bioihbjkbjnl/mcl2 huggingface dataset:
The Use of Bupivacaine and Ropivacaine for Sciatic Nerve Block
Condition: The Duration of Motor Block May Vary Between 12-36 Hrs
Study type: Interventional
Phase: Phase 4

Summary: 
      The duration of motor block for infragluteal parabiceps sciatic nerve block following total
      knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic
      given.
    


Intervention name(s): Bupivacaine; Ropivacaine
Intervention type(s): Drug; Drug
Intervention description(s): Varying doses to determine the duration of analgesia; Varying doses to determine the duration of analgesia
Intervention MeSH terms: Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
A Study of Three Modified-Release Formulations of RO4917523 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open label, randomized, 3-period cross-over study will compare 3
      modified-release formulations of RO4917523 in healthy volunteers. Subjects will be randomized
      to one of six sequences to receive single oral doses of RO4917523 slow, target and fast
      release modified release (MR) capsules along with a reference intravenous microdose with the
      target capsule. A washout period of at least 21 days will occur between treatments.
    


Intervention name(s): RO4917523; RO4917523; RO4917523; RO4917523
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fast release MR capsule, single dose; Target release MR capsule, single dose; Slow release MR capsule, single dose; [13C]-labeled tracer dose i.v.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
The Long-lasting Effects of Repetitive Neck Muscle Vibrations on Postural Disturbances in Standing Position in Chronic Stroke Patients
Condition: Hemiplegia; Stroke
MeSH terms: Stroke; Hemiplegia
Study type: Observational

Summary: 
      One of the causes of disability in patients suffering from a stroke is postural imbalance.
      Sensory stimulation improves the postural symmetry of the subject transitorily and they are
      thought to have an effect on the spatial frame of reference through a sensory recalibration.
      Studies have shown that sensory stimulation by vibration of neck muscles have an immediate
      effect on static balance and when walking. The objective of this preliminary study is to test
      the long-lasting effects of repetitive neck muscle vibrations on postural disturbances in
      standing position and on spatial frame reference in chronic patients.
    

Detailed description: 
      The hypothesis of this study is that the proprioceptive repeated stimulation by vibration of
      neck muscles in the long term improved postural asymmetry in connection with the egocentric
      representation of body disorders.

      The effect of vibration simultaneously on improving postural asymmetry and on improving
      markers of the perception of the body in space (LBA, SSA, Subjective Visual Vertical (SVV),
      Rod and frame) will be assessed.
    

Intervention name(s): Vibration sessions
Intervention type(s): Other
Intervention description(s): The patients will undergo a program of 10 sessions of vibrations of the neck muscle, each of 10 minutes, during a period of 15 days at the rate of one session per day.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with stroke
The Role and Effect of Anemia in Children With Pneumonia
Condition: Anemia; Pneumonia
MeSH terms: Pneumonia; Anemia
Study type: Observational

Summary: 
      This study will measure the effect of anemia on the outcomes of hospitalized children with
      severe pneumonia.
    


Intervention name(s): none - observational only
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children age 6 months to 59 months admitted to the hospital with WHO-defined severe
        pneumonia
A Study of the Effect of Formulation and Tablet Hardness on the Bioavailability of Pictilisib in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1, open-label, randomized, 4-period crossover study is designed to determine the
      relative bioavailability of GDC-0941 administered as a single dose of the market image
      formulation at 3 different hardnesses (hardness 1, 2, and 3) and as a single dose of the
      Phase 2 formulation to healthy male and female volunteers. Participants will be randomly
      assigned to 4 possible treatment sequences, each comprising 4 periods (1 per formulation),
      and GDC-0941 will be administered based on the assigned sequence. The study is expected to
      last 8 weeks.
    


Intervention name(s): GDC-0941; GDC-0941; GDC-0941; GDC-0941
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose market image tablet of hardness 1; Single dose market image tablet of hardness 2; Single dose market image tablet of hardness 3; Single dose Phase 2 tablet formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Internal Limiting Membrane Peeling on Retinal Displacement
Condition: Internal Limiting Membrane Peeling
MeSH terms: Retinal Perforations
Study type: Interventional

Summary: 
      The purpose of this study is to investigate displacement of the retina after idiopathic
      macular hole surgery with different internal limiting membrane peeling patterns.
    

Detailed description: 
      After being informed about the study and potential risks, all patients giving written
      informed consent will undergo a 1-week screening period to determine eligibility for study
      entry. All patients with idiopathic MH will be randomly allocated into two groups, N-T group
      or T-N group.
    

Intervention name(s): idiopathic macular hole (MH) surgery
Intervention type(s): Procedure
Intervention description(s): Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Retinal displacement; Idiopathic macular hole; Internal limiting membrane peeling
Endoscopic Submucosal Dissection Using a Thulium Laser
Condition: Gastric Dysplasia
Study type: Observational

Summary: 
      We aim to evaluate safety and feasibility of a thulium laser system in performing endoscopic
      submucosal dissection of gastric neoplasia.
    

Detailed description: 
      Instead of endoscopic knives, a thin, flexible fiber is inserted through the working channel
      of the endoscope. Acetic acid (1.5%) and indigo carmine dye are sprayed onto the lesion to
      clarify the margin. Markings are made 10 mm outside the tumor margin using a laser fiber with
      a power setting at 30 W. After marking, a mixture of sodium hyaluronate with indigo carmine
      and epinephrine (1:25000) is injected into the submucosa outside the marking dots. A
      circumferential mucosal incision and submucosal dissection are performed by a thulium laser
      fiber with a power setting at 30 to 40 W. Activation of the laser beam is controlled by
      stepping on a foot pedal. Hemostasis during procedure is also attempted using the thulium
      laser. When hemostasis is not achieved properly, additional use of hemostatic forceps or a
      hemoclip will be considered.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients are diagnosed with gastric epithelial neoplasia in a private clinic and
        referred to our hospital for endoscopic resection.
      
Biospecimen description: 
      ESD specimen will be examined by a experienced pathologist.
Study to Evaluate the Effect of Food on the Pharmacokinetics of Surfolase CR Tablet in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Acebrophylline is metabolized by being separated into Ambroxol and 7-theophylline when orally
      administered as a salt composed of an acid-base as a compound that was synthesized by and
      chloride (salifying) the ambroxol to 7-theophylline. Acebrophylline is selectively applied to
      the bronchial or lung tissue and inhibit the activity of phospholipase bronchoalveolar shows
      the expectorant action to raise the surface activity of the alveolar, leukotrienes (LTs) and
      by suppressing the production of prostaglandins (PGs), showed potent anti-inflammatory
      activity, bronchial was celebrated by reducing the bronchial hyperreactivity to normal state
      is allowed to recuperate or extended.

      It was developed to improve compliance improve pharmaceutically Acebrophylline that intake
      twice daily 100mg to Surfolase CR that intake once daily 200mg
    


Intervention name(s): Surfolase CR; Surfolase CR
Intervention type(s): Drug; Drug
Intervention description(s): T1: Surfolase CR (Acebrophylline 200mg) administration after fat intake Surfolase CR(Acebrophylline 200mg) administrated fasting or fat intake at D1 and D8 a.m. 8:00; T0: Surfolase CR(Acebrophylline 200mg) fasting administration Surfolase CR(Acebrophylline 200mg) administrated fasting or fat intake at D1 and D8 a.m. 8:00
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
D-serine and Cognitive Remediation in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators will test the effects of 3 days of D-serine (DSR) on auditory plasticity in
      a sensory based remediation (SBR) paradigm
    

Detailed description: 
      We will enroll 8 subjects in an open label, three session pilot in patients will receive
      three sessions of tone matching SBR.

      5 Subjects will receive D-serine (60mg/kg) taken 1x each week during the SBR sessions.
      Subjects will receive study drug 30 minutes prior to session.

      3 subjects received no intervention
    

Intervention name(s): D-serine
Intervention type(s): Drug
Intervention description(s): D-serine 60 mg/kg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive remediation
ERP Based Single-dose Predictions of Stimulants
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to see if the clinical outcome of stimulant medication
      (methylphenidate) in pediatric Attention Deficit Hyperactivity Disorder can be predicted on
      the bases of changes in Event Related Potentials (ERPs) induced by a single dose of stimulant
      medication. (ERPs are extracted from electroencephalographic (EEG) registrations during the
      performance of an attention task).
    

Detailed description: 
      In the pediatric neuropsychiatric clinic of Ostfold Hospital Trust, Norway, patients
      diagnosed with attention deficit hyperactivity disorder are tested with quantitative EEG
      (QEEG) and ERPs to supplement the neuropsychological examination. In the majority of cases a
      systematic four weeks trial on stimulant medication is offered, and the clinical effects are
      evaluated at the end of the try-out period. This procedure is a clinical routine. In this
      study patients and parents were asked if they were willing to complete a second QEEG/ERP test
      on a single dose of stimulant medication shortly before the onset of the four weeks trial.
      They were explained that the aim of the study was to search for predictors of clinical
      response. They were also informed that this second test was completely voluntary. (In fact
      the vast majority were quite enthusiastic). The patients were characterized as responders
      (REs - medication continued) or non-responders (non-REs - medication stopped) based on
      explicit criteria. The single-dose induced changes in ERPs (and behavioral parameters from
      the attention test; number of errors, reaction times) were examined, and differences between
      REs and non-REs were calculated.

      If the analysis of data show that one or several variables are significantly different in REs
      and non-REs with large effect sizes, these findings may eventually result in the development
      of a useful clinical tool.
    

Intervention name(s): Methylphenidate (MPH)
Intervention type(s): Drug
Intervention description(s): Test 1: No medication. Registration of ERPs and behavioral data during an attention task. Test 2: Test repeated on a single dose of MPH. Outcome measure: Classification as responders or non-responders after a four weeks medication trial, based on rating scales from parents and Teachers.
Other intervention name(s): Ritalin tablets
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Antidiabetic Metformin as a Novel Adjunct to Antidepressants in Major Depressive Disorder Patients
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of our study was to test whether the combined administration of the SSRI fluoxetine
      and metformin, a drug improving metabolic profile and therefore potentially able to mimic the
      influence of supportive living conditions on treatment outcome, results in an improved
      antidepressant efficacy compared with fluoxetine alone.
    

Detailed description: 
      Selective Serotonin Reuptake Inhibitors (SSRIs) represent the standard treatment for Major
      Depressive Disorder (MDD). However, their efficacy is variable and incomplete. In order to
      explain, at least in part, such variable efficacy, we have shown that SSRI administration
      does not affect mood per se but, by enhancing neural plasticity, amplifies the influence of
      the living conditions on mood. Consequently, in a favorable environment, SSRI treatment leads
      to a reduction of symptoms while, in stressful conditions, it could lead to a worse
      prognosis. Here, we test the hypothesis that, given the clear association between living
      conditions and metabolic profile, the modulation of the latter may mimic the effect of the
      environment on SSRI outcome, determining treatment efficacy.

      Metformin is widely used as a first line treatment for patients with type 2 diabetes mellitus
      for more than 60 years for the reduction of hepatic glucose output and increase of the
      insulin mediated utilization of glucose. Previous studies demonstrated that metformin can
      rapidly cross the blood brain barrier and has several beneficial effects in the brain such as
      anti-inflammatory and neuroprotective effects. Furthermore, metformin, along with its
      anti-glycemic effects, has been documented to possess anti-depression effects in patients
      with type 2 diabetes. In Guo's study, 58 participants diagnosed with depression and type 2
      diabetes were divided into two groups: one treated with metformin and the other with a
      placebo for 24 weeks. Analysis of MADRS and HRSD-17 scores showed that metformin
      significantly reduced MADRS scores and HRSD-17 scores. Metformin administration improves
      depressive symptoms in type 2 diabetes mellitus.
    

Intervention name(s): Placebo oral tablet; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Fluoxetine 20 mg capsule plus Placebo tablet administered once daily after food; Fluoxetine 20 mg capsule plus Metformin 1000 mg extended release tablet administered once daily after food
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to establish the dose regimen and evaluate the preliminary
      efficacy and the safety/tolerability of poziotinib in participants with human epidermal
      growth factor receptor 2 (HER2)-positive metastatic breast cancer who have received at least
      two prior HER2-directed treatment regimens.
    

Detailed description: 
      This is a phase 2, open-label, multicenter study to establish the dose regimen and evaluate
      the preliminary efficacy and the safety/tolerability of poziotinib in participants with
      HER2-positive metastatic breast cancer who have received at least two prior HER2-directed
      treatment regimens.

      Each treatment cycle will be 21 days in duration. During each 21-day cycle, participants who
      are eligible for participation will receive poziotinib orally once daily.

      All treated participants will be followed up until disease progression, death, intolerable
      adverse events or up to a maximum of 24 months whichever comes earlier.
    

Intervention name(s): Poziotinib
Intervention type(s): Drug
Intervention description(s): 8 mg oral tablets, administered QD.
Other intervention name(s): HM781-36B
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Poziotinib; Metastatic Breast Cancer; HER2-positive; Pan-HER inhibitor
iSTAT Comparison Study, IRB3785
Condition: Pleural Effusions
MeSH terms: Pleural Effusion
Study type: Observational

Summary: 
      Pleural fluid glucose levels measured with bed-side point of care methods such as finger
      stick glucometers and I-STAT device correlate with the traditional in-lab testing methods.
    

Detailed description: 
      This is a prospective study which will identify patients in VAMC with a diagnosis of pleural
      effusion and undergoing diagnostic thoracentesis.The investigators plan to analyze the two
      bedside point-of-care fluid glucose testing methods (I- STAT device and finger stick
      glucometer) to measure pleural fluid glucose levels. The results obtained from these two
      methods will be compared to the traditionally in lab measured pleural fluid glucose levels.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pleural effusions
      
Biospecimen description: 
      Pleural fluid
    
Keywords: pleural; glucose; glucometer; i-STAT
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions.
Condition: Bioequivalence; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate and compare the bioavailability and therefore to
      assess the bioequivalence of two different formulations of sitagliptin/metformin extended
      release tablets after a single oral dose administration under fed conditions.
    


Intervention name(s): Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
Intervention type(s): Drug
Intervention description(s): The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Clinical Study to Assess Preliminary Efficacy, Safety and Tolerability of HH-120 Nasal Spray in COVID-19 Patients
Condition: Coronavirus Disease 2019(COVID-19)
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      To evaluate the preliminary efficacy and safety of HH-120 nasal spray in the treatment of
      asymptomatic or mild COVID-19.
    

Detailed description: 
      During this study, participants will receive HH-120 nasal spray treatment for 6 consecutive
      days, the efficacy and safety of HH-120 will be assessed throughout the study period based on
      viral clearance, clinical recovery, illness severity and adverse events.
    

Intervention name(s): HH-120 Nasal Spray
Intervention type(s): Biological
Intervention description(s): HH-120 Nasal Spray 8-10 times per day for 6 consecutive days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Treatment
Identification of Novel Genetic Factors That Contribute to Risk for Breast Cancer
Condition: Invasive Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to identify novel genetic factors which distinguish breast
      cancer in younger women compared to older women. By identifying these novel genetic factors
      we believe more specific therapies can be developed and breast cancer may be prevented among
      women with an increased cancer risk. A woman does not have to live in St. Louis to
      participate.
    

Detailed description: 
      Breast cancer takes its greatest toll on younger women, as it is the leading category of
      cancer deaths for women 20-39 years of age. Sadly, survival rates are lowest among women
      diagnosed at a young age. This impact is most significant among African-American women who
      have the highest incidence and mortality rate among women less than 45 years of age. The goal
      of our program is to identify the genetic factors which distinguish breast cancer in younger
      women compared to older women.

      Women who were diagnosed with invasive breast cancer 40 years of age or younger are invited
      to participate. The age at diagnosis is used to determine eligibility, not a woman's current
      age. Women who have undergone genetic testing of the BRCA1, BRCA2, p53, pTEN, e-cadherin, or
      LKB1 genes are eligible to participate. Young women with breast cancer are asked to: sign a
      consent form, submit a sample of blood, release their cancer related records, and answer some
      family history questions.

      We will use a family based case control approach in our analysis. As such, if a woman's
      parents are living, they will be invited to participate as a "comparison" group. The parents
      are asked to: sign a consent form, submit a sample of blood, and release any cancer records.

      A woman does not have to live in St. Louis to participate. All study related materials can be
      mailed directly to the young woman or her parents. There is no expense to the family. All
      materials are kept strictly confidential and participation is completely voluntary.
    

Observational model: Family-Based
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        women diagnosed with invasive breast cancer < 40 years of age
      
Biospecimen description: 
      Blood specimens.
    
Keywords: Breast; Cancer; Young; Women