bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Two Imiquimod Cream 5%
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Imiquimod 5% manufactured by Taro; Aldara - Imiquimod 5%; Imiquimod Vehicle manufactured by Taro
Intervention description: Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks; Treatment applied as a thin layer to target area once a day, 2 days each week, for 16 weeks; Treatment applied as a thin layer to target area once daily, 2 days each week, for 16 weeks
Intervention MeSH terms: Imiquimod
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 425.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic Keratosis

Summary:

      The primary objectives are to establish the therapeutic equivalence of imiquimod cream 5%,
      manufactured by Taro Pharmaceuticals Inc. and Aldara (imiquimod) cream, manufactured by 3M,
      and to show superiority over vehicle in the treatment of AK.

      The secondary objective is to compare the adverse event (AE) profiles of the two creams.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have 4 to 8 clinically diagnosed, non-hyperkeratotic, non-hypertrophic
             AK lesions within a 25 cm2 contiguous treatment area on either the face or balding
             scalp

          -  Women either must be 1 year post-menopausal, surgically sterile, or agree to use a
             medically accepted form or birth control

          -  Free of any systemic or dermatological disorder

          -  Any skin type or race, providing the skin pigmentation will allow discernment of
             erythema

        Exclusion Criteria:

          -  Basal cell or squamous cell carcinoma, or other possible confounding skin conditions
             (on face and scalp)

          -  History of cutaneous hyperreactivity or facial irritation to topical products

          -  Engaging in activities involving excessive or prolonged exposure to sunlight

          -  Receiving systemic cancer chemotherapy, psoralen plus UVA therapy, UVB therapy, laser
             abrasion, dermabrasion, glycolic acids, or chemical peels 6 months prior to study
             entry

          -  Currently using or have used systemic steroids 2 months prior to study

          -  Currently using or have used on the treatment area over-the-counter retinol products,
             corticosteroids, cryosurgery, curettage, 5-fluorouracil, or other topical actinic
             keratosis treatments 28 days prior to randomization

          -  Pregnant or nursing mothers

          -  History of allergy or sensitivity to imiquimod or related compounds or other
             components of the formulation

          -  Taking immunosuppressant medication
Evaluation of Efficacy of Photodynamic Therapy in Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: photodynamic therapy
Intervention description: treatment of bcc with 5_ALA cream 20% topical administration once monthly+ photodynamic therapy (red light) 120 j/cm2 once monthly
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: basal cell carcinoma; photodynamic therapy; photo chemotherapy; basal cell epithelioma

Summary:

      The purpose of this study is to evaluate the efficacy of pdt in treatment of bcc and factors
      that affect response rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven BCCs

        Exclusion Criteria:

          -  rodent ulcer

          -  morphea type

          -  ANA +

          -  history of photosensitivity or photodermatosis or ingestion of phototoxic drugs during
             last month

          -  pregnancy

          -  breast feeding

          -  age< 18

          -  history of another therapeutic intervention for bcc during last 6 months
Vitamin D for Chemoprevention
Condition: Gastrointestinal Cancers; Prostate Cancer; Hypertension
MeSH terms: Gastrointestinal Neoplasms; Hypertension
Intervention: Vitamin D; Placebo
Intervention description: Taken orally every day for three months; Placebo pill taken once daily for 3 month
Intervention MeSH terms: Vitamin D
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 328.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vitamin D; Blacks; cancer; hypertension

Summary:

      This study will help us know the effects of Vitamin D pills in Blacks. The results of this
      study may be the first step in creating ways to prevent the risks of colon and prostate
      cancer. It will also help us develop ways to reduce colon cancer and prostate cancer among
      Blacks. This study will find out if Vitamin D pills can increase Vitamin D to healthy levels
      in our bodies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between the ages of 30 and 80 years

          -  Comfortable communicating in English

          -  Currently has a primary care physician

          -  Willing to discontinue vitamin D or calcium supplements

          -  Willing to have all protocol specific tests run

        Exclusion Criteria:

          -  Plans on taking a vacation or travel to a sunny region within 3 months of vitamin
             supplementation period except for a short period (i.e. 1 weekend)

          -  Pregnant or breast feeding or planning on becoming pregnant in the following year

          -  Pre-existing calcium (including hypercalcemia), parathyroid conditions (including
             hyperparathyroidism), sarcoidosis

          -  No concurrent active malignancies (other than non-melanoma skin cancer) or previous
             diagnosis of prostate cancer

          -  Cognitively impaired

          -  Active thyroid disease (e.g. Graves, Hashimoto's or thyroiditis)

          -  History of nephrolithiasis, chronic liver disease, chronic renal disease, or renal
             dialysis
Dose-Titration and Open-label Extension Study of SRP-4045 in Advanced Stage Duchenne Muscular Dystrophy (DMD) Patients
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: SRP-4045; Placebo
Intervention description: SRP-4045 solution for IV infusion.; SRP-4045 placebo-matching solution for IV infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: Male
Minimum age: 7 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Duchenne muscular dystrophy; Exon Skipping

Summary:

      This is a first-in-human dose-titration and open-label extension study to assess safety,
      tolerability, and pharmacokinetics of SRP-4045 in advanced-stage Duchenne muscular dystrophy
      (DMD) patients with deletions amenable to exon 45 skipping.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotypically confirmed DMD (amenable to exon 45 skipping).

          -  Stable cardiac and pulmonary function.

          -  Limited or no ambulation.

          -  On a stable dose of oral corticosteroids for at least 24 weeks OR has not received
             corticosteroids for at least 24 weeks.

        Exclusion Criteria:

          -  Current or previous treatment with the experimental agents SMT C1100 (BMN-195) or
             PRO045.

          -  Other experimental treatment in the past 12 weeks.

          -  If on cardiac medication, must be on a stable dose for the past 12 weeks.

          -  Major surgery within the past 3 months.

        Other inclusion/exclusion criteria apply.
Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
Condition: Neoplasm Metastasis
MeSH terms: Neoplasm Metastasis; Neoplasms
Intervention: DS-8201a; Ritonavir; Itraconazole
Intervention description: DS-8201a is provided as a sterile lyophilized powder of DS-8201a in a glass vial, which will be dissolved and administered as an intravenous (IV) solution; Ritonavir is a OATP1B inhibitor; an antiretroviral tablet for oral administration; Itraconazole is a CYP3A inhibitor; an antifungal tablet for oral administration
Intervention MeSH terms: Ritonavir; Itraconazole; Trastuzumab deruxtecan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Unresectable or metastatic solid malignant tumors; Solid malignant tumors; Oncology; HER2; Antibody drug conjugate; ADC

Summary:

      HER2-positive cancer is a cancer that tests positive for a protein called human epidermal
      growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study
      will test an experimental drug called DS-8201a that has not been approved by the health
      authorities yet.

      DS-8201a will be tested for safety in patients with advanced solid malignant tumors that test
      positive for HER2. It also will test how DS-8201a moves within the body (pharmacokinetics).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a pathologically documented unresectable or metastatic solid malignant tumor, with
             HER2 expression [immunohistochemistry (IHC) 3+, 2+, or 1+ and/or in situ hybridization
             (ISH) +], Next Generation Sequencing, or other analysis techniques as appropriate]
             that is refractory to or intolerable with at least one prior systemic chemotherapy
             regimen, or for which no standard treatment is available

          -  Has a left ventricular ejection fraction (LVEF) ≥ 50%

          -  Has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1

        Exclusion Criteria:

          -  Has a contraindication for receiving ritonavir or itraconazole according to the
             prescribing information

          -  Has a medical history of myocardial infarction within 6 months before enrollment or
             symptomatic congestive heart failure
The Study of Regional Hemodynamic Changes After Specific Brachial Plexus Block by Ultrasound Guidance
Condition: Upper Limb Nerve Block
Intervention: specific nerve block; ropivacaine
Intervention description: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region; Different concentration of ropivacaine
Intervention MeSH terms: Ropivacaine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: hemodynamics; anaesthetics; brachial plexus; peripheral nerves; skin temperature; sympathetic nervous system; dose-response relationship

Summary:

      Phase 1 Sympathetic block leads to vasodilatation and increases in blood flow. However,
      regional hemodynamic changes of radial and ulnar artery after specific nerve block of
      brachial plexus remains unclear. The aim of the study is to assess the effect of specific
      nerve block of brachial plexus on hemodynamics of upper extremity, and provides evidence for
      further research in patient undergoing microvascular surgery.

      Phase 2 There is no literature about dose-finding studies of sympathetic block after brachial
      plexus block. Little is known regarding the relationship between concentration of local
      anaesthetic and vasodilation of upper extremity. The aim of this randomized, double-blind,
      prospective dose-response study is to determine the ED50 and ED95 of ropivacaine in
      sympathetic block of upper extremity after supraclavicular block
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologist physical status I-III patients

          -  aged 18-70 yr

          -  weighing 40-80 kg

        Exclusion Criteria:

          -  infection at the site of needle insertion

          -  coagulopathy

          -  international normalized ratio >1.4

          -  platelet count <80×109 litre-1

          -  allergy to local anaesthetics

          -  peripheral neurological disease

          -  peripheral vascular disease

          -  patients do not agree to sign the informed consent.
Investigation of Drug-drug Interaction of Nintedanib and Ketoconazole in Healthy Male Volunteers
Condition: Healthy
Intervention: Nintedanib; Nintedanib; Ketoconazole; Nintedanib; Nintedanib; Ketoconazole
Intervention description: low or medium dose depending on pilot part; low dose oral administration; oral administration; low dose oral administration; low or medium dose depending on pilot part; oral administration
Intervention MeSH terms: Ketoconazole; Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current study is to investigate the relative bioavailability of a single
      dose of nintedanib low or high dose with and without coadministration of ketoconazole at
      steady state
    

Eligibility criteria:

        Inclusion criteria:

        1. healthy male subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
The Rilpivirine Cerebrospinal-fluid (CSF) Study
Condition: HIV
Intervention: Rilpivirine
Intervention description: Rilpivirine 26mg
Intervention MeSH terms: Rilpivirine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rilpivirine CSF pharmacokinetics

Summary:

      This is a phase I pharmacokinetic study of HIV positive patients stable on antiretroviral
      therapy who will switch treatment when enrolled from nevirapine to rilpivirine. On day 60 of
      the study the participants will attend clinic where they will have blood collected followed
      by a lumbar puncture where cerebrospinal fluid will be collected to measure drug
      concentration. The participants will then restart their original regime with nevirapine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected males subjects

          -  signed informed consent

          -  willing to switch therapy as per study protocol

          -  no previous exposure to rilpivirine

          -  plasma HIV RNA < 50 copies/mL at screening and on at least one other occasion over the
             last 3 months

          -  currently receiving a stable antiretroviral regimen comprising of TDF/FTC with
             nevirapine with nevirapine dosed either 200 mg twice daily or 400 mg once daily with
             no antiretroviral drug switches for at least 3 months

          -  no clinically-significant resistance documented on any prior HIV-1 genotypic
             resistance testing

          -  subjects in good health upon medical history, physical exam, and laboratory testing

          -  BMI above or equal to 18 and below 32

          -  Male subjects who are heterosexually active must use two forms of barrier
             contraception (e.g., condom and diaphragm) during heterosexual intercourse, from
             screening through completion of the study.

          -  Have local screening laboratory results (haematology and chemistry that fall within
             the normal range of the central laboratory's reference ranges unless the results have
             been determined by the Investigator to have no clinical significance

          -  No contraindications to having a lumbar puncture examination found on MRI of the brain

        Exclusion Criteria:

          -  current alcohol abuse or drug dependence

          -  positive urine drug of abuse screening

          -  active opportunistic infection or significant co-morbidities

          -  current disallowed concomitant medication (as listed in section 4.1.3)

          -  contraindication to MR examination or lumbar puncture examination

          -  recent head injury (in last 30 days) or chronic ongoing neurological diseases
A Study of OPC-41061 Orally Disintegrating (OD) Tablets Using 2 Different Formulations and 2 Dosing Regimens in Healthy Adult Male Subjects
Condition: Healthy Adult Male
Intervention: OPC-41061
Intervention MeSH terms: Tolvaptan
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: Male
Minimum age: 20 Years
Maximum age: 39 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15
      and 30 mg in healthy adult male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight of at least 50.0 kg

          -  BMI [body weight in kg / (height in m)2] of at least 17.6 kg/m2 and less than 25.0
             kg/m2

          -  Judged by the investigator or subinvestigator to be capable of providing written
             informed consent prior to the start of any trial-related procedures and capable of
             complying with the trial procedures for this study.

        Exclusion Criteria:

          -  Judged by the investigator,subinvestigator, or sponsor to have a clinically
             significant abnormality in results of the screening examination (including a notable
             deviation from the site's standard values) or a medical history that could place the
             subject at risk or affect the evaluation of drug absorption, distribution, metabolism,
             or excretion

          -  History of alcohol or drug dependence or abuse within 2 years prior to the trial

          -  History or current infection with hepatitis or acquired immunodeficiency syndrome
             (AIDS) or carrier of hepatitis B positive surface antigen (HBsAg), anti-hepatitis C
             virus (HCV), human immunodeficiency virus (HIV), or syphilis based on the results of
             the Treponema pallidum (TP) antibody test or rapid plasma reagin (RPR) test

          -  History of any severe drug allergy

          -  Positive results in alcohol screening test or urine drug screening test at time of
             screening examination or trial site admission

          -  Use of any other investigational medicinal product (IMP) within 120 days prior to
             Period 1 IMP administration

          -  Consumption of any food or beverage containing St. John's wort within 14 days prior to
             Period 1 IMP administration

          -  Consumption of any food or beverage containing grapefruit, Seville orange, or star
             fruit within 7 days prior to Period 1 IMP administration

          -  Judgment by the investigator or subinvestigator that the subject should not
             participate in the study for any other reason.
CAVATAK (CVA21) in Non-muscle Invasive Bladder Cancer (VLA-012 CANON)
Condition: Non-muscle Invasive Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms
Intervention: CVA21; Mitomycin C
Intervention description: CAVATAK is a purified preparation of CVA21; Chemotherapy
Intervention MeSH terms: Mitomycins; Mitomycin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Coxsackievirus A21; bladder cancer; CVA21; CAVATAK

Summary:

      The study consisted of 2 sequential parts. Part A assessed the safety and tolerability of
      CAVATAK administered via intravesical instillation in patients with non-muscle invasive
      bladder cancer scheduled to undergo TUR. Part B assessed the safety and tolerability of
      CAVATAK administered in sequential combination with low dose Mitomycin C in the same patient
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of NMIBC based on cystoscopic appearance

          -  ECOG 0-2

          -  No intravesical therapy within 6 weeks of study entry

          -  No prior radiation to the pelvis

          -  ANC >1500/mm³; Hb >9.0 g/dL; Platelet >100000/mm³

          -  Serum creatinine ≤ 1.5 mg/dL

          -  Bilirubin within normal limits; AST ≤ 2.5x upper limit of normal (ULN); ALT ≤ 2.5 x
             ULN; alkaline phosphatase ≤ 2.5x ULN unless bone metastasis is present in the absence
             of liver metastasis

          -  INR < 1.2; aPPT = 0.8-1.2; PT = 0.9-1.8

          -  Candidate for TUR and planning to undergo TUR

          -  Negative pregnancy test within 7 days of treatment start

          -  Patients of child-bearing potential must agree to use an effective method of birth
             control

        Exclusion Criteria:

          -  Prior local or systemic treatments for NMIBC

          -  Concurrent treatment with any chemotherapeutic agent

          -  Patients not deemed acceptable for general anaesthesia

          -  Women who are pregnant or lactating

          -  History of vesicoureteric reflux or an indwelling urinary stent

          -  Administration of an investigational agent within 3 months of study entry

          -  Active cardiac disease

          -  Known infection with HIV, hepatitis B or C

          -  Active uncontrolled infection