bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Disseminated High Grade Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Interest of the use of pegylated liposomal doxorubicin (caélyx)
    

Detailed description: 
      R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly
      patients it is often toxic, specially with haematologic and cardiac toxicities.
    

Intervention name(s): Doxorubicin; Doxorubicin pegylated
Intervention type(s): Drug; Drug
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diffuse larg cells lymphoma; chemotherapy; toxicity; diffuse high grade lymphoma
Efficacy and Safety of Jiedu Tongluo Granules for Post-stroke Depression
Condition: Post-stroke Depression
MeSH terms: Stroke; Depression; Depressive Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To explore the efficacy and safety of Jiedu Tongluo granules for post stroke depression. A
      randomized, double-blind, placebo-controlled clinical trial was designed. The treatment group
      was administered the Jiedu Tongluo granules, while the control group was administered the
      placebo.
    


Intervention name(s): Jiedu Tongluo granules; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks.; Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.
Other intervention name(s): The treatment group; The control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Mood Disorders
Condition: Bipolar Disorder; Mood Disorder; Unipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder; Mood Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate repetitive transcranial magnetic stimulation (rTMS) as a
      potential treatment for depression. In rTMS, a rapidly changing magnetic field passes through
      your scalp and skull and generates a small electrical pulses in your brain. rTMS at lower
      intensities has helped some people with depression but we do not know what the results will
      be in your case using higher intensities, or whether you will be randomized to 3 weeks of
      high frequency (20 cycles er second), low frequency (1 cycle per second), or inactive
      (sham)rTMS. You will be assigned to receive one of these types of rTMS over the left front
      art of your brain five times per week for the three weeks. Each rTMS treatment session should
      take between 20-30 minutes of actual stimulation, but weekly ratings, memory testing, and
      blood sampling may require several hours per week. We will also ask you to have brain imaging
      procedures to see if these will predict response to high vs. low frequency rTMS. If you are
      randomized to the 3 weeks of sham rTMS, you will have the opportunity to receive one of the
      active stimulation frequencies for an additional 3 weeks. Responders to any phase will be
      offered an additional month of rTMS prior to study termination and recommendations of
      alternative treatments.
    

Detailed description: 
      Repetitive transcranial magnetic stimulation (rTMS) is a new technique for activating the
      brain noninvasively through the scalp and skull. It has proven effective in producing
      localized effects on brain function and has opened many areas of human brain function to
      direct investigation. Preliminary data also suggest potential therapeutic applications in
      neuropsychiatric illness. We plan to further investigate the possible therapeutic use of rTMS
      in depression under conditions of high frequency (20 Hz), low (1Hz) frequency, and sham and
      to also examine possible cognitive or endocrine effects. Among the priorities of this
      protocol will be to further evaluate the risks of the technique.
    

Intervention name(s): Magstim Super Rapid Magnetic Stimulator; Cadwell MES-10
Intervention type(s): Device; Device
Primary purpose: Treatment
Keywords: Affective Disorders; Repetitive Transcranial Magnetic Stimulation; Mania; Bipolar Disorder; Depression; Unipolar Disorder; Unipolar Depression
Clinical Evaluation of Instrumented Wheel as Biomedical Device Quantifying the Displacement Efficiency
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to validate an instrumented wheel such as a new biomedical
      device. The physicians will compare this instrumented wheel with another instrumentation
      "Ergometer roller", each patient will try the both instrumentations, physical and
      physiological parameters will be measured.

      The increase rate of radial power during the cardiac stress test may be more important when
      the physicians use the instrumented wheel.
    

Detailed description: 
      * The manual wheelchair is used by people for whom walking is difficult or impossible due to
      spinal cord lesions, neurological and muscular diseases, lower limb trauma, age …etc.

      Although the wheelchair help to regain mobility, this made of displacement is nor natural nor
      well-to-do.

        -  The CIC-IT and TSR (Transmissions Services Roulements, Mérignac, France) improved the
           instrumented wheel, adaptable with all wheelchairs, with information wireless
           transmission.

        -  The primary objective of study is to validate the instrumented wheel of manual
           wheelchair such as a new device of evaluation of capacities of displacement in ecologic
           situation.

        -  The primary criteria is to compare the mechanical power calculated using instrumented
           wheel versus the power calculated using ergometer roller during protocol of standard
           cardio-respiratory stress test.

      This study is interventional, mono-centric, controlled and crossover. The population
      concerned is patients with spinal cord injury (SCI) and users of manual wheelchair.

      Number of subjects projected for the entire study: 62 patients The total duration of
      participation of each patient: 7 days ±2days
    

Intervention name(s): Using of instrumented wheel; Using of ergometer roller
Intervention type(s): Device; Device
Intervention description(s): Using of instrumented wheel; Using of ergometer roller
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Instrumented Wheel; Manual Wheelchair; Spinal Cord Injury (SCI); Manual wheelchair Users; Aged between 18-70 years
Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea; OSA
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Early feasibility study to estimate the functionality of a novel intervention based on
      non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the
      Apnea Hypopnea Index (AHI).
    


Intervention name(s): Transcutaneous Upper Airway Stimulation Device
Intervention type(s): Device
Intervention description(s): Multiple frequency stimulation of the hypoglossal nerve
Other intervention name(s): TUAS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Effect of Smoked Plum and Chewing Gum on Postoperative Bowel Function Following Hepatic Resection
Condition: Liver Cancer
MeSH terms: Liver Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Every patient undergoing surgery in the abdomen, such as hepatic resection, will experience
      temporary paralysis of bowel function. This study aims to evaluate whether smoked plum and
      chewing gum can reduce the bowel paralysis after hepatic resection in patients with
      hepatocellular carcinoma. One third of the study population will receive smoked plum, one
      third with chewing gum, and the last will act as empty control.
    

Detailed description: 
      Hepatectomy is widely used to treat patients with hepatocellular carcinoma (HCC), even those
      with intermediate and advanced disease. Despite its well-demonstrated clinical safety and
      efficacy in many patients, it is associated with postoperative morbidity and mortality. One
      complication after hepatectomy is delayed resumption of gastrointestinal function, known as
      postoperative ileus. This can decrease patient comfort and increase morbidity and mortality,
      prolonging hospital stay and raising healthcare costs. While postoperative ileus usually
      resolves within approximately 3 days, it can last longer in some cases as a condition termed
      postoperative paralytic ileus. Postoperative use of opioid-based analgesics can increase
      incidence of postoperative ileus.

      No drugs or interventions to prevent or treat postoperative ileus have been approved by the
      China Drug Administration or the US Food and Drug Administration. Several studies show that
      chewing gum, a new and simple modality, can accelerate complication-free recovery of
      gastrointestinal function following gastrointestinal surgery and obstetrical-gynecological
      surgery. This raises the question whether postoperative smoked plum, or chewing gum can
      reduce risk of postoperative ileus following hepatectomy. To examine this question, we
      conducted a randomized controlled trial to compare incidence of postoperative ileus and
      length of hospital stay in HCC patients who received smoked plum, chewing gum or no
      intervention following hepatectomy.
    

Intervention name(s): smoked plum; gum chewing
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive smoked plum (3 piece each time, three times per day) starting in the first day after resection until flatus; Patients will receive gum chewing (three times per day) in the first day after resection until flatus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evidence of Spreading Vasoconstriction in Human Gingiva
Condition: Vasoconstriction; Oral Soft Tissue Conditions; Dental and Gingival Conditions
MeSH terms: Disease
Study type: Interventional

Summary: 
      The aim of this study is to observe the mechanism of spreading vasoconstriction in human
      healthy gingiva. Epinephrine solution is applied on the attached gingiva in group "A" and on
      the surface of the tooth next to the ginvial sulcus in group "B". The different placement of
      the solution causes different effect in the microcirculation.
    

Detailed description: 
      Spatial regulation of gingival microcirculation has not been revealed yet. Although this
      could be an important mechanism to protect gingiva as it is exposed to mechanical, chemical,
      thermal etc. irritation during whole life. It is especially important during flap surgery.
      Laser Speckle Contrast Imaging (LSCI) is novel non-invasive method with high spatio-temporal
      resolution, therefore it allows us to study remote effect of local vasoconstriction such as
      spreading vasoconstriction in human gingiva.

      The epinephrine is a daily used vasoconstrictor material in dentistry and it will be used to
      trigger remote effect on gingiva. Epinephrine in 1 mg/ml concentration. Solution will be
      dropped on the gingiva at tooth 12 in a fabricated leakage proof well attached to 2mm above
      the marginal gingiva in group "A". The solution will be dropped on the surface of tooth 12
      next to the sulcus into the well in case of group "B". The changes of the blood flow will be
      monitor at the test side with surrounding gingival area by LSCI. The control side in each
      case will be - appropriately to the test side - at tooth 21 with phisiologocal saline.
    

Intervention name(s): Epinephrine
Intervention type(s): Drug
Intervention description(s): Vasoconstrictor solution is applied on the surface of the attached gingiva and on the gingival sulcus.
Other intervention name(s): retrograde vasoconstriction
Intervention MeSH terms: Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: spreading vasoconstriction; gingival microcirculation
Iron Bioavailability of Fortified Oat Drink
Condition: Iron Absorption
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will follow a double blinded randomized controlled study design to enroll 20
      apparently healthy 6 year old children. The children will be fed with two different nutrient
      fortified oat drinks labeled with stable isotopes of iron (Fe-57 or Fe-58 as NaFeEDTA).
      Fourteen days after consumption of meals on Day 2, blood will be drawn from the children for
      stable isotope measurements and iron absorption will be calculated.
    


Intervention name(s): Dietary Intervention (with Vit C then without Vit C); Dietary Intervention (without Vit C followed by with Vit C)
Intervention type(s): Other; Other
Intervention description(s): Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C; Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Iron absorption; Oats; fortified oat beverages
A Phase 1 Study to Evaluate the Effect of the Organic Anion Transporter Inhibitor Probenecid on the Pharmacokinetics of JNJ-64041575 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of multiple-dose administration of
      probenecid on the pharmacokinetics of JNJ-63549109 and JNJ-64167896 after a single dose of
      JNJ-64041575 in healthy adult participants.
    


Intervention name(s): JNJ-64041575; Probenecid
Intervention type(s): Drug; Drug
Intervention description(s): Two 500-mg tablets administered as a single oral dose under fasted conditions on Day 1 or Day 22.; One 500-mg tablet administered as a single oral dose with a total of 30 doses (2 doses on Day -1/21 starting in the evening followed by 4 doses per day on the rest of the days).
Intervention MeSH terms: Probenecid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety Study of NNZ-2566 in Healthy Female Subjects
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to obtain evidence of the safety of NNZ-2566 in healthy female
      volunteers and to determine the pharmacokinetics (PK) of NNZ-2566 in healthy female
      volunteers.
    

Detailed description: 
      To obtain evidence of the safety of NNZ-2566 in healthy female volunteers, compared to
      placebo when administered as a 10 minute intravenous (i.v.) bolus infusion, and when
      administered as a 10-minute bolus infusion immediately followed by a continuous 72-hour
      maintenance infusion.

      To determine the blood pharmacokinetics (PK) of an intravenous dose of NNZ-2566 in healthy
      female volunteers when administered as a 10-minute bolus infusion, and when administered as a
      10-minute bolus followed by a continuous 72-hour maintenance infusion.
    

Intervention name(s): NNZ-2566; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with bicarbonate buffer and normal saline.; Normal saline infusion
Other intervention name(s): Experimental name: NNZ-2566; Sodium Chloride 0.9% Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate, in 11-17 year old subjects, the non-inferiority
      of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax™.
    

Detailed description: 
      Multicentre study with 2 treatment groups. Each subject will have 2 blood samples taken for
      immunogenicity analyses, one prior to vaccination and one taken 30 days later.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Intervention name(s): Meningococcal vaccine GSK134612; Mencevax™ ACWY
Intervention type(s): Biological; Biological
Intervention description(s): One intramuscular dose; One subcutaneous dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immunogenicity; safety; meningococcal vaccine
Replication of the IMPACT COPD Trial in Healthcare Claims Data
Condition: COPD
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as is possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates according to standard practice. Investigators
      assume that the RCT provides the reference standard treatment effect estimate and that
      failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims
      data for replication for a range of possible reasons and does not provide information on the
      validity of the original RCT finding.
    

Intervention name(s): Fluticasone Furoate-Vilanterol Trifenatate; Furoate-umeclidinium-vilanterol
Intervention type(s): Drug; Drug
Intervention description(s): Fluticasone Furoate-Vilanterol Trifenatate dispensing claim is used as the reference group.; Furoate-umeclidinium-vilanterol dispensing claim is used as the exposure group.
Intervention MeSH terms: Fluticasone; Xhance
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve a new user, parallel group, propensity score-matched, retrospective
        cohort study design comparing triple therapy to fluticasone furoate-vilanterol users. The
        patients will be required to have continuous enrollment during a baseline period of 180
        days before initiation of triple therapy or fluticasone furoate-vilanterol (index date). We
        will restrict the analyses to patients with a diagnosis of COPD who have been receiving
        daily maintenance therapy for at least 3 months prior to index date.
A Clinical Trial to Assess the Effects of Food on the Bioavailability of CKD-337
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A cross-over, randomized and open-label clinical trial to evaluate the effects of food on the
      bioavailability of CKD-337 after a single oral dose in healthy male subjects
    

Detailed description: 
      This clinical trial is to evaluate the effects of food on pharmacokinetics of CKD-337.

      Sixteen male subjects are divided into two groups. A group of subjects are administered a
      single oral dose of CKD-337 after ingesting high fat meal and the other take same
      investigational product (IP) in fasting condition. Then their blood is drawn on a fixed
      schedule to analyse bioavailability of CKD-337.

      Finishing the first treatment period, the two groups switch food conditions and initiate the
      second period. The group of people that were administered CKD-337 with food are then dosed
      the same IP in fasting condition, and the other group undergo vice versa.

      Each treatment period was separated by a washout period of at least 7 days.
    

Intervention name(s): High fat diet; CKD-337
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): A diet consisting of more than 900kcal and 35% of fat; Test Drug
Other intervention name(s): Atorvastatin Calcium Trihydrate + Choline Fenofibrate
Intervention MeSH terms: Choline; Atorvastatin; Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dexmedetomidine After Cesarean for the Treatment of Nausea and Shivering
Condition: Shivering; Nausea and Vomiting, Postoperative
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      This is a randomized double blinded trial to determine if a small dose of dexmedetomidine can
      prevent and relieve nausea and shivering, two of the more common complaints after cesarean
      delivery.
    

Detailed description: 
      This study is a randomized, placebo controlled, double blind evaluation of the use of a
      single dose of dexmedetomidine for the prevention of shivering and nausea after cesarean
      delivery. It is hypothesized that patients who receive dexmedetomidine (as compared to
      placebo) will have a reduced severity of postoperative shivering and nausea.

      Study subjects will be have a scheduled cesarean section. They will receive written, informed
      consent obtained before surgery. After enrollment, patients will receive spinal anesthesia
      consisting of 11.25mg bupivacaine, 25 mcg of fentanyl, and 250 mcg of morphine. All IV fluid
      will be warmed.

      After delivery of the neonate, delivery of the placenta, and assurance of adequate uterine
      tone, patients will be randomized in a 1:1 fashion to receive a blinded study syringe
      consisting of either placebo saline, or 10 mcg of dexmedetomidine.

      Study outcomes will be measured on an 11-point Likert scale assessing shivering, nausea,
      pain, pruritus, and sedation. Assessments will be performed on admission to the recovery
      room, and at 30 and 60 minutes.
    

Intervention name(s): Dexmedetomidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 10 mcg intravenous dexmedetomidine; Administration of normal saline
Other intervention name(s): Precedex; Saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dexmedetomidine; cesarean; spinal anesthesia