

* pregnant or lactating women
* positive HIV and hepatitis serology
* history of drug abuse
* history of hypersensitivity to the products used in the trial
* smokers
* respiratory disease such as asthma and COPD
* clinically relevant concomitant disease that may introduce a risk for the subjects'safety
* presence of kidney stones
* dialysis

Primary outcomes:
measure: Glycopyrrolate area under the curve (AUC)
timeFrame: over 72 h after single administration
Secondary outcomes:
measure: Glycopyrrolate other Pharmacokinetic parameters in plasma
timeFrame: Over 72 h after single administration
measure: B17MP and Formoterol pharmacokinetic parameters in plasma
timeFrame: over 24 h after single administration
measure: BDP pharmacokinetic parameters in plasma
timeFrame: over 24 h after single administration
measure: Urine Glycopyrrolate excretion (Ae)
timeFrame: over 72 h after single administration
measure: Urine formoterol excretion (Ae)
timeFrame: Over 24 h after single administration
measure: Adverse events
timeFrame: A period of 3 to 7 weeks (from screening visit to follow-up phone call)
measure: Vital signs
timeFrame: over 24 h after single administration
measure: Electrocardiogram (ECG) parameters
timeFrame: over 24 h after single administration
Other outcomes:
Locations:
city: Nadarzyn
country: Poland
facility: Biovirtus Research Site
state: Mokra 7
city: Lodz
country: Poland
facility: Medical University in Lodz
state: Ul. Kopcińskiego 22
Study officials:
affiliation: Medical University in Lodz
name: Piotr Kuna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Biovirtus
name: Kasia Jarus-Dziedzic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04535297: Consequences of the COVID-19 Lockdown on Health and Well-being of Patients With Parkinson Disease and Post-stroke
Official title: Consequences of the COVID-19 Lockdown on Health and Well-being of Patients With Parkinson Disease and Post-stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Stroke
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with PD or their caregivers, or patients post-stroke or their caregivers

Brief summary: The study aimed at describing the effects of the COVID-19 social distancing on function, health and well-being of patients with Parkinson's disease or post-stroke, and test the association between the patient activation level and these effects.An anonymous survey was distributed through social media and patient associations.Community-living patients with Parkinson's disease or post-stroke were invited to answer the survey.

Detailed description: People with chronic diseases like Parkinson's disease or post-stroke rely on routine medical and rehabilitative care to maintain daily function and health. These are important aspects of self-management. However, this was challenged by the social distancing due to COVID-19, which limited participation in regular routines.

The study objectives were: To (1) describe the effects of the COVID-19 social distancing on function, health and well-being of patients with Parkinson's disease or post-stroke, and (2) test the association between the patient activation level and these effects.

Community-living patients with Parkinson's disease or post-stroke were invited to answer an anonymous survey through social media and patient associations. Part 1 included 27 multiple-choice questions regarding current status and changes in function, health, medical care and well-being. Part 2 consisted of the Patient Activation Measure, describing people's knowledge, skill, and confidence in managing their own health.

Eligibility criteria: Inclusion Criteria:

* People diagnosed with Parkinson's disease or their caregivers, or people post-stroke or their caregivers
* Live in the community
* If a family member or caregiver completed the survey, we asked them to answer in reference to the patient.

Exclusion Criteria:

* diagnosis of COVID-19
* hospitalization in the last 3 months.

Primary outcomes:
measure: Patient Activation Measure (PAM®)
timeFrame: 1 hour
measure: Answers to multiple-choice questions
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Galit Yogev-Seligmann
state: Please Select...
Study officials:
affiliation: University of Haifa
name: Galit Yogev-Seligmann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04522297: Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Syndrome
Official title: Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepato-Renal Syndrome
Lead sponsor: National Hepatology & Tropical Medicine Research Institute
Sponsor class: OTHER_GOV
First posted: 2020-08-21
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hepatorenal syndrome is a functional renal impairment occurring in cirrhotic patients . It develops secondary to splanchnic arterial vasodilatation which decreases the effective blood volume, activate the renin-angiotensin-aldosterone system, and stimulate of sympathetic nervous system.This study aims to compare the efficacy of nor-epinephrine versus midodrine/ octreotide, together with intravenous albumin on renal functions of patients with hepatorenal acute kidney injury.


Eligibility criteria: Inclusion Criteria:

Both sexes aged 18 years or older having cirrhosis, ascites, and a diagnosis of HRS-AKI based on the 2015 International Club of Ascites (ICA) diagnostic criteria

Exclusion Criteria:

Serum creatinine (sCr) \>7 mg/dL Hypotension (mean arterial pressure (MAP) \<70 mm Hg) or sepsis. Recent treatment with vasopressors. Patients with severe cardiovascular disease Known allergy to study medications

Primary outcomes:
measure: Full response
timeFrame: 10 days
Secondary outcomes:
measure: Partial response
timeFrame: 10 days
measure: Reversal
timeFrame: 10 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The National Hepatology and Tropical Research medicine institute
Study officials:
affiliation: Fellow at The National Hepatology and Tropical Research medicine institute
name: Doaa Abdelaziz yousef, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT01360905: Study to Support Fetal Heart Rate and Uterine Contraction for Preterm Labor in Singleton and Multiple Pregnancies
Official title: Study to Determine the Equivalence of the Monica AN24 Monitor to Predicate Devices for (FHR) and (UC) During Pre-term Labor and Multiples
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pre Term Labor
Multiple Pregnancy
Keywords: PTL
Multiples
Lead sponsor: Monica Healthcare Ltd
Sponsor class: INDUSTRY
Collaborators: name: New York Presbyterian Hospital
First posted: 2011-05-26
Enrollment: 8
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is women of \>= 24 weeks of singleton pregnancy or women of \>=24 weeks of multiple pregnancy, that have been admitted to the Labor and delivery suite

Brief summary: The purpose of this study is to compare the Monica AN24 fetal monitor to previously FDA approved devices for Fetal Heart Rate and Uterine Contractions in labor for Multiples and pre term labor.

Detailed description: Clinical Investigation for a non-inferiority/equivalence study that aims to determine the acceptable performance of the Monica AN24 during the first and when possible the second stages of labor by determining whether the Monica AN24 fetal heart rate (FHR) and uterine contractions (UC) monitoring device is non-inferior/equivalent to Doppler FHR and tocodynamometer UC using direct fetal scalp electrode (FSE) FHR and intrauterine pressure catheter (IUPC) UC as a reference, either collected simultaneously with the Monica and Doppler FHR/tocodynamometer UC data, or from previous studies to define the expected accuracy and success rate when comparing Monica FHR and UC with Doppler FHR and tocodynamometer UC respectively

Eligibility criteria: Inclusion Criteria:

* She is \>=24weeks 0days but less than 36 completed weeks, with a singleton pregnancy or \>=34weeks 0days with a multiple pregnancy and has been admitted to the Labor and Delivery Unit
* She is in the latent phase of spontaneous labor, or has been admitted for induction of labor
* She has given her informed consent to participate as a subject
* She has none of the exclusion criteria

Exclusion Criteria:

* Known major fetal malformation or chromosome abnormality
* Involvement in another clinical trial currently or previously in this pregnancy
* Medical or obstetric problem that would preclude the use of abdominal electrodes (e.g., skin eruptions, sensitivity to adhesives)
* Significant medical or obstetric problem that in the investigator's opinion would make the woman incapable of taking part in the study

Primary outcomes:
measure: equivalence with predicate device
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: New York Presbytarian Hospital
name: Fadi Mizra, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04126005: Natural History Study of Patients With Canavan Disease (CANinform Study)
Official title: A Combination Retrospective Medical History and Prospective Observational Study of Patients With Canavan Disease for Assessment of Natural History of Canavan Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Canavan Disease
Keywords: Canavan Disease
AAV
AAV9
Gene therapy
Aspartoacylase
ASPA
ASPA gene
rAAV9
ACY2
Aminoacylase 2
Spongy degeneration
N-acetyl-L-aspartic acid (NAA)
N-acetylaspartate
Rare disease
Inherited Metabolic Disorders
Leukodystrophy
Leukoencephalopathies
Autosomal Recessive Disorder
Neurodevelopmental diseases
CANinform Study
Lead sponsor: Aspa Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-10-14
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Living and deceased patients with Canavan disease

Brief summary: This study uses medical records that allow retrospective data extraction of critical milestone and motor function data. In addition, prospective assessments collect data relevant to the natural history of Canavan disease in children.

Detailed description: The CANinform natural history study is the first multinational effort to rigorously gather both retrospective and prospective data from this patient population. Data collection includes extraction of retrospective data from medical records of living and deceased patients, and collection of prospective, longitudinal data from living patients and their parent(s)/caregiver(s). Motor function assessments are performed remotely in the home via video or in the clinic by qualified study team members. Families will be invited to attend clinic visits and/or will be followed remotely by the clinical site for approximately 3 years.

Eligibility criteria: Inclusion Criteria:

1. Meet age criteria of a specific cohort.
2. Confirmed clinical and biochemical diagnosis of Canavan disease.
3. Available medical records since birth that permit documentation of disease characteristics and developmental milestones.
4. Parent and/or legal guardian is able to read, understand, and sign the informed consent.

Exclusion Criteria:

1. Patient does not meet the Inclusion Criteria.

Primary outcomes:
measure: To characterize the natural history of Canavan disease
timeFrame: approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References:
Clinical trial NCT03327805: Short Term Choline and Cardiovascular Health
Official title: Short Term Choline Supplementation and Cardiovascular Health in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: Choline
Trimethylamine N-Oxide
Vascular health
Lead sponsor: Virginia Polytechnic Institute and State University
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blind, placebo-controlled, crossover design
Primary purpose: PREVENTION

Brief summary: Trimethylamine-N-oxide (TMAO), a metabolite produced by gut microbial metabolism of dietary choline, has recently been causally linked to atherosclerosis in animal models and has been shown to be predictive of cardiovascular disease (CVD) risk in some but not all cohort studies. The relevance of observations in animals to humans is unclear and little information is available on the mechanisms linking TMAO to increased CVD risk. Vascular dysfunction plays a critical role in the initiation and progression of atherothrombotic disease. Whether TMAO impairs vascular function in humans is not known. The purpose of this study is to determine if short term supplementation of dietary choline, which increase TMAO, impairs vascular function.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old, healthy, non-smoking weight stable for previous 6 months (±2.0 kg), BMI\<35 kg/m\^2, verbal and written informed consent, approved for participation by study medical director (Jose Rivero, M.D.)

Exclusion Criteria:

* Smoking, pregnancy, obese (BMI\>35 kg/m\^2), altered dietary patterns within the last month of recruitment, vegetarians, vegans, unstable heart disease or diabetes, untreated high blood pressure or high cholesterol, allergies to choline supplement, taking any medications that could affect the results (ex., aspirin, antibiotics, pre/probiotics 1 month prior to enrollment), those with trimethylaminuria

Primary outcomes:
measure: Change in brachial artery function after supplementation
timeFrame: 30-minute measurement in laboratory
Secondary outcomes:
measure: Change in arterial stiffness after supplementation
timeFrame: 45-minute measurement in laboratory
measure: Change in gut-mediated TMAO levels after supplementation
timeFrame: 5-minute measurement in laboratory
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Virginia Polytechnic and State University
state: Virginia
Study officials:
affiliation: Virginia Polytechnic Institute and State University
name: Kevin Davy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02105805: Weight Loss as Treatment in Heart Disease
Official title: Intentional Weight Loss as Treatment in Obese Patients With Ischaemic Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: intention weight loss
heart failure
6-minute walk test
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2014-04-07
Enrollment: 30
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: 30 obese moderate-to-severe heart failure patients will be randomized to intervention or control in groups of 5-10 subjects.

All will receive dietetic advice according to randomization and according to the European Heart Association.

Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d substituting two daily meals with formula meal replacement.

Control subjects are advised to follow the Nordic Nutrition Recommendations.

Patients will be monitored by blood sampling and assessed by change in physical performance.


Eligibility criteria: Inclusion Criteria:

* bmi \>30
* heart failure, moderate to severe, new york heart association II og III
* stable disease
* age \>18 years
* out-patients
* perform a six minutes walk test
* given consent

Exclusion Criteria:

* unstable disease
* insulin treated diabetes
* pregnancy or lactating
* unstable weight past 6 months (+- 10 kg)
* planned procedures in the time of intervention

Primary outcomes:
measure: Change in six minute walk test from baseline to week 16 (end of study)
timeFrame: weeks 0 and 16
Secondary outcomes:
measure: Change in lipid status from baseline to week 16 (end of study).
timeFrame: weeks 0,1,2,4,6,8,10,12,14,16
Other outcomes:
Locations:
Study officials:
References: