bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of OE-MRI in Patients With H&N Cancer
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Squamous Cell Carcinoma of Head and Neck
Study type: Observational

Summary: 
      Assessment of the use of oxygen enhanced MRI scanning in a cohort of patients with head and
      neck squamous cell carcinomas to identify areas of hypoxia with tumours and relate this to
      treatment outcomes.
    

Detailed description: 
      Oxygen-enhanced MRI (OE-MRI) is a technique being actively investigated for imaging hypoxia
      within cancer tissues. Preliminary clinical data demonstrates the feasibility of using this
      methodology to study patients with head and neck squamous cell carcinoma (HNSCC). The
      investigators wish to investigate using this methodology to identify hypoxic subvolumes
      within HNSCC that may have greater resistance to standard radiotherapy treatment and
      investigate the association of such hypoxic regions with treatment outcomes.
    

Intervention name(s): Oxygen Enhanced MRI scan
Intervention type(s): Diagnostic Test
Intervention description(s): Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        5 non-patient volunteers. 50 patients from Nottingham University Hospitals NHS Trust, UK.
      
Keywords: Oxygen enhanced MRI
FACTO Study (Foster® As Complete Treatment Option)
Condition: Asthmatic Patients
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Double blind, multinational, multicentre, randomised, 2 arm parallel group study
    

Detailed description: 
      Aim of the present investigation is to demonstrate the clinical equivalence between
      fluticasone plus salmeterol 500/100 µg daily and an equipotent dose of CHF1535 in maintaining
      the same asthma control in patients adequately controlled with fluticasone plus salmeterol at
      the above mentioned daily dose.
    

Intervention name(s): FOSTER; Seretide
Intervention type(s): Drug; Drug
Intervention description(s): CHF1535 (beclometasone dipropionate 100 µg plus formoterol 6 µg) pMDI aerosol via HFA-134a propellant 2 inhalations b.i.d. (daily dose 400 µg + 24µg); Fluticasone 250 µg + salmeterol 50 µg DPI (Seretide® Diskus®) 1 inhalation b.i.d. (daily dose 500+100 µg)
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study the Effect of Omeprazole on AB-106 Pharmacokinetics
Condition: Pharmacokinetic Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, fixed sequence phase I clinical study. To evaluate the
      effect of continuous administration of omeprazole magnesium enteric coated tablets on PK
      after single dose AB-106 capsule administration in Chinese healthy male subjects. This study
      includes a screening period (1-28 days before administration), treatment period (34 days),
      and follow-up period ( after the last dose completed 7 ± 3 days). The treatment period of
      this study was divided into two periods, and the subjects were divided into two groups, 12
      subjects in the first group and 10 subjects in the second group. The treatment method and
      research process of each group of subjects are the same. After the first group of subjects
      completes the second cycle and is evaluated by the investigator and sponsor, the second group
      of subjects can start administration. If there are no more than 4 subjects in the first group
      who have vomiting gastrointestinal reaction (vomiting occurs within 8 hours after each cycle
      of administration) after completing the two cycles of administration of AB-106 400 mg, they
      can be added to the second group of subjects, and the number of added subjects shall not
      exceed the number of subjects who have vomiting gastrointestinal reaction. If more than 4
      subjects have gastrointestinal reaction of vomiting, the investigator and sponsor will make a
      comprehensive evaluation, and can reduce the dosage of AB-106 to 200 mg, and 22 subjects will
      be included in the trial at one time or supplemented in the second group to complete the 400
      mg dose group
    


Intervention name(s): Multiple administration of omeprazole Single administration of AB-106
Intervention type(s): Drug
Intervention description(s): Take AB-106 capsule 400 mg orally on an empty stomach in the morning of the first day of the first cycle Take omeprazole magnesium enteric coated tablets 40mg once a day, 30 minutes before breakfast on days 1-4 of the second cycle. On the morning of the fifth day of the second cycle, the subjects will take omeprazole magnesium enteric coated tablets 40 mg, and AB-106 capsules 400 mg after an interval of 1 hour
Intervention MeSH terms: Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty
Condition: Knee Joint Osteoarthrosis; Hyperalgesia; Severe Movement Related Pain
MeSH terms: Osteoarthritis; Hyperalgesia
Study type: Interventional
Phase: Phase 2

Summary: 
      Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for
      osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It
      has been suggested that preoperative degree of intraarticular inflammation is associated to
      postoperative degree of pain and level of function. Furthermore it is known, that patients
      with preoperative inflammation have hyperalgesia and severe movement related pain.

