bioihbjkbjnl/mcl2 huggingface dataset:
Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Lu AF35700
Intervention description: 5 mg tablets for oral administration
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The purpose of this PET study is to verify the binding of Lu AF35700 after multiple oral
      dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. The patient is a man aged between ≤18 and ≥60 years

          2. BMI of ≥19 kg/m2 to ≤ 37 kg/m2

          3. The patient has a primary diagnosis of schizophrenia according to DSM-5™ (code 295.90)

          4. The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤ 4
             (moderately ill) at screening and safety baseline

          5. The patient is currently under oral therapy with one or more of the antipsychotic
             medications listed in Appendix II.

          6. The patient has a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80

          7. The patient has a score of ≤ 4 (moderate) on the following PANSS items at screening
             and at safety baseline: P7 (hostility), G8 (uncooperativeness)

        Exclusion Criteria:

          1. The patient experienced an acute exacerbation requiring hospitalization within the
             last 3 months.

          2. The patient experienced an acute exacerbation requiring change in antipsychotic
             medication (with reference to drug or dose) within the last 4 weeks.

          3. The patient has a diagnosis or history of substance use disorder (except nicotine)
             according to DSM-5-TR® criteria ≤3 months prior to screening

          4. The patient is at significant risk of harming himself or others according to the
             investigator's judgment or as indicated by an answer of "yes" to the question 4 or 5
             on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the Screening Visit within
             the last six months on the lifetime version of C-SSRS.

          5. Based on investigators judgment the patient has a medical or neurological disorder or
             treatment for such disorder that could interfere with the study treatment or impair
             treatment compliance.

          6. The patient has had past episodes of extrapyramidal symptoms (EPS) under current
             medication within the last 3 month

          7. The patient takes other medication than those listed as allowed concomitant medication
             in Appendix III

          8. The patient is occupationally exposed to significant levels of ionizing radiation.

        Other protocol-defined inclusion and exclusion criteria may apply
Investigation of Potential Drug-drug Interactions Between Faldaprevir and the Immunosuppressant Drugs Cyclosporine or Tacrolimus
Condition: Healthy
Intervention: Faldaprevir; Faldaprevir; Cyclosporine; Tacrolimus
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to investigate the effect of multiple-dose faldaprevir
      (FDV) on the single-dose pharmacokinetics of cyclosporine or tacrolimus
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy males or females subjects

          -  Age 18 to 50 years (incl.)

          -  Body mass index (BMI) 18.5 to 29.9 kg/m2 (incl.)

          -  Signed and dated written informed consent prior to admission to the study

        Exclusion criteria:

          -  Any finding in the medical examination (including blood pressure, pulse rate or ECG)
             deviating from normal and judged clinically relevant by the investigator.

          -  Systolic blood pressure (BP) less than 100 mmHg and more than 140 mmHg.

          -  Diastolic BP less than 60 mmHg and more than 90 mmHg.

          -  Pulse rate (PR) less than 50 bpm and more than 90 bpm.

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease judged clinically relevant by the investigator

          -  Positive QuantiFERON-TB Gold In-Tube
Vaccine Therapy For Patients Being Considered For Organ Transplant Who Are at Risk For PTLD
Condition: Lymphoproliferative Disorder
MeSH terms: Lymphoproliferative Disorders
Intervention: Inactivated EBV-infected vaccine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Healthy volunteers: No
Keywords: post-transplant lymphoproliferative disorder

Summary:

      RATIONALE: Vaccines made from a person's white blood cells may help the body build an
      effective immune response.

      PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating
      patients who are being considered for solid organ transplant who are at risk for
      post-transplant lymphoproliferative disorder.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Being considered for a solid organ transplant

          -  At high risk for post-transplant lymphoproliferative disorder

        PATIENT CHARACTERISTICS:

          -  Body weight ≥ 25 kg

          -  Karnofsky performance status 50-100% OR

          -  Lansky performance status 50-100%

          -  Not pregnant

          -  Negative pregnancy test

          -  Fertile patients must use contraception during and for 2 months after completion of
             study treatment

          -  Hemoglobin ≥ 8 g/dL (erythropoietin allowed)

          -  No history of autoimmune disease, including any of the following:

               -  Systemic lupus erythematosus

               -  Sarcoidosis

               -  Rheumatoid arthritis

               -  Glomerulonephritis

               -  Vasculitis

          -  No primary immunodeficiency

          -  No HIV positivity

        PRIOR CONCURRENT THERAPY:

          -  No corticosteroids for 1 month before and for 1 month after the first study
             vaccination, except for the following:

               -  Physiologic steroid dosing (≤ 20 mg/day of prednisone or steroid equivalent) for
                  adrenal insufficiency

               -  Inhaled steroids
A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
Condition: Type 2 Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Intervention: PF-03882845; PF-03882845; PF-03882845; Spironolactone; placebo
Intervention description: 3 mg tablet once daily; up to 10 mg tablet once daily; up to 30 mg once daily; spironolactone 25 mg once daily; placebo once daily
Intervention MeSH terms: Spironolactone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus. albuminuria.

Summary:

      PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary
      purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and
      pharmacodynamics of multiple doses of PF-03882845 in this population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and/or Females between 18-65 years, inclusive.

          -  Body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or
             greater than 110 lb.

          -  Have type 2 diabetes mellitus.

          -  On stable dose of anti-diabetic and anti-hypertensive medication prior to screening.

        Exclusion Criteria:

          -  Recent evidence or medical history of unstable concurrent disease.

          -  Cardiovascular event within 3 months prior to screening.

          -  History of renal transplant.

          -  History of hospitalization for acute kidney injury or acute kidney dialysis within 6
             months prior to screening.
PET Imaging and Bariatric Surgery
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Intervention: F-18 (fallypride)
Intervention description: Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation.
Intervention MeSH terms: Fallypride
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Obesity; Addiction; PET imaging

Summary:

      The purpose of this study is to look at certain areas of the brain that are related to
      addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors'
      (DRD2/3) and other studies have shown that obese people have less of these. We propose that
      low DRD2/3 availability seen in morbidly obese subjects will change with weight loss
      associated with bariatric surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ages 18-60 years

          -  BMI equal to or greater than 40, or equal to or greater than 35 if there are 2 or more
             co-morbidities

          -  Weight less than 350 pounds

        Exclusion Criteria:

          -  History of substance abuse,including but not limited to alcohol, cocaine, marijuana,
             heroin, nicotine

          -  History of psychiatric disorders

          -  Use of any antidepressants or psychotropics in the past 12 months

          -  Diabetes Mellitis

          -  Positive pregnancy test

          -  Any condition felt by the PI or co-investigators to interfere with the individual's
             ability to complete the study

          -  Subjects on medications for the last 3 months, such as sibutramine, which could affect
             the quality of the study, as determined by the PI

          -  Inability to travel to Nashville, TN four times
A Study of LY3314814 in Healthy Participants
Condition: Healthy
Intervention: LY3314814; [13C415N3] LY3314814
Intervention description: Administered orally; Administered as an IV infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: Open label
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to measure how much LY3314814 gets into the bloodstream when it
      is given as a single dose by mouth and as an intravenous (IV) infusion over two hours. The
      study will last at least two weeks for each participant, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females

          -  Have venous access sufficient to allow for blood sampling and intravenous (IV)
             administration of the investigational product

        Exclusion Criteria:

          -  Have a history of significant ophthalmic disease

          -  Have vitiligo or any other clinically significant disorder of skin pigmentation

          -  Have a history of use of antipsychotic drugs, or chronic use of antidepressant or
             anxiolytic drugs, prescribed as well as non-prescribed
BI 836826 Dose Escalation in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Intervention: BI 836826
Intervention description: Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion
Intervention MeSH terms: BI 836826
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose is to investigate the maximum tolerated dose (MTD), safety and tolerability,
      pharmacokinetics and efficacy of BI 836826 monotherapy in patients with relapsed or
      refractory non-Hodgkin lymphoma with at least prior treatments.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients with relapsed or refractory non-Hodgkin lymphoma of B cell origin (mature B
             cell lymphoma according to WHO) not considered candidates for intensive anti-lymphoma
             therapy

          2. Patients must have either aggressive NHL and received at least one prior anti-CD20
             containing immunochemotherapy or indolent NHL and received anti-CD20 therapy and at
             least two prior therapies

          3. Measurable disease on computed tomography (CT) scan with involvement of one clearly
             demarcated lesion =2 cm or two or more clearly demarcated lesions of >1.5 cm at
             longest diameter (this criterion applies only for the expansion cohort)

          4. Relapse or progression of disease with an indication for therapy as per investigator's
             judgement

          5. Life expectancy of =3 months

          6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

        Exclusion criteria:

          1. Primary central nervous system (CNS) lymphoma or known CNS involvement

          2. Prior history of malignancy other than a mature B cell neoplasm according to WHO
             classification (except basal cell or squamous cell carcinoma of the skin, or carcinoma
             in situ of the uterine cervix or breast treated with curative therapy) unless the
             subject has been free of disease and without treatment for at least 5 years

          3. Last chemotherapy <4 weeks prior to visit 1

          4. Last anti-CD20 therapy (non-radiolabelled) <4 weeks prior to visit 1

          5. Last corticosteroid <2 weeks prior to visit 1 unless the dose is less or equal of 10
             mg/day prednisolone or equivalent

          6. High-dose therapy with stem cell support <6 months prior to visit 1

          7. Radio-immunotherapy <3 months prior to visit 1
Demodex Blepharitis Treatment Study
Condition: Chronic Blepharitis
MeSH terms: Blepharitis
Intervention: Terpinen-4-ol; Placebo
Intervention description: Lid scrub once or twice per day for one month.; Lid scrub once or twice per day for one month
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 15 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Blepharitis; Demodex; Mites; Tea Tree oil; Terpinen

Summary:

      This is a randomized clinical trial to determine the safety and efficacy of terpinen-4-ol
      (T4O), the most active ingredient of tea tree oil (TTO), in eradicating ocular demodicosis
      (reducing ocular demodex counts and achieving the clinical improvement with minimal or no
      irritation).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with symptomatic Demodex blepharitis for duration of at least 3 months.

          -  Age range: 15-80 years old.

          -  Both genders and all ethnic groups comparable with the local community.

          -  Able to understand and willing to sign a written informed consent

          -  Able and willing to cooperate with the investigational plan.

          -  Able and willing to complete all mandatory follow-up visits.

        Exclusion Criteria:

          -  Patients who are currently engaged in another clinical trial, unwilling or unable to
             give consent, to accept randomization, or to return for scheduled visits.

          -  Children under 15.

          -  Pregnant women or expecting to be pregnant during the study.

          -  Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.

          -  Concomitant use of ophthalmic topical medications (excluding non-preserved tear
             substitutes).

          -  Concomitant use of systemic antibiotics or steroids.

          -  Contact lens wear (unless discontinued for ≥ 30 days before randomization)

          -  Active ocular infection or allergy

          -  Unable to close eyes or uncontrolled blinking

          -  Presence of aqueous tear deficient dry eye defined by the Fluorescein Clearance Test
             as less than 3 mm wetting in 1-minute Schirmer test with anesthesia.

          -  Previous allergic reaction to TTO-containing products or cosmetic fragrance.
Pharmaco-Magnetic Resonance Spectroscopy (MRS) Study of Clavulanic Acid
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Clavulanic Acid; Placebo
Intervention description: Drug will be given in 250mg capsules.; Placebo
Intervention MeSH terms: Clavulanic Acids; Clavulanic Acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel group inpatient study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A dose-escalation study to determine the optimum dose of Clavulanic Acid (CLAV) for effects
      on craving and efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be able to verbalize understanding of consent form

          2. Be male or female adult volunteers ages 18-65 inclusive.

          3. Have a Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of cocaine use disorder,
             moderate to severe in early remission

          4. Have a Body Mass Index (BMI) of 17.5 to 39.9 kg/m2; and a total body weight of at
             least 45 kg (99 lbs.)

          5. Have a history and brief physical examination that demonstrate no clinically
             significant contraindication for participating in the study, and/ or significant or
             unstable medical or psychiatric illness.

        Exclusion Criteria:

          1. Have a current DSM-5 substance use disorder, mild, moderate, or severe, on any drug of
             abuse other than nicotine, caffeine, and cocaine use disorder in early remission
             verified by Urine Drug Screen (UDS). Alcohol use disorder and marijuana use disorder,
             mild without withdrawal symptoms, will be permitted.

          2. Have any previous medically adverse reaction to CLAV, Augmentin, penicillin,
             Ticarcillin, cephalosporin, or any beta-lactam drug.

          3. Have any illness, condition, and use of medications, in the opinion of the principal
             investigator, sub-investigators which would preclude safe and/or successful completion
             of the study.

          4. Report having human immunodeficiency virus (HIV) infection or test positive for HIV
             during screening

          5. Be pregnant (females).

          6. Unable to tolerate MRI scan for duration of 60 minutes for physical or psychological
             reasons.
A Study of Obinutuzumab in Chinese Participants With CD20+ Malignant Disease
Condition: Lymphocytic Leukemia, Chronic, Diffuse Large B-cell Lymphoma, Follicular Lymphoma
MeSH terms: Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Obinutuzumab
Intervention description: Multiple doses of obinutuzumab.
Intervention MeSH terms: Obinutuzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multi-center, open-label, single-arm study will evaluate the pharmacokinetics and safety
      of obinutuzumab in participants with cluster of differentiation (CD) 20 positive (+)
      malignant disease. Participants will receive multiple doses of obinutuzumab. The anticipated
      time on study treatment is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of CD20+ B-cell lymphoma or B-CLL

          -  Refractory/relapsed CLL, FL, and DLBCL

          -  At least 1 measurable lesion (greater than [>] 1.5 centimeters [cm] in its largest
             dimension) with the exception of CLL

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Life expectancy >6 months

        Exclusion Criteria:

          -  Prior use of any investigational antibody therapy within 6 months of study start

          -  Prior use of any anti-cancer vaccine

          -  Prior administration of rituximab within 3 months of study start

          -  Prior administration of radioimmunotherapy 3 months prior to study entry

          -  Central nervous system lymphoma

          -  History of other malignancy

          -  Evidence of significant, uncontrolled concomitant disease

          -  Abnormal laboratory values

          -  Patients with progressive multifocalleukoencephalopathy (PML)

          -  Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C