bioihbjkbjnl/mcl2 huggingface dataset:
Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      This project aims to develop and test an intervention for the simultaneous treatment of
      cannabis use disorders and tobacco smoking. This is important because over 50% of adults
      seeking treatment to help stop cannabis use also smoke tobacco regularly, which decreases
      their chance for a successful treatment outcome and increases adverse acute and long-term
      psychosocial and health consequences. The proposed treatment will integrate existing
      computer-based behavioral interventions for cannabis and tobacco and use nicotine replacement
      medications to improve outcomes in this difficult to treat clinical population.
    

Detailed description: 
      Approximately 50% of persons seeking treatment for cannabis-use disorders (CUDs) regularly
      smoke tobacco. Combining tobacco with cannabis has become a common method of smoking
      cannabis. Similarities of use, and using together, can make quitting difficult. Stopping
      tobacco simultaneously with cannabis may be beneficial. Little scientific information
      currently addresses how to best target tobacco smoking during treatment for CUDs. Our
      long-term goal is to develop an effective protocol for intervening in tobacco smoking without
      changing cannabis outcomes. A two-phase, Stage 1 therapy development project will accomplish
      the following: First, a treatment protocol and manual will be developed that integrates a
      tailored intervention for tobacco smoking with an intervention for CUD (Aim 1). Utilization
      of web-based counseling programs will standardize delivery of the intervention and foster
      eventual dissemination. A pilot study will provide an initial test of acceptability and
      feasibility. Second, a Stage 1, proof-of-concept study will compare this intervention to one
      that targets CUD only (Aim 2). The hypotheses assert that the intervention (1) will be
      accepted by the majority of eligible participants (2) will result in more tobacco quit
      attempts and rates than the CUD-only treatment; and (3) will not adversely affect cannabis
      outcomes. Last, the project will evaluate the potential of specific moderators of outcomes to
      predict outcomes and inform subsequent treatment development efforts (Aim 3). If the
      hypotheses were confirmed, dissemination of this protocol would reduce adverse psychosocial
      and health consequences of tobacco or cannabis dependence. Findings will inform future
      development of prevention and intervention strategies.
    

Intervention name(s): MET/CBT/CM plus NRT
Intervention type(s): Behavioral
Intervention description(s): Behavioral Treatment for Cannabis plus Behavioral Treatment for Tobacco: both primarily delivered by computer. Additional NRT.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tobacco Use
Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose
      of this study is to evaluate the safety and efficacy of teduglutide in children up to the age
      of 17 with SBS who are dependent on parenteral support. Subjects may choose whether to
      receive the study drug or to participate in a standard-of-care arm. All participants who
      complete the study may be eligible to receive the study drug in a long-term extension study.
    


Intervention name(s): Teduglutide 0.05mg/kg; Teduglutide 0.025 mg/kg; Standard of Care
Intervention type(s): Drug; Drug; Other
Intervention description(s): 0.05 mg/kg; 0.025 mg/kg; Observational cohort for the 24-week treatment period and 4 week follow-up.
Intervention MeSH terms: Teduglutide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Teduglutide; pediatric; GLP-2; parenteral support; Short Bowel Syndrome; short gut syndrome; short gut; SBS; parenteral nutrition
A Drug-drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn about the effect of lanabecestat on how the body
      absorbs and processes dabigatran etexilate and how dabigatran etexilate affects lanabecestat
      when they are taken together. This study will last about 28 days and participants will be
      asked to take an lanabecestat tablet daily for 19 days and a dabigatran etexilate tablet on 3
      occasions. Screening is required within 30 days prior to the start of the study.
    


Intervention name(s): Lanabecestat; Dabigatran etexilate
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY3314814; AZD3293
Intervention MeSH terms: Dabigatran
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The RELAX TO SLEEP Study
Condition: Sleep
Study type: Interventional

Summary: 
      Sleep is a biological process essential for health. Being hospitalized can exacerbate common
      sleep difficulties in children. Factors that contribute to sleep disturbances during
      hospitalization include environmental, physiological, and psychological factors. Although
      sleep interventions exist for healthy children in the community, interventions aimed at
      hospitalized children need to be developed and piloted with rigorous evaluative methods. The
      primary purpose of this study is to examine the feasibility and acceptability of the RELAX TO
      SLEEP program on hospitalized children. Although this study is a pilot study, comparisons
      will be made to examine sleep outcomes between the intervention group and the control group
      including: total nocturnal (19h30-07h29), number of nighttime awakenings, longest stretch of
      nocturnal sleep, and total daytime (07h30-19h29) sleep. Other comparisons include anxiety
      levels and the development of post-hospital maladaptive behaviours.
    


Intervention name(s): Relax To Sleep Program
Intervention type(s): Behavioral
Intervention description(s): The educational portion of the program will consist of a standardized educational booklet and a discussion with the PI and provides a brief overview will be given on normal sleep and sleep patterns, children's sleep needs, and the signs and consequences of sleep disturbance. Second, the educational booklet provides sleep hygiene info. The second component consists of of good sleep habits such as having a regular sleep-wake schedule, avoiding caffeine intake prior to sleep, avoiding stimulating activities near nighttime sleep, avoidance of naps during the day, ensuring that the child is exposed to natural light during the day, providing the child with opportunities to socialize during the day. Finally, the program consists of a relaxation breathing technique for the child.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatric; sleep difficulties in children; Sleep Education
Vitamin D Status After Single Oral Dose of Cholecalciferol in Low Fat Meal Compared to High-fat Meal
Condition: Deficiency, Vitamin D
MeSH terms: Avitaminosis; Vitamin D Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3
      (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal
      associated with the administration of the supplement.
    

Detailed description: 
      Clinical randomized controlled double-blind study with healthy subjects to investigate the
      effect of low and high fat of meal on absorption of vitamin D supplement. Participants were
      randomly in two groups according to sex and BMI.

      In the same date, each group of participants received a meal and dietary supplement of
      vitamin D3 (cholecalciferol) after the first blood sample and a urine sample. Others samples
      were collected in the seventh and fourteenth day after intake the supplement.
    

Intervention name(s): colecalciferol
Intervention type(s): Dietary Supplement
Intervention description(s): 50.000UI single oral dose
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vitamin D; colecalciferol; absorption by Vitamin D
Effects of Inspiratory Muscle Training on Functional Capacity in Patients With Heart Failure.
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Heart failure is a complex clinical syndrome manifesting as inability to supply adequate
      blood flow throughout the body due to any structural or functional cardiac abnormality. The
      most common complaints are exercise intolerance, balance, dyspnea, and fatigue in patients
      with heart failure. It is clearly stated that pulmonary muscle weakness is prevalent and
      contributes to exercise intolerance in patients with heart failure. Purpose of the study was
      to evaluate the efficacy of inspiratory muscle traning on pulmonary muscle strength,
      pulmonary function test, functional capacity and quality of life. The tools used were
      6-minute walk test, spirometry, IMT threshold device for IMT strength, and Quality of life.
      Study was conducted in 20 patients in single group and pre and post values were evaluated.
      The significance this study bears was that it helped defining for us that to how much extent
      we can improve the physical and pulmonary functional capacity using inspiratory muscle
      training. Data were analysed using spss 22.0.mean and standard deviation were calculated.
      Appropirate the stasitical test were used after checking normailty of data. Parametric test
      were used for data analysis using SPSS 22
    


Intervention name(s): Inspiratory Muscle training
Intervention type(s): Other
Intervention description(s): Patients received IMT for 30-minute per day, 3 days per week for 3 weeks using the Threshold Inspiratory Muscle training device (product Phillips). During training, patients were instructed to maintain diaphragmatic breathing, and try to maintain 10-15 breaths, and rested 5-10 between breaths. As soon as the patients managed; they were encouraged to maintain 25-30 breaths at each workload. All patients wore nose-clip during training.
Inspiratory muscle training diaries were checked weekly. The inspiratory load was set at 40%of maximal inspiratory pressure.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Stair Climbing and Descending on Postprandial Blood Glucose
Condition: Postprandial Blood Glucose
Study type: Interventional

Summary: 
      Determine effect of stair climbing and descending on postprandial blood glucose
    

Detailed description: 
      Determine effect of 1, 3, and 10 minutes of stair climbing and descending on postprandial
      blood glucose compared to seated control following consumption of mixed meal
    

Intervention name(s): 1 minute of stair climbing and descending; 3 minute of stair climbing and descending; 10 minute of stair climbing and descending
Intervention type(s): Other; Other; Other
Intervention description(s): 1 minute of stair climbing and descending; 3 minute of stair climbing and descending; 10 minute of stair climbing and descending
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effectiveness of Using an Oil Bath Additive
Condition: Xerosis Cutis
Study type: Interventional

Summary: 
      Epidermis that lacks moisture and/or sebum presents as dry skin, which is often characterized
      by a pattern of fine lines, scaling and itching. In dry skin, the barrier function may be
      compromised. Skin care practices to decrease the risk of development of dry skin and/or to
      improve dry skin condition have barely been investigated. Bathing with bath oils has been
      shown to increase skin hydration, thus helping to stabilize skin barrier function. Therefore,
      the aim of this study is to investigate the effect of bathing every other day on the skin
      barrier. Functional parameters, such as TEWL, stratum corneum hydration (SCH) and skin-pH
      (pH) were measured to characterize skin barrier function.
    


Intervention name(s): Balneum oil bath
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Arteriovenous Fistula Maturation Evaluation Study. FAME Study
Condition: End-stage Renal Disease; Hemodialysis Access Failure; Vascular Access Maturation; Native Arteriovenous Fistula
MeSH terms: Kidney Failure, Chronic; Arteriovenous Fistula; Fistula
Study type: Observational

Summary: 
      Study of the features of hemodynamic and clinical maturation of the native arteriovenous
      fistula for hemodialysis.
    

Detailed description: 
      This is a prospective, single-center, observational study, investigating the clinical and
      hemodynamic features of maturation of hemodialysis native arteriovenous fistula (AVF).
      Hemodynamic features under investigation are the diameter of the feeding brachial artery,
      volume of flow (VF) measured with transcutaneous Duplex ultrasound (DUS), resistivity index
      (RI), diameter and wall thickness of the efferent vein, measured at days 1, 2, 3, 4, 5, 6, 7,
      14, 21, 30, 60 and 90 post creation. Clinical features of maturation are the time of first
      access successful cannulation and the performance of three consecutive adequate dialysis
      sessions.
    

Intervention name(s): Doppler ultrasound study
Intervention type(s): Diagnostic Test
Intervention description(s): Transcutaneous Doppler ultrasound (DUS) study was performed at the mid brachial artery to assess diameter, VF and RI, and at the mid segment of the efferent vein to assess the diameter and wall thickness.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will recruit patients with end-stage renal disease eligible for native
        arteriovenous fistula creation for hemodialysis fulfilling the study's inclusion critera.
      
Keywords: hemodialysis; native arteriovenous fistula; maturation; feeding artery; efferent vein
Neural Glide Technique on the Sciatic Nerve and the Passive Stretching Technique in the Short Hamstring Muscles
Condition: Hamstring Muscles; Sciatic Nerve; Flexibility
Study type: Interventional

Summary: 
      The project consists of studying the differences between neural gliding techniques of the
      sciatic nerve and passive stretching of the hamstring muscles in football players.
    

Detailed description: 
      Study of hamstring shortening in football players through passive muscle stretching and the
      use of the neurodynamic technique of longitudinal sliding of the sciatic nerve.
    

Intervention name(s): Stretching of the hamstring muscles.; Neural slippage of the sciatic nerve.; Passive upper limb mobilisations.
Intervention type(s): Other; Other; Other
Intervention description(s): Passive stretching of the hamstring muscles.; Neurodynamic technique on the sciatic nerve.; Passive mobilisations performed on the upper limbs used as a placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two intervention groups. One control group.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hamstring muscles; Sciatic nerve; Flexibility
Description of the Endothelial Phenotypes From the Subcutaneous Abdominal and Gluteo-femoral Adipose Tissues in Women
Condition: Obesity
Study type: Interventional

Summary: 
      The endothelium is a key barrier between blood and tissue compartments. It is a major target
      of factors involved in metabolic and cardiovascular pathologies. However, the study of native
      human adult endothelial cells is difficult due to the lack of appropriate models and
      thereafter the endothelium is actually not easily accessible for clinical investigation.
      However, our results recently showed that the endothelium from human adipose tissue exhibit
      distinct phenotypes, including endothelial cell number and inflammatory, angiogenic and
      senescent state, according to adipose tissue location, i.e. subcutaneous and visceral. It is
      well recognized that estrogens favour gluteo-femoral adipose tissue deposit and their deficit
      after menopause is associated with increased abdominal and visceral fat mass as well as
      metabolic dysfunctions. These perturbations might be prevented with hormonal therapy.
      However, no data are available concerning the endothelial cells from gluteo-femoral and
      abdominal adipose tissues in women.
    

Detailed description: 
      The adipose tissues (gluteo-femoral and abdominal) will be obtained from women programmed for
      surgery in which the estrogenic status as well as adipose tissue mass profile will be
      evaluated. The phenotype (inflammatory and angiogenic activation and senescent state) of
      native endothelial cells will be determined "in situ" by immunohistochemical and flow
      cytometry approaches and on isolated endothelial cells by Reverse transcriptase-Q Polymerase
      Chain Reaction and Western blot. In vitro approaches will be performed 1) to establish a
      causal relationship between endothelial senescence and activation state, 2) to define the
      impact of the adipose tissue microenvironment on the endothelial cell activation and
      senescence and 3) to study the potential protective effect of estrogens on endothelial
      senescence.
    

Intervention name(s): Adipose tissue surgery
Intervention type(s): Procedure
Intervention description(s): Adipose tissue (gluteo-femoral and abdominal) will be obtained from women programmed for surgery in which the estrogenic status as well as adipose tissue mass profile will be evaluated
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Myotonometric Measurement of Myofascial Trigger Points: Reliability, Validity and Sensitivity
Condition: Muscle Tone Abnormalities
MeSH terms: Congenital Abnormalities; Hypersensitivity
Study type: Observational

Summary: 
      The aims of this study are:

        -  To examine the inter-rater reliability to assess myofascial trigger points using a
           myotonometer

        -  To determinate the strength of the correlation between myotonometric parameters and
           isokinetic parameters

        -  To evaluate the sensitivity of myotonometric measurements to detect the location of
           myofascial trigger points
    

Detailed description: 
      Previous researches have used complicated and expensive methods to measure mechanical
      properties of muscle tone like isokinetic dynamometer.

      The purpose of this investigation is to establish the reliability, validity and sensitivity
      of a myotonometer to assess myofascial trigger points. The results of this study will verify
      the inter-reliability of a myotonometer device in order to evaluate muscle tone, examine
      correlations and associations between myotonometric measurements and isokinetic measurements
      and provide a measurable understanding of the location of myofascial trigger points.

      Assessment:

      Myoton device is a simple and portable tool to obtain quantitative and objective assessments
      of mechanical properties of muscle tone.

      Isokinetic dynamometric technique is considered a valid biomechanics method to measure muscle
      tone in non-injured subjects but isokinetic machine is a heavy and expensive equipment.

      Outcome measures:

      Myotonometric measures will include muscle frequency, decrement (elasticity) and stiffness.

      Isokinetic measures will include passive resistive torque to ankle dorsiflexion and
      dorsiflexion passive range of motion (PROM)

      All outcome measures will be evaluated once.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Subjects must be healthy volunteers and will be recruited from the city of Toledo.
      
Keywords: Myofascial Trigger Points; Myotonometry; Isokinetic Dynamometry; Assessment; Reliability
A Study to Evaluate the Safety and Effectiveness of Restylane-Defyne for Punctual Occlusion
Condition: Mild to Moderate Dry Eye Disease
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional

Summary: 
      A study which participants with mild to moderate dry eye disease will have a punctum of one
      eye injected with Restyalne Defyne and the other eye injected with saline solution.
      Participants will be evaluated over four visits.
    


Intervention name(s): Restylane Defyne
Intervention type(s): Device
Intervention description(s): Restylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL
Intervention model: Single Group Assignment
Intervention model description: Study is set as a single-arm, randomized, single-masked to evaluate Restylane Defyne for canalicular occlusion in participants with mild to moderate dry eye disease. Each participant will have a screening visit, it is then participants will be provided with informed consent form to review and ask questions before written informed consent is obtained. Screening visit occurs 30 days prior to 42 days and will be seen for follow-up exams at 3 , 14 and 42 days.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Dry Eye Disease; Restyalne Defyne
Subcutaneous Testosterone Enanthate Safety in Adult Men Diagnosed With Hypogonadism
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of safety of a concentration controlled testosterone enanthate QuickShot
      Testosterone regimen administered subcutaneously once each week to adult males with
      hypogonadism.
    

Detailed description: 
      Safety assessments, including laboratory assessments, adverse events and injection site
      assessments, will be conducted for all patients at scheduled intervals during the Treatment
      Titration Period.
    

Intervention name(s): Testosterone enanthate auto-injector
Intervention type(s): Combination Product
Intervention description(s): Dose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels
Other intervention name(s): Testosterone; Testosterone enanthate; QuickShot® Testosterone (QST)
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypogonadism; Testosterone enanthate