bioihbjkbjnl/mcl2 huggingface dataset:
rTSST-1 Variant Vaccine Phase 1 First-in-man Trail
Condition: Toxic Shock Syndrome; Vaccination; Sepsis
MeSH terms: Shock, Septic; Shock
Intervention: rTSST-1 Variant Candidate Vaccine
Intervention description: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
Patients 3 µg or more will be randomized.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Toxic Shock Syndrome (TSS) a severe condition with high morbidity and mortality results from
      the hosts overwhelming inflammatory response and cytokine storm. Staphylococcal superantigen
      toxins are the main causative agents. Toxic shock syndrome toxin (TSST-1) being responsible
      for almost all of menstruation associated and more than 50% of all other cases. There is no
      specific therapy.

      The aim of this study is to demonstrate the safety and tolerability of the BioMed recombinant
      toxic shock syndrome toxin (rTSST-1) Variant Vaccine in healthy adults. The second aim of the
      study is to measure antibodies in the blood of these healthy volunteers which have been
      produced in response to treatment with the BioMed rTSST-1 Variant Vaccine. These antibodies
      are expected to be important in resistance against the diseases. 46 healthy adults, male and
      female, age 18-64 years will be assigned to 6 dose groups of the vaccine at the Department of
      Clinical Pharmacology of the Medical University of Vienna. The patients will be monitored for
      vital signs, hematology, clinical chemistry, blood cytokine level and antibodies against
      TSST-1. Immunization will be repeated 4 weeks after the first with the same dose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male and female

          -  18 - 64 years

          -  written informed consent

          -  physical exam: no abnormal findings unless considered irrelevant by the investigator

          -  uneventful medical history

          -  females: adequate contraception

        Exclusion Criteria:

          -  pregnancy

          -  positive virology markers

          -  signs and symptoms of relevant autoimmunity

          -  TSST-1 Ab titer > 1:2000
A Study of the Effects of Single Dose Corticosteroids on Response to Allergens
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Placebo; prednisone; prednisone
Intervention description: Single dose of 5 tablets matching placebo (5 x 0 mg) to prednisone. The washout between treatment periods will be approximately 4 weeks; Single dose of 5 tablets prednisone totaling 10 mg (3 x 0 mg + 2 x 5 mg). The washout between treatment periods will be approximately 4 weeks.; Single dose of 5 tablets prednisone totaling 25 mg (5 x 5 mg). The washout between treatment periods will be approximately 4 weeks.
Intervention MeSH terms: Prednisone
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study will investigate whether changes in inflammatory mediators produced by the nose
      after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel
      drugs for the treatment of allergic asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is allergic to Timothy grass pollen

          -  Female patients have a negative pregnancy test and agree to use birth control
             throughout the study

          -  Male patients agree to use birth control throughout the study

          -  Patient has been a nonsmoker for at least 6 months

          -  Patient agrees to avoid the use of aspirin and other Non-steroidal anti-inflammatory
             drugs (NSAIDs) throughout study

        Exclusion Criteria:

          -  Patient is breastfeeding

          -  Patient has any respiratory disease other than mild stable asthma that does not
             require treatment

          -  Patient consumes more than 3 alcoholic beverages per day

          -  Patient consumes more than 6 caffeinated beverages per day

          -  Patient has had major surgery or has donated or lost 1 unit of blood within 4 weeks of
             screening

          -  Patient has severe allergies
A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries
Condition: Atherosclerosis; Aneurysm
MeSH terms: Aneurysm; Atherosclerosis
Intervention: Cordis Neurovascular ENTERPRISE Self Expanding Stent System; Cordis Neurovascular ENTERPRISE Self Expanding Stent System
Intervention description: Implantation of the device ENTERPRISE used to treat symptomatic stenosis in intracranial arteries.; Implantation of the device ENTERPRISE to treat wide-necked aneurysms
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Atherosclerosis,Wide Neck Aneurysm

Summary:

      Feasibility study to assess safety of treating patients with self expanding stent in
      intracranial arteries.
    

Eligibility criteria:

        Contact site for specific information

        Inclusion Criteria:

          -  Subject meet specific criteria for treatment

          -  Subject must be willing to return to site for 30 day and 6 month follow up evaluations

        Exclusion Criteria:

          -  Stenting, angioplasty or endarterectomy of an extracranial (carotid or vertebral
             artery) or intracranial artery within 30 days prior to expected enrollment date

          -  Previously implanted carotid stent associated with the symptomatic distribution within
             the past 12 weeks
Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Intervention: Eslicarbazepine acetate; Oxcarbazepine
Intervention description: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9; Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)
Intervention MeSH terms: Eslicarbazepine acetate; Oxcarbazepine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Partial; Epilepsy; Eslicarbazepine acetate; Pharmacokinetics; Tolerability

Summary:

      This purpose of this study is to measure the concentrations of two anti-epileptic drugs
      (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid
      and blood plasma of healthy subjects and also to assess how these drugs are tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects

          -  Aged 18-55 years

          -  Body mass index (18.5-29 kg/m3)
A Dose Escalation Study of Adavosertib(MK1775) in Combination With 5-FU or 5-FU/CDDP in Patients With Advanced Solid Tumor (1775-005
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: adavosertib 20 mg; 5-FU 1000 mg/m^2/day; CDDP; adavosertib 65 mg
Intervention description: Adavosertib 20 mg capsule administered orally on days 1-5 of a 21 day cycle.; 5-FU 1000 mg/m^2/day administered as an intravenous (IV) infusion on Days 1-4 of a 21-day cycle; CDDP 60 mg/m^2 to 100 mg/m^2 administered as an IV infusion on Day 1.; Adavosertib 65 mg capsule administered orally on days 1-5 of a 21 day cycle.
Intervention MeSH terms: Cisplatin; Adavosertib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer; Esophageal Cancer; Gastric Cancer

Summary:

      The study evaluates safety of adavosertib in monotherapy, and in combination with
      5-Fluorouracil (5-FU) alone or with 5-FU/cis-diamminedichloroplatinum (CDDP) in Japanese
      participants with solid tumor. The primary hypothesis is that adavosertib is safe and
      tolerable in participants with locally advanced or metastatic solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parts 1 and 2-A: Patient must have a histologically or cytologically confirmed locally
             advanced or metastatic solid tumor failed to respond to standard therapy, progressed
             despite standard therapy, or for which standard therapy does not exist

          -  Parts 2-B and 3: Patient must have a histologically or cytologically confirmed locally
             advanced or metastatic esophageal, head and neck, or gastric cancer, and be a
             candidate of 5-Fluorouracil and Cisplatin regimen defined in this study

          -  Patient must have performance status of 0 or 1 on the ECOG Performance Scale

        Exclusion Criteria:

          -  Patient who has had chemotherapy, radiotherapy, or biological therapy within 4 weeks
             (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study drug or who
             has not recovered from adverse events due to agents administered more than 4 weeks
             earlier

          -  Patient with a known primary central nervous system tumor

          -  Patient has known hypersensitivity to any of the components of the combination study
             therapy or its analogs

          -  Patient is receiving "alternative" cancer medications such as plant-derived products
             and their analogs with anti-tumor activity within 1 week prior to entering the study.

          -  Patient must not have prior radiation therapy to more than 30% of the bone marrow and
             must have recovered for at least 3 weeks from the hematologic toxicity of prior
             radiotherapy
A Study of LY3435151 in Participants With Solid Tumors
Condition: Solid Tumor; Triple-negative Breast Cancer; Gastric Adenocarcinoma; Head and Neck Squamous Cell Carcinoma; Cervical Carcinoma; High Grade Serous Ovarian Carcinoma; Hepatocellular Carcinoma; Undifferentiated Pleomorphic Sarcoma; Leiomyosarcoma
MeSH terms: Carcinoma; Triple Negative Breast Neoplasms; Squamous Cell Carcinoma of Head and Neck; Leiomyosarcoma; Histiocytoma, Malignant Fibrous
Intervention: LY3435151; Pembrolizumab
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: immunotherapy; CD226 agonist

Summary:

      The reason for this study is to see if the study drug LY3435151 is safe in participants with
      advanced solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have certain types of cancer, which your study doctor will discuss
             with you

          -  Participant must have stopped other forms of treatment for cancer, which your study
             doctor will discuss with you

          -  Participant must be able and willing to provide a sample of your tumor before
             beginning treatment and once while on treatment. For certain tumor types, the outcome
             of the biopsy may exclude you from the study treatment (for Phase 1b)

          -  Participant must agree to use birth control

          -  Participant must have progressed through or are intolerant to therapies with known
             clinical benefit, which your study doctor will discuss with you

        Exclusion Criteria:

          -  Participant must not have a history of tuberculosis, uncontrolled HIV or uncontrolled
             hepatitis B or C virus infection

          -  Participant must not have an autoimmune disease, which your study doctor will discuss
             with you

          -  Participant must not use corticosteroids, which your study doctor will discuss with
             you

          -  Participant must not have heart disease, Crohn's disease or brain cancer

          -  Participant must not be pregnant or breastfeeding
Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
Condition: Infant Respiratory Distress Syndrome; Respiratory Insufficiency; Apnea of Prematurity
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency
Intervention: Nasal high frequency ventilation
Intervention description: use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 7 Days
Maximum age: 3 Months
Healthy volunteers: No
Keywords: premature infants; very low birthweight infants; high frequency ventilation; nasal ventilation

Summary:

      The purpose of this study is to test whether application of high frequency ventilation
      through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  birthweight less than 1500 g

          -  Age >7 days

          -  Free of severe intraventricular hemorrhage (Grade III-IV)

          -  requiring nasal continuous positive airway pressure with a stable compensated
             respiratory acidosis (pH 7.25 - 7.45, pCO2 > 43 mm Hg),

          -  medically stable.

        Exclusion Criteria:

          -  major congenital anomalies
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Participants With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
Condition: Advanced Solid Tumors; Relapsed/Refractory Lymphoma
MeSH terms: Lymphoma
Intervention: Alisertib; Itraconazole
Intervention description: Alisertib tablets; Itraconazole oral solution
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the effect of multi-dose administration of itraconazole on the
      single-dose pharmacokinetics (PK) of alisertib.
    

Eligibility criteria:

        Inclusion Criteria

          1. Male and female participants 18 years of age or older.

          2. Participants with histologic or cytologic diagnosis of advanced or metastatic solid
             tumors or lymphomas for which no curative or life-prolonging therapies exist.

          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

        Exclusion Criteria

          1. Systemic treatment with moderate or strong CYP3A inhibitors or inducers must be
             discontinued at least 14 days before the first dose of alisertib, and the use of these
             agents is not permitted during the study (except for the protocol-specified
             administration of itraconazole).

          2. Known gastrointestinal (GI) abnormality (including recurrent nausea or vomiting) or GI
             procedure that could interfere with or modify the oral absorption or tolerance of
             alisertib.

          3. Known hypersensitivity or intolerance to itraconazole or similar class agents.
Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Dabigatran Etexilate in Patients With Stable Severe Renal Disease.
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Intervention: Dabigatran Etexilate
Intervention description: Dabigatran Etexilate 75mg twice daily
Intervention MeSH terms: Dabigatran
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The study to be conducted is a prospective, open label trial. It is designed to evaluate the
      pharmacokinetic/pharmacodynamic and coagulation parameters and safety of dabigatran etexilate
      in patients with chronic kidney disease.
    

Eligibility criteria:

        Inclusion criteria:

          1. Male and female patients aged 18 years and older

          2. Impaired renal function defined as a stable Cockcroft-Gault and/or actual creatinine
             clearance between 15-30 ml/min over the last 3 months before study participation.

          3. The single use of either aspirin or Vitamin K Antagonists

          4. Provision of informed consent.

        Exclusion criteria:

          1. Unstable renal function and Creatinin Clearance <15mL/min

          2. Patients treated with two or more platelet aggregation inhibitors

          3. Use of or indication for therapeutic heparin

          4. Patients with prosthetic heart valves

          5. Haemorrhagic disorder or bleeding diathesis

          6. Platelet count <100 109/L) at screening or during the last 30 days before screening.

          7. Participation in another drug trial in the last 30 days before screening.
A Study of Olaratumab (LY3012207) in Participants With Soft Tissue Sarcoma
Condition: Soft Tissue Sarcoma
MeSH terms: Sarcoma
Intervention: Olaratumab; Doxorubicin; External Beam Radiotherapy
Intervention description: Administered IV; Administered IV
Intervention MeSH terms: Doxorubicin; Olaratumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate potential biomarkers and method of action, efficacy
      and safety of olaratumab in participants with soft tissue sarcoma (STS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a histologically confirmed diagnosis of STS for which olaratumab and doxorubicin
             would be appropriate therapy. Participants with a diagnosis of Grade 1 liposarcoma are
             eligible if there is histological or radiographic evidence of evolution to more
             aggressive disease. Participants with Kaposi's sarcoma and gastrointestinal stromal
             tumors (GIST) will be excluded. Participants must have potentially resectable disease
             (as assessed by the study investigator) and have a primary tumor lesion deemed
             amenable to serial biopsy.

          -  For radiotherapy addendum only: Have a histologically confirmed diagnosis of STS of
             the extremities, Grade 2 or 3, >5 centimeters, for which olaratumab and radiotherapy
             would be appropriate therapy. Participants with Kaposi's sarcoma, GIST or myxoid
             liposarcoma will be excluded.

          -  Have consented to undergo mandatory serial peripheral whole blood and tumor tissue
             sampling.

        Exclusion Criteria:

          -  Have active central nervous system (CNS) or leptomeningeal metastasis (brain
             metastasis) at the time of enrollment. Participants with a history of a CNS metastasis
             previously treated with curative intent (for example, stereotactic radiation or
             surgery) that have not progressed on follow-up imaging, have been asymptomatic for at
             least 60 days and are not receiving systemic corticosteroids and or/anticonvulsants,
             are eligible. Participants with signs or symptoms of neurological compromise should
             have appropriate radiographic imaging performed before enrollment to rule out brain
             metastasis.

          -  Have received prior treatment with doxorubicin, epirubicin, idarubicin, and/or other
             anthracyclines or anthracenediones; the participant has received treatment with
             olaratumab or has participated in a prior olaratumab trial.

          -  For radiotherapy addendum only: Have received previous radiotherapy in the primary
             tumor lesion and/or prior treatment with olaratumab or has participated in a prior
             olaratumab trial.