bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Fortified Rice on Workers' Nutrition Status
Condition: Nutrient Deficiency
Study type: Interventional

Summary: 
      The study is a single center, open label, nutrition intervention study. Healthy adult male
      working at a Singapore construction site are included if they fulfill inclusion and exclusion
      criteria. Volunteers receive fortified rice for their daily lunch and dinner each day of the
      week (i e 14 meals/week) over six months. Nutrition status in blood is measured at baseline
      and after six months of fortified rice consumption.
    

Detailed description: 
      The study is a single center, open label, uncontrolled longitudinal nutrition intervention
      study. Migrant construction workers of either Bangladeshi or Indian ethnicity from a single
      dormitory in Singapore volunteer to participate at the study. Only eligible workers are
      included in the study if they fulfilled all inclusion and exclusion criteria; 20 and 51 years
      old, a BMI between 17.0 to 27.5 kg/m2, willing to adhere to the study procedure for at least
      six months, and sign informed consent, are free of current medical and/or chronic/non
      communicable diseases, no history of heavy smoking or alcohol consumption. The eligible
      subjects receive fortified rice for their daily lunch and dinner each day of the week (i e 14
      meals/week) over six months. The nutrient levels per 100 g fortified rice contain 150 µg
      vitamin A (Vitamin A palmitate), 0.5 mg vitamin B1 (thiamin mononitrate), 7 mg vitamin B3
      (niacin amide), 0.6 mg vitamin B6 (pyridoxine hydrochloride), 1 µg vitamin B12
      (cyanocobalamin), 130 µg folic acid, 4 mg iron (ferric pyrosphosphate), and 6 mg zinc (zinc
      oxide). At baseline and after 6 months of intervention, BMI and vital signs such as blood
      pressure, pulse and body temperature are collected. Also, 10 ml venous blood is sampled at
      baseline and after 6 months of intervention and subsequently tested for hemoglobin, serum
      folate, and serum zinc, serum ferritin and serum vitamin B12 status. In a small subset of the
      migrant construction workers, an extra 5 ml blood sample is taken for homocysteine testing.
    

Intervention name(s): Fortified rice
Intervention type(s): Other
Intervention description(s): 100 g of rice was fortified with 150 µg vitamin A (Vitamin A palmitate), 0.5 mg vitamin B1 (thiamin mononitrate), 7 mg vitamin B3 (niacin amide), 0.6 mg vitamin B6 (pyrodoxine hydrochloride), 1 µg vitamin B12 (cyanocobalamin), 130 µg folic acid, 4 mg iron (ferric pyrosphosphate), and 6 mg zinc (zinc oxide).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Propofol Induction Anaesthesia on the Heart Rate Variability
Condition: Autonomic Nervous System Imbalance
Study type: Observational [Patient Registry]

Summary: 
      The ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually
      blous of propofol during induction anesthesia is reported to reduce both sympathetic and
      parasympathetic tone; however, it is not clear whether the changes in heart rate variability
      are associated with propofol concentration.
    

Detailed description: 
      Because the ANS, especially the sympathetic nervous system, plays a major role in regulating
      cardiovascular homeostasis, knowledge of how anesthetic agents modify sympathetic activity is
      important for understanding subsequent cardiovascular responses.

      Spectral analysis of heart rate variability (HRV) is a promising new approach, widely used,
      noninvasive technique to assess the autonomic indexes of neural cardiac control and has been
      correlated to the integrity and balance of the sympathetic and parasympathetic activation
      status. The presence of low-frequency (LF) and high-frequency (HF) oscillatory rhythms in the
      variability of the R-R interval (RRI) is well established. To date, it is believed that LF is
      mediated by the parasympathetic and sympathetic systems, whereas HF is mediated primarily by
      the parasympathetic system. There has been a lot of methodological analysis developed to
      evaluate the ANS function during anesthesia. In this study, Continuous Wavelet Transform
      (CWT), believed as a reliable and robust method to access cardiorespiratory dynamics of the
      ANS due to its adaptability and adjustability between spectral and temporal scale using a
      window of variable width, was used as a method for analyzing dynamic cardiovascular signals
      during anesthesia.
    

Intervention name(s): Anesthetics
Intervention type(s): Drug
Intervention description(s): The ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration. We will observe the relationship of anesthetics and HRV dynamics.
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients scheduled for surgery under general anesthesia.
CT Scan Using IV Contrast Alone for Pediatric Appendicitis
Condition: Appendicitis; Child; Contrast Media
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      Computed tomography (CT) scan using intravenous contrast (CT IV) as the sole type of contrast
      material, was studied as one method of evaluating children with suspected appendicitis. We
      felt that this technique could provide physicians with a faster and better-tolerated
      alternative to CT imaging which involves patients drinking oral contrast or needing rectal
      contrast administered.

      SPECIFIC AIMS

        1. To test an imaging protocol using CT IV for the evaluation of suspected appendicitis in
           children in the setting of a pediatric emergency department (ED).

        2. To determine test performance characteristics (specificity, sensitivity and diagnostic
           accuracy) of CT IV in detecting appendicitis in children.
    

Detailed description: 
      This was to be a prospective cohort study imaging pediatric patients (3-18 years old) in whom
      the diagnosis of appendicitis was suspected, but not clinically apparent. Patients that were
      to have a CT performed would be invited to participate and if enrolled, would be imaged using
      CT scan with IV contrast alone.

      CT scans would be interpreted in real time by a resident radiologist and/or an attending
      radiologist. ED evaluation would remain unchanged and patient disposition would be based on
      the discretion of the ED provider using all information (patient exam, labs, surgical
      consultation as needed and the results of the CT scan).

      CT scan performance would be determined by comparison of the CT interpretation with patient
      final outcomes as determined by either (1) pathology reports - in patients that went on to
      have surgery (appendectomy) or (2) clinical phone follow up at 24 hrs and then 1 week after
      ED discharge.

      Performance of CT would be compared between the resident and the attending radiologists.

      Further, we would compare the time to obtain a CT scan (defined as ED triage time - Time to
      CT) between our study cohort and a retrospective cohort of patients who had received CT scan
      in the ED for evaluation of appendicitis pre-study (CT using BOTH IV and oral contrast).
    

Intervention name(s): CT Scan using IV contrast alone
Intervention type(s): Other
Intervention description(s): CT scan using IV contrast alone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Appendicitis; Computed tomography; pediatric; child; sensitivity; specificity; contrast administration route; time factors
Family-Centered Behavioral Preparation for Surgery
Condition: Anxiety
Study type: Interventional

Summary: 
      Children experience significant anxiety and distress during the preoperative period.
      Currently available interventions are ineffective and/or associated with significant
      disadvantages. These interventions exclusively target the child and do not attempt to reduce
      parental anxiety. Based on an integration of the literature in both the anesthesia and
      psychological milieus, we developed ADVANCE, a behaviorally oriented anxiety reduction
      program for children undergoing surgery that targets the family as a whole.
    

Detailed description: 
      Children and their parents (n=408) were randomly assigned to one of four groups: 1) Control:
      received standard of care, 2) PPIA: received standard parental presence during induction of
      anesthesia, 3) ADVANCE: received family-centered behavioral preparation, and 4) oral
      Midazolam. We assessed the effect of group assignment on anxiety levels and postoperative
      outcomes.
    

Intervention name(s): ADVANCE; Midazolam; Parental presence
Intervention type(s): Behavioral; Drug; Procedure
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: children; anxiety; behavioral preparation; family; surgery; parents
Effect of Mindfulness Based Stress Reduction (MBSR) Programme for Reducing the Stress Level of Nursing Student
Condition: Stress; Emotion Regulation
Study type: Interventional

Summary: 
      Purpose: This research was planned to determine the effect of mindfulness-based stress
      reduction program on reducing the stress level and emotion regulation of nursing students.

      Design: The research was planned as a pretest, posttest, follow-up and randomized controlled
      study in order to determine the effect of the mindfulness-based stress reduction program on
      the stress level and emotion regulation of nursing students.

      Hypotheses: H1: The perceived stress level scores of nursing students in the intervention
      group participating in the mindfulness-based stress reduction program will decrease compared
      to the nursing students in the control group.

      H2: The perceived stress level of the nursing students in the intervention group
      participating in the mindfulness-based stress reduction program will decrease according to
      their pretest scores.

      H3: Emotion regulation strategies of nursing students in the intervention group participating
      in the mindfulness-based stress reduction program will differ from the nursing students in
      the control group.

      H4: The posttest and follow-up emotion regulation strategies of nursing students in the
      intervention group participating in the mindfulness-based stress reduction program will
      differ from the pretest.
    


Intervention name(s): Mindfulness Based Stress Reduction; continuing a routine life
Intervention type(s): Behavioral; Other
Intervention description(s): The intervention has its roots in meditations and yoga practices. However, it is independent of religious purpose or affiliation.The weekly sessions include a range of mental and bodily practices, including awareness of emotions, awareness of thoughts, awareness of sensations. It involves full awareness of daily activities, using the breath as an anchor for attention.In addition to mindfulness practices and experiential work, psychoeducation and participants' sharing will clarify the issues of stress, stress management and how mindfulness is applied in daily situations and interpersonal communication.; No intervention will be made in the control group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mindfulness; Nursing student
A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative
      to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on
      the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.
    

Detailed description: 
      The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy
      participants to evaluate the relative BA and effect of food on the PK of TAK-831 tablet
      formulation.

      The study will enroll approximately 16 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to TAK-831 in 1 of the 4 treatment sequences as following:

        -  T2 50 mg Fasted + T3 50 mg Fasted + T3 600 mg Fasted + T2 600 mg Fasted + T3 600 mg Fed

        -  T3 50 mg Fasted + T2 600 mg Fasted + T2 50 mg Fasted + T3 600 mg Fasted + T3 600 mg Fed

        -  T2 600 mg Fasted + T3 600 mg Fasted + T3 50 mg Fasted + T2 50 mg Fasted + T3 600 mg Fed

        -  T3 600 mg Fasted + T2 50 mg Fasted + T2 600 mg Fasted + T3 50 mg Fasted + T3 600 mg Fed

      All participants will be asked to take tablet of assigned TAK-831 on Day 1 of each treatment
      period.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is approximately 70 days. Participants will make multiple visits to
      the clinic and will be contacted by clinic approximately 14 days after the last dose of study
      drug for a follow-up assessment.
    

Intervention name(s): TAK-831 T2; TAK-831 T3
Intervention type(s): Drug; Drug
Intervention description(s): TAK-831 T2 Tablets.; TAK-831 T3 Tablets.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
DAAOI-2 add-on Treatment for Treatment-resistant Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      Pharmacotherapy for schizophrenia has limitations such as residual positive and negative
      symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still
      a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA)
      hypothesis, adjuvant NMDA-enhancing agents may have therapeutic benefit. DAAOI-2, a D-amino
      acid oxidase (DAAO) inhibitor, is a NMDA-enhancing agent. The aim of this project is to
      examine the effectiveness and safety of DAAOI-2 add-on treatment for treatment-resistant
      schizophrenia patients in a randomized, double-blind, placebo-controlled trial.
    

Detailed description: 
      Pharmacotherapy for schizophrenia has limitations such as residual positive and negative
      symptoms, cognitive deficits and intolerable side effects. Refractory schizophrenia is still
      a difficult clinical issue at present. According to the N-methyl-D-aspartate (NMDA)
      hypothesis, many clinical trials on NMDA-enhancing agents were studied. Adjuvant
      NMDA-enhancing agents, including glycine, D-amino acids such as D-serine, and sarcosine (a
      glycine transporter I inhibitor), revealed beneficial but limited efficacy for positive and
      negative symptoms.

      The aim of this project is to examine the effectiveness and safety of DAAOI-2 add-on
      treatment for treatment resistant schizophrenia patients in a randomized, double-blind,
      placebo - controlled trial.
    

Intervention name(s): DAAOI-2; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500-2000mg/d, oral, for 6 weeks; oral, for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment resistant; DAAOI; NMDA
Green (Sustainable) VENTOLIN - Pharmacokinetics (PK) Study in Healthy Participants
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be conducted to compare the PK of salbutamol administered via metered dose
      inhalers (MDI) containing propellants 1,1-difluroethane (HFA-152a) and
      1,1,1,2-tetrafluoroethane (HFA-134a) in healthy participants.
    


Intervention name(s): Salbutamol HFA-152a; Salbutamol HFA-134a
Intervention type(s): Drug; Drug
Intervention description(s): Salbutamol HFA-152a will be administered.; Salbutamol HFA-134a will be administered.
Intervention MeSH terms: Norflurane; Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a 2-way cross-over study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cross-over; Healthy volunteers; Salbutamol; Pharmacokinetics
An Evaluation of an Oral Antidiabetic Agent for the Treatment of Type 2 Diabetes
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if an investigational drug is safe and efficacious
      for poorly controlled type 2 diabetes mellitus.
    


Intervention name(s): naveglitazar
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Type 2 diabetes
LK Scleral Lens for Patients With Intractable Ocular Surface Diseases
Condition: Ocular Surface Disease
Study type: Interventional

Summary: 
      Scleral lenses have emerged as an efficacious treatment option for various types of
      intractable ocular surface diseases with many advantageous results. The purpose of this study
      was to report the efficacy and safety of the LK scleral lenses and determine their
      suitability in Asian patients with intractable ocular surface diseases. Subjects with
      intractable ocular surface diseases are enrolled to fit LK scleral lenses for 12 weeks for a
      prospective study. Evaluations are performed at 1, 4, 8 and 12 weeks. General patient
      demographics and medical history, visual acuities, thorough ophthalmic evaluation, ocular
      surface disease index and National Eye Institute 25-Item Visual Function Questionnaire are
      collected for each patient.
    

Detailed description: 
      To date, there are several commercially manufactured scleral lenses of different designs and
      sizes, all of which have been proven to be clinically beneficial in a wide spectrum of
      diseases. Especially in the management of intractable ocular surface diseases, scleral lenses
      with large diameters are commonly used so that the lens entirely rests on the sclera with
      sufficient tear reservoir. PROSE devices (Boston Foundation for Sight, Needham, MA), one of
      the first and representative scleral lenses shown to have long-term clinical benefits for
      complex corneal diseases, have large diameters of 17.5 to 23.0 mm. However, in Republic of
      Korea, only scleral lenses with small diameters are currently available. SoClearⓇ and OnefitⓇ
      scleral lenses, two of the most commonly used scleral lenses in Republic of Korea, possess
      diameters ranging from 14.1 to 15.5 mm and 13.3 to 15.0 mm, respectively, and are not
      actually fully scleral but more of a corneoscleral type lenses. Furthermore, Asians have
      smaller palpebral fissures with tighter eyelids than the Western population, which may
      restrict patients' tolerability of wearing a large scleral lens and limit its clinical
      benefits. Therefore, a more suitable scleral lens for Asians with larger diameter is
      required.

      Accordingly, this study investigates the efficacy and safety of the LK scleral lens (Lucid
      Korea LTD, Seoul, Republic of Korea), which has been newly manufactured to have larger
      diameters than currently available commercial lenses, and determines their suitability in
      Asian patients with intractable ocular surface diseases.
    

Intervention name(s): LK scleral lens
Intervention type(s): Device
Intervention description(s): LK scleral lens fitting and application were done for 12 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cornea; LK scleral lens; Ocular surface disease; Scleral lens
Impact of Pilates Exercise in Children With Juvenile Idiopathic Arthritis
Condition: Juvenile Arthritis; Cardiorespiratory Fitness; Quality of Life
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      Juvenile idiopathic arthritis (JIA) is one of the most common chronic childhood inflammatory
      diseases that is characterized by permanent joint inflammation attributable to immune system
      disturbance.
    

Detailed description: 
      Therapeutic exercises play an essential role as a non-pharmacologic treatment for children
      with JIA. It has effectively been used to reduce pain, improve muscular function, increase
      physical activity and promote quality of life in children with chronic musculoskeletal
      disorders. Clinical Pilates exercise is usually perceived as enjoyable activity by children
      with JIA, thereby, it can help them be more active for extended periods without causing
      discomfort while also allowing them to control their breathing and avoid becoming fatigued.
    

Intervention name(s): Pilates exercises; Conventional physical therapy program
Intervention type(s): Other; Other
Intervention description(s): Mat, Pilates band or elastic bands, and Pilate's ball; pain relief, increasing flexibility, and mobility, improving muscle strength
Other intervention name(s): Pilates band; pain reliving modalities, stretching exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Lifespan Integration After Sexual Trauma
Condition: Symptoms of Post Traumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Sexual Trauma
Study type: Interventional

Summary: 
      A new psychological trauma treatment method is tested on a population (n 100) of adult women
      who have been sexually traumatized at one specific time 0-5 years before they enter the
      study.
    

Detailed description: 
      One treatment session is given with the psychological treatment method Lifespan Integration
      (LI). The main outcome is change on Impact of Event Scale (IES) before and after the
      treatment. The change is analyzed and compared with the change on Impact of Event Scale (IES)
      among the people on the waiting list arm. Self-rating questionnaires are being used 5+/-3
      days before treatment, 20 +/-3 days after treatment, and 6 months +/- 6 weeks after the first
      measurement.
    

Intervention name(s): Lifespan Integration
Intervention type(s): Other
Intervention description(s): A protocol based psychological treatment method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sexual trauma, Lifespan Integration