bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Prehabilitation Protocol on Quality of Life After Thoracoscopic Surgery
Condition: Thoracoscopy; Prehabilitation
Study type: Interventional

Summary: 
      video-assisted thoracic surgery (VATS) is a new approach used in cardio thoracic surgery
      department instead of thoracotomy to treat several diseases.patients underwent thoracoscopic
      surgery without organized educational protocol either before or after the procedure.
      Therefore, this study will be the first clinical research which will increase patients'
      knowledge about thoracoscopy and decrease its complications.
    

Detailed description: 
      The role of thoracic nursing specialty is to support and educate patients, who are suffering
      from thoracic diseases, to achieve the best outcome in terms of physical, psychological,
      social and spiritual well beings. The care provided not only focuses on in-hospital
      treatments that patient received, but also encompasses the whole patient journey including
      lifestyle modification, health concept promotion, self-empowerment and secondary prevention.
      Preoperative prophylactic physiotherapy has been shown to be an important and effective
      approach in preventing or reducing postoperative complications, in addition to optimizing
      treatment by familiarizing the patient with the physiotherapeutic procedures. Quasi
      experimental research design was utilized to conduct this study.Sixty adult patients
      undergoing thoracoscopic surgery included and had the following criteria, the age ranged from
      18-65 years old, both male and female. The patients divided into two equal groups (study and
      control groups), 30 patients for each. The study group received educational nursing protocol
      while the control group received the routine hospital care.
    

Intervention name(s): Educational nursing protocol; Routine hospital care
Intervention type(s): Other; Other
Intervention description(s): It is a booklet given to study group ,which contains Knowledge and practice about thoracoscopy, pre - post operative care and home care instructions; The routine care given by physicians and nurses after thoracoscopic surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Thoracoscopy; Educational nursing protocol; Quality of life
A Study in Healthy Subjects to Investigate Whether Administration of Clazosentan Can Affect Normal Heart Function
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will investigate whether administration of clazosentan can affect normal heart
      function in healthy subjects
    


Intervention name(s): Clazosentan; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Continuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h; Matching placebo infusion; Film-coated tablet containing 400 mg moxifloxacin
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3-way cross-over Phase 1 study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Second-Line Oxaliplatin and Irinotecan Versus Irinotecan Alone for Gemcitabine and S-1 Refractory Pancreatic Cancer
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, open-label, controlled study that will compare the efficacy of
      oxaliplatin in combination with irinotecan to irinotecan alone as second-line treatment for
      patients with gemcitabine and S-1 refractory pancreatic cancer.
    


Intervention name(s): Irinotecan; Oxaliplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxaliplatin; Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls
Condition: HPV Infections
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV study to evaluate the body's immune response of participants to the
      Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with
      increased risk of cervical cancer.
    

Detailed description: 
      This study looks at possible cross reactivity between different HPV serotypes and both
      peripheral antibodies and mucosally-secreted antibodies.
    

Intervention name(s): Cervarix; Gardasil
Intervention type(s): Biological; Biological
Intervention description(s): Three doses of Cervarix at month 0, 1 and 6.; Three doses of Gardasil at month 0, 1 and 6.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: HPV; Human Papilloma Virus; Cervical cancer vaccine
A Study to Determine the Safety and Efficacy of Albiglutide Administered in Combination With Insulin Glargine
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the safety and efficacy of albiglutide in combination with insulin
      glargine as compared with the combination of insulin glargine and preprandial lispro insulin
      in subjects with type 2 diabetes.
    

Detailed description: 
      This randomized, open-label, active-controlled, parallel-group, multicenter study evaluates
      the safety and efficacy of a weekly subcutaneously injected dose of albiglutide in
      combination with insulin glargine as compared with the combination of insulin glargine and
      preprandial lispro insulin in subjects with type 2 diabetes. Subjects with a historical
      diagnosis of type 2 diabetes who are inadequately controlled despite the use of insulin
      glargine or other intermediate- or long-acting insulins for >/= 6 months but < 5 years, with
      or without oral antidiabetic medications, who are unable to achieve a glycosylated hemoglobin
      value of < 7% will be recruited into the study. Subjects must also be willing and capable of
      pursuing an intensive regimen of both basal and preprandial insulin.
    

Intervention name(s): albiglutide + insulin glargine; insulin glargine + preprandial lispro insulin
Intervention type(s): Biological; Drug
Intervention description(s): albiglutide in combination with insulin glargine; insulin glargine in combination with preprandial lispro insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; rGLP-1 protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: open-label; albiglutide; insulin glargine; preprandial insulin
Effectiveness Monitoring of Home Non-invasive Mechanical Ventilation by Digital Diagnosis Platform
Condition: Neuromuscular Diseases; Obesity Hypoventilation Syndrome; Lung Disease, Restrictive
MeSH terms: Lung Diseases; Hypoventilation; Obesity Hypoventilation Syndrome; Neuromuscular Diseases
Study type: Observational [Patient Registry]

Summary: 
      The main objective will be to determine the effectiveness of home non-invasive ventilation by
      flow-time and time-pressure curves analysis in a cohort of patients with this treatment by
      digital diagnosis platform.
    

Detailed description: 
      A multicenter study with observational prospective design will be implemented on 3 spanish
      hospitals in Barcelona. Inclusion criteria will be equivalent sample size of patients with
      restrictive lung disease, neuromuscular pathology and hypoventilation-obesity.

      Digital diagnosis platform will be used to incorporate and unify signals of different medical
      devices: a pneumotachograph on branch ventilator that captures pressure and flow-time
      signals, inductance plethysmography used to like a patient effort sensor and portable pulse
      oximeter recordings. Nocturnal polygraphic or polysomnographic tracings performed and
      recorded on sites will be processed systematically by main asynchronies diagnosis algorithms
      between patient and ventilator. These algorithms providing global and fractionated
      asynchronies count based on time, leaks or saturation criteria which will be used to compared
      effective ventilation phases and phases with nocturnal desaturations. Therefore, prevalence
      and asynchronies model on home NIV can be determine establishing the correlation between
      desaturation phases and respiratory events and identifying minimum tolerable leak level to
      keep adequate ventilation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients affected by restrictive lung disease, neuromuscular disorders or
        hypoventilation-obesity with home non-invasive mechanical ventilation.
      
Keywords: home monitoring; Non-invasive mechanical ventilation
Evaluating the Impact of Different Sugar Replacer Combinations on Gastrointestinal Tolerance
Condition: Tolerance; Healthy Population
Study type: Interventional

Summary: 
      This study is a randomized, double-blind, crossover trial aiming at evaluating the
      gastrointestinal tolerance of 3 sugar replacers mixes at 3 different doses. The investigators
      will also try to understand the factors that could explain the presence or absence of
      symptoms
    

Detailed description: 
      This study is a randomized, double-blind, crossover trial with 23 visits consisting of one
      screening visit, one baseline visit, and 21 study visits (10 test periods each consisting of
      2 test visits and one drop-off visit) across 11 weeks. For this study, 60 generally healthy
      subjects will be randomized to a test sequence and will consume one control product and nine
      test products over the course of the study. Before consumption of any study products, breath
      hydrogen lactulose assessment and collection of stool samples for microbiome analysis will be
      completed. Additionally, midway through the study, data will be reviewed in a blinded manner
      and a stool sample will be collected from a subset of 30 subjects for in vitro fermentation
      tests. Gastrointestinal symptoms and stool information will be collected using the
      Gastrointestinal Tolerance Questionnaire (GITQ) and Bowel Habit Diary with Bristol Stool
      Scale (BHD-BSS). The GITQ and BHD-BSS will be administered for 3 days and 7 days prior to
      study product consumption, respectively. Additionally, the GITQ and BHD-BSS will be collected
      throughout the day of study product consumption and the 2 days after product consumption.
      24-h urine samples will be collected after study product consumption for urinary allulose
      analysis.
    

Intervention name(s): Acute intake of one of the products (active comparator 1 to 9) or Placebo comparator
Intervention type(s): Other
Intervention description(s): One pack of each product (1 to 10) will be consumed on a separate occasion
Other intervention name(s): No sugar chewable candies
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject will be allocated to a sequence of consumption of the 10 different products
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Sugar replacer; Gastrointestinal symptoms; GITQ; BHD-BSS; Acute; microbiota
A Study of LY2775240 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is conducted to determine the side effects related to LY2775240 given orally to
      healthy participants. Blood tests will be done to check how much LY2775240 is absorbed into
      the bloodstream and how long the body takes to get rid of it. Each participant will enroll in
      either Part A or Part B of the study, which will last about 14 weeks and 8 weeks
      respectively, including screening.
    


