bioihbjkbjnl/mcl2 huggingface dataset:
Building Sentences With Preschoolers Who Use AAC
Condition: Down Syndrome; Speech and Language Disorder; Speech Disorders in Children; Speech Intelligibility; Speech Sound Disorder
MeSH terms: Down Syndrome; Language Disorders; Speech Disorders; Speech Sound Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The focus of this investigation is to compare the effectiveness of the AAC Generative
      Language Intervention approach to an AAC Standard of Care condition on preschool sentence
      productions. All children will use existing AAC iPad applications.
    

Detailed description: 
      The central hypothesis is that preschoolers receiving AAC Generative Language Intervention
      will create longer, more grammatically complete sentences compared with the Standard of Care
      condition. Specific Aim 1 compares these interventions for preschoolers with severe speech
      impairments and typical receptive language, and Specific Aim 2 does the same for children
      with Down syndrome. Specific Aim 3 tests for possible moderation of the intervention effect
      by age, dynamic assessment scores, sentence type, receptive language abilities, prior AAC
      use, sex, mental age, and disability. Aims 1 and 2 will be accomplished using randomized
      controlled trials.
    

Intervention name(s): AAC Generative Language Intervention; Standard of Care / Business as Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Parent/Caregiver AAC App Operational Training + Direct AAC Input-Output Language Intervention; Parent/Caregiver AAC App Operational Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Low Intensity Physical Activity Leads to Improvement in Brachial-ankle Pulse Wave Velocity of Hemiplegics
Condition: Hemiplegia; Motor Activity; Physical Activity
MeSH terms: Hemiplegia
Study type: Interventional
Phase: Phase 2

Summary: 
      Low intensity physical activity by half squat of the elderly people with hemiplegia
      significantly slow down the pulse wave velocity of the arteries of the lower limbs of the
      paralyzed side within 8 weeks.
    

Detailed description: 
      Measurement of aortic pulse wave velocity (PWV) is a noninvasive method for assessing
      arterial stiffening in atherosclerosis. In hemiplegics, disuse of the affected limb is
      associated with the muscle wasting leading to development of local atherosclerosis. The
      brachial-ankle aortic PWV (baPWV) is an indicator of early stage disuse syndrome, and is
      measured with a device that is particularly useful in elderly hemiplegics.

      The LIPA regime was designed to result in an increase of 3.3% (about 40 kcal/day) of daily
      energy consumption compared to their individual baseline values. This included aerobic
      exercises and half squats (70° knee flexion) for altogether about 20 minutes, once daily. In
      addition, the subjects performed passive ankle dorsiflexion-plantar flexion, 30 times/minute
      for 10 min, once daily. The LIPA was aimed at affecting the passive range of motion in ankle,
      knee, and hip, and weight bearing on the affected leg in standing position.
    

Intervention name(s): Daily low intensity physical activity by the half squat; stretch exercise and usual activity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): They take a meal three times daily. They are a time to do the manual work every day. They watch the TV for two hours every day. And they do a walk of 30 minutes every day. They do a specific exercise. They were trained to conduct 40kcal period(about 20 min.) for adding to the amount of energy consumption of low-intensity physical activity at baseline.Specific exercise that was done the half squat(max knee flexion 70 degree). This squat is carried out in two seconds round trip. This squat is carried out in two seconds round trip. They grab the edge of the table. They put half the weight of the lower limbs paralyzed side. This observer once a week, to record their behavior over 24 hours. Intervention period is up to a maximum of 12 weeks.; They take a meal three times daily.They are a time to do the manual work every day.They watch the TV for two hours every day.And they do a walk of 30 minutes every day.They do whole body stretch exercise for 20 minute in a day. An observer once a week, to record their behavior over 24 hours.Their behavior was used to calculate the amount of energy consumption.They are informed of the kcal a day from the viewer.
Other intervention name(s): low intensity physical activity; whole body stretch exercise and usual activity
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulse wave velocity; low intensity physical activity; hemiplegia
Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and
      pharmacodynamics of MYK-461 in human subjects. This is a sequential group, single ascending
      (oral) dose study in NYHA Class I, II, or III patient volunteers aged 18-65 years.
    


Intervention name(s): MYK-461
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Of Efficacy Of Tazarotene 0.045% Vs Halobetasol Propionate 0.01% Lotion For Treatment of Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      Psoriasis is a serious, immune-driven illness that affects around 2% of the population and
      has a wide range of clinical manifestations 1-3 . Many patients have localized illness, and
      topical therapy can be an important part of treatment.

      tazarotene is the first receptor-selective retinoid for the topical treatment of plaque
      psoriasis. On application, tazarotene is rapidly hydrolyzed to its main metabolite,
      tazarotenic acid, which binds to retinoic acid receptors (RARs) in the nucleus. Tazarotenic
      acid selectively binds to RARs b and g . The predominant type of RAR expressed in the human
      epidermis is RAR, indicating that it may be an important mediator of retinoid action in skin.
      .
    

Detailed description: 
      Topical Corticosteroids is commonly used in situations of mild to moderate disease severity.
      However, long-term safety is still an issue, especially when utilizing stronger
      formulations,which come with a higher risk of local cutaneous adverse events (AEs).
      Telangiectasia, suppression of the hypothalamic-pituitary-adrenal (HPA) axis, and skin
      shrinkage are some of these negative consequences. By regulating gene transcription,
      tazarotene normalizes abnormal keratinocyte differentiation, reduces epidermal
      hyperproliferation, and decreases inflammation, the three pathogenic factors in psoriasis,
      thereby producing a more normal expression of skin differentiation in psoriatic lesions
    

Intervention name(s): Tazarotene 0.045% Topical Application Lotion [ARAZLO]
Intervention type(s): Drug
Intervention description(s): [ARAZLO]
Intervention MeSH terms: Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate sUA Lowering Activity, Safety and Efficacy of Oral Ulodesine Added to Allopurinol
Condition: Gout; Hyperuricemia; Arthritis; Joint Disease
MeSH terms: Arthritis; Joint Diseases; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether ulodesine and allopurinol combined for 12
      weeks are effective in treating gout in patients who are not adequately responding to
      allopurinol alone.
    


Intervention name(s): ulodesine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral dose administered daily for 84 days.; Oral dose administered daily for 84 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gout; hyperuricemia; arthritis; joint diseases; allopurinol
Nutrition and Body Composition in Acute Lymphoblastic Leukemia
Condition: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Vitamin D Deficiency
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      Many adolescents with acute lymphoblastic leukemia (ALL) have been found to have low bone
      density by the end of treatment. This can lead to long-term suffering in survivors due to
      poor bone health. Vitamin D is known to be associated with bone health and previous research
      has established that Vitamin D insufficiency is very common at diagnosis of ALL and worsens
      over the course of treatment. Researchers have also learned that a relationship exists
      between both Vitamin D and fat tissue and ALL and fat tissue.

      In adolescents being treated for ALL as well as in early survivors, this randomized study
      will therefore examine the effect of Vitamin D and calcium supplementation on correcting
      Vitamin D insufficiency and on improving bone density in the context of changes in body
      composition and body fat. Bone density will be measured by a radiology exam called qCT
      (quantitative computed tomography) while body composition and body fat will be measured by a
      different radiology exam called a DXA (dual energy x-ray absorptiometry scan) . The study
      will also examine in depth the relationship between these three elements - Vitamin D
      insufficiency, obesity, and ALL - and their impact on bone density.
    


Intervention name(s): Vitamin D and Calcium Citrate
Intervention type(s): Dietary Supplement
Intervention description(s): Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6-7 months)
Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day for approximately 6-7 months
Other intervention name(s): 1,25-Dihydroxycholecalciferol; Calcitriol; Rocaltrol (Roche); Calcium carbonate
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Calcitriol; Dihydroxycholecalciferols; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Leukemia; ALL; Vitamin D; Bone Density; Body Fat; Obesity; Adipose
Effects and Safety of Steam Eye Mask With Acupoints Stimulation
Condition: Dry Eye Symptom; Eye Fatigue
MeSH terms: Dry Eye Syndromes; Asthenopia; Fatigue
Study type: Interventional

Summary: 
      To evaluate the effects and safety of the steam eye mask with acupoints stimulation by the
      moist heat of approximately 40 degree C for 20 minutes and massage acupoints on eyebrows for
      eye fatigue, dry eye symptoms and symptom-induced decline of Quality of life (QoL) in VDT
      users.
    

Detailed description: 
      A prospective study is conducted to evaluate the effect of the steam eye mask with acupoints
      stimulation on eye fatigue and dry eye symptoms in VDT users. The effects and safety of the
      single therapy by the moist heat of approximately 40 degree C for 20 minutes with eyebrows
      acupoints massage for the first 3 minutes are evaluated in the single application study, and
      the effects and safety of the repeated therapy by the moist heat applied and massage
      acupoints on eyebrows once per working day for two weeks are evaluated in the repeated
      application study.
    

Intervention name(s): Steam Eye Mask with acupoints stimulation; Steam Eye Mask
Intervention type(s): Other; Other
Intervention description(s): A participant needs to use SEM with acupoints stimulation once a day for 10 days and use hands to massage the acupoints on the eyebrows for the first 3 minutes, total application time at least for 20 minutes.; A participant needs to use SEM once a day for 10 days, total application time at least for 20 minutes.
Other intervention name(s): SEM with acupoints stimulation; SEM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Steam Eye Mask; Acupoints Stimulation; Dry Eye Symptom; Eye Fatigue; Visual Display Terminal; Moist Heat; Massage
Efficacy of a Mobile-based Multidomain Intervention to Improve Cognitive Function and Health-related Outcomes Among Older Korean Adults With a High Risk of Dementia
Condition: Cognitive Decline; Cognitive Impairment, Mild; Aging; Dementia
MeSH terms: Dementia; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study investigated the efficacy of the Silvia program, a mobile-based multidomain
      intervention, to improve cognitive function and health-related outcomes of older adults with
      a high risk of dementia. We compare its effects to a conventional paper-based multidomain
      program on various health indicators related to risk factors of dementia.
    


Intervention name(s): mobile-based; paper-based
Intervention type(s): Device; Other
Intervention description(s): Participants who were randomly assigned to the mobile-based intervention group were provided multidomain programs based on scientific evidence of ways to improve brain-health and reduce dementia risk for 10 minutes per day and at least 50 minutes per week.; Participants who were randomly assigned to the paper-based intervention group were provided with the Korean version of the dementia prevention booklet published by the WHO.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Vaccination With Peptides From Anti-apoptotic Proteins in Relapsed Multiple Myeloma
Condition: Relapsed Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Anti-apoptotic proteins from the Bcl-2 family are known to play a key role in oncogenesis and
      are overexpressed in myeloma cells. Studies have shown that dendritic cells exposed to
      proteasome inhibition present exogene antigens better than unexposed dendritic cells.
      Patients with relapse of multiple myeloma will be offered vaccination with peptides derived
      from antiapoptotic proteins from the Bcl-2 family in combination with an immunostimulatory
      adjuvant. The vaccination will be given in relation to treatment with the proteasome
      inhibitor bortezomib.
    


Intervention name(s): peptides derived from antiapoptotic proteins
Intervention type(s): Biological
Intervention description(s): 8 Vaccinations on day 2 and 9 in every bortezomib treatment series
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple myeloma; vaccination; antiapoptotic proteins; proteasome inhibition
Therapeutic Equivalence of OsvaRen® Tablets and OsvaRen® Granules
Condition: Hyperphosphatemia; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Phosphate binders are crucial to the control of elevated phosphate levels in patients with
      chronic kidney disease. With the new formulation of granules the pill burden of patients is
      sought to be reduced.

      This study is about efficacy and safety of the new drug formulation and compares it to the
      "old" formulation which are film-coated tablets.
    

Detailed description: 
      The study is aimed at demonstrating the therapeutic equivalence of both products, i.e.
      granules versus tablets.

      Secondary objectives are: Comparing both preparations with regard to the number of patients
      reaching serum phosphate levels < 1.76 mmol/L and the difference in serum phosphate levels
      between the first and last visit under each treatment. Furthermore, it is the aim of this
      study to evaluate the safety profile of OsvaRen® granules in comparison to OsvaRen® tablets.
      Especially serum calcium, magnesium, and PTH are of interest.
    

Intervention name(s): Osvaren Granules; Osvaren film-coated tablets
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PGL4001 Efficacy Assessment in Reduction of Symptoms Due to Uterine Leiomyomata (PEARLIII-extension Study)
Condition: Uterine Fibroids
MeSH terms: Leiomyoma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is the long-term extension of a phase III, efficacy and safety open-label (protocol
      PGL09-026) with PGL4001 10mg tablets once daily for three months, blinded towards the
      administration of progestin or placebo tablets after end of PGL4001 treatment.

      This extension study consists of three periods of 3 months open-label PGL4001 treatment, each
      followed by ten days of double-blind treatment with progestin or placebo and then a period
      without treatment.
    


Intervention name(s): PGL4001, placebo, drug free period; PGL4001, progestin, drug free period
Intervention type(s): Drug; Drug
Intervention description(s): PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ending with a drug free period until return of menses.; PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets) during 3 periods each ending with a drug free period until return of menses.
Other intervention name(s): Ulipristal acetate; Ulipristal acetate
Intervention MeSH terms: Ulipristal acetate; Progestins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Local Anesthesic on Diaphragmatic Function After Upper Abdominal Surgery
Condition: Hepatectomy
Study type: Interventional
Phase: Phase 3

Summary: 
      Upper abdominal surgery is known to induce such pulmonary complications as pneumonia,
      atelectasis, pleural effusion. The post operative diaphragmatic dysfunction participates to
      these complications and lasts for 7 days after upper abdominal surgery. The sniff-test is a
      recognized tool for measuring the diaphragmatic function.The purpose of this study is to
      evaluate the effectiveness of parietal analgesia with continuous infiltration of local
      anesthesic on diaphragmatic function after upper abdominal surgery through a subcostal
      incision. Our main outcome is to measure the diaphragmatic function with the sniff test in 44
      patients with parietal infiltration of ropivacaine and in 44 patients with placebo. Our
      secondary outcomes are the evaluation of the effect of continuous parietal analgesia with
      ropivacaine on IPmax and EPmax, oxygen saturation, post operative pulmonary complications and
      post operative recovery. This prospective study will determine if the pre peritoneal local
      infiltration of ropivacaine is useful to decrease post operative diaphragmatic dysfunction.
    


Intervention name(s): Sniff test; Infusion of Ropivacaine during 48 hours; Continuous parietal infusion with parietal catheter; Infusion of placebo during 48 hours; NaCl
Intervention type(s): Procedure; Drug; Device; Drug; Drug
Intervention description(s): Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo; 20 ml Bolus (7,5 mg/ml) then continuous administration of 10 ml per hour (2 mg/ml) during 48 hours of Ropivacaine.
20 ml Bolus (NaCl 0.9 %) then continuous administration of 10 ml per hour, during 48 hours of NaCl 0.9 %.; Continuous parietal infiltration of Ropivacaine or placebo
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diaphragmatic function; sniff-test; pulmonary complications; upper abdominal surgery
Radiosurgery and Avastin for Recurrent Malignant Gliomas
Condition: Malignant Glioma
MeSH terms: Glioma
Study type: Interventional

Summary: 
      The purpose of this study is to assess the central nervous system (CNS) toxicity in patients
      with recurrent malignant gliomas treated with concurrent Avastin and stereotactic
      radiosurgery (SRS).
    

Detailed description: 
      In this pilot study, 15 human subjects with recurrent, unifocal malignant gliomas up to 5-cm
      in maximum dimension no longer responding to conventional chemotherapy but able to tolerate
      further chemotherapy will be enrolled. The primary endpoint of this study will be the
      proportion of patients who experience CNS toxicity, with secondary endpoints progression-free
      survival, overall survival, steroid dosage, development of radionecrosis, quality of life,
      objective radiographic response and performance status.
    

Intervention name(s): Stereotactic Radiosurgery (SRS); Bevacizumab
Intervention type(s): Radiation; Drug
Intervention description(s): Tumor Volume < 2.0cm receives 24 Gy in 1 fraction Tumor Volume 2.0-2.9cm receives 18 Gy in 1 faction Tumor Volume 3.0-4.9cm receives 25 Gy in 5Gy/fraction; Bevacizumab (Avastin) 10 mg/kg given the day before SRS and 2 weeks after SRS
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent
Effects of PRJ-205 on Performance in Trained Young Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      Compare a dietary supplement (PRJ-205) and placebo during 1 or 4 days on aerobic exercise
      performance, oxidative stress and muscle damage.

      The hypothesis is that supplementation with PRJ-205 improve aerobic performance
    

Detailed description: 
      Twenty young active males will be recruited and randomized to either placebo or PRJ-205.
      Subjects will take the designated treatment in an acute dosage and chronically, 4 days of
      treatment.

      They will undergo 3 exercise tasks (before the administration of the product, 1.5h after the
      acute administration of the product and after 4 days of treatment). VO2max and anaerobic
      threshold will be measured during the tests. Blood samples will be taken to measure muscle
      damage and oxidative stress.
    

Intervention name(s): PRJ-205; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 1 sachet per day; 1 sachet per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Performance