bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Pegcetacoplan
Intervention description: Complement (C3) Inhibitor
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH; Paroxysmal Nocturnal Hemoglobinuria; Complement inhibitor; Anemia; Hemoglobinuria; hematologic diseases; extravascular hemolysis (EVH); intravascular hemolysis (IVH); C3 inhibitor

Summary:

      This study will be the initial exploration of pegcetacoplan in patients with PNH. The
      assessments of the safety, tolerability, PK, and PD following administration of single and
      multiples doses of pegcetacoplan will guide decisions to further develop the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female

          -  At least 18 years of age

          -  Weigh >55 kg

          -  Diagnosed with PNH

          -  On treatment with eculizumab (Soliris®) for at least 3 months

          -  Hb < 10 g/dL at screening OR have received at least one transfusion within 12 months
             prior to screening

          -  Platelet count of >30,000/mm3

          -  Absolute neutrophil count > 500/mm3

          -  Women of child-bearing potential (WOCBP) must have a negative pregnancy test at
             screening and must agree to use protocol defined methods of contraception for the
             duration of the study (see below)

          -  Males with female partners of child bearing potential must agree to use protocol
             defined methods of contraception (see below) and agree to refrain from donating sperm
             for the duration of the study

          -  Willing and able to give informed consent

        Exclusion Criteria:

          -  Active bacterial infection

          -  Known infection with hepatitis B, C or HIV

          -  Hereditary complement deficiency

          -  History of bone marrow transplantation

          -  Participation in any other investigational drug trial or exposure to other
             investigational agent, device or procedure within 30 days

          -  Evidence of QTcF prolongation defined as > 450 ms for males and > 470 ms for females
             at screening

          -  Creatinine clearance (CrCl) < 50 mL/min (Cockcroft-Gault formula) at screening

          -  Breast-feeding women

          -  History of meningococcal disease

          -  No vaccination against N. meningitidis types A, C, W, Y and B (administered as two
             separate vaccinations), Pneumococcal conjugate vaccine or Pneumococcal polysaccharide
             vaccine 23 (PCV13 or PPSV23, respectively) and Haemophilus influenzae Type B (Hib)
             vaccination within 2 years prior to Day 1 (Visit 2) dosing.
Laparoscopic Narrow Band Imaging for Detection of Occult Cancer Metastases
Condition: Gastrointestinal and Gynecologic Malignancies
MeSH terms: Neoplasms
Intervention: Laparoscopic narrow band imaging; Standard white-light laparoscopy
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Adult patients evaluated at Lahey Clinic with known or suspected gastrointestinal or
      gynecologic malignancies and with an indication for diagnostic laparoscopy will be offered
      participation in the study. The proposed study is a randomized, controlled feasibility trial
      with crossover design. The study's aim is to evaluate the effectiveness of laparoscopic
      narrow band imaging (NBI) compared to standard white-light laparoscopy for detection of
      peritoneal cancer metastases. Study patients will undergo laparoscopic evaluation of the
      peritoneal cavity using a routine white-light videolaparoscope with the capability of NBI.
      The order of white-light and NBI laparoscopy will be randomized for each patient (crossover
      design). Frozen-section histopathology biopsies will be retrieved of all suspicious-appearing
      abnormalities using best clinical practices. The number of detected peritoneal metastases
      will be compared between each diagnostic laparoscopy technique. To gauge the rate of
      potentially missed metastases, peritoneal cancer recurrence will be surveyed through a 1-year
      follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients

          -  diagnosis or suspicion of malignancy of the gastrointestinal or gynecologic tract

        Exclusion Criteria:

          -  clinical contraindication to diagnostic laparoscopy
A Study of Baricitinib in Healthy Participants
Condition: Healthy
Intervention: Baricitinib suspension; Baricitinib tablet
Intervention description: Administered orally; Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are to determine:

        -  If there are any differences in the amount of baricitinib in the blood/body when taken
           in two different forms.

        -  How a high-fat, high-calorie meal affects the amount of baricitinib in the blood/body.

        -  The safety and tolerability of baricitinib.

      The study has two parts. Individuals will participate in only one part.

      Participants will be admitted to the clinical research unit (CRU) and will be discharged from
      the CRU following the completion of 3 overnight stays.

      Each part of this study will last from 8-10 days, not including screening. Follow-up will
      occur 7 to 14 days after the last dose of baricitinib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males or females, as determined by medical history and physical
             examination

          -  Women not of child-bearing potential

          -  Have a body mass index (BMI) of 18.5 to 29.9 kilograms per meter squared (kg/m²)
             inclusive, at screening

        Exclusion Criteria:

          -  Have received live vaccine(s) within 3 months of screening, or intend to during the
             study

          -  Have a current or recent history (less than [<] 30 days prior to screening and/or <45
             days prior to Day -1 in Period 1) of a clinically significant bacterial, fungal
             parasitic, viral (not including rhinopharyngitis), or mycobacterial infection
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.
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants
Condition: Healthy Participants
Intervention: TAK-418; TAK-418 Placebo
Intervention description: TAK-418 Capsule.; TAK-418 placebo-matching capsules.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the safety and tolerability of TAK-418 following
      single oral doses in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a male or female participants with a body mass index (BMI) within the range of 18.5
             -30.0 kilogram per square meter (kg/m^2) at the Screening Visit.

          2. Is a nonsmoker who has not used tobacco or nicotine-containing products (example,
             nicotine patch) for at least 6 months before trial drug administration of the initial
             dose of trial drug or invasive procedure.

          3. Must be judged to be in good health by the investigator, based on clinical evaluations
             including laboratory safety tests, medical history, physical examination, 12-lead ECG,
             and vital sign measurements performed at the Screening Visit and before administration
             of the initial dose of trial drug or invasive procedure as per principal
             investigator's judgment.

          4. Female subjects with no childbearing potential, defined by at least 1 of the following
             criteria:

               -  Postmenopausal (defined as 12 months of spontaneous amenorrhea in women aged
                  greater than [>]45 years, 6 months of spontaneous amenorrhea in women aged >45
                  years with serum follicle-stimulating hormone [FSH] levels >40
                  milli-international units per milliliter [mIU/mL]). Appropriate documentation of
                  FSH levels is required.

               -  Surgically sterile by hysterectomy and/or bilateral oophorectomy with appropriate
                  documentation of surgical procedure.

               -  Had a tubal ligation with appropriate documentation of surgical procedure.

               -  Has a congenital condition resulting in no uterus.

        Exclusion Criteria:

          1. Has had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter
             [mL]) within 4 weeks before the Screening Visit.

          2. Has a risk of suicide according to the investigator's clinical judgment per the
             Columbia-Suicide Severity Rating Scale at Screening or has made a suicide attempt in
             the 6 months before Screening.
Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: PF-05221304
Intervention description: 25 mg dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Hepatic impairment PK study
    

Eligibility criteria:

        Key Exclusion Criteria:

        All subjects -

          -  Adults <18 years of age and >70 years of age

          -  BMI < 17.5 and > 35.4 kg/m2

          -  HIV positive

          -  Conditions that affect drug absorption

          -  Positive breath alcohol test

        Healthy/ those without hepatic impairment -

          -  Known or suspected hepatic impairment

          -  Evidence of Hepatitis B or C

          -  On any chronic medications

        Those with varying degrees of hepatic impairment -

          -  Not meeting Classification A, B, or C of hepatic impairment based on Child-Pugh
             Classification

          -  Evidence of Hepatic carcinoma or hepatorenal syndrome or limited predicted life
             expectancy

          -  Recent GI bleed

          -  Moderate or severe renal impairment

          -  Hepatic encephalopathy Grade 3 or higher
Psilocybin-assisted Group Therapy for Demoralization in Long-term AIDS Survivors
Condition: Distress; Depression; Grief
MeSH terms: Depression
Intervention: Psilocybin; Modified brief Supportive Expressive Group Therapy
Intervention description: One individual oral psilocybin treatment session; Ten sessions of twice-weekly manualized group therapy
Intervention MeSH terms: Psilocybin; N,N-Dimethyltryptamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: HIV/AIDS; Demoralization; Psilocybin; Group therapy

Summary:

      The purpose of this study is to determine whether psilocybin-assisted group psychotherapy is
      a safe and feasible treatment for demoralization in long-term AIDS survivors (LTAS).
    

Eligibility criteria:

        Inclusion Criterion:

          -  Older individuals who are long-term AIDS survivors and suffer from moderate-to-severe
             demoralization.

        Exclusion Criteria:

          -  A physical, neurological or cognitive condition that makes participating in the study
             unsafe or unfeasible.

          -  Regular psychotropic medication use.

          -  Personal or family history of serious mental illness.

          -  Severe depression requiring immediate standard-of-care treatment.

          -  Exclusion by the clinical judgment of the study investigators.
This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)
Condition: SARS-CoV-2 Infection
MeSH terms: Infections; COVID-19
Intervention: CT-P59
Intervention description: administered
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group,
      Single Ascending Dose Study to evaluate Safety, Tolerability and Virology of CT-P59 in
      Patient with Mild Symptoms of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2)
      Infection.
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient must meet all of the following criteria to be randomized in this study:

          1. Adult male or female patient, aged between 18 to 60 years (both inclusive).

          2. Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription
             Polymerase Chain Reaction (RT-PCR) at Screening.

          3. Patient has mild conditions meeting all of the following criteria:

               1. Oxygen saturation ≥ 94% on room air.

               2. Not requiring supplemental oxygen.

          4. Onset of symptom is no more than 7 days prior to the study drug administration.

        Exclusion Criteria:

        1. Patient with severe condition meeting one of the following:

          1. Respiratory distress with respiratory rate ≥ 30 breaths/min.

          2. Requires supplemental oxygen.

          3. Experience shock.

          4. Complicated with other organs failure, and intensive care unit monitoring treatment is
             needed by investigator's discretion.

          5. Any other conditions suspected of being severe symptoms of SARS-CoV-2 infection, in
             the opinion of the investigator, including but not limited to radiographic findings in
             lung.
A Study to Evaluate the Effect of Single-Dose Intravenous Rifampin as a Prototypic Inhibitor of Organic Anion Transporting Polypeptide (OATP) 1B1 and OATP1B3 on the Single-Dose Pharmacokinetics (PK) of Oral TAK-906 in Healthy Adult Participants
Condition: Healthy Volunteers
Intervention: TAK-906; Rifampin
Intervention description: TAK-906 capsule.; Rifampin infusion.
Intervention MeSH terms: Rifampin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the effect of single dose intravenous rifampin on
      the single-dose PK of orally administered TAK-906.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Continuous non smoker who has not used nicotine containing products for at least 3
             months prior to the first dosing and throughout the study, based on screening urine
             cotinine test.

          2. Body Mass Index (BMI) greater than or equal to (>=) 18.0 and less than or equal to
             (<=) 30.0 kilogram per square meter (kg/ m^2) at screening.

          3. Medically healthy with no clinically significant medical history, physical
             examination, laboratory profiles, vital signs, or ECGs, as deemed by the investigator
             or designee.

        Exclusion Criteria:

          1. Positive urine drug or alcohol results at screening and each check in.

          2. Positive urine cotinine at screening.

          3. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B
             surface antigen (HBsAg), or hepatitis C virus (HCV).

          4. QT interval with Fridericia's correction (QTcF) interval is >450 millisecond (msec) or
             ECG findings are deemed abnormal with clinical significance by the investigator or
             designee at screening.

          5. Estimated creatinine clearance <90 milliliter per minute (mL/min) at screening.

          6. Has been on a diet incompatible with the on-study diet, in the opinion of the
             investigator or designee, within the 30 days prior to the first dosing and throughout
             the study.

          7. Donation of blood or significant blood loss (example, approximately 500 milliliter
             [mL]) within 56 days prior to the first dosing.

          8. Plasma donation within 7 days prior to the first dosing.
Relative Bioavailability Study to Investigate and to Compare Two Different Formulations of Hyoscine Butylbromide in Healthy Male and Female Volunteers
Condition: Healthy
Intervention: Hyoscine butylbromide; Hyoscine butylbromide
Intervention description: sugar coated tablets for oral administration; drops for oral administration
Intervention MeSH terms: Scopolamine; Butylscopolammonium Bromide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current trial is to establish the bioequivalence of 2 hyoscine
      butylbromide dose forms following oral administration.
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male and female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
Condition: Chronic Functional Diarrhea of Unknown Origin
MeSH terms: Diarrhea
Intervention: Diosmectite (Smecta®)
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Intervention model description: The study is interventional Phase 1 without individual benefit.
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to assess the concentration of elemental impurities in
      blood and urine after chronic administration of Smecta® in subjects with chronic functional
      diarrhoea. For exploratory purposes, the potential effects of diosmectite on bowel microbiote
      composition will be investigated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects, between 18 and 60 years old inclusive, BMI between 19 and 32
             kg/m2 inclusive (minimum body weight of 50 kg at screening).

          -  Functional chronic diarrhoea defined as loose or watery stools occurring in at least
             75% of stools for the last 3 months (with symptom onset at least 6 months before
             diagnosis).

        Exclusion Criteria:

          -  No history of suspected organic or drug induced cause to chronic diarrhoea.
Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity
Condition: Obesity
MeSH terms: Obesity
Intervention: PF-06882961; Rosuvastatin; Midazolam
Intervention description: 120 mg and 200 mg BID; 10 mg single dose; 2mg single dose
Intervention MeSH terms: Midazolam; Rosuvastatin Calcium
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Crossover Assignment
Intervention model description: Crossover
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: obesity

Summary:

      A Phase 1 Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On
      Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With
      Obesity
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body Mass Index (BMI) ≥ 30.0 kg/m2 and not more than 45.4 kg/m2 at Screening.

          -  Stable body weight, defined as <5 kg change (per participant report) for 90 days
             before Screening

        Exclusion Criteria:

          -  Known prior participation in a trial involving PF-06882961.

          -  Known intolerance or hypersensitivity to GLP-1R agonists.

          -  Known hypersensitivity to rosuvastatin or midazolam.

          -  Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at
             screening. Note: prior diagnoses of gestational diabetes during pregnancy only are
             eligible if they meet the other eligibility criteria

          -  Any lifetime history of a suicide attempt.

          -  Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
             within 60 days prior to dosing.

          -  Participation in a formal weight reduction program (eg, Weight Watchers) within 90
             days prior to Screening.