Intervention name(s): LY2775240; Placebo; Apremilast
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Apremilast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Treatment Of Fever In The Emergency Department
Condition: Fever
MeSH terms: Emergencies; Fever
Study type: Observational

Summary: 
      Fever is a frequent cause of admission to the Emergency Department (ED) around the world.
      While it can be caused by a wide range of conditions, the most effective treatment based on
      its etiology is still undetermined. This observational, prospective, single-center study
      enrolled adult patients who accessed the ED for fever, with the aim to define the most
      effective treatment for them.
    

Detailed description: 
      Physicians were free to administer paracetamol 1000 mg (P), the combination paracetamol 500
      mg/ibuprofen 150 mg (PI) or Ibuprofen 600 mg (I).The primary endpoint was both 1-degree and
      1-point reduction in body temperature for all associated symptoms on the Numeric Rating Scale
      (NRS) after 1 hour (T1). Secondary endpoint was the reduction of at least 2 points on the NRS
      after two hours (T2). Adverse events, the needing of a rescue therapy and the response based
      on the underlying etiology (bacterial, viral, or immune/neoplastic) were also evaluated.
    

Intervention name(s): Paracetamol
Intervention type(s): Drug
Intervention description(s): Emergency physicians were free to administer paracetamol 1000 mg (P), the combination paracetamol 500 mg/ibuprofen 150 mg (PI) or Ibuprofen 600 mg (I)
Other intervention name(s): Combination of paracetamol/ibuprofen
Intervention MeSH terms: Acetaminophen; Ibuprofen
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults > 18 years old with fever and associated symptoms accessing the ED
      
Keywords: Fever; Paracetamol; Paracetamol/Ibuprofen; Emergency Department
Safety and Immunogenicity Study to Assess TDV, a Live Attenuated Tetravalent Vaccine for Prevention of Dengue Fever
Condition: Dengue Fever
MeSH terms: Dengue; Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety of Takeda's Tetravalent Dengue Vaccine
      Candidate (TDV) (previously DENVax) in healthy adults when given as either a subcutaneous
      (SC) or intradermal (ID) injection at two dose levels (low and high). The vaccine will be
      given as two doses 90 days apart. Safety assessments include injection site evaluation and
      adverse events. The immune response generated after vaccination will be assessed up to 9
      months after the first vaccination.
    

Detailed description: 
      This is a single center, placebo-controlled, randomized study assessing the safety and
      tolerability of two dose levels (low and high) of TDV administered subcutaneously or
      intradermally in two doses separated by an interval of 90 days. Initial dosing of low dose
      cohort will be performed and Day 21 safety assessed prior to administration of second dose to
      low dose cohort on Day 90 and initial dosing of high dose cohort. Day 21 safety for the high
      dose cohort will be assessed prior to administration of second dose for this cohort. Safety
      (local injection site reactions and solicited and unsolicited adverse events) will be
      assessed through Day 120 post-first (1 month after the second dose). Immunogenicity will be
      assessed at specified time points up to Day 120 post-prime (1 month after the second dose)
      and again on Days 180 and 270 (6 and 9 months post-first).
    

Intervention name(s): TDV - Low Dose; TDV - High Dose; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8 x 10^3 PFU, TDV-2: 5 x 10^3 PFU, TDV-3: 1 x 10^4 PFU, and TDV-4: 2 x 10^5 PFU, total virus per dose 2.2 x 10^5 PFU; TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2 x 10^4 PFU, TDV-2: 5 x 10^4 PFU, TDV-3: 1 x 10^5 PFU, and TDV-4: 3 x 10^5 PFU, total virus per dose : 4.7 x 10^5 PFU. TDV administered intradermally.; Phosphate Buffered Saline (PBS)
Other intervention name(s): Live attenuated tetravalent dengue vaccine; Live attenuated tetravalent dengue vaccine; PBS
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dengue fever; live attenuated tetravalent dengue vaccine; TDV; Drug therapy
Effect of Treatment on Connective Tissue in Low Back Pain
Condition: Low Back Pain; Connective Tissue Defect (Diagnosis)
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the effects of instrument assisted soft tissue
      mobilization (IASTM) and kinesiology taping (KT) that are additional treatment to the
      conservative treatment for the lumbar region and hamstrings and connective tissue thickness
      in patients with chronic non-specific low back pain (CNSLBP).
    


Intervention name(s): IASTM application; Kinesio Tape® Tex Gold)
Intervention type(s): Other; Other
Intervention description(s): IASTM application .; Kinesio Tape® Tex Gold)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Transcranial Direct Current Stimulation in Offenders
Condition: Aggression; Risk-Taking; Antisocial Behavior
MeSH terms: Aggression; Antisocial Personality Disorder
Study type: Interventional

Summary: 
      This study investigates the effect of upregulating prefrontal cortex activity on risk-taking,
      and antisocial and aggressive behavior in violent offenders. In the double-blind, randomized
      controlled trial, using a within-subject crossover design, each participant will undergo
      anodal transcranial direct current stimulation of the right dorsolateral prefrontal cortex
      and sham stimulation. After each stimulation session, neural activity and behavioral
      responses to tasks assessing risk-taking and aggressive behavior will be recorded. The effect
      of tDCS on violent offenders will also be assessed in comparison to age and gender-matched
      healthy controls.
    


Intervention name(s): Transcranial direct current stimulation; Sham transcranial direct current stimulation
Intervention type(s): Device; Device
Intervention description(s): Transcranial direct current stimulation will be administered for 20 minutes using a CE approved stimulator (NeuroConn, Ilmenau, Germany).; The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, open-label, multiple-treatment multiple-dose, 2-period, 2-sequence study
      will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered
      with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in
      healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral
      doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2,
      all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study
      treatment is up to 20 days.
    


Intervention name(s): atazanavir; danoprevir; ritonavir; tenofovir disoproxil fumarate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): multiple oral doses; multiple oral doses; multiple oral doses; single oral doses
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Tenofovir
Intervention model: Parallel Assignment
Masking: None (Open Label)
Brain-Train Home Based Pain Treatment
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      A study examining the effectiveness of neurofeedback therapy for the treatment of Central
      Neuropathic Pain (CNP), in patients with a Spinal Cord Injury, using a small user-friendly
      device which can be operated by patients at home.
    

Detailed description: 
      Spinal Cord Injury (SCI) affects a person's ability to move and feel sensation from the body.
      SCI is also an indirect cause of a persistent pain, called Central Neuropathic Pain (CNP).
      This pain typically develops several months after the injury.

      In 30% to 40% of SCI patients, severe CNP affects their everyday living including sleep and
      mood. Medical treatment of CNP is moderately effective and costly, both to the patient and to
      the health care system.

      In a previous study, some characteristic 'signatures' of brain waves that are related to CNP
      were defined. Based on this, a novel treatment for CNP based on neurofeedback was developed
      and clinically tested on five SCI patients. Electroencephalograph (EEG) was used to record
      patients' brain waves and shown to patients on a computer screen in a simple graphical form
      (e.g. bars). Patients were trained to change their brain activity at will and, as a
      consequence, their pain was reduced. Costly laboratory devices were used and once the study
      was over, an adequate alternative could not be offered to patients.

      In this study, a cheap, portable, wireless and user friendly, Conformité Européenne (CE)
      marked EEG device will be used to train 10 patients to self-administer the therapy in the
      comfort of their homes. Participants will be given initial training to use the equipment then
      will be asked to use the system at home for 3 months - initially, 3-5 times a week then,
      if/when pain subsides, at least once a week or as required.

      The primary purpose of the study is to determine whether a portable system for
      neuromodulation is a useful tool for administering therapy for pain (intensity of pain will
      be measured by the visual numerical scale (VNS)).

      The secondary purpose of the study is a quantitative analysis of changes in the brain
      activity due to therapy, as measured by EEG; patients' perspective of the home based
      neuro-therapy (assessed by questionnaires and one-to-one, semi-structured interviews).
    

Intervention name(s): Neurofeedback training
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury