bioihbjkbjnl/mcl2 huggingface dataset:
Ultherapy™ Treatment Following Sculptra® Treatment
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      This clinical trial will evaluate clinical outcomes associated with the non-invasive
      Ultherapy™ treatment to improve skin laxity and tightening following a Sculptra® treatment.
    

Detailed description: 
      This study is a prospective,single-center, randomized clinical trial. Up to thirty (30)
      subjects will be treated. Enrolled subjects will be assigned to one of three (3) groups. Up
      to 10 subjects per group.
    

Intervention name(s): Ulthera® System; Sculptra®; Sculptra® treatment followed by Ultherapy™ treatment
Intervention type(s): Device; Drug; Other
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin on the lower face.; Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart.; Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.
Other intervention name(s): Ultherapy™; Poly-L-Lactic acid fillers
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy™ treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening; Skin laxity on the face and neck.
Effects of Synchronised Auditory Stimulations of the Sleep Slow Oscillation on Deep Sleep Quality
Condition: Healthy
Study type: Interventional

Summary: 
      This monocentric, cross-over, randomised, double blind and placebo-controlled study evaluates
      the effects of auditory stimulations of the sleep slow oscillation on deep sleep quality.
    

Detailed description: 
      Sleep quality impairment has long been identified as a risk factor to develop
      cardio-vascular, metabolic and more recently neurodegenerative diseases. The slow wave sleep,
      characterized by slow oscillations, has a major role on memory and hormones releasing. Here,
      we aim to assess a miniaturized sleep device that would automatically detect and stimulate
      sleep slow oscillations with sounds to enhance deep sleep quality.

      The subjects realize 3 conditions :

        -  Up condition : Auditory stimulations are delivered in synchrony with the up phase of
           slow oscillations during N3 sleep stage.

        -  Random condition : Auditory stimulations are randomly delivered during N3 sleep stage.

        -  Placebo condition: The device is worn without any auditory stimulations delivered.

      The subjects are equipped with a reference polysomnography and the auditory stimulation
      device during 3 nights and one habituation night prior to them. A wash out period of 6 days
      between each night will be respected.
    

Intervention name(s): Stimulation of up-phase of sleep slow oscillation; Random stimulation of up phase of sleep slow oscillation; No stimulation
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Sleep; Auditory stimulations; Slow oscillations
Valsartan for Suppression of Plaque Volume and Restenosis After Drug-Eluting Stent
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate that angiotensin-converting enzyme (ACE) inhibitors and angiotensin-converting
      enzyme receptor blockers (ARBs) reduce the risk of restenosis after DES implantation.
    

Detailed description: 
      Stimulation of the angiotensin II type 1 (AT1) receptors after arterial injury promotes
      vascular smooth muscle cell (VSMC) migration, proliferation, and extracellular matrix
      production, leading to the hope that blockade of this receptor by angiotensin-converting
      enzyme inhibitors (ACEI) or specific (AT1) receptor antagonists (ARBs) might reduce intimal
      hyperplasia. However, despite confirmatory evidence in several animal models of restenosis,
      the large scale MERCATOR and MARCATOR trials of cilazapril with balloon angioplasty failed to
      show benefit. In 1999, Kondo reported the results of a randomized pilot trial of 100 patients
      who received Palmaz-Schatz stents and were randomized to receive the ACE inhibitor quinapril
      or placebo. The volume of neointimal hyperplasia assessed by IVUS was significantly less
      quinapril than the control group (18 ± 0.6 mm3 vs. 25 ± 0.6 mm3; p < 0.05). The quinapril
      group's restenosis rate was 16%, with the quinapril benefit being observed only in patients
      with the D/D and I/D genotypes. Also, other study reported on a consecutively treated cohort
      of 1,598 stented patients, noting that ACE inhibitor usage at the time and after stenting
      reduced the risk of subsequent revascularization dramatically (adjusted odds ratio, 0.46; p =
      0.001). In the ValPREST trial which is a single-center randomized trial of patients receiving
      stents for type B2/C lesions, comparing valsartan (and ARV) 80 mgs daily with open treatment,
      patients randomized to valsartan had a 19% incidence of restenosis compared with 39% in the
      open treatment arm (p = 0.005).

      Recently, several randomized studies were conducted to compare the safety and efficacy of the
      two leading drug-eluting stent (DES). However, data on the association of ARBs for
      suppression of neointimal hyperplasia are limited in the DES era. Therefore, a pivotal
      randomized study is warranted.
    

Intervention name(s): Valsartan
Intervention type(s): Drug
Intervention description(s): Valsartan 160mg per day
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stents; angiotensin-converting enzyme
A Study of EDP-235 in Healthy Subjects
Condition: SARS CoV 2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, double-blind, placebo-controlled study. It will assess the
      safety, tolerability, and pharmacokinetics of orally administered single and multiple doses
      of EDP-235 in healthy adult subjects.
    

Detailed description: 
      The first phase assesses single ascending doses of EDP-235 or placebo in healthy subjects. A
      "fasted" and "fed" two-part cohort will also assess food effect.

      The second phase assesses multiple ascending doses of EDP-235 or placebo for 7-days in
      healthy subjects.

      Each cohort within each phase will enroll a total of 8 subjects who will be randomized to
      receive EDP-235 or placebo.
    

Intervention name(s): EDP-235; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Placebo to match EDP-235, oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: First-in-Human; Single Ascending Dose; Multiple Ascending Dose; Healthy Volunteer; COVID-19
Effects of Two Doses of Thylakoids on OGTT
Condition: Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      This cross-over intervention study aims to investigate the effect of two doses of thylakoids
      to an oral glucose tolerance test (OGTT) on glucose and insulin homeostasis as well as
      appetite regulating hormones in healthy volunteers.
    

Detailed description: 
      A minimum of twenty healthy volunteers are recruited to participate in an OGTT at three
      different occasions separated by one week. At two of the occasions a green leaf extract,
      thylakoids, is added to a glucose solution; 5 gram or 10 gram in randomized order. The third
      occasion, without added thylakoids, serve as control.

      Blood samples are taken fasting and 15, 30, 45, 60, 90, 120 and 180 minutes after the glucose
      load.

      Blood samples are analysed for p-glucose, p-insulin, p-C-peptide, p-ghrelin, p-CCK and
      p-GLP-1.
    

Intervention name(s): Experimental: Thylakoids 5 g; Experimental: Thylakoids 10 g; Placebo Comparator: Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 75 g pure glucose + 5 g chloroplast membranes from spinach leaves in a dried powder.; 75 g pure glucose + 10 g chloroplast membranes from spinach leaves in a dried powder.; 75 g pure glucose.
Other intervention name(s): Appethyl; Appethyl
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity
Condition: Lower Limb Spasticity
MeSH terms: Muscle Spasticity
Study type: Observational

Summary: 
      The purpose of this study is to assess the longitudinal attainment of subject centred and
      functional related goals (cumulated Goal Attainment Scale Total (GAS T) score) after
      abobotulinumtoxinA injection (including following repeated injection cycles where they occur)
      alongside spasticity management used in real life settings over a period of 18 months (and a
      maximum of six injection cycles).
    


Intervention name(s): Botulinum toxin type A
Intervention type(s): Biological
Intervention description(s): This is an observational study designed to reflect real world clinical practice in the use of abobotulinumtoxinA. AbobotulinumtoxinA injected doses, frequency of injections, number of injection sites and volume injected per site are in accordance with the current USPI and physician's clinical practice.
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients with lower limb spasticity
Alcohol Brief Counseling in Primary Care
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of a brief intervention for the reduction of alcohol
      use among risky alcohol users in primary care delivered by paramedics. Half of the
      participants will receive a brief intervention and half will receive written guidelines on
      safe alcohol use.
    

Detailed description: 
      Randomized controlled trial with a pragmatic emphasis undertaken in real world primary care.

      The brief intervention has been designed and piloted by the mental health team at the Chilean
      ministry of health, as also the written support material. This intervention is the same that
      is being implemented national wide.

      The implementation will include training of the paramedics, and then an accreditation session
      with a simulated participant in a double sided mirror.

      Randomization will take place on site using a opaque envelope. The sequence will be keep on
      site in a secured box.

      Data will be registered by the same person delivering the intervention and kept safe at the
      clinical sites. Once a month the data will be physically transferred to the operational
      center at the San Joaquin site of the Catholic University of Chile.

      Bimonthly visits will be performed to the centers by a member of the team to assure that the
      protocol is being followed and data audit.

