bioihbjkbjnl/mcl2 huggingface dataset:
Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
Condition: HIV Infections; Sinusitis
MeSH terms: Sinusitis
Study type: Interventional

Summary: 
      To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of
      pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin
      ) in reducing symptoms and recurrence of acute HIV-related sinusitis.

      Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with
      potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of
      life-threatening sepsis, and progress to central nervous system involvement. Symptoms of
      sinusitis in HIV patients are often refractory to aggressive Western medical management, and
      antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and
      herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic
      therapy.
    

Detailed description: 
      Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with
      potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of
      life-threatening sepsis, and progress to central nervous system involvement. Symptoms of
      sinusitis in HIV patients are often refractory to aggressive Western medical management, and
      antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and
      herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic
      therapy.

      Patients are randomized to receive either Traditional Chinese Medicine (acupuncture and
      herbal treatment) or conventional antibiotic therapy (Sudafed and Augmentin). Treatment
      continues for 8 weeks, followed by a 4 week washout, with final follow-up at week 12.
      Patients must undergo endoscopic nasal exam and CT scan of paranasal sinus prior to study
      entry and at week 12.
    

Intervention name(s): Clavulanate potassium; Pseudoephedrine hydrochloride; Amoxicillin trihydrate
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Pseudoephedrine; Ephedrine
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: AIDS-Related Opportunistic Infections; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Sinusitis; Ephedrine; Acupuncture Therapy; Drugs, Chinese Herbal; Medicine, Chinese Traditional; Drug Combinations; Antibiotics, Combined; Amoxicillin-Potassium Clavulanate Combination
Mitomycin C With Hyperthermia and Intravesical Mitomycin C to Treat Recurrent Bladder Cancer
Condition: Transitional Cell Carcinoma of Bladder; Superficial Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Hyperthermia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Hypothesis: In selected patients external hyperthermia will be used in combination with
      intravesical Mitomycin-C (MMC) to treat recurrent transitional cell carcinoma (TCC) of the
      bladder after local resection and standard adjuvant therapy and thus prevent or delay
      recurrence and the need for radical cystectomy.
    

Detailed description: 
      It is well established that tumor cells are sensitive to heat and when combined with a
      chemotherapeutic agent, drug uptake and intracellular distribution of drug within malignant
      cells is improved due to increased cellular permeability. Further, hyperthermia inhibits
      deoxyribonucleic acid (DNA) repair as a result of increased reaction between DNA and
      chemotherapy. By heating bladder tissue and accelerating the necessary series of reactions to
      link agents such as mitomycin C to cell DNA, this effect may be optimized. Depending on the
      extent of resection (and location, size, and depth of invasion of remaining tumor) after
      transurethral resection of the bladder tumor(TURBT), recommended adjuvant therapy consists of
      intravesical chemotherapy. MMC has been studied at doses as high as 80 mg without producing
      significant or irreversible side effects. The most commonly used dose of mitomycin is 40 mg.2

      This pilot study proposes to use Mitomycin C at a dose of 40 mg in conjunction with deep
      hyperthermia to enhance the effect intravesical chemotherapy as second-line treatment of
      recurrent TCC (Stage Ta, T1, or Tis) of the bladder after surgical resection and standard
      adjuvant therapy.
    

Intervention name(s): Hyperthermia System; Mitomycin C
Intervention type(s): Device; Drug
Intervention description(s): Hyperthermia applied to heat the bladder to a temperature of 42 degrees Celsius for 40-60 minutes concurrent with mitomycin Treatment Schedule: 6 Weekly Sessions (Induction) followed by 4 Monthly Sessions (Maintenance) until documented second recurrence; 40 mg in 40 ml sterile water instilled into bladder
Other intervention name(s): BSD 2000 Hyperthermia system; Mutamycin
Intervention MeSH terms: Mitomycins; Mitomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma
Condition: Chronic Lymphocytic Leukemia; Non-Hodgkin Lymphoma
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, multicenter study evaluating the safety and PK profile of
      ABT-199 under a once daily dosing schedule. Two arms will be implemented for dose escalation:
      Arm A, CLL/SLL subjects and Arm B, NHL subjects. Arm A is designed to enroll approximately
      116 subjects with relapsed or refractory CLL or SLL and Arm B is designed to enroll
      approximately 95 subjects with relapsed or refractory NHL. Fifty-six subjects were enrolled
      in Arm A and approximately 55 subjects will be enrolled in Arm B during the dose escalation
      portion of the study, with the objective of defining dose limiting toxicities (DLTs) and the
      MTD. Once the MTD is declared for the arm, approximately 60 additional CLL/SLL subjects in
      Arm A and approximately 20 additional DLBCL subjects and 20 additional follicular lymphoma
      subjects in Arm B will be enrolled in an expanded safety portion of the study at the
      recommended phase 2 dose (RPTD) and schedule.
    

Detailed description: 
      Interventional Study Design - Primary Purpose: Determination of safety and tolerability.
    

Intervention name(s): ABT-199
Intervention type(s): Drug
Intervention description(s): Arm A (Cohorts 1-8) and Arm B (Cohort 1-6): Subjects in dose escalation phase will receive 1 dose of ABT-199, followed by 6 days off drug, followed by continuous once daily dosing with ABT-199. Arm B (Cohorts 7+): Subjects in dose escalation phase will receive continuous once daily dosing with ABT-199. Arm A and Arm B: Subjects in expanded safety cohort will receive continuous once daily dosing with ABT-199.
Intervention MeSH terms: Venetoclax
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; Maximum Tolerated Dose; Pharmacokinetics; ABT-199; Preliminary Efficacy; Cancer; Non-Hodgkin Lymphoma; Chronic Lymphocytic Leukemia
Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To determine the time course of development of resistance to atevirdine mesylate ( U-87201E )
      in patients with HIV isolates showing in vitro resistance to zidovudine ( AZT ). To determine
      the genotype changes in HIV reverse transcriptase associated with in vitro AZT resistance to
      U-87201E. To determine the genotype and phenotype effects of treatment with a
      nondideoxynucleoside agent on the alterations of the HIV-1 population associated with in
      vitro AZT resistance. To determine whether serial passage of patient pre-drug HIV isolates in
      the presence of U-87201E will generate the resistant mutants that may subsequently emerge in
      the patients.
    


Intervention name(s): Atevirdine mesylate
Intervention type(s): Drug
Intervention MeSH terms: Atevirdine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virus Replication; Acquired Immunodeficiency Syndrome; Antiviral Agents
Correlation of Non-invasive Assessment, Using C.A 2.0 Device, Versus Invasive Assessment of LVEDP
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The purpose of the study is to determine the accuracy of non-invasive assessment of LVEDP
      using the investigational device C.A 2.0.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects undergoing elective cardiac catheterization, during which LVED and aortic
        pressures are recorded
An Open-Label Extension Study Assessing the Long-Term Efficacy and Safety of ALX-0061 in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a multicenter, open-label extension (OLE) Phase II study designed to evaluate the
      long-term efficacy and safety of ALX-0061 (i.e., vobarilizumab) administered subcutaneously
      (s.c.) in subjects with active rheumatoid arthritis (RA) who had completed the treatment and
      assessment period of one of the preceding Phase IIb studies with ALX-0061 (ALX0061-C201 and
      ALX0061-C202; placebo and ALX-0061 treatment arms only), and who achieved at least 20%
      improvement in swollen joint count (SJC) and/or tender joint count (TJC) (66/68 counts)
      compared to Baseline at the final visit of the preceding study (i.e., Week 24 for Study
      ALX0061-C201 and Week 12 for Study ALX0061-C202).
    

Detailed description: 
      Eligible subjects received one of the following treatments during the preceding Phase IIb
      studies ALX0061-C201 and ALX0061-C202:

        -  Study ALX0061-C201:

             -  Placebo (+ methotrexate [MTX]), or

             -  ALX-0061 75 mg every 4 weeks (q4w) (+ MTX), or

             -  ALX-0061 150 mg q4w (+ MTX), or

             -  ALX-0061 150 mg every 2 weeks (q2w) (+ MTX), or

             -  ALX-0061 225 mg q2w (+ MTX), for 24 weeks

        -  Study ALX0061-C202:

             -  ALX-0061 150 mg q4w, or

             -  ALX-0061 150 mg q2w, or

             -  ALX-0061 225 mg q2w, for 12 weeks

      At the Week 24 (ALX0061-C201) or Week 12 (ALX0061-C202) visit of the previous study, informed
      consent was obtained from all subjects who were deemed potentially eligible for the OLE
      study, according to the inclusion and exclusion criteria. This was marked as the Week 0 visit
      of the C203 study. Of note, the Baseline time point in the analyses of this study was defined
      the Baseline value of the parent study.

      In this OLE study, eligible subjects received ALX-0061 150 mg s.c. injections, beginning at
      Week 0 and every 2 weeks thereafter, up to and including Week 102. Eligible subjects from the
      preceding study ALX0061-C201 also continued their MTX treatment.

      Maintenance of the response (i.e., at least 20% improvement in both SJC and TJC compared to
      Baseline of the preceding study) was reassessed at the study visits at Weeks 12, 24, 36, 48,
      60, 72, 84, and 96. Subjects who failed to maintain response and met the Efficacy
      Discontinuation Criteria were discontinued from this study.
    

Intervention name(s): ALX-0061
Intervention type(s): Biological
Intervention description(s): Subjects received ALX-0061 150 mg s.c. injections, beginning at Week 0 and q2w thereafter, up to and including Week 102. Subjects from the preceding study ALX0061-C201 also continued their MTX treatment.
Other intervention name(s): Vobarilizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Compare SB16 (Proposed Denosumab Biosimilar) to Prolia® in Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomised, double-blind, multicentre study to evaluate the efficacy, safety, PK,
      PD, and immunogenicity of SB16 compared to Prolia® in postmenopausal women with osteoporosis.
    

Detailed description: 
      Subjects will be randomised in a 1:1 ratio to receive either SB16 or Prolia®. At Month 12,
      subjects in Prolia® treatment group will be randomised again in a 1:1 ratio to either
      continue on Prolia® treatment or be transitioned to SB16 treatment. Investigational product
      (60 mg in 1 mL of SB16 or Prolia®) will be given subcutaneously every 6 months up to Month
      12, and the last assessment will be done at Month 18.
    

Intervention name(s): SB16 (Proposed Denosumab Biosimilar); Prolia® (Denosumab)
Intervention type(s): Drug; Drug
Intervention description(s): Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months.
At Month 12, subjects transited from Prolia® group to SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously.; Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months.
Intervention MeSH terms: Denosumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of K-757 in Healthy Overweight/Obese Volunteers
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a multiple dose study to evaluate the safety, tolerability, PK, and PD of K-757
      alone, in combination with sitagliptin, or in combination with K-833.
    


Intervention name(s): K-757; K-757 and open-label sitagliptin; Matching placebo to K-757; Matching placebo to K-757 and matching placebo to K-833; K-757 and K-833; Matching placebo to K-757, open-label sitagliptin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): administered orally; both administered orally; administered orally; both administered orally; both administered orally; both administered orally
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Obesity
Gan & Lee Insulin Glargine Target Type (2) Evaluating Research
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      • To evaluate equivalence of Gan & Lee Insulin Glargine Injection and Lantus® in terms of
      immunogenicity

      Secondary Objective:

      Immunogenicity:

      • To evaluate the percentage of subjects with negative anti-insulin antibodies (AIA) at
      baseline who develop confirmed positive AIA up to Week 26, the percentage of subjects with at
      least a 4-fold increase in titers compared to baseline value, mean change from baseline in
      AIA titers between treatment groups, the percentage of subjects with confirmed positive AIA
      who develop any anti-insulin neutralizing antibodies up to visit Week 26, and the percentage
      of subjects in each treatment group with confirmed positive AIA up to visit Week 26

      Safety:

      • To evaluate the safety of Gan & Lee Insulin Glargine Injection in comparison with that of
      Lantus®

      Efficacy:

      • To evaluate the efficacy of Gan & Lee Insulin Glargine Injection in comparison with that of
      Lantus®
    


Intervention name(s): Gan & Lee Insulin Glargine Injection; Lantus®
Intervention type(s): Biological; Biological
Intervention description(s): Route of administration: subcutaneous injection; Route of administration: subcutaneous injection
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects who meet the study eligibility criteria will be centrally randomized 1:1 in an open-label fashion to receive either Gan & Lee Insulin Glargine Injection or Lantus® for 26 weeks.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Diabetes Type 2; Type 2; Basal; Insulin; Glargine; T2DM; Diabetes Mellitus
Innate Immune Responses in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      We hypothesize that ongoing and more severe airway inflammation in COPD may result from the
      impairment in activation of innate immune response
    


Intervention name(s): Budesonide
Intervention type(s): Drug
Intervention description(s): Inhaled budesonide 400 mcg twice a day for 2 weeks
Other intervention name(s): Rhinocort
Intervention MeSH terms: Budesonide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to see how ETC-1002 is tolerated in the body, to
      measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level
      of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and
      urine in patients with elevated LDL-cholesterol with or without statin intolerance.
    

Detailed description: 
      Hypercholesterolemic patients either with or without a history of statin intolerance (1:1
      ratio) will be randomized to receive once daily by mouth capsules containing either ETC-1002,
      ezetimibe, or ETC-1002 + ezetimibe. This study will explore the safety and efficacy of
      concomitant administration of ETC-1002 and ezetimibe, while also exploring the effect of
      ezetimibe on ETC-1002 systemic exposure.
    

Intervention name(s): ETC-1002; Ezetimibe
Intervention type(s): Drug; Drug
Intervention description(s): Patients receive ETC-1002; Patients receive ezetimibe
Other intervention name(s): Zetia
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Statin intolerant; Statin tolerant; LDL; Cholesterol
Effects of Positive End-Expiratory Pressure on Biventricular Function During One-Lung Ventilation
Condition: Lung Cancer
Study type: Interventional

Summary: 
      One lung ventilation (OLV) is essential during thoracic surgery. During OLV, intrapulmonary
      shunt can be increased resulting hypoxemia. Wang et al measured intrapulmonary shunt by
      transesophageal echocardiography. Although OLV technique had been advanced so far, hypoxemia
      during OLV reaches about 10% in spite of inspired oxygen fraction 100%. Applying
      PEEP(Positive End-expiratory Pressure) at dependent lung and CPAP at non-dependent lung can
      mitigate the hypoxemia. Above all, PEEP can be easily applicable. However, there are
      controversial studies whether it is supportive or not. In this prospective, cross-over study,
      the investigators are planning to investigate the effects of PEEP on intrapulmonary shunt,
      oxygenation and cardiac function as well.
    


Intervention name(s): PEEP
Intervention type(s): Procedure
Intervention description(s): After induction of anesthesia, including insertion of TEE probe, change position from supine to lateral position. Measure ABGA and cardiac indices for the baseline value. Apply each PEEP (0, 5, 10 cmH2O) serially at the random order. 6 sequences (0->5->10, 0->10->5, 5->10->0, 5->0->10, 10->5->0, 10->0->5) are equally applied to 6 patients (total 6x6=36 patients) who agreed to this study. Measure ABGA and cardiac indices after 20 min at each step of peep apply(3 times).
Other intervention name(s): Positive EndExpiratory Pressure breathing(PEEP)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to
      safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with
      NASH
    

Detailed description: 
      This is a 2-part, randomized, double-blind, multicenter, placebo-controlled study to evaluate
      the safety and efficacy of Vonafexor in patients with NASH who likely have stage F2 to F3
      fibrosis at approximately 50 global clinical sites. Overall, approximately 114 eligible
      patients will be enrolled: 24 patients in Part A (Safety Run-in Cohort), followed by 90
      patients in Part B.

      In Part A, 24 patients will be randomized on Day 1 to 1 of 4 parallel treatment groups: 100
      mg Vonafexor twice daily (BID), 200 mg Vonafexor once daily (QD), 400 mg Vonafexor QD, or
      placebo BID. In Part B, 90 patients will be randomized on Day 1 to 1 of 3 parallel treatment
      groups: 100 mg Vonafexor QD, 200 mg Vonafexor QD, or placebo QD.
    

Intervention name(s): Vonafexor; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral tablets; Oral tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: EYP001 (vonafexor); Liver Diseases; Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; NASH
Phase 1 Safety Study of ALRN-5281 in Healthy Subjects
Condition: Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of a single
      dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.
    


Intervention name(s): ALRN-5281 0.015 mg/kg; ALRN-5281 0.05 mg/kg; ALRN-5281 0.15 mg/kg; Placebo 0.015 mg/kg; Placebo 0.05mg/kg; Placebo 0.15mg/kg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment