bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150
Condition: Hemophilia A, Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one
      of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient
      levels. In a person with haemophilia, the clotting process is much slower and the person
      experiences bleeding episodes that can result in serious problems and potential disability.

      The current haemophilia standard of care is to maintain FVIII activity level above 1%.
      Sometimes, patients can develop antibodies (so called "inhibitors") against FVIII and it is
      no longer effective at controlling bleeds. Bleeds in these patients are currently treated
      using other proteins involved in the clotting process.

      The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds
      in "inhibitor" patients. This study consists of two parts, A and B. The purpose of part A is
      to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to
      efficacy and safety (dose-finding part). Part A is expected to last 9 - 29 months. The
      purpose of part B is to confirm efficacy and safety of the dose found in part A in all
      participating patients (confirmatory part). Part B is expected to last 12-32 months.

      Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or
      B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6
      months, will participate in this study.

      Patient's bleeds will be treated with BAY86-6150 and with a rescue medication if no response
      is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be
      required to keep an electronic diary.
    


Intervention name(s): BAY86-6150; eptacog alfa [activated]; BAY86-6150
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Four dose levels (6.5 µg/kg, 20 µg/kg, 50 µg/kg and 90 µg/kg) of BAY86-6150 will be studied.; comparative PK/PD (pharmacokinetics/pharmacodynamics) evaluation; Confirmation of recommended dose of BAY86-6150 to be evaluated further as determined in Part A.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemophilia, haemophilia, inhibitor, FVIIa, Factor VII activated, bypassing
Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary study objective is to determine the efficacy of ondansetron (0.33 mg twice daily)
      administered orally for a period of 16 weeks in reducing risky drinking among currently
      drinking subjects with alcohol use disorder who have selected genotypes at the serotonin
      transporter and receptor genes. The secondary objective is to assess the safety and
      tolerability of ondansetron in subjects with alcohol use disorder who have selected genotypes
      at the serotonin transporter and receptor genes.
    

Detailed description: 
      Alcohol use disorder (AUD) is a heterogeneous and chronic relapsing disorder that includes
      both acute (binge drinking) and chronic (frequent heavy drinking) dimensions. Perhaps because
      of this heterogeneity, the therapeutic effect size of the approved medicines for the
      treatment of AUD has been small. In an effort to overcome the heterogeneity of response to a
      particular medication, recent studies have instituted a personalized approach to therapy.
      Major breakthroughs in pharmacogenetics have made it possible to identify discrete subgroups
      of the AUD population according to genetic profiles in order to target the subjects who are
      most likely to respond to treatment with a particular agent. In addition, genetic variation
      contributing to the risk of alcohol dependence may be differentially associated with
      treatment response Thus a successful personalized medicinal approach should ensure that
      targeted subgroups achieve an optimal treatment response with high predictability. Such an
      approach holds the potential to identify not only robust responders to treatment but also
      those who might have minimal or modest adverse effects from the putative therapeutic
      medication. From a practical clinical standpoint, a personalized medicine approach starts
      with a genetic screen to identify the "right" subject, who can then be treated with the
      appropriate medication, with a high probability of a positive treatment outcome and,
      therefore, a substantial impact on public health.
    

Intervention name(s): Ondansetron; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ondansetron (0.33 mg) bid+ BBCET counseling; Placebo + BBCET counseling
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 2 x 2 factorial design: treatment intervention (active, placebo) x genotype (responsive, non-responsive)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcoholism, treatment, serotonin transporter
Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions
Condition: Asthma
Study type: Observational

Summary: 
      This study is designed as a multicenter, observational, non-interventional, open label,
      26-week study in order to observe how asthma control changes under treatment with Mometasone
      Fuorat/Indacaterol/ Glycopyrronium (MF/IND/GLY) Breezhaler® sensor system or under treatment
      with fixed-dose combination (FDC) triple therapy after 26 weeks of treatment.
    

Detailed description: 
      Subjects in one group will receive MF/IND/GLY together with the Propeller add-on sensor for
      the Breezhaler® and access to the smartphone app according to label. Subjects in the other
      group will receive any triple FDC according to label. The physician's decision to initiate or
      switch a patient to MF/IND/GLY Breezhaler® system or any other triple FDC must have been
      taken prior to and independently from the decision to include the patient in the study.
    

Intervention name(s): MF/IND/GLY plus sensor system; FDC therapy
Intervention type(s): Combination Product; Drug
Intervention description(s): There is no treatment allocation. Patients administered MF/IND/GLY plus sensor system by prescription that have started before inclusion of the patient into the study will be enrolled.
Subjects will receive MF/IND/GLY together with the Propeller add-on sensor for the Breezhaler® according to label.; There is no treatment allocation. Patients administered FDC therapy by prescription that have started before inclusion of the patient into the study will be enrolled.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be enrolled from approximately 25 pulmonology centers across Germany.
      
Keywords: mobile Health; mHealth; Propeller Health; MF/IND/GLY Breezhaler®; FDC; Fixed dose combination; Mometasone Fuorat; Indacaterol; Glycopyrronium
Train New Examiners Via Modified Gingival Margin Plaque
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to train new examiners while testing two commercial products
      using our standard one-day brushing study regimen by measuring gingival margin plaque index.
    


Intervention name(s): Fluoride; Triclosan/Fluoride
Intervention type(s): Drug; Drug
Intervention description(s): Brush twice daily; Brush twice daily
Intervention MeSH terms: Triclosan; Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Divalproex Sodium (Depakote) for Explosive Tempers in Adolescents and Adults
Condition: Attention Deficit and Disruptive Behavior Disorders; Marijuana Abuse
MeSH terms: Marijuana Abuse; Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effectiveness of divalproex sodium (Depakote)
      versus placebo in treating disruptive behavior disorder and explosive tempers in adolescents
      and adults.
    

Detailed description: 
      Disruptive behavior disorders among children and adolescents are readily diagnosed; however,
      few individuals with such disorders receive drug treatment. Depakote is a mood stabilizing
      medication that may be beneficial in treating individuals with disruptive behavior disorders.
      The purpose of this study is to examine the effectiveness of Depakote in reducing temper
      outbursts and improving mood in individuals with disruptive behavior disorders. In addition,
      this study will determine the safety and effectiveness of Depakote in treating individuals
      with substance disorders who also have disruptive behavior disorders.

      This study will last 6 weeks. Participants will be randomly assigned to receive treatment
      with Depakote or placebo. Medication will be given in a single evening dose if tolerated;
      otherwise, medication will be given twice per day. Participants will be assigned to a
      fixed-flexible dosing schedule and dosages will increase based on weight. All participants
      will attend weekly psychotherapy and family counseling sessions throughout the study.
      Participants who are substance abusers will also receive substance abuse counseling. Weekly
      study visits will include a physical exam, blood collection, and drug tests. Teachers and
      guidance counselors will be contacted to assess the participant's behavior from week to week.
      Some participants will complete a follow-up study, in which they will take part in phone
      interviews.
    

Intervention name(s): Divalproex Sodium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants are titrated over 2 weeks, as tolerated to 10 mgs / pound, and blood levels are checked to determine that the blood level is between 50-110 micrograms / ml.; Participants will be on matching placebo.
Other intervention name(s): Depakote
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD, disruptive behavior disorder, marijuana abuse
Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The objective of the study is to collect data on the use of the Rhythmia HDx mapping system
      running commercially available Software Version 2.0 or any future commercially available
      Software Version with DirectSense technology and the IntellaMap OrionTM mapping catheter in
      patients indicated for ablation treatment for de-novo Paroxysmal Atrial Fibrillation (PAF).
      The study will collect specific information to characterize the DirectSense technology in
      subjects undergoing catheter-based endocardial mapping and ablation for de-novo PAF using a
      commercial Rhythmia HDx mapping system. The clinical local impedance data will be used in
      order to generate usage guidance on the DirectSense local impedance feature in the management
      of de-novo PAF cases requiring Pulmonary Vein Isolation (PVI) and in order to further develop
      a future lesion indexing feature.
    


Intervention name(s): Ablation procedure
Intervention type(s): Device
Intervention description(s): Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways
      to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as
      trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances
      to them without harming normal cells. It is not yet known whether docetaxel and carboplatin
      are more effective with or without trastuzumab in treating breast cancer.

      PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with
      carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone
      before surgery in treating women with locally advanced breast cancer.
    


Intervention name(s): trastuzumab; carboplatin; docetaxel; trastuzumab
Intervention type(s): Biological; Drug; Drug; Biological
Intervention description(s): Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV; Cycle 1-8 Day 1 or 2 AUC = 6 IV; Cycle 1-8 Day 1 or 2: 75 mg/m2 IV; Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
Other intervention name(s): Herceptin; Taxotere; Herceptin
Intervention MeSH terms: Carboplatin; Docetaxel; Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage II breast cancer
Cell Phone Application for Vision Assessment
Condition: Visual Impairment
MeSH terms: Vision Disorders; Vision, Low
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate how visual acuity assessed with Peek Acuity (a cell
      phone application to check visual acuity) among preschool and school-aged children 3 to less
      than18 years of age (1) compares to the standard visual acuity exam in the ophthalmology
      clinic and (2) performs as a screening test for ocular abnormalities that warrant referral
      for an eye exam.
    

Detailed description: 
      Current recommendations suggest that children begin visual acuity screening as early as
      possible with most children capable at 3 years old though some may not be able to cooperate
      until 4 years of age. While visual acuity screening is standard in schools and pediatric
      clinics, the specificity of the exams has been questioned. A number of community screening
      exams rely on outdated and flawed methods that may not accurately access the vision of all
      children. Because many children who fail these vision screenings are referred to
      ophthalmology clinics without a true visual acuity deficit, a more accurate but accessible,
      cost effective, and feasible vision screening exam is necessary. One solution is a smart
      phone application designed to assess visual acuity, called Peek Acuity. The application is
      available for android operating system and can be downloaded as a free beta from the Google
      Play Store. A short tutorial walks users through the application. The application displays a
      single letter "E" in 4 positions, 0, 90, 180, and 270 degrees (rolling "E") that does not
      require English comprehension. Patients are instructed to point in the direction of the arms
      of the "E." The examiner records the responses by swiping the screen in the direction the
      patient points. The application uses responses to calculate visual acuity and typical exams
      can be completed within 2 minutes.

      In one study, Peek Acuity visual assessments have been shown to be comparable to that
      determined by the ophthalmology clinic in patients aged 55 years and older. This study also
      found that the Peek Acuity is efficient, with an average exam time of 77 seconds compared to
      82 seconds using the standard Snellen eye chart.
    

Intervention name(s): Peek Acuity; Standard Visual Screening
Intervention type(s): Other; Other
Intervention description(s): Cell phone application for visual acuity screening; Visual screening exam conducted in Duke University Eye Center
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patient randomly assigned to either be screened first with standard clinic technique or cell phone application. Patient is then screened with other method.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: screening; cell phone application
Nitrogen Balance in Infants After Post Cardiothoracic Surgery
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective is to the amount of protein infants require after cardiopulmonary bypass
      surgery.
    

Detailed description: 
      Postoperative neonates are susceptible to the adverse effects of surgery that is
      characterized by a breakdown of body stores. Without appropriate nutritional consideration
      this process can lead to increased physiological instability. It has been extensively
      documented that critically ill patients are typically catabolic. This results in body
      nitrogen losses from the breakdown of somatic protein to fuel metabolic processes such as,
      gluconeogenesis. The evaluation of this catabolic response is particularly crucial in infants
      due to their limited fat and lean body mass reserves. Quantifying the amount of protein
      needed to maintain body composition and to meet the demands of surgical stress is of clinical
      importance when considering factors associated with postoperative morbidity, such as delayed
      wound healing, impaired growth and prolonged hospital stay.

      The results obtained from this study will assist with determining an appropriate level of
      protein for the development of optimal nutrition prescriptions that are aimed at reducing
      catabolism of body stores.
    

Intervention name(s): Standard protein delivery; Intervention 1 (2.2g/kg/day); Intervention 2 (3.0 g/kg/day)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Protein delivery of 1.5 g/kg/day.; protein delivery of 2.2g/kg/day; protein delivery of 3.0 g/kg/day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Infants; Nitrogen Balance; Cardiothoracic surgery; Congenital heart disease; Malnutrition
Hippocampal-Avoiding Whole Brain Irradiation With Simultaneous Integrated Boost for Treatment of Brain Metastases
Condition: Brain Neoplasms, Adult, Malignant
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesize that avoidance of the hippocampal region with WBRT (Whole-Brain
      Radiotherapy ) may delay or reduce the onset, frequency, and/or severity of NCF
      (neurocognitive function) decline, as measured with clinical neurocognitive tools.
    

Detailed description: 
      We propose to use conformal avoidance of the hippocampal region during whole brain
      radiotherapy to reduce the dose to the hippocampi, thereby putatively limiting the
      radiation-induced inflammation of the hippocampal region and subsequent alteration of the
      microenvironment of the neural progenitor cells
    

Intervention name(s): Radiotherapy
Intervention type(s): Radiation
Intervention description(s): Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of 5% Lidocaine Patch With Placebo Patch in Subjects With Herpes Zoster Associated Pain
Condition: Herpes Zoster Pain
MeSH terms: Herpes Zoster
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled study designed to assess the efficacy
      and safety of 5% lidocaine patch, following placebo or active patch applications in placebo
      insensitive subjects.
    


Intervention name(s): 5% Lidocaine patch; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5% Lidocaine patch to be placed on the site of pain; Placebo patch to be placed on the site of pain
Other intervention name(s): Lignopad
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Evoked Potentials Recording Modalities in Healthy Volunteer Population
Condition: Attitude to Computers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to compare three different techniques of EEG recording for
      extraction of P300 Evoked Related Potentials (ERPs).
    

Detailed description: 
      Brain Computer Interface (BCI) are used to restore control and communication in patient with
      severe disabilities such as Locked In Syndrome (LIS) patients.

      The aim of this study is to identify the most relevant recording technique for extraction of
      P300 ERPs in EEG signals. Three different electrodes (needle, standard ,silver) will be
      simultaneously compared in a prospective design in 10 healthy volunteers, as suggested by
      principal investigator.
    

Intervention name(s): EEG Recording (Emotiv)
Intervention type(s): Device
Intervention description(s): Record EEG during auditory oddball paradigms:
with Emotiv EEG headset EMOTIV CAP (see http://www.emotiv.com)
with 3 electrodes : 3 different types of electrodes at the time (needle, cupule 5mm, cupule 10mm)
Other intervention name(s): EEG recording
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Brain computer interface; EEG recording; Electrodes