bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being done to find out if the addition of boceprevir to standard of care (SOC)
      treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for
      participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not
      successfully treated by previous SOC. All participants will receive treatment with SOC alone
      for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional
      weeks of combined treatment.
    


Intervention name(s): boceprevir; PegIFN-2b; RBV
Intervention type(s): Drug; Biological; Drug
Other intervention name(s): SCH 503034; Peginterferon alfa-2b; PegIntron; SCH 054031; Ribavirin; Rebetol
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate the Efficacy of Capsimax on Metabolic Rate
Condition: Metabolism
Study type: Interventional

Summary: 
      Capsimax™ is a proprietary Capsicum Extract that employs Beadlet Technology. In the previous
      study it has been used to investigate its effect in reducing body fat/weight and increase
      metabolic rate. In this study, Capsimax™ will be used to assess effect on Resting Energy
      Expenditure (REE) using Indirect Calorimetry.
    


Intervention name(s): Capsimax; Micro Crystalline Cellulose
Intervention type(s): Other; Other
Intervention description(s): 1 capsule to be taken before breakfast.; 1 capsule to be taken before breakfast.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blind, randomized, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Impact of Neurally Adjusted Ventilator Assist (NAVA) Mode on Patient Ventilator Asynchrony Using Non-invasive Ventilation (NAVA-NIV)
Condition: Weaning Period
Study type: Observational

Summary: 
      Non-invasive ventilation (NIV) has been proposed to reduce the incidence of ventilatory
      dysfunction following mechanical ventilation weaning. However, the nasogastric tube reduces
      the airtightness of the facial mask used to perform non-invasive ventilation and induces air
      leaks. The presence of leaks at the patient-mask interface can increase the risk of
      patient-ventilator asynchrony, which in turn leads to increase patient discomfort. Neurally
      adjusted ventilatory assist (NAVA)could contribute to decreasing asynchrony. Its principle is
      to record the diaphragmatic electrical activity and to control the ventilator. The
      investigators hypothesized driving the ventilator based on a neural signal (diaphragm
      electrical activity) would reduce patient-ventilator asynchronies in NIV
    


Intervention name(s): Device: Neurally Adjusted Ventilatory Assistance
Intervention type(s): Other
Intervention description(s): Device: Neurally Adjusted Ventilatory Assistance
In ICU following extubation NIV was performed as follows:
facial mask with PSV/NIV mode to define settings for NAVA ventilation facial use with NAVA/NIV mode
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        NIV required on post extubation period
Sub-dissociative Dose Ketamine Dosing Study
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Goal is to determine if in adults presenting to the Emergency Department (ED) with moderate
      to severe acute pain, Ketamine administered at 0.15 mg/kg will provide similar pain relief to
      Ketamine administered at 0.3 mg/kg, with fewer adverse effects.
    

Detailed description: 
      Study investigators will enroll participants who present to the Emergency Department (ED)
      with moderate to severe acute pain, and require intravenous pain medication. Participants
      will be double-blinded and randomized to one of the two treatment groups.

      Investigators aim to determine if ketamine 0.15 mg/kg IVPB is non-inferior to ketamine 0.3
      mg/kg IVBP for the treatment of acute moderate to severe pain in the Emergency Department
      (ED). Study investigators hypothesize that in adults presenting to the ED with moderate to
      severe acute pain, SDK administered at 0.15 mg/kg will provide similar pain relief to SDK at
      0.3 mg/kg, with reduced adverse effects.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The sequence will be generated using randomization permuted blocks of 2 and 4 patients, with the allocated dose revealed using an online randomization module within the REDCap data management system.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bone Health and Microbiome in Persons With Type 1 Diabetes
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      It is well-established that persons with type 1 diabetes (T1D) are at an increased risk for
      morbidity and mortality related to bone fracture due to poor bone health, however we do not
      fully understand the mechanism behind the increased fracture risk. We are examining bone
      health and the microbiome in adolescents and young adults with type 1 diabetes to better
      understand the reasons behind this increased risk.
    

Detailed description: 
      This pilot study aims to look at measures of bone health, the gut microbiome and measures of
      glycemia/glycemic variability in those with preclinical and clinical diabetes. Our primary
      and secondary outcomes are to characterize these variables, with our long term objectives to
      better understand the natural history of bone health in T1D, help characterize the etiology
      of worse bone health in those with T1D, and try to identify potential time periods for
      intervention.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Type 1 Diabetes
Effectiveness of Commercial Video Games in Subacute Stroke Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Stroke creats dependancy of patients due to various associated impairments. The use of
      low-cost technologies for neurological rehabilitation may be beneficial for the treatment of
      these patients.
    

Detailed description: 
      To determine the effectiveness of a structured protocol using semi-immersive virtual reality
      with commercial videogames for balance, postural control, functional independence, quality of
      life and motivation in patients who have suffered an ischemic and / or hemorrhagic stroke in
      subacute phase and are being treated in a mid-stay hospital.

      Patients and methods: Randomized Controlled Trial. Simple blind. Control group will receive
      conventional therapy (physical therapy and occupational therapy) intervention being based on
      a task-oriented approach, with five weekly sessions of Physical Therapy and Occupational
      Therapy with duration of 45 minutes per session.

      The experimental group will receive in addition to the above an experimental intervention
      during 8 weeks providing additional treatment using virtual reality semi-immersive complement
      is added by means of commercial video games implemented with the Xbox 360º video game console
      in conjunction with the Kinect device.
    

Intervention name(s): Semi-immersive virtual reality; Conventional Rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Each participant will receive 24 additional sessions of semiinmersive virtual Reality therapy sessions on Monday, Wednesday and Friday, after realizing the conventional therapy sessions. The duration of each VR session will be gradually increased in time-intensity (5 minutes during the first week to 20 minutes during the last week) and motor requirements.; Conventional rehabilitation consisting of five weekly sessions of Physical therapy and Occupational Therapy, based on a task-oriented approach, lasting 45 minutes each.
Other intervention name(s): Commercial video games; Physical therapy and Occupational Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly distributed to a control group or experimental group using the QuickCalcs application of GraphPad Software.
The following considerations will be taken into account:
Control group: 8 weeks of conventional rehabilitation based on a task-oriented approach. Consisting of five weekly sessions of physical therapy and of occupational therapy, lasting 45 minutes each.
Experimental group: 8 weeks of conventional rehabilitation provided identically as in the control group, plus virtual reality semi-immersive sessions. VR sessions will be applied following a protocol using commercial video games, three days a week (Monday, Wednesday and Friday) after the conventional rehabilitation sessions.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Balance; Baropodometry; Video games; Virtual reality
Cervical Lidocaine for Intrauterine Device Insertion Pain
Condition: Pain
Study type: Interventional

Summary: 
      The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain
      associated with intrauterine device (IUD) insertion. They will be randomized to either
      placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically
      via angio-catheter just before intrauterine device insertion. Anticipated pain scores will be
      assessed using a visual analog scale prior to insertion. Using the same pain scale, patients
      will again be asked at the end of the procedure to rate their pain.
    

Detailed description: 
      Double blind randomized controlled trial.

      Primary outcome: Pain reported on Visual Analog Scale (VAS) Intervention: 2% lidocaine gel at
      the tenaculum site and intracervical prior to intrauterine device placement
    

Intervention name(s): 2% lidocaine gel; Water based lubricant
Intervention type(s): Drug; Drug
Intervention description(s): 3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to Intrauterine device insertion; 3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to intrauterine device insertion
Other intervention name(s): Lidocaine; KY gel
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: intrauterine device; pain; lidocaine gel
Safety and Efficacy Study of a Triple Combination Therapy in Subjects With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effectiveness of four different strength combinations of three approved
      anti-hypertension therapies (olmesartan medoxomil, amlodipine, and hydrochlorothiazide) for
      lowering blood pressure.
    


Intervention name(s): Olmesartan medoxomil; Amlodipine; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40mg olmesartan medoxomil; Amlodipine 10mg; Hydrochlorothiazide 25mg
Other intervention name(s): Benicar; Norvasc
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The purpose of this study is to explore efficacy, tolerability and safety of paliperidone
      Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone
      ER in a naturalistic setting.
    

Detailed description: 
      This is an observational, prospective, multicenter 6-month study to explore efficacy,
      tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients
      who started treatment with paliperidone ER in a naturalistic setting. The primary objective
      is to explore changes in Clinical Global Impression of Severity (CGI-S) score from baseline
      up to 26 weeks, in subgroups of schizophrenia patients who started treatment with
      paliperidone ER. Secondary objectives are: 1) To explore changes in mental health and social
      functioning based on routine outcome assessments in the Netherlands, the Health of the Nation
      Outcome Scales (HoNOS) and Global Assessment of Functioning (GAF), in schizophrenia patients
      who started treatment with paliperidone ER ; 2) To explore changes in patient's satisfaction
      with treatment, changes in number of ambulant contacts, changes in body weight, changes in
      concomitant therapy and to explore adverse events in schizophrenia patients who started
      treatment with paliperidone ER; and to explore possible association between CGI-S, GAF and
      HoNOS.

      The patients will receive paliperidone ER (6 mg, 9 mg or other dosages as directed on the
      label) once daily for the period of 6 month. Which dosage of paliperidone ER the patients
      receive will be at the discretion of the investigator and according the Summary of Product
      Characteristics (SmPC). Because the study is observational, dosage, administration and
      duration of treatment is at discretion of treating physician.
    

Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention description(s): 6 mg tablet once daily, variable treatment length.
Intervention MeSH terms: Paliperidone Palmitate
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Schizophrenia patients meeting DSM-IV criteria receiving paliperidone ER, as part of the
        common practice of participating physicians. Patients may enter the study as soon as their
        paliperidone ER treatment starts or when it has been less than 14 days after their
        treatment start.
      
Keywords: Paliperidone ER; Schizophrenia
Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients
Condition: HIV Infections
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to gather information on the safety and immunogenicity of an
      investigational smallpox vaccine in HIV infected populations. Subjects will receive two
      vaccinations
    


Intervention name(s): IMVAMUNE (MVA-BN)
Intervention type(s): Biological
Intervention description(s): 2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous
Other intervention name(s): IMVANEX
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; treatment experienced; treatment vaccinia naive
Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
Condition: Oropharyngeal Candidiasis; Candidemia; Invasive Candidiasis; Esophageal Candidiasis
MeSH terms: Candidiasis; Candidemia; Candidiasis, Invasive
Study type: Interventional
Phase: Phase 1

Summary: 
      Children with fungal infections will be divided into two groups by weight. Children weighing
      < 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days
      than children weighing > 25 kg.
    

Detailed description: 
      This is a prospective, multicenter, open-label, repeat-dose study conducted in two groups.
      Subjects in Group 1 and Group 2 will receive treatment for 10 to 14 days (per investigator
      clinical judgment); dose level (3.0 mg/kg or 4.5 mg/kg) will be determined by the subject's
      weight at baseline. Study procedures in both groups will be similar except that serial blood
      samples for assessment of pharmacokinetics will be collected in Group 1. Subjects may only
      participate in one group of the study.

      At least 24 subjects, with at least 8 in each of three age ranges, will be enrolled in Group
      1 (PK + safety). At least 36 subjects will be enrolled in Group 2 (safety), with at least 12
      in each of the three age ranges.
    

Intervention name(s): Micafungin
Intervention type(s): Drug
Intervention description(s): IV
Other intervention name(s): FK463
Intervention MeSH terms: Micafungin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Antifungal; Micafungin; Echinocandin; Candidiasis
Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The B7441003 study will assess PF-06412562 for motor benefit in Parkinson's disease subjects.
      Safety, tolerability and PK of PF-06412562 in Parkinson's disease subjects will also be
      evaluated.
    


Intervention name(s): PF-06412562; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single oral split dose 30+20 mg QD; tablet, matching placebo, QD
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Plaque psoriasis is a chronic relapsing inflammatory skin disease that is characterized by
      keratinocyte hyper-proliferation and epidermal hyperplasia. Standard treatment for psoriasis
      generally requires long-term use of topical therapies, psoralen and ultraviolet A (PUVA),
      ultraviolet B (UVB) and/or systemic immunosuppressant therapies to achieve and maintain
      adequate disease control. This is a multicenter, randomized, double-blind study conducted in
      participants with moderate to severe plaque psoriasis. The study will evaluate the efficacy,
      safety, pharmacokinetic and pharmacodynamics profile of 960 milligram (mg) GSK2982772
      administered as a once daily modified release (MR) formulation. Participants will be
      randomized in a 2:1 ratio to receive either 960 mg GSK2982772 or placebo for 12 weeks. The
      duration of the study, including Screening and follow-up, will be approximately 21 weeks for
      each participant.
    


Intervention name(s): GSK2982772; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2982772 will be available as MR tablet at a unit dose strength of 480 mg.; GSK2982772 matching placebo tablets will be administered via the oral route.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will randomized in ratio of 2:1 to receive either 960 mg GSK2982772 or placebo
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Plaque Psoriasis; Modified Release; GSK2982772; Skin Biopsy
Cryotherapy and Body Slimming
Condition: Obesity; Cryotherapy Effect; Weight Loss
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of cryotherapy on the slimming of
      subcutaneous fat mass in the abdomen and saddlebags. Cryotherapy is a completely non-invasive
      method that induces a selective reduction of fat cells by localized and controlled cooling in
      areas such as the abdomen, flanks, inner knees, inner thighs, back and arms.

      Adipose tissue is composed of two types of tissue: white and brown adipose tissue. Studies
      have shown that exposure to cold induces an increase in the number of brown adipocytes
      (detected by PET/CT-scan) under the effect of the hormone irisin produced by the muscles. In
      addition, another study has shown that prolonged exposure to cold reduces the size of brown
      adipocytes leading to thermogenesis, suggesting that cold exposure may contribute to the
      control of obesity.

      The freezing technology of this cryotherapy unit allows the temperature of the subcutaneous
      adipose tissue to move almost instantaneously from -6°C to -10°C, gradually causing the
      reduction of subcutaneous adipose tissue.
    

Detailed description: 
      Prospective, monocentric pilot and comparative (before and after) study in simple blind
      (assessor different from the operator).

        -  The effectiveness of cryotherapy will be evaluated by the metric measurement of the
           treated areas: waist circumference, from the hips to the level of the saddlebags.

        -  Measurement of subcutaneous fat mass with iDXA scanner on treated areas

        -  Metabolic parameters from a blood test: Liver function (AST, ALT, gamma GT),
           inflammatory markers, plasmatic fatty acids, glycerol, total cholesterol, triglycerides,
           lipids, blood sugar, insulin, lactate.
    

Intervention name(s): Cryotherapy on abdomen and saddlebags
Intervention type(s): Device
Intervention description(s): Application of variable temperature (-10°c to -7°c) on the treated areas using the cryotherapy device FG660L-006 (Beijing ADSS Development CO., Ltd)
Intervention model: Single Group Assignment
Intervention model description: Assessment of the effectiveness and tolerance of cryotherapy in the thinning of the abdomen and saddelbags
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; cryotherapy; weight loss; saddlebags
Characterization of Dyslipidemia in Adolescent Obesity
Condition: Obesity
MeSH terms: Obesity; Dyslipidemias; Pediatric Obesity
Study type: Observational

Summary: 
      The primary objective of this pilot study is to characterize the profile of lipoprotein,
      inflammatory, and metabolic markers of cardiovascular disease in obese adolescents as
      compared to normal-weight age-matched controls.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Enrollment will be representative of the ethnic population of Charlotte, NC, estimated as
        50% Caucasian, 35% African American, 10% Hispanic, and 5 % other.
      
Biospecimen description: 
      Whole Blood and serum