louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00680576: Adolescent Substance Abuse: Progressive Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance Abuse
Keywords: adolescent substance abuse
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2008-05-20
Enrollment: 140
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out more about how to provide effective further treatment for adolescents who have received six weeks of group therapy for substance-use problems and continue to use drugs. Treatments used in the study include a group therapy (MET/CBT), an individual therapy (CBT), and a family therapy (FFT). The study will look at whether abstinence or a very low level of use is a better guide for deciding whether further treatment is needed, how well different combinations of treatment work to reduce substance use, and whether it is possible to predict in advance which adolescents will respond best to which types of treatment. Study investigators expect that a treatment strategy using what is learned about these issues in the first half of the project to develop an "adaptive" treatment model will work better than a "fixed" treatment to reduce adolescent substance use.


Eligibility criteria: Inclusion Criteria:

1. 13 to 18 years if age
2. Meet DSM-IV (APA, 1994) diagnostic criteria for substance abuse or dependence
3. Live in the Albuquerque metropolitan area or surrounding communities
4. Sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake).

Exclusion Criteria:

1. There is evidence of psychotic or organic state of sufficient severity to interfere with the understanding of study instruments and procedures
2. The adolescent is deemed dangerous to self or others during evaluation
3. Services other than outpatient treatment are required for the adolescent (e.g., inpatient, detoxification)
4. Marijuana use is reported as being less than 13% of days in the previous 90 days.

Primary outcomes:
measure: Urine drug screens
timeFrame: Pretx, 6, 14 and 22 weeks, 3 and 6 months after initial treatment session
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Oregon Res. Inst. Center for Family & Adolescent Research (CFAR)
state: New Mexico
Study officials:
affiliation: Oregon Research Institute Center for Family and Adolescent Research (ORI/CFAR)
name: Holly B Waldron, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05621876: Evaluation of an IgG Deficiency Rapid Screening Test: A Performance Study With Primary Immunodeficiency (PID) Patients in Tunisia
Official title: Evaluation of an IgG Deficiency Rapid Screening Test (RDT) With Human Capillary Samples: A Protocol to Generate RDT Performance Data in Primary Immunodeficiency Patients (PID)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Primary Immunodeficiency Diseases
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Bill and Melinda Gates Foundation
name: Institut Pasteur de Tunis
name: Centre National de Greffe de Moelle Osseuse
First posted: 2022-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PID patients prior to receiving IV-Ig treatment infusions for the first time or during follow-up at the NBMT center in Tunis. The day of their monthly infusion, they are expected to have the lowest residual IgG level. These patients have previously been identified with AG, HAG, CVID and HIGM and this is why they are receiving IV-Ig therapy at NBMT. Patients will be 6 months of age or older and the patient or guardian must give consent for participation.

Brief summary: To evaluate the usability and utility of the device, % agreement between the PID-RDT and the referent assay (serum/plasma), and % agreement between capillary blood and venous blood samples using the PID-RDT within confirmed PID patients prior to receipt of their monthly IV-Ig treatment.


Eligibility criteria: Inclusion Criteria:

* Must be 6 months of age.
* The types of PID presenting for IV-Ig therapy will include Evaluation of PID RDT with human capillary blood (version 1.0) \| 8agammaglobulinemia (AG), hypogammaglobulinemia (HAG), common variable immunodeficiency (CVID), and hyper IgM syndrome (HIGM).

Exclusion Criteria:

-

Primary outcomes:
measure: To evaluateusability among end users of the PID rapid screening tests using capillary blood samples obtained from PID patients, prior to receipt of IV-Ig treatment.
timeFrame: 3 month
measure: To evaluate % agreement between the PID RDT(using capillary blood)and the referent test (serum/plasma).
timeFrame: 3 months
Secondary outcomes:
measure: To determinethe utility of the PID RDTwith PID patients.
timeFrame: 3 months
measure: To determine% agreement between capillary and venous blood samples using the PID RDT
timeFrame: 3 months
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: National Bone Marrow Transplant center
Study officials:
References:
Clinical trial NCT04350476: COVID-19 Remote Monitoring
Official title: Remote Monitoring in Patients With Coronavirus Disease (COVID-19)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Cardiac Arrhythmias
Keywords: COVID-19
Cardiac Arrhythmias
Atrial Fibrillation
Telemetry
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a non-randomized study. Based on clinical assessment, patients will be provided with the following home monitoring system: VitalConnect Vital Sign Patch (San Jose, California) This patch provides continuous real-time monitoring of cardiac telemetry, heart rate, respiratory rate and oxygen saturation. Duration of monitoring is typically up to 7 days.

This patch is applied to the upper left side of the chest wall, attached with a hypoallergenic adhesive material. (This device is FDA approved for this indication).
Primary purpose: SCREENING

Brief summary: The objective of the study is to assess the impact of remote cardiac and vital sign monitoring in patients with coronavirus disease (COVID-19) in the outpatient setting.

Detailed description: The objective of the study is to assess the impact of remote cardiac and vital sign monitoring in patients with coronavirus disease (COVID-19) in the outpatient setting. This study will enroll COVID-19 positive patients previously evaluated at Mount Sinai Hospital/Mount Sinai Health System (MSHS) and affiliated hospitals deemed appropriate for home monitoring. Patients will be monitored remotely in the outpatient setting for 1-3 weeks following diagnosis and/or treatment for COVID-19 at MSH/MSHS.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with coronavirus and determined to be eligible for home monitoring and self-care, and either

  1. Not admitted to the hospital, and permitted to recover at home
  2. Discharged from inpatient hospitalization, during the acute recovery period
* 18 years old or older with the ability to understand the requirements of the study and sign the informed consent form (or able to provide over-the-phone verbal consent).

Exclusion Criteria:

N/A

Primary outcomes:
measure: Number of different arrhythmias
timeFrame: 7-14 Days
measure: Temperature
timeFrame: 7-14 Days
measure: Oxygen Saturation
timeFrame: 7-14 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Y Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Martin Goldman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01961427: Dose and Response of Dietary Nitrate in Healthy and Active Men
Official title: Dose and Response of Dietary and Inorganic Nitrate in Healthy and Active Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: dietary nitrate
beetroot juice
exercise performance
oxygen consumption
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
Collaborators: name: University of Zurich
First posted: 2013-10-11
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: It was shown by some researchers that dietary nitrate such as beet root juice can lower oxygen consumption in men and act as a performance enhancing supplement.

It was not shown, what the optimal dosage is and if there is any difference in oxygen consumption comparing beet root juice and inorganic nitrate.

Therefore, the aim of the study is to conduct a study ingesting different sodium nitrate and beet root juice dosages. We would measure nitrate and nitrite concentrations in the blood at different time points and the subjects have to perform an exercise test measuring oxygen consumption 3 hours after the ingestion of nitrate.

Detailed description: 1. The subjects have to ingest 7 different dosages of either beetroot juice or sodium nitrate on seven different occasions. Every hour a blood withdrawal is taken to measure nitrate and nitrite concentration in the blood.
2. The subjects have to ingest 7 different dosages of either beetroot juice or sodium nitrate on seven different occasions. Three hours after the intake of the supplement the subjects have to perform an exercise test on a bicycle. They have to cycle 5 min at 50% of maximal oxygen consumption and 8min at 80% of maximal oxygen consumption separated by a 5min break. Oxygen consumption would be measured during the whole exercise test. Blood withdrawal is taken before the ingestion, after 3 hours and after the test.

Eligibility criteria: Inclusion Criteria:

* age 18 to 45
* healthy active men
* non-smoking

Exclusion Criteria:

* medication intake during study phase

Primary outcomes:
measure: oxygen consumption
timeFrame: 30min
Secondary outcomes:
measure: Blood pressure
timeFrame: 6 hours
measure: oxygen saturation
timeFrame: 6 hours
measure: Rating of perceived exertion (RPE)
timeFrame: during the 7 weeks of study phase
measure: Heart rate
timeFrame: during the 7 weeks of study phase
measure: Nitrate and nitrite concentration
timeFrame: 6 hours
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: Lucerne
Study officials:
affiliation: Sportmedizin Nottwil
name: Claudio Perret, Dr. sc. nat.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03760627: Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan
Official title: Evaluation of A Mindfulness Resiliency Training Program for Refugees Living in Jordan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Mental Health Wellness 1
War-Related Trauma
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 39
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a stepped wedge cluster randomized trial design. The design involves random and sequential crossover of clusters from control to intervention until all clusters are exposed. The controls from the previous session who were available for the parallel portion of the study, will later become the treatment group while another control group is recruited for them, which in turn will become an intervention group and so forth.
Primary purpose: SUPPORTIVE_CARE

Brief summary: To estimate the efficacy of a structured, scalable and replicable psychosocial intervention targeting refugees living in Jordan, Amman who have been forced to flee their homes due to regional conflicts.

Detailed description: The study is designed to examine the effects of the Mindfulness Resiliency Training Program (MRTP) conducted at Collateral Repair Project (CRP) on the resilience of refugees. The study group and the control group will be recruited from refugees currently residing in Amman, Jordan who are participating in the MRTP at CRP, an ongoing program independent of our study.

In order to assess the effect of the MRTP on participant resiliency, the three survey tools described above will be used:

1. the Strength and Difficulties Questionnaire (SDQ) as a measure of the individual's degree of traumatization and
2. the Child and Youth Resiliency Measure (CYRM-12) (for adolescents) or the Adult Resiliency Measure (ARM-12) (for adults) as a measure of resiliency

Eligibility criteria: Inclusion Criteria:

* Participants who will be recruited in the study are adult and adolescent (13-19 years) refugees, Syrian and non-Syrians, who are currently residing in Amman, Jordan who will be participating in the MRTP at CRP.

Exclusion Criteria:

* Jordanian refugees residing in Amman, Jordan.

Primary outcomes:
measure: Assess Mindfulness Resiliency Adolescents
timeFrame: 2 months
measure: Assess Mindfulness Resiliency Adolescents
timeFrame: 6 months
measure: Assess Mindfulness Resiliency Adults
timeFrame: 2 months
measure: Assess Mindfulness Resiliency Adults
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Collateral repair Project
Study officials:
affiliation: Yale University
name: Saquib Lakhani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Prachi Syngal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01359527: Dual Energy X-ray Absorptiometry (DXA) Comparison Hip Resurfacing Versus Total Hip Arthroplasty (THA)
Official title: A Dual Energy X-Ray Absorptiometry Comparison Of Periprosthetic Bone Loss Between Patients Undergoing Hip Resurfacing Surgery And Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Hip
Keywords: Total Hip Replacement
Hip Resurfacing
Femoral Remodeling
Bone Loss
Bone Mineral Density
BMD
DXA
DEXA
THA
Lead sponsor: Spokane Joint Replacement Center
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing hip replacement or resurfacing for osteoarthritis

Brief summary: This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement.

Detailed description: This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement. The goal is to evaluate the bone loss in the proximal femur resulting from hip resurfacing surgery and to compare this to the bone loss in the proximal femur resulting from total hip arthroplasty.

Eligibility criteria: Inclusion Criteria:

* Age of at least 20 years
* Osteoarthritis
* Elective Total Hip Arthroplasty / Resurfacing
* Signed Informed Consent

Exclusion Criteria:

* Osteoporosis
* Revisions
* Femoral dysplasia
* Trochanteric osteotomy
* Inflammatory arthritis
* Breast-feeding, pregnancy, or women of child-bearing potential without documentation of a negative pregnancy test and not utilizing contraception
* Patients with a history of having taken or currently taking PTH, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the Investigator's opinion are known to affect bone mineral density in a substantial way
* Patients with severe medical condition(s) that in the view of the Investigator prohibits participation in the study
* Use of any other investigational agent in the last 30 days

Primary outcomes:
measure: Bone Mineral Density
timeFrame: Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Secondary outcomes:
measure: Harris Hip Score
timeFrame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
affiliation: Spokane Joint Replacement Center
name: David Scott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03304327: Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)
Official title: Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion
Keywords: Yoga
Mindfulness
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 16
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to establish the tolerability of mindfulness and yoga therapy in the post-concussion period.

Detailed description: Athletes and patients aged 15 - 60 will receive standard sports concussion evaluations at the Duke Sports Science Institute (SSI) and will learn about the study by the primary clinicians evaluating sports concussion at the SSI. Subjects will receive yoga training either at their home or at the Center for Living Campus at Duke. Subjects will complete their yoga assignments for 5 consecutive days, along with a symptom checklist. On the 6th day, subjects will complete the symptom checklist and mail all checklists to the study team in a stamped envelope. We expect to enroll 20 subjects.

If a subject has significant worsening of their symptoms and wishes to discontinue the study, they are requested to contact the study PI, Joel Morgenlander, MD. At that time, Dr. Morgenlander will document the specific reasons for discontinuation of the protocol. All follow-up care for their concussion will be through the provider they are already seeing for concussion. There is no significant risk to the athlete for participation except possible transient increase in their concussion symptoms. Benefits include possible hastening of recovery from their concussive symptoms and receiving training in mindfulness and yoga from a certified yoga instructor.

Eligibility criteria: Inclusion Criteria:

* Injury sustained within 30 days of enrollment
* Being seen for concussion at the Sports Science Institute (SSI) at Duke University Medical Center
* living in a 30 mile radius of the SSI
* SCAT5 (Sport Concussion Assessment Tool 5) modified symptom checklist score of greater than 12

Primary outcomes:
measure: Tolerability of mindfulness yoga therapy in the post-concussion period as measured by a rating scale.
timeFrame: up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Joel Morgenlander
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04192227: Comparison of Two Group Wellness Interventions in TBI Partner Caregivers
Official title: Comparison of Two Group Wellness Interventions in Partner Caregivers of Individuals With Traumatic Brain Injury: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Partner Caregiver
Keywords: Spouse
Partner
Caregivers
Brain Injuries
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: Rehabilitation Hospital of Indiana
First posted: 2019-12-10
Enrollment: 90
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: The purpose of this research study is to compare the effect of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). The study is designed to evaluate how well these treatments can help TBI partner caregivers improve approach/avoidance behaviors.

Detailed description: A multi-site randomized controlled trial will be conducted to evaluate the effectiveness of two different types of group wellness interventions for partner caregivers of individuals with traumatic brain injury (TBI). 92 participants will be recruited. Participants are randomly assigned to one of two wellness groups. Each group will involve six weekly 75-minute live video conference sessions as well as independent homework assignments that will be discussed in closed social media forums with peers and facilitators. Participants will complete self-report measures (approach and avoidance, anxiety, depression, caregiver appraisal, resilience, self efficacy, social integration, quality of life.) prior to intervention participation, within a week of class 6, and at 3-months post-intervention.. Intervention effectiveness will be determined by improvements between baseline and follow-up on a self-report measure of approach/avoidance behaviors.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age.
* read and speak English fluently.
* have been in an intimate relationship with a person with TBI for at least one year prior to their injury.
* partner was discharged from inpatient rehabilitation at least 3 months ago.
* provide care to partner on a daily basis.
* have access to the internet in a private location.

Primary outcomes:
measure: Change on Behavioral Inhibition Scale (BIS)
timeFrame: 6 weeks (between pre- and post testing)
measure: Change on Behavioral Activation Scale (BAS)
timeFrame: 6 weeks (between pre- and post testing)
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Rehabilitation Hospital of Indiana
state: Indiana
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: