bioihbjkbjnl/mcl2 huggingface dataset:
Mobile Phone Text for Optimizing Asthma Treatment
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The study aims at providing information on how the Short Message Service (SMS) tool
      influences self-management in asthma patients and to assess the resulting health related
      effect. A wide range of models and theories exist in the compliance area, such as technical
      models, communication models, cognitive models and self-management models and theories. The
      use of some of these theories and models will serve as theoretical and explanatory tools for
      studying how and why the SMS tool influences the patient's self-management.

      Objective:

      The objective of this study is to assess the health-related effects of a SMS compliance and
      monitoring system for optimized asthma treatment in a controlled trial setting.
    


Intervention name(s): SMS support
Intervention type(s): Behavioral
Intervention description(s): The intervention consisted of sequences of SMS messages sent to the intervention group, each containing 2 or 3 monitoring questions and one reminder to take the preventive medication. The SMS sequence was as follows.
Remember to take your preventive asthma medication (sent at 8.00 am).
Were you awakened during the night due to your asthma? Answer YES or NO.
How many times have you taken your asthma attack medication during the last 24 hours? Answer a number.
What was your peak flow this morning? Answer a number (optional, depending on the participant's use of a spirometer prior to the study).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Immersive Care - Virtual Mirror Therapy
Condition: Stroke
Study type: Interventional

Summary: 
      The purpose of this implementation study is - primarily - to investigate the feasibility,
      acceptability, tolerability of a new virtual reality application in stroke patients, and
      -secondarily - to gain initial insights in the preliminary clinical effects of this
      application.
    

Detailed description: 
      Although immersive technologies have great potential in healthcare, they are still relatively
      unknown and underutilized in this field. In this study a new virtual reality (VR) application
      will be implemented and tested in two groups of stroke patients (10 acute phase/10 chronic
      phase). In an attempt to reactivate the affected upper limb in stroke patients, therapists
      often use mirror therapy. Using a mirror, the movement of a paralyzed limb is feigned in
      order to reprogram the brain. A patient performs exercises with the healthy limb, but through
      the mirror the patient seems to use the affected limb. A high number of repetitions is
      essential to stimulate the so-called neuroplasticity of the brain, but this makes mirror
      therapy monotonous. In addition, the therapy also has its limitations. Activities are limited
      by the physical boundaries of the modality, with exercises largely limited to distal
      movements and simple functional activities. Larger, free-standing mirrors provide a wider
      range of motion for therapeutic activities, but offer less protection against environmental
      distraction. With VR, these obstacles can be overcome. By focusing on virtual mirror therapy
      using a VR headset, therapists hope to create a more pleasant and realistic experience for
      the patients.
    

Intervention name(s): Virtual mirror therapy via VR headset
Intervention type(s): Device
Intervention description(s): Participants will perform Activities of Daily Living (ADL) in a virtual environment through a VR headset. The application is based on mirror therapy. Participants will execute certain arm movements with their non-affected arm, while seeing their affected arm perform said movement in the virtual environment.
Other intervention name(s): VR mirror therapy; VR application; Mirror therapy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Upper extremity; Rehabilitation; Virtual Reality; Immersive technology; Mirror therapy
Safety and Efficacy of Celecoxib Versus Diclofenac in the Treatment of Ankylosing Spondylitis
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the safety and efficacy of once-daily and twice-daily celecoxib versus diclofenac
      for the treatment of ankylosing spondylitis
    


Intervention name(s): Celecoxib; Celecoxib; Diclofenac
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 mg oral capsule once daily for 12 weeks; 200 mg oral capsule twice daily for 12 weeks; 75 mg oral capsule twice daily for 12 weeks
Intervention MeSH terms: Celecoxib; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Single-incision Sling vs Urethral Bulking During Prolapse Surgery for Occult Stress Incontinence
Condition: Stress Incontinence, Female
MeSH terms: Urinary Incontinence, Stress; Prolapse
Study type: Observational

Summary: 
      The aim is to compare outcomes of two different procedures to prevent occult stress urinary
      incontinence (SUI) in patients who are having pelvic organ prolapse surgeries
    

Detailed description: 
      The aim is to compare outcomes of two different procedures to prevent occult stress urinary
      incontinence (SUI) in patients who are having pelvic organ prolapse surgeries. Charts will be
      reviewed for patients who had single- incision sling or urethral bulking injection with other
      prolapse surgeries to address occult stress incontinence at The Christ Hospital from the
      period of January 2019 to June 2021. Patients who didn't have any occult stress incontinence
      pre-operatively and didn't receive any anti-incontinence procedure during their prolapse
      surgery will be included as a control group. Surgical details, adverse events and
      postoperative voiding times will be collected from the chart. Patients will be contacted by a
      telephone to administer a validated questionnaire; a 3-day bladder diary to quantify urinary
      incontinence will be send to the patient to complete and return by mail.

      The purpose of the study is to investigate whether urethral bulking is as effective as
      single- incision sling in treating occult stress incontinence.
    

Intervention name(s): Single incision sling; Bulkamid bulking agent
Intervention type(s): Device; Drug
Intervention description(s): Single incision sling is used to treat occult SUI; Urethral bulking by Bulkamid is used to treat occult SUI
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with advanced prolapse and preoperative evaluation showed occult stress
        incontinence
Pharmacokinetic Study of Intranasal CT001 in Children 1-17 Years of Age Undergoing Elective Surgical Procedures
Condition: Analgesia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective non-randomized, open-label, single dose (and a second dose if needed),
      PK study in 25 children age 1-17 years. The proposed number of study participants by subset
      is: 8 paediatric participants 1-2 years; 8 paediatric participants >2-6 years and 9
      paediatric participants >6-17 years.
    


Intervention name(s): CT001
Intervention type(s): Combination Product
Intervention description(s): Sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg as nasal spray, followed by an additional dose 10 -15 minutes after, if needed.
Intervention model: Single Group Assignment
Intervention model description: The study population will receive a target dose of intranasal CT001 corresponding to sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg (and an additional dose 10 -15 minutes after, if needed) prior to an elective surgical, procedure.
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of IMSI to Treat Male Infertility
Condition: Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      Intracytoplasmic Morphologically Selected Sperm (IMSI) is a modification of IntraCytoplasmic
      Sperm Injection (ICSI) with a choice of the spermatozoon to be injected done at a 6000x
      magnification instead of 400x commonly used in ICSI. The purpose of this study is to evaluate
      the efficiency and the indications of IMSI through a multicentric randomised trial.
    

Detailed description: 
      Intracytoplasmic sperm injection (ICSI) is largely used to treat male infertility. Usually,
      choice of the spermatozoon to be injected is done at a 400x magnification. Recently, a new
      microscopic technic (Intracytoplasmic Morphologically Selected Sperm Injection-IMSI) allows
      to make this choice at a 6000x magnification, which permits to identify sperm abnormalities
      such as nuclear vacuoles not seen in conventional ICSI. This selection may improve ICSI
      outcome. However only few data from randomised trials, have been published and the
      indications of IMSI remain to be identified. The present study aims to evaluate the
      efficiency and the indications of IMSI through a multicentric randomised trial. The patients
      enrolled in the study must present a male infertility and will have complete sperm
      examination, including morphology, DNA fragmentation and nuclear immaturity. The main
      endpoint will be the percentage of delivery.
    

Intervention name(s): IMSI; ICSI
Intervention type(s): Procedure; Procedure
Intervention description(s): Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) is a modification of IntraCytoplasmic Sperm Injection (ICSI) with a choice of the spermatozoon to be injected done at a 6000x magnification instead of 400x commonly used in ICSI; ICSI is largely choice of the spermatozoon to be injected done at a 400x magnification
Other intervention name(s): Intracytoplasmic sperm injection (ICSI)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IMSI; ICSI; ART Assisted reproductive technology; Spermatozoa; male infertility; vacuoles
Long Term Follow Up for RAD001 Therapy of Angiomyolipomata in Patients With Tuberous Sclerosis (TSC) and Sporadic Lymphangioleiomyomatosis (LAM)
Condition: Tuberous Sclerosis; Angiolipoma
MeSH terms: Tuberous Sclerosis; Lymphangioleiomyomatosis; Angiomyolipoma; Angiolipoma; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open label long term follow up study, open to those subjects who were previously
      enrolled in"RAD001 Therapy of Angiomyolipomata in Patients with Tuberous Sclerosis Complex
      and Sporadic Lymphangioleiomyomatosis", CCHMC IRB #2008-0812 and who meet the criteria for
      this long-term follow-up study.

      The hypothesis is that the drug will inhibit the growth of the angiomyolipomas and possibly
      even cause regression.
    

Detailed description: 
      Tuberous sclerosis complex is a genetic disorder with a birth incidence of approximately one
      in six thousand. Angiomyolipomas occur in eighty percent of persons with TS, and in up to 60%
      of persons with LAM. They are fatty tumors that often occur in kidney or liver as well as
      other parts of the body. They can grow and cause damage to surrounding kidney tissue and even
      renal failure. They may also leak blood causing potentially life-threatening hemorrhage.

      Laboratory studies have shown that RAD001 suppresses the chemical that cause tumors to grow
      in tuberous sclerosis and sporadic LAM. The use of RAD001 to treat angiomyolipomas in
      tuberous sclerosis or sporadic LAM is considered experimental.
    

Intervention name(s): everolimus (RAD001)
Intervention type(s): Drug
Intervention description(s): Subjects will resume the dosing regimen that they were receiving at the completion of the initial RAD001 study.
Other intervention name(s): RAD001
Intervention MeSH terms: Everolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tuberous Sclerosis Complex (TSC); Angiolipoma; mTOR; Everolimus
Subcutaneous Immunotherapy for Mouse in Adults
Condition: Asthma; Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an open label trial of mouse allergenic extract administered by subcutaneous
      injection in adults with asthma and mouse sensitivity. The study is designed to evaluate:

        -  the safety of this therapy when given by injection

        -  biomarkers of the immune response and

        -  whether the therapy would be effective in treating allergic asthma.
    

Detailed description: 
      The primary objective of the study is to assess if treatment with mouse subcutaneous
      immunotherapy (SCIT), using the per protocol allergenic extract doses, is safe. This will be
      done by determining the rate of related adverse events and serious adverse events in the
      course of treatment.

      Secondary objectives include:

        -  determination of whether a 24 week treatment with mouse SCIT, using the per protocol
           allergenic extract doses, will induce a 3-fold increase in mouse-specific serum
           immunoglobulin E (IgE)

        -  determination of whether a 24 week treatment with mouse SCIT, using the per protocol
           allergenic extract doses, will induce changes in the serum levels of mouse-specific
           immunoglobulin G (IgG) and immunoglobulin subclass 4 (IgG4).
    

Intervention name(s): Mouse Allergenic Extract
Intervention type(s): Biological
Intervention description(s): Subjects will receive escalating doses of glycerinated mouse allergenic extract administered subcutaneously up to a maximum study dose (MSD) of 0.4 mL of extract at a concentration of 1:10 wt/vol., per protocol.
Other intervention name(s): mouse epithelial extract; allergenic extract of Mus musculus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: subcutaneous immunotherapy (SCIT); glycerinated mouse allergenic extract; mouse specific IgE; mouse specific IgG and IgG4; mouse prick skin test wheal
The Preventive Value of Acupoint Sensitization Based on Stable Angina Pectoris
Condition: The Clinical Value of Acupoint Sensitization
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional

Summary: 
      This study, taking stable angina pectoris as a research carrier, aims to explore the
      preventive value of acupoint sensitization by conducting a double-blind multi-center
      randomized controlled trial to compare the effect of stimulating acupoints with different
      sensitivity on the prevention of angina pectoris.

      After the inclusion of eligible patients, the pressure-pain threshold of disease-related
      acupoints will be detected by using Von Frey detector. Then, the patients will be randomly
      divided into experimental group and control group. The patients in experimental group will be
      given acupoints pressure on the five acupoints with the lowest pressure-pain threshold, while
      the patients in control group will be given acupoints pressure on the five acupoints with the
      five acupoints with the highest pressure-pain threshold. The two groups will be treated with
      acupoints pressure 12 times within 4 weeks. The patients will be evaluated three times at
      baseline, the end of treatment and four weeks after the end of treatment respectively,
      including angina attack frequency, CCS classification and SAQ score.
    


Intervention name(s): Hypersensitive acupoint group; Hyposensitive acupoint group
Intervention type(s): Procedure; Procedure
Intervention description(s): The first five acupoints in the sensitization sequence were pressed using the traditional Chinese medicine acupoint pressing technique, and each acupoint was pressed for two minutes.; The last five acupoints in the sensitization sequence were pressed using the traditional Chinese medicine acupoint pressing technique, and each acupoint was pressed for two minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      The purpose of this study is to establish reliability and validity of the Norwegian version
      of the Comfort behavioral scale.
    

Detailed description: 
      Structured pain assessment is the foundation for the management of pain. Several different
      pain measurement tools exists, among them the Comfort behavioral scale (van Dijk, 2005),
      developed from the original Comfort scale (Ambuel, 1992). The psychometric properties of the
      Comfort scale have been tested in several studies, but so far no Norwegian version of the
      scale has been developed and tested. Neither has the scale been tested in spontaneously
      breathing children undergoing minor surgery. The aim of this study is to establish incipient
      psychometric properties of the Norwegian version of the scale among children aged 0-3 years
      admitted for elective minor surgery.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children admitted to Telemark Hospital (level II hospital) and meeting the inclusion and
        exclusion criteria specified
      
Keywords: COMFORT behavioral scale; pain assessment scale; child; validity; reliability
Safety and Efficacy of SQIN™ on Xerosis in Adults With Mobility Problems and Paralysis
Condition: Xerosis
MeSH terms: Paralysis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      In the general population, xerosis is often caused by external factors such as seasonal
      changes. In that case, the best way to relieve dry skin is to use a standard moisturizer.
      However, for those suffering of mobility problems due to age or paralysis (e.g., spinal cord
      injury, multiple sclerosis, Parkinson's, etc), xerosis is often severe and chronic because of
      the multiple causes (endogenous rather than exogenous ones) underlying such mobility
      impairment-related skin problems. This study is a double-blind, randomized study with
      positive control (active comparator) to assess the safety and efficacy of SQIN with CanSATs
      (Co-Activation of Natural Synergistically Acting Target-receptorS) technology on dry skin in
      patients suffering of paralysis.
    

Detailed description: 
      Xerosis is a medical term for dry skin. When it results in skin that is scaly and itchy, the
      condition is called pruritus. This occurs when natural moisture is drawn out of the skin. The
      skin needs moisture to protect itself. The best way to relieve dry skin normally, for those
      suffering of seasonal dry skin problems, is to use standard moisturizers. However, for those
      suffering of mobility problems due to age or paralysis (spinal cord injury, multiple
      sclerosis, Parkinson's, Alzheimer's, muscular dystrophy, amputation, cerebral palsy, or other
      comparable disorders), xerosis becomes severe and chronic because of the multiple causes
      (endogenous metabolic problems and dysfunctions rather than exogenous ones). SQIN with
      CanSATs technology is designed to act upon multiple mechanisms for enhanced protecting,
      moisturizing, and repairing effects. Based upon preliminary evidence, SQIN with CanSATs
      technology can thus elicit significantly superior effects compared with standard,
      commercially available moisturizers.
    

Intervention name(s): SQIN; standard moisturizing cream (Glaxal Base)
Intervention type(s): Other; Other
Intervention description(s): Each patient will be asked to self-apply both creams (experimental vs positive control) on the right and left sides of their body (sides will be randomly assigned).
Other intervention name(s): SQIN on one side - control cream on other side
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and efficacy of two doses of
      dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD
      (MPH) and placebo in children ages 6-12 diagnosed with ADHD.
    


Intervention name(s): Focalin XR
Intervention type(s): Drug
Intervention MeSH terms: Dexmethylphenidate Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: ADHD, children
Renal Function Among Thalassemia Patients Treated by a Oral Chelator Deferasirox
Condition: Thalassemia; Iron Overload
MeSH terms: Thalassemia; Iron Overload
Study type: Observational

Summary: 
      Thalassemia Major patients developed Iron Overload due to blood transfusions and intestinal
      iron absorption. Renal function caused by Iron overload was studied in a previous study and
      shows principally tubular disfunction. In this previous study the Iron chelator used was
      Deferrioxamine. In the last five years an oral Iron chelator was introduced and approved by
      the FDA, Deferasirox, (Novartis, Switzerland and USA). The purpose of this study is to assess
      the renal function in Thalassemia Major patients treated with this new oral iron chelator and
      compare the results with our previous study.
    

Detailed description: 
      Patients with Thalassemia Major. The laboratory tests that will be studied are: Urine dip
      stick, Urea, Creatinine, Na, K, Uric Acid, Calcium, Phosphorus in serum and urine, and N
      acetyl-b-D-glucosaminidase in Urine.Blood gases will be also taken in serum samples.

      The overall iron accumulation will also be calculated based in the amount of Packed Cells
      Units transfused. The total iron burden will also assessed by measurement of Transferrin
      saturation and Serum Ferritin.
    

Intervention name(s): Deferasirox
Intervention type(s): Drug
Intervention MeSH terms: Deferasirox
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with Thalassemia Major or Intermedia treated by Iron chelators or by blood
        transfusions without treatment with iron chelators
      
Keywords: Renal Function