bioihbjkbjnl/mcl2 huggingface dataset:
The Application of Sling Exercise Training in People With Chronic Stroke
Condition: Chronic Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this single-blinded, randomized controlled study aims to investigate the
      effects of sling exercise training (SET) for core muscle on gait performance in people with
      chronic stroke.
    

Detailed description: 
      Background and purpose: Balance and gait performance are often impaired in people post
      stroke. Evidence showed positive correlations between trunk control and balance and walking
      ability. Previous studies applying core muscle training reported positive effects on
      improving trunk control and sitting balance among patients with chronic stroke, but benefits
      on standing balance and gait performance remain undetermined. Sling exercise training (SET)
      has been suggested for improving core muscle stability and strength in people with stroke.
      However, studies about effects of SET on gait performance in stroke populations are limited.
      Therefore, the present study aims to investigate the effects of SET for core muscle on gait
      performance in people with chronic stroke.

      Methods: Thirty-eight individuals with chronic stroke will be recruited and assigned to one
      of the two groups by randomization, sling exercise training group and conventional training
      group. The training is 30 minutes per session, 3 sessions per week for total of 4 weeks. Gait
      performance is the primary outcome to include gait speed, stride length, single leg support
      time and temporal and spatial symmetry measured by GAITRite® System. Secondary outcomes
      include balance, timed up-and-go (TUG) test and trunk performance. All outcomes will be
      assessed before, after the 4-week training program and at 4-week follow-up.
    

Intervention name(s): Sling exercise training; Conventional balance training
Intervention type(s): Other; Other
Intervention description(s): All participants will receive exercise training for 30 min/ session, 3 sessions/ week for 4 weeks (a total of 12 training sessions). The training includes 20 min of sling exercise training and 10 min treadmill training.; All participants will receive exercise training for 30 min/ session, 3 sessions/ week for 4 weeks (a total of 12 training sessions). The training includes 20 min of balance exercise training and 10 min treadmill training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Core control; Sling exercise training; Gait; Chronic stroke
Evaluate the Safety of Depakote Extended Release Tablets in the Treatment of Mania Associated With Bipolar Disorder in Children and Adolescents
Condition: Bipolar I Disorder, Manic or Mixed
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if long-term treatment, up to 6 months, with Depakote ER is safe and effective
      in the treatment of bipolar I disorder in children and adolescents.
    


Intervention name(s): divalproex sodium
Intervention type(s): Drug
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar I Disorder; Depakote ER; divalproex sodium
Clinical Benefits of a Novel Sleep-focused Mind-body Program on Gulf War Illness (GWI) Symptoms
Condition: Sleep Disturbance; Persian Gulf War Syndrome in Veteran
MeSH terms: Dyssomnias; Parasomnias; Persian Gulf Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate clinical benefits of a novel sleep-focused
      mind-body program on Gulf War Illness (GWI) symptoms.
    

Detailed description: 
      This randomized study investigates whether two treatment conditions:Mind-Body Bridging (MBB)
      and Supportive Education (SED) are effective in improving sleep disturbance and self-reported
      indicators of other co-morbid symptoms in veterans with GWI. The two treatment conditions
      will each comprise 3 sessions of 2 hr. duration and conducted over 3 consecutive weeks (Week
      1-3).
    

Intervention name(s): Mind-Body Bridging Program; Supportive Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.; This intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics.
Other intervention name(s): MBBP; SED
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Lifestyle on Caries and Apical Periodontitis
Condition: Apical Periodontitis; Caries; Lifestyle; Inflammation; Endodontics
MeSH terms: Periodontitis; Periapical Periodontitis; Inflammation
Study type: Observational [Patient Registry]

Summary: 
      This study aimed to link lifestyle factors (Mediterranean diet adherence, stress, sleep
      quality, physical activity) to caries and apical periodontitis in 149 university-based
      individuals. Data included clinical and radiographic assessments and lifestyle
      questionnaires. Statistical tests and logistic regression were employed to analyze the
      relationships between these factors and oral health conditions.
    

Detailed description: 
      The aim of this study was to evaluate the association between lifestyle (adherence to the
      Mediterranean diet, stress, sleep quality, and level of physical activity) with the presence
      of caries and apical periodontitis (AP) in a University-based cohort of individuals.

      A total of 149 patients were included in this cross-sectional study. In addition to clinical
      (cold test, percussion test, evaluation of tooth mobility) and radiographic (bitewing Rx,
      periapical Rx, and OPT) parameters, validated questionnaires were used to investigate
      patient's lifestyle. Data on the number of decayed, missing, and filled teeth (DMFT score)
      and the severity of apical periodontitis (PAI score) were extrapolated from the available
      clinical and instrumental investigations. Shapiro-Wilk test was used to evaluate the normal
      distribution of data; Wilcoxon rank-sum test (Mann-Whitney) was used to compare continuous
      variables. Fisher's test was used to compare dichotomized variables. A logistic regression
      model was performed for the multivariate analysis.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All consecutive patients attending the Unit of Endodontics at the University of Siena were
        screened between September 2020 and August 2021. Patients were eligible based on the
        inclusion criteria. Individuals were included in the study after they read and signed the
        written informed consent, in accordance with the Declaration of Helsinki.
      
Keywords: Apical periodontitis; caries; inflammation; Endodontics; lifestyle
Effect of Morning Snack on Cognitive Performance in Adults
Condition: Nutrition; Cognitive Change; Food Intake Control; Satiety
Study type: Interventional

Summary: 
      To characterize the effects of three chocolate snacks on cognitive performance, subjective
      appetite, food intake control, and glycemic response in normal weight adults.
    

Detailed description: 
      On 4 separate mornings, 7 days apart, 12 hours after an overnight fast, and 3 hours after a
      standardized breakfast of a cereal bar, orange juice and fruit cup, participants will consume
      isocaloric snacks of white chocolate, 2 types of dark chocolate or control (water), followed
      by an ad libitum pizza lunch 90 minutes later. Upon arrival, at baseline (0 minutes),
      participants will be asked to complete the motivation-to-eat, global vigor and subjective
      emotion visual analogue scales (VAS), a battery of cognitive performance tasks and have blood
      samples taken, as reported and validated in our previous studies. Over the 90 minute testing
      period, blood samples will be taken,the VAS questions will be completed and cognitive tasks
      will be completed. Cognitive performance assessments will include learning and memory,
      spatial memory, attention and processing speed, and executive functions. VAS measuring
      physical comfort is completed pre- and post-meal. Ad libitum food intake from a test meal
      will be measured.
    

Intervention name(s): Control; White chocolate; Dark chocolate 1; Dark chocolate 2
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Water; Experimental snack treatment; Experimental snack treatment; Experimental snack treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A random and within subject, repeated measures experiment to study the effect of chocolate on cognitive performance, subjective appetite, food intake, and glycemic response in normal weight adults.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Healthy adults; Cognitive performance; Chocolate; Food intake; Glycemic response
Effect of BIA 5-1058 400 mg on Warfarin Pharmacokinetics
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is:

        -  To investigate CYP2C9 inhibition by BIA 5-1058 through the assessment of its effect on
           the Pharmacokinetic (PK) of S-warfarin, a substrate of CYP2C9.

        -  To assess the effect of warfarin on the PK of BIA 5-1058.
    

Detailed description: 
      This study was an open label, three period, fixed sequence study in healthy male and female
      subjects performed at a single study center.

      The study comprised:

        -  Screening during Days -28 to -2 (both inclusive).

        -  Three treatment periods separated by a washout period of at least 10 days.

      Duration of Treatment:

      The duration of participation for each subject was approximately 2 months and 2 weeks
      (including the screening period).
    

Intervention name(s): BIA 5-1058; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): Oral BIA 5-1058 (Zamicastat) 100 mg tablets; Oral Warfarin (Coumadin) 5 mg film coated tablets
Other intervention name(s): Zamicastat; Coumadin
Intervention MeSH terms: Warfarin; Zamicastat
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided
      accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount
      of normal tissue that needs to be removed.

      PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see
      how well it works in treating patients with early-stage breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  is to investigate the impact of a short fractionated schedule given preoperatively on
           local control, cosmesis and breast fibrosis.

        -  To further design optimal treatment strategies for individual breast cancer patients
           treated with breast-conserving therapy (BCT) on the basis of biological parameters,
           including the expression profile of the primary tumor, for both m-RNA as for micro-RNA,
           with first, a focus on radiotherapy responsiveness and second, on local recurrence rate,
           distant metastases and survival.

        -  proteomics will be studied in fine-needle aspiration samples. A classifier can be build
           (genomic or proteomic or any kind of molecular signature) to identify responders and
           non-responders

        -  quality of life

      OUTLINE: Patients undergo image-guided preoperative accelerated partial-breast irradiation
      (PAPBI) 10 times over 12 days (10 x 4 Gy) and later in the study 5 times 6 Gy. Six weeks
      after completion of image-guided PAPBI, patients undergo surgery.
    

Intervention name(s): biopsy; fine-needle aspiration; accelerated partial breast irradiation; image-guided radiation therapy
Intervention type(s): Procedure; Procedure; Radiation; Radiation
Intervention description(s): before treatment a biopsy will be taken to confirm breast cancer type; at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; invasive breast cancer; adenocarcinoma of the breast
Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study performed to evaluate the role of vitamin D supplementation on the strength
      of levator ani muscle in menopausal women with pelvic organ prolapse
    

Detailed description: 
      Forty eight POP women were divided into experimental and control groups in this
      quasi-experimental study. The experimental group was given 0.5 mcg alfacalcidol orally for
      three months. We measured levator ani muscle strength, serum 25-hydroxy-vitamin D3 levels,
      and serum Vitamin D Receptor (VDR) levels at zero months and three months preoperative.
      Enzyme-linked immunosorbent assay (ELISA) assessed VDR and myoblast determination protein 1
      (MyoD) protein expressions in levator ani muscle surgical biopsies.
    

Intervention name(s): Alfacalcidol 0.0005 MG; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Alfacalcidol 0.5 mcg is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured; Placebo drug is given orally for 3 months, then vitamin D3 and vitamin D receptor levels are measured
Intervention MeSH terms: Alfacalcidol; Hydroxycholecalciferols
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Alfacalcidol; MyoD expression; pelvic organ prolapse; vitamin D receptorr; levator ani muscle strength
Greek Physicians Perceptions Regarding Generics Prescribing in Glaucoma
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      This attempts to investigate the perceptions of Greek Ophthalmologists regarding generics
      prescription in glaucoma by means of a structured questionnaire.
    

Detailed description: 
      The following dimensions will be recorded

        1. Overall physician's empathy regarding generics in glaucoma

        2. Physician's prescribing habits regarding generics in glaucoma

        3. Physician's perceptions regarding generics cost-effectiveness in glaucoma

        4. Physician's perceptions regarding adequacy of Greek regulatory authorities (generic
           market in glaucoma)

        5. Physician's perceptions regarding adequacy of European regulatory authorities (generic
           market in glaucoma)
    

Sampling method: Non-Probability Sample
Study population: 
        Greek Medical Council Members
      
Keywords: Greece; Ophthalmology; Glaucoma; Generics; Perception
Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates
Condition: Extreme Prematurity,Extremely Low Birthweight; Extremely Low Birth Weight; Very Low Birth Weight Infant; Neonatal Hypoglycemia
MeSH terms: Hypoglycemia; Body Weight; Birth Weight
Study type: Observational

Summary: 
      Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted
      to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959. It is a
      suitable method for parenteral nutrition access and medications administration. Despite the
      benefits of the UVC, its potential complications must be considered. Thus, it is vital to
      determine the appropriate penetration length of the UVC.
    

Detailed description: 
      UVC insertion has benefits and potential complications such as infection, intestinal
      necrosis, thrombosis, ascites, hydrothorax, cardiac tamponade, cardiac arrhythmias, pleural
      effusion, pericarditis and pericardial effusion. The complications may be due to insertion of
      catheter in an inappropriate location. Imaging procedures such as plain thoracoabdominal
      x-ray is needed after catheter insertion to specify the location of the catheter tip. In
      addition to preventing complications, insertion of umbilical venous catheter in an
      appropriate location is essential for umbilical catheterisation effectiveness. There are
      different methods to determine the length of catheter which must be inserted in umbilical
      vessels. The UVC formulae are based on either body surface measurement such as Dunn method,
      Umbilical to Intermammary Distance (UIMD), Umbilical to Nipple Distance (UN)-1 and
      birthweight based formula method such as Shukla and Modified Shukla. Shukla and UN-1 Methods
      have been widely used in the world. However, the accuracy of these two methods in estimating
      the length of umbilical venous catheter has not still demonstrated.
    

Intervention name(s): UVC insertion
Intervention type(s): Procedure
Intervention description(s): To compare two formulae namely UN-1 and Shukla method to estimate the UVC insertion length in achieving optimum UVC tip position.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All term and preterm newborns admitted in Singapore General Hospital requiring UVC
        insertion with no major congenital malformation will be included in the study.
Evaluation the Impact of Subcutaneous Irrigation on Wound Complications
Condition: Cesarean Section; Complications, Wound, Hematoma
MeSH terms: Hematoma; Wounds and Injuries
Study type: Interventional

Summary: 
      to evaluate the effect of subcutaneous irrigation on wound complications
    

Detailed description: 
      Cesarean section is the most common abdominal operation performed worldwide. As with every
      other surgical procedure, it is sometimes accompanied by surgical complications. Wound
      complications are encountered in approximately 5% of women that undergo CS and include
      haematomas, seromas and infection. To evaluate the effects and benefits of subcutaneous
      irrigation during cesarean section we decide to conduct this randomized study.
    

Intervention name(s): subcutaneous saline irrigation
Intervention type(s): Other
Intervention description(s): 200 cc saline irrigation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization will be performed by an online software. Randomized cards will be in sealed envelopes and will be open by surgeon at the time of surgery.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Wound; infection; cesarean section
Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.
Condition: Hydrogen Sulfide; Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      The aim of the study is to investigate whether inhalation treatment with high-sulfide waters
      from some spas (referred to as "thermal waters"), performed for 12 consecutive days, is able
      to change circulating H2S levels and alter bone metabolism. Identifying a clear correlation
      between circulating levels of H2S and sulfur water administration, as well as a potential
      anabolic effect on bone, would set the stage for new studies that could have important
      clinical implications for promoting health and preventing osteoporosis
    


Intervention name(s): inhalatory treatment with sulfureous aerosol
Intervention type(s): Other
Intervention description(s): osteopenic patients are subject to a 12-days cycle of 30 minutes-long inhalatory treatment with sulfureous aerosol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Intensity, Specificity and Reversibility of Inspiratory Muscle Training in Asthmatics
Condition: Asthma
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Inspiratory muscle training (IMT) can reverse or delay the complications from the
      deterioration of inspiratory muscle function in asthma. Thus, the IMT has been considered a
      treatment option for people with asthma. The aim of this study is to investigate the training
      principles of intensity, specificity and reversibility of IMT in asthmatics.
    


Intervention name(s): High-intensity IMT; Low-intensity IMT
Intervention type(s): Device; Device
Intervention description(s): 30 breaths at 50% of the maximal inspiratory pressure, twice daily for 6 weeks; 30 breaths at 15% of the maximal inspiratory pressure, twice daily for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Sequential Intensive Chemotherapy Followed by RIC for Refractory and Relapse AML
Condition: Acute Leukemia
MeSH terms: Leukemia; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with refractory and relapse leukemia had poor outcome even with allogeneic stem cell
      transplantation. In our previous retrospective study, the overall survival is 14.6+/-8.8%
      while 90% patients eventually relapsed with marrow ablative conditioning mostly standard
      iv-Bu-Cy or Cy-TBI. The accumulated TRM is 29.5+/-11.5%. Thus our data suggested that the
      conventional transplantation approach may not be able to overcome the refractory disease. A
      new strategy to combined a low dose regimen following intensive chemotherapy for tumor
      reduction seems to be effect in both relapsed. high-risk and refractory AML or ALL. In this
      study, we focus on a new treatment strategy for particular refractory AML patients.
    

Detailed description: 
      This is a single arm phase II trial to test the efficacy and feasibility of new sequential
      intensive chemo and transplantation approach for refractory leukemia. Patients with
      refractory acute myeloid or lymphoblastic leukemia are enrolled in this trial. Patients will
      received intensive chemotherapy including Fludarabine, cytarabine and idarubicin as
      (FLAG-IDA). Seven days after the chemotherapy, sequential transplantation conditioning
      regimen as fludarabine and busulfan will be given.
    

Intervention name(s): intensive chemo - RIC preparation
Intervention type(s): Drug
Intervention description(s): The intensive chemotherapy is composed of fludarabine 35mg/m2 + high-dose cytarabine 2g/m2 D1-5 + idarubicin (12mg/m2) D5-7. The reduced intensity preparation regimen will start 7 days after the chemotherapy with fludarabine 35mg/m2 for 5 days + iv busulfan 3.2mg/kg/day for 3 days followed by stem cell infusion 2 days later.
Other intervention name(s): FLAG-IDA-RIC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: feasibility, effective and safety; intensive chemotherapy; RIC regimen; refractory or relapse leukemia; allogeneic stem cell transplantation