bioihbjkbjnl/mcl2 huggingface dataset:
A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia
Condition: Idiopathic Hypersomnia
MeSH terms: Disorders of Excessive Somnolence; Idiopathic Hypersomnia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of administering a
      single intravenous (IV) infusion dose of TAK-925 to adult participants with idiopathic
      hypersomnia (IH).
    

Detailed description: 
      The drug being tested in this study in participants with IH is called TAK-925. The study will
      have 2-treatment crossover groups. The study will evaluate the pharmacokinetics (PK),
      pharmacodynamics (PD), safety, and tolerability of a single intravenous (IV) dose of Dose A
      in participants with IH.

      The study will enroll 40 patients. Participants will be randomly assigned to one of the two
      treatment sequence groups as indicated below:

        -  TAK-925 + Placebo

        -  Placebo + TAK-925

      On Day 1 of each treatment period, TAK-925 or placebo will be administered as a single 9-hour
      IV infusion.

      The multicenter study will be conducted in the United States and Japan. The overall duration
      of treatment in this study is approximately 41 days including screening up to 28 days,
      confinement for 6 days and end of study follow up telephone call on Study Day 11.
    

Intervention name(s): TAK-925; TAK-925 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-925 IV infusion.; TAK-925 placebo-matching IV infusion.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Identifying Biological Markers for Severe Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      The primary objective of this study is to investigate the biological components of major
      depression. The investigators are particularity interested in genetic variation and how it
      contributes to cortisol (because cortisol is higher in severe depression than mild depression
      or healthy controls) and how it contributes to clinical symptoms, especially suicidal
      ideation/behavior and psychosis.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inpatient hospitals, outpatient clinics, community.
      
Biospecimen description: 
      We will be retaining biospecimens including, whole blood, serum, hair and saliva tissues
      samples.
Dexmedetomidine-Propofol Versus Ketamine-Propofol for Sedation of CT Guided Bone Biopsy
Condition: Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare the effectiveness and safety of a dexmedetomidine-propofol
      combination and a ketamine-Propofol combination for sedation of CT guided bone biopsy.
    

Detailed description: 
      Assessment of boney lesions is an common activity in the care of cancer patients. CT guided
      Percutaneous needle biopsies have a low complication rate. usually, this procedure is done
      under sedation.

      Propofol is a non-barbiturate hypnotic and sedative. It facilitates gamma-aminobutyric acid
      mediated inhibitory neurotransmission. It's known to have anti-emetic, antipruritic,
      anticonvulsant and amnestic effects. Despite being effective and potent, Propofol's main
      disadvantages is its dose-dependent hypotension and respiratory depression .Ketamine is a
      phencyclidine derivative which acts as a N-methyl-D-aspartate (NMDA) receptor antagonist. It
      is a dissociative anesthetic and provides some analgesia. It maintains airway reflexes and
      spontaneous respiration. Combining Propofol and ketamine preserves the sedative and analgesic
      efficacy while reducing their adverse effects. Dexmedetomidine is a highly selective
      α2-agonist. It is eight times more specific compared with clonidine. It has a perioperative
      anxiolytic, sedative properties as well as some analgesic properties .Dexmedetomidine is
      usually used for mild to moderate sedation and Propofol could be added to deepen the level of
      sedation
    

Intervention name(s): Dexmedetomidine-propofol; Ketamine-Propofol
Intervention type(s): Drug; Drug
Intervention description(s): 1 microgram/kg dexmedetomidine+2.5 mg/kg propofol intravenous (IV) bolus, 0.5 microgram g/kg/h dexmedetomidine+2.5 mg/kg/h propofol infusion; 1 mg/kg ketamine+2.5 mg/kg propofol iv bolus, 0.25 mg/kg/h ketamine+2.5mg/kg/h propofol infusion
Other intervention name(s): precedex; ketofol
Intervention MeSH terms: Dexmedetomidine; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
The Efficacy of Si-Ni-Tang (a Chinese Herbal Formula) for Severe Sepsis
Condition: Severe Sepsis
MeSH terms: Sepsis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of Si-Ni-Tang (a Chinese Herbal Formula
      documented in Shang Han Lun) in treating severe sepsis.
    


Intervention name(s): Si-Ni-Tang
Intervention type(s): Drug
Intervention description(s): Treatment adheres to the International guidelines for management of severe sepsis and septic shock( 2012) and the Surviving Sepsis Campaign updated bundles in response to new evidence in 2015 for both the treatment group and the control group. In addition, 150ml of Si-Ni-Tang will be given by p.o. or by a nasogastric tube once a day for 3 days in the treatment group.
Other intervention name(s): Sini decoction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Severe Sepsis; Sini Decoction; Immune Function; Mortality
Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.
Condition: Schizophrenia; Schizoaffective Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to demonstrate the bioequivalence, with respect to
      risperidone and its active moiety, of a single oral dose of risperidone given as a 4 mg
      orally-disintegrating tablet and as a 4 mg conventional RISPERDAL tablet. In addition, their
      tolerability and safety will be documented.
    

Detailed description: 
      This is a single-center, open, randomized, 2-way crossover bioequivalence study in 40
      subjects with schizophrenia or schizoaffective disorder. The study will consist of 2
      treatment periods, 5 days per period. The subjects will receive a single 4 mg RISPERDAL
      conventional tablet in period 1 and a single 4 mg orally-disintegrating tablet in period 2;
      or the orally disintegrating tablet in period 1 and conventional tablet in period 2. A
      washout period of at least 10 days between Day 1 of Period 1 and Day 1 of Period 2 will
      separate the 2 treatments. In both treatment periods plasma concentrations of the drug will
      be measured. Serial blood collections will be made beginning at 0 hour (immediately before
      study drug administration) and continuing up to 96 hours after study drug administration in
      each period. Safety will be evaluated throughout the study using physical examinations,
      electrocardiogram recordings (ECG), clinical laboratory testing (hematology, serum chemistry,
      urinalysis), vital signs measurements, pregnancy testing, drug screening, and monitoring of
      adverse events. The study will be approximately 6 weeks long (including the screening
      period). Subjects will enter the study facility 3 days before the first administration of
      study medication on Day 1 of the first period. They will remain at the facility until all
      study-related procedures are completed on Day 5 of the second study period, a period of
      approximately 18 days. 4 mg risperidone (either conventional tablet or orally-disintegrating
      tablet), single dose, oral intake
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Risperidone; Orally-disintegrating tablet; Bioequivalence
Fluvastatin Versus Hepatitis C Virus
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional

Summary: 
      This is a dose finding and efficacy trial for fluvastatin versus hepatitis C.
    

Detailed description: 
      Four different oral doses of fluvastatin will be used for 14 days and the viral load of
      hepatitis C will be measured weekly. This has been extended to different doses for 9-12
      weeks.
    

Intervention name(s): fluvastatin
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; fluvastatin
The Clinical Application and Efficacy Verification of an Innovative Carbon Fiber Dressing
Condition: Wounds
Study type: Interventional

Summary: 
      The research uses hydrophilic-based dressing (KoCarbonTM) which is developed by Medical
      Technology Company Limited (Bio-medical Carbon Technology; BCT) to investigate the wound
      healing effects of activated-carbon-fiber-based wound dressing on different types of
      wounds.The dressing is composed by three layers. The first layer is a material of
      polyethylene terephthalate (PET) weave which is great breathable; Second layer, the activated
      carbon fiber cloth, is as the absorption of excess tissue fluid, bacteria and contaminations.
      It reduces the smell of wound and restrains the development of bacteria. In addition,
      activated carbon has features of far-infrared and anion, which promote blood circulation,
      speed up metabolism and shorten the time of wound healing. The third layer is a polyethlene
      (PE) film, which touches the wound surface and provides the anti-adhesion effects.

      The aim of this study is to investigate how the application of the dressing affects the wound
      healing conditions on four different types of wounds, including general traumatic wounds,
      elective surgery wound, diabetes foot ulcer (level 2) and chronic wounds. Due to the
      characteristics of great fluid absorption and far-infrared features, the hydrophilic-based
      dressing (KoCarbonTM) is expected to work perfectly on improving the wound repair conditions.
    


Intervention name(s): hydrophilic-based dressing (KoCarbonTM)
Intervention type(s): Device
Intervention description(s): "BCT" Hydrophilic Wound Dressing consists of PET non-woven, activated carbon fiber (ACF) cloth and PE film. The PET non-woven is vapor permeable to allow air exchange for the wound. The absorbent ACF absorbs exudate, bacteria and odor to create an effective barrier. Furthermore, far infrared ray (FIR) emitted from ACF accelerates blood circulation and metabolism to reduce healing period. The PE film helps to minimize wound trauma at dressing changes.
Other intervention name(s): "BCT" hydrophilic wound dressing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wound healing; carbon
Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette's Disorder (TD)
Condition: Tourette's Disorder
MeSH terms: Tourette Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of the current trial is to determine efficacy and safety of once-weekly aripiprazole
      in reducing Total Tic Severity (TTS) score in children and adolescents with Tourette's
      Disorder.
    


Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Aripiprazole tablets once weekly for 8 weeks.; Aripiprazole matching-placebo once-weekly for 8 weeks.
Other intervention name(s): ABILIFY
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tourette's Disorder; Tic disorders
A Study of MEDI-575 in Subjects With Recurrent Glioblastoma Multiforme
Condition: Glioblastoma Multiforme
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this Phase II study is to evaluate the progression-free survival at
      6 months in adult subjects with a first recurrence of Glioblastoma Multiforme who are treated
      with MEDI-575.
    

Detailed description: 
      This is a Phase 2, multicenter, open-label, single-arm study to evaluate the antitumor
      activity, safety, and pharmacology of MEDI-575 in adult subjects with first recurrence of
      GBM.

      Approximately 55 subjects will be enrolled to determine the preliminary efficacy profile of
      MEDI-575 in the treatment of subjects with first recurrence of GBM. Subjects will receive
      MEDI-575 as a 60-minute IV infusion on Day 1 every 21 days until disease progression,
      initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for
      subject withdrawal.

      The primary assessment of antitumor activity is PFS-6; tumor response and progression will be
      determined using Updated Response Assessment Criteria of High Grade Gliomas- Neuro-Oncology
      Working Group v.1. Approximately 15 investigational sites in the United States will
      participate in this study. All subjects will be followed every 3 months for the duration of
      the trial (defined as 9 months from the date the last subject is entered into the trial or
      when the sponsor stops the study.
    

Intervention name(s): MEDI-575
Intervention type(s): Drug
Intervention description(s): MEDI-575 as an IV infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glioblastoma
AZD2115 Single Ascending Dose Study
Condition: Chronic Obstructive Pulmonary Disease; Lung Disease Causing Persistent Narrowing of the Airways
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      AZD2115 Single Ascending Dose Study
    


Intervention name(s): AZD2115; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose, oral inhalation (nebuliser solution); Single dose, oral inhalation (nebuliser solution)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Safety; tolerability; healthy; inhaled; respiratory disease
Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      The investigators objective is to compare short course (5 days) to long course (14
      days)antibiotics for the treatment of acute bacterial sinusitis in children. The
      investigators hypothesize that short course therapy will lead to more frequent relapses of
      sinusitis and will not reduce resistant organisms.
    

Detailed description: 
      This was a prospective, randomized, double-blind study comparing short course (5 days) to
      long course (14 days) antimicrobial therapy for children between 1 and 10 years of age with
      acute bacterial sinusitis. The major outcome measure is the proportion of children with a
      clinical relapse on day 10 in the short course therapy group compared to day 20 in the long
      course therapy group. In addition, the proportion of respiratory flora that are resistant to
      antibiotics on day 30 will be compared to baseline in each group.
    

Intervention name(s): Amoxicillin-Potassium Clavulanate Combination; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): All subjects will be started on treatment with 5 days of high dose amoxicillin (90mg/kg) with potassium clavulanate (6.4 mg/kg) twice daily in bottle A. The allocation to group B1 or B2 will be concealed until after the family and subject has signed the assent and consent, respectively. The maximum dose will be 2 gms twice daily. After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days.; After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days.
Other intervention name(s): there are none; there are none
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Child; Child, preschool; Sinusitis; Antimicrobial agents
OatMeal and Insulin Resistance: OMA-IR
Condition: Diabetes Mellitus Type 2; Insulin Resistance
MeSH terms: Diabetes Mellitus; Insulin Resistance; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Insulin resistance is a central feature of Diabetes mellitus type 2 (Stumvoll et al. 2005).
      Hypo- and hyperglycemic states are associated with adverse inpatient outcomes (ADA et al.
      2006 Diab Care) and with the development of microvascular complications (UKPDS 34 Lancet
      1998).

      A long known therapy for the acute treatment of patients with deteriorated glucose metabolism
      and insulin resistance are carbohydrate days. The principle of the therapy was firstly
      introduced in 1903 by Carl von Noorden (Noorden et al. 1903). The diabetic patients were
      treated for several days with a carbohydrate rich diet with fat restriction. Surprisingly,
      this resulted in an amelioration of glucosuria. Today it's still a valuable tool for patients
      with uncontrollable diabetes mellitus and severe insulin resistance (Willms B. 1989). But up
      to now there has been no systemic evaluation of carbohydrate days in patients with
      deteriorated Diabetes mellitus and insulin resistance.

      The investigators conducted a pilot study with 14 patients to evaluate the efficacy of two
      days of oatmeal on insulin resistance and glucose metabolism in an acute clinical setting and
      after a four week outpatient period. Inclusion criteria were type 2 diabetes with
      deteriorated glucose metabolism, insulin resistance defined as an insulin dosage of more than
      1 U per day and kg bodyweight. Within this pilot trial the investigators found a marked
      decrease of insulin requirements (~40%) and mean daily blood glucose to a mean blood glucose
      of 114.7±36.7 mg/dl in the acute setting as well as after the four week outpatient period
      (Lammert et al. 2006).

      The most important shortcomings of this study were the hypocaloric interventions in both
      groups (diabetes-adapted diet: 1500kcal/d vs. oatmeal 1200kcal/d) making it difficult to
      attribute the observed effects to oatmeal alone as well as the uncontrolled nature. These
      design flaws have been addressed within this new clinical trial. The investigators plan an
      open label, cross-over study with isocaloric interventions (oatmeal and diabetes-adapted
      diet: ~ 1200kcal/d). The intervention comprises two days of oatmeal (third and fourth day)
      within a 5 day hospital stay. The control is only treated with 5 days of diabetes adapted
      diet. Thereafter, the patients are followed every four weeks for an overall of 16 weeks.
    


Intervention name(s): Diet: carbohydrate days. (Name: oatmeal.)
Intervention type(s): Behavioral
Intervention description(s): Dietary intervention with two days of oatmeal compared to normal diabetes adapted diet in insulin resistant subjects.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Yield of Cryoprobe vs Flexible Forceps Pleural Biopsy
Condition: Pleural Effusion; Pleurisy; Tuberculosis; Metastatic Malignancy
MeSH terms: Tuberculosis; Pleurisy; Pleural Effusion
Study type: Interventional

Summary: 
      This is a prospective study to assess the yield of pleural biopsy obtained with the routine
      flexible thoracoscopic biopsy forceps versus that obtained with a flexible cryoprobe during
      semirigid thoracoscopy
    

Detailed description: 
      Consecutive patients with exudative pleural effusions who are planned to undergo semirigid
      thoracoscopy will be enrolled in the study if they satisfy the inclusion criteria. They will
      be randomized in 1:1 ratio using a computer-generated randomization sequence to the following
      groups:

      Group A: Four pleural biopsy specimens obtained using the flexible cryoprobe followed by
      eight pleural biopsy specimens obtained using the flexible thoracoscopic forceps OR Group B:
      The above two procedures will be performed in the reverse order The biopsies will be
      performed from different areas of the involved pleura with the two techniques. Thoracoscopy
      will be performed in the bronchoscopy suite on spontaneously breathing subjects (fasting for
      8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete
      aseptic precautions.
    

Intervention name(s): Cryoprobe pleural biopsy first; Flexible forceps biopsy first
Intervention type(s): Device; Device
Intervention description(s): Four pleural biopsy specimens will be obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm) followed by 6-10 pleural biopsy specimens obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter).; Six to ten pleural biopsy specimens will be obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter) followed by four pleural biopsy specimens obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: thoracoscopy; pleuroscopy; semirigid thoracoscopy; flexible cryoprobe; cryobiopsy; pleural biopsy