bioihbjkbjnl/mcl2 huggingface dataset:
Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Intervention: FreeStyle Navigator; Standard SMBG
Intervention description: Masked CGM day 1 to 15, unmasked CGM days 15 to 100; Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CGM; MDI

Summary:

      To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic
      control by;

        1. regularly checking and understanding Continuous Glucose data & trend arrows at times
           other than the standard pre-meal bolus calculation test times and

        2. review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care
           Professional (HCP) and adjusting behaviours & therapy from interpretation of the
           Continuous Glucose profiles.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years and over

          -  Type 1 diabetes on MDI with bolus injections for >6 months prior to study enrolment or
             Type 2 diabetes treated with 2 or more insulin injections daily.

          -  In the investigator's opinion, thought technically capable of using FreeStyle
             Navigator GM System device.

          -  HbA1c between 7.5 and 12.0% (58 to 108 mmol/mol) for previous test obtained within 6
             months prior to point of enrolment

        Exclusion Criteria:

          -  Concomitant disease or condition that may compromise patient safety, including
             unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any
             uncontrolled chronic medical condition

          -  Female subject is pregnant or planning to become pregnant within the planned study
             duration. Subjects who become pregnant during the study will be discontinued from the
             study.

          -  Currently using / has previously used a Continuous Glucose Monitoring System within
             the last 6 months.

          -  Currently using Continuous Subcutaneous Insulin Infusion (CSII)

          -  Currently using basal/long acting insulin only.

          -  Participating in another study of a glucose monitoring device / drug that could affect
             glucose measurements / management

          -  Known allergy to medical grade adhesives

          -  In the investigators opinion is unsuitable to participate due to any other
             cause/reason.
PharmacofMRI of Anxiolytic Medications (Pregabalin)
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Intervention: Pregabalin 50mg; Pregabalin 200 MG; placebo
Intervention description: One dose of oral pregabalin (50 mg) to be administered one hour prior to fMRI scan; One dose of oral pregabalin (200 mg) to be administered one hour prior to fMRI scan; One dose of matched oral placebo to be administered one hour prior to fMRI scan
Intervention MeSH terms: Pregabalin
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: anxiety; functional magnetic resonance imaging; fMRI; pregabalin; Lyrica

Summary:

      The purpose of this study is to use functional magnetic resonance imaging (fMRI) in healthy
      controls to examine the acute effects of certain anxiolytic medications on brain function. In
      this case, the medication pregabalin will be used. The investigators hypothesize that
      pregabalin (at doses of 50 mg and 200 mg, versus placebo) will yield a reduction in amygdala
      and insula activity (in a dose-dependent fashion) during emotion processing using fMRI.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male, or female (not pregnant or intending to become pregnant during the study)

          -  Between the ages of 18-30.

          -  In good general health.

          -  No specific contraindications to the drug being administered

        Exclusion Criteria:

          -  Subjects with a history of DSM-IV depressive disorder, psychotic disorder, anxiety
             disorder

          -  Subjects who meet criteria for substance abuse or dependence within the last 6 months

          -  Subjects with an positive urine screen for illicit drugs having clinically significant
             abnormal laboratory, ECG or physical examination findings not resolved by the baseline
             visit

          -  Patients who have taken psychotropic drugs or antidepressants (including monoamine
             oxidase inhibitors, MAOI's) within the last year

          -  Subjects who are left-handed.

          -  Subjects suffering suffers from claustrophobia, or phobia for injections or blood

          -  Magnetic Resonance Imaging related exclusion criteria: cardiac pacemaker, metal
             fragments in eyes/skin/body (shrapnel), subjects who have ever been a metal
             worker/welder; history of eye surgery/eyes washed out because of metal,
             aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid,
             heart valve replacement, subjects who are in the first trimester of pregnancy,
             subjects with an I.U.D. (birth control device), a shunt (ventricular or spinal),
             electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (TENS unit).
Human Urinary Kallidinogenase Improve Short Term Motor Functional Outcome of Acute Ischemia Stroke Patients
Condition: Stroke, Acute
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Intervention: Kallikrein
Intervention description: HUK has been approved by China's State Food and Drug Administration as a state category I new drug for the treatment of stroke patients. Based on the available evidence, HUK injection ameliorates neurological deficits and improves long-term outcomes.
Intervention MeSH terms: Kallikreins
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Acute cerebral infarction is a common type of ischemic stroke, causing brain dysfunction in
      patients with high morbidity and disability. With the changes in people's diet, lifestyle
      patterns and population aging, the incidence of acute cerebral infarction has increased year
      by year, which has become an important cause of disability and death in middle-aged and
      elderly patients. The human urinary kallidinogenase (HUK) was used in China in the management
      of acute ischemic stroke (AIS) in recent years. However, the mechanism of HUK on AIS has not
      been systematically investigated. This study aimed to assess the effect of HUK on motor
      functional outcome and relative corticospinal tract recovery in the patients with AIS.
      Diffusion tensor imaging(DTI) and diffusion tensor tractography(DTT) have all been used to
      observe features of cerebral white matter fibrous structures. In addition, diffusion tensor
      tractography which is used to trace fiber bundle and evaluate white matter fiber bundle
      integrity and direction is the only non-invasive imaging method to display the corticospinal
      tract in vivo.
    

Eligibility criteria:

        Inclusion Criteria:

        18 years old ≤ age <80 years old; Within 72 hours of onset; Diagnosed as acute cerebral
        infarction, and confirmed by magnetic resonance imaging as an acute infarct in the
        unilateral corticospinal tract; The patient's onset muscle strength grade <4; No history of
        cerebral infarction or residual physical activity disorder; No other intracranial lesions;
        Patients or their legal representatives voluntarily Sign the informed consent form;

        Exclusion Criteria:

        Intracranial hemorrhagic disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
        Transient ischemic attack; Intravenous thrombolysis and interventional thrombectomy;
        Serious physical illness affects limb movement before enrollment ; Apply other drugs with
        nutritional nerves and regeneration during the study period; Unstable vital signs, severe
        liver and kidney diseases or malignant tumors; Incomprehensible or incapable of obeying the
        research procedure or being unable to follow up due to mental illness, cognitive or
        emotional disorders;
Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.
Condition: Pulpitis - Irreversible
MeSH terms: Pulpitis
Intervention: Pro Root MTA®; EBRRM®
Intervention description: Patients in this group will receive the pulpotomy with Pro Root MTA®.; Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 64.0
Sex: All
Minimum age: 10 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Although many pulpotomy agents are commercially available, there is a dearth of clinical
      research comparing the efficacy of these agents in treating individuals with irreversible
      pulpitis. Bioceramic and MTA both have similar clinical uses, but Bioceramic is distinguished
      from MTA by its superior chemical, physical, and biological properties. This study aims to
      address this knowledge deficit by assessing the performance of biocompatible materials in
      pulpotomy procedures for the treatment of symptomatic permanent teeth in adults with deep
      caries. For permanent teeth with a completed root and a diagnosis of irreversible pulpitis
      without apical periodontitis, this research will compare the success rates of MTA and EBRRM
      pulpotomy procedures in order to provide evidence-based clinical practice guidelines for the
      treatment of this disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with diagnosis of irreversible pulpitis without apical periodontitis

          2. Either gender

          3. Lower Age 10 Years - Upper Age 40 Years

        Exclusion Criteria:

          -  Teeth displaying indications of resorption.

          -  Teeth that have not fully developed, characterized by open apices.

          -  Canals that are calcified or obstructed.

          -  Perforations that were caused by the dentist.

          -  Fractures in the root

          -  Teeth that cannot be restored

          -  • Teeth that are unable to withstand frigid temperatures, have a sinus infection, or
             have swelling around them.

          -  There has been no pulp exposure despite the removal of carious lesion.

          -  Ten minutes after a pulpotomy, hemorrhage could not be stopped.

          -  Necrotic or partly necrotic pulp is indicated by insufficient bleeding after exposure.
Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Photodynamic therapy; Imiquimod
Intervention description: Administered 4 weeks after completion of imiquimod therapy; Imiquimod 3.75% cream, up to 2 packets, applied topically daily for two 2-week cycles separated by a no-treatment interval of 2-weeks, followed observation
Intervention MeSH terms: Imiquimod; Aminolevulinic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Imiquimod; Photodynamic therapy; Actinic keratoses; Sequential therapy; Therapeutic uses

Summary:

      The purpose of this study is to explore the effect of treating actinic keratoses of the face
      with imiquimod 3.75% cream followed by photodynamic therapy in comparison to treatment with
      imiquimod alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults; 18 and over

          -  At least 10 and no more than 30 clinically typical actinic keratoses on the face

        Exclusion Criteria:

          -  Hypertrophic actinic keratoses or other skin lesions on the head that might required
             excluded treatment during the study

          -  Known contraindication to treatment with imiquimod or photodynamic therapy

          -  Condition that would limit compliance, be a potential safety risk, or require therapy
             with an excluded treatment

          -  Systemically immunocompromised

          -  Pregnant or nursing

          -  Dermatologic disease and/or condition in treatment area that might exacerbated by
             treatment with imiquimod, cause difficulty with examination, or require therapy with
             an excluded treatment

          -  Participation in another clinical study

          -  Treatment within the past 60 days with:

               -  Ultraviolet therapy

               -  Systemic immunomodulators

               -  Chemotherapeutic or cytotoxic agents

               -  Investigational agents

          -  Treatment on the head within the past 60 days with:

               -  Imiquimod

               -  Photodynamic therapy

               -  Red or blue light source therapy

               -  Cryotherapy or chemotherapy

               -  Surgical excision or curettage

               -  Topical corticosteroids

               -  Laser

               -  Dermabrasion

               -  Chemical peel

               -  Topical retinoids

               -  Topical 5-fluorouracil

               -  Topical pimecrolimus or tacrolimus

               -  Topical diclofenac

          -  Treatment for actinic keratoses on the head within the past 60 days
Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: hylan G-F 20; 1% sodium hyaluronate
Intervention description: Three 2 cc injections at weekly intervals; Three 2 cc injections at weekly intervals
Intervention MeSH terms: Hyaluronic Acid; Hylan
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate whether the investigators can develop a computer
      algorithm to predict which individual patients will respond to injections of hyaluronic acid
      (HA) products for knee osteoarthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Symptomatic knee osteoarthritis presenting to physician's office

          -  Radiographic evidence of knee osteoarthritis

          -  Age 18 years or older

          -  Failed minimum of 3 months of non-operative treatment, including, but not limited to,
             Tylenol, anti-inflammatory medication, cortisone injection, physical therapy, bracing,
             and/or heel wedge

          -  Symptoms for at least 3 months

        Exclusion Criteria:

          -  Associated ligamentous instability

          -  History of deep knee infection

          -  Candidate for total knee arthroplasty or arthroscopy

          -  Peripheral neuropathy.

          -  X-rays that are completely negative and only MRI evidence or arthroscopic evidence
             (from previous arthroscopy) of OA.

          -  Prior HA injections at any point in the past

          -  Chondrocalcinosis

          -  Patients with precautions or contraindications for viscosupplementation use

          -  Cortisone injection within past 3 months
Treating Acutely Agitated Patients With Asenapine Sublingual Tablets
Condition: Agitation
MeSH terms: Psychomotor Agitation
Intervention: Asenapine; Placebo
Intervention description: Asenapine Sublingual Tablet 10mg, single-dose; Placebo Sublingual Tablet, single-dose
Intervention MeSH terms: Asenapine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute Agitation; schizophrenia; bipolar; psychosis; panss-ec

Summary:

      Our proposal is to administer asenapine to patients who are clinically agitated and in need
      of immediate intervention. At present there are no controlled studies that we know of that
      explores the use of asenapine for this purpose. Establishing the utility of asenapine for
      this common clinical problem will support its use as an additional treatment option in
      acutely agitated patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients will be between the ages of 18 and 65

          -  Be acutely agitated as determined by a total score of ≧ 14 on the PANSS-EC and at
             least one individual item score of ≧ 4

          -  Patients must have the capacity to provide informed consent, and such consent will be
             obtained prior to participation

        Exclusion Criteria:

          -  Patient is knowingly pregnant

          -  Patient is less than 18 or greater than 65 years old

          -  Patient had a past adverse or allergic response to Asenapine
Buprenorphine to Improve HIV Care Engagement and Outcomes
Condition: HIV; Substance Related Disorders
MeSH terms: Substance-Related Disorders
Intervention: Buprenorphine/naloxone; Methadone Maintenance Therapy
Intervention description: Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.; Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
Intervention MeSH terms: Buprenorphine; Methadone; Buprenorphine, Naloxone Drug Combination; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 281.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare two models of substance abuse treatment in Vietnam,
      and how they each affect HIV care. In Vietnam, the current model for treating people with HIV
      who are also dependent on opioids is to refer them to methadone maintenance treatment
      centers. The new model the protocol will study is treatment of HIV and opioid dependence with
      buprenorphine/naloxone and counseling in the HIV clinic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV positive

          -  Current moderate or severe Diagnostic and Statistical Manual (DSM-V) opioid use
             disorder

          -  Urine drug screen positive for opioids

          -  Interested in receiving treatment for opioid dependence

          -  Age at least 18 years old

          -  Willing to practice an effective method of birth control, if female

        Exclusion Criteria:

          -  Known hypersensitivity to buprenorphine or naloxone

          -  aspartate aminotransferase (AST) & alanine aminotransferase (ALT) > 5x upper limit

          -  Currently pregnant or breastfeeding

          -  Serious medical or psychiatric illness in past 30 days (e.g. opportunistic infection,
             psychosis) that precludes safe participation in the opinion of study physician

          -  Methadone maintenance treatment within 30 days of consent
Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Pregabalin; Lorazepam; Pregabalin; Placebo
Intervention description: Pregabalin 150-300 mg given twice a day; Lorazepam 3-4 mg given twice a day; Pregabalin 450-600 mg given twice a day; Placebo
Intervention MeSH terms: Pregabalin; Lorazepam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 615.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to characterize the safety and efficacy in patients with
      generalized anxiety disorder after short- (3 months) and long-term (6 months) use of
      Pregabalin (Lyrica).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis Generalized Anxiety Disorder

          -  HAM-A score >=18 and HAM-D (item 1) score >=2 at screening and baseline

          -  Needs pharmacological treatment

        Exclusion Criteria:

          -  Current or past diagnosis of any other DSM IV Axis I disorders

          -  A history of failed treatment with a benzodiazepine

          -  Any clinically significant, serious, or unstable hematologic, autoimmune, endocrine,
             cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder