bioihbjkbjnl/mcl2 huggingface dataset:
Analysis of Adherence in Subjects Undergoing Differin Gel, 0.1% Treatment of Moderate to Severe Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to investigate potential differences between four
      treatment intervention groups in the adherence to treatment with Differin® Gel, 0.1%.
      Differin is approved by the Food and Drug Administration (FDA) to treat acne.
    

Detailed description: 
      Subjects will be enrolled and randomized in a 1:1:1:1 ratio to one of four treatment
      intervention groups. All Subjects will be treated once-daily for 12 weeks with Differin® Gel,
      0.1%. The four intervention groups were designated according to follow-up strategies as
      follows:

        -  More frequent than normal office visits

        -  Electronic reminders (voice, e-mail, text messages)

        -  Parental involvement/intervention reminders

        -  No intervention or reminders
    

Intervention name(s): Adapalene; frequent visits; electronic reminder; Parent reminder; Standard of care
Intervention type(s): Drug; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): All Subjects will treat the face once daily in the evening.; This group will be asked to return to the study center on weeks 1, 2, 4 and 8 for office visits (to remind the Subject to apply the study medication); in addition to the study visits on Weeks 6 and 12.; This group will receive a daily electronic reminder by email, text pager, or phone message (approximately at the same time each day) to use the study medication within a 4-hour window after the reminder and will return to the study center for study visits on Weeks 6 and 12.; In this group parents will be prompted by a daily electronic message by email, text pager, or phone message (approximately at the same time each day) to remind the Subject to use the study medication within a 4-hour window after the reminder. Parents will be instructed to then verbally deliver the message to the study Subject. Subjects will return to the study center for study visits on Weeks 6 and 12.; This group is considered to be the "standard of care" arm and will return to the study center for study visits on Weeks 6 and 12. This group will not receive any kind of reminders other than the instructions provided by the study staff during the study visits.
Other intervention name(s): Differin® Gel, 0.1%
Intervention MeSH terms: Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study of ONO-1078 in Patients With Chronic Sinusitis
Condition: Chronic Sinusitis
MeSH terms: Sinusitis; Chronic Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the efficacy and safety of ONO-1078 in patients with chronic sinusitis in a
      double-blind, randomized, placebo-controlled, parallel group, multi-center study
    


Intervention name(s): Placebo; Pranlukast hydrate
Intervention type(s): Drug; Drug
Intervention description(s): 0 mg BID for 12 weeks; 225 mg BID for 12 weeks
Intervention MeSH terms: Pranlukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-1078; chronic sinusitis
Effect of Neflamapimod on Brain Inflammation in Alzheimer's Disease Patients
Condition: Alzheimer Disease
MeSH terms: Infectious Encephalitis; Alzheimer Disease; Encephalitis; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      For this project, neflamapimod and placebo will be provided free of charge by the EIP company
      (www.eippharma.com). Neflamapimod is currently tested in 2 clinical trials in AD, one in
      Europe (The Netherlands) and one in the USA (clinical trials.gov/VX-745). The company
      commenced in May 2015 dosing in two phase 2a clinical studies in patients with Early AD: one
      in the Netherlands that is focused on PET amyloid imaging as the primary biomarker of drug
      effect, and one in the US (California) that is focused on Cerebrospinal fluid (CSF)
      evaluation to determine CSF drug concentrations and effects on inflammatory markers and
      disease biomarkers. Pharmacokinetic evaluation in these patients has demonstrated blood drug
      concentration levels in the predicted therapeutic range; and importantly, the data from the
      US study demonstrate that the drug achieves target drug concentrations in CSF, thus
      confirming the drug robustly enters the brain in humans.

      The present project offers us a unique chance to test this promising drug in AD patients. The
      aim of the study is to focus on PET neuroinflammation imaging as the primary biomarker of
      this drug effect. The chosen biomarker for imaging neuroinflammation in patients is [1
      8F]-DPA714.
    

Detailed description: 
      The present project is an intervention proof of concept study to test the efficacy of
      neflamapimod in a population of AD patients at an early stage.

      To track the impact of this drug in patients, the investigators will use an innovative
      radiotracer, [18F]DPA-714, as a promising ligand of microglial activation targeting the
      translocator protein (TSPO), specific of microglial activation. The use of [18F]DPA-714 will
      allow to monitor the evolution of neuroinflammation in patients as a function of treatment.
      The main objective will be to compare the level of inflammation using the [18F]DPA-714 in
      neflamapimod and placebo groups after 12 weeks of treatment. Blood and cerebrospinal fluid
      (CSF) samples and magnetic resonance imaging (MRI) will also be collected to assess
      inflammation markers and brain structure respectively in these patients.
    

Intervention name(s): VX-745; placebo
Intervention type(s): Drug; Drug
Intervention description(s): active drug capsules; placebo capsules
Other intervention name(s): neflamapimod
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Our mono-centric project will consist in a double-blinded randomized placebo-controlled study, assessing the effect of neflamapimod on brain inflammation in patients suffering of AD by using [18F]-DPA714
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of DHEA for Myotonic Dystrophy
Condition: Myotonic Dystrophy
MeSH terms: Myotonic Dystrophy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To test the efficacy and safety of two doses of dehydroepiandrosterone (DHEA) in adults with
      myotonic dystrophy
    

Detailed description: 
      Myotonic dystrophy is an inherited disorder that affects 1 per 8000 adults. The disease is
      characterize by muscular dystrophy, myotonia, cardiac disorders, cognitive function
      impairment, hypersomnia, hair loss, endocrine disorders. Recent small studies suggested that
      DHEA treatment may improve muscle strength in adults with myotonic dystrophy. Thus, the
      current study aims at investigating the safety and efficacy of a prolonged treatment with
      DHEA in adults with myotonic dystrophy.
    

Intervention name(s): dehydroepiandrosterone 100 and 400 mg
Intervention type(s): Drug
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: myotonic dystrophy; hypersomnia; dehydroepiandrosterone
Bayer/Cognitive Assessments With Multiple Sclerosis Subjects
Condition: Multiple Sclerosis, Relapsing-remitting; Multiple Sclerosis, Secondary Progressive
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Observational

Summary: 
      This study is designed to identify a brief screening evaluation for MS patients that is
      sensitive and specific to the MS population and which correlates with the findings of our
      standard-of-care neuropsychological assessments.
    

Detailed description: 
      Seventy five randomly identified patients will be evaluated. Consenting patients will perform
      a Symbol Digit Modalities Test (SDMT) and have the MS Center´s standard neuropsychological
      assessment performed. Tests comprising the standard assessment will be the RBANS (Randolph,
      1998), Multiscore Depression Inventory, Cross and Clock Drawings. The selfreported Beck
      Depression Inventory (BDI-II) will also be obtained. An Expanded Disability Status Scale
      (EDSS) will be recorded for each patient. The RBANS consists of six scales labeled (1)
      Immediate Memory, (2) Visuospatial/ Constructional, (3) Language, (4) Attention, (5) Delayed
      Memory, and (6) Total. Depression will be assessed by the BDI and the MultiScore Depression
      Inventory.

      The SDMT will be administered using standard instructions either orally or in writing. Use of
      the established norms for the SDMT will be used to determine if the MS patient is
      demonstrating some cognitive dysfunction. Scores less than 1.0 to 1.5 standard deviations
      below mean are suggestive of cerebral dysfunction. The results will be controlled for age,
      gender, and educational level.

      Additionally, the results of the 75 patient assessments will be reviewed to see the
      concordance between the results of the SDMT and the Neuropsychological Battery. The
      association of cognitive dysfunction as identified by the SDMT will be correlated with each
      of the six RBANS scales and other parameters of the cognitive aspects of the Battery.
      Statistical analysis will determine the sensitivity and specificity of the SDMT in
      determining abnormalities as well as an optimum cutpoint. This analysis will indicate
      possible cognitive problems and the need for further testing and, potentially, intervention.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from patients diagnosed with MS at the University of Louisville
        Neurologists PCS.
Mangoselect®: Characterization, Pharmacokinetics and Bioavailability of Xanthone Metabolites
Condition: Dietary Modification
Study type: Interventional

Summary: 
      The aim of this study is to compare pharmacokinetics and bioavailability of phenolic
      compounds, mainly xanthones, from a mangosteen extract, either ingested in a dry powder form
      or in an encapsulated form. Absorption and metabolism will be determined by measuring urinary
      excretion of phenolic metabolites and blood metabolic profile over 72 hours by means of High
      Pressure Liquid Chromatography (HPLC) coupled with tandem mass spectroscopy.

      The design of this study is a cross-over, double-blind and randomized trial on 10 healthy
      subjects.
    


Intervention name(s): MNGDPF; MNGEF
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Standardized mangosteen extract in dry powder form; Standardized mangosteen extract in encapsulated form
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Pediatric Hip Plate Versus Cannulated Screw in Pediatric Femoral Neck Fracture
Condition: Femoral Neck Fractures
MeSH terms: Fractures, Bone; Femoral Neck Fractures
Study type: Observational

Summary: 
      The purpose of this study is to compare the early postoperative radiologic and clinical
      outcomes of pediatric hip plate and cannulated screw fixation in pediatric femoral neck
      fracture (Delbet type II and Delbet type III).
    

Detailed description: 
      The children aged 3 to 14 years with femoral neck fracture that were treated with pediatric
      hip plate and cannulated screw fixation.
    

Intervention name(s): Pediatric hip plate; Cannulated screw
Intervention type(s): Procedure; Procedure
Intervention description(s): Children were treated with pediatric hip plate.; Children were treated with cannulated screw.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pediatric femoral neck fracture(Delbet type II and Delbet type III)
Safety and Efficacy of Autologous SVF Cells in Treating Patients With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      it's a self-control, double blind study of autologous adipose-derived stromal vascular
      fraction (SVF) to treat 50 osteoarthritic knees of grade II or III (K-L scale) under
      IRB-approved protocol in a feasibility and safety study.
    

Detailed description: 
      The adipose-derived SVF was obtained through disaggregation of lipoaspirate and resuspension
      of the SVF in 2 ml saline, with at least 50 million nucleated SVF cells and a mean viability
      of 85%, injected per single knee and the other knee treated with placebo.

      Cell suspension and placebo will be injected using ultrasound guidance. Safety and knee
      function will be evaluated by questionaires monthly and MRI in every three months post-op.
    

Intervention name(s): autologous SVF; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): SVF will be obtained from lipoaspirates of subjects which will contain more than 5 millions nucleated cells.; a Placebo treatment without SVF cells
Other intervention name(s): Stromal Vascular Fraction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SVF; Stromal Vascular Fraction; osteoarthritis(OA); knee; adipose
Study of ABT-700 in Subjects With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1/1b open-label study evaluating the safety, pharmacokinetics (PK), and
      preliminary efficacy of ABT-700 in subjects with advanced solid tumors that may have MET
      amplification or c-Met overexpression. ABT-700, previously known as h224G11 in publications,
      is an anti-c-Met antibody. The early clinical development plan for ABT-700 is based on the
      activity demonstrated in preclinical models. Up to 124 subjects will be enrolled.
    


Intervention name(s): ABT-700; docetaxel; FOLFIRI; cetuximab; erlotinib; ABT-700
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): ABT-700 will be administered by intravenous infusion at escalating dose levels on day 1 in 21-day dosing cycles. Additional subjects will be enrolled in an dose expansion cohort that will further evaluate ABT-700.; Docetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles.; 5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles.; Cetuximab will be administered by intravenous infusion weekly.; Erlotinib will be taken orally daily.; ABT-700 will be administered by intravenous infusion on Day 1 and Day 15 in 28-day dosing cycles.
Intervention MeSH terms: Docetaxel; Cetuximab; Erlotinib Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: c-Met overexpression; MET amplification; Neoplasms; h224G11
Evaluation of Efficacy and Safety of VX-548 for Acute Pain After an Abdominoplasty
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of VX-548 in treating acute
      pain after an abdominoplasty.
    


Intervention name(s): VX-548; HB/APAP; Placebo (matched to VX-548); Placebo (matched to HB/APAP)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets for oral administration.; Capsules for oral administration.; Placebo matched to VX-548 for oral administration.; Placebo matched to HB/APAP for oral administration.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Understand the Effect of Itraconazole on the Levels of a Study Medicine Called ARV-471 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to understand if a strong CYP3A4 inhibitor (itraconazole)
      affects how ARV-471 is processed and eliminated in healthy adults.

      All participants in this study will receive one dose of ARV-471 alone by mouth in Period 1.
      In Period 2, everyone will receive itraconazole by mouth once a day for multiple days.
      Participants will also receive one dose of ARV-471 by mouth. The levels of ARV-471 in Period
      1 will be compared to the levels of ARV-471 in Period 2 to determine if the CYP3A4 inhibitor
      affects how ARV-471 is processed differently in healthy adults.
    


Intervention name(s): ARV-471; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single dose of ARV-471 by mouth in Period 1 and Period 2, with a washout period of at least 10 days between doses of ARV-471; Participants will receive itraconazole by mouth once a day for 11 days in Period 2.
Other intervention name(s): PF-07850327; Sporanox
Intervention MeSH terms: Itraconazole
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Pregabalin on the Spinal Anesthesia
Condition: Block
Study type: Interventional

Summary: 
      Pregabalin, an anticonvulsant is widely used for treatment of neuropathic pain. Recently, it
      was reported that premedication of pregabalin before general anesthesia is effective to
      reduce postoperative pain. Up to date, there is no study about the effect of premedication of
      pregabalin on the spinal anesthesia. Therefore, in this study, investigators investigate the
      effect of premedication of pregabalin on the spinal anesthesia.
    

Detailed description: 
      In this study, investigators investigate the effect of premedication of pregabaline 150 mg on
      the spinal anesthesia. Two hours before spinal anesthesia, placebo pill was administered to
      patients in the group C and pregabalin 150 mg was administered to patients in the group P,
      respectively. Time for the onset of blockade, cephalad level of analgesia and duration of
      analgesia were measured.
    

Intervention name(s): Placebo; Pregabalin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: pregabalin; spinal anesthesia
Minocycline and Celecoxib as Adjunctive Treatments of Bipolar Depression
Condition: Depression; Bipolar Disorder; Bipolar Depression; Mood Disorders
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder; Mood Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Bipolar disorder is a leading cause of disability worldwide. A high proportion of patients
      with bipolar disorder experience persistent depressive symptoms that do not respond to
      standard drug treatments. Recent evidence has suggested that anti-inflammatory treatment may
      reduce depressive symptoms. Minocycline is a tetracycline antibiotic with good central
      nervous system (CNS) penetration that has been suggested to be effective as an adjunct drug
      in improving depressive symptoms. Celecoxib, a selective cyclooxygenase 2 (COX-2) inhibitor,
      has also shown promising results in the treatment of depressive symptoms. In this factorial
      design, double blind, randomised controlled trial the investigators will determine the
      efficacy of minocycline and/or celecoxib as an adjunct to treatment as usual (TAU) in
      patients experiencing a depressive phase of bipolar I or II disorder. The investigators
      hypothesise that augmentation with minocycline and/or celecoxib will lead to an improvement
      in depressive symptoms in participants in comparison with placebo.
    


Intervention name(s): Minocycline; Celecoxib; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Minocycline; Celecoxib
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dexanabinol in Severe Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Each year a large number of patients are hospitalized at Shock Trauma Centers with severe
      head injuries. Bleeding into and swelling of these patients' brains may cause compression of
      vital structures, disability and death. Sometimes surgery is needed. Unfortunately, the
      investigators have no medication to treat the bad effects of head trauma. Part of the brain
      damage is due to toxic chemicals (including one called glutamate) that are released by the
      damaged nerves. Dexanabinol may prevent some of the bad effects of glutamate on the brain and
      may protect the brain against uncontrollable swelling and death.
    

Detailed description: 
      Dexanabinol is a synthetic, non-psychotropic cannabinoid derivative that because of its
      dextro-configuration is compatible with activation of cannabinoid receptors in the brain. It
      combines the ability to block NMDA receptors and neuroinflammatory cascades in the same
      molecule. Dexanabinol scavenges free radicals, protects neurons from toxicity of free radical
      generators and inhibits lipopolysaccharide-induced production of prostaglandin E2, NO and
      TNF-a by macrophages in culture.
    

Intervention name(s): Dexanabinol
Intervention type(s): Drug
Intervention MeSH terms: HU 211
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Fibrin Glue vs. Suture in Pterygium Surgery
Condition: Conjunctival Autograft
MeSH terms: Pterygium
Study type: Interventional

Summary: 
      The use of Fibrin glue to place conjunctival graft will be as effective as suturing the
      graft, but will require much less operative time and will be better tolerated by the
      patients.
    

Detailed description: 
      Pterygium surgery requires removal of the pterygia from cornea and conjunctiva and an
      additional technique to prevent recurrence which may be as high as 50%.

      Suturing a conjunctival auto-graft has become one of the most popular and effective methods
      in preventing recurrence. However suturing requires long operative time (10-20 minutes with
      removal alone less than 5 minutes) and requires sutures removal after 1-2 weeks which is very
      inconvenient to the patient.

      Using Fibrin Glue (Quixil) has been used in several places in pterygium surgery and we
      believe it will be as effective as suturing the graft, will use much less OR time (reduce
      surgery time from 40 minutes to 20-25 minutes) and will be less expensive since 2 ml glue
      (around 80US$) suffice for 10 cases, while one vicryl suture costs around 34 US$.
    

Intervention name(s): Fibrin Glue, Quixil; Suture
Intervention type(s): Procedure; Procedure
Intervention description(s): quixil 0.1 ml; vicryl 10/0
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pterygium; conjunctival graft; recurrence; primary pterygium