bioihbjkbjnl/mcl2 huggingface dataset:
Muscle Protein Metabolism in Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      Obesity is associated with reduced adenosine triphosphate (ATP) turnover in skeletal muscle,
      a condition that can impair muscle metabolism. The proposed research will discover mechanisms
      responsible for decreased content in mitochondrial proteins as well as in protein
      β-F1-ATPase, which is directly responsible for ATP assembly, in the muscle of obese
      individuals. This research will further examine the effectiveness of interventions, such as
      increased plasma amino acid availability and exercise, to increase the rate of production of
      mitochondrial proteins as well as that of β-F1-ATPase in the muscle of obese individuals. The
      findings will help to develop appropriate interventions to improve muscle ATP turnover and
      metabolism in obese people.
    


Intervention name(s): Increase in the levels of plasma amino acids; Aerobic exercise
Intervention type(s): Other; Other
Intervention description(s): Aminosyn 15%; 160 mg/kg FFM/h for 4 hours; Moderate intensity for 45 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: muscle; mitochondria; amino acids; exercise
Platelet-Rich Plasma (PRP) in Reconstructive Surgery on Children With Retractable Burn Sequelae on Extremities
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      Does the addition of Platelet-Rich Plasma (PRP) to release of burn contractures and skin
      graft on the limbs of children with retractable burn sequelae reduce the initial time of the
      compressive treatment and maintain or lower the graft's retraction?
    

Detailed description: 
      Hypothesis:

        1. The use of PRP will allow to initiate sooner the compressive treatment during the post
           graft surgery evolution, in fewer days on average than the traditional method (18 ds).

        2. The use of PRP will maintain the same initial size of the graft. The study's domain
           corresponds to burn sequelae on children in treatment with reconstructive surgery due to
           retractile sequelae located on their upper and lower limbs, with functional compromise
           during their growth process.

      One of the treatments used for this problem is the surgical technique of with release of burn
      contractures and skin graft.

      Split skin grafts are at risk of suboptimal "take" due to bleeding and infection which would,
      on the one hand, delay the initiation of the rehabilitation with preventive compression to
      avoid the retraction of the grafted area.

      20% of the children that arrive in COANIQUEM (approximately 7,000 annually), require
      rehabilitation. Of these, 32% have surgery and 9% of those are release of burn contractures
      and skin graft mainly on extremities.
    

Intervention name(s): With PRP
Intervention type(s): Procedure
Intervention description(s): Release of burn contractures and skin graft on the affected limb, a rigorous haemostasis. The surgeon must distribute the activated PRP evenly, forming a very fine clot over it. Immediately the split skin graft must be applied, duly fenestrated. The grafted zone will be measured in it's longest width and length, taking a standardized photograph. On the 5th day the nurse will evaluate the graft's conditions. The evaluation will be done following a previously established follow-up protocol. Measurements of width & length of graft and standardized photo taken at the initiation of the compressive system. Measurement of graft's width & length and standardized photo at the end of the compressive system according protocol. Statistical analysis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Burn sequelae; PRP; Children
Effect of Self-directed and Supervised Pulmonary Rehabilitation Approach on Cough and Sputum.
Condition: COPD; Pulmonary Disease
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      Chronic obstructive pulmonary disease (COPD)is a multifactorial, progressive chronic lung
      disease that causes airflow restriction. Study was conducted To Compare the effects of
      supervised and self-directed pulmonary rehabilitation on cough and sputum expectoration in
      patients of chronic obstructive pulmonary disease.
    

Detailed description: 
      To Compare the effects of supervised and self-directed pulmonary rehabilitation on cough and
      sputum expectoration in patients of chronic obstructive pulmonary disease. It was a
      randomised control trial and participants were COPD Patients.
    

Intervention name(s): Physiotherapy Treatment
Intervention type(s): Other
Intervention description(s): Pulmonary Rehabilitation Techniques
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Antiarrhythmic Therapy Versus Catheter Ablation for Atrial Fibrillation in Hypertrophic Cardiomyopathy
Condition: Atrial Fibrillation; Hypertrophic Cardiomyopathy
MeSH terms: Atrial Fibrillation; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      Paroxysmal or chronic atrial fibrillation (AF) develops in about 20- 25% of adult patients
      with hypertrophic cardiomyopathy (HCM) and represents an important complication in the
      clinical course of the disease, with adverse long-term consequences on functional status and
      outcome.

      Therefore, aggressive therapeutic strategies are indicated to restore and maintain sinus
      rhythm (SR) in patients with HCM. Nevertheless, pharmacologic prevention of AF recurrence is
      challenging because of the limited long-term efficacy and potentially hazardous side effects
      of available treatment options. Currently radiofrequency catheter ablation (RFCA) of AF is
      successfully used in clinical practice. However, comparison of the efficacy and safety of
      these two therapeutic options has not been done up till now in randomized manner in this
      group of patients.

      Thus, the aim of the present study is to compare the efficacy and safety of RFCA vs.
      antiarrhythmic drug therapy in patients with HCM and AF.
    


Intervention name(s): RF catheter ablation; Antiarrhythmic drugs
Intervention type(s): Procedure; Drug
Intervention description(s): RF catheter ablation; One of AA drugs (preferably Amiodarone) and cardioversion in cases of chronic AF
Intervention MeSH terms: Anti-Arrhythmia Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation; Hypertrophic cardiomyopathy; RF ablation; Antiarrhythmic drugs
Drug Interaction Oral Contraceptive Pill (OCP)
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effects of BMS-650032 on Pharmacokinetics (PK) of ethinyl estradiol (EE) and
      norelgestromin (NGMN) in healthy female subjects
    


Intervention name(s): Ortho Tri-Cyclen®; BMS-650032
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 1 Tablet, once daily; Tablets, Oral, 600 mg, BID
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Asunaprevir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
The Clinical and Biological Effects of Leucocyte and Platelet-rich Fibrin (L-PRF) on Post-extraction Sockets Healing
Condition: Tooth Extraction
Study type: Interventional

Summary: 
      This study evaluates the clinical and biological effects of leucocyte and platelet-rich
      fibrin (L-PRF) on post-extraction sockets healing.
    

Detailed description: 
      Tooth extraction is one of the most frequent dental surgical procedures. Following tooth
      extraction, dimensional changes of the alveolus are inevitable, which consequently decrease
      the height and width of alveolar bone and impair ideal implant placement and conventional
      prosthetic treatment. In order to reduce the bone resorption after tooth extraction, the use
      of platelet concentrates has been proposed. Platelet rich fibrin (PRF) is a second generation
      of platelet concentrates consisting of platelets, leukocyte and growth factors harvested from
      blood. PRF not only supports hemostasis but also favors the natural wound healing process.
      Over the past decade, PRF has gained tremendous momentum having been utilized for a variety
      of dental and medical procedures including the management of post-extraction sockets. To
      date, several studies have assessed the efficacy of the use of PRF in promoting
      postextraction sockets healing. However, results remain contradictory and mainly focus on the
      clinical and radiological hard and soft tissue healing, aesthetics and postoperative
      discomfort. The mechanistic hypothesis is that growth factors released by PRF preparations
      modulate the wound healing process but the effect of local PRF application on the kinetics of
      release of wound healing modulators has not been studied so far. There is also a lack of
      information in the literature regarding the biological evaluation during postextraction
      sockets healing to understand the potential mechanisms. In order to assess the presence or
      follow dynamics of biomarkers, in this study wound fluid (WF) will be collected from the
      post-extraction sockets and utilized for multiplex immunoassay. Multiplex immunoassay allows
      simultaneous quantification of multiple markers providing unique information for a more
      complete understanding of the potential mechanism of PRF and spontaneous extraction socket
      healing. Therefore, the aim of this randomized clinical trial is to evaluate the effects of
      PRF on biomarkers response during post-extraction sockets healing.
    

Intervention name(s): leucocyte and platelet-rich fibrin (L-PRF)
Intervention type(s): Other
Intervention description(s): The blood collected from each patient will be centrifuged immediately at 2700 rpm for 12 min to separate L-PRF.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split-mouth design allowing to assess two types of treatment in the same patient.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
A Study Evaluating the Safety, Tolerability and Efficacy of Two Injections of SM04690 for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this phase 2, placebo-controlled, double-blind, parallel group study
      is to provide an initial evaluation of two intra-articular (IA) injections of SM04690 (each
      at the dose of 0.07mg per 2mL injection) approximately six months apart into the target knee
      of moderately to severely symptomatic osteoarthritis (OA) subjects. Subjects who complete
      this 52-week long study will be eligible to enter the extension phase for an additional 52
      weeks of treatment.
    


Intervention name(s): Placebo; SM04690
Intervention type(s): Drug; Drug
Intervention description(s): Healthcare professional-administered intra-articular injections; first performed on Day 1 and second at Week 24. (In the extension phase, healthcare professional-administered intra-articular injections; first performed at Week 52 and second at Week 76.); Healthcare professional-administered intra-articular injections; first performed on Day 1 and second at Week 24. (In the extension phase, healthcare professional-administered intra-articular injections; first performed at Week 52 and second at Week 76.)
Intervention MeSH terms: Lorecivivint
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SM04690; Wnt pathway inhibitor; osteoarthritis; Samumed
Brain Imaging Studies of the Effect of Inhalant Use Disorder
Condition: Inhalant Use Disorder
Study type: Observational

Summary: 
      Inhalants substance misuse is an important public health problem whose prevalence is
      approximately 1% in the general population and 7% among high school students in Mexico.
      Furthermore Inhalants substance misuse has increased in the recent years (Villatoro et al.,
      2011). According to the Diagnostic and Statistical Manual of Mental Disorders fifth edition
      (DSM-5) inhalant use disorder is a problematic pattern of use of a hydrocarbon-based inhalant
      substance leading to clinically significant impairment or distress. There are studies to
      suggest that long-term exposure to inhalants is associated with structural brain
      abnormalities, as well as neuropsychological impairments. However many of these studies have
      been limited to the gross anatomical report, therefore is necessary the use of complimentary
      techniques which provide a better understanding of brain. To the date there is no evidence of
      the use of positron emission tomography, and there are few studies have employed other
      magnetic resonance imaging methodologies such as diffusion tensor imaging that can be used to
      know the metabolic activity and white matter tract integrity respectively in inhalant use
      disorder participants. The purpose of this study is evaluates the effects of the inhalant use
      disorder in the brain. The investigators will be using positron emission tomography (PET),
      Magnetic Resonance Imaging (MRI) and diffusion tensor imaging (DTI). As well as, this study
      will examine the impact of inhalants consumption on executive function performance and the
      transcriptomic changes associated with inhalants consumption. The investigators hope that the
      data gathered from this study will lead to the development of more effective treatments
    


Intervention name(s): Positron emission tomography scan; Magnetic resonance imaging
Intervention type(s): Radiation; Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants in inhalant use disorder treatment program or Normal Control Subjects
        volunteers
      
Biospecimen description: 
      cDNA obtained from reversal transcription of RNA isolated from periferical blood cells
    
Keywords: Inhalant use disorder; Positron emission tomography; Magnetic Resonance Imaging; Executive functions assessment; Transcriptome
PAP Adherence After Diet/Lifestyle Intervention in OSA Patients
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to explore the role of diet/lifestyle intervention on Positive
      airway pressure (PAP) treatment adherence in patients with obstructive sleep apnea
      (OSA).Specifically, we evaluated the effects of a combination of PAP and weight-loss
      Mediterranean diet intervention on improving PAP adherence, Body mass index (ΒΜΙ), daytime
      symptoms, mainly sleepiness and arterial blood pressure measurements over the effect of
      standard care alone.
    

Detailed description: 
      We designed a parallel, randomized, controlled, clinical trial. Eligible participants are
      adult, overweight and obese men and women, diagnosed with moderate-to-severe OSA
      [apnea-hypopnea index (AHI)≥15 events/h] through an attended overnight polysomnography.
      Participants, after written informed consent, were blindly randomized to a standard care
      group (SCG, n=37) and a Mediterranean diet group (MDG, n=37). Study groups were prescribed
      PAP. The SCG received oral healthy lifestyle advice and counseling on physical activity and
      sleep habits, while the MDG was additionally subjected to a 6-month behavioral intervention
      aiming at weight loss and increasing adherence to the Mediterranean diet. PAP adherence
      (hours of device use), BMI, daytime sleepiness, evaluated by Epworth Sleepiness Scale (ESS)
      and arterial blood pressure measurements were evaluated pre- and post-intervention.
    

Intervention name(s): MDG intervention
Intervention type(s): Behavioral
Intervention description(s): 6-month behavioral intervention aiming at weight loss and increasing adherence to the Mediterranean diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: obstructive sleep apnea; treatment adherence; Positive airway pressure (PAP) treatment; diet/lifestyle intervention; Mediterranean diet
A Phase 3 Study of NI-071 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate similarity between NI-071 and infliximab(the
      comparator) in terms of efficacy in patients with Rheumatoid Arthritis not adequately
      responding to Methotrexate.
    


Intervention name(s): NI-071; Infliximab
Intervention type(s): Biological; Biological
Intervention description(s): 100mg/vial; 100mg/vial
Other intervention name(s): Remicade
Intervention MeSH terms: Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Socket Preservation With Er:YAG and Nd:YAG Lasers
Condition: Post-extraction Bone Regeneration
Study type: Interventional

Summary: 
      Alveolar bone regeneration after laser-assisted extraction will be compared with bone
      regeneration after standard extraction procedure.
    


Intervention name(s): Er:YAG and Nd:YAG lasers; Standard extraction
Intervention type(s): Device; Procedure
Intervention description(s): Extraction followed by Er:YAG laser degranulation, Nd:YAG laser disinfection, Er:YAG deepithelialization, Nd:YAG blood clot stabilization and photobiomodulation. The photobiomodulation step repeated on day 3, 5, and 7.; Standard extraction procedure
Other intervention name(s): Twinlight; laser alveolar preservation; LightWalker; Fotona
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to either laser or control group.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: tooth extraction; alveolar bone; bone regeneration; laser
A Feasibility Study to Determine PET/CT Imaging of Blood Flow to the Bone
Condition: Normal Subjects
Study type: Interventional

Summary: 
      To evaluate if a commonly used medical bone scan, called positron emission
      tomography/computed tomography (PET/CT) with sodium fluoride can measure bone blood flow to
      the hip.
    

Detailed description: 
      The purpose of this research is to validate technique on a commonly used medical bone scan,
      called positron emission tomography/computed tomography (PET/CT) along with sodium fluoride
      as the tracer for determining blood flow to the bone. Up to 12 subjects will have PET/CT
      scans so that we can determine the repeatability and reliability of the images prior to using
      PET/CT for this use on subjects in the Phase 1b part of Dr. Nancy Lane's clinical research
      study entitled "A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple
      Ascending Dose Study of the Safety and Tolerability of Intravenous LLP2A-Alendronate in Adult
      Men and Women with Osteopenia Secondary to Glucocorticoids" (IRB Protocol #866350).
    

Intervention name(s): PET/CT Scan
Intervention type(s): Device
Intervention description(s): PET/CT scanning with sodium fluoride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
A Pharmacodynamics and Safety Study of DSP-9632P in Patients With Levodopa-Induced Dyskinesia in Parkinson's Disease
Condition: Levodopa-induced Dyskinesia; Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label of single transdermal dose of DSP-9632P to evaluate the dopamine
      release derived from levodopa in brain, and a randomized, double-blind, placebo-controlled,
      2-way crossover of multiple transdermal doses of DSP-9632P to evaluate the safety and
      tolerability in patients with levodopa-induced dyskinesia in Parkinson's disease.
    

Detailed description: 
      This study consists of Part A and Part B. Part A is an open-label part to evaluate the amount
      of striatal dopamine release derived from levodopa following single transdermal
      administration of DSP-9632P using 11Craclopride PET in patients with levodopa-induced
      dyskinesia in Parkinson's disease. Part A consists of screening, Period 1, Period 2, Period
      3, Period 4, and follow-up period. Each period consists of 2 days, Day 1 and Day 2. There
      will be a 7-day or longer washout of DSP-9632P between Periods 3 and 4. Subjects will be
      hospitalized in each period.

      Part B is a randomized, double-blind, placebo-controlled, crossover part to evaluate the
      safety and tolerability of DSP-9632P following multiple transdermal administration in
      patients with levodopa-induced dyskinesia in Parkinson's disease. Part B consists of
      screening, placebo lead-in period, baseline period, Period 1, Period 2, and follow-up period.
      Period 1 and Period 2 consist of 9 days. Subjects will be hospitalized for 10 days 9 nights
      from baseline period to Period 1 and for 9 days 8 nights in Period 2. There will be a 7-day
      or longer washout of DSP-9632P between Periods 1 and 2.

      Subjects will concomitantly use any of the levodopa formulation from the time of informed
      consent to the end of study.
    

Intervention name(s): DSP-9632P 27.5 mg; DSP-9632P 82.5 mg; Placebo; DSP-9632P 55.0 mg; Levodopa formulation
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of DSP-9632P 27.5 mg; Single dose of DSP-9632P 82.5 mg; Placebo for DSP-9632P; Multiple dose of DSP-9632P 55.0 mg; Single dose of Levodopa formulation
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment