bioihbjkbjnl/mcl2 huggingface dataset:
ART Restorations With High-viscosity Glass-ionomer Cement Versus Hall Technique in Primary Molars
Condition: Primary Teeth Retained
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary molars are the teeth with the highest caries tendency among primary teeth due to
      their anatomical features such as wide and flat interface areas. However, some difficulties
      are encountered during the removal of caries due to the structural features of primary molars
      and the young age of the child. Therefore, in the treatment of primary molars, Atraumatic
      Restorative Treatment (ART), in which the soft parts of the carious lesion are cleaned with
      the help of a sharp hand tool and restored with an adhesive glass ionomer cement (GIC) that
      releases fluoride, in the following years, the deciduous teeth were removed with a minimally
      invasive approach. Hall technique, in which a stainless steel crown (SSC) is placed without
      preparation for treatment, has come to the fore.
    

Detailed description: 
      Many restorative materials, especially GIC, have been used for ART procedures, and with the
      advancing technology, high-viscosity glass ionomer cements with improved mechanical and
      chemical properties have emerged. In recent years, zinc-added HVGICs and nano-filled
      resin-modified HVGICs have been introduced.

      The Hall Technique has been suggested in the treatment of asymptomatic decayed primary molars
      in anxious and fearful patients to ensure patient cooperation. In this technique, it is aimed
      to stop the progression of caries by covering the carious deciduous molars with SSC and
      cutting their relationship with the oral environment, without the need for local anesthesia
      and tooth preparation. Thus, as the bacteria cannot use the carbohydrates in the oral
      environment, the number of bacteria in the environment will also decrease.
    

Intervention name(s): High viscosity glass ionomer cement; Stainless steel crown
Intervention type(s): Drug; Device
Intervention description(s): High viscosity glass ionomer cement; Stainless steel crown
Other intervention name(s): EQUIA Forte (GC Corp., Leuven, BE); 3M ESPE, St. Paul, USA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Myfortic® for Minimal Change Nephrotic Syndrome (MCNS): a Randomized Study
Condition: Nephrosis, Lipoid
MeSH terms: Nephrotic Syndrome; Nephrosis; Nephrosis, Lipoid
Study type: Interventional
Phase: Phase 4

Summary: 
      Study objective: To investigate the potential therapeutic efficacy of enteric-coated
      mycophenolate sodium combined with low-dose corticosteroid as first-line treatment for
      minimal change nephrotic syndrome (MCNS).
    

Detailed description: 
      This is a prospective, open-label, randomized study in which patients who present for the
      first time with a clinical diagnosis of idiopathic MCNS proven on renal biopsy will be
      assigned to either conventional standard-dose prednisolone monotherapy or myfortic combined
      with low-dose prednisolone treatment for 6 months. Clinical response and relapse rates within
      6 months of treatment cessation will be the main outcome parameters.
    

Intervention name(s): Myfortic plus low-dose steroid; Prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): Prednisolone: 0.25 mg/kg/day for 8 weeks then 0.15 mg/kg/day for 8 weeks then 0.1 mg/kg/day for 8 weeks then off Myfortic: 720 mg b.i.d. (540 mg b.i.d. if body weight less than 60 kg) for 24 weeks then off; 1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician
Other intervention name(s): Mycophenolate sodium
Intervention MeSH terms: Mycophenolic Acid; Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Minimal Change Nephrotic Syndrome; Corticosteroid; Mycophenolate; Remission; Safety
Alpha-s1 Casein Hydrolysate on Sleep
Condition: Chronic Insomnia; Polysomnography
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      This study investigates the impact of Aalpha-s1 casein hydrolysate (ACH; Lactium®) on sleep
      quality in individuals with chronic insomnia, employing both subjective sleep profiles and
      objective polysomnography (PSG) recordings.
    

Detailed description: 
      During the trial, the use of food or health products containing sedative or hypnotic
      ingredients or formulations is prohibited.
    

Intervention name(s): alpha-s1 casein hydrolysate; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 150mg of Prelactium per capsule; 150mg of Maltodextrin per capsule
Other intervention name(s): Prelactium
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Alpha-s1 casein hydrolysate; Randomized controlled trial; insomnia; Polysomnography
The Effectiveness of Telerehabilitation-Based Physiotherapy in COVID 19 Patients
Condition: Covid19; Telerehabilitation; Physical Therapy
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength
      can be observed in individuals who have been diagnosed with COVID19 and have been discharged.
      In our study, it was aimed to investigate the effect of telerehabilitation physical therapy
      intervention to these cases by using videoconferencing method on the physical condition of
      the cases.
    

Detailed description: 
      Problems such as breathlessness, exercise intolerance and loss of peripheral muscle strength
      can be observed in individuals who have been diagnosed with COVID19 and have been discharged.
      In our study, it was aimed to investigate the effect of telerehabilitation physical therapy
      intervention to these cases by using videoconferencing method on the physical condition of
      the cases. The exercise program will be a total of 6 weeks, 3 days a week. Online access will
      be carried out synchronously by telephone or computer, and training sessions will not be
      recorded in order to protect patient personal information. The cases will be evaluated online
      at the beginning of the study and at the end of the 6-week exercise program. The selected
      evaluation parameters have been selected considering the ease of online application.
    

Intervention name(s): Physiotherapy
Intervention type(s): Other
Intervention description(s): Program content Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; videoconference
A Study in Healthy Japanese Men to Test How Different Doses of BI 1323495 Are Tolerated and How Itraconazole Influences the Amount of BI 1323495 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of the single-rising dose (SRD) part and the multiple rising dose (MD)
      part is to investigate safety, tolerability, pharmacokinetics and pharmacodynamics (for MD
      part only) following single rising doses and multiple oral doses of BI 1323495 in healthy
      male Japanese subjects genotyped as poor metabolizers (PM) and extensive metabolizers (EM) of
      UGT2B17.

      The main objective of the drug-drug interaction (DDI) part is to investigate the relative
      bioavailability of a single oral dose of BI 1323495 when given alone (treatment R) or in
      combination with itraconazole (treatment T) in healthy male subjects genotyped as PM of
      UGT2B17.
    


Intervention name(s): BI 1323495; Placebo; Itraconazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI 1323495; Placebo; Itraconazole
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Postlicensure Observational Safety Study of 13vPnC Administered to Infants and Toddlers
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Observational

Summary: 
      The purpose of the study is to expand the understanding of the safety profile of 13vPnC in
      routine use following licensure and introduction of the vaccine.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): No Intervention
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60,000 infants total: at least 43,000 infants who receive all 3 primary series doses of
        13vPnC plus 15,000 additional infants who receive less than 3 doses of 13vPnC
      
Keywords: Pneumococcal conjugate vaccine
Virtual Reality in the Management of Pain in Pediatrics: a Multi-center Randomized Clinical Trial (RealPED)
Condition: Virtual Reality; Pediatric ALL; Pain, Procedural
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      The goal of this clinical trial is to test if the use of virtual reality glasses reduces the
      pain and anxiety that children feel when they perform a blood test.

      Children between 7 and 12 years old from 5 health centers and 2 hospitals will participate,
      and the children will be divided into two groups. In the control group, the analysis will be
      done in the usual way (for example, distracting with questions) and in the intervention
      group, the analysis will be done while the children use virtual reality.

      The satisfaction of parents and nursing will also be analyzed.
    


Intervention name(s): Virtual reality
Intervention type(s): Behavioral
Intervention description(s): In the virtual reality group, patients will view a video with the virtual reality glasses from the beginning to the end of the venipuncture.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients are randomized in a 1:1 ratio to the intervention group (use of virtual reality during blood collection) and the control group (usual care). The randomization sequence is different for each participating center.
Masking: None (Open Label)
Primary purpose: Health Services Research
AZD9056 Relative Bioavailability Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aims of this study are to compare the blood levels achieved with a new formulation of
      AZD9056 to an existing formulation of AZD9056 used in previous studies.
    


Intervention name(s): AZD9056 formulation Phase III 50 mg (T); AZD9056 formulation Phase IIb 50 mg (R); AZD9056 formulation Phase III 200 mg (T); AZD9056 formulation Phase IIb 200mg (R)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Given as 50 mg tablet (T); Given as 50 mg tablet (R); Given as 400 mg (2 x 200 mg tablet (T)); Given as 400 mg (2 x 200 mg tablet (R))
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Relative Bioavailability; AZD9056
Comparing Naproxen to Sumatriptan for Emergency Headache Patients
Condition: Migraine; Tension-type Headache; Primary Headache Disorder
MeSH terms: Tension-Type Headache; Headache Disorders; Headache Disorders, Primary; Emergencies; Headache
Study type: Interventional
Phase: Phase 4

Summary: 
      2/3 of patients discharged from an emergency department after treatment for an acute headache
      will still be bothered by headache within 24 hours of emergency department (ED) treatment.
      The goal of this study is to compare two medications, naproxen and sumatriptan, to determine
      which is better for the treatment of recurrent headache within 24 hours of emergency
      department discharge.
    

Detailed description: 
      Two-thirds of the five million headache patients who present to US emergency departments (ED)
      annually are suffering an acute exacerbation of a primary headache disorder. Of these acute
      primary headaches, migraine is the most frequently encountered disease entity in the ED,
      accounting for 60% of primary headaches, followed by tension-type headaches, which represent
      10% of all primary headaches seen in the ED. About ¼ of all acute primary headaches seen in
      the ED cannot readily be given a specific diagnosis3. Multiple parenteral treatments are used
      to treat acute primary headaches1, but to date, regardless of specific headache diagnosis, no
      medication eliminates the frequent recurrence of headache after ED discharge. To date, it is
      unknown which medication patients should be given when discharged from an ED after treatment
      for a primary headache. This study will compare two oral headache treatments to determine
      which one relives pain more effectively.

      Specific aims:

      1) To determine which of two oral medications is more efficacious for all acute primary
      headache patients who are discharged from an ED.

      Primary hypotheses:

      In the 48 hour period following ED treatment for a primary headache, sumatriptan 100mg will
      relieve pain better than naproxen 500mg, as measured by an 11-point numerical rating scale
      for pain.
    

Intervention name(s): Sumatriptan 100 mg; Naproxen
Intervention type(s): Drug; Drug
Intervention description(s): Sumatriptan 100mg tablet; Naproxen 500mg tablet
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Emergency department; headache; migraine
Impact of Transcranial Direct Current Stimulation on Language Functions in Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to determine if non-invasive electrical brain stimulation can
      improve word-retrieval in Mild Cognitive Impairment (MCI).
    

Detailed description: 
      Previous studies showed that anodal transcranial direct current stimulation (atDCS) can have
      beneficial effects on word-retrieval in healthy younger and older subjects. The present study
      aims to extend these findings by assessing whether atDCS can also improve known impairments
      of word-retrieval in Mild Cognitive Impairment. atDCS will be applied to the left inferior
      frontal gyrus in a sham controlled cross-over within subjects design. Simultaneous functional
      magnetic resonance imaging (fMRI) will assess underlying neural effects of the stimulation.
    

Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): anodal tDCS will be delivered with a constant current of 1 mA during resting-state and task-related fMRI and will continue until the end of the word-generation task. For both stimulation conditions (atDCS, sham) the current will be initially increased in a ramp-like fashion over 10 s, eliciting a tingling sensation on the scalp that fades over seconds. During sham stimulation the current will be turned off after 30 s.
Other intervention name(s): DC-Stimulator Plus, neuroConn GmbH
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: MCI; Word-retrieval; tDCS; fMRI
Improving Outcomes for Hypertensive Children
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Approximately 200 children age 6 - <18 years receiving medications for essential hypertension
      (HTN) will be recruited from the Pediatric Hypertension Clinic at the time of a routine
      clinic visit. Participating subjects will be asked to wear the ambulatory blood pressure
      monitor (ABPM) for 24 hours within 2 weeks of the qualifying visit. Measurements obtained
      with the ABPM will be compared to measurements obtained by routine clinical procedures
      documented in the subject's clinical chart. Kappa statistic will be utilized to compare
      differences in documented BP control between the two measures as well as changes in
      therapeutic management decisions by treating physicians with the addition of the ABPM
      readings. The overall goal is to confirm that ABPM leads to an increased detection of
      uncontrolled HTN along with a similar increase in adjustments increasing anti-hypertensive
      medication regimens.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 200 children age 6 - <18 years receiving medications for essential HTN will
        be recruited from the Pediatric Hypertension Clinic at the time of a routine clinic visit.
      
Biospecimen description: 
      none collected
    
Keywords: Hypertension
A Novel Laparoscopic Hepatectomy Posture, Left Lateral Position Plus Jackknife Position
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Since the first report of laparoscopic resection of a benign hepatic tumor by Professor H.
      Reith in 1991, the laparoscope has been widely used in liver disease. Based on its advantages
      in laparoscopic vision and amplification, laparoscopic hepatectomy (LH) has been well
      recognized globally. Generally speaking, for lesions located in the left, front or lower part
      of the liver, corresponding to Couinaud segments II, III, IVb, V and VI, an LH surgery is
      recommended; however, for lesions located in segments VII and VIII, the surgery is high
      technically difficult due to poor exposure. Therefore,the investigators employ the left
      lateral position plus jackknife position to better expose lesions in these segments, hoping
      to reduce surgical time and bleeding in LH.
    


Intervention name(s): Jackknife posture
Intervention type(s): Procedure
Intervention description(s): patients with left lateral position plus jackknife position when perform laparoscopic hepatectomy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients were diagnosed with hepatocellular carcinoma (HCC) based on the criteria
        established by the European Association for the Study of the Liver
Prevention of Excessive Weight Gain by Discouraging Students From Drinking Sodas
Condition: Overweight; Children
MeSH terms: Overweight; Weight Gain
Study type: Interventional

Summary: 
      The purpose of this study was to encourage students to reduce soft drinks intake,
      substituting it by water, in order to prevent and control overweight prevalence.
    

Detailed description: 
      During seven months of one school year, a healthy lifestyle education programme was
      implemented using simple messages encouraging water consumption instead of sugar sweetened
      carbonated beverages. The messages were previously tested for understanding in two small
      groups of children of the same age and socio-economic background as the study participants.
      Also, beliefs and behaviors of children in these focus groups were recorded in order to
      orient activities and the production of printed materials to be given to participants.
      Education was delivered via classroom activities; banners were hung promoting water
      consumption, and water bottles with the logo of the campaign were given to children and
      schoolteachers.
    

Intervention name(s): Lifestyle modification
Intervention type(s): Behavioral
Intervention description(s): The centre of the campaign was to encourage the exchange of sugar-sweetened beverages for water. Ten one-hour sessions of activities facilitated by four trained research assistants were assigned for each class. The activities required 20-30 min and teachers were encouraged to reiterate the message during their lesson. Classroom quizzes and games using water v. sugar-sweetened carbonated beverages as the theme, as well as song and drawing competitions, were promoted. In addition, a musician using a tambourine helped each class to collectively develop songs related to drinking water and reducing the consumption of sugar-sweetened carbonated beverages. This musical activity was conducted during three one-hour sessions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: randomized controlled trials; soft drinks; hypercholesterolemia; serum cholesterol; blood glucose; overweight; carbonated beverages
Safety and Efficacy of Azzalure/Dysport, Restylane/Emervel Filler and Restylane Skinbooster Treatment
Condition: Aesthetics
Study type: Interventional
Phase: Phase 4

Summary: 
      The efficacy and safety, as well as subject satisfaction will be evaluated after single
      treatment with Azzalure/Dysport alone or Restylane/Emervel filler alone followed by repeated
      combined treatment with Azzalure/Dysport, Restylane/Emervel filler and Restylane Skinbooster.
      Subjects will be followed for up to 18 months after initial treatment.
    


Intervention name(s): Azzalure or Dysport; Restylane or Emervel filler; Restylane Skinbooster
Intervention type(s): Drug; Device; Device
Intervention description(s): Glabellar lines; Facial tissue augmentation; Facial skin rejuvenation
Other intervention name(s): Botulinum toxin; Hyaluronic acid; Hyaluronic acid
Intervention MeSH terms: Botulinum Toxins; abobotulinumtoxinA; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment