bioihbjkbjnl/mcl2 huggingface dataset:
An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chronic Hepatitis B
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to
      patients with HBeAg-negative chronic hepatitis B in Morocco. Patients will receive Pegasys
      180 mcg subcutaneously weekly for 48 weeks and efficacy and safety will be recorded during
      treatment and for 24 weeks of follow-up.
    


Intervention name(s): Peginterferon alfa-2a [Pegasys]
Intervention type(s): Drug
Intervention description(s): 180 mcg subcutaneously weekly, 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nurse-led Program Efficacy on Blood Pressure Control
Condition: Hypertension; Home Blood Pressure Measurement
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The diagnosis and control of hypertension depend on accurate measurements of blood pressure
      (BP); alternative approaches to measuring BP, such as ambulatory blood pressure monitoring or
      home blood-pressure self-measurement (HBPM), are gaining increasing acceptance in the
      diagnosis of hypertension and the monitoring of hypertensive patients.To achieve accurate BP
      measurements at home, measurement guidelines must be closely followed. However, previous
      studies have shown that patient compliance is in most cases unsatisfactory.The study aims at
      evaluating the efficacy of a family nurse (FN)-led home blood pressure management (HBPM)
      training program in improving BP control based on a comparison with routine care and
      management.
    

Detailed description: 
      The quality of HBPM was found to be higher in patients who received some form of training in
      BP measurement from healthcare professionals than in patients who did not receive training.
      Although self-estimation of BP may be prone to error, this risk can be minimized through
      adequate patient education and training that includes simple but nonetheless important
      recommendations. However, unclear is whether specific training offered by nurses, who
      frequently have a close relationship with their hypertensive patients, could result higher
      patient adherence to HBPM recommendations. Therefore, we assume that a specifically tailored
      training program conducted by a family nurse (FN), when provided in addition to usual care,
      could improve patient adherence to HBPM recommendations.

      Study design: single-blind, multicenter, randomized controlled trial.
    

Intervention name(s): Nurse-led program on accuracy of blood pressure self-measurement
Intervention type(s): Behavioral
Intervention description(s): The training program was performed in accordance with current guidelines and consisted of a 1-h educational session led by one family nurse (FN) tasked with instruction of the patients. During the training program the FN emphasized that since morning and evening blood pressure (BP) values can widely differ, especially in patients taking medications, BP should be measured twice a day, in the morning and at evening, at specific fixed times (between 6:00 am and 9:00 am and between 6:00 pm and 9:00 pm) at least during the first week of monitoring. Thereafter, measurements can be taken before antihypertensive drugs are taken.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
516-BOTOX Urinary Incontinence Detrusor
Condition: Urinary Incontinence; Urinary Bladder, Overactive
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Study type: Observational

Summary: 
      The specific aim of this study is to evaluate the safety and efficacy of each of 2 dosages of
      BOTOX® (200 U or 300 U) compared to placebo injected into the detrusor for the treatment of
      urinary incontinence caused by neurogenic detrusor overactivity in patients who have not been
      adequately managed with anticholinergic therapy.
    


Sampling method: Non-Probability Sample
Study population: 
        The study will recruit 260 patients nationwide with an expected recruitment of 6 patients
        at the VA San Diego Healthcare System. Patients must be between 18-80 years of age and will
        include patients with neurogenic detrusor overactivity as a result of spinal cord injury or
        multiple sclerosis, with urinary incontinence, who have not been adequately managed with
        anticholinergic therapy. 50% of the patients randomized will be of spinal cord injury
        etiology and 50% of multiple sclerosis etiology.
A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multicenter, open-label, dose-exploration and dose-expansion study to evaluate the
      safety, tolerability, antitumor activity, PK and immunogenicity of MEDI4736 in combination
      with tremelimumab in subjects with select advanced solid tumors.
    


Intervention name(s): MEDI4736; tremelimumab
Intervention type(s): Biological; Biological
Intervention description(s): MEDI4736 is administered by IV infusion in combination with tremelimumab; Tremelimumab is administered by IV infusion in combination with MEDI4736
Intervention MeSH terms: Durvalumab; Tremelimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: advanced solid tumors; durvalumab; tremelimumab
Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain
Condition: Alzheimer Disease; Healthy Volunteers; Progressive Supranuclear Palsy
MeSH terms: Alzheimer Disease; Supranuclear Palsy, Progressive
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The overall goal of this imaging trial is to evaluate [18F]MNI-958, a tau targeted PET
      radioligand, in individuals with Alzheimer's disease (AD), Progressive Supranuclear Palsy
      (PSP), and healthy volunteers (HV).
    


Intervention name(s): [18F]MNI-958; [18F]Florbetapir; DaTscan
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will undergo PET imaging using [18F]MNI-958, a PET radioligand for imaging tau.; Subjects with Alzheimer's disease will receive a [18F]florbetapir scan to compare distribution of tau in the brain compared to that of [18F]MNI-958.; DaTscan SPECT imaging will be completed in those PSP subjects who have not previously had DATScan imaging as part of the screening procedures.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: AD; HV; PSP
Activ C European Multicenter Study
Condition: Intervertebral Disc Replacement; Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who
      suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be
      enrolled into the study. An 18-month recruitment period is planned with a 4-year
      postoperative follow-up period for each subject. Thus, it is anticipated that the study will
      require a minimum of 5.5 years. Patients will be assessed preoperatively, intraoperatively,
      prior to discharge and again at 6 weeks, 6 months, 1 year, 2 years and 4 years
      postoperatively from the date of surgery.
    

Detailed description: 
      The activ C Disc Prosthesis pursues the goal of restoring the disc function, the geometry and
      motion of the cervical disc. Its concept is based on a ball and socket joint, anchored
      between adjacent vertebral bodies. The modular prosthesis comprises the following elements:
      an inferior CoCr plate component anchored in the endplate of the caudal vertebral body. The
      UHMWPE inlay is securely fixed in this inferior component. The second element is the superior
      CoCr component, which is anchored in the end plate of the cranial vertebral body. It forms a
      ball joint with the inlay of the inferior plate component.

      The activ C product range enables reconstruction of various disc heights as well as
      adaptation to the end plate sizes. Secure primary anchorage of the prosthesis to the
      vertebral bodies is achieved by convexly shaped superior end pla tes and fixation means
      (spikes and grooves on the superior end plate, a small keel on the inferior end plate),
      whereas secondary stability is facilitated by an osseointegrative Plasmapore® coating.

      The objective of the study is to collect outcome information on the Activ® C Disc Prosthesis.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult patients
      
Keywords: cervical spine; total disc replacement (cTDR); degenerative disc disease; activ® C; clinical outcome; long-term results; NDI; VAS; heterotopic ossification (HO); range of motion (ROM); adjacent segment degeneration
Dairy Intake and Brain Health in Aging
Condition: Aged Healthy Volunteer
Study type: Observational

Summary: 
      The purpose of this study is to learn if dairy food consumption may help brain health in
      aging by protecting nerve cells from oxidative damage.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy elderly individuals with an age range of 60-85 years.
      
Keywords: Glutathione; Dairy consumption; Brain; Humans
A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients
Condition: Idiopathic Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to investigate efficacy and safety of SPM 962 in
      Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group
      comparative study following once-daily multiple transdermal doses of SPM 962 within a range
      of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.
    


Intervention name(s): SPM 962
Intervention type(s): Drug
Intervention description(s): transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks
Other intervention name(s): rotigotine
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SPM 962; rotigotine; Idiopathic Restless Legs Syndrome; RLS
Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants (V260-024)
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the efficacy, safety, and immunogenicity of a 3-dose regimen of
      RotaTeq™ (V260) in healthy Chinese infants. Approximately 4040 participants at least 6 weeks
      and up to 12 weeks of age at the time of the first vaccination with V260 or placebo will be
      enrolled and randomized (1:1) to receive either V260 or placebo. Participants will also
      receive the routine China Expanded Program on Immunization (EPI) vaccines (oral poliovirus
      vaccine [OPV] and diphtheria, tetanus, and acellular pertussis vaccine [DTaP]) either
      staggered or concomitantly with V260 or placebo. All participants will be followed for
      efficacy and safety. Immune responses to OPV and DTaP will be evaluated in a subset of
      participants. The primary hypothesis of the study states that V260 will be efficacious in
      preventing any severity of rotavirus gastroenteritis as compared with placebo.
    


Intervention name(s): V260; Placebo to V260; OPV; DTaP
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine); Placebo control; Oral poliovirus vaccine administered according to the standard of care; Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Role of Circadian and Homeostatic Systems in the Regulation of Wakefulness in Adult Patients With Attention Deficit Disorder With or Without Hyperactivity
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      In a previous protocol, we highlighted an excessive daytime sleepiness at the Maintenance of
      Wakefulness Tests (MWT) in 36% of adult Attention Deficit Disorder with or without
      Hyperactivity (ADHD) patients. In 40% of cases this sleepiness was associated with a sleep
      disorder objectified by polysomnography (PSG): apnea hypopnea syndrome (AHI) ≥ 10/h and / or
      Periodicals Movements of Lower Limb (PLMI) ≥ 15/h. However, among patients with no sleep
      disorder PSG, we can question the central origin of the Excessive Daytime Sleepiness. Thus,
      we wish to determine potential changes in the regulation of sleep / wake cycle through a
      protocol of extended wake.

      The principal objective is to compare the objective sleepiness in sleepy patients with ADHD
      and healthy subjects during a protocol of extended wake.

      It's an observational study of interventional type realized in patient with ADHD syndrome
      deprived of psychostimulant treatment (for 72 hours) and healthy subject, investigating the
      implication of the homeostatic and circadian systems in the preservation of awakening.
    


Intervention name(s): Neuropsychological tests
Intervention type(s): Other
Intervention description(s): The tests are :
Go/NoGo paradigm, Continuous Performance Test (CPT) II , Wisconsin Card Sorting Test (WCST), virtual CPT, Classic and virtual Stroop, PSG, MWT
These tests will be repeated during 32h each 4h (T0h, T4h, T8h, T12h, T16h, T20h, T24h, T28h et T32h).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ADHD Patient; Healthy subjects; Sleepiness; PSG; MWT; EEG; cognitive tests
A Study of the ADME of [14C]RIST4721 in Healthy Male Subjects
Condition: Healthy; ADME
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, Open-label Study of Absorption-Distribution-Metabolism-Excretion (ADME) of
      [14C]RIST4721 Following a Single Oral Dose to Healthy Male Subjects
    


Intervention name(s): [14C]RIST4271
Intervention type(s): Drug
Intervention description(s): [14C]RIST4271 oral solution
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Effect of Diluted Sodium Hypochlorite Solution and Moisturizers on Skin Barrier Function in Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      The goal is this study is to investigate the effects of dilute bleach on the skin of subjects
      with atopic dermatitis and those with healthy skin. The second goal is to evaluate the
      effects of different moisturizers on the skin barrier of subjects with and without atopic
      dermatitis. The investigators hypothesize that the bleach bath will increase the skin pH,
      decrease the skin hydration, and increase skin water loss in all study subjects. Secondly,
      the investigators hypothesize that moisturizers with the lowest pH and the highest water to
      oil ratio will result in improved skin barrier function. Furthermore, the investigators
      believe there will be a greater improvement in patients with atopic dermatitis.
    

Detailed description: 
      The study has two main parts. Subjects in both groups will have one forearm in a dilute
      bleach bath and the other arm in a water bath for 10 minutes. The change in skin will be
      measured using different painless devices. The second part of the study involves application
      of 4 various moisturizers. The change in skin will be measured over a period of time using
      the non-invasive devices.
    

Intervention name(s): Bleach Bath and Moisturizers
Intervention type(s): Other
Intervention description(s): All subjects will have one forearm in a bleach bath and the other forearm in a water bath for 10 minutes. Following the bath, skin barrier function will be evaluated. Secondly, moisturizers will be applied to the arms and the skin barrier will be evaluated overtime.
Other intervention name(s): Hypochlorite Solution
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: atopic dermatitis
Protocolized vs Discretionary Use of Opioids in Acute Pain
Condition: Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      We are testing whether patients who received protocolized pain management (1 mg of IV
      hydromorphone followed by an additional 1 mg Intravenous (IV) hydromorphone 15 minutes later
      if the patients wants more) will have better pain relief and no more adverse events than
      patients receiving discretionary care, in which the patients receives whatever IV opioid the
      treating physician wants to give, in whatever dose.
    


Intervention name(s): Hydromorphone; IV opioid
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg IV hydromorphone followed by an optional 1mg IV hydromorphone 15 minutes later; Any IV opioid in the dose chosen by the treating physician. May include hydromorphone as well.
Other intervention name(s): Dilaudid; Discretionary care
Intervention MeSH terms: Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hydromorphone; acute pain; Protocolized; Efficacy; Safety
Cost-effectiveness of Two Painkillers for Treating Pain After Limb Injuries
Condition: Soft Tissue Injuries
MeSH terms: Wounds and Injuries; Soft Tissue Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Background: Paracetamol and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen
      are commonly used oral analgesics in emergency departments (ED) not only in Hong Kong but
      throughout the world. There are no large-scale (n>100), prospective, randomised studies
      comparing paracetamol with ibuprofen in the management of acute soft tissue injury.

      As paracetamol is cheaper than most NSAIDs, may be as effective in the management of acute
      pain and possibly with fewer adverse effects, a large-scale, randomised, controlled trial is
      needed to answer questions of relative analgesic efficacy, safety and cost-effectiveness.
      Previous comparative studies on NSAIDS have been done in this unit and have suggested
      equivalence between two NSAIDs and paracetamol, but numbers were small and drug doses were
      modest.

      Objective: To compare the efficacy, safety and cost between oral ibuprofen and paracetamol in
      pain control for acute soft tissue injuries in an ED setting

      Design: Prospective, double-blind, randomised controlled trial with three arms: oral
      paracetamol with placebo; oral ibuprofen with placebo; paracetamol and ibuprofen in
      combination

      Participants: 783 subjects having sustained isolated soft tissue limb injury without
      significant fracture presenting to the ED of Prince of Wales Hospital

      Main outcome measures: Pain relief profiles of paracetamol, ibuprofen and the combination of
      both; adverse effect profiles of paracetamol, ibuprofen and the combination of both; overall
      cost effectiveness of paracetamol, ibuprofen and the combination of both from the perspective
      of the healthcare provider
    


Intervention name(s): Paracetamol; Ibuprofen; Paracetamol Placebo; Ibuprofen placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1g qid; 400mg tid; equivalent to 1g qid; Equivalent to 400mg tid
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Soft Tissue Injuries
A Multicenter Open-label Study Investigating the Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration by Injection Into the Deltoid Muscle in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot
      formulation in patients with schizophrenia after repeated administration by injection into
      the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
    


Intervention name(s): OPC-14597 IMD
Intervention type(s): Drug
Intervention description(s): Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Aripiprazole; Deltoid
Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate efficacy, safety and pharmacokinetics of the
      vedolizumab (MLN0002) induction and maintenance therapy in Japanese participants with
      moderate or severe ulcerative colitis (UC).
    

Detailed description: 
      This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled,
      parallel-group study to examine the efficacy, safety, and pharmacokinetics of MLN0002
      (Vedolizumab) in induction and maintenance therapy in Japanese patients with moderately or
      severely active ulcerative colitis.
    

Intervention name(s): Vedolizumab; Vedolizumab placebo
Intervention type(s): Drug; Drug
Intervention description(s): Vedolizumab intravenous infusion; Vedolizumab placebo
Other intervention name(s): MLN0002
Intervention MeSH terms: Vedolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Safety and Pharmacokinetic Comparison of Exforge® and G-0081 in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates safety and pharmacokinetic comparison of G-0081, a combination tablet
      of amlodipine and valsartan (test formulation), and Exforge®, a combination tablet of
      amlodipine and valsartan (reference formulation) for single dose in healthy volunteers
    


Intervention name(s): Test formulation; Reference formulation
Intervention type(s): Drug; Drug
Intervention description(s): A single oral dose of a combination tablet of amlodipine orotate 10mg and valsartan 160mg; A single oral dose of a combination tablet of amlodipine besylate 10mg and valsartan 160mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics