bioihbjkbjnl/mcl2 huggingface dataset:
A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion Of [14C] Fruquintinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, single-center study to evaluate pharmacokinetics and safety of
      HMPL-013 in approximately 6 healthy male subjects receiving a single oral 5mg dose of
      HMPL-013 containing approximately 100 microcuries of [14C] HMPL-013. This study will
      investigate the absorption, drug biotransformation and mass balance of HMPL-013, seek to
      identify the compound's major metabolites and supply information for clinical application.
    

Detailed description: 
      This study will be an open-label, mass balance study of fruquintinib administered orally at
      5mg (100mCi). Subjects will be screened for eligibility up to 14 days prior to entry into the
      study. For study period, subjects will be admitted to the clinical research unit (CRU) on the
      day before dosing and fast overnight (approximately 10 hours). On the morning of dosing for
      study period, subjects will receive a single oral dose of 5 mg fruquintinib in the fasted
      state. Subjects will remain at the CRU for at least 336 hours after administration of study
      drug for collection of serial blood samples for pharmacokinetic (PK) analysis and safety
      monitoring.
    

Intervention name(s): fruquintinib
Intervention type(s): Drug
Intervention description(s): fruquintinib suspension, 5mg ( 100mCi), oral, taken once, fast
Other intervention name(s): HMPL-013
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: mass balance; 14C
Bone Mineral Density and Cancer Recurrence in Patients With Early Stage Prostate Cancer
Condition: Osteoporosis; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Osteoporosis
Study type: Observational

Summary: 
      RATIONALE: Measuring bone mineral density may help doctors predict whether prostate cancer
      will come back. It may also help the study of prostate cancer in the future.

      PURPOSE: This clinical trial is studying whether bone mineral density affects cancer
      recurrence in patients with early stage prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine bone mineral density (BMD) in patients with clinically significant early stage
           prostate cancer.

        -  Determine whether patients who have a higher level of BMD and have had a radical
           prostatectomy for cure are less likely to have an early relapse (i.e., less than 3
           years) than those patients with a low level of BMD.

      OUTLINE: This is a case-controlled study followed by a prospective, longitudinal, cohort
      study.

      Patients undergo bone mineral density (BMD) measurements by dual-energy x-ray absorptiometry
      with a densitometer. Posteroanterior measurements of the total hip are also recorded.

      Patients also undergo blood collection to examine markers that provide evidence of systemic
      disease.

      Patients are followed every 6 months for 3 years.

      PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
    

Intervention name(s): dual x-ray absorptiometry
Intervention type(s): Procedure
Intervention description(s): Dual x-ray absortiometry by densitometer will be performed to measure bone mineral density
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects will be recruited from urologists' offices and the oncological practices of CINJ.
        This will be done by verbal communication through the office staff and with the
        distribution of a brochure briefly describing the study. If a person is interested, he will
        be given information that briefly describes the study and his name will be taken down. A
        research assistant will call him and set up a meeting, preferably at the same time he is
        scheduled to see his physician. At that meeting, a research assistant will go over the
        consent form with him and cover all questions concerning the study. Eligibility (based on
        history) will also be verified at this meeting. If he wishes to participate, he will be
        instructed to sign the consent and an appointment for the blood tests and DXA scan will be
        arranged.
      
Keywords: osteoporosis; stage I prostate cancer
A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the safety and efficacy of multiple dose levels
      of the investigational product (study drug), IPI-145, in combination with methotrexate
      compared to methotrexate alone in subjects with active moderate-to-severe Rheumatoid
      Arthritis.
    

Detailed description: 
      This Phase 2 study is designed to examine the efficacy and safety of multiple dose levels of
      IPI-145 in subjects with active moderate-to-severe Rheumatoid Arthritis receiving a
      background stable dose of methotrexate. The study will employ a randomized, double-blind,
      placebo-controlled, parallel design.

      Approximately 316 adult subjects who meet all eligibility criteria at Screening will be
      randomized at Baseline in a 1:1:1:1 ratio to one of 4 dose groups.

      All treatments will be administered twice a day (BID). After randomization, subjects will
      enter a 12-week Treatment Period, where study drug (IPI-145 or placebo) will be
      self-administered BID as an outpatient. During the Treatment Period, subjects will return to
      the clinic for efficacy and safety assessments every 2 weeks. Following Treatment Period
      completion at Week 12, subjects will enter a 3-week Follow-up Period which includes one
      clinic visit approximately 3 weeks after the last dose of study drug.
    

Intervention name(s): IPI-145; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.; 2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI)
      cycles , in cases of repeated implantation failure. It is found that it will improve the
      implantation rate.
    

Detailed description: 
      The investigators can combine office hysteroscopy to diagnose hidden endometrial pathology,
      with hysteroscopically guided endometrial snip from the fundus of the uterus, trying to
      improve the pregnancy rate.
    

Intervention name(s): Office hysteroscopy and endometrial snip; Office hysteroscopy
Intervention type(s): Procedure; Procedure
Intervention description(s): Office hysteroscopy with endometrial snip; Office hysteroscopy
Other intervention name(s): Office hysteroscopy combined with endometrial snip; Outpatient hysteroscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Office hysteroscopy,; intrauterine insemination; endometrial scrap
Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam in
      Healthy Adult Subjects
    


Intervention name(s): Midazolam; SSP-004184SS
Intervention type(s): Drug; Drug
Other intervention name(s): SPD602
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of LY3537031 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of LY3537031 in
      healthy participants. The blood tests will be performed to check how much LY3537031 gets into
      the bloodstream, how long the body takes to eliminate it and how body handles LY3537031. Each
      participant will receive a single dose of LY3537031 or placebo. The study will last up to
      approximately 71 days for each participant, including screening.
    


Intervention name(s): LY3537031; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC.; Administered SC.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Effect of Facial Effleurage on Acute Rhinosinusitis
Condition: Rhinosinusitis Acute
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      Rhinosinusitis accounts for 12% of the total antibiotic prescriptions filled in the United
      States annually; however, the majority of rhinosinusitis cases have been proposed to have a
      viral etiology, or are capable of spontaneously resolving. This overuse of antibiotics is
      contributing to the development of antibiotic-resistant human pathogenic bacteria, and
      increasing patient mortality to previously easily cured diseases. This is also causing an
      unnecessary financial burden especially for uninsured, rural families. Facial Effleurage (FE)
      is an osteopathic manipulative therapy that allows physicians an alternative therapy to
      prescribing antibiotics; however, the only scientific literature on the technique is weak in
      design and execution. This will be a randomized, placebo-controlled clinical trial to test
      the ability of FE to reduce symptom severity over time, reduce the cellular infiltrate into
      the nasal cavity, and to more quickly resolve the symptoms of rhinosinusitis compared to
      antibiotic treatment. This methodical approach to the efficacy of FE has the potential to
      impact the treatment recommendations of physicians immediately, and to convince more
      physicians to prescribe less antibiotics and rely more heavily on FE.
    


Intervention name(s): Sham Treatment; Facial Effleurage; Antibiotics
Intervention type(s): Other; Other; Drug
Intervention description(s): All movements of facial effleurage except applying pressure; Facial massage to remove any lymphatic blockages; Appropriate "standard-of-care" antibiotics as determined by the physician.
Other intervention name(s): Osteopathic Manipulative Therapy
Intervention MeSH terms: Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Osteopathic Manipulative Treatment
Treatment of Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      We are trying to determine if longer duration of therapy with metronidazole or combination
      therapy of metronidazole plus azithromycin results in better cure rates for BV
    

Detailed description: 
      Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the
      U.S. and has been associated with complications including preterm delivery of infants, pelvic
      inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of
      sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of
      BV has been advocated for decreasing the prevalence of these complications. The etiology of
      BV remains unknown and the current treatment regimens are inadequate in terms of initial cure
      and recurrence rates. Further, half of all women who meet the clinical diagnostic criteria
      for BV are asymptomatic and treatment of these women remains controversial. More detailed
      characterization of the origins, natural history and response to therapy would supply data to
      guide control efforts. We will approach these problems through a multifaceted
      interdisciplinary evaluation of women with and without BV.

      The specific aims {and hypotheses} of this project are:

        1. To conduct studies to determine optimal agents and duration of therapy for BV
           {Hypothesis: Longer duration of therapy and combination therapy will result in higher
           cure rates and lower recurrence rates of BV; response to therapy differs between women
           with asymptomatic BV and symptomatic BV}

        2. To examine the role of condoms in the prevention of BV {Hypothesis: BV is a sexually
           transmitted infection, thus recurrence rates of BV will be lower among women with higher
           condom usage rates}

        3. To further explore the role of Mobiluncus spp., organisms strongly associated with the
           syndrome, by utilizing specimens derived from the above studies.

      {Hypothesis: Mobiluncus is involved in the pathogenesis of BV at least in a subset of women,
      and the persistence of this organism is associated with lack of cure and recurrence of BV}
    

Intervention name(s): metronidazole and azithromycin
Intervention type(s): Drug
Intervention MeSH terms: Azithromycin; Metronidazole
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bacterial vaginosis; treatment
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to perform a relative bioavailability study between two
      formulations of sildenafil citrate.
    

Detailed description: 
      Bio-equivalence between two formulations of sildenafil citrate
    

Intervention name(s): sildenafil citrate 100 mg CT; sildenafil citrate 100 mg CT; Viagra®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sildenafil citrate 100 mg CT, single dose without water; sildenafil citrate 100 mg CT, single dose with water; sildenafil citrate 100 mg film-coated tablet (Viagra®), single dose
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Sildenafil; Bio-equivalence
Absorption of Corticosteroids in Children With Juvenile Dermatomyositis
Condition: Vasculitis, Hypersensitivity; Connective Tissue Diseases; Dermatomyositis; Vasculitis
MeSH terms: Dermatomyositis; Vasculitis; Vasculitis, Leukocytoclastic, Cutaneous; Connective Tissue Diseases; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Juvenile dermatomyositis (JDM) is a connective tissue disease that causes skin rash and weak
      muscles in children. The purpose of this study is to measure the absorption of oral
      prednisolone and intravenous (IV) methylprednisolone and to determine levels of disease
      activity indicators in the blood. These levels will be compared to see if there are patterns
      specific to active and less active JDM.
    

Detailed description: 
      JDM is a connective tissue disease that is characterized by inflammation of the muscles and
      the skin. Corticosteroids, such as prednisolone and methylprednisolone, can be administered
      to help control symptoms of the disease, but absorption patterns of these medications in oral
      and IV forms are unknown. This study will assess absorption of oral prednisolone and IV
      methylprednisolone, measure levels of two disease activity indicators (von Willebrand factor
      and neopterin), and correlate these values in children with JDM.

      Patients will participate in this study twice within a period of up to a year, once when the
      patient's disease is active, and again 6 to 12 months later when the disease is less active.
      Each of the two study periods will last two nights and two days. Patients will be admitted to
      the hospital the first night, and a small IV port will be inserted in the patient's arm the
      first morning to allow for multiple blood draws without additional needle sticks. Patients
      will receive oral prednisolone the first morning and IV methylprednisolone the second
      morning. Baseline blood draws will be performed prior to administration of drug, with 13
      additional draws over a 6 hour period following drug administration. Following the final
      blood draw on the second day, the IV port will be removed from the patient's arm and the
      patient will be discharged from the hospital.

      Blood drawn from patients will be assessed for absorption of the drugs and levels of von
      Willebrand factor and neopterin. Patients will undergo the same sequence of events sometime
      between 6 to 12 months after the first hospitalization, after their vasculitis is judged to
      be less active.
    

Intervention name(s): Methylprednisolone; Prednisolone
Intervention type(s): Drug; Drug
Intervention description(s): IV; Oral
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular Disease; Respiratory Disease; Rare Diseases; Vasculitis
Internet-based CBT After Stroke Pilot
Condition: Stroke; Depression
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Mood disorders occur in 25-30% of stroke patients and are associated with lower quality of
      life, higher mortality, increased healthcare utilization, and higher costs. Cognitive
      behavioral therapy (CBT) interventions have been shown to both treat and prevent post-stroke
      mood disorders, thus having the ability to improve quality of life and reduce costs. This
      study aims to test the feasibility of internet-based CBT combined with a telephone/email
      based coaching service after stroke.
    


Intervention name(s): Cognitive behavioral therapy
Intervention type(s): Behavioral
Intervention description(s): An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Use of a Novel Computerized Decision Aid for Prenatal Aneuploidy Screening
Condition: Aneuploidy; Pregnancy Complications
MeSH terms: Pregnancy Complications; Aneuploidy
Study type: Interventional

Summary: 
      The investigators aim to assess whether use of a novel, tablet-based computerized decision
      aid for aneuploidy screening is similar to routine care with a brief genetic counseling visit
      in improving patient knowledge and decreasing decisional conflict.
    

Detailed description: 
      184 women will be randomized in a 1:1 fashion to use of a novel computerized iPad-based
      decision aid in addition to routine counseling or routine counseling only during a single
      study visit. This decision aid was developed at a 10th grade literacy level using input from
      Maternal Fetal Medicine physicians and certified genetic counselors, and piloted by 20
      English and Spanish speaking women of varying education levels. Following completion of
      genetic counseling, participants will complete several surveys assessing knowledge and
      decision conflict. Data will be abstracted regarding demographics, screening and diagnostic
      testing uptake, and testing results.
    

Intervention name(s): iPad-based decision aid; Genetic counseling appointment
Intervention type(s): Other; Other
Intervention description(s): This is a novel decision aid developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.; All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Decision aid
Phase IV Study of Qsymia in Obese Patients
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this clinical trial is to evaluate the weight loss effect and safety after
      administration of the test drug Qsymia in obese patients.

      To this end, the primary objective is to compare the weight change rate (%) between the study
      groups compared to the placebo groups at week 56 after administration of the investigational
      product.

      The secondary objective is to compare the weight change rate (%) at each evaluation point
      after administration of the investigational product, the proportions of subjects who lost
      more than 5% and more than 10% of weight at each evaluation point, and changes in
      weight/BMI/waist circumference/heart rate/blood pressure between the study groups compared to
      the placebo groups.
    


Intervention name(s): Qsymia 3.75Mg-23Mg Extended Release Capsule; Qsymia 7.5Mg-46Mg Extended Release Capsule; Qsymia 11.25Mg-69Mg Extended Release Capsule; Qsymia 15Mg-92Mg Extended Release Capsule; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): From W0 to W2, once a daily.; From W2 to W14, once a daily.
At W14, if the weight loss rate is 3% or more, from W14 to W56(the end of visit), once a daily.; At W14, if the weight loss rate is NOT 3% or more, from W14 to W16, once a daily.; At W14, if the weight loss rate is NOT 3% or more, from W16 to W56(the end of visit), once a daily.; From W0(Randomisation) to W56(the End of visit) once a daily.
Other intervention name(s): Low dose titration; Low dose maintenance; High dose titration; High dose maintenance
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Qsymia; Phentermine; Topiramate; Alvogen Korea