bioihbjkbjnl/mcl2 huggingface dataset:
Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal
Condition: Healthy
Intervention: 1064 nm Nd:YAG laser; Imiquimod, 5% cream
Intervention description: The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy; 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month
Intervention MeSH terms: Imiquimod
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tattoos; Black/blue tattoos

Summary:

      The purpose of this study is to evaluate the efficacy of tattoo removal using topical
      imiquimod, 5% cream in conjunction with the 1064nm Nd:YAG laser. This procedure for tattoo
      removal will be compared to a laser removal alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  2 tattoos no larger than 25cm2, professionally made, with approximately the same age,
             containing blue/black ink.

        Exclusion Criteria:

          -  Hypersensitivity to imiquimod

          -  Current sun tan

          -  Use of vitamin E, non-steroid anti-inflammatory drugs, coumadin or aspirin for the
             past 10 days

          -  Amateur tattoos

          -  Pregnancy

          -  Breast-feeding status

          -  Immunosuppression

          -  Auto-immune diseases.
This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood
Condition: Healthy
Intervention: Empagliflozin/linagliptin/metformin HCl; Empagliflozin; Linagliptin; Metformin HCl
Intervention description: Once daily; Once daily; Once daily; Once daily
Intervention MeSH terms: Metformin; Empagliflozin; Linagliptin
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: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To establish the bioequivalence of one fixed dose combination (FDC) tablet of
      empagliflozin/linagliptin/metformin extended release (XR) versus the free combination of
      empagliflozin tablet, linagliptin tablet, and metformin XR tablets administered as a single
      dose under fed conditions
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female subjects according to the assessment of the investigator, based
             on a complete medical history including a physical examination, vital signs (Blood
             Pressure (BP), Pulse Rate (PR)), 12-lead Electrocardiogram (ECG), and clinical
             laboratory tests

          -  Age of 18 to 55 years (incl.)

          -  BMI of 18.5 to 29.9 kg/m2 (incl.)

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice (GCP) and local legislation

          -  Female subjects of childbearing potential willing to use adequate contraception.

          -  Further inclusion criteria apply

        Exclusion Criteria:

          -  Any finding in the medical examination (including Blood Pressure (BP), Pulse Rate
             (PR), or Electrocardiogram (ECG)) is deviating from normal and judged as clinically
             relevant by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
             diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
             range of 45 to 90 beats per minute (BPM)

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease judged as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological, or hormonal disorders

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures or stroke), and other relevant neurological or psychiatric disorders

          -  Further exclusion criteria apply
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
Condition: Clostridium Infections
MeSH terms: Clostridium Infections
Intervention: Vaccine diluent buffer (Placebo); C. difficile toxoid vaccine (2 µg); C. difficile toxoid vaccine (10 µg); C. difficile toxoid vaccine (50 µg)
Intervention description: 0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.; 0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.; 0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.; 0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clostridium difficile

Summary:

      The purpose of this study is to determine the safety and tolerability of a modified C.
      difficile vaccine at 3 dose levels compared with a placebo control administered via
      intramuscular injection in healthy elderly subjects aged > or = 65 years. This is the
      companion study to H-030-008, in which healthy younger adults have already been dosed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult males or females, > or = 65 years

          -  In good general health

          -  Clinical lab tests within normal range

          -  Females must be post-menopausal

          -  Able and willing to participate for duration of study and must not participate in any
             other experimental study for at least 60 days after receiving the last dose of study
             vaccine

        Exclusion Criteria:

          -  Evidence of C. difficile infection

          -  Evidence of any previous antibiotic-associated diarrhea

          -  Active or inactive inflammatory bowel disease, irritable colon syndrome, chronic
             abdominal pain or other chronic diarrhea

          -  History of malignancy within 5 years

          -  History of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction

          -  Known or suspected history of immunodeficiency

          -  Active or inactive immune-mediated or inflammatory disease

          -  History of drug or alcohol abuse disorders;

          -  Serology positive for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus
             (HCV)

          -  Receipt of antibiotic therapy or an investigational drug within prior 30 days

          -  Blood or organ donation within prior 30 days.
Computerized Health Education to Promote Physical Activity
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Tailored Physical Activity Intervention
Intervention description: Tailored physical activity computer reports will be provided to patients and physicians.
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 394.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Physical Activity; Wellness Programs; Health Promotion; Blood Pressure, High

Summary:

      This study will test the efficacy of providing primary care physicians and their patients
      with computer-tailored information, based on patients' responses to survey questions. The
      health education messages are designed to encourage patients to become physically active and
      to encourage physicians to counsel their patients about exercise.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to speak and read English

          -  Current patient of a physician participating in this study (if selecting a new
             physician, may deliberately select one that is involved in the study, in order to
             participate)

          -  Ability to complete all written surveys

          -  Accessible for follow-up telephone surveys

          -  Ability to undergo exercise testing

        Exclusion Criteria:

          -  Currently participating in another research study

          -  Planning to move out of the Philadelphia area

          -  Unable to walk without pain

          -  Pregnant or planning to become pregnant in the year following study entry

          -  Excessive drinking

          -  Coronary heart disease

          -  Congestive heart failure

          -  Peripheral vascular disease

          -  Cerebrovascular disease

          -  Chronic obstructive pulmonary disease

          -  Arrhythmia

          -  Recurrent seizures

          -  Dizziness

          -  Balance problems

          -  Psychoses
Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body
Condition: Healthy Volunteers
Intervention: Rotigotine transdermal patch
Intervention description: Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours
Intervention MeSH terms: Rotigotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rotigotine; Neupro®; Transdermal Patch

Summary:

      The major aim of this study is to investigate and compare the drug amount delivered to the
      body after sequential application of two Rotigotine patches of two different formulations
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy White, male volunteers between 18 and 55 years of age (inclusive).

          -  BMI between 19 and 28 kg/m^2 (inclusive)

        Exclusion Criteria:

          -  Previous participation in a clinical study with Rotigotine

          -  History or current condition of epilepsy and/or seizures

          -  Known clinically relevant allergy or known/suspected clinically relevant drug
             hypersensitivity

          -  History of significant skin hypersensitivity to adhesives or other transdermal
             products or recently unresolved contact dermatitis

          -  History or present condition of an atopic or eczematous dermatitis, psoriasis, and/or
             an active skin disease

          -  Clinically relevant abnormality in physical examination, ECG, vital signs or safety
             laboratory examinations

          -  Positive HIV, hepatitis B or C test or positive alcohol or drug test

          -  Relevant hepatic or renal dysfunction

          -  Intake of medication that might interfere with the test drug within 2 weeks prior to
             dosing
Wide-Bandwidth Open Canal Hearing Aid For Better Multitalker Speech Understanding
Condition: Hearing Impairment
MeSH terms: Hearing Loss; Deafness
Intervention: Hearing Aid
Intervention description: Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hearing Loss, Eardrum, Transducer, Hearing in Noise

Summary:

      Our goal is to design and build a new hearing aid system, which mitigates the most common
      complaints that hearing aid users have. These include hearing in multi-talker situations,
      poor sound quality, unwanted whistling resulting from feedback, and a dislike of the sound of
      their own voice. Current efforts, with limited success, use signal processing methods rather
      than restoring more closely the normal auditory function. We plan to achieve our goal by
      reducing to practice three key enabling concepts. The first is to replace the current
      acoustic transducer with a non-acoustic mechanical output transducer that directly actuates
      the tympanic membrane (TM). This transducer, called the EarLens, floats on the tympanic
      membrane in a manner similar to the way a contract lens floats on the eye. The second is to
      increase the output bandwidth of the hearing aid. The third key concept is to place a
      wide-bandwidth microphone in the ear canal to capture the pinna diffraction cues similarly to
      the way the normal ear functions. Our central hypothesis is that a hearing aid that delivers
      amplified wide-bandwidth mechanical stimuli, directionally dependent cues, in an open canal
      configuration will perform better than conventional hearing aids when there are competing
      talkers in the background. First phase includes verification the capability of the system to
      deliver sufficient maximum equivalent pressure output (MEPO) to treat the degree of hearing
      loss in the target fitting range.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hearing loss less than 60 dB at any frequency, no conductive hearing loss

        Exclusion Criteria:

          -  Collapsed ear canal, damaged or repaired middle ear, too much sensory hearing loss
Investigation of Interactions Between Faldaprevir, Itraconazole, Atorvastatin and Rosuvastatin
Condition: Healthy
Intervention: Itraconazole; Atorvastatin; Faldaprevir; Rosuvastatin; Faldaprevir
Intervention description: twice daily; single dose; once daily; single dose; once daily
Intervention MeSH terms: Itraconazole; Atorvastatin; Rosuvastatin Calcium
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the effect of steady-state itraconazole on the pharmacokinetics of
      steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose
      pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the
      single-dose pharmacokinetics of rosuvastatin
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male and female subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Study of Dasatinib (BMS-354825) in Patients With Solid Tumors
Condition: Tumors
MeSH terms: Neoplasms
Intervention: Dasatinib; Dasatinib; Dasatinib
Intervention description: tablets, Oral, 100 mg, once daily for 4 weeks; tablets, Oral, 150 mg, once daily, 4 weeks; tablets, Oral, 200 mg, once daily for 4 weeks
Intervention MeSH terms: Dasatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Solid tumors (including relapsed disease) that are refractory to standard therapies or for which no effective standard therapy exists

Summary:

      The primary objective of this study is to determine the maximum tolerated dose (MTD) or the
      maximum administered dose (MAD) of Dasatinib (BMS-354825) in patients in Japan.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Performance status (general conditions) specified by the Eastern Cooperative Oncology
             Group: 0-2

          -  Histologic or cytologic diagnosis of a solid tumor which has progressed on or
             following standard therapies (including relapsed disease) or for which no standard
             therapy exists.

          -  men and women, ages 20 and over

          -  women of childbearing potential (WOCBP) must be using an adequate method of
             contraception to avoid pregnancy throughout the study and for up to 3 months after the
             study in such a manner that the risk of pregnancy is minimized

          -  Adequate hepatic function

        Exclusion Criteria:

          -  Participants who are eligible and willing to undergo transplantation at pre- study.

          -  Women who are pregnant or breastfeeding with known brain metastasis or symptoms of
             brain metastasis

          -  Uncontrolled or significant bleeding disorder unrelated to a primary tumor

          -  Dementia or mental illness that would prohibit understanding or giving informed
             consent.

          -  Severe allergy to drugs required for appropriate supportive care of patients in this
             study.

          -  History of gastrointestinal surgery or of any digestive disorder which has the
             potential to inhibit absorption of the study drug.

          -  Pleural effusion > Grade 1

          -  Patient with dysphagia

          -  Does not agree to blood/blood products transfusion(s)

          -  Donated blood over 200 mL within 4 weeks prior to the start of study therapy

          -  Medication that known to have a risk of causing Torsade de pointes

          -  Participants who are compulsorily detained for legal reasons or treatment of either a
             psychiatric or physical (e.g., infectious disease) illness must not be enrolled into
             this study
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Pregnenolone300; Pregnenolone500; Placebo
Intervention description: 300mg; 500mg; placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Double-blind, placebo-controlled, parallel design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No

Summary:

      To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the
      role of neuroactive steroids in individuals with alcohol use disorder (AUD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female individuals, ages 18 to 68.

          -  Subjects must meet current Diagnostic and Statistical Manual of Mental Disorders 5th
             edition (DSM-V) criteria for alcohol use disorder; documented positive urine
             toxicology screen for alcohol at intake or collateral information from family members,
             significant others, room-mates etc., on recent use.

          -  Subject has voluntarily given informed consent and signed the informed consent
             document.

          -  Able to read English and complete study evaluations.

        Exclusion Criteria:

          -  Women who are pregnant, or nursing or are of childbearing potential and not practicing
             an effective means of birth control.

          -  Meet current criteria for use disorder on another psychoactive substance, such as,
             heroin, amphetamines, hallucinogens/Phencyclidine (PCP), excluding alcohol and
             nicotine.

          -  Any current use of opiates or past history of opiate use disorder (assessed via urine
             toxicology and self report).

          -  Current use of any psychoactive drugs (urine toxicology), including anxiolytics,
             naltrexone or antabuse.

          -  Any psychotic disorder or current Axis I psychiatric symptoms requiring specific
             attention.

          -  Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac
             pathology which in the opinion of study physician would preclude patient from fully
             cooperating or be of potential harm during the course of the study.

          -  Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK0893; MK0893-matched Placebo; Propranolol Hydrochloride (HCL)
Intervention description: Single dose of MK0893 1000 mg (ten 100 mg tablets); Single dose of placebo to MK0893 (ten tablets); Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment was approximately 7 weeks.
Intervention MeSH terms: Propranolol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This study will assess the effect of combined treatment with MK0893 plus propranolol versus
      placebo plus propranolol on hypoglycemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has Type 2 Diabetes (T2DM)

          -  Participant is either: Not on an oral antihyperglycemic medication for at least 6
             weeks; on a single oral antihyperglycemic medication that is not a peroxisome
             proliferator-activated gamma (PPAR-gamma) agonist (e.g. Avandia); OR on a combination
             of no more than two antihyperglycemic medications that are not PPAR-gamma) agonists

          -  Participant has not received insulin for at least 6 months

          -  Participant has not been treated with a PPAR-gamma agonist for at least 12 weeks

          -  Participant has been a nonsmoker for at least 6 months

          -  Female participants who are non-pregnant and highly unlikely to conceive due to
             surgical sterilization, post-menopausal status, not heterosexually active, or willing
             to use 2 birth control methods

        Exclusion Criteria:

          -  Participant has a history of stroke, seizures, or neurological disorders

          -  Participant cannot tolerate insulin or propranolol

          -  Participant has a history of asthma, emphysema or chronic bronchitis

          -  Participant is on a weight loss program that is not in the maintenance phase or has
             been treated with a weight loss medication within 8 weeks of screening

          -  Participant is on or may require treatment with drugs that affect the immune system or
             with corticosteroids

          -  Participant has a history of heart failure or coronary artery disease

          -  Participant has a history of uncontrolled high blood pressure

          -  Participant is Human Immunodeficiency (HIV), hepatitis B or hepatitis C positive

          -  Participant has a history of Type 1 diabetes

          -  Participant has a history of hypoglycemia unawareness documented by a blood glucose
             concentration < 55 mg/dL (3.1 mol/L) without symptoms of hypoglycemia.