louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02218021: A Study of the Abuse Liability Potential of Samidorphan in Healthy, Non-Dependent, Recreational Opioid Users
Official title: A Randomized, Double-Blind, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Abuse Potential and Safety of Orally Administered Samidorphan in Non-Dependent Recreational Opioid Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Alkermes
ALKS 33
ALKS 5461
Samidorphan
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-15
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the abuse potential and safety of samidorphan in healthy, non-dependent, adult, recreational opioid users.


Eligibility criteria: Inclusion Criteria:

* Be in good general physical health
* Body mass index of 18-34 kg/m2, inclusive with minimum weight of 50 kg
* Recreational opioid use experience for non-therapeutic purposes (at \>/= 10 times in lifetime and \>/= 1 in previous 3 months
* Agree to use an approved method of birth control for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Currently pregnant or breastfeeding
* History of or current infection with hepatitis B virus, hepatitis C virus or HIV
* Current or history of any clinically significant medical or psychiatric condition
* Current or history of in the last 2 years of dependence on alcohol or any illicit drugs
* Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
* Have a history of intolerance or hypersensitivity to opioid antagonists, opioid agonists or related drugs (eg, naltrexone, naloxone, oxycodone, morphine)
* Additional criteria may apply

Primary outcomes:
measure: Pharmacodynamics: Abuse potential measured by visual analog scales (VAS)
timeFrame: Approximately 4 weeks
Secondary outcomes:
measure: Safety: Incidence of adverse events (AEs)
timeFrame: Approximately 5.5 weeks
measure: Pharmacokinetics: Plasma concentrations of samidorphan and metabolite
timeFrame: Approximately 4 weeks
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Alkermes Investigational Site
state: Kansas
Study officials:
affiliation: Alkermes, Inc.
name: Sanjeev Pathak, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03813121: The Effects of Sedatives on Tobacco Use Disorder
Official title: The Effects of Sedatives on Tobacco Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Tobacco Use Disorder
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This proposal will obtain preliminary data on the effect of a single sub-anesthetic dose of a sedative on cigarette craving and smoking behavior as well as measuring tolerability and acceptability.


Eligibility criteria: Inclusion Criteria:

* smoke at least 5 cigarettes per day
* smoked at least 2 years
* negative urine drug screen for psychoactive drugs and negative breath alcohol concentration
* live in Little Rock AR or surrounding area

Exclusion Criteria:

* unstable or stable medical condition that would interact with study medication or participation
* serious head trauma or neurological disorder
* hypertension, abnormal ECG or metabolic blood results
* meet criteria for psychosis, schizophrenia, major depressive disorder, or bipolar disorder
* use of psychoactive drugs or medications
* BMI \> 40
* among women, pregnancy or breastfeeding

Primary outcomes:
measure: Side Effects
timeFrame: about 1 week post infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Merideth Addicott, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02121821: Impact Evaluation of the Pilot SMS Mother Reminder System
Official title: Impact Evaluation of the Pilot SMS Mother Reminder System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Effects of the SMS Mother Reminder System on Use of Health Care.
Lead sponsor: African Strategies for Health
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2014-04-24
Enrollment: 11454
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aims to assess the effects of the SMS Mother Reminder system on use of health care in Uganda. A secondary aim of the study is to determine the behavioral factors and cost-effectiveness, as well as test the usability of the SMS Mother Reminder in Uganda.

Detailed description: USAID/Uganda is commissioning a prospective impact evaluation of the initial SMS component of Uganda's National Health Record Program (NHRP) in order to inform strategic targeting of eHealth and future investments after the pilot phase of the NHRP mobile platform "SMS Mother Reminder". This impact evaluation will be designed to answer the following questions:

Primary evaluation question:

• What is the effect on maternal health outcomes (ANC4 and IPTP2) of the village health teams' use of the SMS Mother Reminder system?

Secondary evaluation questions:

* What factors most influence changes in health workers, village health teams and expectant women's knowledge, attitudes and practices in maternal health?
* To what extent is using the SMS Mother Reminder application to track and inform pregnant women a cost-effective intervention from the perspectives of USAID?
* To what extent can users easily carry out specific tasks (e.g. entering the information of pregnant women) of the SMS Mother Reminder application on mobile devices?

This study is funded by USAID through the African Strategies for Health project.

Eligibility criteria: Inclusion Criteria:

* Pregnant

Exclusion Criteria:

-

Primary outcomes:
measure: ANC visits
timeFrame: 1 year
measure: SP doses
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gulu
country: Uganda
facility: Gulu District Health Centers
Study officials:
affiliation: Brandeis University
name: Donald Shepard, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03596021: The Turkish Validity and Reliability of "Toe Walking Scale" in Children With Idiopathic Toe Walking
Official title: Turkish Version of "Toe Walking Scale"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise
Rehabilitation
Reliability
Validity
Keywords: exercise
toe walking
scale
reliability
validity
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: diagnosed with toe walking by the pediatric neurologist and conducted to us.

Brief summary: In clinics, many scales have been developed to examine daily living activities and function in children with idiopatic toe walking. "The Idiopatic Toe Walking (ITW)" was developed in 2010 by Cylie M.Williams, contains 21 items which measure medical, birth \& developmental history and assessment. The aim of the investigator's study was to investigate translating the ITW scale and using it in clinics reliably and valiably with a Turkish version of ITW in children with idiopatic toe walking.

Detailed description: Demographic information was recorded which are included gender, age, using orthosis, botox/surgical history, use and duration of walkers/child-runner (WCR). The scale was translated into Turkish with the following translation steps. Thirty four children with idiopatic toe walking were included in the study. Internal structure consistency and test-retest reliability were measured for reliability analyses. For each item on the scale, Cronbach's alpha coefficient and item-total score correlations were calculated. The scale was administered for test-retest reliability at baseline and one week later by one rater. Test-retest reliability was assessed by Pearson's correlation test with observational gait analysis and 'co-validity' was investigated, statistically.

Eligibility criteria: Inclusion Criteria:

* older than 3 years
* without neurologic, orthopethic or psychiatric illnesses
* still walking on toe

Exclusion Criteria:

* absence of any known medical conditions
* no voluntary to participate
* older than 18 years or younger than 3 years

Primary outcomes:
measure: TOE WALKING SCALE
timeFrame: First: May 2018 Last: one weeks later
Secondary outcomes:
measure: Observational gait analysis
timeFrame: First: May 2018 Last: one weeks later
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Müberra Tanrıverdi
Study officials:
affiliation: Bezmialem Vakif University
name: Akın İşcan, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT00716521: Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers
Official title: Subject- And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 3-Way Crossover Study To Study Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Methodology Study
Keywords: mobile actigraphy inpatient polysomnography actigraphy ambien
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the feasibility of conducting sleep studies in a clinical research unit environment. In addition, the sensitivity of polysomnography and mobile actigraphy technologies will be compared for evaluating sleep stages and sleep architecture.


Eligibility criteria: Inclusion Criteria:

* Age 18-55
* BMI 18-30 kg/m2
* body weight \> 50 kg

Exclusion Criteria:

* no history of sleep disorder
* no concurrent medications
* no alcohol use
* no medical issues
* no smoking

Primary outcomes:
measure: onset to persistent sleep
timeFrame: minutes
Secondary outcomes:
measure: awakenings after sleep onset
timeFrame: minutes
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03181321: The First Twenty for Volunteer Firefighters
Official title: The First Twenty for Volunteer Firefighters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cardiovascular Diseases
Occupational Injuries
Keywords: nutrition
fitness
cardiovascular disease
firefighters
obesity
injury
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Development and Research Institutes, Inc.
First posted: 2017-06-08
Enrollment: 419
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The investigators will conduct a 6 month, two-arm, CRCT: TF20 vs. Control (which will receive delayed treatment after 6 months). Eligible fire departments volunteering for the trial will be randomized to one of the two study treatment arms. Treatment outcomes will be assessed at baseline and 6 months by our staff.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the efficacy of an internet-based firefighter health and wellness program for volunteer fire departments.

Detailed description: A national sample of volunteer fire departments will be recruited for a 6 month, CRCT with a cross-over treatment design to determine the efficacy of The First Twenty (TF20), a wellness program focused on nutrition and fitness for firefighters. Modifications to the existing TF20 will be made to enhance the health coaching features and include tools for program evaluation. Study outcomes (changes in weight, BMI, body fat percentage, waist circumference, dietary intakes, blood pressure, and fitness activities) will be assessed pre- and post-intervention.

This will be the first internet-based, occupationally tailored health and wellness program implemented for the volunteer fire service. TF20 will be an essential cost effective tool to address the epidemic of unhealthy body composition, nutrition and fitness among firefighters.

Eligibility criteria: Inclusion Criteria:

* first responder within a participating fire department
* willing to complete all assessments
* internet accessibility through a computer, tablet or smartphone and ability to use devices appropriately

Exclusion Criteria:

- not a first responder within a participating fire department

Primary outcomes:
measure: Change in Body Mass Index (BMI)
timeFrame: baseline, 6 months
measure: Change in Body Fat Percentage
timeFrame: baseline, 6 months
measure: Change in Waist Circumference
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Change in Food and nutrient intake as assessed by the Food Frequency Questionnaire (FFQ)
timeFrame: baseline, 6 months
measure: Change in self reported physical activity and inactivity
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Rena S Day, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05934721: Relationship Between Rheumatoid Arthritis Severity and Cognition in the Elderly: The Role of Nociplastic Pain
Official title: The Mediating Effect of Nociplastic Pain on the Relationship Between Rheumatoid Arthritis Severity and Cognition in Geriatric Patients: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Rheumatic Diseases
Rheumatoid Polyarthritis
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community-dwelling adults aged 65-90 years with a diagnosis of RA for 10-30 years who meet the ACR/EULAR 2010 classification criteria.

Brief summary: this study aims to determine if nociplastic pain mediates the relationship between rheumatoid arthritis (RA) severity and cognitive impairment in geriatric patients 100 patients aged 65-90 years with long-standing RA and assess their disease severity, cognition, and pain sensitization will be recruited. Expectations that patients with more severe RA will have worse cognitive function, and that this relationship will be mediated by higher levels of nociplastic pain.


Eligibility criteria: Inclusion Criteria:

* Age 65-90 years
* diagnosed with RA for 10-30 years
* meet ACR/EULAR 2010 criteria

Exclusion Criteria:

* Other inflammatory arthritides
* dementia
* severe depression
* recent corticosteroid or immunosuppressant use

Primary outcomes:
measure: Cognitive function as measured by the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline
measure: Centralized pain as measured by the Central Sensitization Inventory (CSI)
timeFrame: Baseline
measure: RA disease severity as measured by the Physician Global Assessment (0-10 VAS)
timeFrame: Baseline
Secondary outcomes:
measure: 28-joint swollen/tender joint count
timeFrame: Baseline
measure: Patient Global Assessment (0-10 VAS)
timeFrame: Baseline
measure: Inflammatory markers (ESR)
timeFrame: Baseline
measure: Inflammatory markers (CRP)
timeFrame: Baseline
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References:
Clinical trial NCT02523521: Impact of an Exercise Program for Children Aged 4 to 6 Years With Bronchopulmonary Dysplasia
Official title: Impacte d'un Programa d'Exercici Per Nens d'Entre 4 a 6 Anys Amb Displàsia Broncopulmonar
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Healthy
Lead sponsor: Hospital de Nens de Barcelona
Sponsor class: OTHER
First posted: 2015-08-14
Enrollment: 52
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the effects of a physical activity program for children with Bronchopulmonary Dysplasia.

Detailed description: Primary objectives is: to compare exercise tolerance and aerobic capacity between healthy children with Bronchopulmonary Dysplasia children Only Bronchopulmonary Dysplasia children will realise the physical activity program.

Secondary objectives are: to analyse lung function and to evaluate flexibility.

Eligibility criteria: Bronchopulmonary Dysplasia Children

Inclusion Criteria:

* age between 4 to 6 years old
* Bronchopulmonary Dysplasia diagnostic
* ex-prematurity
* accept to participate.

Exclusion Criteria:

* congenital malformations
* neuromuscular disorders
* gait alterations
* difficulties for communication and understanding
* wheezing or pulmonary disease two weeks before to start the program
* hemodynamic changes (heart rate \> 130bpm, systolic blood pressure \> 130bpm, diastolic blood pressure \> 80bpm).
* heart and/or lung transplantation.

Healthy children Criteria:

Inclusion Criteria:

* age between 4 to 6 years old.

Exclusion Criteria:

* antecedents of pulmonary or cardiac chronic disease
* congenital malformations
* neuromuscular disorders
* gait alterations
* difficulties for communication and understanding
* wheezing or pulmonary disease two weeks before to start the program
* hemodynamic changes (heart rate \> 130bpm, systolic blood pressure \> 130bpm, diastolic blood pressure \> 80bpm).
* heart and/or lung transplantation.

Primary outcomes:
measure: effort tolerance measured by six minute walking test
timeFrame: six minutes
measure: aerobic capacity measured by shuttle run test
timeFrame: 15 minutes
Secondary outcomes:
measure: lung function measured by spirometry
timeFrame: 5 minutes
measure: flexibility measured by sit and reach test
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de Nens
Study officials:
affiliation: Hospital de Nens de Barcelona
name: Natalia Morales
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00873821: A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED)
Official title: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-04-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo in subjects with type 2 diabetes who have inadequate control on metformin.


Eligibility criteria: Inclusion Criteria:

* Subject has a BMI \< 42 kg/m2
* Subject is taking \>1500 mg metformin per day for at least 8 weeks
* Subject has HbA1c value of 7.0% and \< 11% at screening
* Subject is willing to follow AHA weight maintaining diet and exercise program
* Subject is a nonsmoker for at least 6 months

Exclusion Criteria:

* Subject has type 1 diabetes
* Subject has a history of stroke or chronic seizure
* Subject has a history of neoplastic disease
* Subject has a history of gastrointestinal, cardiovascular, blood, liver kidney, respiratory, immunological or genitourinary disorders or diseases
* Subject is currently taking 2 or more diabetes medications
* Subject has glaucoma or is blind
* If female, subject is pregnant or breastfeeding
* Subject consumes \> 3 alcoholic beverages per day
* Subject has had major surgery or has donated blood in the last 4 weeks

Primary outcomes:
measure: Number of Participants With Any Clinical Adverse Experience
timeFrame: 2 months
measure: Number of Participants With Any Laboratory Adverse Experience
timeFrame: 2 months
measure: Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration
timeFrame: Baseline (predose Day 1) to Day 13
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: