bioihbjkbjnl/mcl2 huggingface dataset:
To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
Condition: Healthy
Intervention: RP6530
Intervention description: Single oral dose
Intervention MeSH terms: Tenalisib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Fasting; Fed condition; Pharmacokinetics

Summary:

      This is a single centre, open label, randomized, two-treatment, two-period, two-sequence,
      single dose crossover food effect study in 18 subjects. The subjects will receive the study
      medication under either fed or fast during each treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male volunteers; aged 18 to 45 years;

          -  Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥ 50 kg;

          -  Non- smokers or ex-smokers;

          -  Able to give informed consent.

        Exclusion Criteria:

          -  Subjects with evidence or history of clinically significant disease;

          -  Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis
             B)) or Hepatitis C Virus (HCV (C)) tests;

          -  Subjects who have received any investigational drug in the previous 28 days;

          -  Subjects participated in a study with PI3k inhibitors at least once in past year;

          -  Subjects who have received drugs metabolised by CYP3A4 enzyme in the previous 28 days.
Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Condition: Cervical Intraepithelial Neoplasia Grade 2/3; High-risk HPV (Any Strain)
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Intervention: Artesunate Suppositories
Intervention MeSH terms: Artesunate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cervical dysplasia; HPV; Treatment; preinvasive; cervix; vaginal suppository; Cornelia Trimble; abnormal pap; CIN

Summary:

      This phase I research protocol is designed to assess immunogenicity and clinical endpoints in
      patients with human papillomavirus (HPV) 16 cervical intraepithelial neoplasia (CIN)2/3. The
      protocol tests the use of artesunate in suppository formulation applied intravaginally in
      patients with cervical dysplasia (CIN2/3).

      The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility
      of intravaginal administration of artesunate in health women with CIN2/3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years

          -  Capable of informed consent

          -  HPV-positive by DNA test

          -  Histologically confirmed CIN 2, CIN 3, or CIN 2/3

          -  Body weight ≥ 50 kg

          -  Immune competent

        Exclusion Criteria:

          -  Pregnant and nursing women

          -  HIV seropositive

          -  Active autoimmune disease

          -  Taking immunosuppressive medication

          -  Evidence of concurrent adenocarcinoma in situ

          -  Concurrent malignancy except for nonmelanoma skin lesions
Single Dose Partial Breast Radiotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Radiosurgery
Intervention description: Single dose or radiation in 15Gy, 18Gy or 21Gy
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Female
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cancer of Breast; Cancer of the Breast; Neoplasms, Breast; Single dose radiation; Radiotherapy; Preoperative

Summary:

      This study seeks to determine the maximum tolerated dose of a single-dose partial breast
      radiation given before lumpectomy using a radiosurgery technique. Lumpectomy will be
      performed within 3 weeks (+/- 1 week) of completing radiation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with a biopsy proven diagnosis of low/intermediate grade ductal carcinoma in
             situ or invasive ductal (or other favorable histology) carcinoma of the breast

          -  Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging
             evidence of multicentric or multifocal disease, no pregnant women, and no comorbid
             conditions precluding surgery)

          -  Clinical T1N0M0

          -  55 years of age or older

          -  Estrogen receptor (ER) positive,

          -  No evidence of lymphovascular space invasion on initial biopsy

          -  Not pregnant. If not post-menopausal must adhere to birth control measures

          -  White blood cell count > 3000, Hemoglobin > 9, platelets >100000

          -  Must be eligible for MRI on initial evaluation and GFR at least 60 ml/min

        Exclusion Criteria:

          -  Neoadjuvant chemotherapy

          -  Breast implants

          -  Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus,
             rheumatoid arthritis, scleroderma)

          -  Patients unable to receive study treatment planning secondary to body habitus or
             inability to lie flat on the stomach at length

