bioihbjkbjnl/mcl2 huggingface dataset:
Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring
Condition: Sleep Apnea, Obstructive; Sleep Apnea; Sleep; Snoring
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Snoring
Study type: Interventional

Summary: 
      Sleep Disordered Breathing (SDB) is a spectrum of conditions spanning from Simple Snoring to
      Severe Sleep apnea. SDB has multiple underlying mechanisms. Some portion of patients have
      issues with upper airway dilator muscle control; and such patients may be amenable to upper
      airway muscle training exercises using neuromuscular stimulation techniques. The
      investigators and others have published on the topic of neuromyopathy in the upper airway,
      defining a subgroup of OSA patients who may be amenable to training exercises. Based on this
      background, the investigators seek to test the hypothesis that upper airway tongue muscle
      training using transoral surface neuromuscular electrical stimulation may have benefits to
      patients with Simple Snoring.
    


Intervention name(s): Transoral Neurostimulation Device (Snoozeal)
Intervention type(s): Device
Intervention description(s): Use of the Transoral Neurostimulation Device for 20 minutes, morning and night, every day for at least 4 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Upper Airway Conditioning; Snoring; Snore; Sleep; OSA; Sleep Apnea; Neurostimulation
Protein Extrusion and Postprandial Amino Acid Handling
Condition: Postprandial Plasma Amino Acid Availability
Study type: Interventional

Summary: 
      The bulk of research that has investigated the effect of dietary protein on muscle tissue in
      humans has used isolated, minimally processed protein powders. However, the protein that we
      consume on a daily basis has typically undergone various processing methods, and evidence
      suggests these can change the way our bodies metabolise the protein. 'Extrusion' is a common
      processing method that uses high pressure to produce protein containing cereals and meat
      replacement foods. There is currently no research looking at how extrusion affects the way a
      protein source is digested and absorbed in humans. This study will compare the availability
      of ingested protein in the blood in the hours following consumption of an extruded versus a
      non-extruded source.
    


Intervention name(s): Dry protein blend ingestion; Extruded protein blend ingestion
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ingestion of protein blend powders mixed in water; Ingestion of protein blend powders mixed in water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study of RO6799477 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, randomized, double-blind, placebo-controlled, single dose study will
      investigate the safety, pharmacokinetics, pharmacodynamics of RO6799477 in healthy
      volunteers.
    


Intervention name(s): RO6799477
Intervention type(s): Drug
Intervention description(s): Single doses of RO6799477
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Rituximab in Primary Lymphocyte Predominant Hodgkin´s Disease(RIPL)
Condition: Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)
MeSH terms: Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in
      clinical stage IA using the monoclonal anti-CD20 antibody rituximab
    


Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma; LPHD; Rituximab
Lycopene in Preventing Prostate Cancer in Healthy Participants
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the
      development or recurrence of cancer. The dietary supplement lycopene may prevent the
      development of prostate cancer.

      PURPOSE: This phase I trial is studying the side effects and best dose of lycopene in
      preventing prostate cancer in healthy participants.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the toxicity and safety of lycopene supplementation as chemoprevention for
           prostate cancer in healthy participants.

        -  Determine the pharmacokinetics of this agent in these participants.

        -  Determine the dose range of this agent in these participants.

      OUTLINE: This is a dose-escalation study.

      Participants ingest a single-dose of oral lycopene over a maximum of 15 minutes on day 1.

      Cohorts of 5 participants receive escalating doses of lycopene until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5
      participants experience dose-limiting toxicity.

      Participants are evaluated periodically for 28 days.

      PROJECTED ACCRUAL: A total of 25 participants will be accrued for this study.
    

Intervention name(s): lycopene
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Lycopene
Primary purpose: Prevention
Keywords: prostate cancer
Does Vildagliptin Affect Portal Vein Pressure In Patients With Type 2 Diabetes Mellitus? A Cross Sectional Study
Condition: Drug Mechanism; Drug Usage
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This study investigated how vildagliptin (a di-peptidyl peptidase 4 inhibitor) affects portal
      vein pressure and hepatosteatosis in patients with type 2 diabetes mellitus.
    

Detailed description: 
      Group 1 used metformin (1000 mg bid) and gliclazide (60 mg qd); Group 2 used the same amounts
      of metformin and gliclazide, with the addition of vildagliptin (50 mg bid). The patients were
      prospectively assigned to each of these two groups for the purpose of this study. Using
      Doppler ultrasound, all cases were measured for portal vein flow velocity, portal vein flow
      and portal vein diameter. Degree of hepatosteatosis was also recorded.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        type 2 Diabetes Mellitus (DM)
      
Keywords: Vildagliptin; Portal Vein Pressure; Hepatosteatosis
MEDI5083 Alone and in Combination With Durvalumab, Tremelimumab, and/or Docetaxel.
Condition: Advanced Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, pharmacokinetics and Immunogenicity of
      Medi5083 alone or in combination with Durvalumab,Tremelimumab, and/or Docetaxel in adult
      subjects with advanced solid tumors.
    

Detailed description: 
      This is a global Phase 1, first-time-in-human, multicenter, dose-escalation and
      dose-expansion study of MEDI5083 alone or in combination with Durvalumab, Tremelimumab,
      and/or Docetaxel.
    

Intervention name(s): MEDI5083 monotherapy; MEID5083 with Durvalumab or Tremelimumab; Medi5083 with Durvalumab and Docetaxel
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Dose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab; Sequential Medi5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab; Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel
Intervention MeSH terms: Docetaxel; Durvalumab; Tremelimumab; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Inflammatory Markers in Obstructive Sleep Apnea (OSA) Patients.
Condition: Obstructive Sleep Apnea of Adult
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The aim of our study was to assess the levels of inflammatory biomarkers in a large sample of
      OSA patients and to investigate any correlation between these markers with clinical and
      polysomnographic (PSG) parameters.

      Subjects undergone a PSG for OSA diagnosis were recruited. Patients with known comorbidities
      were excluded from the study. Included patients were grouped according to apnea-hypopnea
      index (AHI) as mild, moderate and severe. Patients with AHI < 5 served as control group.
      Demographic, PSG data, serum levels of hs-C-reactive protein (hs-CRP), fibrinogen,
      erythrocyte sedimentation rate (ESR) and Uric Acid (UA) were measured and compared between
      groups.
    

Detailed description: 
      Systemic inflammation is important in obstructive sleep apnea (OSA) pathophysiology and its
      comorbidity. The objective of this study was to investigate how early biomarkers of
      inflammation may be altered in OSA patients. To complete this goal the investigators assessed
      the circulating levels of four inflammatory markers, hs-C-reactive protein (hs-CRP),
      Fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) in a representative
      population of consecutively enrolled, untreated and otherwise healthy subjects with a
      clinical suspicion of obstructive sleep apnea. A secondary objective was to investigate any
      correlation between these markers with clinical and polysomnographic (PSG) parameters of
      these subjects.Subjects who had undergone a PSG for OSA diagnosis were recruited. Patients
      with known comorbidities were excluded from the study. Included patients were grouped
      according to apnea-hypopnea index (AHI) as mild, moderate and severe. Patients with AHI < 5
      served as control group. Demographic, PSG data, serum levels of hs-CRP, fibrinogen, ESR and
      UA were measured and compared between groups.
    

Intervention name(s): Venous blood collection for biomarkers measurements
Intervention type(s): Procedure
Intervention description(s): Venous blood was collected in all subjects for measurements of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) between 8:00 and 9:00 AM, following an overnight fast, shortly after the conclusion of the overnight polysomnography (PSG).
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Consecutive patients, who were admitted to the Sleep Disorders Center, Department of
        Thoracic Medicine, University of Crete Medical School, for evaluation of suspected
        sleep-disordered breathing, were considered as potential recruits for this study.
Vaccine Therapy in Treating Lung Cancer Patients With Cancer Stem Cells
Condition: Neoplasms, Lung
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Most studies of cancer stem cells (CSC) involve the inoculation of cells from human tumors
      into immunosuppressed mice, preventing an assessment on the immunologic interactions and
      effects of CSCs. In this study, the investigators examined the vaccination effects produced
      by CSC-enriched populations from histologically distinct murine tumors after their
      inoculation into different syngeneic immunocompetent hosts. Enriched CSCs were immunogenic
      and more effective as an antigen source than unselected tumor cells in inducing protective
      antitumor immunity.Immune sera from CSC-vaccinated hosts contained high levels of IgG which
      bound to CSCs, resulting in CSC lysis in the presence of complement.CTLs generated from
      peripheral blood mononuclear cells or splenocytes harvested from CSC-vaccinated hosts were
      capable of killing CSCs in vitro. Mechanistic investigations established that CSC-primed
      antibodies and T cells were capable of selective targeting CSCs and conferring antitumor
      immunity.
    

Detailed description: 
      To assess the feasibility of generating CSC-loaded DC vaccines for clinical use, the
      investigators will harvest peripheral blood and tumor specimen from patients with Lung
      Cancer. The investigators will purify T, B cells and generate DCs from the PBMCs of the Lung
      cancer patient.On the other hand, investigators will isolate ALDHhigh and ALDHlow tumor cells
      from the tumor specimen of the Lung cancer patient using a similar protocol as investigators
      reported .

      Aim 1: To demonstrate, in vitro, the relative cellular anti-Lung cancer CSC immunity induced
      by Lung cancer CSC-DC primed cytotoxic T cells.

      Aim 2: To determine, in vitro, specific binding and lysis of Lung cancer CSCs by antibodies
      produced by purified B cells from PBMCs stimulated with Lung cancer CSC-DC.
    

Intervention name(s): cancer stem cell vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Treximet ™ Pharmacy Budget Impact Model Database Validation Study
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      The purpose of this retrospective claims database study was to compare the change in
      migraine-related prescription (i.e. NSAIDs, Opioids, Ergots) utilization among migraine
      suffers following initiation of Treximet ™ (sumatriptan/naproxen) compared with subjects
      initiating treatment with other orally available triptans. The study was used to validate the
      migraine-related prescription utilization patterns predicted by the Treximet ™ Budget Impact
      Model.

      The SourceLx dataset from the family of Wolters Kluwer databases was used for this analysis.
      The database contains 30% of prescription claims filled in the United States (US),
      approximately 160 million patient lives. The data has broad representative coverage at both
      the geographic and payment levels.
    


Intervention name(s): Sumatriptan/Naproxen combination; other oral triptans
Intervention type(s): Drug; Drug
Intervention description(s): Sumatriptan and Naproxen Sodium; almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
Other intervention name(s): Treximet (TM)
Intervention MeSH terms: Naproxen; Sumatriptan
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subject data from a claims database having at least one pharmacy claim for Treximet ™ or an
        orally administered triptan during the study period.
      
Keywords: Triptans; Migraine
Alpha-1 Anti-Trypsin (AAT) Treatment in Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Alpha 1-Antitrypsin Deficiency; Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Acute myocardial infarction is characterized by an intense inflammatory response.

      The degree of the response influences clinical outcome, with 'more' inflammation promoting
      heart failure. In this study we plan to determine whether treatment with plasma derived
      alpha-1 antitrypsin will quench the inflammatory response in patients with acute ST-segment
      elevation myocardial infarction (STEMI).
    


Intervention name(s): Alpha 1-Antitrypsin
Intervention type(s): Drug
Other intervention name(s): Prolastin C; Aralast NP
Intervention MeSH terms: Alpha 1-Antitrypsin; Protein C Inhibitor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute myocardial infarction; Heart Failure; Inflammation
Oral Contraceptives, Insulin Resistance and Cardiovascular Risk Profile in Pre-Menopausal Women
Condition: Insulin Sensitivity; Cardiovascular Risk; Perimenopausal Disorder
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Birth control pills are the most commonly used method of birth control. The purpose of this
      research study is to examine whether birth control pills change heart disease risk and how
      the body handles blood sugar when given to different women.
    

Detailed description: 
      The oral contraceptive pill is the most commonly used birth control method. It is debated
      whether the birth control pill affects how the body handles insulin and sugar, or whether the
      pill changes heart disease risk. The goal of this study is to evaluate whether certain
      factors, such as how the body processes hormones, and demographic factors (e.g. body weight
      and race), influence how the pill affects the handling of insulin and sugar, and heart
      health.
    

Intervention name(s): Ortho Cyclen®
Intervention type(s): Drug
Intervention description(s): Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.
Other intervention name(s): Orthocyclen; Sprintec; Previfem; MonoNessa
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Same drug (orthocyclen) was administered to 2 groups (Caucasian women of reproductive age, and African American women of reproductive age)
Masking: None (Open Label)
Primary purpose: Screening
Keywords: oral contraceptive; birth control pill; women; healthy volunteer; insulin sensitivity; insulin resistance; cardiovascular risk factors; endothelial function; estrogen metabolism; racial difference; glucose intolerance
Safety and Effectiveness Study: Role Playing Game for Friends and Family of Service Members
Condition: Communication
Study type: Interventional

Summary: 
      This project is a partnership between Soar Technology, the University of Southern California
      (USC) Center for Innovation and Research on Veterans and Military Families (CIR) and the USC
      Creative Media and Behavioral Health Center (CM&BHC) to conduct a Safety and Effectiveness
      Study (SES) for an educational role-playing game developed by Soar Technology, Inc. The
      purpose of the intervention to be delivered by Soar Technology is to educate families and
      friends with the ultimate goal of empowering them to have a conversation with the
      veteran/service member about readjustment issues. The study will assess the safety and
      effectiveness of the provided game using personal interviews, play testing, and surveys. The
      game playing experience is hypothesized to be safe and effective with respect to having
      conversations with veterans/service members following deployment.
    

Detailed description: 
      The intervention is a multi-scenario role playing simulation. Participants view the scenario
      and answer questions about what has been displayed as typical for post deployment service
      members. Participants receive immediate feedback with respect to expectations set by
      simulation developers.
    

Intervention name(s): Role-playing game
Intervention type(s): Behavioral
Intervention description(s): Eligible participants will be invited to engage with a role-playing game for 30 minutes. The role play presents situations where a service member/veteran interacts with family or friends.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: veterans, military, families
Safety Study of HBV-002 West Nile Vaccine in Healthy Adults
Condition: West Nile Virus Disease
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase 1 trial is to evaluate the clinical safety of HBV-002 vaccine in
      healthy adults.
    

Detailed description: 
      West Nile virus is an emerging infectious disease in the U.S. and worldwide and has been
      identified by the CDC as a significant public health risk. Since the introduction of West
      Nile virus into the U.S. in 1999, annual outbreaks have caused severe and fatal encephalitis
      in humans and equines and death in a variety of species of feral birds throughout the U.S.
      and parts of Canada. In addition, more recent findings show evidence of West Nile virus human
      and equine infection in several countries of tropical America. The virus has now been found
      in bird populations in all 48 states of the continental U.S, and human cases of West Nile
      disease have been documented in 45 states and the District of Columbia. To date, there is no
      approved commercial vaccine available for prevention of West Nile virus disease in humans.
    

Intervention name(s): WN-80E; WN-80E; WN-80E; WN-80E
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Three injections of the study vaccine [Low Dose of WN-80E API (5 µg) + Alhydrogel (3.5 mg)] given one month apart; Three injections of the study vaccine [Medium Dose WN-80E API (15 µg) + Alhydrogel (3.5 mg)] given one month apart; Three injections of the study vaccine [High Dose WN-80E API (50 µg) + Alhydrogel (3.5 mg)] given one month apart; Three injections of the study vaccine [High Dose WN-80E API (50 µg)] given one month apart
Other intervention name(s): HBV-002 vaccine; HBV-002 vaccine; HBV-002 vaccine; HBV-002 vaccine
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: West Nile Virus; West Nile Vaccine; West Nile virus disease; Hawaii Biotech