bioihbjkbjnl/mcl2 huggingface dataset:
Treatment and Prevention of Middle Ear Morbidity in Head and Neck Cancer Patients Following Radiotherapy
Condition: Otitis Media With Effusion; Chronic Otitis Media; Hearing Loss
MeSH terms: Head and Neck Neoplasms; Hearing Loss; Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional

Summary: 
      To investigate the incidence of tuba dysfunction (TD) and middle ear (ME) morbidity after
      radiotherapy (RT) to the Head & Neck and test the effect of auto-inflation of the Eustachian
      tube (ET) on middle ear effusion with a special designed balloon (Otovent®) and thereby
      better hearing and ear related quality of life after cancer treatment.
    

Detailed description: 
      Middle ear complications and TD are common following RT to the Head & Neck, where the
      radiation field involves the ET and ME. These are due to mucositis and swelling in the
      surrounding pharyngeal tissue and on the long-term fibrosis. The ET is a small channel from
      the middle ear to the upper part of the pharynx. It is normally closed but briefly opens
      while swallowing or yawning. The ME pressure then equalizes and optimize sound conduction to
      the inner ear. If the function of the ET is impaired it can lead to negative pressure and
      effusion. This causes pain, tinnitus, otitis media with effusion (OME), chronic otitis media
      (COM) and hearing loss. Last can be none reversible. Almost everyone experience middle ear
      morbidity short after RT, but on the long-term up to 20 % have chronic otitis media and TD
      with significant hearing impairment and the need for hearing aid. Conventional treatment with
      insertion of ventilation tubes in to the tympanic membrane is not recommended for
      radiation-induced ME problems.

      Methods and materials: The investigators will by randomized controlled trials examine the
      effect of auto-inflation of the ET on ME morbidity with a custom-made balloon called
      Otovent®. Examination of the ear is conducted by otoscopy, pure tone and impedance audiometry
      and questionnaires.
    

Intervention name(s): Otovent®
Intervention type(s): Device
Intervention description(s): Otovent® is a special designed balloon that is blown up through the nose, also referred to as auto-inflation of the eustachian tube. The patients use the Otovent® 5 times a day.
Other intervention name(s): Auto-inflation device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Head and neck neoplasms; Radiotherapy; Otitis media
Psychomotor Therapy for Very Premature Infants
Condition: Premature Infant
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Our current reflexion is that sensory dys-stimulations, including vestibule-proprioceptive
      disorders and unbalanced between brain and brainstem maturation of the neonatal period
      involve an early deviant development for immature infants that will be cascaded through the
      brain scaffolding and later development. The primary purpose is to determine whether the
      Early Psychomotor Therapy Intervention Program improves development and behavior in very
      preterm infants (VPI) at 24-month corrected age (CA).
    

Detailed description: 
      VPI < 30 week of amenorrhea were randomized, in a simple blind controlled trial. The
      psychomotor development was evaluated according to the Bayley Scales of Infant
      Development-III (BSID-III) at 2 years CA. An intermediate point was provided at 9 months CA.
      Pediatric standardized assessments and psychologist semi-directive interviews were conducted.
      Parents also completed a self-administering questionnaire relating to the post-traumatic
      stress. The intervention consisted on 20 therapy sessions between 2 and 9 months CA, in order
      to support infants' development, and parent-infant interactions and adjustment.

      Extended description of the protocol, including more technical information (as compared to
      the Brief Summary) if desired. Do not include the entire protocol; do not duplicate
      information recorded in other data elements, such as eligibility criteria or outcome
      measures.
    

