bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety, Tolerability, and Blood Pressure Effect of an Oral Dose of Sumatriptan Alone and in Combination With MK-0974 (Telcagepant) in Migraine Patients (0974-026)
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: telcagepant potassium; sumatriptan; sumatriptan placebo; telcagepant potassium placebo
Intervention description: Single oral dose of 2 x 300 mg capsules.; single oral dose of 100 mg sumatriptan; single oral dose; single oral dose of 2 MK-0974 placebo capsules
Intervention MeSH terms: Sumatriptan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Study to understand the effects of migraine treatments on blood pressure in participants with
      migraine. The primary hypothesis is that the effect on semi-recumbent mean arterial pressure
      following the coadministration of telcagepant and sumatriptan is similar to that following
      administration of sumatriptan alone. That is, the true mean treatment difference (sumatriptan
      with telcagepant sumatriptan alone) in time-weighted mean arterial pressure for 2.5 hours
      following dosing is less than 5 mmHg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  History of migraine for longer than 6 months.

          -  Free from migraine 24 hours before each dosing.

          -  Judged to be in good health.

          -  Nonsmoker

        Exclusion Criteria:

          -  Under age of legal consent.

          -  Legally or mentally incapacitated or has significant emotional problems.

          -  Taking any medications from about 2 weeks before the first dose of study medication.

          -  Has had surgery or donated blood or participated in another investigation study within
             4 weeks prior to screening

          -  Currently a regular user of any illicit drugs or has a history of drug/alcohol abuse
             within about 2 years

          -  Consumes more than 6 caffeinated beverages per day
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
Condition: Chronic Kidney Disease, Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Etelcalcetide
Intervention description: A single IV-bolus dose of 0.035 mg/kg etelcalcetide into the venous line of the dialysis circuit at the end of a hemodialysis session.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Secondary Hyperparathyroidism, chronic kidney disease, hemodialysis

Summary:

      This is a study to evaluate the safety and pharmacokinetics in pediatric patients with
      secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of
      hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject's parent has provided informed consent and subject has provided assent

          -  Children Age 2 to less than 18 years

          -  Diagnosed with chronic kidney disease

          -  Diagnosed with secondary hyperparathyroidism receiving hemodialysis,

          -  Weighing at least 7 kg

          -  Laboratory results within specified range.

        Exclusion Criteria:

          -  Currently receiving treatment in another investigation device or drug study

          -  Subject has received cinacalcet therapy within 30 days

          -  History of prolongation QT interval

          -  Subject is taking any medications that are on the QT prolongation medication list

          -  Electrocardiograph (ECG) measurements within specified range.
Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405
Condition: Hypertension(HTN)
MeSH terms: Hypertension
Intervention: HGP0904; HGP0608; HGP1405
Intervention MeSH terms: Losartan; Amlodipine; Chlorthalidone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Male
Minimum age: 19 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate the pharmacokinetic interaction and safety
      between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy
      male volunteers
    

Eligibility criteria:

        Inclusion Criteria:

          -  19~45 years old

          -  Healthy men

        Exclusion Criteria:

          -  Gastroentestinal disease affecting drug absorption
A Study Comparing Two Topicals in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: FMX101 vehicle; Hydro-alcohol solution
Intervention description: FMX101 vehicle - hydrophobic oil based vehicle (Test Article A); Hydro-alcohol solution based vehicle (Test Article B)
Intervention MeSH terms: Minocycline
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects will be randomized (1:1) to treatment with Test Article A to one side of the face versus Test Article B on the contralateral side.
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      A Randomized, Evaluator-Blinded, Bilateral Comparison Study to Evaluate the Safety and
      Efficacy of Two Topicals in the Treatment of Subjects With Acne Vulgaris (Study FX2018-23).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has facial acne vulgaris with:

             16 inflammatory lesions (papules, pustules) The inflammatory lesion count on the right
             and left side of the face should be similar IGA score of moderate (3) on both the
             right and left side of the face

        Exclusion Criteria:

          -  Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any
             dermatological condition of the face or facial hair (eg, beard, sideburns, mustache)
             that could interfere with the clinical evaluations.

          -  More than two facial nodules/cysts

          -  Sunburn on the face
A Multiple-Dose Study of MK-1006 (MK-1006-004)(TERMINATED)
Condition: Type 2 Diabetes
Intervention: MK-1006; Comparator: Placebo comparator
Intervention description: MK-1006 capsules (10 mg and 20 mg) administered orally from 20 mg to 120 mg per dose over a multiple dosing period.; Dose-matched MK-1006 placebo capsules (1 mg, 10 mg and 20 mg) administered orally over a multiple dosing period.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will asses the safety, tolerability, multiple-dose pharmacokinetics and
      pharmacodynamics of MK1006 in participants with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant has a BMI less than or equal to 42 kg/m^2 at the screening visit

          -  Participant has been diagnosed with Type 2 Diabetes that is being treated either by
             diet and exercise alone or by single or combination oral anti-hyperglycemic
             medications

          -  Participant is willing to follow a diet containing approximately 50% carbohydrates,
             20% protein, and 30% fat during the study

          -  Participant is a nonsmoker and has not used nicotine containing products for ~ 6
             months before start of study

        Exclusion Criteria:

          -  Participant must not be treated with three or more oral anti-hyperglycemic
             medications, insulin, or PPAR-gamma agonists

          -  Participant has a history of stroke, chronic seizures, or a major neurological
             disorder

          -  Participant has had an eye infection or other inflammatory eye condition within 2
             weeks of first dose of study drug

          -  Participant has glaucoma or is blind

          -  Participant has a condition known to be related to cataract development

          -  Participant has had or will have incisional eye surgery within 6 months before
             screening or has had laser surgery (other than Lasik) within 3 months of screening

          -  Participant has a history of type 1 diabetes or ketoacidosis

          -  Participant cannot stop taking certain current medications during the study

          -  Participant consumes greater than 3 alcoholic beverages per day

          -  Participant consumes more than 6 servings of caffeinated beverages per day (1 serving
             is ~ 120 mg caffeine)

          -  Participant has a history of significant multiple or severe allergies or has had a
             reaction to or is intolerant of prescription/non-prescription drugs or food

          -  Participant uses recreational drugs or has had a history of drug abuse within 6 months
             of start of study
Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution
Condition: Healthy
Intervention: Placebo; BI 1015550; BI 1015550; BI1015550; BI 1015550
Intervention description: Placebo to BI 1015550; medium dose 1 powder for oral solution; medium dose 2 powder for oral solution; low dose 2 powder for oral solution; low dose 1 powder for oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI
      1015550 in healthy male volunteers
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male subjects

        Exclusion criteria:

          1. Any relevant deviation from healthy conditions

          2. Subjects unable to understand or to comply with study requirements
Intracavernosal Injection of Botulinum Toxin Type A in the Treatment of Vascular Erectile Dysfunction
Condition: Vasculogenic Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Intervention: Botulinum Toxin Type A; Normal Saline
Intervention description: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A.; The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: Male
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Evidence has been arising that Botulinum toxin injections can relax smooth muscles fibers in
      the treatment of obesity and hyperactive bladder. Would a similar effect on cavernosal smooth
      muscles help in the treatment of resistant erectile dysfunction not responding to medical and
      injection therapy, thus avoiding surgical treatment options.

      The treatment group will be injected intracavernously with 50 units of BTX-A. The control
      group, 12 patients, will be injected with a normal saline injection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  24 males will be included in the study recruited from Andrology, Sexology & STD's
             outpatient clinic, Kasr El Aini Hospitals, Cairo University, complaining of Vascular
             ED proved by penile duplex.

          -  Unable to develop erections sufficient for intercourse.

          -  Failing to respond to first line and second line treatments for Erectile Dysfunction
             with surgery as the only remaining treatment option.

          -  Age between 40 to 70 years.

        Exclusion Criteria:

          -  Significant cardiovascular disease interfering with sexual activity
Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics
Condition: Healthy Volunteers
Intervention: Copanlisib (Aliqopa, BAY80-6946); Metformin
Intervention description: The copanlisib dose for this study is the standard dose recently approved and also used in Phase 1, 2 and 3 studies across the copanlisib development program: 60 mg i.v. infusion administered intermittently on Days 1, 8 and 15 of a 28-day cycle.
In this study subjects will receive a single i.v. dose of 60 mg copanlisib on day 8.; Single dose of 1000 mg is administered orally.
Intervention MeSH terms: Metformin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to learn about a drug-drug interaction. When two medications are
      taken together at the same time, one medication may change the activity of the other
      medication in the body - this is called a drug-drug interaction. This study is looking at the
      effect the Bayer study drug, copanlisib, has on metformin, a commonly used medication to
      treat diabetes. During the study, blood and urine samples will be collected and analyzed to
      learn about pharmacokinetics (how copanlisib changes metformin levels in the body) and
      pharmacodynamics (the effect metformin has on the body when taken together with copanlisib)
      when someone takes both copanlisib and metformin together.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female subjects - as determined by the investigator or medically
             qualified designee based on medical evaluations, including medical history, physical
             examination, laboratory tests and cardiac monitoring

          -  Aged 18 to 45 years at the first screening visit

          -  Body Mass Index (BMI) of 18.0 - 34 kg / m*2 , with body weight ≥ 50 kg

          -  Creatinine clearance ≥ 90 mL/min using the Modification of Diet in Renal Disease

          -  Adequate end organ and bone marrow function

        Exclusion Criteria:

          -  Existing relevant diseases of vital organs (e.g. liver diseases, heart diseases),
             central nervous system (for example seizures) or other organs (e.g. diabetes mellitus)

          -  Incompletely cured pre-existing diseases for which it can be assumed that the
             absorption, distribution, metabolism, elimination and effects of the study drugs will
             not be normal

          -  Relevant respiratory insufficiency / disorder

          -  Administration of strong CYP3A4 inhibitors or inducers within 2 weeks prior to dosing

          -  Known history of hypersensitivity (or known allergic reaction) to copanlisib,
             metformin, related compounds, or any components of the formulation
Exploratory Study to Evaluate QR-010 in Subjects With Cystic Fibrosis ΔF508 CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: QR-010
Intervention description: Single-stranded RNA antisense oligonucleotide in isoosmolar solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; CF; ΔF508; CFTR; QR-010; antisense oligonucleotide; RNA therapy; F508del; NPD; nasal potential difference

Summary:

      Exploratory proof of concept study to determine whether intranasal administration of QR-010
      in subjects with cystic fibrosis, homozygous or compound heterozygous for the ΔF508 mutation,
      can increase the function of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF as defined by iontophoretic pilocarpine sweat chloride test
             (sweat chloride) of > 60 mmol/L

          -  Nasal potential difference (NPD) measurement at Screening consistent with CF

          -  Confirmation of CFTR gene mutations homozygous or compound heterozygous for the ΔF508
             mutation

          -  Body mass index (BMI) of ≥ 18 kg/m2

          -  Non-smoking for a minimum of 2 years

          -  Stable lung function

          -  FEV1 ≥40% of predicted normal for age, gender, and height at Screening

        Exclusion Criteria:

          -  Breast-feeding or pregnant

          -  Acute allergy or infection affecting nasal conditions not resolved within 14 days
             prior Screening

          -  Use of lumacaftor or ivacaftor

          -  Use of any investigational drug or device

          -  Hemoptysis
Single Dose CHG Pharmacokinetic Study
Condition: Surgical Skin Preparation
Intervention: Chlorhexidine Gluconate
Intervention description: 2% CHG
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking description: laboratory-blinded, 3-period, 3-sequence, crossover study
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A single 2% topical application of ReadyPrep® CHG was applied on either the abdomen
      (Treatment-1) or the groin (Treatment-2) whereas Treatment-3 consisted of a control treatment
      where the same procedure as Treatment-1 and -2 was performed, but without the topical
      application of ReadyPrep® CHG. The treatments were separated by a wash-out of 7 calendar
      days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects were male or female, aged ≥ 18 and ≤ 60 years (inclusive). The main inclusion
             criteria were:

               -  non- or ex-smokers

               -  body mass index (BMI) ≥19.00 kg/m2 and ≤32.00 kg/m2 and a body weight ≥ 55 kg

               -  negative pregnancy test for female subjects

               -  healthy according to medical history, complete physical examination (including
                  vital signs and skin examination) and laboratory tests (general biochemistry,
                  hematology and urinalysis)
The Efficacy of Doxazosin for Cocaine Users
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Doxazosin; Placebo
Intervention description: Medication induction occurred at a rate of 2mg/week until 8mg/day target dose was achieved as follows:
Dox-Fast Group: Defined as participants reaching the target dose after a 4-week titration period. Participants were stabilized on doxazosin or placebo over weeks 4-13 (for Dox-Fast group)
Dox-Slow Group: Defined as participants reaching the target dose after an 8-week titration period. Participants were stabilized on doxazosin or placebo over weeks 8-13 (for Dox-Slow group)
Both doxazosin groups will be tapered off doxazosin or placebo over study weeks 14-17.; Participants will be administered a sugar pill to mimic the doxazosin active medication with administration being the same as the active medication.
Intervention MeSH terms: Doxazosin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Cocaine Dependence; Substance Related Disorders

Summary:

      Doxazosin, an alpha 1-adrenergic receptor, may play an important role in cocaine addiction in
      humans. This study will evaluate the effectiveness of doxazosin in preventing drug relapse
      among cocaine dependent participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV diagnosis criteria for cocaine dependence, as determined by self-reported
             use of cocaine at least once weekly for at least 1 month prior to study entry; a
             positive urine test for cocaine; and a score greater than 3 on the Severity of
             Dependence Scale

          -  If female, willing to use contraception throughout the study

        Exclusion Criteria:

          -  Meets DSM-IV diagnosis criteria for dependence on any drugs other than cocaine, or
             tobacco

          -  Current major psychiatric illness, including schizophrenia, bipolar disorder, or other
             psychotic disorder

          -  Current suicidal or homicidal ideation

          -  Current use of a prescribed psychotropic medication that cannot be discontinued

          -  History of or current major medical illness, including major heart, kidney, endocrine,
             or liver disorder; abnormal liver function (SGOT or SGPT levels three times greater
             than normal); or high blood pressure or low blood pressure

          -  High risk factor for heart disease, seizure disorders, or any illness for which
             disulfiram or methadone treatment would be inadvisable

          -  Currently taking metronidazole or clotrimazole

          -  Pregnant or breastfeeding