bioihbjkbjnl/mcl2 huggingface dataset:
A Pragmatic Randomized Control Trial Comparing Models of Care in the Management of Prescription Opioid Misuse
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial evaluates two standard of care treatments for opioid addiction: methadone and
      buprenorphine/naloxone. In order to improve patient care, the study will address real-world
      treatment conditions, including strict regulations for methadone dosing (i.e. initially
      dispensed daily at the pharmacy until stabilisation) vs. flexible take-home dosing for
      buprenorphine/naloxone. The OPTIMA study is designed with the intention to support
      patient-provider decision-making and evaluate health related outcomes with the overall aim of
      improving treatment outcomes through enhancing patient-centered approaches in clinical care.
    

Detailed description: 
      This is a multicenter, open-label, 2-arm, randomized trial with a pragmatic design involving
      276 individuals with prescription opioid use disorder. Participants will be randomized to
      receive either:

        1. Methadone provided via initial daily witnessed ingestion as per local guidelines.

        2. Buprenorphine/naloxone maintenance therapy provided via flexible take-home dose regimens
           dispensed as per the physician's discretion, once clinical stability is achieved.

      Once randomized to a study medication and treatment initiation and induction has begun, study
      physicians and participants will discuss the treatment plans and procedures going forward.
      Once treatment initiation has taken place, the participant will attend study visits every 2
      weeks (including collection of urine samples) for the 24-week intervention period. For all
      study sites, standardized guidelines exist and will be adhered to for the safe induction of
      both medications. Frequency of illicit opioid use, intensity of craving and other secondary
      endpoints will also be assessed via standardized questionnaires.
    

Intervention name(s): Methadone; Buprenorphine-Naloxone
Intervention type(s): Drug; Drug
Intervention description(s): Methadone is a synthetic analgesic drug used as a substitute drug in the treatment of opioid use disorder. Methadone is administered via strict daily witnessed ingestion.; Buprenorphine/Naloxone is an opioid agonist treatment used to treat opioid use disorder. Buprenorphine/Naloxone is administered via flexible take home dosing once the patient has reached stabilization as per physician discretion.
Other intervention name(s): Methadose; Suboxone
Intervention MeSH terms: Buprenorphine; Methadone; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid agonist treatment; pragmatic; prescription opioid use; patient engagement
A Clinical Trial Testing the Efficacy of PDT in Preventing Amputation in Diabetic Patients
Condition: Diabetic Foot Infection; Osteomyelitis; Photo Antimicrobial Chemotherapy
MeSH terms: Osteomyelitis; Diabetic Foot
Study type: Interventional

Summary: 
      The feet of diabetic patients continue to be an important problem in medicine. In general,
      patients with diabetic foot have some sort of amputation, especially in underserved
      populations. It is clearly necessary to develop novel treatment strategies for this worldwide
      health problem. Photodynamic therapy (PDT) , is a low cost and highly effective alternative
      treatment concerning infections avoiding amputations in the diabetic foot.
    

Detailed description: 
      Patients with infected diabetic foot were grouped according to the Wagner system for
      classifying foot lesions. All patients presented Wagner Grade 3 classification, with
      osteomyelitis in one or more toes. The study included only patients who had circulatory
      viability.

      For PDT treatment the fistula and/or ulcer was used as a gateway to the bone. The treated
      area (bones and fingers) was irrigated with a solution of phenothiazinium salts. After that,
      light irradiation was performed with optical fibers or led device above the wound. PDT
      treatment always in outpatients, once or twice a week.
    

Intervention name(s): PDT; Ciprofloxacin
Intervention type(s): Radiation; Other
Intervention description(s): clinical treatment of infected diabetic foot; antibiotics and or surgical debridment
Other intervention name(s): photoantimicrobial chemotherapy; Conventional treatment
Intervention MeSH terms: Ciprofloxacin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: non-randomized clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetic foot; Osteomyelitis; PACT; PDT; Singlet oxygen; antimicrobial; diabetes; Wagner scale
Phase 1 PK, Bioavailability, Safety Study of Clonidine MBT w Catapres in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetic dose proportionality of 50 μg
      and 100 μg Clonidine and comparative bioavailability of clonidine with that from the
      Reference drug, Catapres® 100 μg oral tablets following single dose administration in healthy
      subjects.
    

Detailed description: 
      A single blind, randomised, 3-period, 3-sequence single-dose crossover study to determine the
      pharmacokinetic dose proportionality of Clonidine MBT 50 μg and Clonidine MBT 100 μg and
      comparative bioavailability of clonidine from the Reference drug, Catapres® 100 μg oral
      tablets following single dose administration in healthy male and female subjects.

      36 subjects will be randomised for 30 to complete the study. The study will comprise of 3
      Treatment Periods (1, 2 and 3) and a post study follow up (7 - 12 days after the last dose).
      Study drug will be administered on the morning of Day 1. Pharmacokinetic (PK) blood samples
      will be collected for each of three treatment periods. Safety will be evaluated at specified
      times throughout the study. There will be at least 7 days between dose administrations.
    

Intervention name(s): Clonidine MBT 50µg; Clonidine MBT 100µg; Catapres 100μg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clonidine MBT 50µg, single dose; Clonidine MBT 100µg, single dose; Catapres tablet 100μg, single dose
Other intervention name(s): Clonidine Lauriad; Clonidine Lauriad; Catapres
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clonidine
Effects of Drugs on Responses to Brain and Emotional Processes
Condition: Autism Spectrum Disorder; Healthy
MeSH terms: Autism Spectrum Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To study the effects of a psychostimulant on responses to affective touch in individuals with
      a range of autistic traits
    


Intervention name(s): MDMA; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be given 1.5mg/kg of MDMA; Participants will be given a placebo capsule that will only contain lactose.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
Condition: Knee Osteoarthritis; Primary Total Knee Arthroplasty; Physical Therapy; Pain; Knee Extension
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to learn if using an Interspace between the Popliteal Artery and
      Capsule of the Knee (iPACK) injection technique (also called a "nerve block") that numbs the
      nerves going to the back part of the knee to aid in physical therapy after surgery. The iPACK
      technique uses a numbing solution (local anesthetics) that is injected behind the knee to
      reduce pain and to help straighten the knee. This block may affect movement in the leg and
      make the legs weak, but thing is rare. A few institutions use the iPACK block for patients
      having total knee replacements, with the hope of providing good pain relief combined with
      improved mobility after surgery.
    


Intervention name(s): Ropivacaine; Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block; Saline
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): Local anesthetic (numbing drug); An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.; An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
Other intervention name(s): Naropin; iPACK; Posterior Capsule; Salt water placebo
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: iPACK; Interspace between the Popliteal Artery and Capsule of the Knee; Posterior Capsule block; Nerve Block
The Effect of Xolair (Omalizumab) on Allergy Blood Cells
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood
      tests will be done in a test tube to see if they react differently before and after
      treatment. The blood cells will be mixed with to whatever the person is allergic.
    

Detailed description: 
      Must be allergic-asthma with IgE between 30 and 700 IU/ml.
    

Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously; Placebo Injection
Other intervention name(s): Xolair; rhumabe35
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Allergic Asthma; Anti IgE; Xolair; Basophil; IL-13; IL-4; Histamine
DAPHNE Scale Validation in Frontotemporal Lobar Degeneration
Condition: Frontotemporal Lobar Degeneration
MeSH terms: Frontotemporal Lobar Degeneration
Study type: Observational

Summary: 
      Psycho-behavioral disorders assessment is crucial for the diagnosis and follow-up of patients
      with frontotemporal degeneration (FTD). DAPHNE scientific staff have therefore developed a
      quantification and follow-up scale specifically dedicated to patients with FTD in current
      clinical practice. This scale is called DAPHNE to Disinhibition, Apathy, Perseveration, Hyper
      orality, Negligence and loss of Empathy.
    

Detailed description: 
      Psycho-behavioral disorders assessment is crucial for the diagnosis and follow-up of patients
      with frontotemporal degeneration (FTD). DAPHNE scientific staff have therefore developed a
      quantification and follow-up scale specifically dedicated to patients with FTD in current
      clinical practice. This scale is called DAPHNE to Disinhibition, Apathy, Perseveration,
      Hyperorality, Negligence and loss of Empathy. This study aims to validate this scale. This
      validation will include methodological steps required to develop a new clinical tool, by
      studying internal consistency, loyalty, and concurrent validity in comparison with validated
      existing tools. Complementarily, sensitivity and specificity will be assessed via a control
      population including patients with Alzheimer's disease, , progressive supranuclear palsy and
      bipolar disorder with cognitive disorders.
    

Intervention name(s): Psycho-behavioural assessment
Intervention type(s): Other
Intervention description(s): DAPHNE Scale
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Frontotemporal lobar degeneration according Neary (1998) and Raskowsky (2011)
        diagnostic criteria.
Bacterial Genomic Sequencing in Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection
      (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as
      evidenced by routine microbiology cultures. Recent work by the group on the genitourinary
      microbiome (GUM) has shown that female urine, even in the absence of culture evidence of
      bacteria does have evidence of bacterial DNA. Bacterial 16S rRNA can be isolated from urine
      and sequenced to identify bacterial species present in urine. From this the investigators can
      hypothesize that urinary bacteria contribute to urinary symptoms and that there is a
      difference in the bacterial communities in the urine of women who respond to Solifenacin, a
      drug used to treat OAB, versus those that do not.
    

Detailed description: 
      This is a prospective study with two groups: Women who have accepted a clinical
      recommendation for OAB treatment with solifenacin and a comparator (control) group of women
      unaffected by OAB. All women will have a baseline urine assessment with bacterial genome
      sequencing. Solifenacin treated patients will also have urine assessments with bacterial
      genomic sequencing at 4 and 12 weeks on treatment.
    

Intervention name(s): Solifenacin
Intervention type(s): Drug
Intervention description(s): 5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks
Other intervention name(s): Vesicare
Intervention MeSH terms: Solifenacin Succinate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Overactive Bladder; OAB; Urinary Tract Infection; UTI; Microbiome; Bacteria; Solifenacin; 16S rRNA sequence
Effectiveness and Safety of Intradermal Tranexamic Acid Injection as An Adjunctive Treatment for Melasma in Skin Type IV - V
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional

Summary: 
      A double-blind, randomized, split-face controlled trial of 34 female patients with melasma
      was conducted. All subject were randomized to receive either intradermal tranexamic acid or
      placebo injection on the right or the left side of their face.
    

Detailed description: 
      All subject were randomized to receive either 10 mg of intradermal tranexamic acid or placebo
      injection on the right or the left side of their face.

      The primary outcome was improvement of melasma lesions assessed by modified Melasma Area and
      Severity Index (mMASI) score and mexameter examination which includes Melanin Index (MI) and
      Erythema Index (EI).

      Measurements were done at baseline and every two weeks for twelve weeks. Additionally, side
      effects of therapy and subjects' satisfactory assessment with patient global assessment
      (PtGA) were also documented.
    

Intervention name(s): Tranexamic acid injection; Injection Water
Intervention type(s): Drug; Drug
Intervention description(s): The tranexamic acid injection was given intradermally to the facial skin; The 0.9% normal saline injection was given intradermally to the facial skin
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects were randomized to receive either 10 mg of intradermal tranexamic acid injection or placebo on one side of the face with 1:1 ratio. The allocation sequence was generated with a computer by an analyst.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: melasma; tranexamic acid; modified melasma area and severity index; melanin index; erythema index
Application of Unilateral Epidural Anesthesia in Older Patients With Hip Fracture
Condition: Spinal Anesthesia
MeSH terms: Hip Fractures
Study type: Observational [Patient Registry]

Summary: 
      Because of population ageing, fragility fractures have become a huge burden on healthcare
      systems and wider society. Fractures result in a sharp drop in both short-term and long-term
      quality of life, they have a strong influence on activities of daily living and mobility, and
      they are associated with a significant increase in 1-year mortality (18%-36%). Surgery can
      benefit elderly patients with hip fractures to an extent, but it entails inevitable risks,
      particularly with respect to general anesthesia. In recent years unilateral spinal anesthesia
      has attracted attention due to the advantages of hemodynamic stability, reduced anesthetic
      dosage, and sufficient sensory block.

      On the basis of a previous study, in the current study anesthetics were directly implanted
      into the unilateral epidural space in elderly patients with hip fractures prior to the
      completion of surgery. Data from 106 patients with old hip fractures who had undergone
      surgical treatment incorporating unilateral epidural anesthesia (UEA) or combined lumbar and
      epidural anesthesia were retrospectively analyzed in an attempt to provide a feasible
      solution for this kind of patients' anesthesia.
    

Detailed description: 
      Surgery can benefit elderly patients with hip fractures to an extent, but it entails
      inevitable risks, particularly with respect to general anesthesia. In recent years unilateral
      spinal anesthesia has attracted attention due to the advantages of hemodynamic stability,
      reduced anesthetic dosage, and sufficient sensory block. On the basis of a previous study, in
      the current study anesthetics were directly implanted into the unilateral epidural space in
      elderly patients with hip fractures prior to the completion of surgery.
    

Intervention name(s): unilateral epidural anesthesia; combined lumbar and epidural anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): The patients received unilateral epidural anesthesia; The patients received combined lumbar and epidural anesthesia
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The totally 106 older patients (49 male, 57 female) aged 65-94 years with hip fractures who
        underwent surgery between January 2018 and June 2020 at the Orthopedic Department of our
        Hospital.
      
Keywords: unilateral epidural anesthesia; combined lumbar and epidural anesthesia
Pharmacokinetics Study of CKD-11101 and NESP After IV Administration in Health Male Volunteers
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics of CKD-11101 and NESP after
      IV administration in health male volunteers
    

Detailed description: 
      Healthy volunteers are administrated CKD-11101 60μg and NESP 60μg once intravenously.
      (crossover) Every time before and after taking each medication, PK parameters and safety of
      CKD-11101 60μg and NESP 60μg are performed using a blood sample and conducting some
      tests(Laboratory test, V/S and Physical Examination, etc) respectively.
    

Intervention name(s): NESP 60μg; CKD-11101 60μg
Intervention type(s): Drug; Drug
Intervention description(s): Administrated NESP 60μg once intravenously; Administrated CKD-11101 60μg once intravenously
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CKD-11101; NESP; Darbepoetin alfa; Anemia; intravenous; Pharmacokinetics; Phase 1
Post-stroke Neural Plasticity With Atomoxetine
Condition: Atomoxetine Hydrochloride; Placebos
Study type: Interventional
Phase: Phase 2

Summary: 
      This proposal evaluates the safety and effectiveness of a noradrenergic drug named
      atomoxetine combined with motor training to enhance cortical plasticity and improve hand
      function after stroke.
    

Detailed description: 
      Extensive studies in laboratory animals and humans over the last ten years indicate that some
      medications, especially amphetamine, given with specific physical therapy may improve motor
      learning (and therefore recovery from stroke) more than physical therapy alone. However, the
      number of patients in clinical trials who have received physical therapy and amphetamine is
      very small, for two reasons: because amphetamine may interact with many other medications
      that stroke patients are already taking, and because its potential for addiction precludes
      its use on a daily basis. The investigators now wish to evaluate the effectiveness of a more
      selective medication, atomoxetine, known to have many fewer side effects and no potential for
      drug addiction. The proposed mechanism by which amphetamine enhances recovery is by
      increasing central levels of norepinephrine. While the investigators already know that this
      drug is more selective than amphetamine, the investigators would like to evaluate its effects
      on hand motor learning and motor recovery in chronic stroke patients in a clinical setting.
    

Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.; Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
Other intervention name(s): Strattera; Sham
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: motor training; motor recovery; human; neuroplasticity; transcranial magnetic stimulation