          -  HER-2/neu positive

          -  Positive serum pregnancy test
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
Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Intervention: Pembrolizumab
Intervention description: Arm1：Pre-operative Pembrolizumab+chemoradiotherapy
Intervention MeSH terms: Pembrolizumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Participants will receive carboplatin (AUC=2) IV and paclitaxel (50mg/m²) IV on day 1,8,15,22,29. And radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week. Participants will also receive pembrolizumab (2mg/kg) IV on days 1 and 22. Surgery will be performed within 6 weeks after completion of preoperative therapy described above
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: esophageal squamous cell carcinoma; neoadjuvant chemoradiotherapy; pembrolizumab; immune therapy; checkpoint inhibitor

Summary:

      This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy
      with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell
      carcinoma. And this study will provide valuable information for further clinical trials of
      preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A patient will be eligible for inclusion in this study only if ALL of the following
             criteria apply:

               1. Histologically confirmed cT2-T4a,N0-N+,M0 resectable esophageal squamous cell
                  carcinoma

               2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

               3. Patients approve and sign the informed consent

        Exclusion Criteria:

          -  1. Patients with active autoimmune disease or history of autoimmune disease 2.
             Patients who have a condition requiring systemic treatment with either corticosteroids
             or other immunosuppressive medications 3. Subjects with a history of symptomatic
             interstitial lung disease 4. History of allergy to study drug components 5. Women must
             not be pregnant or breast-feeding 6. Men with female partners (WOCBP) that are not
             willing to use contraception 7. Patient has received prior chemotherapy, radiotherapy,
             target therapy and immune therapy for this malignancy or for any other past malignancy
             8. Underlying medical conditions that, in the Investigator's opinion, will make the
             administration of study drug hazardous or obscure the interpretation of toxicity or
             adverse events
Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
Condition: Head and Neck Cancer
MeSH terms: Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Metformin; Cisplatin; Radiation Therapy
Intervention description: Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.; Dosed at 100mg/m2 on days 1, 22, and 43; 70 Gy in 2 Gy once daily fractions of 35 fractions
Intervention MeSH terms: Metformin; Cisplatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety of adding metformin to standard of
      care. The standard of care treatment will be cisplatin once every 3 weeks for 3 treatments
      and radiation for 7 weeks.

      Metformin is a medication that is currently used to treat diabetes. Increasing amounts of
      metformin will be given to groups of patients already receiving normal treatment for their
      cancer to see if metformin causes any good effects by killing your cancer or bad effects
      (side effects).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced squamous cell cancer of the head and neck, stage III or IV disease
             (T1-2, N2a-3 or T3-4).

          -  Measurable disease

          -  No prior chemotherapy or radiation for head and neck squamous cell cancer

          -  Life expectancy of greater than 3 months.

          -  Adequate labs

        Exclusion Criteria:

          -  Known metastatic disease.

          -  Nasopharyngeal carcinoma

          -  History of allergic reactions attributed to metformin or other agents used in study.

          -  Known diagnosis of diabetes requiring insulin for control.

          -  Administration of metformin within last 4 weeks.
A Study of LY3164530 in Participants With Cancer
Condition: Neoplasms; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis
Intervention: LY3164530
Intervention description: Administered IV.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the safety of a study drug known as LY3164530
      in participants with cancer that is advanced and/or has spread to another part(s) of the
      body.
    

Eligibility criteria:

        Inclusion Criteria

          -  Have advanced or metastatic cancer and be an appropriate candidate for experimental
             therapy.

          -  Have adequate organ function.

          -  Prior Treatments:

               -  Systemic treatments: Must have discontinued previous systemic treatments for
                  cancer and recovered from the acute effects of therapy. Participants must have
                  discontinued:

                    -  Cytotoxic therapies or targeted agents that are small molecule inhibitors
                       for 5 half-lives or at least 28 days.

                    -  Mitomycin-C or nitrosourea therapy for at least 42 days and biologic agents
                       for at least 28 days.

               -  Radiation therapy and surgery must be completed 4 weeks prior to therapy, except
                  for limited field radiation therapy, which must be completed 2 weeks before
                  therapy.

          -  If participant is of reproductive potential, must agree to use medically approved
             contraceptive precautions during the study and for three months following the last
             dose of study drug.

          -  If the participant is a female of childbearing potential, must have had a negative
             serum or urine pregnancy test within 14 days of the first dose of study drug and must
             not be breast feeding.

        Exclusion Criteria:

          -  Must not have taken an unapproved drug as treatment for any indication within the last
             28 days prior to starting study treatment.

          -  Must not have an active symptomatic fungal, bacterial or viral infection, including
             human immunodeficiency virus (HIV) or Hepatitis A, B, or C.

          -  Must not have a serious preexisting medical conditions or concomitant disorders.

          -  Must not have leukemia.

          -  Must not have QT interval of >470 millisecond.

          -  Must not have a serious cardiac condition, such as congestive heart failure, unstable
             angina pectoris, or heart attack within the last 3 months.
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
Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
Condition: Healthy
Intervention: RPH-104; Sodium chloride Sterile Injection 0.9% w/v
Intervention description: Anti-IL-1 Mab; Sterile saline solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety; tolerability; RPH-104; RPH104; Anti-IL1 beta; Anti-IL1

Summary:

      The purpose of this first in human study is to evaluate the safety and tolerability of
      RPH-104 in humans.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects.

          -  Male or female subjects between 18 and 35 years old (inclusive).

          -  Subject who has normal body weight as determined by a body mass index (BMI) of between
             18 kg/m² and 30 kg/m² (inclusive) and within a body weight of ≥50kg and ≤120kg.

        Exclusion Criteria:

          -  Subject who has a history or presence of cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrinological, dermatological, neurological, psychiatric, and
             hematological or immunological disorder(s), and/or any condition that could constitute
             a potential safety risk factor or could alter the absorption, distribution, metabolism
             or elimination of the study drugs.

          -  Subject who has positive immunoglobulin-M (IgM) antibodies against Epstein-Barr virus
             (EBV)-viral capsid antigen (VCA) (IgM-anti-EBV-VCA) and Cytomegalovirus (CMV).

          -  Subject who has a positive Quantiferon TB-Gold (TB) test

          -  Subject who is positive to Human Immunodeficiency Virus-1/2 antibody (HIV-1/2Ab).

          -  Subject who has serum hepatitis, or is a carrier of the Hepatitis B surface antigen
             (HBsAg), or is Hepatitis C virus antibody (HCV-Ab) positive.
Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
Condition: Dengue
MeSH terms: Dengue
Intervention: D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
Intervention description: IM injection delivered by Biojector
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dengue; DNA vaccine

Summary:

      The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Available to participate for the duration of the study (approximately 12 months)

          -  Completion and review of knowledge assement quiz

        Exclusion Criteria:

          -  Pregnant (by history or as ascertained by pregnancy test) or lactating female

          -  Female who intends to become pregnant during the study

          -  Plan to have elective surgery during the study period

          -  HIV infection

          -  Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and
             topical steroids are allowed)

          -  History of splenectomy

          -  Administration of a vaccine not foreseen by the study protocol during the period
             starting 30 days before each dose of vaccine and ending 30 days after vaccination

          -  Evidence of active (acute or chronic) hepatitis B or C infection

          -  Autoimmune diseaseor subjects who describe a first-degree relative with clearly
             documented autoimmune disease

          -  Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal
             abnormality, as determined by physical examination or basic laboratory screening

          -  Clinical or laboratory evidence of significant anemia

          -  History of flavivirus infection or previous receipt of flavivirus vaccine

          -  Positive serology for flaviviruses (all four dengue virus serotypes, Japanese
             encephalitis, Yellow fever virus, and West Nile virus), HIV-1, Hepatitis B surface
             antigen, or anti-hepatitis C virus antibodies prior to enrollment

          -  Use of any investigational or non-registered drug or vaccine other than the study
             vaccine within 60 days preceding the first dose of study vaccine, or planned use
             during the study period.

          -  Previous history of allergic or anaphylactic reaction to any vaccine

          -  Planned travel to areas with endemic dengue during the study period

          -  Any other significant finding which, in the opinion of the investigator, would
             increase the risk of having an adverse outcome from participating in this protocol