      The participants will receive an economical incentive for the follow up visit. Participants
      will be reached throw telephone at least twice to schedule that visit. If not possible, a
      telephonic outcome assessment or a domiciliary visit will be performed to minimize the lost
      in follow up.
    

Intervention name(s): AUDIT brief intervention; Pamphlet on alcohol use
Intervention type(s): Behavioral; Other
Intervention description(s): Intervention will be provided following the Chilean ministry of health implementation manual on the AUDIT associated brief intervention. The pamphlet on alcohol use will be provided to participants.; Only the pamphlet on alcohol use will be provided (the same received by participants on the intervention group). This is not an active intervention based on the current literature.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: alcohol drinking; hazardous alcohol use; risky alcohol consumption; heavy alcohol consumption
Mindfulness for Resilience in Early Life
Condition: Adolescent With Early Life Stress; Resilience
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      Early life stress (ELS) is associated with a number of psychiatric and medical conditions
      later in life, thought to be caused by subsequent disruptions in biological processes
      involved in regulation of stress responses. Given that these alterations have long-lasting
      effects, there is a great need for effective preventative interventions. The long-term goal
      of this project is to identify early interventions that may most powerfully mitigate risk for
      psychiatric illness among adolescents with exposure to early life stress (ELS), with a focus
      on interventions that can be widely and effectively implemented, have the potential for
      long-lasting benefits, and can effectively engage targeted neurobiological processes and
      networks. The specific aims of the present study are to 1) examine how ELS impacts biological
      processes associated with regulation of stress, and 2) identify how MBI impacts affective
      symptoms and biological processes dysregulated by ELS.

      This study supports the efforts to reduce the effects of early adversity in children by
      testing an impact of an effective psychological intervention on disrupted biological
      processes caused by early adversity. Successful achievement of the proposed aims will
      contribute to a) the knowledge base needed to reduce the effects of trauma and stress in
      children and families and b) the development of easily implemented and disseminated
      preventative interventions.

      The proposed study will utilize a multi-method design to examine the effect of mindfulness on
      biological processes (i.e., stress responses) disrupted by exposure to ELS among adolescents
      age 13 to 15. Adolescents will first complete self-report measures of childhood adverse
      experiences, trauma, and neglect. Forty eligible adolescents will be next randomly assigned
      to either an eight session mindfulness-based stress reduction intervention for teens or no
      treatment. Pre- and post-intervention assessment will include (a) self-report measures of
      symptoms and emotion regulation, (b) a blood draw for assessment of inflammatory markers and
      gene expression, and (c) a stress task with saliva cortisol collected before and after this
      task.
    


Intervention name(s): Mindfulness
Intervention type(s): Behavioral
Intervention description(s): Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Adolescents are randomly assigned to either a mindfulness intervention or no intervention.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Early life stress; Adolescent; Mindfulness; Neurobiological; Stress; Resilience
Open Pilot Trial of TES for Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate whether using oscillating TES (random noise stimulation) or
      intermittent tDCS will have greater antidepressant effects in depressed subjects, compared to
      standard tDCS.
    


Intervention name(s): tDCS (Eldith DC-Stimulator (CE certified))
Intervention type(s): Device
Intervention description(s): For participants receiving intermittent tDCS or oscillating TES, one electrode will be placed over the left pF3 electrode site (overlying the left dorsolateral prefrontal cortex and identified on the scalp using an EEG cap based on the 10/20 system) and the other over the right temporal area.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression; transcranial direct current stimulation (tDCS); random noise stimulation; oscillatory tDCS; intermittent tDCS
TAK-648 Multiple-Rising Dose Study in Healthy Japanese Participants and Non-Japanese Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, randomized, double-blind, placebo-controlled, 2-center, multiple-dose
      study in healthy participants and participants with type 2 diabetes mellitus (T2DM). This
      study will evaluate the safety, tolerability and pharmacokinetics (PK) of TAK-648 when
      administered as multiple oral doses of TAK-648 solution at escalating dose levels in healthy
      participants of Japanese decent and participants with T2DM.
    

Detailed description: 
      The drug being evaluated in this study is TAK-648 for the treatment of T2DM.

      This study will consist of 2 parts: (1) multiple ascending doses in participants with T2DM
      treated with a stable dose of metformin, (2) multiple ascending doses in healthy participants
      of Japanese descent.

      Part 1 of this study will consist of 2 multiple dose treatment cohorts (Cohorts 1-2
      designated as P1C1 and P1C2) dosed sequentially in escalating order. The projected doses of
      TAK-648 for Part 1 are 0.15 and 0.35 mg of TAK-648, but may be adjusted higher or lower, and
      additional cohorts may be added, based on available safety and pharmacokinetic (PK) data. All
      cohorts in Part 1 will consist of 8 (2 placebo) T2DM participants.

      Part 2 of this study will consist of 3 multiple dose treatment cohorts (Cohorts 1-3
      designated as P2C1, P2C2 and P2C3) in healthy participants of Japanese descent dosed
      sequentially in escalating order. The projected doses of TAK-648 chosen for Part 2 are 0.05,
      0.15 and 0.35 mg of TAK-648, but may be adjusted higher or lower based on available safety
      and PK data. All cohorts in Part 2 will consist of 8 (2 placebo) healthy participants of
      Japanese descent.

      Additional cohorts may be recruited and studied as necessary to better evaluate safety,
      tolerability, PK, and/or PD parameters.
    

Intervention name(s): TAK-648; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-648 solution; TAK-648 placebo-matching solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Phase III Randomized, Double-Blind Study of Prednisone for Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES: I. Characterize the effect of prednisone on muscle protein metabolism in patients
      with Duchenne muscular dystrophy.

      II. Determine whether prednisone changes levels of insulin-like growth factor 1, growth
      hormone, and insulin.

      III. Characterize the effect of prednisone on muscle morphometry and muscle localization of
      utrophin.

      IV. Compare the prednisone response in patients with Duchenne muscular dystrophy to that seen
      in normal individuals and in patients with facioscapulohumeral dystrophy.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are randomly assigned to
      prednisone or placebo. Therapy is administered daily for 12 weeks; prednisone is then
      tapered.
    

Intervention name(s): prednisone
Intervention type(s): Drug
Intervention MeSH terms: Prednisone
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Duchenne muscular dystrophy; genetic diseases and dysmorphic syndromes; muscular dystrophy; neurologic and psychiatric disorders; rare disease
Gut-derived Neuropeptides in Cerebrospinal Fluid of Patients With Parkinson's Disease and Healthy Controls
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      In previous work, the investigators analyzed the concentration of gut-derived peptides
      (ghrelin, pancreatic polypeptide [PP]) in serum of patients with Parkinson's disease (PD).
      The investigators have shown that the secretion pattern differs between PD patients and
      controls. Beside ghrelin and pancreatic polypeptide other gut-derived peptides (e.g.
      Glucagon-like-Peptide 1[GLP-1], Amylin, etc.) might be relevant for PD as well. The rational
      to investigate gut-derived peptides in the neurological disorder Parkinson's disease (PD) is
      based on the following considerations:

        -  Receptors for gut-derived peptides are expressed in Central Nervous System (CNS)
           structures that are affected by the neurodegenerative process underlying Parkinson's
           disease

        -  Gut-derived peptides are involved in the modulation of higher brain functions (mood,
           cognition, reward-related behaviour) that are frequently altered in Parkinson's disease.

        -  The secretion of gut peptides is (co-)regulated by the vagal nerve that is dysfunctional
           in Parkinson's disease.

        -  Certain gut-derived peptides (ghrelin, GLP-1) stimulate neurogenesis and might be able
           to prevent cell death in neurodegenerative disorders, including Parkinson's disease.

      Objective:

      Collection of CSF and serum samples in a standardized way in order to quantitatively measure
      the concentration of gut-derived peptides (ghrelin, leptin, glucose-dependent insulinotropic
      peptide [GIP], GLP-1, amylin, PP, peptide YY [PYY], and insulin). Scientific questions:

        1. Do CSF (and serum) concentrations of these gut peptides differ between PD patients and
           controls?

        2. Do CSF (and serum) concentrations of the investigated peptides correlate with clinical
           and / or epidemiological characteristics of the investigated subjects (age, gender, BMI,
           disease duration, severity of motor impairments, presence of non-motor symptoms,
           co-morbidities, medication, etc.)?
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Parkinson's disease
      
Biospecimen description: 
      CSF and serum samples