Intervention name(s): Early post hospital discharge psychomotor therapy
Intervention type(s): Other
Intervention description(s): The intervention consisted on 20 psychomotor therapy sessions between 2 and 9 months, in order to support infants' development, and parent-infant interactions and adjustment. The therapy was based on body and emotional positive feelings and experiences, leading to improve sensory motor and perceptive integration, interactive and exploratory behaviors, physiological and tonic-emotional self-regulation, motor organization and early coordination. The intervention was a partnership with the parents, leading to decode the baby needs and expectations, for the parents to experiment more positive feelings, to become more confident in their own skills and more sensitive, and in synchrony with their baby. Intervention was supported by a detailed assessment scale implemented in the regional network related to the follow-up for vulnerable babies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuromotor sequelae; Cognitive disorders; Cerebral development; Psychomotoricity; Postural management; Motor coordination; Parenthood
Bioavailability Study of Pravastatin Sodium 40 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the relative bioavailability of pravastatin sodium
      40 mg tablets with that of Pravachol® 40 mg tablets in healthy adult male subjects under
      fasting conditions.
    

Detailed description: 
      Criteria for Evaluation: FDA Bioequivalence Criteria

      Statistical Methods: FDA bioequivalence statistical methods
    

Intervention name(s): pravastatin sodium; Pravachol®
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg Tablet; 40 mg tablet
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Healthy Subjects
Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed
Condition: Anticoagulant-related Major Bleed
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      This is an observational study based on data collected via an audit of electronic medical
      charts. The study population will include adult US patients treated with andexanet alfa or
      4F-PCC during a hospitalization for an anticoagulation-related major bleed, and their
      characteristics, treatments and outcomes will be described.
    

Detailed description: 
      This observational study will include adult US patients treated with andexanet alfa or 4F-PCC
      during a hospitalization for an anticoagulation-related major bleed. Data will be collected
      via an audit of electronic medical charts. The primary objectives are to describe the
      patients' characteristics, treatments and outcomes, including length of stay and in-hospital
      mortality. Secondary objectives include subgroup analyses, including by bleed location.
      Potential differences between patients treated with andexanet alfa versus 4F-PCC, and
      potential differences in patient characteristics over time, will be assessed. If this
      assessment confirms that treatment groups can be adequately balanced and that patient
      characteristics have not substantially changed over time (i.e. no channeling bias is
      observed), the risk of in-hospital mortality with andexanet alfa versus 4F-PCC will be
      assessed in a comparative effectiveness analysis. If treatment groups cannot be balanced or
      clear signs of channelling bias are observed, the comparative analyses will be considered
      unfeasible and will not be performed.
    

Intervention name(s): Andexanet alfa; 4F-PCC
Intervention type(s): Drug; Drug
Intervention description(s): Andexanet alfa; Four-Factor Prothrombin Complex Concentrate (4F-PCC)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an
        anticoagulation-related major bleed
Evaluate Efficacy and Safety of Oral SHR0302 in Subjects Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will
      enroll approximately 330 subjects aged 12 to 75 years old with moderate to severe atopic
      dermatitis.
    

Detailed description: 
      This study consists of a screening period followed by a placebo-controlled treatment period
      and then an extension treatment period and completed after a follow-up period after the
      completion of active treatment.
    

Intervention name(s): Core Treatment Active Experimental: SHR0302 Dose#1; Core Treatment Active Experimental: SHR0302 Dose#2; Core Treatment Placebo Comparator: Placebo; Extension Treatment Active Experimental: SHR0302 Dose#1; Extension Treatment Active Experimental: SHR0302 Dose#2
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks; Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks; Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks; Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks; Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Interventions for Depressed Low Income Mothers and Their Infants
Condition: Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      This study will compare three interventions for depressed, low income mothers and determine
      which is most effective in treating maternal depression and in fostering development in
      infants.
    

Detailed description: 
      Poorly educated, low income mothers are at high risk for becoming depressed. The effects of
      living in poverty and being reared by a depressed parent can be detrimental to an infant's
      development. Effective interventions to reduce maternal depression and strengthen the
      mother-infant relationships are needed.

      Participants will be randomly assigned to one of three groups. Group 1 mothers will receive
      16 weekly sessions of interpersonal psychotherapy (IP) designed to directly treat maternal
      depression. Group 1 participants will have monthly follow-up visits for 1 year. Participants
      in Group 2 will receive 16 weekly sessions of IP followed by 1 year of in-home, infant-parent
      psychotherapy, an intervention addressing relationship difficulties between depressed mothers
      and their infants. Group 3 mothers will be invited to attend informational meetings as well
      as be referred to local services available to people with depression.

      All mother-child pairs will be evaluated when the child is 12, 16, 24, and 36 months of age.
      Evaluations will involve questionnaires, diagnostic interviews, developmental assessments,
      and video- and audio-taped measures.
    

Intervention name(s): Maternal interpersonal psychotherapy (IP); Infant-parent psychotherapy; Informational meetings plus treatment as usual
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive 16 weekly sessions of maternal IP designed to directly treat maternal depression.; Participants will receive 1 year of in-home, infant-parent psychotherapy, an intervention addressing relationship difficulties between depressed mothers and their infants.; Participants will be invited to attend informational meetings as well as be referred to local services available to people with depression.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mother-Child Relations; Infant; Child Development; Poverty
Limited Market Release - MotionSense Clinical Use Evaluation
Condition: Knee Arthroplasty; Patient Engagement; Patient-Reported Outcome Measures (PROMs)
Study type: Interventional

Summary: 
      Prospective evaluation of patient compliance and prescribed home exercise program using
      MotionSense wearable system during recovery from primary total knee arthroplasty.
    

Detailed description: 
      During the proposed study, the MotionSense wearable system will be used by patients
      undergoing total knee arthroplasty (TKA) surgery leading up to and after their surgery. The
      patients will be using the system to monitor their recovery during daily activities, log
      daily pain scores and patient reported outcomes while also supporting their prescribed home
      exercise program. Each patient will thereby participate in outpatient physiotherapy in line
      with their current standard of care, while the physiotherapist will leverage the
      opportunities of the presented platform to give the patient personalized reminders for their
      patient-specific home exercise program. The surgeon / research nurse will additionally be
      able to monitor the patients recovery remotely as the sensor / app data is shared to the
      OrthoLogIQ platform.
    

Intervention name(s): MotionSense
Intervention type(s): Device
Intervention description(s): MotionSense Wearable: Remote patient monitoring
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: MotionSense
Chlorhexidine as Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions
Condition: Non-carious Cervical Lesions
MeSH terms: Uterine Cervical Diseases
Study type: Interventional

Summary: 
      This study aims to evaluate the effect of chlorhexidine digluconate (CRX) application in
      etched dentin on the retention of noncarious cervical lesions restorations.

      A randomized controlled split-mouth and blind trial will be carried out. Patients with at
      least two non-carious cervical lesions (NCL) will be selected. NCL will be randomly assigned
      according the type of teeth (incisors, canine or pre-molars) into two groups: control or
      experimental group (application of 2% CRX for 60 seconds after the acid etching procedure).
      Class V restorations will be performed out with an etch-and-rinse adhesive system (Adper
      Single Bond 2-3M ESPE) and a composite resin (Filtek Z350-3M ESPE) according the manufacture
      instructions, by previously trained operators. The restorations will be evaluated by a
      calibrate examiner at 1 week (baseline), and 6-month, 12-month and 24-month, using the World
      Dental Federation (FDI) criteria. The outcome is retention of the restoration.
    


Intervention name(s): Treatment with chlorhexidine; Water pre-treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): Application of 2% chlorhexidine digluconate (60 seconds) after the etching procedure and before the adhesive system.; Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chlorhexidine; Matrix metalloproteinases (MMP) inhibitor; Adhesive system; Controlled clinical trial; Dental restoration; Noncarious cervical lesions; Dental restoration failure
Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes Relation Between Anthropometric Measurements and Balance in Children With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Type 1 diabetes mellitus is the most common chronic metabolic disorder in children. Diabetic
      children who take proper nutrition and good care attain normal growth status. Factors
      affecting growth in diabetic patients include gender, age at diagnosis, duration of disease,
      glycemic control, and puberty status. Moreover, diabetes mellitus has negative impact on
      vestibular system, affect proprioception and lower limb muscle fatigue resulting in reduced
      balance.
    

Detailed description: 
      Limited literature is available regarding the relation between anthropometric measurements
      and balance in children with diabetes mellitus. Therefore, the current study will be
      conducted to investigate the relation between anthropometric measurements (weight, height and
      body mass index) and balance in children with diabetes mellitus.
    

Intervention name(s): children with Diabetes Mellitus, Type 1
Intervention type(s): Other
Intervention description(s): assessment of Relation between anthropometric measurements and balance in children with type 1 diabetes
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with T1DM will be selected from Abu El-Rish Hospial, Cairo University. Sample size
        estimation will be carried out based on a pilot study to determine the recruited number of
        participants. Participants will be recruited according to the following criteria.
      
Keywords: Diabetes mellitus; anthropometric measurements; balance; Diabetes Mellitus, Type 1
The Effect of Tai Chi Chuan in Older Adults
Condition: Healthy Aging; Motor Learning; Cognitive Function
Study type: Interventional

Summary: 
      30 healthy older participants were enrolled in the study and were randomly classified into
      two groups. In the experimental group (n = 15) participants received 10-week Tai Chi Chuan
      practice intervention, in the control group (n=15) participants were asked do not change
      their living habits in 10 weeks. All participants had no practice Tai Chi Chuan before.
    

Detailed description: 
      All participants had to proceed with familiarization with cognitive function tests before all
      measurements and evaluation. Study protocol began in the early morning after overnight
      fasting (10.7 ± 4.7 h). Firstly, participants were asked to lay in the supine position for 15
      minutes in rest to measure resting heart rate (HR) and heart rate variability (HRV) during
      the last 10 minutes and blood pressure afterward. Subsequently, participants completed PSS-10
      and HADS questionnaires, and then a venous blood sample was taken for BDNF and irisin
      concentrations measurements. Then measurements of cognitive functions and motor learning were
      performed. After baseline assessments, participants were randomized to the experimental and
      control groups. The experimental group subjects (n=15; 13 women) participated in 10 weeks Tai
      Chi practice. In the control group, participants (n=15; 13 women) were instructed do not to
      engage in any additional sports practice. All tests and measurements were repeated after 10
      weeks in the same order as it was at the beginning of the study.
    

Intervention name(s): Tai Chi Chuan trainings
Intervention type(s): Other
Intervention description(s): 10 weeks of Tai Chi Chuan practice by 6-year experienced training teacher, 2 times per week, 60 min per session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Genicular Nerve Block for Total Knee Arthroplasty
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after
      total knee replacement.
    

Detailed description: 
      Part of the way in which pain is controlled during total knee replacement surgery is through
      a nerve block. The investigators have developed an effective protocol for pain control after
      knee replacement, but know that many patients still experience pain around the knee after
      knee replacement. There are nerves around the knee that carry pain impulses from behind the
      knee. The investigators believe that placing numbing medicine around these nerves can help
      with pain in front of the knee after surgery, in addition to the standard nerve block placed
      for knee replacement surgery. This may result in taking less pain medication by mouth,and
      having less pain with movement. For this study, before the operation, either a placebo
      solution or the local anesthetic bupivacaine (a numbing solution) will be placed at three
      sites around the knee where these nerves reside. The investigators will evaluate how
      participants feel in recovery after surgery, during the stay in the hospital, and call at
      home one week after surgery. Knowing if numbing these nerves helps with pain after surgery
      will help us further refine our postoperative care plan for patients.
    

Intervention name(s): 15mL 0.25% bupivacaine; Genicular nerve block; Saline
Intervention type(s): Drug; Procedure; Drug
Intervention description(s): Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline; The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves.
After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml of 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.; Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Total knee replacement