bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19
Condition: Acute Respiratory Distress Syndrome; SARS-CoV-2
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Intervention: PLN-74809; Placebo
Intervention description: PLN-74809; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants
      with acute respiratory distress syndrome (ARDS) associated with at least severe COVID-19
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ARDS (Berlin Criteria)

          -  Hospitalized with at least severe COVID-19 (FDA 2020)

          -  Receiving support for acute lung injury/respiratory distress via supplemental oxygen

          -  Serum aspartate aminotransferase (AST) concentration ≤ 120 U/L and serum alanine
             aminotransferase (ALT) concentration ≤ 150 U/L

          -  Serum total bilirubin ≤ 1.8 mg/dL, in the absence of Gilbert's syndrome or hemolysis

        Exclusion Criteria:

          -  Greater than 72 hours since time of onset of ARDS.

          -  Greater than 7 days since start of mechanical ventilation.

          -  Currently receiving or anticipated to receive extracorporeal life support (ECLS),
             extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation

          -  Unwillingness to follow lung protective ventilation strategy (i.e., tidal volume of 6
             mL/kg of predicted body weight and prone positioning) and fluid management protocol
             (Fluids and Catheters Treatment Trial [FACTT] Conservative or Lite) per local
             institutional standards (HFOV).
Open-label Safety Extension Study of 5 and 10 mg of Vortioxetine (Lu AA21004) in Long-term Treatment of Major Depressive Disorder in Adults
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine (Lu AA21004)
Intervention description: 5 or 10 mg/day; tablets; orally
Intervention MeSH terms: Vortioxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Long-term; Safety; Open-label

Summary:

      The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine
      over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed
      6-week acute treatment in study NCT00839423 / 11492A.
    

Eligibility criteria:

        Inclusion Criteria:

        - Patients who completed 6-week short-term treatment study for Major Depressive Episode
        (MDE), NCT00839423 / 11492A, followed by a 2-week taper period

        Exclusion Criteria:

          -  Any current psychiatric disorder other than MDD as defined in the Diagnostic and
             Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV TR)

          -  Female patients of childbearing potential who are not using effective contraception

          -  Use of any psychoactive medication

        Other protocol-defined inclusion and exclusion criteria may apply.
LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: LGX818
Intervention description: BRAF inhibitor. LGX818 was administered QD orally on a daily schedule (21-day cycles) as a flat-fixed dose and not by body weight or body surface area. LGX818 100 mg capsules and 50 mg capsules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: open-label study; BRAF inhibitor; LGX818; MEK1620; MAPK1/2 inhibitor; Pi3K inhibitor; FGFR; c-Met; CDK4/6; metastatic melanoma; BRAF; V600

Summary:

      The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity
      of LGX818 in combination with selected agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  locally advanced or metastatic melanoma

          -  confirmed BRAF V600 mutation

          -  patients naïve to a selective BRAF inhibitor

          -  fresh tumor biopsy at baseline, and patient agrees for a mandatory biopsy at the time
             of relapse

          -  life expectancy ≥ 3 months

          -  World Health Organization (WHO) Performance Status ≤ 2.

        Exclusion Criteria:

          -  Previous treatment with RAF-inhibitor

          -  Symptomatic or untreated leptomeningeal disease

          -  Symptomatic brain metastases.

          -  Known acute or chronic pancreatitis

          -  Clinically significant cardiac disease

          -  AST/SGOT and ALT/SGPT > 2.5 x ULN, or > 5 x ULN if liver metastases are present

          -  Impairment of gastrointestinal (GI) function or GI disease that may significantly
             alter the absorption of oral interventional drug

          -  Previous or concurrent malignancy.

          -  Other severe, acute, or chronic medical or psychiatric condition or laboratory
             abnormality that may increase the risk associated with study participation

        Specific exclusion criteria for each treatment arm:

        LGX818/MEK162:

        History or current evidence of retinal disease History of Gilbert's syndrome.

        LGX818/BKM120:

        Patients with diabetes mellitus requiring insulin treatment Patient has mood disorders

        LGX818/BGJ398:

        History and/or current evidence of ectopic mineralization/ calcification Current evidence
        of corneal disorder/ keratopathy Patients with current evidence of endocrine alteration of
        calcium/phosphate homeostasis.

        History of congenital long QT- syndrome and/or hypokalaemia CTCAE Grade ≥ 3 and/or
        magnesium levels below the clinically relevant lower limits before study entry.

        Ionized (i) calcium (Ca) > ULN Serum inorganic phosphorus (Pi) > ULN

        LGX818/LEE011 History of congenital long QT- syndrome and/or hypokalaemia CTCAE Grade ≥ 3
        and/or magnesium levels below the clinically relevant lower limits before study entry.
Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer
Condition: Neoplasms; Febrile Neutropenia
MeSH terms: Neutropenia; Febrile Neutropenia; Hyperthermia; Fever
Intervention: CAZ-AVI; Vancomycin; Linezolid; Cefepime; Meropenem; Piperacillin/tazobactam
Intervention description: Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam); 15 mg/kg; 600 mg; 2 g; 1 g; 4.5 g
Intervention MeSH terms: Vancomycin; Meropenem; Tazobactam; Linezolid; Piperacillin; Cefepime; Piperacillin, Tazobactam Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the effect, safety, and tolerability of ceftazidime-avibactam
      (CAZ-AVI) plus vancomycin or linezolid compared to standard of care plus vancomycin or
      linezolid as empiric therapy in febrile neutropenic adults with cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with neutropenic fever who have existing malignancy or have undergone
             hematopoietic stem cell transplantation

          -  Requires hospitalization for intravenous (IV) empiric antibiotic therapy

        Exclusion Criteria:

          -  Fungal or viral infection requiring additional therapy

          -  Known acute viral hepatitis

          -  Known to be human immunodeficiency virus (HIV) positive

          -  Expected requirement for hemodialysis while on study therapy

          -  Received >24 hours of systemic antibacterial therapy within 72 hours of initiation of
             inpatient IV study drug

          -  Past or current history of epilepsy or seizure disorder

          -  Evidence of immediately life-threatening disease, progressively fatal disease, or life
             expectancy of 3 months or less.
In Vivo Patient Preoperative Skin Prep Persistence
Condition: Bacterial Recovery of Skin Flora Post-Product Application
Intervention: 3M CHG/IPA Surgical Skin Preparation - Abdominal Region; Normal Saline - Abdominal Region; 3M CHG/IPA Surgical Skin Preparation - Inguinal Region; Normal Saline - Inguinal Region
Intervention description: Chlorhexidine gluconate 2% / Isopropyl alcohol 70%; 0.9% sodium chloride applied with foam applicator; Chlorhexidine gluconate 2% / Isopropyl alcohol 70%; 0.9% sodium chloride applied with foam applicator
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of
      the abdominal and inguinal regions of human subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of any race

          -  Subjects in good general health

          -  Minimum skin flora baseline requirements on abdomen and groin

        Exclusion Criteria:

          -  Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin
             disorders (including acne) on the applicable test areas

          -  Topical antimicrobial exposure within 14 days prior to screening and treatment days

          -  Use of systemic or topical antibiotics, steroid medications, or any other products
             known to affect the normal microbial flora of the skin within 14 days prior to
             screening and treatment days
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
Condition: Kidney Transplantation
Intervention: Tacrolimus Modified Release (MR); tacrolimus
Intervention description: Oral; Oral
Intervention MeSH terms: Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Pharmacokinetics; Therapy; Immunosuppression; Drugs, Investigational; Adult

Summary:

      A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable
      kidney transplant patients converted from a Prograf® based immunosuppression regimen to a
      modified release tacrolimus based immunosuppression regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is currently receiving Prograf ® based immunosuppressive therapy for kidney
             transplantation.

          -  Patient has stable whole blood trough level concentrations of Prograf® and is
             clinically stable

        Exclusion Criteria:

          -  Patient has previously received an organ transplant other than a kidney

          -  Patient is currently receiving sirolimus immunosuppression therapy.
Virtual Patient Behavioral Response Training for Family Caregivers
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Caring Response App; Traditional Educational/Resources Program
Intervention description: Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.; Participants will receive a traditional educational/resources program, containing a workbook and online resources.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 156.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Our study is designed to help caregivers of someone with Alzheimer's Disease and related
      dementia to understand and deal with the difficult behaviors of a person with dementia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Care for an individual with Alzheimer's Disease or other dementia.

          -  Own a smartphone or tablet and have Internet access.

          -  Minimum age of 18 years old.

          -  Spend at least 8 hours/week caring for a person with dementia.

        Exclusion Criteria:

          -  Severe psychological or physical illness.

          -  Inability to read and follow English instructions.

          -  High level of depressive symptoms.

          -  Unwillingness to participate in all aspects of the study.
Dose Range Finding Study of MK-0941 in Patients With Type 2 Diabetes Mellitus on Insulin (MK-0941-007 AM3 EXT1 AM1)(TERMINATED)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-0941; Comparator: Placebo; Lantus; Metformin
Intervention description: MK-0941 tablets three times daily; Matching placebo to MK-0941 three times daily; Lantus injection once daily; Metformin ≥1500 mg/day at a stable dose for at least 6 weeks before Screening and for the duration of the study. The number of randomized participants who receive metformin will be capped at 70% of enrollment.
Intervention MeSH terms: Metformin; Insulin Glargine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 813.0
Sex: All
Minimum age: 21 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants
      taking insulin for type 2 diabetes mellitus. The primary hypotheses of this study are that
      treatment with MK-0941 added to insulin will provide greater reduction in hemoglobin A1c
      (HbA1c) level than will placebo added to insulin at 14 weeks, and that MK-0941 will be
      well-tolerated at 1 or more doses that demonstrate efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  has type 2 diabetes mellitus

          -  has body mass index >20 and <43 kg/m^2

          -  is a male, or a female who is unlikely to conceive

          -  currently on a stable dose of insulin with or without metformin for Type 2 diabetes
             mellitus

        Extension Study Inclusion Criteria:

          -  completed the base study either on double-blind study medication or as part of the
             post-treatment follow up population

          -  had ≥85% compliance with double-blind and open-label medication during the base study
             double-blind treatment period

        Exclusion Criteria:

          -  has any history of Type 1 diabetes mellitus or ketoacidosis

          -  has received more that 1 week of thiazolidinedione (such as pioglitazone or
             rosiglitazone) therapy or injectable increatin-based therapy (such as Byetta) within
             the prior 8 weeks

          -  has had ≥2 episodes during their lifetime or >1 episode within the past year resulting
             in hypoglycemic seizures, comas, or unconsciousness

          -  is on a weight loss program and is not in the maintenance phase, or patient is taking
             a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of
             Visit 1

          -  has undergone surgery within 30 days prior to Visit 1 or has planned major surgery
Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; PF-04937319 10 mg; PF-04937319 50 mg; PF-04937319 100 mg; Glimepiride
Intervention description: Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days; Combination of tablets and capsules, dose of 10 mg, a total of 3 pills/dose, administered once daily for 84-days; Combination of tablets and capsules, dose of 50 mg, a total of 3 pills/dose, administered once daily for 84-days; Combination of tablets and capsules, dose of 100 mg, a total of 3 pills/dose, administered once daily for 84-days; Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days
Intervention MeSH terms: Glimepiride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 304.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: T2DM; PF-04937319; Phase 2

Summary:

      This is a study to understand efficacy and safety of investigational agent (PF-04937319)
      compared to approved agent (glimepiride) in patients with diabetes on metformin
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with
             1 other oral agent

        Exclusion Criteria:

          -  Subjects with recent cardiovascular events, those with evidence of diabetic
             complications
The Study of AZD8529 for Smoking Cessation in Female Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: AZD8529
Intervention description: comparison of different dosages of drug
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 214.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking; smoking cessation; cigarette

Summary:

      To evaluate the efficacy and safety of AZD8529 for smoking cessation in female smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be a female smoker between the ages of 18 to 75 years.

          -  Want to quit smoking.

          -  Be currently (last 30 days) smoking 10 or more cigarettes per day and report less than
             3 months of consecutive smoking abstinence during the past year.

          -  Be able, in the opinion of the site investigator (SI), to understand and follow all
             protocol-specified instructions and understand and provide written informed consent.

          -  Be willing to provide personal information for entry into a clinical trial registry.

          -  Agree to use and continue using at least one acceptable contraceptive method (oral
             contraceptives, IUDs, contraceptive implants under the skin, contraceptive rings or
             patches or injections, diaphragms with spermicide, condoms with spermicide, or
             abstinence) or, if not of childbearing potential, must fulfill one of the following
             criteria at screening: post-menopausal defined as amenorrhea for at least 12 months
             and with follicle stimulating hormone (FSH) levels in the laboratory defined
             post-menopausal range and/or documentation of irreversible surgical sterilization by
             hysterectomy, bilateral oophorectomy or bilateral salpingectomy or tubal ligation
             verified by the Site Investigator.

          -  Agree not to use any other smoking behavioral intervention (self-help or formal
             treatment), acupuncture, or other smoking cessation pharmacotherapy during the study.

          -  Agree to refrain from using dietary/herbal supplements other than vitamins and
             minerals for 7 days prior to receiving study drug and throughout the 13-week treatment
             period.

          -  Agree to attend all required clinic appointments (including 3 eye exams) during the
             course of the 19-week study.

        Exclusion Criteria:

          -  Please contact the site for more information
NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis
Condition: Coronavirus; Covid19
MeSH terms: COVID-19
Intervention: Soterix taVNS model 0125-LTE Stimulator - Active-Active Group; Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group
Intervention description: Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.; Participants will receive sham taVNS stimulation for weeks 1&2 and active stimulation for weeks 3&4 of the stimulation portion of this study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of the research is to test out a new form of treatment that examines stimulation
      of a nerve in the participant's ear. This is called transcutaneous (through the skin)
      auricular (ear) vagus nerve stimulation (taVNS) which means that the participant will receive
      stimulation through the ear. The taVNS device looks like an ear bud used with a smart phone
      or computer. The study team is investigating whether or not taVNS can treat neurologic
      symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms the participant may
      experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue,
      irritability, etc. This study is entirely online and all assessments will be completed
      virtually.
    

Eligibility criteria:

        Inclusion Criteria:

          -  COVID positive

          -  At home

          -  Afebrile

          -  Anxiety

          -  Depression

          -  Vertigo

          -  Anosmia

          -  Headaches

          -  Irritability

          -  Cognitive Processing

        Exclusion Criteria:

          -  Damage to left ear anatomy

          -  Unstable hemodynamic effects

          -  Ischemic or hemorrhagic stroke after developing COVID

          -  Unable to give consent, follow instructions

          -  Unable to read or write or speak English

          -  No access to home WiFi