bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to evaluate the effect of desvenlafaxine administered as
      DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount
      of drug in the body and the effect of the drug will also be evaluated.
    


Intervention name(s): Desvenlafaxine Succinate Sustained Release; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg DVS SR tablet days 1-6, period 2 only.; 4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.
Intervention MeSH terms: Midazolam; Desvenlafaxine Succinate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depression
Gender and Neural Substrates of Stress and Craving
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Observational

Summary: 
      Cocaine dependence is an insidious disease underscored by a powerful proclivity to relapse
      despite an individual's ability to recognize the deleterious consequences of continued drug
      use. To date, there are only a limited number of treatments, and no FDA approved medications
      for the treatment of cocaine dependence. Attempts to find reliable and successful treatments
      for cocaine dependence may be marred by gender differences in brain chemistry, structure, and
      function that are manifested as drug craving and relapse. For example, cues, drug exposure,
      and stress promote relapse, yet females appear be more susceptible to stress induced relapse,
      while males may be more susceptible to cue induced relapse. Therefore identifying the neural
      substrates involved in processing the valence of internal and external stimuli may provide
      further insight into cocaine dependence and provide more effective therapeutic strategies
      aimed at preventing relapse.

      Corticotropin releasing hormone (CRH) is a pharmacological activator of the hypothalamic
      pituitary adrenal (HPA) axis, and has been implicated in stress induced drug relapse.
      Corticotropin releasing hormone receptors are located at extrahypothalamic brain nuclei that
      have been implicated in determining the significance of both internal (somatic) and external
      (environmental) stimuli. The primary directive of this pilot project is to utilize functional
      magnetic resonance imaging (fMRI) to identify possible brain nuclei associated with with
      stress induced drug craving in cocaine dependent females.
    


Intervention name(s): Acthrel
Intervention type(s): Drug
Intervention description(s): 1 ug/kg, i.v., 1 minute
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 20 cocaine dependent subjects (10 cocaine dependent females and 10 cocaine
        dependent males) will be enrolled in the study. Inclusion/exclusion criteria are listed in
        Section E, Human Subjects. Cocaine subjects will be matched for age and nicotine
        dependence. Women taking birth control pills, or Depo Provera (medroxyprogesterone acetate)
        will be excluded from study participation.

        Subjects will be recruited through the use of flyers, advertisements on the MUSC website,
        MUSC broadcast messages, advertisement in local newspapers and weeklies, and similar
        ongoing studies within the Clinical Neuroscience Division.
      
Keywords: CRH; cocaine; functional magnetic resonance imaging; gender differences
Children Immune Functions
Condition: Diarrhea; Upper Respiratory Infections
MeSH terms: Infections; Respiratory Tract Infections; Diarrhea
Study type: Interventional

Summary: 
      The purpose of the planned study is to investigate the effect of heat-treated lactobacilli on
      diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind,
      placebo-controlled study.
    

Detailed description: 
      The beneficial effect of heat-treated lactobacilli for treatment of symptomatic diarrhea was
      clearly documented and the purpose of this planned study is to investigate the effect on
      reduction of days with diarrhea in a preventive setting in healthy children 1-4 years old.
      Moreover, the study is intended to evaluate the impact on the immune status of the children.
    

Intervention name(s): heat-treated lactobacilli or placebo
Intervention type(s): Dietary Supplement
Intervention description(s): Daily supplement of sachet with 1 g of powder over a 5 months period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Diarrhea; Children; Heat-treated lactobacilli
A Study to Assess the Safety of Brexanolone in the Treatment of Adolescent Female Participants With Postpartum Depression (PPD)
Condition: Post Partum Depression
MeSH terms: Depression, Postpartum; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center study evaluating the safety, tolerability, and pharmacokinetics of
      brexanolone in the treatment of adolescent female participants with postpartum depression
      (PPD).
    


Intervention name(s): Brexanolone
Intervention type(s): Drug
Intervention description(s): Administered as IV infusion.
Intervention MeSH terms: Brexanolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Communicating Multiple Disease Risks: A Translation of Risk Prediction Science
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      Epidemiology seeks to improve public health by identifying risk factors for cancer and other
      diseases and conveying that information to relevant audiences (e.g., physicians, the public).
      The audience is presumed to understand and use that information to make appropriate decisions
      about lifestyle behaviors and medical treatments. Yet, even though a single risk factor can
      affect the risk of multiple health outcomes, this information is seldom communicated to
      people in a way that optimizes their understanding of the importance of engaging in a single
      healthy behavior. Providing individuals with the ability to understand how a single behavior
      (obtaining sufficient physical activity) could affect their risk of developing multiple
      diseases could foster a more coherent and meaningful picture of the behavior's importance in
      reducing health risks, increase motivation and intentions to engage in the behavior, and over
      time improve public health.

      The proposed study translates epidemiological data about five diseases that cause significant
      morbidity and mortality (i.e., colon cancer, breast cancer (women), heart disease, diabetes,
      and stroke) into a visual display that conveys individualized risk estimates in a
      comprehensible, meaningful, and useful way to diverse lay audiences.
    


Intervention name(s): Risk Assessment App; Audio Recording - Sleep; Surveys; Audio Recording - Exercise; Text message reminders; Text Message Survey
Intervention type(s): Behavioral; Behavioral; Other; Behavioral; Other; Other
Intervention description(s): The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.; -Participants imagine themselves improving sleep hygiene; Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.; Participants imagine themselves improving exercise; -Reminders to practice mental imagery; -Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Participants were randomly assigned by a computer algorithm to one of six intervention arms according to a 3 (risk display format: text, table, ladder) x 2 (imagery behavior: exercise, sleep) between-subjects factorial design. Although randomization was done at the same time and at the beginning of the study, participants received the risk display intervention first, then answered a survey containing two of the primary outcomes, then received the mental imagery intervention followed by another survey.
Masking: Single (Investigator)
Primary purpose: Prevention
Characterizing Clinical and Pharmacological Neuroimaging Biomarkers
Condition: Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is part of a larger overall study that seeks to characterize clinical and
      pharmacological neuroimaging biomarkers. The purpose of this registered protocol is
      understand the effect of emotion on cognitions by specifically examining the effect of reward
      processing on working memory in patients with schizophrenia.
    

Detailed description: 
      Cognition rarely occurs in the 'real world' in isolation, and typically occurs under
      emotional influences that may alter how cognition occurs. Understanding these motivational
      and cognitive interactions will help better assess mechanisms that underlie the cognitive and
      negative symptoms of schizophrenia.

      To better understand the effect of emotion on cognitions, this study will examine the effect
      of reward processing on working memory in patients with schizophrenia. To this end, this will
      be a two-pronged approach.

      The first prong, is to understand the neural mechanisms of incentivized spatial working
      memory processes. fMRI will be used and a paradigm will be employed that combines reward
      processing and working memory to understand how patients with schizophrenia recruit neural
      systems in response to rewarded working memory.

      To further understand this, this study will compare the neural effects in patients with
      schizophrenia with patients with depression, another group of psychiatric patients who also
      suffer from cognitive and motivational deficits. Both of these groups suffer from cognitive
      and motivational deficits, yet the treatments and disease presentations differ.

      It is hypothesized that the ways in which cognitive and motivational processes interact in
      the brain will have some similarities, but also differences, that distinguish the two
      psychiatric illnesses. As part of this aim, a group of typical, healthy adults subjects will
      be recruited as a control. A subset of healthy participants that passed the medical and
      psychiatric screen will be invited to participate in the ketamine portion of the study which
      will be completed during the MRI session.
    

Intervention name(s): MRI; Ketamine
Intervention type(s): Other; Drug
Intervention description(s): Patients and volunteers will receive an MRI.; Ketamine will be administered to a subset of healthy controls that agree to receive the drug as part of receiving an MRI.
Other intervention name(s): Magnetic Resonance Imaging
Intervention MeSH terms: Ketamine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Treatment of ATFL Tears With PRP
Condition: Soft Tissue Healing
Study type: Interventional

Summary: 
      PRP will enhance ATFL tears healing by time and quality.
    


Intervention name(s): PGRF; placebo saline
Intervention type(s): Biological; Biological
Intervention description(s): injection of 6cc into injured area; injection of 6cc into injured area
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PRP; ATFL
Study of EVP-6308 to Assess the Dose- and Concentration-dependent Displacement of [18F]MNI-659 by EVP-6308
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-arm, multiple ascending dose Phase I study to assess the dose-
      and concentration-dependent displacement of [18F]MNI-659 [a PET tracer targeting
      phosphodiesterase 10 (PDE10)] by EVP-6308.
    


Intervention name(s): EVP-6308
Intervention type(s): Drug
Intervention description(s): Arms 1, 2, 3, 4
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Enzyme occupancy; Positron emission tomography (PET); Phosphodiesterase 10 inhibitor
AkLief Evaluation in Acne-induced Post-Inflammatory Hyperpigmentation
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris; Hyperpigmentation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Trifarotene 50 microgram
      per gram (mcg/g) cream compared to its vehicle cream in the treatment of moderate acne
      vulgaris with risk of acne-induced post inflammatory hyperpigmentation (PIH) after 24 weeks
      of treatment in facial acne participants
    


Intervention name(s): Trifarotene Cream; Trifarotene Vehicle Cream
Intervention type(s): Drug; Drug
Intervention description(s): Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream on the face once daily, in the evening for 24 weeks; Participants will apply a thin a layer of trifarotene vehicle cream on the face once daily, in the evening for 24 weeks
Other intervention name(s): Aklief
Intervention MeSH terms: Trifarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acne vulgaris; Trifarotene; Aklief; CD5789
Effect of Binaural Beats on Level of Anxiety and Toleration in Patients Undergoing Upper Gastrointestinal Endoscopy Without Sedation
Condition: Patient Satisfaction; Anxiety State; Tolerance
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      To investigate the anxiolytic effects of binaural beat-embedded audio in patients undergoing
      sedation-free upper gastrointestinal endoscopy
    

Detailed description: 
      The study was conducted with the participation of 96 patients who were referred for endoscopy
      for various reasons. Data were collected by two researchers. Patients between the ages of
      18-70 who had scheduled upper gastrointestinal endoscopy appointments were included in the
      study, regardless of gender and underlying diseases. Patients who had undergone endoscopic
      procedures before, were using medication for anxiety and panic disorders, required urgent
      endoscopic intervention, had advanced dementia, had hearing problems, had anatomical or
      inflammatory disorders in the external ear canals, and those who did not want to listen to
      music for 15 minutes before the procedure were not included in the study.
    

Intervention name(s): binaural music
Intervention type(s): Other
Intervention description(s): In the binaural music group, an MP3 player and in-ear stereo headphones were provided. Music therapy was applied for 15 min before the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Vasoactive and Anti-inflammatory Effects of Prasugrel in Acute Coronary Syndrome
Condition: Acute Coronary Syndrome; Unstable Angina
MeSH terms: Acute Coronary Syndrome; Angina, Unstable; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To test the vasoactive and anti-inflammatory effects of prasugrel in patients with acute
      coronary syndrome endothelial function -as a surrogate parameter of NO bioavailability- and
      different markers of inflammation, oxidative stress and platelet activation will be assessed
      in patients with unstable angina.
    

Detailed description: 
      Trial Objectives To test the vasoactive and anti-inflammatory effects of prasugrel in
      patients with acute coronary syndrome, endothelial function -as a surrogate parameter of NO
      bioavailability- and different markers of inflammation, oxidative stress and platelet
      activation will be assessed in patients with unstable angina.

      Trial Design Single center, double blind, double-dummy, randomized, parallel trial.

      Endpoints

      Primary Endpoint Assessment of endothelial function (FMD) via high-resolution ultrasound
      (Sonoline G50, 12 MHz linear array transducer, Siemens, Germany) by experienced sonographer.

      Secondary Endpoints

        -  Non-invasive assessment of microvascular perfusion and oxygen saturation by laser
           Doppler perfusion imaging and tissue spectrometry (O2C, Lea Medizintechnik, Giessen,
           Germany)

        -  Determination of leukocyte activity: plasma MPO levels (ELISA), plasma elastase levels
           (ELISA)

        -  Assessment of platelet activity: plasma levels of sCD40 ligand (ELISA), RANTES (ELISA)

        -  Measurement of different oxidative stress markers: hsCRP (ELISA), CD40 ligand (ELISA),
           carbonylated proteins (ELISA), urinary 8-iso-PGF2α (gas chromatography mass
           spectrometry)

        -  Determination of platelet-leukocyte aggregates by fluorescent activated cell sorter
           (FACS)

        -  Assessment of platelet function (PADA-test)
    

Intervention name(s): Prasugrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): 3 months treatment; 3 months treatment
Other intervention name(s): Efient; Plavix
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase I Trial to Determine the Safety and Pharmacokinetics of CRS3123.
Condition: Clostridium Difficile Infection
MeSH terms: Clostridium Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single center, randomized, placebo-controlled, double-blind, multiple
      ascending dose study to evaluate the safety and tolerability of CRS3123, a methionyl-tRNA
      synthetase inhibitor. In this study, doses of 200, 400, and 600 mg, or 100mg are planned and
      will be given orally every 12 hours for 10 days. Up to 30 healthy male and female subjects 18
      to 45 years, inclusive. The primary objective: of the study is to determine the safety and
      tolerability of escalating doses of CRS3123 following oral administration of multiple doses
      to healthy adults. The study duration is 46 weeks.
    

Detailed description: 
      This is a Phase I, single center, randomized, placebo-controlled, double-blind, multiple
      ascending dose study to evaluate the safety and tolerability of CRS3123,a fully synthetic,
      oral, antimicrobial that targets methionyl-tRNA synthetase of gram-positive bacteria,
      including Clostridium difficile. This protocol will study oral doses of 200, 400, and 600 mg,
      or 100mg given orally every 12 hours for 10 days. Subjects will be divided into 3 cohorts, A,
      B, and C. Cohorts A and C will be given 200mg and 600mg of CRS3123 or placebo.The dose for
      cohort B and study progression and dose escalation to Cohorts B and C will require a full
      (planned) SMC review of all safety data obtained through Day 18. Should safety data review of
      the 200 mg dose result in an unfavorable safety profile, the study design allows for
      reduction in dose to 100 mg to be given in Cohort B. If this is the case, there will be no
      Cohort C. Up to 30 healthy male and female subjects 18 to 45 years, inclusive. The primary
      objective: of the study is to determine the safety and tolerability of escalating doses of
      CRS3123 following oral administration of multiple doses to healthy adults. The secondary
      objective will be to determine the plasma, urine and fecal concentrations and systemic
      exposure of CRS3123 after multiple oral doses.The study duration is 46 weeks.
    

Intervention name(s): Placebo; CRS3123
Intervention type(s): Other; Drug
Intervention description(s): Placebo capsules have the same inert components as CRS3123; 2 subjects randomized in each cohorts recieve 200mg, 400mg; and 600mg, or 100mg are planned respectively given orally every 12 hours for 10 days; CRS3123, a methionyl-tRNA synthetase inhibitor, formulated in 100 and 200 mg capsules; 8 subjects randomized in Cohorts A through C receive doses of 200 mg, 400 mg; and 600 mg or 100mg are planned respectively given orally every 12 hours for 10 days.
Intervention MeSH terms: REP 3123
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: follow-up to 10-0008, Clostridium difficile, dose-escalating, CRS3123
Sequence and Time-of-day Infusion of immunoCHemotherapy Affect Response in Oesophageal Cancer in the NeOadjuvant Setting
Condition: Esophagus Cancer
MeSH terms: Esophageal Neoplasms
Study type: Observational

Summary: 
      It is reported that compared to chemotherapy alone, immunochemotherapy has significantly
      improved the overall survival of patients with advanced metastatic ESCC. However, there are
      still more than 30% of patients who cannot benefit from this treatment modality. In addition
      to these factors, the time-of-day infusion and administration sequence of immunochemotherapy
      have been reported to be associated with tumor responses and overall survival. In this study,
      The investigators aimed to explore the roles of infusion time and administration sequence of
      immunochemotherapy in predicting tumor responses and overall survival in patients with
      advanced ESCC.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed as potentially resectable (including initially-unresectable) esophageal
        squamous cell carcinoma via pathological specimen, KPS ≥ 80, has adequate organ function
        and no distant metastasis are included in the study
A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety of a study drug known as LY3209590
      in Japanese participants with type 2 diabetes. Side effects and tolerability will be
      documented. Blood samples will be taken to compare how the body handles the drug and how it
      affects blood sugar levels. The study will last almost five months for each participant.
    


Intervention name(s): LY3209590; Insulin Degludec
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC.; Administered SC.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Accuracy of Methemoglobin Measurement of Various Rainbow Pulse Oximeter Sensors
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by
      administering sodium nitrite intravenously in healthy volunteers. The accuracy of the
      noninvasive HbMet measurement by a Pulse Oximeter Sensor will be assessed by comparison to
      blood measurements from a laboratory analyzer.
    


Intervention name(s): Pulse Oximeter Sensor
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other