bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Ovarian Cancer
Condition: Tumor; Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: NKTR-102 q14d; NKTR-102 q21d
Intervention description: NKTR-102 given on a q14 day schedule; NKTR-102 given on a q21 day schedule
Intervention MeSH terms: Etirinotecan pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients
      with metastatic or locally advanced platinum-resistant ovarian cancer.

      Approximately 70 patients will be randomized 1:1 into one of two treatment arms. NKTR-102
      will be administered at a dose level of 145 mg/m^2 in both arms. In Arm A, NKTR-102 will be
      given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. After the
      initial 70 patients have been enrolled, Arm B will enroll approximately 110 additional
      patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically confirmed diagnosis of epithelial ovarian cancer,
             primary peritoneal cancer or fallopian tube cancer

          2. Inoperable metastatic or locally advanced ovarian cancer

          3. Platinum-resistant ovarian cancer defined as progression by RECIST within 6 months of
             last dose of most recent platinum drug

          4. Platinum-resistant patients who have progressed after receiving PLD
             (Doxil/Caelyx)therapy in a platinum-resistant setting or who otherwise unable to
             receive PLD therapy.

          5. Diseases must be measurable as defined by RECIST in at least 1 lesion not previously
             irradiated.

          6. ECOG performance score of 0 or 1.

          7. Adequate organ and bone marrow functions at Screening.

        Exclusion Criteria:

          1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) and have not recovered to NCI-CTCAE grade 1 toxicity
             prior to Day 1 of Cycle 1

          2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle 1 or
             minor surgery within 2 weeks prior to Day 1 of Cycle 1

          3. Patients who have received CYP3A4 inducers or inhibitors.

          4. Patients who have received any treatment with a camptothecin derivative (eg.
             irinotecan, topotecan, SN38 investigational agents, etc.).

          5. Patients with CNS metastases.
Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
Condition: Cancer Survivor; Prevention of Human Papillomavirus Infection
MeSH terms: Infections; Papillomavirus Infections
Intervention: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58); laboratory biomarker analysis; survey administration; medical chart review
Intervention description: Given IM; Correlative studies; Ancillary studies; Ancillary studies
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1499.0
Sex: All
Minimum age: 9 Years
Maximum age: 26 Years
Healthy volunteers: No

Summary:

      This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer
      survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine
      initiation among young cancer survivors, and (2) determining the immune response to and
      safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  AIM 1 (SURVEY) (AIM 1 is closed to enrollment)

          -  Cancer survivor

          -  Between 12 and 60 months after completion of cancer therapy (chemotherapy, radiation,
             hematopoietic cell transplant [HCT])

          -  Scheduled for a return clinic visit at one of the participating institutions

          -  English or Spanish-speaking

          -  Willing to provide informed consent/assent for study participation

          -  AIM 2 (VACCINE EVALUATION)

          -  Meets all inclusion criteria outlined in Aim 1

          -  Survey response indicated no prior history of HPV vaccination OR patient has no prior
             history of HPV vaccination by self - or parent/caregiver-report

          -  English or Spanish-speaking

          -  Medical clearance from treating clinician for study participation

          -  Agrees to return to participating institution for 3 HPV vaccine injections

          -  Willing to provide informed consent/assent for study participation

        Exclusion Criteria:

          -  AIM 2 (VACCINE EVALUATION)

          -  Allergy to any component of the HPV vaccine including yeast and aluminum

          -  Thrombocytopenia (platelet count < 50K) or coagulation disorder that would
             contraindicate intramuscular injection

          -  Transfusion of blood products or intravenous immune globulin within 3 months of study
             entry

          -  Female, and a) currently pregnant or lactating, or b) of childbearing potential and
             unwilling to avoid pregnancy during the vaccine phase of study (beginning at Day 1 and
             continuing until at least 4 weeks after all 3 vaccine doses have been administered)
To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa; Acne Inversa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Intervention: INCB054707; Placebo
Intervention description: Oral; Tablet; Oral; Tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Triple
Enrollment: 209.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis
      suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week
      open-label extension period. All eligible participants will be invited to continue treatment
      for an additional 48-week Long-term extension period (also open label).
    

Eligibility criteria:

        Inclusion Criteria:

          -  HS disease duration of at least 3 months before screening.

          -  Willingness to avoid pregnancy or fathering children.

          -  Active HS in at least 2 distinct anatomical areas.

          -  Participants agree NOT to use topical antiseptics on the areas affected by HS lesions
             during the placebo-controlled 16-week treatment period

        Exclusion Criteria:

          -  Draining fistula count of > 20 at screening or baseline.

          -  Women who are pregnant (or who are considering pregnancy) or lactating.

          -  Medical history including thrombocytopenia, coagulopathy or platelet dysfunction,
             Q-wave interval abnormalities, current or history of certain infections, cancer,
             lymphoproliferative disorders and other medical conditions at the discretion of the
             investigator.

          -  History of failure to treatment of inflammatory diseases with JAK inhibitors.

          -  Have evidence of active or latent or inadequately treated infection with Mycobacterium
             tuberculosis.

          -  Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.

          -  Laboratory values outside of the protocol-defined ranges.
18F-FTC-146 PET/CT in Newly-Diagnosed Osteosarcoma
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Intervention: 18-F FTC 146
Intervention description: Radiotracer, 10 mCi at pre- and post- chemotherapy, intravenous administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research is to evaluate the study drug, 18F FTC-146, as a positron
      emission tomography (PET) / computed tomography (CT) radiotracer imaging agent to evaluate
      tumor status in patients newly diagnosed with osteosarcoma ("bone cancer").
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with biopsy proven osteosarcoma requiring local surgical intervention.

          -  ECOG ≤ 2

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Chemotherapy in the past 2 months.

          -  Prior history of allergic reaction to 18F FTC 146.

          -  Pregnant or nursing
Use of Metformin to Reduce Cardiac Toxicity in Breast Cancer
Condition: Breast Cancer; Breast Tumors
MeSH terms: Breast Neoplasms; Cardiotoxicity
Intervention: Metformin; Doxorubicin
Intervention description: Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.; Standard of care treatment with doxorubicin
Intervention MeSH terms: Metformin; Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: breast; cancer; doxorubicin; metformin; cardiotoxicity; ejection fraction; LVEF

Summary:

      The goal of this study is to determine if co-administration of metformin and doxorubicin in
      breast cancer patients receiving neoadjuvant or adjuvant therapy will reduce the number of
      patients who develop a significant change in left ventricle ejection fraction (LVEF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Breast cancer requiring neoadjuvant or adjuvant therapy with doxorubicin

          -  Complete metabolic panel demonstrating adequate organ functions as defined by the
             following: Aspartate transaminase (AST) less than 2.5 times Upper Limit of Normal
             (ULN); Alanine transaminase (ALT) less than 2.5 times ULN; alkaline phosphatase less
             than 2.5 times ULN; serum creatinine less than 1.5 mg/dL; serum bilirubin less than
             ULN

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Age greater than or equal to 21 years

        Exclusion Criteria:

          -  Known diabetes

          -  History of cardiac arrhythmias or symptomatic cardiac disease

          -  Currently taking antiarrhythmic medications, beta-blockers, or other rate controlling
             cardiac medications

          -  Currently taking metformin and/or sulfonylureas

          -  Known hypersensitivity or intolerance to metformin

          -  Baseline ejection fraction of less than 50% measured by echocardiogram

          -  Known hypersensitivity to contrast used during echocardiogram

          -  Risk factors associated with increased risk of metformin-associated lactic acidosis
             (e.g. congestive heard failure, history of acidosis, habitual intake of 3 or more
             alcoholic beverages per day)

          -  Pregnant or breast feeding
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: SABER-Bupivacaine Treatment 1a; Placebo SABER-Bupivacaine Treatment 1b; Bupivacaine HCl Treatment 1c; SABER-Bupivacaine Treatment 2a; Placebo SABER-Bupivacaine Treatment 2b; Bupivacaine HCl Treatment 2c
Intervention description: 5.0 ml; 5.0 ml; 40 ml; 7.5 ml; 7.5 ml; 40 ml
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 115.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Postoperative pain; Local anaesthesia; Postoperative pain after open abdominal hysterectomy surgery

Summary:

      The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain
      control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and
      safety evaluations. The study duration consists of a screening period up to 14 days and a
      treatment period 14 days with a long term follow up visit at 6 months. The study will provide
      further data on the efficacy and safety of the product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A planned elective, abdominal hysterectomy

          -  Patients suitable for general anaesthesia

        Exclusion Criteria:

          -  Known clinically significant hepatic, gastrointestinal, renal, haematological,
             urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities

          -  Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances.
             History of cured localised malignancies is allowed (i.e. basal or squamous cell skin
             carcinoma, breast carcinoma or cervical carcinoma)

          -  Abnormal ECG

          -  Prolonged QT syndrome

          -  Current or regular use of analgesic medication for other indication(s)
Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.
Condition: Hepatobiliary Disorders; Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Digestive System Diseases; Liver Diseases
Intervention: Semaglutide; Placebo
Intervention description: Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg); Once daily administration subcutaneously ( s.c., under the skin)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 320.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once
      daily versus placebo in subjects with non-alcoholic steatohepatitis
    

Eligibility criteria:

        Inclusion Criteria: - Informed consent obtained before any trial-related activities.
        Trial-related activities are any procedures that are carried out as part of the trial,
        including activities to determine suitability for the trial except for protocol described
        pre-screening activities which require a separate informed consent. - Male or female, aged
        18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive))
        at the time of signing informed consent - Local histological diagnosis of NASH followed by
        histological confirmation of NASH based on central pathologist evaluation of a liver biopsy
        obtained up to 21 weeks before screening - Histologic evidence of NASH based on central
        pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH
        fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central
        pathologist evaluation Exclusion Criteria: - Known or suspected abuse of alcohol (above 20
        g/day for women or above 30 g/day for men), alcohol dependence* or narcotics. (* = assessed
        by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type
        1 diabetes according to medical records - HbA1c above 10% at screening - History or
        presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at
        screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary
        thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) ≤
        25.0 kg/sqm at the screening visit (visit 1) - Female who is pregnant, breast-feeding or
        intends to become pregnant or is of childbearing potential and not using an adequate
        contraceptive method (adequate contraceptive measures as required by local regulation or
        practice)
Intravenous Immunoglobulin (IVIG) in Lung Transplantation
Condition: Hypogammaglobulinemia; Lung Transplantation
MeSH terms: Agammaglobulinemia
Intervention: IVIG; Placebo
Intervention description: 10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks; 0.1% Albumin in an equal volume to the investigational product
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hypogammaglobulinemia; Lung Transplantation

Summary:

      The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent
      bacterial infections in lung transplant patients with low serum levels of immunoglobulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Lung transplant recipients > 3 months after transplant surgery

          -  Immunoglobulin G (IgG) < 500 mg/dL

          -  Stable medical regimen

        Exclusion Criteria:

          -  Acute rejection

          -  Active infection

          -  Contraindication to IVIG

          -  Pregnancy

          -  Recent thrombotic event
Topical Endoxifen in Women
Condition: Mammographic Breast Density
Intervention: Topical endoxifen; Placebo
Intervention description: topical solution; topical
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 90.0
Sex: Female
Minimum age: 40 Years
Maximum age: 74 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Karma CREME-1 consisted of 90 participants from the Karma Cohort. The major focus of the
      pilot trial was to estimate time to mammographic density change. The primary objective was to
      determine the effect size of the breast density change between topical placebo and two doses
      of topical endoxifen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant in the Karma Cohort

          -  Attending the national mammography screening program, i.e., aged 40-74 and have
             performed a screening mammogram maximum 3 months prior to study inclusion

          -  Mammographic density ~4.5 % density (volumetric) measured by Volpara, at the screening
             mammogram performed in connection to baseline (maximum 3 months prior to inclusion).
             The threshold value of 4.5% corresponds to the clinical Bl-RADS score A

          -  Postmenopausal, defined as no period of menstruation during last 12 months independent
             of any hormonal treatment

          -  Informed consent must be signed before any study specific assessments are performed

        Exclusion Criteria:

          -  Any previous or current diagnosis of breast cancer (including carcinoma in situ).

          -  Any previous diagnosis of cancer with the exception of non-melanoma skin cancer and in
             situ cancer of the cervix.

          -  A history of major surgery of the breast, e.g., reduction or enlargement, which might
             affect density measurements.

          -  Mammographic Bl-RADS malignancy code 3, or above, at baseline mammography, or at
             mammography during time of treatment. Recall for additional examinations due to
             technical problems with the mammogram is accepted.

          -  Currently using estrogen and progesterone based hormone replacement therapy (oral or
             patches). Local estrogen treatment is accepted (ex. Vagifem).

          -  Non-medical approved drugs against hot-flashes including phytoestrogen.
Safety and Efficacy of Bictegravir + Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Condition: HIV-1 Infection
Intervention: BIC; F/TAF; DTG; BIC Placebo; DTG Placebo; B/F/TAF
Intervention description: 75 mg tablet administered orally once daily; 200/25 mg FDC tablet administered orally once daily; 50 mg tablet administered orally once daily; Tablet administered orally once daily; Tablet administered orally once daily; 50/200/25 mg FDC tablet administered orally once daily
Intervention MeSH terms: Dolutegravir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 98.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adult; HIV; naive

Summary:

      This study will evaluate the efficacy, safety and tolerability of bictegravir (BIC) +
      emtricitabine/tenofovir alafenamide (F/TAF) fixed dose combination (FDC) versus dolutegravir
      (DTG) + F/TAF in HIV-1 Infected, antiretroviral treatment-naive adults. This study will also
      evaluate the pharmacokinetic (PK) profile of BIC, emtricitabine and TAF.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Antiretroviral naive (≤ 10 days of prior therapy with any antiretroviral agent)

          -  Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening

          -  Screening genotype report provided by Gilead Sciences must show sensitivity to
             tenofovir (TFV) and emtricitabine (FTC)

          -  Adequate renal function as measured by estimated glomerular filtration rate ≥ 70
             mL/min according to the Cockcroft-Gault formula

          -  CD4+ cell count ≥ 200 cells/µL at screening

        Key Exclusion Criteria:

          -  A new AIDS-defining condition diagnosed within the 30 days prior to screening as
             defined in the study protocol

          -  Prior use of antiretrovirals in the setting of pre-exposure prophylaxis (PrEP) or post
             exposure prophylaxis (PEP)

          -  Chronic hepatitis B virus (HBV) infection

          -  Hepatitis C infection (Individuals who are hepatitis C virus (HCV) Ab positive, but
             have a documented negative HCV RNA, are eligible)

          -  Active, serious infections (other than HIV-1 infection) requiring parenteral
             antibiotic or antifungal therapy within 30 days prior to baseline

          -  Participation in any other clinical trial without prior approval from the sponsor is
             prohibited while participating in this trial

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.