bioihbjkbjnl/mcl2 huggingface dataset:
Tiagabine, Sertraline, or Donepezil for the Treatment of Cocaine Dependence - 9
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this CREST (Clinical Rapid Evaluation Screening Trial) study is the use of
      tiagabine, sertraline, or donepezil for the treatment of cocaine dependence using a modified
      placebo-controlled experimental design.
    

Detailed description: 
      Considerable progress in preclinical research has provided a basis for hypothesis driven
      clinical trials in cocaine dependence. A greater mechanistic understanding of both cocaine
      and many clinically approved medications has led to the identification of many promising
      medications for the treatment of cocaine dependence.

      For this reason NIDA has developed a CREST (Clinical Rapid Evaluation Screening Trial)
      protocol to provide a needed incremental medication screening step between preclinical
      research and full blown expensive Phase III pivotal trials. While patients receive manual
      based psychotherapy, three medications are screened compared to unmatched placebo in an
      eight-week, 80-subject, four cell design trial. Other important features of the CREST
      protocol include collecting baseline measurements over a two week period and analyzing
      primary outcome measures (quantitative urine toxicology and clinical global improvement
      scales) in terms of a composite score of overall individual patient improvement.

      The three medications being evaluated in this trial include tiagabine, sertraline, and
      donepzil. Tiagabine is hypothesized to interfere with glutamatergic cocaine mechanisms
      relevant to addiction. Sertraline is a potent and selective inhibitor of neuronal 5-HT
      reuptake, which may modulate the reinforcing and cueing effects of cocaine. Donepezil is
      hypothesized to interfere with cholinergic cocaine mechanisms relevant to addiction.
    

Intervention name(s): Sertraline
Intervention type(s): Drug
Intervention MeSH terms: Sertraline
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: cocaine dependence
Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution
Condition: Postmenopause
Study type: Interventional
Phase: Phase 1

Summary: 
      This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also
      called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA).

      About 24 subjects will take part in this study. Each subject's participation in this study
      will last for about 10 weeks. During this study, each subject will receive 3 different types
      of BZA/CE tablets plus an oral solution containing only BZA. The purpose of this study is to
      learn how the tablet dosage forms dissolve and are absorbed by the body compared to the BZA
      oral solution. In addition, information will also be learned about the safety and
      tolerability of these dosage forms given to healthy postmenopausal women.
    


Intervention name(s): bazedoxifene/conjugated estrogens combination tablet
Intervention type(s): Drug
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Keywords: Health
Comparison of Mini Squat and Endurance Training in Improving Quality of Life in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Interventional type of study in which one group of participants will be given mini squats
      training and other endurance training to improve the quality of life of knee osteoarthritis
      patients.
    

Detailed description: 
      Interventional type of study in which one group of participants will be given mini squats
      training and other endurance training to improve the quality of life of knee osteoarthritis
      patients. 3 sessions per week for 4 weeks along with interferential therapy
    

Intervention name(s): Mini Squats Training; Endurance Training
Intervention type(s): Other; Other
Intervention description(s): Mini Squats at a rate of ten squats at minimum range around 10-15 degrees at start along with Interferential Therapy for 10 minutes.; Endurance training by the use of medium resistance therapeutic band at start along with Interferential Therapy for 10 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind Randomized control trial
Masking: Single (Participant)
Primary purpose: Treatment
Image and Model Based Analysis of Lung Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this research study is to develop CT scanning and image analysis techniques to
      help define and measure several key properties of the pulmonary system that cannot be
      obtained by other tests or exams.
    

Detailed description: 
      Specifically, the investigators are interested in understanding the difference between the
      normal aging process and the events that lead to emphysema. Additionally, the investigators
      are interested in understanding the earliest signs (lung inflammation) of the disease process
      leading to three lung diseases, which include emphysema, fibrosis and sarcoidosis; all of
      which are described as "inflammatory lung diseases." The investigators will be using the data
      from this study to help define the normal values for the measured properties as well as
      deviation from normal values in smokers without defined lung disease and patients with
      inflammatory lung disease. The investigators believe that the analysis and scanning
      techniques being developed as part of this research will provide new and previously
      unavailable information on normal and diseased lungs so that ultimately the investigators can
      detect specific changes in the lungs due to a disease and measure any improvements in the
      anatomy and/or function of the pulmonary system after a patient has undergone treatment. This
      study involves research using X-Ray computed tomography (CT) scanner, which is similar to
      previous CT scanners but operates much faster and provides finer image detail.
    

Intervention name(s): Pulmonary Function Test; CT Scans; Questionnaires; MRI; Xenon gas
Intervention type(s): Diagnostic Test; Diagnostic Test; Behavioral; Diagnostic Test; Biological
Intervention description(s): Spirometry, Diffusing Capacity of the Lungs (DLCO), Lung Volumes; volume scans, perfusion scan, ventilation scan; Human Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire; proton scans, hyperpolarized 3-Helium scan; ventilation CT scans
Intervention MeSH terms: Xenon
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Is the Walking Velocity an Efficient Outcome of Rehabilitation Program in Non- Specific Low Back Pain Patient
Condition: Non-specific Low Back Pain; Functional Capacities
MeSH terms: Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Despite the prevalence of chronic low back pain, functional symptomatology of this disease
      remains poor and treatment decisions are based mainly on subjective data (importance and pain
      tolerance). However, there are some experimental elements that involve objective assessment
      of locomotor capabilities - at forefront objectives which the walking velocity in the
      evaluation of this pathology in terms of severity of functional impairment. Recent evidence
      suggest the effectiveness of physical rehabilitation program for improving patients
      functional capacities and their reintegration in socio-professional life. This retrospective
      study aims to quantify the evolution of the parameters collected during standardized walking
      tests performed before and after rehabilitation program. These patients have systematically
      carry out a comfortable walk test (400m walk test) and a brisk walk test (200m) at the
      beginning and end of their program. Furthermore, a maximal stress test on a treadmill was
      performed before the program in order to detect any cardiovascular events and to allow the
      personalization of the effort level required (target heart rate) during rehabilitation. In
      this study the evolution of the comfortable and fast speed will be collected and compared
      with the stress test data, and other measured parameters (functional score of Quebec, muscle
      Tests Shirado and Sorensen).
    


Intervention name(s): Physical Rehabilitation program
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Non-specific low back pain patients included for rehabilitation program
Association of Genes to Resistance to Weight Loss in Obese Patients
Condition: Obesity; Metabolic Syndrome; Dyslipidemia
MeSH terms: Obesity; Metabolic Syndrome; Dyslipidemias; Syndrome; Weight Loss
Study type: Observational

Summary: 
      The overall goal of this study is to determine whether variations in the perilipin, and
      several other, genes would be a useful tool for physicians who are caring for morbidly obese
      patients to guide therapy.

      The main hypotheses to be tested is that sequence variations (polymorphisms) in the perilipin
      gene and several other obesity-related genes are associated with resistance to weight loss
      for obese individuals on energy restricted diets, potentially playing a role in the
      development of obesity related complications.
    

Detailed description: 
      The PRIMARY goal of this study is to investigate the association of perilipin gene
      polymorphisms, with obese subjects who are "resistant" to weight loss in a defined program.

      The SECONDARY goal of this study is to investigate if additional candidate obesity genes that
      have previously been associated with obesity or energy metabolism show association with
      resistance to weight loss in subjects on an energy restricted diet. Additionally, we would
      like to investigate if any metabolic syndrome parameters, such as dyslipidemia or abnormal
      fasting glucose are associated with perilipin or variations in other obesity-related genes.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Caucasian adults between the age of 21 and 70 years, inclusive, who fit the criteria for
        patients undergoing bariatric surgery at the Geisinger Clinic.
      
Biospecimen description: 
      DNA to be analyzed by genotyping
    
Keywords: obesity; genes; polymorphisms; weight loss; haplotype; diplotype
Evaluation of the Trabecular Metal™ Revision Hip Cup Using Bone Mineral Density (DEXA)
Condition: Revision, Joint
Study type: Interventional

Summary: 
      In 1997, the FDA approved the use of Trabecular Metal™ (Zimmer, Trabecular Metal Technology,
      Inc., Parsippany, NJ) for acetabular cups, a porous tantalum structural biomaterial that was
      developed to address the limitations of other implant materials, with the potential to
      improve implant fixation.

      Porous tantalum (80% porosity) offers potentially greater ingrowth and bone graft
      incorporation, believed to be restricted by the low porosity of other commonly used implants
      (30%). Additionally, the low modulus of elasticity property (3 MPa) of porous tantalum
      provides more normal physiological loading conditions which theoretically reduce stress
      shielding and resultant bone loss surrounding the implant. These properties are much desired
      advantages for implants used in cementless THA.

      Various porous tantalum implants have shown favorable clinical results. Unger et al. reported
      excellent bone graft incorporation of the acetabular component based on serial radiograph
      data at a minimum 1-year follow-up.

      Dual-energy X-ray absorptiometry (DEXA) is a well-established method for detecting
      periprosthetic bone mass changes around the femoral and acetabular THA components.

      The primary objective of this study is to quantify and compare periprosthetic bone mineral
      density (BMD) changes in THA revision patients receiving Trabecular Metal™ and metal-backed
      acetabular components, measured using DEXA scanning techniques. Additionally, this study will
      analyze and compare clinical outcomes of these patients, based on SF-12v2 and HOOS.
    

Detailed description: 
      none provided.
    

Intervention name(s): Trabecular Metal Revision Cup; Trabecular Metal Modular Cup
Intervention type(s): Device; Device
Intervention description(s): Revision of the acetabular cup; Revision of the acetabular cup
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: revision total hip arthroplasty; bone mineral density; trabecular metal; DEXA
Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis
Condition: Spasticity; Multiple Sclerosis
MeSH terms: Muscle Spasticity; Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled,
      parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS
      patients with spasticity.

      Eligible subjects will be removed from anti-spasticity medications for at least one week and
      then begin study drug treatment with daily doses increasing up to the target dose which will
      then be maintained for at least 12 weeks. A down-titration will then occur over two weeks.
    

Detailed description: 
      This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled,
      parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS
      patients with spasticity.

      Eligible subjects will be removed from anti-spasticity medications for at least one week and
      then begin study drug treatment with daily doses increasing up to the target dose which will
      then be maintained for at least 12 weeks. A down-titration will then occur over two weeks
      with the final study visit occurring at 19 weeks from start of achieving the target dose or
      22 weeks from the Study Visit 1.
    

Intervention name(s): arbaclofen; baclofen; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40 mg/day as 20 mg arbaclofen ER administered orally 2 times per day; 80 mg/day as 20 mg baclofen administered orally 4 times per day; arbaclofen image matched placebo tablets administered orally 2 times/day or baclofen image matched placebo capsules administered orally 4 times/day
Other intervention name(s): OS440; AERT
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spasticity; multiple sclerosis; arbaclofen
Milrinone Pharmacokinetics and Acute Kidney Injury
Condition: Congenital Heart Disease; Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Heart Diseases; Heart Defects, Congenital; Wounds and Injuries
Study type: Observational

Summary: 
      Acute kidney injury (AKI) occurs in 40% of children following heart surgery. Serum creatinine
      (Scr) is a late biomarker of AKI, rising 24-48 hours after surgery. Thus, for medicines
      excreted in the urine, AKI could potentially lead to toxic levels in the blood. Urinary
      biomarkers have the ability to detect AKI earlier. Whether early detection of AKI through
      urinary biomarkers can predict altered drug levels is unknown.

      Milrinone is used to improve heart function after surgery, but accumulates in AKI resulting
      in low blood pressure. Dose adjustments are not currently possible because of the late rise
      in SCr, and are based on clinical parameters that may lead to clinically relevant over or
      under-dosing. Thus, this study will address an important knowledge gap being the first to use
      elevations of AKI biomarker concentrations to anticipate increased milrinone levels.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients less than or equal to 1 year who present for cardiac surgery at Cincinnati
        Children's Hospital Medical Center who meet the eligibility criteria.
Nociceptin Concentration in Synovial Fluid and Plasma
Condition: Pain; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      Nociceptin/Orphanin is a novel opioid peptide system associated with inflammatory response.
      Currently is it uncertain as to the presence of absence of nociceptin in synovial fluid of
      patients. Nociceptin levels will be measured pre-operatively and post-operatively in plasma
      levels of patients receiving primary total knee arthroplasty. Nociceptin levels will also be
      measured in synovial fluid levels prior to surgical manipulation.
    

Detailed description: 
      This is a prospective observational study where nociceptin levels will be drawn from the
      patient's serum as well as from the patient's synovial fluid. The blood draws will be
      completed by the anesthesia team and the synovial fluid and tissue will be obtained by the
      orthopedic team. The initial blood draw will be in the preoperative area and the second blood
      draw will be five minutes after the release of the tourniquet. The synovial fluid will be
      drawn by the surgeon with the first incision. There will be no randomization nor control
      group.

      Endpoints:

        1. The level or absence of nociceptin in synovial fluid in patients receiving total knee
           primary arthroplasty will be measured via ELISA in picograms per volume.

        2. The level or absence of nociceptin in plasma in patients receiving total knee primary
           arthroplasty both in the preoperative period (less than 1 hour prior to surgery and 5
           minutes after the tourniquet is removed) via ELISA in picograms per volume.

        3. Determine the changes if any of nociception plasma levels during the perioperative
           course of patients receiving total primary knee arthroplasty.

      Secondary Study Endpoints:

        1. Determine the effect if present of history of chronic pain and opioid use on the levels
           of nociception present in patients' synovial fluid and plasma receiving primary total
           knee arthroplasty.

        2. Determine the effect if present of demographic factors on the levels of nociception
           present in patients' synovial fluid and plasma receiving primary total knee arthroplasty
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Sequential patients receiving primary unilateral knee arthroplasty by the same surgeon
Dose-finding Study for SAR442168 in Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To determine the dose-response relationship for SAR442168 to reduce the number of new active
      brain lesions.

      Secondary Objectives:

        -  To evaluate efficacy of SAR442168 on disease activity as assessed by imaging measures.

        -  To evaluate the safety and tolerability of SAR442168.
    

Detailed description: 
      The total study duration was 24 weeks which included a screening period of 4 weeks, a
      treatment period of 16 weeks, and a follow-up period of up to 4 weeks. Participants who
      completed the Week 16 visit were proposed to be enrolled in a long-term extension safety and
      efficacy study to assess safety, tolerability and efficacy of SAR442168.
    

Intervention name(s): SAR442168; Placebo; Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: Film coated tablet; Route of administration: Oral; Pharmaceutical form: Film coated tablet; Route of administration: Oral; Pharmaceutical form: Solution for injection; Route of administration: Intravenous
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Recovery After Stress Toolkit (ReSeT): Pilot Study
Condition: Post-traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Experiencing an accident and staying in the hospital can be scary and traumatic for children.
      The goal of this project is to develop an online resource to help children and their parents
      develop effective coping skills to manage their stress. Children ages 8-17 who exhibit signs
      of posttraumatic stress will view 8 online modules and attend weekly videoconferencing
      sessions with a therapist. Parents will have 4 modules to assist them in supporting their
      child after the injury.
    

Detailed description: 
      The overarching goal of this project is to provide a research and treatment resource for the
      management of psychological distress in children who have been hospitalized for a physical
      trauma. The investigators will pilot an innovative, brief e-health approach to treatment of
      PTSS designed to be delivered through the trauma system. The investigators will create
      interactive web-based psychoeducational modules that are developmentally tailored for school
      age children (8 to 17 years) for use with synchronous e-health therapy sessions with a
      trained therapist. Companion modules for parents will help parents to understand and respond
      to their child's PTSS. The investigators will perform a single-arm pilot trial of a brief
      e-health approach to treatment of PTSS (i.e., Recovery after Stress Toolkit; ReSeT). ( delete
      with usual care.)
    

Intervention name(s): Recovery after Stress Toolkit (ReSeT)
Intervention type(s): Behavioral
Intervention description(s): ReSeT involves online modules with parallel videoconferencing sessions. ReSeT integrates two evidence-based treatment methods: cognitive behavioral therapy coping skills (coping CBT) and direct exposure to trauma reminders through a trauma narrative.
Intervention model: Single Group Assignment
Intervention model description: This is a single group design as all eligible participants will be offered the 8 session Recovery after Stress Toolkit (ReSeT) program, including 8 self-guided child modules and 4 parent modules, as well as 8 parallel videoconferencing sessions with a therapist.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: post-traumatic stress; medical stress; e-health
A Study of TRK-170 for the Treatment of Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      In Crohn's Disease Patients

        -  To evaluate the efficacy of TRK-170

        -  To evaluate the PK characteristics of TRK-170

        -  To assess the safety of TRK-170
    


Intervention name(s): TRK-170; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Crohn's Disease Activity Index; Crohn's Disease; Inflammatory Bowel Disease