louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03668444: Mobile Support to Improve Recovery and Treatment Court Outcomes
Official title: Mobile Support to Improve Recovery and Treatment Court Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Use
Keywords: Text Messaging
Lead sponsor: Live Inspired, LLC
Sponsor class: INDUSTRY
Collaborators: name: The Miriam Hospital
First posted: 2018-09-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Control Trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will fully develop and implement an interactive text messaging intervention system for individuals sentenced to DTC. Upon completion of programming and testing of messages the investigators will enroll 40 participants and randomize participant to a control condition (TAU Group) or the intervention condition (TXS Group). Assessments will occur at enrollment, and day 30 follow up.

Detailed description: This study builds on pilot work in which Live Inspired LLC and research partners, have a history of collaboration in the development, revision, and evaluation of web-based and mobile phone technologies to promote behavior change. For this project the investigators will fully develop and implement an interactive text messaging intervention system for individuals sentenced to DTC who are entering the program, at which time participants are expected to begin addressing underlying issues related to their addiction, and during which time participants are highly vulnerable to relapse and noncompliance with mandated activities. Outcomes will include participation in and compliance with Court-mandated appointments, abstinence from drug use (measured by urine testing), participation in substance abuse treatment, participation in education/employment training programs, and participation in related programs and workshops as directed by the Court. Data will be collected directly from Court records using a database established by the participating courts for this study.

Eligibility criteria: Inclusion Criteria:

To be eligible, participants must be

1. Age \>18;
2. Newly enrolled in the drug court program \[within 1 month\];
3. Own a mobile phone and use text messaging;
4. have a phone plan that allows unlimited texting;
5. Agree to participate in the study protocol and be available for all assessments through the final 30-day assessment; and
6. Speak and read English.

Exclusion criteria:

We will exclude anyone who is not able to participate in the intervention or assessments (e.g., deaf, blind, or otherwise impaired and unable to participate in computerized assessment).

Primary outcomes:
measure: Feasibility as measured by study completion
timeFrame: 30 day
measure: Acceptability as measured by rating of text messages
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Miriam Hospital
name: Ernestine Jennings, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05925244: The Anabolic and Catabolic Effect of Loaded and Unloaded Exercise on Articular Cartilage Health
Official title: A Preliminary Study on the Effect of Loaded and Unloaded Exercise on Anabolic and Turnover Activity of Articular Cartilage in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: articular cartilage
walking exercise
sCOMP
PIIANP
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The serum concentration of cartilage oligomeric matrix protein (sCOMP) has been considered a mechano-sensitive biomarker of articular cartilage turnover, and N-propeptide of type II collagen (PIIANP) is a proposed biomarker of type II collagen synthesis. Few studies have investigated both the anabolic and turnover response of articular cartilage as a result of acute changes in body weight mass during exercise. Using a repeated measures cross-over design, fifteen healthy adults (age 18-30 years) performed three, 30-minute bouts of treadmill walking exercise under 3 loading conditions: (1) control (no alteration to body mass); (2) loaded (12% increase in body mass using a weighted vest); and (3) unloaded (12% decrease in body mass using lower body positive pressure). Venous blood was collected before, immediately after, and 15 and 30 minutes after exercise to investigate cartilage turnover (sCOMP) and anabolism (PIIANP).


Eligibility criteria: Inclusion Criteria:

* Healthy
* 18-30 years old

Exclusion Criteria:

* Traumatic injury to the lower extremity in the past year
* Hip, knee, or ankle surgery
* Radiographic evidence of joint degeneration
* Cardiovascular disease
* Ankylosing spondylitis
* Psoriatic arthritis
* Chronic reactive arthritis
* Renal problems requiring peritoneal dialysis or hemodialysis
* Not currently using any prescription or non-prescription medications and/or nutritional supplements

Primary outcomes:
measure: Serum cartilage oligomeric matrix protein (sCOMP)
timeFrame: sCOMP was measured at baseline, immediately post, and 15- and 30-minutes post exercise.
measure: N-propeptide of type II collagen (PIIANP)
timeFrame: PIIANP was measured at baseline, immediately post, and 15- and 30-minutes post exercise.
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Stephen M Cornish, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06430944: Comparative Study Between Single and Double Limb Hip Spica Cast in Fracture Femur in Young Children
Official title: Comparative Study Between Single and Double Limb Hip Spica Cast in Fracture Femur in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femur Fracture
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We performed a randomized control trial including 84 children aged two to six years who presented with femoral fractures. They were randomized into two groups; the first was managed by single limb cast fixation (42 patients), and the second was managed by double limb cast fixation (42 patients). The primary outcomes were postprocedural functional outcomes and parents' satisfaction, while the secondary outcomes were the rates of complications.

Detailed description: Femoral fractures are frequent in children and compose 1% to 2% of all pediatric fractures. Conservative management is associated with good results, whether by single or double-limb cast fixations. We aim to compare both procedures regarding functional outcomes, complications, and parents' satisfaction. Eighty-four children were eligible to be included in our study; 42 underwent single limb spica casts, and the other 42 patients underwent double limb spica casts. Both groups had similar baseline characteristics like age, gender, fracture side, and fracture classification.

Eligibility criteria: Inclusion Criteria:

* children aged 2 to 6 years
* Children with femur shaft fractures

Exclusion Criteria:

* Children younger than 2 years or older than 6 years
* Articular fractures or fractures that cant be managed with a cast
* Old fractures older than 3 weeks

Primary outcomes:
measure: Flynn's score
timeFrame: 6 months
Secondary outcomes:
measure: loss of reduction
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Al Ainy-Cairo University- Faculty of Medicine
state: Manial
Study officials:
References:
Clinical trial NCT01165944: Effectiveness Study of Pramlintide to Treat Post-Transplant Diabetes Mellitus
Official title: Effectiveness of Pramlintide on Control of Post-Transplant Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus
Keywords: Post transplant diabetes mellitus
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Amylin Pharmaceuticals, LLC.
First posted: 2010-07-20
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Post-transplant diabetes mellitus (PTDM) develops in up to 30% of patients undergoing solid organ transplantation. This disease is difficult to treat as the levels of glycemia fluctuate in response to variations in doses of steroid and other immunosuppressive agents. At the same time, poorly controlled hyperglycemia affects negatively graft function and survival as well as on the ability of the immunocompromised host to fight infections. The investigators hypothesize that the addition of Pramlintide (Symlin) to the management of patients with PTDM would help patients with post-transplant diabetes attain better control at the critical time of titration of immunosuppressive regimens. The primary objective of this proposal is to improve glycemic control of diabetes with Pramlintide in patients with post-transplant diabetes at 3 and 6 months of therapy.


Eligibility criteria: Inclusion Criteria:

* Post-transplant diabetes (PTMD)
* Aged 20-70
* Diagnosis of diabetes within the last 6-18 months
* Stable medications
* Stable weight for 3 months
* Serum creatinine \< 1.5 mg/dL

Exclusion Criteria:

* Pre-transplant diabetes
* Major postoperative complications following transplant
* Pregnancy
* Significant GI discomfort with nausea or vomiting
* Inability to learn continuous glucose monitoring
* Development of diabetes more than 4 years after transplant
* omen of child-bearing potential who use birth control pills and have fasting triglycerides of \> 400 mg/dL

Primary outcomes:
measure: HgA1c
timeFrame: 6 months
Secondary outcomes:
measure: Continuous glucose monitoring
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Boris Draznin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01288144: Clinical Decision Support for Women With a History of Gestational Diabetes
Official title: Clinical Decision Support for Women With a History of Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus
Keywords: Screening
Gestational diabetes mellitus
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2011-02-02
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The investigators hypothesize that computer-assisted decision support will increase the percentage of women with a history of gestational diabetes who receive appropriate follow-up screening.

Specific Aim 1: Develop an algorithm to identify cases of gestational diabetes among patients in the Partners Health Care system using administrative and laboratory data.

Specific Aim 2: Assess primary care provider knowledge, attitudes, beliefs, and barriers to compliance regarding screening guidelines for women with a history of gestational diabetes.

Specific Aim 3: Test whether a computer-assisted decision support tool to identify patients with a GDM history and prompt screening will increase compliance with guidelines. The investigators hypothesize that decision support will significantly increase in the percentage of women screened.

Detailed description: Approximately 5 percent of women are diagnosed with gestational diabetes (GDM) during pregnancy. These women face an increased risk of progression to type 2 diabetes1 and may benefit from lifestyle interventions and screening to detect early disease. However, studies have shown that less than half of women are screened appropriately in the postpartum period. This performance gap may reflect both lack of communication between obstetric and primary care providers and lack of knowledge of appropriate screening guidelines. The investigators plan to assess a quality improvement initiative, using administrative and clinical data, to identify women with a history of GDM and implement decision support to enhance quality of care.

Eligibility criteria: Inclusion:

* Primary care clinic (gynecology, internal medicine, community health center)
* Use longitudinal medical record (LMR) program for documentation
* Previously participated in rct of decision support intervention

Exclusion:

* None

Primary outcomes:
measure: Rate of screening
timeFrame: 1 year following implementation at all sites (Nov. 2011)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zera CA, Bates DW, Stuebe AM, Ecker JL, Seely EW. Diabetes Screening Reminder for Women With Prior Gestational Diabetes: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):109-14. doi: 10.1097/AOG.0000000000000883.
Clinical trial NCT01717092: Epidemiological Study of Chronic Thromboembolic Pulmonary Hypertension in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: To Assess the Long-term Risk for Adverse Events After PE.
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2012-10-30
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism.

Brief summary: Chronic thromboembolic pulmonary hypertension (CTPH) is associated with considerable morbidity and mortality. Its incidence after pulmonary embolism and associated risk factors are not well documented in Chinese population. We conducted a prospective, long-term, follow-up study to assess the incidence of symptomatic CTPH in consecutive patients with an acute episode of pulmonary embolism but without prior venous thromboembolism. Patients with unexplained persistent dyspnea during follow-up underwent transthoracic echocardiography and, if supportive findings were present, ventilation-perfusion lung scanning and pulmonary angiography. CTPH was considered to be present if systolic and mean pulmonary-artery pressures exceeded 40 mm Hg and 25 mm Hg, respectively; pulmonary-capillary wedge pressure was normal; and there was angiographic evidence of disease.


Eligibility criteria: Inclusion Criteria:

* Patients with an episode of acute symptomatic pulmonary embolism without prior pulmonary embolism or venous thrombosis

Exclusion Criteria:

* Have other diseases (e.g., systemic sclerosis or severe emphysema) that could have caused nonthromboembolic pulmonary hypertension,
* Have preexisting exertional dyspnea,
* Geographically inaccessible for follow-up,
* Decline to participate in the study.

Primary outcomes:
measure: The cumulative incidence of symptomatic CTEPH
timeFrame: 2 years
Secondary outcomes:
measure: Risk factors for Recurrent VTE and CTEPH
timeFrame: 2 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu hospital
state: Shaanxi
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT03234192: Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.
Official title: A Randomized Clinical Controlled Study Comparing the Effectiveness of the Astym Technique, the Graston Technique, and Therapeutic Ultrasound in the Treatment of Lateral Epicondylosis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lateral Epicondylitis
Tennis Elbow
Posterolateral Rotator Instability
Keywords: extensor carpi radialis brevis
Therapeutic Ultrasound
Astym Treatment Technique
Graston Treatment Technique
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of three common techniques for the treatment of lateral epicondylosis. Through objective and subjective assessments this study will determine the effectiveness of the Astym Treatment Technique, the Graston Treatment Technique, and therapeutic ultrasound in the conservative treatment of lateral epicondylosis. It is hypothesized that the more manual Astym technique and Graston technique will produce more significant results than the more frequently utilized ultrasound.


Eligibility criteria: Inclusion Criteria:

* Clients who are admitted to NYULMC Center for Musculoskeletal Care for outpatient occupational or physical therapy with a diagnosis of lateral epicondylosis will be included. To participate in the study participants must:
* Be able to follow a home exercise program
* Be able to consent to participation in the research study

Exclusion Criteria:

* Clients who are deemed unable to consent to participation in the research study and/or unable to following a home exercise program will not be included in this study
* Clients with additional acute orthopedic injuries and/or surgeries to the involved upper extremity will not be included in this study.
* Clients with open wounds of the involved upper extremity that will interfere with treatment techniques will not be involved in this study.

Primary outcomes:
measure: Patient Rated Tennis Elbow Evaluation (PRTEE)
timeFrame: 30 Minutes
measure: QuickDASH
timeFrame: 30 Minutes
Secondary outcomes:
measure: EQ-5D-5L
timeFrame: 30 Minutes
measure: Range of motion
timeFrame: 30 Minutes
measure: Grip strength
timeFrame: 30 Minutes
measure: Numeric Rating Scale for Pain
timeFrame: 30 Minutes
measure: Cozens Test
timeFrame: 30 Minutes
measure: Mills Test
timeFrame: 30 Minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Steve Vanlew, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04587492: Metabolomics of Children With SMA
Official title: Metabolome of Children With Spinal Muscular Atrophy Treated With Nusinersen
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Muscular Atrophy
Keywords: Spinal Muscular Atrophy, nusinersen, metabolome
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 35
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with genetically diagnosed SMA

Brief summary: The aim of the proposed project is to evaluate whether the metabolome of patients with spinal muscular atrophy (SMA) before the initiation of treatment with nusinersen differs from the metabolome of healthy individuals and whether it changes 14 months after treatment with nusinersen.

Detailed description: Spinal muscular atrophy (SMA) is a severe, debilitating disease and is an important source of morbidity and mortality of children. Novel disease modifying therapies can alter the natural course of the disease. However, many aspects of their action remain unknown. Metabolomics is the large-scale study of metabolites, within cells, biofluids, tissues or organisms. Collectively, these small molecules and their interactions within a biological system are known as the metabolome.

The aim of this study is to evaluate whether the metabolome of patients with SMA before the initiation of disease modifying therapy with nusinersen differs from the metabolome of healthy individuals. Next, we would like to asses whether tretament with nusinersen alters the metabolome of patients with SMA. Utilizing metabolomics, we would like to assess whether we can identify parameters reflecting the state of the disease in a particular patient, and parameters with diagnostic and/or prognostic value. Using metabolomics, we will aim to identify SMA patients that will positively respond to gene therapy.

Eligibility criteria: Inclusion Criteria:

* Genetically confirmed SMA
* Age up to 21 years

Exclusion Criteria:

* None

Primary outcomes:
measure: Metabolomic difference from healthy children
timeFrame: Beginning of study
measure: Metabolomic change before and after treatment
timeFrame: At least 14 months of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Biotechnical faculty
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
References: