bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Safety and Tolerability of sc Immunotherapy With DM-101 in Adults With Birch Pollen Allergy
Condition: Birch Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Intervention: DM-101; Placebo to match DM-101
Intervention description: DM-101 administered by subcutaneous (SC) injection; Placebo to match DM-101 administered by SC injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 4 sequential study cohorts with ascending DM-101 doses. In each cohort two treatment arms: placebo and active drug
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Randomized, double-blind placebo-controlled phase I study to investigate the safety and
      tolerability of ascending doses of DM-101 in adult subjects with birch pollen allergy.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or females, aged 18 to 65 years

          -  Good general health

          -  A documented clinical history of birch pollen-induced allergic rhinitis or
             rhinoconjunctivitis with symptoms that interfere with daily activities or sleep and
             remain bothersome despite the use of relevant symptomatic medication, and have been
             present over, at least, 2 allergy seasons.

          -  Bet v 1 specific serum IgE ≥ 0.7 kU/L

          -  Positive SPT to birch pollen allergen, with a wheal diameter ≥ 5 mm

          -  Body weight ≥50 kg and body mass index (BMI) within the range 18-35 kg/m2.

        Key Exclusion Criteria:

          -  History or findings on physical examination of any significant disease or disorder
             which, in the opinion of the Investigator, may put the subject at risk because of
             participation in the study, influence the results of the study or the subject's
             ability to participate in the study.

          -  Current diagnosis of asthma (other than seasonal during the birch pollen allergy
             season), requiring Global Initiative for Asthma (GINA) Step 2 or higher treatment, or
             asthma partially controlled or uncontrolled according to GINA classification in the 6
             months before Screening.

          -  History of asthma deterioration that resulted in emergency treatment or
             hospitalisation in the 12 months before screening, or a life-threatening asthma attack
             at any time in the past.

          -  Forced Expiratory Volume in one second (FEV1) < 70% of predicted, regardless of asthma
             status at screening or baseline assessment at the first dosing visit.

          -  History of severe drug allergy, severe angioedema or systemic allergic reaction of
             Grade 3 or greater, according to the World Allergy Organization (WAO) scale, due to
             any cause.
Effect of Stimulant Drugs on Social Perception
Condition: Healthy; MDMA ('Ecstasy')
Intervention: 3,4-Methylenedioxymethamphetamine; methamphetamine
Intervention description: Participants will be given 0.75mg/kg of 1.5mg/kg MDMA; Please see above.
Intervention MeSH terms: Methamphetamine; N-Methyl-3,4-methylenedioxyamphetamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study will improve our understanding of the "prosocial" effects of ±
      3,4-Methylenedioxymethamphetamine (MDMA), relative to a prototypical stimulant,
      methamphetamine (MA). The investigators seek to characterize the "uniquely social" effects of
      MDMA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High school degree

          -  English fluency

          -  Healthy

          -  Has used MDMA

        Exclusion Criteria:

          -  Pregnant or trying to become pregnant

          -  Any medical or psychiatry condition
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
Condition: Congenital Nasolacrimal Duct Obstruction
MeSH terms: Lacrimal Duct Obstruction
Intervention: Besivance Treatment Group; Polytrim Treatment Group
Intervention description: Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.; Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
Intervention MeSH terms: Trimethoprim; Polymyxins; Polymyxin B; Besifloxacin; Fluoroquinolones
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 1 Month
Maximum age: 12 Months
Healthy volunteers: No

Summary:

      The goal of the study is to evaluate the application of Besivance™ (besifloxacin ophthalmic
      suspension, 0.6%) to treat congenital nasolacrimal duct obstruction in children. The
      hypothesis of the study is that Besivance™ is as safe and effective as the current standard
      of care for the treatment of nasolacrimal duct obstruction in children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persons who have been diagnosed with congenital Nasolacrimal Duct Obstruction (NLDO)
             with infection by the Principal Investigator

          -  Both males and females

          -  Persons who are age of 1 to 12 months at time of diagnosis (time of diagnosis is
             defined as when the Principal Investigator makes clinical diagnosis.)

        Exclusion Criteria:

          -  Persons who have received any antibiotic treatment for NLDO with infection for more
             than 2 week in the past 4 weeks.

          -  Persons who are currently receiving systemic antibiotic treatment that cannot be
             discontinued.

          -  Persons with any other ocular anomalies that could potentially interfere with
             interpretation of study results.

          -  Persons who have had any prior nasolacrimal duct system procedures such as stenting or
             probing.

          -  Persons who have previously participated in any clinical trial(s) of Besivance™

          -  Persons who have participated in any other clinical trial(s) of any investigational
             agent(s) within 30 days prior to the Baseline visit

          -  Persons who have any chronic diseases that might interfere with study participation
The Effects of AZD2171 in Patients With Non-Small Cell Lung Cancer or Head & Neck Cancer
Condition: Carcinoma; Non-Small-Cell Lung Carcinoma; Head and Neck Neoplasms
MeSH terms: Carcinoma; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms
Intervention: AZD2171
Intervention description: oral tablet
Intervention MeSH terms: Cediranib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RECENTIN

Summary:

      This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC.
      The safety and tolerability of AZD2171 will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed head and neck cancer (HNC) or unresectable
             stage IIIb or IV non-small cell lung cancer (NSCLC)

          -  At least one lesion able to be used for tumor biopsy and to be measured by FDG-PET
             Scan

          -  Considered suitable for treatment of NSCLC with no prior biological or immunological
             therapy for disease

          -  Or considered suitable for treatment for metastatic or recurrent HNC with no prior
             biological or immunological therapy for disease

        Exclusion Criteria:

          -  NSCLC: Have received more than 2 previous chemotherapy regimens or have received the
             last chemotherapy or radiotherapy within 28 days of first dose of AZD2171

          -  HNC: Previous chemotherapy or radiotherapy if received 28 days of first dose of
             AZD2171

          -  Untreatable, unstable brain or meningeal metastases.

          -  Abnormal liver and kidney blood chemistries

          -  History of poorly controlled hypertension with resting blood pressure of >150/100

          -  Recent (< 14 days) major surgery or a surgical incision not fully healed

          -  Diabetes patients with type I insulin dependent diabetes or poorly controlled type II

          -  Significant hemorrhage or hemoptysis

          -  Presence of necrotic/hemorrhagic tumor or metastases
Study Evaluating The Safety Of AAB-003 (PF-05236812) In Subjects With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: AAB-003 (PF-05236812); AAB-003 (PF-05236812); AAB-003 (PF-05236812); AAB-003 (PF-05236812); AAB-003 (PF-05236812); Placebo
Intervention description: 0.5 mg/kg AAB-003, IV; 1 mg/kg AAB-003, IV; 2 mg/kg AAB-003, IV; 4 mg/kg AAB-003, IV; 8 mg/kg AAB-003, IV; Placebo, IV
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 50 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Randomized; Safety Study; Adaptive; Double Blind

Summary:

      This is a study to evaluate the safety of multiple doses of AAB-003 (PF-05236812) in patients
      with mild to moderate Alzheimer's Disease. Patients will receive either AAB-003 (PF-05236812)
      or placebo. Each patient's participation will last approximately 41 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable Alzheimer's Disease with MMSE score of 16-26, and brain MRI
             consistent with the diagnosis of Alzheimer's Disease

          -  Concurrent use of cholinesterase inhibitor or memantine allowed, if stable.

          -  Caregiver will participate and be able to attend clinic visits with patient

        Exclusion Criteria:

          -  Significant neurological disease other than Alzheimer's Disease

          -  Major psychiatric disorder

          -  Contraindication to undergo brain MRI (e.g., pacemaker, CSF shunt, or foreign metal
             objects in the body)

          -  Women of childbearing potential
A Pharmacokinetic Study on Co-administration of Tamiflu (Oseltamivir) and Rimantadine in Healthy Volunteers
Condition: Healthy Volunteer
Intervention: oseltamivir [Tamiflu]; rimantadine
Intervention description: multiple oral doses; multiple oral doses
Intervention MeSH terms: Oseltamivir; Rimantadine
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This open label, randomized, three-period crossover study will evaluate the effect of
      co-administration of Tamiflu (oseltamivir) and rimantadine on the pharmacokinetics of Tamiflu
      and rimantadine. Healthy volunteers will receive multiple oral doses of Tamiflu, rimantadine
      or Tamiflu plus rimantadine in random order, with a minimum wash-out period of 7 days between
      treatments. Anticipated time on study is up to 11 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults, aged 18 to 45 years

          -  Healthy as judged by general physical examination, medical history, vital signs,
             12-lead ECG and laboratory tests

          -  Body Mass Index (BMI) 18-34 kg/m2

          -  Willing not to participate in any other trial including an investigational drug for 3
             months following the last dose

          -  Male subjects must agree to use a barrier contraception during the study and for 3
             months after discontinuation of treatment

          -  Female subjects of non-child bearing potential or under effective contraception who
             are either post-menopausal, surgically sterile, or who agree to use barrier
             contraception during the whole study in addition to an intrauterine device or hormonal
             contraception for at least 3 months prior to 1st dose, during the study and for 3
             months after discontinuation of treatment

        Exclusion Criteria:

          -  History of or current clinically significant disease or disorder

          -  Positive Hepatitis B, Hepatitis C, HIV 1 or 2 test result

          -  Positive pregnancy test or lactating women

          -  Clinically relevant history of allergy or hypersensitivity

          -  Clinically relevant history of abuse of alcohol or other drugs; tobacco smoking is
             allowed (</= 10 cigarettes a day or equivalent of tobacco in cigars or pipe)

          -  Any major illness within 30 days prior to screening examination

          -  Administration of any medication during the 7 days prior to drug administration,
             except for paracetamol and aspirin (up to 48 hours before first dose) and oral
             contraceptives

          -  Participation in a clinical study with an investigational drug within 3 months prior
             to study day 1

          -  Donation or loss of more than 500 mL of blood within the 3 months prior to study day 1
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
Condition: Healthy Volunteers
Intervention: TAK-788; Placebo; TAK-788
Intervention description: TAK-788 capsules.; TAK-788 placebo-matching capsules.; TAK-788 DiC.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 69.0
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 assess the safety, tolerability of TAK-788 and to identify a
      tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to
      characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC
      formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative
      to a reference (Process A) DiC of TAK-788 in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Body weight of greater than or equal to (>=) 45 kilogram (kg) (women) or >=55 kg (men)
             and a body mass index of 18.0 to 30.0 kilogram per square meter (kg/m^2) at screening.

          2. Nonsmoker (never smoked or greater than [>] 20 years from last occurrence of smoking).

          3. Normal organ function including hepatic, renal, and bone marrow function.

        Exclusion Criteria:

          1. Manifestations of malabsorption due to prior gastro-intestinal (GI) surgery, GI
             disease, or for an unknown other reason that may alter the PK of TAK-788.

          2. Pulmonary infection ongoing or within 30 days of informed consent.

          3. Inability to undergo venipuncture and/or tolerate venous access.

          4. Inability to tolerate multiple blood sampling.

          5. Ongoing or active infection, including but not limited to, the requirement for
             intravenous (IV) antibiotics.
The Effect of Topiramate on Etonogestrel Concentrations in Contraceptive Implant Users
Condition: Migraine; Migraine;Menstrual; Contraception
MeSH terms: Migraine Disorders
Intervention: Topiramate
Intervention description: Topiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day:
Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily
Intervention MeSH terms: Topiramate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on serum ENG levels in contraceptive implant users
Masking: None (Open Label)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A prospective, non-inferiority study to evaluate the pharmacokinetic effect of topiramate on
      serum Etonogestrel (ENG) levels in contraceptive implant users.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women, who have had an ENG implant for 12-36 months at the time of enrollment;

          -  Will maintain their implant during the study without modifications.

        Exclusion Criteria:

          -  Women who are taking any medications or supplements known to be

               1. Cytochrome P-450 enzyme inducers, inhibitors, or substrates, and

               2. are not willing to abstain from any of these medications or supplements during
                  the entire course of the study.

          -  Women with liver disease (i.e. hepatitis, fatty liver disease), and

          -  Women with abnormal liver or renal function, or

          -  Women with abnormal electrolytes on their screening blood work.
Bioequivalence Study Of Diltiazem In 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. De C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. De C.V.
Condition: Healthy
Intervention: TILACEM; ANGIOTROFIN
Intervention description: At 08:00 hours on day 1, CIF-BIOTEC personnel will start to administer the study drug. Each volunteer will receive a single dose of 60 mg of Diltiazem. The study drugs will be ingested with 250 mL of drinking water. Research Pharmacy personnel will inspect the volunteer's oropharynx to ensure that he/she has swallowed the tablet and record their observations in the corresponding forms.; At 08:00 hours on day 1, CIF-BIOTEC Pharmacy personnel will start to administer the study drug. Each volunteer will receive a single dose of 60 mg of Diltiazem. The study drugs will be ingested with 250 mL of drinking water. Research Pharmacy personnel will inspect the volunteer's oropharynx to ensure that he/she has swallowed the tablet and record their observations in the corresponding forms.
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: diltiazem; angiotrofin; bioequivalence

Summary:

      This study will research the existance of actual bioequivalence between Diltiazem in 60 Mg
      Tablets As Tilazem 60® Made by Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made by
      Amstrong Laboratorios De Mexico, S.A. DE C.V.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
             (Healthy is defined as no clinically relevant abnormalities identified by a detailed
             medical history, full physical examination, including blood pressure and pulse rate
             measurement, 12-lead ECG and clinical laboratory tests).

          -  Both genders

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 or ± 10% variation of the ideal weight;
             and a total body weight >50 kg (110 lbs).

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing).

          -  Any condition possibly affecting drug absorption (eg, gastrectomy).

          -  A positive urine drug screen
A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Grazoprevir; Placebo
Intervention description: 10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days; Placebo tablet, orally, once a day for 7 days
Intervention MeSH terms: Grazoprevir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 91.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This multiple dose study will assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)-
      infected participants. The primary hypothesis is that administration of grazoprevir for 7
      days is sufficiently safe and well tolerated in HCV-infected males.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Baseline health is stable.

          -  Has a clinical diagnosis of chronic HCV infection.

        Exclusion Criteria:

          -  Has a history of stroke or chronic seizures.

          -  Has a history of cancer.

          -  Has a history of human immunodeficiency virus (HIV) infection.

          -  Has had major surgery, donated blood or participated in another investigational study
             within the past 3 months.