bioihbjkbjnl/mcl2 huggingface dataset:
Enoxaparin in the Prevention of Placental Insufficiency in Pregnant Women
Condition: Placental Insufficiency; Enoxaparin
MeSH terms: Placental Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Assessment of the effectiveness of Enoxaparin, at a preventive dose, combined with Aspirin
      treatment versus Aspirin only treatment in reducing placental insufficiency in pregnant
      women.
    

Detailed description: 
      Randomized, prospective, monocentric, open-label comparative study with two parallel groups
      (Enoxaparin, at a preventive dose, combined with Aspirin versus Aspirin alone), with the main
      objective being to evaluate the effectiveness of enoxaparin, at a preventive dose, in
      reducing placental insufficiency during pregnancy in pregnant women.
    

Intervention name(s): Enoxaparin 40 mg / 0.4 mL Prefilled Syringe; Aspirin 100 mg Oral Tablet, Enteric Coated
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Genotype - Phenotype Correlations of LINCL
Condition: Batten Disease; Late-Infantile Neuronal Ceroid Lipfuscinosis
MeSH terms: Neuronal Ceroid-Lipofuscinoses
Study type: Observational

Summary: 
      In a separate protocol the Department of Genetic Medicine is proposing to carry out a study
      using gene transfer to treat the central nervous system (CNS) manifestations of late
      infantile neuronal ceroid lipofuscinosis (LINCL), a fatal, rare, recessive disorder of the
      (CNS) in children. In the context that there is little known about the genotype - phenotype
      correlations of LINCL, and that our referral far exceed the number (n=11) of children that
      will be entered into the gene transfer protocol, we are proposing to capitalize on this
      unique opportunity to evaluate this disorder in this separate study. In this context, the aim
      of this protocol is to study the genotype - phenotype correlations of the CNS manifestations
      of late infantile neuronal ceroid lipofuscinosis. This will be accomplished by comparing the
      genotype to a neurologic assessment, and LINCL clinical rating scale; magnetic resonance
      imaging (MRI) and magnetic resonance spectroscopic (MRS) assessments of the CNS; and routine
      clinical evaluations.
    

Detailed description: 
      This proposed clinical protocol is designed to assess genotype - phenotype correlations of
      LINCL, including a preliminary assessment regarding the genotype - phenotype correlations of
      progressive CNS deterioration inherent to this disorder. The trial will include the primary
      endpoint of neurological assessment including the LINCL clinical rating scale and parental
      evaluations; and the secondary endpoint of magnetic resonance imaging (MRI) and magnetic
      resonance spectroscopic (MRS) assessments of the CNS.

      The study will be carried out in children diagnosed with LINCL in all stages. The staging is
      based on a modification of the scale of Steinfeld et al (Steinfeld, 2002). The study
      anticipates a total n=30 children assessed over a period of 18 months. Of these, we
      anticipate that approximately two-thirds will not be entered into the proposed gene therapy
      protocol and thus approximately n=20 will be available for this study to be reassessed at 1
      year. Thus, we anticipate that we will be able to capture a one-time genotype - phenotype
      snapshot for all n=30, and a 1 year genotype - phenotype progression assessment for n=20.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will be carried out in children diagnosed with LINCL in all stages.
      
Biospecimen description: 
      whole blood, serum
    
Keywords: Batten Disease; Late Infantile Neuronal Lipofuscinosis; LINCL
Sugammadex on Remifentanil Ce for Preventing Emergence Cough in Female
Condition: Gallbladder Diseases
MeSH terms: Gallbladder Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the optimal Ce of remifentanil for preventing
      emergence cough following extubation during general anesthesia in female who are reversed
      with sugammadex or neostigmine.
    

Detailed description: 
      Remifentanil is a potent ultrashort-acting opioid, with rapid onset and offset of drug
      effect. It allows rapid anesthetic emergence even after a prolonged infusion, and decreases
      the at-risk time during extubation. In addition, cough suppression of remifentanil enables
      smooth extubation with reduced complications. However, the infusion of remifentanil
      suppresses the emergence cough effectively in clinical practice, whereas it still delays the
      awakening from anesthesia, resulting in prolonged emergence time. Reduced Ce of remifentanil
      during emergence would decrease the adverse events that are associated with remifentanil
      infusion.
    

Intervention name(s): Sugammadex Injectable Product; Neostigmine Injectable Product
Intervention type(s): Drug; Drug
Intervention description(s): Sugammadex of 2 mg/kg is injected.; Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Study to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant Botulinum Vaccine A/B in Healthy Adults
Condition: RECOMBINANT BOTULINUM VACCINE A/B
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to evaluate the safety and tolerability of a two-dose regimen
      (Day 0 and Day 28) of recombinant Botulinum Vaccine (rBV) A/B in healthy volunteers when
      given intramuscularly at three ascending dosage levels by cohort and a two-dose regimen (Day
      0 and Day 28) of a formulation containing only antigens at the 40 ug total immunizing protein
      dosage level.
    

Detailed description: 
      The Phase 1 clinical trial is designed as a single-center, open-label, non-randomized study
      to evaluate the safety, tolerability and immunogenicity of a two-dose schedule of rBV A/B in
      healthy volunteers at three ascending dosage levels, 5 ug, 10 ug and 20 ug serotype-specific
      antigen (10 ug, 20 ug and 40 ug total immunizing protein) in three dosing cohorts and a
      two-dose regimen (Day 0 and Day 28) of a formulation containing only antigens at the 40 ug
      total immunizing protein dosage level. Approximately 44 volunteers (11 per cohort) are
      expected to be enrolled. Cohorts will enroll consecutively beginning with the lowest dosage
      level. Volunteers in each cohort will receive a two injection series at the assigned dosage
      level given as a 0.5 mL intramuscular (i.m.) injection on Day 0 and Day 28. Potential
      volunteers for study participation will undergo qualification screening for this study during
      the 21 days prior to the date scheduled for vaccination. After successful completion of the
      informed consent process and all screening assessments, volunteers will be scheduled for
      vaccination. Volunteers will report acute adverse events daily for 28 days after each
      vaccination and return to the clinic at regular intervals according to the Schedule of Study
      Assessments with the last scheduled follow-up 168 days (± 7 days) after the initial
      vaccination (Day 0).
    

Intervention name(s): rBV A/B
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Botulinum; Recombinant Botulinum Vaccine; botulinum neurotoxins
Memory Changes in Patients With Major Depression Disorder Treated With ECT
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional

Summary: 
      The basic memory changes (impairment) present in patients with major depression and the
      influence of the treatment with ECT.
    

Detailed description: 
      Current literature provides insufficient information on the degree of cognitive impairment
      during and after electroconvulsive therapy (ECT), mostly due to the fact that applied tests
      lacked sensitivity and flexibility. Our goal was to evaluate cognitive functioning in adult
      depressed patients treated with bi & uni lateral & ECT, using tests sensitive for detection
      of possible acute and medium-term memory changes.(9) Major depressive disorder (MDD) is
      estimated to affect around 16 million Americans (Substance Abuse and Mental Health Services
      Administration [SAMHSA], 2013) and, according to the World Health Organization, is the
      leading cause of disability worldwide (World Health Organization 2012). Among In the U.S.
      workforce, the prevalence of MDD has been estimated at 7.6% .(2) Electroconvulsive therapy
      (ECT) is an effective treatment for severe depression but entails cognitive adverse effects,
      particularly the effects on memory. ECT may cause a temporary deficit in the cognitive
      processes of information encoding, consolidation, and retrieval. Transient memory
      disturbances are regarded as an inevitable adverse effect of therapeutic convulsions. Various
      strategies have been tried to decrease the cognitive adverse effects while retaining the
      antidepressant effect, including the use of unilateral instead of bilateral electrode
      placement, changes in waveform, and reducing the electrical stimulus intensity, (4).
    

Intervention name(s): ECT
Intervention type(s): Device
Intervention description(s): Electroconvulsive therapy was administered by using bidirectional constant current, brief-pulse devices. During the procedure, the patients were sedated using propofol or thiopenthal. Succinylcholine (1 mg/kg) was used as muscle relaxant, and glycopyrrolate (0.2 mg) or atropine was used as an anticholinergic agent when necessary. The mean charges were 351 (SD, 143) mC for the unilateral electrode placement group, 417 (SD, 192) mC for the bitemporal electrode placement group and 260 (SD, 76) mC for the bifrontal electrode placement group, (Brus, Ole MSc, 2017).
The average course of treatment for depression is 6 to 12 treatments, but some patients may require as many as 20 treatments,
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Pharmacokinetics of High-dose Tigecycline in Critically Ill Patients
Condition: Septic Shock; Antibiotic Resistant Infection; Critical Illness
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      The objective of this study is to describe the pharmacokinetics of tigecycline in critically
      ill patients receiving continuous venovenous haemodialysis (CVVHD) and to evaluate the
      frequency of pharmacokinetic/pharmacodynamic target attainment with high dosing strategy (200
      mg loading dose and 100 mg/12h).
    

Detailed description: 
      This is a prospective observational study performed on critically ill patients. Inclusion
      criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical
      and surgical patients will be included. Any type of infections will be included (pulmonary,
      abdominal, urinary tract, etc.) Antibiotics regimen includes: tigecycline (200 mg every 12
      hours intravenously), meropenem (2 grams every 8 hours intravenously).

      Blood samples (3 mL) will be collected 2, 4, 8 and 12 hours after each dose of tigecycline
      for 3 consecutive days. The standard arterial canula will be used to obtain samples.

      In each case CVVHD will be started and continued for at least 3 days' period. 30 minutes
      after a collection each sample will be centrifuged for 10 minutes at 3,000 rpms.
      Subsequently, supernatant will be collected and frozen.

      Serum tigecycline concentration will be measured with high performance liquid chromatography.

      Each patient's hemodynamics parameters will be recorded with the use of transpulmonary
      thermodilution technique (PICCO). Other therapies i.e.: ventilatory support, sedation, an
      antifungal agent will be given as required.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to ICU due to severer sepsis recognition. Both medical and surgical
        patients will be included. Any site of infection will be treated in the manner.

        In each case CVVHD will be initiated and continued. Each patient will receive 200 mg
        tigecycline q 12h, 2 g meropenem q 8 h. Other treatment as required.
      
Biospecimen description: 
      Patients' arterial blood samples.
    
Keywords: tigecycline; pharmacokinetics
Traction Manipulation of Upper Cervical Spine on Cervicogenic Dizziness
Condition: Dizziness; Neck Pain
MeSH terms: Vertigo; Neck Pain; Dizziness
Study type: Interventional

Summary: 
      Manual therapy reduces symptoms in patients with cervicogenic dizziness. The mobilization and
      manipulation of upper cervical spine are the most popular treatment in this patients. The
      International Federation of Orthopaedic Manipulative Physical Therapists suggest different
      recommendations for the safety application of manual therapy techniques in the upper cervical
      spine, traction manipulation techniques complies with this conditions. However, there isn´t
      investigation about the effect of traction manipulation in patients with cervicogenic
      dizziness. The aim of this study is to investigate the effects of traction manipulation in
      dizziness intensity, range of motion of cervical spine and quality of life on patients with
      cervicogenic dizziness.
    


Intervention name(s): Intervention Group; Control Group
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Manual Therapy; Physiotherapy; Manipulation
Nifedipine for Acute Tocolysis of Preterm Labor
Condition: Preterm Labor
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if nifedipine treatment of women in preterm labor
      receiving corticosteroids results in postponement of delivery when compared to placebo.
    


Intervention name(s): Nifedipine; Placebo; Usual care
Intervention type(s): Drug; Drug; Other
Intervention description(s): Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.; Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.; Usual evaluation, monitoring and care for women with preterm labor.
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Fish Oil on Insulin Sensitivity
Condition: Metabolic Syndrome X; Type 2 Diabetes Mellitus; Sarcopenia
MeSH terms: Sarcopenia; Diabetes Mellitus, Type 2; Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a prolonged (9 month) high (6g/d) of marine
      oil improves insulin sensitivity and glucose control in subjects with impaired glucose
      regulation.
    

Detailed description: 
      The incidence of Type 2 diabetes is related both to age and obesity. The disease impacts on
      quality of life and treatments represent a major health cost. Prevention or delayed onset of
      the disease remains a key target. Animal studies have shown that provision of high amounts of
      fish oil in the diet improves insulin sensitivity but human trials have proved equivocal.
      Recent dose-response trials in animals have shown the improved insulin sensitivity only
      occurs when the proportion of n-3 long chain polyunsaturated fatty acids (n-3 PUFA),
      docosahexaenoic acid and eicosapentaenoic acid, exceeds 14% of the total phospholipid
      fraction within tissue cell membranes. To achieve such values in humans would require a high
      dose of n-3 PUFA supplied over a prolonged period of time. This is tested within the current
      study where a daily dose of 6 g day of fish oil (containing a total of 3g docosahexaenoic
      acid plus eicosapentaenoic acid) is supplied for 9 months. As well as improving control of
      glycemia increased insulin sensitivity may also enhance protein metabolism and reduce the
      impact of frailty in older subjects.
    

Intervention name(s): EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates; Maize (corn) oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 6 x 1g capsules per day of marine oil (contains 3g/d docosahexaenoic acid plus eicosapentaenoic acid) for a 9 month period; 6 x 1g capsules per day for 9 months
Other intervention name(s): EPAX 6000TG code F0-5222/XT; Banner chemicals product GL-518/XT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
Condition: Submandibular Gland Tumor; Parotid Gland Tumor
MeSH terms: Parotid Neoplasms; Submandibular Gland Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is determine salivary gland disposition of d-limonene, the primary
      component in citrus peel and a common dietary supplement.

      Salivary gland tissue and saliva will be collected to determine concentration of d-limonene
      and its metabolites in these tissues.
    

Detailed description: 
      Primary Objective: To determine the bioavailability of Alda-341 in salivary gland tissue.

      Secondary Objective: To determine the bioavailability of Alda-341 in saliva and blood
    

Intervention name(s): Alda-341
Intervention type(s): Drug
Intervention description(s): Dietary supplement d-limonene orally administered as a drug.
Other intervention name(s): d-limonene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
First-in-human Study to Assess the Safety and Pharmacokinetics of LML134 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study to assess the safety, tolerability and pharmacokinetics of ascending single and
      multiple doses of the investigational medicinal product in healthy volunteers
    


Intervention name(s): LML134; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LML134 will be administered first as single doses and then as multiple doses; All study cohorts (except food effect cohort) are placebo controlled
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: healthy volunteers
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN2/4delta30[ME]) in Healthy Adults
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and
      subtropical regions of the world. The purpose of this study is to test the safety of and
      immune response to a new dengue virus vaccine in healthy adults.
    

Detailed description: 
      Dengue viruses cause dengue fever, as well as the more severe dengue hemorrhagic fever/shock
      syndrome. More than 2 billion people living in tropical and subtropical regions of the world
      are at risk of dengue virus infection, which is the leading cause of hospitalization and
      death in children in several tropical Asian countries. This study will evaluate the safety
      and immunogenicity of a live attenuated dengue virus vaccine called rDEN2/4delta30(ME), which
      is derived from the DEN2 and DEN4 serotypes.

      This study will last 180 days. Participants in Cohort 1 will be randomly assigned to receive
      rDEN2/4delta30(ME) or placebo at study entry. Cohort 2 will begin only after safety review of
      all participants in Cohort 1. Participants in Cohort 2 will receive a higher dose of
      rDEN2/4delta30(ME) or placebo.

      After vaccination, participants will be observed for at least 30 minutes for immediate
      adverse reactions. Participants will also be asked to monitor their temperature every day for
      16 days. Study visits will occur every other day after vaccination until Day 16, followed by
      4 additional visits at selected days through Day 180. Blood collection and a targeted
      physical exam will occur at each study visit. Some participants will be asked to undergo a
      skin biopsy or additional blood collection at selected visits.
    

Intervention name(s): rDEN2/4delta30(ME) Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated rDEN2/4delta30(ME) vaccine (one of two doses); Placebo for rDEN2/4delta30(ME) vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dengue Vaccine; Dengue Virus; Dengue Hemorrhagic Fever; Dengue Shock Syndrome
Exogenous Ketones in Type 2 Diabetes
Condition: Ketosis; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Exogenous ketone supplements are proposed to have glucose-lowering potential, provide an
      alternative fuel for the brain and to enhance cognitive function. No studies have tested
      whether exogenous ketones can lower blood glucose in people with type 2 diabetes. In
      addition, the impact of exogenous ketones on brain blood flow, cognitive function or
      brain-derived neurotrophic factor in humans is unknown. The purpose of this study is to
      determine if acutely ingesting exogenous ketones, in the form of a ketone monoester drink,
      can lower glucose and improve measures of brain/cognitive function in humans with type 2
      diabetes. Participants will consume a ketone monoester drink or placebo with blood samples,
      brain blood flow, and cognitive function assessed over 180 minutes. The researchers will also
      test how the ketone monoester drink impacts appetite and measures of inflammation.
    


Intervention name(s): Ketone monoester; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.; Acute ingestion of taste-matched placebo prior to assessment of outcomes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science