bioihbjkbjnl/mcl2 huggingface dataset:
Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before
      surgery.

      PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol
      before surgery in treating patients who have localized prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the
           development of prostate cancer in patients with localized prostate cancer.

        -  Assess the toxicity of this drug in these patients.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one
      of 2 arms.

        -  Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo
           prostatectomy.

        -  Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.

      PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within
      18 months.
    

Intervention name(s): doxercalciferol; conventional surgery
Intervention type(s): Dietary Supplement; Procedure
Intervention description(s): Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.; Procedure: Prostatectomy for prostate cancer
Other intervention name(s): Localized adenocarcinoma of the prostate; Prostatectomy - no dietary supplement
Intervention MeSH terms: 1 alpha-hydroxyergocalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; stage I prostate cancer; stage II prostate cancer
Safety and Efficacy of Intravenous Acetaminophen (IV APAP) in Adult Inpatients
Condition: Acute Pain; Fever
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will be investigating safety and efficacy administration of repeated dose of IV
      Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult
      patients.
    

Detailed description: 
      • To assess the safety of IV Acetaminophen when used over five days for the treatment of
      acute pain or fever in adult inpatients

      Secondary Objectives:

        -  To compare the efficacy of IV Acetaminophen 650 milligram (mg) every four (q4) hours vs.
           1 gram (g) every 6 (q6) hours over 5 days of treatment

        -  To compare the safety of IV Acetaminophen 650 mg q4 hours vs. 1 g q6 hours over 5 days
           of treatment

        -  To compare the safety of IV Acetaminophen vs. standard of care (SOC) treatment over 5
           days of treatment

        -  To compare the efficacy of IV Acetaminophen vs. standard of care treatment over 5 days
           of treatment
    

Intervention name(s): IV Acetaminophen
Intervention type(s): Drug
Intervention description(s): Arm 1: 1 g IV Acetaminophen every 6 hours administered for five days. Arm 2: 650 mg IV Acetaminophen every 4 hours administered for five days. Arm 3: The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.
Other intervention name(s): IV Acetaminophen (IV APAP)
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute pain; Fever; IV Acetaminophen; Analgesic
Comparison of Diagnostic Performances of 68Ga-DOTATATE PET-CT and 18F-FDOPA PET-CT in Paragangliomas and Pheochromocytomas Evaluation
Condition: Paragangliomas; Pheochromocytomas
MeSH terms: Pheochromocytoma; Paraganglioma
Study type: Interventional

Summary: 
      18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and
      Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as
      dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine
      Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography)
      imaging using peptide receptors has gained an increasing role in the management of NETs. The
      use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of
      Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of
      SSTRs-expressing tumors, including PGLs.

      In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than
      other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the
      most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and
      68Ga-DOTATATE PET-CT have never been compared in this clinical setting.
    


Intervention name(s): PET-CT
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Self Selected Exercise Intensity in PAD Patients
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Study type: Interventional

Summary: 
      Although the benefits of supervised walking training in patients with peripheral arterial
      disease (PAD) and symptoms of intermittent claudication (IC) are well established, one of the
      main problems found in this type of protocol is low adherence to training, which is possibly
      related to pain during training. In addition, little is known about the impact of performing
      exercise with pain on cerebral blood flow and cardiovascular health indicators. Thus, the
      objective of the present study will be to analyze the acute effects of walking exercise with
      self-selected intensity on the cardiovascular health indicators of patients with PAD.
      Therefore, 17 patients with PAD will undergo three experimental sessions: exercise with
      self-selected intensity, exercise until maximum pain and control. The responses of the
      cardiovascular variables (heart rate variability, blood pressure, heart rate, arterial
      stiffness and endothelial function) will be obtained before and after the sessions. In
      addition, during the session cardiovascular responses (cerebral blood flow, blood pressure
      and heart rate), perceptual and affective responses, as well as information about the
      exercises performed during the session will be obtained. The responses before and after
      exercise will be analyzed using the two-way analysis of variance for repeated measures
      (ANOVA) and the Newman-Keuls post-hoc test. The value of P <0.05 will be considered
      significant.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): Three conditions will be tested: self-selected exercise, walking with pain exercise, and control session.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peripheral artery disease; Exercise; Cerebral blood flow; Cardiovascular system
Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Vomiting
Study type: Interventional
Phase: Phase 3

Summary: 
      The Olanzapine Regimen will be superior to the Standard Regimen, as measured by the
      proportion of patients with Complete Response in the 120 hours following AC chemotherapy.
    


Intervention name(s): Experimental drug: Aprepitant; Experimental drug: Ondansetron; Experimental drug: Dexamethasone; Experimental drug: Olanzapine; Standard: Aprepitant; Standard: Ondansetron; Standard: Dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Day 1: 125mg QD; Day 2 to Day 3: 80mg QD; Day 1: 8mg BD, First dose 8mg, Second dose 8mg, 8 hours after first dose; Day 1: 12mg QD; Day 1 to Day 5: 10mg QD; Day 1: 125mg QD, Day 2 to Day3: 80mg QD; Day 1: 8mg BD, First dose 8mg, second dose 8mg, 8 hours after first dose; Day 1: 12mg QD ; Day 2 to Day 3: 4mg BD
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Ondansetron; Olanzapine; Aprepitant; Fosaprepitant; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
DNR and AraC Combined to Fractionated Mylotarg® in Patients With First Relapse of AML
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      For several years, the effective standard induction chemotherapy for AML has been limited to
      the association of anthracycline and aracytine. GO is the first effective targeted antibody
      used in leukemia patients. In a previous study, we showed efficacy and safety of fractionated
      doses of GO used as a single agent for treatment of adult AML patients in first relapse. In
      the present study the possibility of combining fractionated doses of GO to escalated doses of
      a 3+7 regimen old is studied in relapsed AML patients > 50 and <70 years.
    

Detailed description: 
      Induction course are:

      GO 3mg/m2 on days 1, 4,7 + the three dose levels were as follows:

      level 1: DNR: 45 mg/m2 x 3 days + AraC: 100 mg/m2 x 7 days level 2: DNR: 60 mg/m2 x 3 days +
      AraC: 100 mg/m2 x 7 days level 3: DNR 60 mg/m2 x 3 days + AraC: 200 mg/m2 x 7 days. with 20
      mg of methylprednisolone prior to each GO infusion. Consolidation course: patients in CR may
      receive 2 additional courses of consolidation chemotherapy with Amsacrine 90 mg/m2 daily for
      3 days, and Ara-C (1g/m2/12 hours x 3 days) + GO 3 mg/m2 on day 1.

      Treatment with HSCT is offered at the discretion of the physician in charge of the patient. A
      delay between last infusion of GO and HSCT above 3 months is recommended
    

Intervention name(s): Mylotarg
Intervention type(s): Drug
Intervention description(s): Dose level study
Other intervention name(s): Gemtuzumab Ozogamicin
Intervention MeSH terms: Gemtuzumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Myeloid Leukemia; First relapsing AML
Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Human Immunodeficiency Virus (HIV)-Positive Adults
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the safety and immunogenicity of a GlaxoSmithKline
      (GSK) Biologicals' candidate tuberculosis vaccine (692342) administered to Human
      Immunodeficiency Virus (HIV)-positive adults aged 18 to 59 years, living in a tuberculosis
      endemic region.

      Subjects will be followed-up for 3 years.

      Subjects will be enrolled in 3 cohorts:

        -  HIV-positive adults on highly active antiretroviral therapy

        -  HIV-positive adults not on highly active antiretroviral therapy

        -  HIV-negative adults

      Each cohort will have 2 groups.
    

Detailed description: 
      This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading
      to the update of the outcome measures and the inclusion and exclusion criteria.
    

Intervention name(s): GSK's investigational vaccine 692342; Physiological saline
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular, 2 doses; Intramuscular, 2 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Tuberculosis vaccine
Continuous Measurement of Glymphatic Activity in the Human Brain During Sleep-Wake States
Condition: Healthy
Study type: Interventional

Summary: 
      This is a cross-over randomized study to validate the Sponsor investigational medical device
      against measurements of glymphatic function from MRI-based neuroimaging, EEG, blood
      biomarkers and cognitive tests in healthy older volunteers.
    

Detailed description: 
      The study population will consist of healthy individuals, ages 50 to 65, that are cognitively
      normal and do not have a medical history of neurological or sleep disorder, cardiovascular
      disease, hypertension, or diabetes. The objectives of this study are to define whether sleep-
      and wake-associated device measurements (i) faithfully reflect glymphatic function measured
      by non-invasive MRI measures of glymphatic function; (ii) replicate pre-clinical findings
      between sleep EEG power bands and glymphatic flow; (iii) predict plasma levels of Alzheimer's
      disease (AD)-related biomarkers; and (iv) predict morning cognitive performance.
    

Intervention name(s): Device measurements
Intervention type(s): Diagnostic Test
Intervention description(s): Overnight device measurements
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cross-over randomized study
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
A Study to Evaluate the Pharmacodynamic Effects of Single Oral Doses of PF-06648671 on β-Amyloid (Aβ) Concentrations in Cerebrospinal Fluid (CSF)
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is phase 1 investigator-and-subject blind, sponsor open, randomized, placebo controlled,
      parallel study in healthy subjects to evaluate the pharmacodynamics effect of single oral
      doses of PF-06648671 on CSF Aβ concentrations using serial CSF sampling methodology.
    

Detailed description: 
      This study is investigator-and-subject blind, sponsor open, randomized, placebo-controlled,
      parallel study in healthy subjects to evaluate central (CSF) and peripheral (plasma)
      pharmacodynamics effects (Abeta) over 36 hours post single doses of PF-06648671. Two cohorts
      will be run in sequential. the first cohort is to evaluate the Abeta effect at top dose of
      300 mg PF-06648671 and second cohort is to evaluate the Abeta effect at top dose (if more
      subjects are required) and/or 1-2 lower doses
    

Intervention name(s): PF-06648671; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Experimental Pfizer compound which will be dosed as oral suspension, single dose at 300 mg and/or 1-2 lower doses; Placebo which will be dosed as oral suspension, single doses to match PF-06648671
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Phase 1; Double blind; Placebo-Controlled; Parallel Design; CSF Aβ Concentrations; PF-06648671
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine the efficacy of peginterferon beta-1a in
      reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis
      (RMS) at 1 year. The secondary objectives of this study are to determine whether
      peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the
      total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance
      imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the
      progression of disability.
    

Detailed description: 
      This is a global multicenter, randomized, double-blind, parallel-group, placebo-controlled
      study. The treatment period is 96 weeks (2 years) in duration. Treatment Year 1 (Week 0 to
      Week 48) is referred to as the placebo-controlled treatment period of the study. At the
      beginning of Treatment Year 1, participants were randomized to receive placebo, peginterferon
      beta-1a 125 μg every 2 weeks, or peginterferon beta-1a 125 μg every 4 weeks. At the end of
      Treatment Year 1, participants in the placebo group were re-randomized to receive
      peginterferon beta-1a treatment so that during treatment Year 2 (Weeks 48 to Week 96) all
      participants received peginterferon beta-1a 125 μg every 2 or every 4 weeks. Per protocol,
      all primary and secondary endpoints pertain to Year 1 data.
    

Intervention name(s): BIIB017 (peginterferon beta-1a); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.; Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.
Other intervention name(s): PEG IFN ß-1a; PEGylated interferon beta-1a; Plegridy
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: interferon; injectable; MS; SC; PEGylated; Interferon beta-1a; relapsing; PEG; multiple sclerosis; subcutaneous
Generation of Positive Biological Samples to Leuprolide Acetate for Doping Control
Condition: There Are no Conditions Under Study. Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The study consists of the generation of biological samples (in urine) positive to leuprorelin
      acetate for doping control by new developed methods, and establish the analytical parameters
      that reveal the administration of Leuprorelin acetate in healthy volunteers with these
      methods.
    


Intervention name(s): LEUPRORELIN ACETATE
Intervention type(s): Drug
Intervention MeSH terms: Leuprolide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of a Probiotic-based Product on Blood Pressure
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The aim of the present study was to examine the efficacy of a probiotic-based product on
      either reducing hypertension or preventing a high normal blood pressure from reaching
      hypertensive levels.
    


Intervention name(s): Fermented blueberry drink; Placebo drink; Sachets with probiotic bacterial powder; Sachets with placebo powder
Intervention type(s): Other; Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study to Investigate Safety With Special Emphasis on ECG Effects and Tolerability After Oral Doses of Dextromethorphan Hydrobromide Monohydrate in Healthy Male and Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the current study is to investigate the safety with special emphasis
      on ECG effects, and tolerability of dextromethorphan hydrobromide monohydrate (2mg/mL syrup)
      in healthy male and female subjects following oral administration of 30 mg q.i.d. and 90 mg
      q.i.d. for 2 days followed by a single morning dose (extensive metabolisers of CYP 2D6) and
      for 10 days followed by a single morning dose (poor metabolisers of CYP 2D6).

      Additionally pharmacokinetic properties of dextromethorphan and its main metabolites
      dextrorphan, 3-hydroxymorphinan, and 3-methoxymorphinan will be investigated
    


Intervention name(s): Dextromethorphan syrup - low dose; Dextromethorphan syrup - high dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Dextromethorphan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study to Compare the Efficacy and Safety of a Combination of Ketoconazole and Clindamycin Compared to Tetracycline/Amphotericin B Combination Cream for the Treatment of Bacterial Vaginosis and Vaginal Candidiasis (P08077)
Condition: Vaginosis, Bacterial; Candidiasis, Vulvovaginal
MeSH terms: Candidiasis; Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Vaginal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to compare the safety and efficacy of the use of a intravaginal ovule
      containing a combination of Ketoconazole and Clindamycin to the use of an intravaginal cream
      containing a combination Tetracycline and Amphotericin B for the treatment of bacterial
      vaginosis and/or mixed or isolated vaginal candidiasis.
    


Intervention name(s): 100 mg clindamycin /800 mg ketoconazole vaginal ovule; 100 mg tetracycline hydrochloride /50 mg amphotericin B cream
Intervention type(s): Drug; Drug
Intervention description(s): 1 vaginal ovule for 3 consecutive days; 1 applicator (4 g) full of cream intravaginally for 7 to 10 days
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Amphotericin B; Tetracycline; Ketoconazole; Liposomal amphotericin B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Telerehabilitation After Total Knee Arthroplasty
Condition: Telerehabilitation; Total Knee Arthoplasty; Physiotherapy
Study type: Interventional

Summary: 
      The aim of this study was to assess the function, pain intensity and walking distance in
      patients prior to and after total knee arthroplasty, who received therapy either in a clinic
      under direct supervision of a physical therapist and patients who received
      telerehabilitation.
    

Detailed description: 
      The study population consisted of 105 patients who had knee arthroplasty due to knee
      arthrosis followed by 6- weeks physiotherapy, mean age 68.5 ± 7.3 years. The patients were
      randomly divided into two groups: I - telerehabilitation group (n=54), and II clinical
      control group (n=51), who received physiotherapy supervised by physiotherapist. All patients
      were given the following tests: VAS (0-10), 6-Minute Walk Test, and KSS - Knee Society Score.
    

Intervention name(s): telerehabilitation; standard physiotherapy
Intervention type(s): Other; Procedure
Intervention description(s): Procedure for both groups:
I pre surgery evaluation
initial training in hospital
physiotherapeutic programme telerehabilitation versus standard 7 times a week
Therapy duration: 6 weeks post-surgery II 6weeks post-surgery evaluation; standard physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients (n=105) were randomly divided into two groups: telerehabilitation group (n=54) - 42 women and 12 men and control group (n=51) 40 women and 11 men - direct physiotherapist supervised group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: disability; geriatric