bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Medication With or Without Psychotherapy for Complicated Grief
Condition: Complicated Grief; Bereavement
Intervention: Citalopram; Complicated Grief Treatment; Placebo
Intervention description: 16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.; Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.; 16 weeks of daily inactive medication. It will be administered in a double-blind fashion.
Intervention MeSH terms: Citalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 395.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Grief; Bereavement; Psychotherapy; Medication; Treatment study

Summary:

      The major goal of this 4-site, double blind, placebo-controlled intervention trial is to
      assess the efficacy of medication (Citalopram) alone or with psychotherapy (Complicated Grief
      Therapy) to treat the symptoms of complicated grief.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with Complicated Grief and this is the patient's most important (primary)
             problem

          -  Ability to give informed consent

          -  Fluent in English

          -  Willingness to have sessions audiotaped

          -  Willingness to undergo random assignment

        Exclusion Criteria:

          -  Diagnosis of one or more of the following disorders: Schizophrenia or other psychotic
             disorder, current (past 6 months) substance abuse, Bipolar Disorder, current manic
             episode, Dementia

          -  Pregnant or lactating women and women of childbearing potential not using medically
             accepted forms of contraception

          -  Acute, unstable or severe medical illness such as (but not limited to) stroke,
             epilepsy, or other neurodegenerative disorders, metastatic or active cancer, hepatic
             disease, or primary renal disease requiring dialysis

          -  Prior intolerance of citalopram

          -  Pending or active disability claim or lawsuit related to the death
ET-01 in Subjects With Lateral Canthal Lines, LCL-209
Condition: Lateral Canthal Lines, LCL; Crow's Feet
Intervention: botulinum toxin, Type A; Vehicle
Intervention description: topical liniment; Vehicle Formulation
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: vehicle controlled, parallel group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: Female
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A,
      topical, in lateral canthal lines (LCL).
    

Eligibility criteria:

        Inclusion Criteria:

          -  females 25 - 65 years of age

          -  minimal to moderate Crow's Feet wrinkles at rest

          -  moderate to severe Crow's Feet on contraction

          -  adequate vision to assess facial wrinkles in a mirror

          -  willingness to refrain from products affecting skin remodeling

          -  female subjects must be not pregnant and non-lactating

          -  subjects should be in good general health

        Exclusion Criteria:

          -  history of adverse reactions to any prior botulinum toxin treatments

          -  history of vaccination or non-response to any prior botulinum toxin treatments

          -  botulinum toxin treatment in the prior 6 months

          -  present or history of neuromuscular disease, eyelid ptosis, muscle weakness,
             paralysis, or "dry eye"

          -  history of peri-ocular surgery, brow lift or related procedures

          -  procedures affecting the lateral canthal region in the prior 12 months

          -  application of topical prescription medication to the treatment area

          -  female subjects who are pregnant or are nursing a child
Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial)
Condition: Solid Tumor
MeSH terms: Neoplasms
Intervention: Debio 1347
Intervention description: Debio 1347 oral tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to assess the efficacy of Debio 1347 in terms of
      objective response rate (ORR) in participants with solid tumors harboring fibroblast growth
      factor receptor (FGFR)1-3 gene fusion/rearrangement.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologically or histologically confirmed advanced solid tumor

          -  Radiographic progression on prior systemic therapy; prior localized therapy (i.e.,
             radiation, ablation, embolization) is allowed provided radiographic progression
             out-of-field or in the treatment, field is shown

          -  Locally-advanced (unresectable) or metastatic disease harboring an FGFR1-3 gene
             fusion/rearrangement potentially leading to a functional FGFR aberrant protein,
             identified through local and/or central molecular assay

        Exclusion Criteria:

          -  History of hypersensitivity to any of the excipients in the Debio 1347 formulation

          -  History and/or current evidence of ectopic mineralization/calcification, including but
             not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting
             calcified lymph nodes, lung nodules and asymptomatic vascular or cartilage/tendon
             calcifications

          -  Administration of any investigational agent within 2 weeks prior to initial dosing
             with Debio 1347 (3 weeks for immune checkpoint inhibitors)
A Study to Evaluate Immune Response and Safety of Two Doses of GSK Biologicals' HRV Liquid Vaccine in Healthy Infants.
Condition: Infections, Rotavirus; Rotavirus Vaccines
MeSH terms: Rotavirus Infections
Intervention: Rotarix™; Placebo
Intervention description: oral doses; oral dose
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 375.0
Sex: All
Minimum age: 5 Weeks
Maximum age: 10 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Placebo; Double blind; Gastroenteritis; Randomized; Oral live attenuated human rotavirus liquid vaccine

Summary:

      This study will provide data on the immune response and safety of GSK Biologicals' HRV liquid
      vaccine when given along with the routine infant immunizations in Philippines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infants between, and including, 5-10 weeks of age at the time of the first
             dose of HRV liquid vaccine or placebo.

          -  Birth weight of the subject should be > 2000 grams.

          -  Written informed consent obtained from the parent or guardian of the subject.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine within 30 days preceding the first dose of study vaccine, or planned use
             during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             except for DTPw, HBV and OPV vaccines within 14 days before each dose of HRV liquid
             vaccine or placebo and ending 14 days after. BCG is administered at birth according to
             the local EPI.

          -  Concurrently participating in another clinical study, at any time during the study
             period.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the HRV liquid vaccine or placebo.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.
A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Necitumumab; Gemcitabine; Cisplatin
Intervention description: Administered IV; Administered IV; Administered IV
Intervention MeSH terms: Gemcitabine; Necitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see how participants with late stage lung cancer do on
      gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the
      drugs are in combination and to see how long the medicine stays in the body. The study will
      last approximately 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed squamous Non-small Cell Lung Cancer (NSCLC)

          -  Stage IV disease at time of study entry based on American Joint Committee on Cancer
             7th edition

          -  Measurable disease at time of study entry as defined by Response Evaluation Criteria
             in Solid Tumors (RECIST), Version 1.1

          -  Required to have a performance status (PS) 0-1

        Exclusion Criteria:

          -  Nonsquamous NSCLC

          -  Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors,
             or any therapies targeting the epidermal growth factor receptor (EGFR), vascular
             endothelial growth factor (VEGF), or VEGF receptor

          -  Previous chemotherapy for NSCLC

          -  Major surgery or received any investigational therapy in the 4 weeks prior to study
             enrollment

          -  Chest irradiation within 12 weeks prior to randomization (except palliative
             irradiation of bone lesions, which is allowed)

          -  Brain metastases that are symptomatic or require ongoing treatment with steroids or
             anticonvulsants (participants who have undergone previous radiotherapy for brain
             metastases, who are now nonsymptomatic and no longer require treatment with steroids
             or anticonvulsants, are eligible)
Safety, Tolerability and Efficacy Study of STX209 in Subjects With Fragile X Syndrome
Condition: Fragile X Syndrome
MeSH terms: Fragile X Syndrome; Syndrome
Intervention: STX209; Placebo
Intervention description: Variable dose from 1 mg bid to 10 mg tid, Capsule, Oral, 4 weeks; variable dose (same flexible dose titration protocol), bid to tid, capsule, Oral, 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 63.0
Sex: All
Minimum age: 6 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: fragile X syndrome; irritability; behavior problems

Summary:

      The study objective is to explore the efficacy, safety and tolerability of STX209 for
      treatment of irritability in subjects with FSX. We hypothesize that STX209 will improve
      irritability and other typical problem behaviors associated with fragile X syndrome. We also
      hypothesize that STX209 will be safe and well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects 12 to 40 years of age eventually expanding to 6 years of age

          -  Molecular documentation of the fragile X mutation.

          -  Clinical Global Impression - Severity (CGI-S) rating for problem behavior of moderate
             or higher at screening and at Visit 1

          -  An Aberrant Behavior Checklist (ABC-C) Irritability Subscale score >12 and at least 3
             items on the Irritability Subscale rated at least moderate or above.

          -  Current treatment with no more than three psychoactive medications, including
             anti-epileptics.

          -  Current pharmacological treatment regimen has been stable for at least 4 weeks.

        Exclusion Criteria:

          -  Subjects with a history of seizure disorder who are not currently receiving treatment
             with antiepileptics.

          -  Subjects with any condition, including alcohol and drug abuse, which might interfere
             with the conduct of the study, confound interpretation of the study results, or
             endanger their own well-being. This includes, but is not limited to impairment of
             renal function, evidence or history of malignancy or any significant hematological,
             endocrine, cardiovascular, respiratory, hepatic, or gastrointestinal disease.

          -  Subjects who plan to initiate or change pharmacologic or non-pharmacologic
             interventions during the course of the study.

          -  Subjects who are currently receiving treatment with racemic baclofen.

          -  Subjects currently treated with vigabatrin or tiagabine.

          -  Subjects taking another investigational drug currently or within the last 30 days.
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.
Zalutumumab in Non-curable Patients With SCCHN
Condition: Head and Neck Cancer; Squamous Cell Cancer
MeSH terms: Neoplasms, Squamous Cell; Carcinoma, Squamous Cell
Intervention: Zalutumumab
Intervention description: Individual dose titration weekly i.v. doses
Intervention MeSH terms: Zalutumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females age ≥ 18 years

          2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral
             cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy

          3. Failure to at least one course of standard platinum-based chemotherapy

        Exclusion Criteria:

          1. Three or more prior chemotherapy regimens

          2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors

          3. Past or current malignancy other than SCCHN, except for certain other cancer diseases
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
Condition: Breast Cancer; Metastatic Breast Cancer; MBC; HER2 Positive; HER2; Estrogen Receptor Positive; ER; Triple Negative
MeSH terms: Breast Neoplasms
Intervention: Lucitanib
Intervention description: Lucitanib is a potent, orally available selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors (FGFR1-3), vascular endothelial growth factor receptors (VEGFR1-3), and platelet-derived growth factor receptors alpha and beta (PDGFR alpha and beta)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Metastatic breast cancer; MBC; HER2 positive; HER2+; Estrogen receptor positive; ER+; Triple negative; FGFR1; 11q; FGF aberrant; Biomarker negative; FGF non-aberrant

Summary:

      The purpose of this study is to determine whether lucitanib is safe and effective in the
      treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment
      of patients with biomarker negative (FGF non-aberrant) metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed metastatic breast cancer relapsed or
             refractory to approved standard available treatment

          -  Prior treatment with standard first line therapy in the metastatic setting

          -  Availability of tumor tissue sufficient for confirmatory testing of FGFR1 and 11q
             amplification status

          -  Demonstrated progression of disease by radiological or clinical assessment (Measurable
             disease according to RECIST Version 1.1 is NOT required for enrollment)

          -  Estimated life expectancy >6 months

        Exclusion Criteria:

          -  Current or recent treatment with biologic anticancer therapies

          -  Ongoing AEs from prior anticancer therapies

          -  Active central nervous system (CNS) metastases

          -  Clinically significant or uncontrolled hypertension or cardiac disease

          -  Females who are pregnant or breastfeeding
A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer
Condition: Breast Cancer; Metastasis
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Dasatinib; Dasatinib
Intervention description: Tablets, Oral, 100 mg, twice daily as long as the patient benefits (avg <6 months); Tablets, Oral, 70 mg, twice daily as long as the patient benefits (avg <6 months)
Intervention MeSH terms: Dasatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent, locally-advanced, or 'triple negative' metastatic breast cancer

Summary:

      This study will determine whether the investigational drug dasatinib is effective in
      treatment of women with progressive advanced triple-negative breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  females, 18 or older

          -  recurrent or progressive locally advanced, or 'triple negative' metastatic breast
             cancer

          -  paraffin-embedded tissue block must be available

          -  measurable disease

          -  prior chemotherapy with an anthracycline, a taxane, or both (neoadjuvant, adjuvant, or
             metastatic setting)

          -  0, 1 or 2 chemotherapies in the metastatic setting

          -  adequate organ function

        Exclusion Criteria:

          -  Metastatic disease confined to bone only

          -  Symptomatic CNS metastasis

          -  Concurrent medical condition which may increase the risk of toxicity

          -  Unable to take oral medication