bioihbjkbjnl/mcl2 huggingface dataset:
Alemtuzumab in Treating Patients With Advanced Chronic Lymphocytic Leukemia That Did Not Respond to Previous Fludarabine
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as alemtuzumab, can block cancer growth in different
      ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and
      help kill them or carry cancer-killing substances to them.

      PURPOSE: This phase II trial is studying how well giving alemtuzumab by injection works in
      treating patients with advanced chronic lymphocytic leukemia that did not respond to previous
      fludarabine.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the safety and efficacy of subcutaneous alemtuzumab vs intravenous alemtuzumab
           in patients with fludarabine-refractory advanced chronic lymphocytic leukemia.

        -  Determine the response in patients with high-risk genetic abnormalities (unmutated
           immunoglobulin variable heavy-chain [IgVH] status, del [17p], del [11q]) treated with
           subcutaneous alemtuzumab after progression on fludarabine.

      OUTLINE: This is a multicenter study.

      Patients receive alemtuzumab IV once, followed 1 week later by alemtuzumab subcutaneously
      once weekly for up to 12 weeks.

      PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
    

Intervention name(s): alemtuzumab
Intervention type(s): Biological
Intervention MeSH terms: Alemtuzumab
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia
Cyclosporine Dose Adjustment According to Calcineurin Activity After Allogeneic Hematopoietic Stem-cell Transplantation
Condition: Hematopoietic Stem Cell Transplantation; Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to assess whether an adaptation of cyclosporine (CsA) dose
      according to a longitudinal calcineurin (CN) activity monitoring would prevent the onset of
      graft-versus-host disease (GVHD).
    

Detailed description: 
      Our previous studies established a correlation between increased calcineurin (CN) activity
      and the risk of developing severe acute GVHD in allogeneic stem cell transplant recipients
      receiving immunosuppressive therapy with calcineurin inhibitors.

      This proof-of-concept trial is aiming at evaluating CALCIneurin activity as a monitoring
      biomarker of efficacy of cyCLOsporine - (CALCICLO) - for the prophylaxis of acute GVHD. Our
      aim is to assess whether a longitudinal monitoring of CN activity would permit to adapt and
      optimize the dose of CsA that would prevent the onset of severe acute GVHD, yet still
      maintaining an acceptable tolerability profile.
    

Intervention name(s): Dose adaptation according to CN activity monitoring; Cyclosporine (CsA)
Intervention type(s): Behavioral; Drug
Intervention description(s): The protocol of the CALCICLO trial consisted in a CsA dose adaptation during the first 100 days following transplantation. This dose adaptation was performed according to both residual CsA blood and CN activity levels only if the safety of vital functions - especially renal, liver, and neurological - was preserved as assessed by clinical evaluations and laboratory analyses such as creatinine clearance higher than 40 ml/min, serum bilirubin lower than 40 µM and absence of neurological signs. According to the protocol, CsA blood levels and CN activity were measured concomitantly at least once a week from day 0 to day 15, twice a week from day 16 to day 35 and then once a week until day 100.; Cyclosporine (CsA)
Intervention MeSH terms: Cyclosporine; Cyclosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Investigate the Effect of AZD1656 on the Pharmacokinetics of Sitagliptin in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of AZD1656 on Sitagliptin
      pharmacokinetics and vice versa in patients with Type 2 Diabetes Mellitus.
    


Intervention name(s): AZD1656; Sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet bd,; Oral tablet od
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus, Sitagliptin
Nebulized Amikacin Versus Intravenous Amikacin in the Treatment of Nosocomial Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      The investigator's goal in this study is to evaluate the efficacy and safety of nebulized
      amikacin versus intravenous amikacin in patients with hospital and ventilator acquired
      pneumonia in surgical patients admitted to the intensive care units infected with gram
      negative bacilli
    

Detailed description: 
      prospective, randomized, controlled study on post-cardiac surgery patients , included two
      groups, over one year period. The first group was administered intravenous (IV) amikacin 20
      mg/kg once daily. The second group was prescribed amikacin nebulizer 400 mg twice daily. Both
      groups were co-administered intravenous (IV) piperacillin/tazobactam empirically.
    

Intervention name(s): Nebulized Amikacin; Intravenous Amikacin
Intervention type(s): Drug; Drug
Intervention description(s): 400mg twice daily nebulized amikacin; 20mg/kg once daily intravenous amikacin
Intervention MeSH terms: Amikacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of repeated daily administration of
      rifampicin on the pharmacokinetics (what the body does to the medication) of abiraterone
      following single-dose administration of abiraterone acetate tablets in healthy male
      participants.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-center
      (study conducted at one site), 2-period, sequential-design (studies that combine both
      longitudinal and cross sectional methods), to evaluate the effects of rifampicin on the
      pharmacokinetics of abiraterone acetate in healthy male participants. The study consists of a
      screening phase, an open-label treatment phase, and a follow up phase. The screening phase
      will be within 14 days before the first study medication administration. The treatment phase
      will consist of 2 treatment periods, Period 1: a single oral dose of abiraterone acetate
      tablets, and Period 2: a daily oral dose of rifampicin capsules alongwith a single oral dose
      of abiraterone acetate tablets. The 2 periods will be separated by a washout period of at
      least 7 days. Blood sample collection for pharmacokinetic assessments will be done for
      determination of abiraterone and rifampicin concentrations. The follow up phase will be of 14
      days. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram,
      vital signs, and physical examinations will be monitored throughout the study. The total
      study duration will be approximately 31 days.
    

Intervention name(s): Abiraterone acetate; Rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): Type=exact number, unit=mg, number=1,000, form=tablet, route=oral. Abiraterone acetate administered on Day 1 of Period 1, and Day 14 of Period 2.; Type=exact number, unit=mg, number=600, form=capsule, route=oral. Rifampicin administered on Days 8 to 13 of Period 2.
Other intervention name(s): ZYTIGA; RIFADIN
Intervention MeSH terms: Rifampin; Abiraterone Acetate
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Pharmacokinetics; Abiraterone acetate; Abiraterone; JNJ-589485; JNJ-212082; Zytiga; Rifampicin; Rifadin; CYP3A4 inducer
Blood Pressure Lowering Effect of Supplementation With Korea Red Ginseng Associated With Reductions in Circulating Lp-PLA2 Activity and Lysophospatidylcholines and an Increase in Dihydrobiopterin in Prehypertensive Subjects
Condition: Prehypertension
MeSH terms: Prehypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated effects of red ginseng consumption on blood pressure (BP) and fasting
      plasma metabolomes.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled study was conducted on nonobese, nondiabetic
      and prehypertensive subjects. Over a 12 week test period, the red ginseng group (n=31)
      consumed 10 capsules (total 5g) daily containing red ginseng, while the placebo group (n=31)
      consumed the same product without red ginseng. Fasting plasma metabolomes were profiled using
      UPLC-LTQ-Orbitrap mass spectrometry.
    

Intervention name(s): KRG; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5g Korea red ginseng (KRG); 5g placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Observational Study Evaluating Long-Term Effectiveness of Duodopa/Duopa in Patients With Advanced Parkinson's Disease
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      This study is a non-interventional post-marketing observational study (PMOS) of participants
      with advanced Parkinson's disease (PD) treated with Duodopa/Duopa in a routine clinical
      setting. Effectiveness of treatment will be collected with physician and
      participant/caregiver health outcomes beginning with PMOS enrollment (baseline visit), at the
      start of Duodopa/Duopa treatment via percutaneous endoscopic gastrostomy-with jejunal
      extension (PEG-J), at regularly scheduled visits closest to Months 3 and 6, and every 6
      months thereafter up to 36 months. An additional cohort of participants will be enrolled who
      in addition will be evaluated with a wearable device.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Advanced Parkinson's disease
      
Keywords: Advanced Parkinson's Disease; Duodopa/Duopa; carbidopa levodopa enteral suspension (CLES); levodopa-carbidopa intestinal gel (LCIG); OFF time; motor and non-motor symptoms; dyskinesia; tremor; Quality of Life; Observational; Long-term; Caregiver Burden; effectiveness; fluctuations
TEDS in Prolonged Mechanical Ventilation
Condition: Mechanical Ventilation
Study type: Interventional

Summary: 
      Muscle atrophy and diaphragm dysfunction are common with prolonged mechanical ventilation
      (PMV). Electrical stimulation has been shown to be beneficial in severe chronic heart failure
      and chronic obstructive pulmonary disease. However, its effect on PMV is unclear. This study
      examined the effects of transcutaneous electrical diaphragmatic stimulation (TEDS) on
      respiratory muscle strength and weaning outcomes in patients with PMV.
    

Detailed description: 
      Subjects on ventilation for ≥21 days were randomly assigned to TEDS or control groups. The
      TEDS group received muscle electrical stimulation for 30 min/session/day throughout the
      intervention. Weaning parameters and respiratory muscle strength (Pimax, Pemax) were
      assessed. The hospitalization outcome, including weaning rate and length of stay, was
      followed up until discharge.
    

Intervention name(s): TEDS
Intervention type(s): Device
Intervention description(s): An non-invasive intervention. During the intervention, the electrode was placed on the skin stimulated muscle.
Other intervention name(s): transcutaneous electrical diaphragmatic stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: electrical stimulation; diaphragmatic; weaning
Physical Activity in Children With Inherited Cardiac Diseases
Condition: Long QT Syndrome; Brugada Syndrome; Catecholaminergic Polymorphic Ventricular Tachycardia; Hypertrophic Cardiomyopathy; Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Tachycardia; Tachycardia, Ventricular; Cardiomyopathy, Hypertrophic; Cardiomyopathy, Dilated; Heart Diseases; Long QT Syndrome; Brugada Syndrome; Syndrome
Study type: Observational

Summary: 
      Use lay language.

      Current guidelines regarding physical activity in patients with inherited arrhythmia and
      cardiomyopathy are mostly dedicated to adult patients, with a special focus on sports
      competition. Their application to the pediatric population has been scarcely evaluated.

      Physical activity is well known for its health benefits but may be dangerous in this
      population, which leads to confusion within the medical community and among patients. Actual
      physical activity of children with such inherited cardiac disorders is unknown.

      This study aimed to assess the level of physical activity in children with inherited
      arrhythmia and cardiomyopathy, and the adherence to the current European guidelines on the
      subject. Secondary objectives aimed to assess through a qualitative analysis the impact of
      the disease on physical activity and daily life in this population.

      The level of physical activity and adherence to current guidelines will be determined from
      interviews between the patient and the principal investigator. Each patient will be
      questioned in order to explore the experiences, motivations and feelings of participants
      regarding physical activity. The standardized questionnaire was created by the principal
      investigator and members of the clinical research team.

      The investigators believe that many children practice physical activity outside the current
      guidelines and hope to identify the main determinants of physical activity in this
      population.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This study will take place in two paediatric tertiaty hospitals : the paediatric and
        congenital cardiology department of Montpellier university hospital and the paediatric
        cardiology and rehabilitation unit of St-Pierre institute in Palavas-Les-Flots, France.

        Children aged from 6 to 18 years old with genetic and/or clinical diagnosis of inherited
        cardiomyopathies (hypertrophic cardiomyopathy, dilated cardiomyopathy and arrythmogenic
        right ventricular cardiomyopathy) or inherited primary arrhythmia syndrome (long QT
        syndrome, brugada syndrome and catecholaminergic polymorphic ventricular tachycardia) are
        eligible to participate in this study. Each subject accepting to participate during the
        annual follow up consultation will be enrolled
      
Keywords: Arrythmogenic right ventricular cardiomyopathy; Physical activity; Inherited cardiac disease; Peadiarics
Trial With Autologous Dendritic Cell Vaccination in Patients With Stage II-III HER2 Negative Breast Cancer
Condition: Stage II Breast Cancer; Stage III Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Molecular expression in breast cancer (BC) defines special fenotypes with different
      prognostic and predictive features.Since the addition of trastuzumab and lapatinib to
      chemotherapy, HER2 overexpressing tumors have become the best responders to systemic
      therapies, reaching pathologic complete response rates (pCR) around 50%. But HER2 negative
      tumors (luminal A and triple negative) are characterized by low chemosensitivity (luminal A)
      or early distant relapse after diagnosis (triple negative BC) . In this open, prospective,
      non-randomized and multicentric phase II study the investigators include stage II and III
      HER2 negative BC patients that are going to receive neoadjuvant sequential chemotherapy
      Epirubicin+Ciclofosfamide x 4 and then Docetaxel x 4)with an individualized vaccination with
      autologous dendritic cells pulsed with their own tumor. The hypothesis is that the
      reinforcement of the immune system with the autologous dendritic cell vaccination against
      HER2 negative BC could increase pathologic complete responses (pCR) and disease free
      survival(DFS), when added to chemo, surgery and radiation therapy and in a maintenance
      schedule.
    

Detailed description: 
      Chemotherapy schedule:

        -  dose dense epirubucin 100 mgr/m2 plus ciclofosfamide 600 mgr/m2 every two weeks for four
           cycles with with GM-CSF support on day +1 (pegylated filgastrim) or on days +5 to +9
           (filgastrim) subcutaneously

        -  docetaxel 80-100 mgr/m2 every three weeks for four cycles. Addition of GM-CSF if
           docetaxel doses are > 85 mgr/m2
    

Intervention name(s): Autologous dendritic cell vaccination
Intervention type(s): Biological
Intervention description(s): Autologous dendritic cell vaccination. Dendritic cells are pulsed with their own tumor antigens
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; neoadjuvant chemotherapy; autologous dendritic cell vaccination
Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW

        1. In rising single doses

        2. With and without a 64 g fat breakfast at one selected dose
    


Intervention name(s): BILN 2061 ZW single rising doses; Placebo; BILN 2061 ZW fixed dose; Standardized breakfast
Intervention type(s): Drug; Drug; Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
Condition: Diphtheria; Tetanus; Pertussis; Polio
MeSH terms: Whooping Cough; Diphtheria
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at
      2, 3, and 4 months of age in order to meet the regulatory requirements for the license
      renewal as for any other product registered in China, and to generate additional clinical
      data using the three-dose primary vaccination schedule in some other Chinese provinces.

      Primary Objective

        -  To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in
           the study population.
    

Detailed description: 
      Each study participant will receive an injection of PENTAXIM® at 2, 3, and 4 months of age
      and will be monitored for safety through the entire study period.

      The duration of each participant in the trial will be approximately 3 to 4 months.
    

Intervention name(s): DTacP IPV//PRP~T combined vaccine: PENTAXIM®
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): PENTAXIM®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pentaxim®; Whole-cell Pertussis vaccine; Acellular Pertussis vaccine; Haemophilus influenzae type b polysaccharide; Inactivated Polio vaccine; Pentavac®
A Study on Intestinal Gas Symptoms to Evaluate the Effects of Gas Defense in Otherwise Healthy Adult
Condition: Abdominal Pain; Abdominal Cramps; Flatulence
MeSH terms: Colic; Abdominal Pain; Flatulence
Study type: Interventional

Summary: 
      This is a randomized, double-blind, placebo-controlled trial to determine the safety and
      efficacy of Digestive Advantage™ Gas Defense formula, a probiotic dietary supplement. The
      study will last approximately four weeks, and subjects will be seen at a
      screening/randomization visit, and two follow-up visits.

      Study procedures will include administering questionnaires for assessment of the study
      product's effect on intestinal gas symptoms and quality of life.
    


Intervention name(s): BC-130 (Gas Defense); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Product Dosing:
Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food)
Gas Defense Serving Size: 1 tablet Active Ingredients: B. Coagulans, Enzyme Blend (Cellulase - Trichoderma longibrachiatum, Cellulase - Aspergillus niger, Hemicellulase, Alpha Galactosidase, Invertase) Inactive Ingredients: vegetable capsule, Magnesium Stearate, Silicon Dioxide, Maltodextrin Contains: Wheat, Fish.; Product Dosing:
Take one capsule daily, at approximately the same time of day, without regard to food (may be taken with or without food)
Placebo - matched in size and color to the active product Inactive Ingredients: microcrystalline cellulose, FD&C yellow #5 Lake, FD&C blue #1 Lake, FD&C red #46 Lake and vegetable capsule
Other intervention name(s): Gas Defense
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Study of ACT-129968 in Adult Patients With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy and safety of different doses of ACT-129968 in adult
      patients with seasonal allergic rhinitis, due to mountain cedar pollen.
    


Intervention name(s): ACT-129968; ACT-129968; Cetirizine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily; ACT-129968 (Dose 4) & matching placebo administered orally once daily; Ceterizine administered once daily; Matching placebo administered twice daily.
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Seasonal allergic rhinitis; SAR; Allergic rhinitis; Allergies