      The aim of this study is to investigate the effect of a preoperative intraarticular injection
      of Methylprednisoloneacetate in reducing acute postoperative pain after total knee
      arthroplasty in patients with signs of severe pre-operative inflammation and pain.
    


Intervention name(s): Methylprednisoloneacetate; Lidocaine; sodium chloride
Intervention type(s): Drug; Drug; Other
Other intervention name(s): Depo-Medrol; saline
Intervention MeSH terms: Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Lidocaine; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age
Condition: Preterm Children
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      In recent years, several studies confirm that some of preterm children have language
      developmental disabilities, in production, in comprehension, or in written language. These
      language impairments lead to learning disabilities. There are, however, contradictions
      concerning the origin and nature of language dysfunctions. Some studies find lexical
      disorders (number of words used by the child), others preferentially phonological disorders
      (sounds used in the language), others also disorders of the morphosyntaxe (organization of
      the sentences) and fragilities that affect pragmatics (understanding situations).

      The computer-evaluation of the language is carried out at five and a half year coupled with
      the medical and neuropsychological examinations. The language assessment lasts 30 to 45
      minutes per child. It is carried out using a laptop computer that allows the submission of
      stimuli and recording of the child's responses. The language evaluation scale is the battery
      CléA (Pasquet F et al, 2014), standardized reference tool for the realization of a language
      evaluation. The assessment includes three tests: comprehension of words and phrases,
      production of words and phrases, and judgment of sentences. Each time, the child sees images
      and hears words or phrases. Sometimes he has to say what he sees on the computer screen.

      As usual, a speech-language assessment is not carried out, routinely, at the age of 5 years
      in the context of the follow-up of children born very preterm.

      The evaluation proposed to the child in this research will be carried out at a significant
      period of development, before writing. This assessment will not only assess the structure of
      the child's language, but also determine if there are possible difficulties in learning to
      read and write.

      The expected benefits for the health of the children included in the trial therefore concern
      the detection or characterization of any developmental fragilities affecting the language.
      These screenings or characterizations will make it possible to advocate a speech
      rehabilitation if necessary.
    


Intervention name(s): computer-evaluation of the language
Intervention type(s): Behavioral
Intervention description(s): A computer-evaluation of the language will be done for children born very preterm preterm in 2011 in the region of Haute-Normandie in France
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluation of Organisational Changes to Promote Smoking Cessation
Condition: Adult Smokers
Study type: Interventional

Summary: 
      The Department of Family Practice at Michigan State University partnered with BCBSM with a
      grant from the Robert Wood Johnson Foundation to recruit primary care practices for a 3 year
      study designed to assess smoking cessation referral rates by primary care physicians in
      Michigan.
    

Detailed description: 
      There are two main research questions to our study: 1) Whether provider referral rates to
      smoking cessation services and quitline counseling are enhanced by comparative feedback
      profiles to individual providers and provider groups (Study 1) and 2) Whether health plan
      members who receive pharmacotherapy for smoking cessation have higher participation rates in
      smoking cessation services if they receive proactive, invitational phone calls (Study 2).
    

Intervention name(s): Feeback group
Intervention type(s): Behavioral
Intervention description(s): The intervention practices received a quarterly comparative feedback performance report based on the Achievable Benchmarks of Care (ABC) research conducted by Kieffe (YEAR).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Adult smokers
Effects of Home Based Step Aerobic Exercises
Condition: Aerobic Exercise
Study type: Interventional

Summary: 
      The aim of this study is to determine the effects of commercially produced new generation
      smart step board and step-aerobic exercises for 6 weeks on the functional capacity and
      physical performance of young sedentary individuals.
    

Detailed description: 
      The aim of this study is to determine the effects of commercially produced new generation
      smart step board and step-aerobic exercises for 6 weeks on the functional capacity and
      physical performance of young sedentary individuals. The primary outcomes to be evaluated are
      the functional improvements in individuals' balance, functional capacity, muscle strength,
      and resting heart rate after 6 weeks of step-aerobic exercises. Secondary results are the
      evaluation of the effects of individuals on jumping performance and exercise motivation. It
      is thought that the results obtained in the study will reveal new information for studies
      investigating home-based exercise and rehabilitation practices and may provide evidence for
      larger studies involving a diagnosis of a disease in the future.
    

Intervention name(s): Moderate-intensity aerobic activities
Intervention type(s): Other
Intervention description(s): The exercise intensity of the individual is planned at 50-60% heart rate reserve using the Karvonen method.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: home-based exercise; step-aerobic exercise; wearable technology
Deep Brain Stimulation in Severe Obsessive-compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Deep brain stimulation is an established treatment for movement disorders. New indications
      for deep brain stimulation are under investigation, among them severe and treatment-resistant
      obsessive-compulsive disorder. Here, the investigators investigate clinical outcomes, safety
      and mechanism of action of DBS in the BNST in a series of 11 participants with severe
      therapy-refractory OCD.
    


Intervention name(s): Deep brain stimulation
Intervention type(s): Device
Intervention description(s): Stereotactic functional neurosurgery was first developed in 1947 and is today an established treatment for movement disorders. The surgical procedure is initiated by mounting a stereotactic frame on the head of the patient and a magnetic resonance image (MRI) is performed. Using a computerized navigational system the target structure is identified on the MRI and a trajectory chosen. In the operating theatre a burrhole is made on each side of the midline for the implantation of two electrodes. The electrodes are about 1.3 mm in diameter with several contacts at their distal end. An extension cable is tunneled under the skin, connecting the electrodes with a neuropacemaker placed below the clavicle in a subcutaneous pocket. The hospitalization time after surgery is dependent on the time needed for programming of the device, but the patients can usually return home within 3-5 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Deep brain stimulation; Bed nucleus of stria terminalis; Obsessive-compulsive disorder
A Study of 14C JNJ-67953964 in Healthy Adult Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetic (PK), metabolism, and routes of
      excretion of aticaprant and its metabolites in excreta and in plasma after a single oral dose
      14C-aticaprant in healthy adult male participants.
    


Intervention name(s): 14C-aticaprant
Intervention type(s): Drug
Intervention description(s): 14C-aticaprant will be administered orally as capsule on Day 1.
Other intervention name(s): JNJ-67953964
Intervention MeSH terms: Aticaprant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
MYL-1401A Efficacy and Safety Comparability Study to Humira®
Condition: Psoriasis; Arthritis, Psoriatic
MeSH terms: Arthritis, Psoriatic; Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the equivalence of MYL-1401A to Humira® with regards to efficacy in subjects with
      moderate-to-severe chronic plaque psoriasis
    

Detailed description: 
      Eligible subjects will be randomly assigned based on predefined stratification factors of
      weight, geographic region, and presence of psoriatic arthritis:

      Randomization is 2:1 to MYL-1401A or Humira®, respectively.

      The study will be conducted in the outpatient setting and comprises 3 periods: a screening
      period of up to 4 weeks, a 52-week treatment period, and a safety follow-up for 8 weeks.

      A subject will be considered to have completed the study once they have completed the 52-week
      treatment period and the 8-week follow-up visit.
    

Intervention name(s): MYL-1401A (Adalimumab); Humira® (Adalimumab)
Intervention type(s): Biological; Biological
Intervention description(s): MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose; Humira® initial dose of 80 mg administered sc, followed by 40 mg sc given every other week starting 1 week after the initial dose
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adalimumab; Biologics; Biosimilar
Port Will be Flushed Every 3 Months Instead of Every 4-6 Wks, as Recommended by Port Manufacturer.
Condition: Complication of Catheter
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of port (PAC) flushes
      every 3 months rather than every four to six weeks.

      It is routine practice to flush ports every four to six weeks, according to the
      manufacturer's recommendations, using salt solution followed heparin if needed. This study
      examines the effectiveness of port flushes at an alternative interval of 3 months, reducing
      the number of visits to the health-care provider.
    

Detailed description: 
      This is a phase II, non-blinded, non-inferiority prospective cohort trial of patients with
      ports (PAC) after a systemic therapy to evaluate the safety and effectiveness of PAC flushes
      in 3 months intervals. Patients with any type of cancer are eligible. The study will extend 1
      year from enrollment of the last patient. Each enrolled patient will have his or her port
      flushed five times in 3 month intervals.

      Patients will be enrolled after the completion of systemic therapy and after completion of
      the restaging follow up, which is the time period from 4 weeks to 3 months after
      discontinuation of the chemotherapy. Once patients are enrolled to extended interval PAC
      flushes, they will be followed for one year. At the end of the year patients will return to
      standard PAC flushes. If patients experience any PAC malfunction, it would be considered a
      PAC failure and the flushing will reverted back to the schedule recommended by the
      manufacturer.
    

Intervention name(s): Reduced port-flush schedule
Intervention type(s): Other
Intervention description(s): 3-month port-flushing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: port; catheter; infusion; flush; cleanse; chemotherapy
Exercise Habit and M-PAC
Condition: Public Health
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The promotion of physical activity (PA) is paramount to public health, yet interventions in
      the social cognitive tradition have yielded negligible improvements. Two reasons for these
      results may be the over reliance on intention as the proximal determinant of behaviour and a
      lack of consideration of implicit/automatic determinants of PA. The purpose of this study was
      to apply Multi-Process Action Control (M-PAC), a framework centered on PA
      intention-translation and the gradual building of habit to examine PA change using a two-arm
      parallel design, randomized controlled trial.
    

Detailed description: 
      Background: Two of the most prominent limitations of traditional social cognitive models used
      to understand moderate-to-vigorous physical activity (MVPA) are the gap between intention and
      behaviour and the lack of consideration of implicit processes in behavioural enactment. Thus,
      new models are now being examined that attempt to consider these potential limitations.
      Multi-Process Action Control (M-PAC) is one such attempt to build a more comprehensive
      schematic, whereby intention is established via the means of constructs from traditional
      social cognitive theories (i.e., outcome expectations, perceived capability), but the success
      of translating this intention to behaviour depends on behavioural-regulation (self-regulatory
      tactics) (BR), affective judgments (expected pleasure) (AJ) and opportunity (time, access).
      Over time, M-PAC proposes that habit (stimulus -behaviour bonds) and identity (role-behaviour
      bonds) develop from performing the behaviour and largely contribute to the maintenance of PA.

      Aim: The purpose of this study was to conduct at two-arm parallel design, RCT to determine if
      the M-PAC experimental group would demonstrate greater change in PA and post-intention
      constructs across time.

      Methods: Participants (n=94) were inactive new gym members and were randomized into a control
      or M-PAC experimental group. The experimental group attended a workshop and received a
      booster phone call follow-up at week four. Measures for both groups included accelerometry
      and M-PAC at baseline and at week eight.
    

Intervention name(s): M-PAC Group
Intervention type(s): Behavioral
Intervention description(s): Participants attended a workshop, completed a worksheet and received a booster phone call follow-up at week four.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise; Habit; MVPA; M-PAC; Automaticity; Physical Activity
Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A multicenter, randomized, open-lable, single-dose, two-cycle, double-cross bioequivalence
      study comparing the pharmacokinetic profile of LY01612 (Doxorubicin hydrochloride liposome
      injection) and CAELYX® in Chinese subjects with advanced breast cancer
    


Intervention name(s): Doxorubicin hydrochloride liposome injection
Intervention type(s): Drug
Intervention description(s): Doxorubicin hydrochloride liposome injection was administered intravenously for 90min (±3min) with an infusion pump on day 1 and day 29 of the trial. Doxorubicin hydrochloride liposome injection was diluted with 250mL 5% glucose injection.
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment