bioihbjkbjnl/mcl2 huggingface dataset:
Photobiomodulation Therapy in Persons With Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional

Summary: 
      This study will test whether photobiomodulation therapy improves muscle endurance and
      decreases inflammation in persons with relapsing-remitting multiple sclerosis. We will also
      investigate mechanisms for any improvements.
    

Detailed description: 
      Persons with multiple sclerosis (MS) MS commonly experience muscle weakness and fatigue which
      may contribute to the commonly reported symptomatic fatigue. Photobiomodulation therapy
      (PBMT) induced with light in the visible red to near infrared (VIS/NIR) region of the
      spectrum (600-1000 nm) can stimulate cytochrome c oxidase and improve mitochondrial function.
      PBMT is an emerging therapeutic modality for soft tissue injury, chronic inflammation,
      neurodegeneration , and retinal diseases. PBMT has also been used to enhance muscle
      endurance, strength and recovery in healthy adults. We propose that in persons with MS, PBMT
      will 1) enhance regional muscle endurance after acute treatment and 2) enhance functional
      endurance after extended treatment. We will also test to determine if improvements are due to
      central or peripheral neuromuscular or cardiovascular mechanisms. Final, we will explore if
      regional PBMT can result in systemic anti-inflammatory effects.
    

Intervention name(s): Photobiomodulation Therapy; Placebo
Intervention type(s): Other; Other
Intervention description(s): Photobiomodulation therapy, a mix of red lights thought to improve mitochondrial function will be applied in and acute and chronic manner to test whether muscle fatigue improves in persons with MS.; Device with sham light source
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Study on Pharmacokinetics of Hydronidone
Condition: Pharmacokinetics of Hydronidone
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetic characteristics of hydronidone capsules (specification: 30
      mg/ pill) in healthy subjects And the effect of feeding on pharmacokinetics to provide
      evidence for phase II/III clinical trial protocols.
    


Intervention name(s): Hydronidone
Intervention type(s): Drug
Intervention description(s): Take hydroxynitone capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Open-Label CA-008 (Vocacapsaicin) in Bunionectomy
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.
    

Detailed description: 
      This is a Phase 2, single-center, open-label study evaluating a single dose of CA-008 4.2 mg
      administered with different standard-of-care anesthetic regimens during an elective
      unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus
      deformity (bunionectomy).
    

Intervention name(s): CA-008; Ketorolac; Acetaminophen IV; Fentanyl; Bupivacaine Hydrochloride; Lidocaine HCl; Celecoxib; Acetaminophen Oral; Lidocaine Hydrochloride; Exparel
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug: CA-008 4.2 mg reconstituted in saline; 30 mg IV at the onset of anesthesia; 1 g at the onset of anesthesia; 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery; 0.25% 30 mL (75 mg) prior to surgery; 1.5% 12 mL at the end of surgery; 200 mg PO bid each day postoperative; 1 g postoperative; 2% 15 mL at the end of surgery; Bupivacaine liposome injection suspension
Other intervention name(s): Vocacapsaicin
Intervention MeSH terms: Acetaminophen; Celecoxib; Ketorolac; Lidocaine; Fentanyl; Bupivacaine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Tolerability and Pharmacokinetic of BI 409306
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the safety and tolerability of
      BI 409306 in healthy male genotyped volunteers following oral administration of single rising
      doses.

      The secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate
      release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when
      administered as immediate release solid oral dosage compared to oral drinking solution and
      (3) to compare the safety and pharmacokinetic profiles between two different groups of
      genotyped subjects.
    


Intervention name(s): Placebo; Placebo .; BI 409306
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solution for oral administration; Immediate release solid oral dosage; Immediate release solid oral dosage medium
Intervention MeSH terms: BI 409306
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Observational Program to Assess Routine Use of Add-back Therapy in Patients With Endometriosis in Russian Federation, Planned for 6-month Course of Lucrin Depot® (Leuprorelin)
Condition: Genital Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      The purpose of this study is to assess rates of administration of add-back therapy in
      patients with endometriosis in the Russian Federation, during a 6-month course of
      gonadoliberin agonist leuprorelin 3.75 mg.
    

Detailed description: 
      This was a non-interventional, observational program in which Lucrin Depot (leuprorelin
      acetate) and add-back therapy (hormone and non-hormone) were prescribed in the usual manner
      in accordance with the terms of the local marketing authorization with regards to dose,
      population and indication (for leuprorelin acetate) and with regards to the local guidelines
      or therapeutic recommendation (for add-back therapy).

      The rationale for the study was the necessity to characterize the patient population and
      long-term leuprorelin acetate administration in the Russian Federation. Further, it was
      important to characterize the compliance, tolerability, and safety profile of this therapy in
      the routine clinical care setting in the Russian Federation.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Lucrin Depot; genital endometriosis; 6 months therapy
Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects
Condition: Dyslexia
MeSH terms: Dyslexia
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the efficacy and safety of a new medical device
      (Atoldys/ Lexilens glasses) on the improvement of reading skills of young dyslexic subjects.
    

Detailed description: 
      Dyslexia is defined as a specific learning disability that is characterized by reading
      difficulties, in the absence of intellectual disability, neurological or psychiatric
      disorder, uncorrected sensory disturbance (sight, hearing) or an educational deficiency.

      Dyslexia appears in the child from the earliest stages of learning in the form of a
      difficulty in mastering the learning of reading. This disorder is manifested by a generally
      hesitant reading, slowed down, full of errors, requiring a lot of effort for the child and
      may impact his reading comprehension. The dyslexia-related deficiency is of variable
      intensity depending on the individual; it may be accompanied by calculus disorders
      (dyscalculia), oral language (dysphasia), motor coordination (dyspraxia) or attention
      disorders with or without hyperactivity. In nearly 40% of cases, a child affected by Dys
      disorders presents several learning disorders.

      To date, the causes of dyslexia are not yet clearly established. The wide variety of symptoms
      and disorders associated with dyslexia does not facilitate the identification of precise
      neurobiological / psycho cognitive mechanisms. There are therefore several theories:
      phonological, visual, temporal, cerebellar or proprioceptive auditory processing.

      Recently, following work published in 2017, an anatomical cause based on Maxwell's spots
      could also be a cause of dyslexia.

      The aim of this study is to evaluate a new medical device (class I CE marked) to compensate
      this probable anatomical cause: the Atoldys/ Lexilens glasses
    

Intervention name(s): Atoldys/ Lexilens - SHAM; SHAM- Atoldys/ Lexilens
Intervention type(s): Device; Device
Intervention description(s): Atoldys/ Lexilens: glasses with specific light frequency SHAM: glasses with no frequency; SHAM: glasses with no frequency Atoldys/ Lexilens: glasses with specific light frequency
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Topical Corticosteroid Use on Insulin Sensitivity and Bone Turnover
Condition: Atopic Dermatitis; Atopic Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators believe that the emerging epidemiological evidence connecting topical use
      of corticosteroids to the development of type 2 diabetes and osteoporosis point to
      potentially massive, yet clinically unacknowledged problems associated with topical
      corticosteroid treatment. Using state-of-the-art methodology, the present study will
      delineate the impact of topical corticosteroid use on insulin sensitivity and bone turnover
      markers in patients with atopic dermatitis and, thus, provide important data that may have
      implications for millions of people using topical corticosteroids.
    


Intervention name(s): Betnovate, betamethasone dipropionate ointment 0.1% and placebo; Protopic, tacrolimus ointment 0.1%
Intervention type(s): Drug; Drug
Intervention description(s): Explore the systemic effects of Betnovate; Compare the systemic effects of Betnovate to Protopic
Intervention MeSH terms: Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Tacrolimus; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomised, two-arm, active comparator, double-dummy, double-blinded trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: topical corticosteroids; topical calcineurin inhibitors
Effects of Feet Mechanical Stimulation on Cardiovascular Autonomic Profile and Inflammation in Parkinson's Disease
Condition: Parkinson's Disease; Autonomic Neuropathy; Inflammation; Hypertension
MeSH terms: Parkinson Disease; Inflammation
Study type: Interventional

Summary: 
      In the present study, investigators test the hypothesis that a controlled mechanical pressure
      applied on specific sites of both fore-feet (ES) can reduce the inflammatory state and
      arterial blood pressure in patients with Parkinson's Disease by increasing the overall
      parasympathetic activity and reducing vascular sympathetic modulation.
    

Detailed description: 
      Neuroinflammation may contribute to the cascade of events leading to neuronal loss in
      Parkinson's disease (PD) thus facilitating motor and autonomic impairment. A link between
      autonomic function and chronic and acute inflammation has been previously described.
      Specifically, active inflammatory state was associated with an overall increased sympathetic
      tone, whereas the parasympathetic cholinergic activation seemed to promote a decrease of
      inflammatory compounds in inflamed tissues. In addition, a functional link between peripheral
      sensory afferents and autonomic control has been reported. In a recent study it was observed
      that in PD patients a somatosensory activation by mechanical stimulation of specific sites of
      the fore-foot (effective stimulus, ES), improved gait, increased cardiac vagal modulation and
      decreased vascular sympathetic activity at rest. This latter effect was associated with a
      decline in arterial blood pressure values.

      The present study is aimed at:

        -  Addressing the magnitude of the inflammatory state in PD patients.

        -  Testing the hypothesis that a change in the autonomic profile of PD patients induced by
           ES, consistent with cardiovascular increased parasympathetic and decreased sympathetic
           activities, may promote an overall reduction of the PD inflammatory state.
    

Intervention name(s): Foot Mechanical Stimulation (Gondola®, CE marking n° 0476)
Intervention type(s): Device
Intervention description(s): The feet mechanical stimulation will be performed by Gondola (Gondola®, CE marking n° 0476).
Other intervention name(s): Pressure-controlled mechanical stimulator (Gondola®)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Foot mechanical stimulation; Autonomic nervous system; Inflammation; Parkinson's disease; Spectral analysis; Heart rate variability; Blood pressure variability
Impairments of Oral Language in Mobius Syndrome
Condition: Möbius Sequence
MeSH terms: Mobius Syndrome
Study type: Observational

Summary: 
      The Möbius syndrome constitutes a congenital disorder classically caused by genetic and
      environmental factors. The clinical manifestations include lesion of the facial and abducens
      nerves associated with limb malformations specially club foot. The speech-language
      manifestations include compromise of oral and deglutition, speech and language functions,
      secondary to cranial nerves lesions and mental retardation. The language compromise in this
      disorder is still not well known. In this way, the main objective of this study is to
      characterize the oral language in a population of fifteen subjects with Möbius syndrome with
      age ranging from two to thirteen years old, from both sexes, seen in one of the three main
      center for genetic diagnosis in the state of Ceará. The present work is a descriptive study
      of a cross-sectional design conducted from February to December/2002, using a clinical
      evaluation of language components including morphology, syntax, semantics and pragmatics. The
      investigators identified exclusive speech involvement in 20,0% of the subjects, language
      disturbance in 46,7%, speech and language disturbance in 13,3% and oral language involvement
      in 26,7%. The investigators conclude that the language disturbance in the Möbius syndrome
      presents with a variable compromise of all oral language components. The delay in
      linguistical development, incomprehensive speech and the deficit of constructions of
      sentences and narrations are constant.
    

Detailed description: 
      In this way, the main objective of this study is to characterize the oral language in a
      population of fifteen subjects with Möbius syndrome with age ranging from two to thirteen
      years old, from both sexes, seen in one of the three main center for genetic diagnosis in the
      state of Ceará. The present work is a descriptive study of a cross-sectional design conducted
      from February to December/2002, using a clinical evaluation of language components including
      morphology, syntax, semantics and pragmatics.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        fifteen subjects with Möbius syndrome with age ranging from two to thirteen years old, from
        both sexes, seen in one of the three main center for genetic diagnosis in the state of
        Ceará, Brazil.
      
Keywords: Möbius syndrome; Language; Speech, Language and Hearing Sciences
Effectiveness of Interfaces Program to Promote Work Ability of People With Disabilities
Condition: Disabilities Mental; Disabilities Physical
MeSH terms: Deafness; Blindness
Study type: Interventional

Summary: 
      the objectives of the study is to Evaluate the effectiveness of "The Interfaces Program" to
      promote person's components, performance and improving the work environment of people with
      disabilities.
    

Detailed description: 
      People with disabilities experience many barriers in trying to integrate into the competitive
      market. The barriers may be result of the unique characteristics of the individual
      (characteristics of the disability, occupational history, work self-efficacy, etc.), the
      characteristics of the occupation and occupational performance (characteristics of the job
      and the job demands) and environmental barriers (accessibility, discrimination, stigma and
      lack of opportunities, etc.). The main response to the integration problems of people with
      disabilities in the world of work is supported employment service. Supported employment
      focuses primarily on placement of the individual and do not relate to barriers relating to
      the individual's ability to develop a career.

      The present study examines the effectiveness of a new intervention program "The interfaces
      program " aiming to promote career development process among people with disabilities working
      in the competitive market. The program presents an integration of the
      Person-Environment-Occupation-Performance (PEOP) model and lead career development theories.
      The ultimate goal of this study is to examine the effectiveness of the "interfaces program"
      by examining its impact on the promotion of objective and subjective measures among people
      with disabilities who work and receive supported employment services.
    

Intervention name(s): The Interfaces Program; IPS
Intervention type(s): Behavioral; Behavioral
Intervention description(s): career development program; supported employment using the individual placement and support (IPS) model
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: career development, people with disabilities
Echo Doppler (ED )Score and D-dimer (DD) Level in the Evaluation of VTE Recurrence After Anticoagulant Treatment Cessation
Condition: Previous Vka Treatment; Previous Proximal VTE
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial is to perform a prospective multicentric study to determine
      predictive ED score and D-dimer level in the evaluation of the thromboembolic event
      recurrence after anticoagulant treatment cessation.

      The patients are included in the study from the anticoagulant treatment cessation. An ED
      score and a blood sample are performed at this time and one month later. Then, the patients
      are followed up by phone for 2 years.
    

Detailed description: 
      DDimer levels are centralized in University Hospital of Grenoble at the end of the study
    

Intervention name(s): ED, DDimers and phone follow up
Intervention type(s): Other
Intervention description(s): ED score, DDimers level and phone questionnary
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: VTE; VKA treatment; VKA treatment cessation
Reduced IV Fluids to Improve Clearance of HDMTX in Children w/Lymphoma or Acute Lymphoblastic Leukemia
Condition: Lymphoma; Acute Lymphoblastic Leukemia; Pediatric Cancer; Pediatric ALL; Pediatric Lymphoma
MeSH terms: Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine whether a reduced volume hydration regimen will lead to a shorter time to
      methotrexate clearance when compared to a standard intravenous (IV) hydration regimen.
    

Detailed description: 
      This study uses a prospective randomized controlled crossover study design. Neither patients
      nor clinicians are blinded to the standard versus reduced intravenous fluids (IVF) regimen.
      Patients are randomized to begin with standard volume or reduced volume IVF. Over the course
      of 4 cycles of High Dose Methotrexate (HDMTX), patients alternate between standard and
      reduced volume post hydration fluids protocols.
    

Intervention name(s): Intravenous fluids
Intervention type(s): Drug
Intervention description(s): Administration of post HDMTX intravenous fluids (IVF)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study uses a prospective randomized controlled crossover study design.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: High Dose Methotrexate; HDMTX; Intravenous Fluids
qQ-lab Daily-IBS for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome (IBS)
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      -  Primary purpose: To assess satisfaction with overall improvement in symptoms, including
           individual bowel symptoms, after 4 weeks of administration of gQ-lab to patients with
           irritable bowel syndrome (IBS).

        -  Secondary purposes: To assess the correlation between intestinal attachment and
           therapeutic effects of gQ-lab through the visual analog scale (VAS) assessment of each
           IBS-related symptom and measurement of changes in quality of life and fecal flora in the
           placebo group and gQ-lab group after 4 weeks of gQ-lab administration.

      To assess safety, including adverse reactions, vital signs (including weight), physical
      examination, and changes in blood test results.

      To examine the rate of positive gut quotient (gQ) values in patients diagnosed with IBS as
      per the ROME III criteria. Further, to examine how the ROME III-based symptom scale score
      compared with that of the quality of life scale in the gQ questionnaire.
    


Intervention name(s): gQ-lab daily; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): probiotics; powdered skim milk, lactose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo-controlled, parallel-group
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment