bioihbjkbjnl/mcl2 huggingface dataset:
Association of 5-HT3 Receptor Gene Polymorphism With the Efficiency of Ondansetron for Postoperative Nausea and Vomiting
Condition: Post Operative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      Postoperative nausea and vomiting (PONV) is a common and distressing complication in patients
      undergoing general anesthesia. However, although 5-hydroxytryptamine type 3 (5-HT3) receptor
      antagonists have significantly reduced PONV, it is reported that over 35% of patients treated
      with ondansetron experience PONV. Though the cause of failure in ondansetron treatment is not
      clear, the investigators assumed that polymorphism in the 5-HT3 receptor gene would
      contribute to such inter-individual variation. In this study, the investigators examine
      whether the polymorphisms of 5-HT3 receptor gene affect the efficacy of ondansetron to
      prevent PONV in patients undergoing general anesthesia for laparoscopic surgery.
    


Intervention name(s): administration of ondanstron and screening of genomic DNA
Intervention type(s): Dietary Supplement
Intervention description(s): Thirty minutes before the end of surgery, ondansetron 0.1 mg/kg is administered intravenously. We assess an episode of PONV at first 2 h and 2-24 h after surgery. Genomic DNA was prepared and screened. The incidence of PONV is compared among genotypes in 5-HT3 receptor gene polymorphisms (5-HT3a: S253N; 5-HT3b: Y129S, -100_-102delAAG).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: ondanstron; gene polymorphism; postoperative nausea and vomiting; laparoscopic surgery under general anesthesia
Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement
Condition: Orthodontic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to compare pain control effectiveness of two medicines
      and a placebo (a dummy pill that does not contain any pain relieving medication) to see which
      one works better at preventing pain when taken both 1 hour before and 6 hours after
      orthodontic separators are placed. The research hypothesis is that there will be a
      significant difference in pain as measured by Visual Analogue Scales (VAS) over time and that
      this effect will differ for acetaminophen versus ibuprofen.
    


Intervention name(s): Acetaminophen; Avicel (placebo); Ibuprofen
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: pain; orthodontic; acetaminophen; ibuprofen; separator
Exposure in Epigenetic Regulation of Immune Response in Chronic Beryllium Disease (CBD)
Condition: Chronic Beryllium Disease
MeSH terms: Berylliosis
Study type: Observational

Summary: 
      This study will provide important results for each aim, while also providing an integrative
      transcriptional and epigenomic profile of CBD.

      In Aim 1 the Investigator will define genome-wide epigenetic alterations of CBD, by
      determining genes that are DM in pivotal immune cells, in the target organ (CD4+ BAL cells)
      in CBD compared to BeS and healthy controls. In addition, the Investigator will determine the
      impact of Be exposure on the methylation profile of CBD and BeS cells compared to each other
      and normal controls. This information will be used to define DM regions, genes and their
      networks.

      Using the cases and controls from Aim 1, we will evaluate the gene-expression from these same
      subjects in Aim 2 to define functional epigenetic loci based on DE in CD4+ BAL cells with and
      without Be exposure. The Investigator will also integrate ENCODE/RE methylation, histone
      modification, and chromatin accessibility data as well as our genome-wide association study
      (GWAS) data to prioritize epigenetic marks and networks for confirmation and validation in
      Aim 3. In Aim 3, the Investigator will test the generalizability of their findings, explore
      the potential of methylation marks as biomarkers of disease in PBMCs and determine if change
      in methylation of these targets with AZA or folic acid affects key immune and regulatory
      pathways in a second set of CBD and BeS subjects. Throughout the Aims, the Investigator will
      use both fresh CD4+ T cells to directly assess disease relevance and Be-stimulated cultured
      CD4+ T cells (compared to unstimulated cultured T cells) to assess the impact of
      environmental exposure .
    


Intervention name(s): Nothing
Intervention type(s): Other
Intervention description(s): No interventions will be administered.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        We will enroll subjects using standard case and control definitions. We will enroll up to
        150 subjects. Controls will be frequency matched on age, gender, race and smoking status to
        limit methylation changes related to these factors.
A Dose-Block Randomized, Placebo Controlled (Double-blind), Active Controlled(Open-label), Dose-escalation Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study design of this trial is a Dose-Block Randomized, Placebo controlled (Double-blind),
      Active Controlled(Open-label), Dose-escalation.
    

Detailed description: 
      -  Extended in vivo half-life of HL2351 is also anticipated to provide improved therapeutic
           efficacy based on sustained maintenance of an effective concentration.

        -  A safety concern may be addressed by utilizing IL-1Ra that is being used after getting
           approval by the EMA and the US FDA and known to be relatively safe, and the Fc fusion
           technology that has been already applied to various therapeutic agents.
    

Intervention name(s): HL2351; Kineret(Anakinra)
Intervention type(s): Biological; Biological
Intervention description(s): Dose-escalation For 5 level dose groups A ~ E(each 1, 2, 4, 8, 12mg/kg), 10 subjects (8 for the study drug and 2 for placebo) are randomized to each dose group, and the study drug or placebo is subcutaneously administered for the relevant dose group.; Active comparator(group F) is implemented in parallel with dose groups A~E in an open-label manner and 8 subjects subcutaneously administer Kineret® 100 mg.
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: First In Human; CAPS, SoJIA, AOSD, Bechet Disease, Rheumatoid arthritis
Ultra-sounded Guided Regional Blockade for Lipoma Excision
Condition: Lipomas
MeSH terms: Lipoma
Study type: Interventional

Summary: 
      There is limited information on using the ultrasonography for block placement concerning
      lipoma excision. A new type of regional blockade, performed under ultrasound, can ensure
      proper block placement with accurate local anesthetics deposition. Investigators hypothesized
      that ultrasound guidance can reduce the number of needle passes to complete the block
      placement. Investigators will compare namely ultrasound guided regional blockade and
      traditional method regarding the number of needle passes to complete the block placement.
    

Detailed description: 
      50 patients between the ages of 18 and 60 years with American Society of Anesthesiologists
      (ASA) physical status I-III, scheduled for superficial subcutaneous lipoma (sized from 5 to 7
      cm) excision will be enrolled in prospective comparative randomized clinical study.

      Patients will be randomized into two groups: U (n = 25), in whom regional blockade was
      performed using US-guidance; and C (n = 25), in whom regional block was performed using the
      traditional method. Patients will be randomly assigned on a one-to-one ratio. Randomization
      will be performed by means of a computer generated random-numbers table. Group allocation
      will be concealed in sealed opaque envelopes that will not opened until patient consent had
      been obtained.

      All patients will be pre-medicated with oral diazepam (7.5 mg) 30 min before the procedure,
      and IV fentanyl (50 ug) will be administered 5 minutes before placement of the block. Before
      the procedure, an IV access and standard monitoring of electrocardiogram (ECG), noninvasive
      blood pressure (NIBP), and peripheral oxygen saturation (SPO2) will be established.

      Primary outcome includes the number of needle attempts (number of skin punctures and needle
      redirections) needed to complete the block placement. It will be documented by an
      investigator blinded to the aim of the study. Patient demographics, duration of surgery,
      patient's ASA physical status and other study outcomes will be documented by independent
      investigators who were not involved in the block placement procedure and were blinded to the
      group assignment.
    

Intervention name(s): Ultrasound guidance
Intervention type(s): Procedure
Intervention description(s): In the second arm, ultrasound will be used to guide the regional block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ultrasound; regional blockade; lipoma
Long-term Safety Study of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and
      an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40
      consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on
      study.
    

Detailed description: 
      Both insulin hyposecretion and insulin-resistance are considered to be involved in the
      development of type 2 diabetes mellitus.

      Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients
      with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV
      (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2
      peptide hormones released in response to nutrient ingestion. It is expected that inhibition
      of DPP-IV will improve glycemic control in patients with type 2 diabetes.

      "To evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor,
      this extension study was administered for 40 consecutive weeks (52 weeks from the start of
      treatment in the phase 2 dose-ranging study) to participants who completed a phase 2/3
      α-glucosidase inhibitor add on study 322/CCT-003 (NCT01263483).
    

Intervention name(s): Alogliptin and voglibose; Alogliptin and voglibose
Intervention type(s): Drug; Drug
Intervention description(s): Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.; Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
Other intervention name(s): SYR-322; Voglibose; BASEN®; SYR-322; Voglibose; BASEN®
Intervention MeSH terms: Inositol; Alogliptin; Voglibose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus - Type 2; Diabetes Mellitus; Drug Therapy
A Novel Selective Block of the Suprascapular Nerve
Condition: Ligament Injury; Fracture
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients who receive the lateral and sagittal infraclavicular block (LSIB) tend to supinate
      their hand and forearm which may hamper optimal positioning for surgery of the dorsal side of
      the hand. The investigators think that this supination is caused by lateral rotation in the
      shoulder. The main lateral rotator of the shoulder is the infraspinatus muscle, which is
      innervated by the suprascapular nerve (SSN).The investigators hypothesized that optimal
      positioning of the hand for surgery on the dorsal side of the hand may be achieved by
      performing a SSN block (SSNB) in addition to the LSIB.
    

Detailed description: 
      According to the hypothesis the investigators will perform a double blind , placebo
      controlled study to answer the research question above.
    

Intervention name(s): LSIB + SSNB
Intervention type(s): Procedure
Intervention description(s): Patients will receive LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml Ropivacaine 5 mg/ml) or LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml placebo, saline)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brachial plexus block; Suprascapular nerve block
Fast Identification of Pathogen in the Setting of Hospital-acquired Pneumonia Using Ion Mobility Spectrometry
Condition: Acute Lower Respiratory Tract Infection; Pneumonia
MeSH terms: Pneumonia; Respiratory Tract Infections; Healthcare-Associated Pneumonia
Study type: Observational

Summary: 
      With this study the investigators want to determine, if a fast identification of germs,
      causing hospital-acquired infections of the lower respiratory tract, is possible through the
      use of MCC-IMS technology - a method that allows on time detection and identification of very
      small amounts of substances in gas samples. Therefore aspiration samples from the respiratory
      tracts of ventilated patients, which are suspected to develop such an infection, will be
      collected, cultivated and analyzed by MCC-IMS. The investigators want to determine if MCC-IMS
      diagnostic could be a faster alternative to conventional microbiological methods. The results
      of the MCC-IMS analyses therefore will be compared with results of conventional
      microbiological methods.
    

Detailed description: 
      In this clinical feasibility study it is to be investigated if MCC-IMS analyses over clinical
      samples from ventilated critically ill patients could be a fast and secure alternative to
      conventional microbiological diagnostic methods in the identification of human pathogenic
      microbes in the setting of hospital-acquired pneumonia. Therefore aspiration samples from
      intubated and ventilated critically ill patients, which are suspected to develop such an
      infection, will be collected and cultivated for a short period of time. The headspace over
      these cultures will be analyzed using MCC-IMS - a technology that allows on time detection
      and identification of very small amounts of substances in complex and humid gas samples.
      Conventional microbiological investigations, including MALDI-TOF, will be carried out
      parallel to the MCC-IMS analyses.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients will be recruited from two intensive care units of the university hospital.
      
Biospecimen description: 
      aspiration samples from the respiratory system (tracheal secretion sample, BAL)
    
Keywords: ion mobility spectrometry; hospital-acquired pneumonia; microbiological investigation; intensive care
Rhythmic Auditory Stimulation and Walking Speed in the 6-minute Walk Test
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis
Study type: Observational

Summary: 
      The aim of this study is to investigate if rhythmic auditory stimulation can influence
      walking speed, during a 6MWT in patients with myasthenia gravis (MG).
    

Detailed description: 
      Background

        1. The 6-minute walk test (6MWT) is widely used in the clinic to measure treatment efficacy
           and disease progression in patients with neuromuscular diseases and is found valid and
           reliable to measure decrease in walking speed.

        2. Rhythmic auditory stimulation has repeatedly been shown to improve gait parameters in
           individuals with neurologic impairment.

      The aim of this study is to investigate if rhythmic auditory stimulation can influence
      walking speed, during a 6MWT in patients with myasthenia gravis.

      Patients with MG are asked to complete two 6MWTs separated by minimum 30 minutes of rest.
      Before the 6MWTs patient is instructed to walk 60 m as fast as possible, and their steps per
      minute (SPM) is recorded. When completing the 6MWTs, one of the tests is accompanied by music
      (m6MWT) with a beat per minute (BPM) corresponding to patients' SPM. The order of the 6MWTs
      is randomly decided by pre-ordered sealed envelopes.
    

Intervention name(s): 6-minute walk test
Intervention type(s): Other
Intervention description(s): The 6-minute walk test (6MWT) is widely used in the clinic to measure treatment efficacy and disease progression in patients with neuromuscular diseases and is found valid and reliable to measure decrease in walking speed for neuromuscular patients.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with MG seen in the Department of Neurology, Rigshospitalet, fulfilling the
        inclusion criteria.
      
Keywords: Fatigue; 6-minute walk test; Rhythmic Auditory Stimulation
The Effect of Multiple-Task Training in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The Activities of Daily Living requires the ability to perform multiple activities at the
      same time, not just the motor or cognitive activity. When many tasks are performed at the
      same time, the attention capacity is effectively used and attention is shared according to
      the difficulty and priority of the tasks. There is evidence that patients with Multiple
      Sclerosis (MS) have reduced performance during multitasking.

      In this study, the investigators aim to investigate the effect of multitasking training on
      balance, mobility, upper extremity performance and cognitive functions in patients with MS.
    

Detailed description: 
      Patients with MS between 0-1,5 score according to the Extended Disability Status Scale (EDSS)
      will be included in the study. The balance, mobility, upper extremity performance, the
      cognitive function will be evaluated twice.

      The study was designed as a prospective, randomized controlled study. The patients will be
      randomly assigned to three groups, the "multi-task training (MT)" group, the "single task
      training (ST)" group, and "control" group. The training will be twice a week for 6 weeks.

      Statistical analyses will be performed using the SPSS software version 15 (SPSS Inc. Chicago,
      IL, USA). The pre-training and post-training measurements of groups will be compared with the
      Wilcoxon Test. The significance level was set at p< 0.05
    

Intervention name(s): Multi-task training; Single task training
Intervention type(s): Other; Other
Intervention description(s): In the multitasking training group, a second motor task in the first two weeks, a cognitive task in the third and fourth week, both motor and cognitive tasks in the last two weeks will be added to these 10 different motor tasks.; An exercise program consisting of 10 different motor tasks will be implemented in a single task training group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Multi-task training; Balance; Mobility; Cognition; Upper extremity function
A Biomarker Database to Investigate Blood-Based and Digital Biomarkers in Participants Screened for Alzheimer's Disease (Bio-Hermes)
Condition: Alzheimer Disease; Alzheimer Disease, Early Onset; Mild Cognitive Impairment; Memory Loss; Memory Disorders; Memory Impairment
MeSH terms: Alzheimer Disease; Memory Disorders; Amnesia; Cognitive Dysfunction
Study type: Observational

Summary: 
      The purpose of this study (Bio-Hermes) is to develop a blood, digital, and brain amyloid PET
      scan biomarker database that can be used to determine whether a meaningful relationship
      exists between digital tests, blood amyloid-beta, p-tau, and neurofilament biomarker levels
      and amyloid-beta levels identified through brain amyloid PET images. Blood collected will
      also be genetically sequenced to gain insights about genes and brain amyloid. The Bio-Hermes
      study will include 1,000 volunteers over the age of 60 screened for Preclinical Alzheimer's
      Disease, Prodromal AD, or Mild Dementia AD, and includes an endpoint enrollment requirement
      of 200 participants from underrepresented minority populations.
    


Intervention name(s): Biomarker Data Collection
Intervention type(s): Other
Intervention description(s): During this study, a sample of your blood will be collected and you will have a PET scan taken of your brain. Blood sample results will be compared to PET scan pictures to understand how well the markers in the blood predict whether there is amyloid in the brain. Blood samples will also be collected that contain your genes. These genetic samples will also be compared to PET scans to help researchers understand how different people react to medicines and to understand the genetic causes of Alzheimer's disease. Some of the samples will be stored for future analysis.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 1,000 participants
      
Biospecimen description: 
      Beta-Amyloid, Phospho-Tau, Neurofilament Light Chain, DNA, RNA
    
Keywords: Alzheimer's disease; Alzheimer Disease, Early Onset; Mild Cognitive Impairment; Memory Loss; Memory Disorders; Memory Impairment; Older Volunteers; Healthy Volunteers
Smoking Young Asthmatics: Change of Inflammation During Tobacco Cessation and Steroid Treatment
Condition: Asthma
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study describing changes in inflammation of the airways in asthmatics before and
      after smoking cessation and steroid treatment.
    

Detailed description: 
      84 smoking asthmatics will be included. 50% will be treated with varenicline and 50% with
      placebo tablets for 12 weeks. All will be treated with inhaled steroid for 12 weeks.

      Study period: About 26 weeks including asthma screening. 4 visits will be performed.
      Inflammation will be described through sputum induction, and several other pulmonary medical
      tests will be performed, including NO, methacholine, spirometry, CO, blood samples, skin
      prick test and asthma questionaires.
    

Intervention name(s): Varenicline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Varenicline 2 mg x 1 day 7 to week 12; similar tabl
Other intervention name(s): Placebo; Varenicline
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment