bioihbjkbjnl/mcl2 huggingface dataset:
How Accurate INFANIB is Among Hospitalized Preterm Infants
Condition: Preterm Infants
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Reliability of infant neurological international battery (INFANIB) among hospitalized preterm
      infants will be checked. This study will mainly focus on test-retest reliability.
    

Detailed description: 
      Background: NICU is a specialised intensive care unit that treats and cares for premature or
      critically ill newborn babies. A special category of high-risk babies consists of premature
      infants. Their motor growth differs from that of healthy full-term infants and their
      occurrence of motor disorders is greater. The outcome of neuromotor disorders can be
      substantially changed by treatments during the first year of life. So in order to detect
      these neuromotor disorder there must be a reliable screening tool present. Hence, in this
      study we will check reliability of INFANIB.

      Purpose: Reliability of INFANIB among hospitalized preterm infants. Methodology: It will be
      an observational study and will be carried out in Neonatal Intensive Care Unit (NICU). The
      study will recruit preterm infants that are stable and are present without any respiratory
      assistive devices.

      INFANIB screening tool will be performed on these infants. It has 20 items that measure the
      state of the infant for body tone and posture, primitive reflexes and French angles in the
      supine, prone, sitting, standing and suspended position upto 18 months. But we will take only
      preterm infants so only 14 items will be assessed and infants will be scored accordingly. The
      main focus will be on test- retest reliability.

      Discussion: A similar research has been carried out in Iran and China, that established that
      reliability of INFANIB is excellent. Another research was carried out in India that stated
      INFANIB's reliability to be low. So this study is required to be carried out in India to know
      the actual results.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Stable preterm infants admitted in Neonatal intensive care unit.
      
Keywords: Neonatal; Preterm; NICU; Newborn; INFANIB
Safety Study of AZT-04 for Cosmetic Use
Condition: Study of Three Doses of AZT-04 for Skin Appearance
Study type: Interventional

Summary: 
      Double Blind, Three Cohort, Placebo-controlled Trial to Assess Safety, Tolerance and Induced
      Bacterial Colony Counts of Three Ascending Doses of AZT-04 in Healthy Adult Volunteers
    

Detailed description: 
      This is a single-center, prospective, double-blind, three cohort pilot study to assess the
      tolerability and induced changes in skin microbiome population and diversity of three
      ascending doses of test article code AZT-04 in normal, healthy subjects.

      The study will consist of up to 7 scheduled study visits. There will be three cohorts in this
      study, each cohort composed of 6 subjects (total number of subjects is at least 18). Each
      cohort will be treated with both a placebo ointment and an ointment containing different
      concentrations of the Staphylococcus epidermidis. Approximately 1 ml of placebo ointment and
      1 ml of AZT-04 ointment (test product composed of a commensal strain of Staphylococcus
      epidermidis) will be applied topically to two separate skin sites on the back, each site
      approximately 8 x 5 cm. Skin microbiome sampling will be performed before application of any
      test article (i.e., baseline) and each subsequent day for four (4) consecutive days. Samples
      will be shipped to a laboratory chosen by the Sponsor for analyses
    

Intervention name(s): AZT-04
Intervention type(s): Other
Intervention description(s): Staphylococcus epidermidis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Laparoscopic Adjustable Gastric Banding as a Treatment for Morbid Obesity in Adolescents
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the LAP-BAND system is safe and effective
      in morbidly obese adolescents.
    

Detailed description: 
      The aim of this research is to evaluate the safety and efficacy of the use of the Lap-Band
      system in the morbidly obese adolescent population in the United States. We also propose to
      take advantage of the opportunity for liver biopsy and the data collected for the FDA study
      in adolescents to answer several questions: 1) what is the true incidence of non-alcoholic
      fatty liver disease (NAFLD) and its variants in morbidly obese adolescents; 2) what is the
      course of the NAFLD disease in adolescents who have undergone weight loss, including the
      progression from steatosis to NASH/ fibrosis or the progression of NASH to cirrhosis? 3) What
      are the factors implicated in this progression and 4) Is there a link between the excess
      visceral fat, MS and NAFLD as assessed by parallel changes in metabolic syndrome (MS) and
      NAFLD following weight loss intervention. The LAPBAND may provide obese adolescents with a
      significantly less morbid and reversible surgical option for weight loss.
    

Intervention name(s): Placement of an adjustable gastric band
Intervention type(s): Device
Intervention description(s): Laparoscopic placement of an adjustable gastric band around the upper portion of the stomach and subsequent adjustments of the band via a subcutaneous port as needed to maintain appropriate restriction.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Morbid obesity; Adolescents; Gastric restrictive procedure; Adjustable gastric band; Treatment
The Role of Stress in Self-Control, Coping, and Emotion Regulation
Condition: Stress
Study type: Observational

Summary: 
      The purpose of this study is to examine the effects of stress on mental and physical health
      and behavior.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      Blood taken for understanding genetic factors.
    
Keywords: stress; self-control; emotion regulation; health
Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers
Condition: Experimental Pain; Hyperalgesia
MeSH terms: Hyperalgesia
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to assess the anti-hyperalgesic effect of dextromethorphan in
      healthy volunteers compared to placebo.
    

Detailed description: 
      This is a cross-over group, double-blind, randomized clinical trial in healthy volunteers
      comparing dextromethorphan and inactive control on freeze-induced hyperalgesia, experimental
      pain, diffuse noxious inhibitory control (DNIC), pupillary reaction and reaction time.

      The influence of CYP3A4 and MDR1 polymorphism on the dextromethorphan analgesic efficacy will
      be measured.

      The study design is divided in two study sequences and each subject participates in the two
      study sequences and receive the two treatments (dextromethorphan and placebo).

      Each study sequence consists of 3 assessment days (Day -1, Day 0 = first treatment
      administration and Day 1).
    

Intervention name(s): Pulmodexane® 30mg; lactose
Intervention type(s): Drug; Drug
Intervention description(s): The study design is divided in two study sequences and each subject participates in the two study sequences and receive the two treatments (dextromethorphan and placebo).; The study design is divided in two study sequences and each subject participates in the two study sequences and receive the two treatments (dextromethorphan and placebo).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Antinociception; Freeze-induced hyperalgesia model; Dextromethorphan; NMDA-receptors; Pharmacogenetic; CYP3A4 gene; MDR1 gene
Effect of QMix 2in1 as Final Irrigation Protocol on Periapical Healing
Condition: Periapical Diseases
MeSH terms: Periapical Diseases
Study type: Interventional

Summary: 
      Aim: To compare the 12-month radiographic outcome of root canal treatment with and without
      the additional use of QMix 2-in-1 (Dentsply Tulsa, Maillefer, Ballaigues, Switzerland)
      irrigation solution.

      Methodology: The study included 60 single-rooted teeth with periapical radiolucency of 60
      patients, randomized into two groups using randomized block design with block sizes of 10
      patients in each. Root canals were prepared with WaveOne Gold files (Dentsply Sirona,
      Maillefer, Ballaigues, Switzerland) and irrigation was performed with 5 mL 2.5% sodium
      hypochlorite (NaOCl) using side-vented needles during instrumentation. The final irrigation
      protocol was performed using 5 mL 2.5% NaOCl (n= 30) or 5 ml QMix 2-in-1 (n=30). Then the
      root canals were irrigated with 5 mL of distilled water and filled with gutta-percha and AH
      Plus sealer (Dentsply Sirona), using the cold lateral compaction technique. The patients were
      recalled after 12 months and evaluated radiographically according to perapical index (PAI)
      scores. Pre and post-treatment PAI scores were compared and teeth were considered 'healthy'
      (PAI ≤ 2) or 'diseased' (PAI ≥ 3). The Mann Whitney U test was used to compare the
      differences between the post-operative and follow-up images of the treatment groups. The
      Wilcoxon signed rank test was applied to examine the changes in PAI score from baseline to
      the follow-up evaluation in each group.
    

Detailed description: 
      This randomized controlled trial was conducted to evaluate radiographic periapical repair
      after endodontic treatment using QMix 2-in-1 (Dentsply Tulsa, Maillefer, Ballaigues,
      Switzerland) and NaOCl irrigation in single-rooted teeth with apical periodontitis.
    

Intervention name(s): QMix 2in1
Intervention type(s): Other
Intervention description(s): In QMix 2in1 group root canals were irrigated with Mix as a final irrigation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: QMix 2-in-1; Sodium hypochlorite; Chlorhexidine; Treatment outcome; Radiographic healing
Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of
      fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients
      with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a
      treatment period (12 months). The study will provide further data on safety and tolerability
      of ciclesonide.
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide; Fluticasone propionate; Salmeterol
Comparison of Two Calorie Restricted MediterrAsian Diet on Weight Loss in FTO rs9939609 Overweight Carriers
Condition: Obesity; Dietary Modification
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Background: Obesity treatment should be individualized since some calorie restricted diet
      doesn't work for some individuals.

      Objective: we assess the effect of two different calorie restriction with MediterrAsian diet
      on weight loss of FTO rs9939609 carriers with overweight.

      Methods: we recruit 80 healthy overweight participants aged 20-45 years that randomly
      allocated in two interventional group [group 1: Mediterrasian diet according to adjusted
      ideal body weight with 500 calories restriction (RD) and group 2: without 500 calories
      restriction (NRD)+ Moderate physical activity]. Anthropometric indices will be assesses for
      all participants weekly for two month. The criteria for weight loss is 250-500 grams weekly.
      Metabolic indices, physical activity and psychologic aspects will be assesses at baseline and
      the end of the intervention. Dietary adherence will be checked by 24hr recalls at day 0, 30
      and 60. At the end of the study, we compare carriers with different alleles (AA+TA and TT) in
      two intervention groups to find out which calorie restriction is appropriate for each
      genotype. Significant p-value is less than 0.05.
    

Detailed description: 
      no data yet
    

Intervention name(s): MediterrAsian diet
Intervention type(s): Behavioral
Intervention description(s): no other description
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: overweight; Caloric Restriction
Psychosocial Determinants of Continuing or Discontinuing Infertility Treatment: A Psychological Analysis
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The current study aims to explore and analyse the decision making process of couples in
      regards to continuing or discontinuing infertility treatment. A longitudinal, prospective
      cohort design is used which allows the monitoring of patients over a longer period of time.
      Data will be collected quantitatively (questionnaires) as well as qualitatively (in-depth
      interviews) to allow for a more specific and in depth experience than can be obtained by
      using a questionnaire study. Innovative aspects of the study include:

        1. exploration of determinants of continuing and discontinuing infertility treatment by
           using a comprehensive psychological theory (both surface and in-depth)

        2. exploration of gender differences in the decision making process in continuing or
           discontinuing treatment

        3. longitudinal and prospective arm of the study will allow to gain insight into the
           'process'

        4. prediction of continuing/discontinuing treatment based on psychological variables.
    


Intervention name(s): self-report questionnaire
Intervention type(s): Behavioral
Intervention description(s): validated self-report questionnaires on psychosocial determinants
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: drop-out; predictors of treatment continuation/discontinuation; IVF/ICSI; infertility; counseling; psychology; Assisted Reproduction; Counselling
Low-Dose Atropine for Treatment of Myopia
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 3

Summary: 
      Study Objectives

      The objectives for this randomized trial are:

        1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia
           progression over a two-year treatment period in children aged 5 to less than 13 years
           (Primary Outcome On-Treatment).

        2. To determine the efficacy of atropine treatment on myopia progression 6 months following
           cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).

      Synopsis of Study Design The current study is designed as an efficacy study, making effort to
      maximize adherence to treatment group assignments. After a run-in phase during which all
      participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are
      updated if required) to assess their ability to adhere to daily eye drops, participants are
      randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off
      treatment.
    

Detailed description: 
      Study Objectives

      The objectives for this randomized trial are:

        1. To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia
           progression over a two-year treatment period in children aged 5 to less than 13 years
           with myopia -1.00 to -6.00D at the time of enrollment (Primary Outcome On-Treatment).

        2. To determine the efficacy of atropine treatment on myopia progression 6 months following
           cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).

      Synopsis of Study Design The current study is designed as an efficacy study, making effort to
      maximize adherence to treatment group assignments. After a run-in phase during which all
      participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are
      updated if required) to assess their ability to adhere to daily eye drops, participants are
      randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off
      treatment.
    

Intervention name(s): Atropine; Placebo Eyedrops
Intervention type(s): Drug; Other
Intervention description(s): Daily 0.01% atropine eyedrops; Daily placebo eyedrops
Other intervention name(s): Low-Dose Atropine
Intervention MeSH terms: Atropine; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myopia; atropine
Valsartan in Elderly Isolated Systolic Hypertension Study
Condition: Aged; Systolic Hypertension
MeSH terms: Hypertension; Isolated Systolic Hypertension; Systolic Murmurs
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the incidence of cardiovascular events between two target
      systolic blood pressure levels, below 140 mmHg and below 150 mmHg under treatment with
      valsartan in elderly isolated systolic hypertensive patients in Japan.
    

Detailed description: 
      Although antihypertensive therapy has been proven to reduce cardiovascular morbidity and
      mortality, it is unclear how much blood pressure should be decreased in elderly patients with
      hypertension. The Valsartan in Elderly Isolated Systolic Hypertension (VALISH) study is a
      multicenter parallel-group study comparing the incidence of cardiovascular events between two
      target systolic blood pressure levels, below 140 mmHg and below 150 mmHg, under treatment
      with valsartan, an angiotensin II receptor blocker, as an initial antihypertensive drug in
      elderly patients with isolated systolic hypertension. The number of patients to be recruited
      is 3,000 and the duration of follow-up is at least 2 years. This 3,000-patient trial was
      designed with a two-sided α level of 0.05 and 80% power to detect the difference in incidence
      of cardiovascular events between the target blood pressure levels based on estimation of the
      cardiovascular events ratio as 21.5/1,000 patient-years and 29.1/1,000 patient-years for the
      two blood pressure levels. The VALISH study, a large-scale investigator-initiated trial in
      Japan, will determine whether age should be considered in setting target blood pressure in
      treatment of isolated systolic hypertension in elderly patients.
    

Intervention name(s): target blood pressure
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: isolated systolic hypertension; valsartan; target blood pressure
Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety
Condition: Adult Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      ALTU-238 is a long acting crystalline formulation of recombinant human growth hormone (rhGH)
      that is being developed for the treatment of growth hormone deficiency in adults and
      children. ALTU-238 is designed to require fewer injections than the currently available
      formulations of rhGH.
    


Intervention name(s): ALTU-238
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of TRK-700 in Patient With Post-Herpetic Neuralgia
Condition: Post-Herpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      In Post-Herpetic Neuralgia(PHN) patients:

        -  To conduct an explorative investigation of the efficacy and safety of repeated oral
           doses of TRK-700 via a randomized double blind comparative study

        -  To measure the plasma concentration of TRK-700 and its metabolites
    


Intervention name(s): TRK-700; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TRK-700; Post-Herpetic Neuralgia
Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy
Condition: Hypertension; Hypertrophy, Left Ventricular
MeSH terms: Hypertension; Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients
      with hypertension and left ventricular hypertrophy
    


Intervention name(s): Valsartan; Amlodipine; Hydrochlorothiazide; Losartan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 160 mg film coated tablets taken orally once daily in the morning.; 5 mg or 10 mg tablets taken orally once daily in the morning.; 12.5 mg or 25 mg tablets taken orally once daily in the morning.; 100 mg tablets taken orally once daily in the morning.
Intervention MeSH terms: Losartan; Amlodipine; Valsartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Left ventricular hypertrophy, hypertension, valsartan, amlodipine