bioihbjkbjnl/mcl2 huggingface dataset:
TVTO Versus TVTFFM for Urinary Stress Incontinence
Condition: Urinary Stress Incontinence Treated by TVT
MeSH terms: Urinary Incontinence, Stress
Study type: Observational

Summary: 
      Women who had urinary stress incontinence and underwent one of two procedures: the classic
      TVTO or the Folke-Flam method of surgical operation, will be evaluated and compared.
    

Detailed description: 
      We will enroll women that underwent one of the two surgeries: TVTO or the modification where
      the needle passes somewhat to the side to prevent the post operative pain, for urinary stress
      incontinence. Data will be collected from the charts. Telephone interviews will be carried
      out. Physical examination will also be incorporated.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with Urinary Stress Incontinence treated by TVT
Effects Of Atorvastatin On Macrophage Activity And Plaque Inflammation Using Magnetic Resonance Imaging
Condition: Atherosclerotic Carotid Disease; Atheroma; Atherosclerosis
MeSH terms: Atherosclerosis; Inflammation; Plaque, Atherosclerotic
Study type: Observational

Summary: 
      A new way of scanning narrowing in the arteries (main blood vessels) caused by fatty deposits
      known as plaques has been developed. Heart attacks and strokes occur when plaques become
      inflamed, depending on the artery affected. Currently used clinical tests can only tell us
      how much the vessel is blocked by the plaque and not how inflamed (i.e. dangerous) it is.
      This new method of scanning using magnetic resonance imaging (MRI) and a special agent called
      Sinerim can identify inflamed plaques. This study will evaluate patients with plaques in
      their arteries in their neck at risk of strokes to see whether treatment with a
      cholesterol-lowering drug called atorvastatin can reduce the amount of inflammation within
      the artery wall within the first three months of treatment. If this effect can be measured
      using MRI scanning with the use of Sinerim then the results of this study will provide
      additional clinical validation of the use of MRI scanning combined with agents such as
      Sinerem®.
    


Intervention name(s): atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Keywords: atherosclerotic plaque; USPIO; Atheroma; thrombo-embolic stroke; magnetic resonance imaging; Ultra small Super-Paramagnetic Iron Oxide
AMAZ-02 Effect on Exercise ToLerance in Healthy, Overweight Middle Aged Subjects (ATLAS Trial)
Condition: Muscle Function, Mitochondrial Function; Overweight; Healthy Aging
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This is a Phase 2 randomized, double-blind, placebo-controlled study enrolling 90 healthy,
      overweight, middle aged subjects (30 placebo, 30 low dose and 30 high dose AMAZ-02
      intervention), 40-65 years of age, who are otherwise healthy. AMAZ-02, a food derived
      ingredient, will be given as a daily oral dose for 4 months.
    


Intervention name(s): Mitopure 500mg; Mitopure 1000mg; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Mitopure containing softgels; Mitopure containing softgels; Placebo containing softgels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety, Tolerability and Pharmacokinetics of Inhalative Administration of BIBN 4096 BS in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study is to obtain information about the safety, tolerability
      and pharmacokinetics of BIBN 4096 BS after single inhalative administration of increasing
      doses in healthy male and female volunteers
    


Intervention name(s): BIBN 4096 BS - in single rising doses; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olcegepant
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Mechanisms of Impaired Brain Blood Flow With Aging
Condition: Aging
Study type: Interventional

Summary: 
      Aging is the primary risk factor for Alzheimer's disease (AD), which is a rapidly growing
      public health concern. Understanding the mechanisms of normal brain aging may provide insight
      into the factors linking advancing age to increased risk for AD and thereby lead to new
      therapeutic targets for preventing or slowing AD progression. Cardiovascular changes,
      including impaired cerebrovascular function, occur with aging and may increase risk for AD;
      however, the mechanisms by which cerebrovascular function becomes impaired in older adults
      are incompletely understood. The overall goal of this project is to examine potential
      mechanisms of age-related declines in cerebrovascular function in humans. The investigators
      hypothesize that brain macro-vascular endothelial dysfunction, secondary to oxidative stress,
      plays an important role in mediating age-related changes in brain blood flow and
      cerebrovascular reactivity. The results of this pilot study have the potential to identify
      novel targets of cerebrovascular aging and will help guide the design of future clinical
      trials aimed at improving cerebral blood flow in older adults.
    


Intervention name(s): Ascorbic Acid; Normal Saline
Intervention type(s): Other; Other
Intervention description(s): Ascorbic acid will be infused into an antecubital vein using a IV infusion pump beginning with a priming bolus of 0.06 g Ascorbic Acid per kg fat-free mass dissolved in 100 ml of saline followed by a "drip-infusion" of 0.02 g Ascorbic Acid per kg fat-free mass dissolved in 30 ml of saline.; Normal saline will be infused by the research nurse into an antecubital vein using an IV infusion pump.
Other intervention name(s): Vitamin C
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Effects of Lactobacillus Plantarum on Cortisol, IgA and Alpha-amylase Levels in Human Saliva During Stress
Condition: Stress Reaction
MeSH terms: Fractures, Stress
Study type: Interventional

Summary: 
      In the present study the main goal has been to clarify the effect of the probiotic bacteria
      Lactobacillus plantarum 299v on the salivary cortisol level in young adults under examination
      stress. Salivary IgA from minor glands and in whole human saliva was measured as alternative
      marker of stress. The hypothesis was that the levels of cortisol would be reduced or
      stabilized in the test group in comparison to the placebo group where the cortisol levels
      were expected to increase due to the examination-induced stress. By contrast, the salivary
      IgA levels were expected to increase in the test group in comparison to the placebo group.
    


Intervention name(s): Probiotic (Lactobacillus Plantarum); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparison of Robot-Assisted Gait Training and Conventional Therapy in Multiple Sclerosis Patients
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The aim of this study is to compare conventional neurorehabilitation with robot-assisted gait
      training program in terms of fatigue, anxiety, depression and quality of life.
    

Detailed description: 
      Gait disturbances are common in Multiple Sclerosis (MS) patients. Nowadays, gait training
      with robot assisted technology is used for rehabilitation. In several studies conventional
      rehabilitation was compared with robot assisted rehabilitation program, and they found no
      superior effects of robot assisted walking program. In this study we aimed to compare these
      modalities in terms of fatigue, anxiety and quality of life.
    

Intervention name(s): robot assisted gait therapy; Conventional rehabilitation
Intervention type(s): Other; Other
Intervention description(s): The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton.; Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: rehabilitation; robot assisted gait training
Risk Factor for Readmission and Death of Lower Respiratory Infections in Older Adults
Condition: Lower Respiratory Infection; Anemia; Readmission; Death
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Anemia; Death
Study type: Observational

Summary: 
      Lower respiratory tract infection(LRTI) is a prevalent disease that threatens the health of
      older people worldwide. Anemia is also a common disorder in the elderly, and its prevalence
      increases significantly with age. Most factors that contribute to the development of anemia
      are improvable. Therefore, we investigated whether anemia was a risk factor for LRTI-caused
      readmission and death in the elderly occurring within 1 year of discharge from the hospital.
    

Detailed description: 
      Objectives: To investigate the effect of anemia on readmission and deaths in the older adults
      following lower respiratory tract infection (LRTI)-caused hospitalization.

      Design: A retrospective cohort study. Setting and Participants: Older patients (age: ≥ 80
      years) hospitalized at the Department of Geriatrics, from March 2016 to December 2019 to
      undergo treatment for LRTIs were included.

      Methods: The patients were divided into two groups (anemia and non-anemia) based on the level
      of hemoglobin. They were kept under observation till the occurrence of mortality event or 1
      year after discharge. The primary follow-up outcome was LRTI-caused readmission and/or death.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): no intervention
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Elderly patients (age: ≥ 80 years), hospitalized (from 31 March 2016 to 27 December 2019)
        at the Department of Geriatrics of a hospital in Beijing, China, and were with lower
        respiratory tract infection(LRTI) (including pneumonia and acute exacerbation of chronic
        obstructive pulmonary disease) were included. 215 patients (age: >/=80 years) who were
        hospitalized due to LRTI and discharged after being cured were studied. Of these 215
        patients, 149 belonged to the anemia group, and 66 belonged to the non-anemia group. The
        mean age of the cohort at the time of inclusion was 88.73 (SD 4.765) years, and 77.2% of
        the patients were men.
A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
Condition: Hepatic Impairment; Healthy Volunteers
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of ASP0367 in participants with mild and
      moderate hepatic impairment compared to healthy participants with normal hepatic function.
      The study will also evaluate the safety and tolerability of ASP0367 in participants with mild
      and moderate hepatic impairment compared to healthy participants with normal hepatic
      function.
    

Detailed description: 
      The study will comprise of three groups based on hepatic function. Participants will be
      screened for up to 28 days prior to investigational product (IP) administration on Day 1.
      Eligible participants will be admitted to the clinical unit on Day -1 and will be residential
      for a single period of six days/five nights. On Day 1, participants will receive a single
      oral dose of ASP0367 under fasting conditions followed by a 96-hour in-house blood and urine
      sampling period. Participants are to remain semirecumbent for four hours postdose. Standard
      safety and tolerability assessments will be conducted. Participants will be discharged from
      the clinical unit on Day 5 on the condition that all required assessments have been performed
      and that there are no medical reasons for a longer stay in the clinical unit.

      The study will be completed with an end-of-study visit (ESV). The ESV will take place five to
      nine days after the last pharmacokinetic sample is collected or at the time of early
      discontinuation from the study.
    

Intervention name(s): Bocidelpar
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): MA-0211, ASP0367
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mild and moderate hepatic impairment; Liver function; ASP0367; Pharmacokinetics; MA-0211; Healthy Volunteers
Remote Postconditioning in Patients With Acute Myocardial Infarction Treated by Primary Percutaneous Coronary Intervention (PCI)
Condition: Myocardial Reperfusion Injury; Myocardial Ischemia; Myocardial Infarction
MeSH terms: Myocardial Infarction; Myocardial Ischemia; Reperfusion Injury; Myocardial Reperfusion Injury; Infarction; Ischemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Background: Experimental studies suggest that remote limb ischaemic postconditioning
      (RemPostCon) can reduce infarct size in pigs. Initial clinical applications support the
      beneficial role of RemPostCon in preserving endothelial function during upper limb ischemia
      in healthy volunteers and in patients with stable coronary artery disease.

      Aim of the study: To evaluate the feasibility, safety and efficacy of RemPostCon in the
      setting of STEMI and primary PCI (pPCI) and to investigate potential circulating mediators of
      its effects.

      Patients and methods: Patients who undergo pPCI for anterior STEMI within 6 hours since the
      onset of symptoms are randomly assigned to receive either RemPostCon + pPCI or pPCI alone in
      a single-blind fashion. All patients receive therapy according to the current international
      guidelines. Three cycles of ischemia-reperfusion are provided to the lower limb inflating a
      cuff to 200 mmHg. Each cycle consists of 5' of ischaemia, followed by 5' of reperfusion.
      RemPostCon is started at the time of angioplasty in the infarct related artery. Primary
      endpoint is the area under the curve (AUC) of creatinine kinase - MB (CK - MB). Cardiac
      magnetic resonance (CMR) is performed early before discharge and 4 months after the event, if
      there are no contraindications.
    


Intervention name(s): Remote Postconditioning
Intervention type(s): Procedure
Intervention description(s): Lower limb compression using a cuff inflated to 200 mmHg for 5 ' followed by 5' of reperfusion fo three times during 30'
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Remote Postconditioning; Myocardial reperfusion Injury; Myocardial Infarction; Primary PCI
The VERISMART Trial
Condition: Atrial Flutter
MeSH terms: Atrial Flutter
Study type: Interventional

Summary: 
      Catheter ablation is now routinely used in the management of heart rhythm disorders. One of
      the problems with the approach is that it has not been possible to determine whether the
      ablation catheter is in direct contact with the heart tissue or not. This is important
      because too much contact has safety implications and too little means that the therapy will
      be ineffective. Recently two different technologies have been developed to determine contact.
      Currently it is not know if one is superior to the other, and the objective of this trial is
      to determine whether there is a difference when treating a rhythm called atrial flutter.
    


Intervention name(s): Ablation Catheter
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Evaluation of the Effects of Simulation Based Breastfeeding Training
Condition: Breastfeeding; Education
Study type: Interventional

Summary: 
      This study is a randomized controlled experimental study conducted to determine the effect of
      applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal
      period on the success of women in breastfeeding, their self-efficacy perception regarding
      breastfeeding and their attitude towards and knowledge of breastfeeding.
    

Detailed description: 
      This study is a randomized controlled experimental study conducted to determine the effect of
      applied breastfeeding training given through Lactation Simulation Model (LSM) in antenatal
      period on the success of women in breastfeeding, their self-efficacy perception regarding
      breastfeeding and their attitude towards and knowledge of breastfeeding. The research was
      carried out with the participation of two groups. In this context, applied breastfeeding
      training with LSM was given to pregnant women in the intervention group (simulation training
      group, n=64) during antenatal period, and standard training-video training under the hospital
      protocol (video training group, n = 64) was provided to pregnant women in the control group.
      Then, breastfeeding success, breastfeeding self efficacy, attitude and knowledge levels
      regarding breastfeeding were evaluated in the postnatal period. The data of the research were
      collected through Participant Description Questionnaire, LATCH Assessment Tool, Breastfeeding
      Attitude and Knowledge Questionnaire, Breastfeeding Self efﬁcacy Scale and Postnatal Period
      Follow-up Questionnaire. In addition, LSM was employed in the implementation for the
      simulation training group. Research data were analyzed by using SPSS 23.0 statistics program.
    

Intervention name(s): simulation training group
Intervention type(s): Other
Intervention description(s): In this study, applied breastfeeding training with Lactation Simulation Model was given to pregnant women in the intervention group (simulation training group, n=64) during antenatal period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: antenatal period; simulation based breastfeeding training
Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases
Condition: Brain and Central Nervous System Tumors; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms; Brain Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining
      whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining whole-brain radiation therapy
      with thalidomide and temozolomide in treating patients who have newly diagnosed brain
      metastases.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the overall median survival time of patients with newly diagnosed brain
           metastases treated with whole-brain radiotherapy in combination with thalidomide and
           temozolomide.

        -  Determine the radiographic response rate, median time to tumor progression, and median
           time to neurologic response and progression in patients treated with this regimen.

        -  Determine the cause of death of patients treated with this regimen.

        -  Determine the toxicity of this regimen in these patients.

        -  Assess quality of life of patients treated with this regimen.

      OUTLINE: This is a multicenter study.

      Patients undergo radiotherapy daily 5 days a week for 3 weeks. Beginning on the day before
      the first radiation treatment, patients receive oral thalidomide once daily and oral
      temozolomide once daily for 21 days. Patients continue to receive thalidomide daily for up to
      2 years in the absence of disease progression or unacceptable toxicity.

      Quality of life is assessed at baseline, 1 and 3 months after completing radiotherapy, and
      then every 3 months thereafter.

      Patients are followed at 1 and 3 months and then every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 10 months.
    

Intervention name(s): temozolomide; thalidomide; radiation therapy
Intervention type(s): Drug; Drug; Radiation
Intervention MeSH terms: Thalidomide; Temozolomide
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult tumors metastatic to brain; unspecified adult solid tumor, protocol specific
A Study to Evaluate Scales for Repetitive and Restricted Behaviors in Children, Adolescents, and Adults With Autism Spectrum Disorder (ASD)
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a non-drug study seeking to characterize different scales to measure repetitive and
      restrictive behaviors in different ASD sub-populations over time. This study will also
      explore the use of digital biomarkers.
    


Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): No interventions are administered in this study
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other