bioihbjkbjnl/mcl2 huggingface dataset:
High-Dose Melphalan, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma in First Relapse
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining peripheral stem cell transplantation with chemotherapy and radiation therapy may
      allow the doctor to give higher doses of radiation and chemotherapy drugs and kill more tumor
      cells.

      PURPOSE: Phase II trial to study the effectiveness of high-dose melphalan plus total-body
      irradiation and peripheral stem cell transplantation in treating patients with multiple
      myeloma in first relapse.
    

Detailed description: 
      OBJECTIVES: I. Assess bone marrow reconstitution and peripheral blood cell counts of patients
      with multiple myeloma treated with high-dose melphalan (L-PAM) and total-body irradiation
      (TBI) followed by peripheral blood stem cell (PBSC) rescue. II. Assess the efficacy of
      intravenous L-PAM and TBI for treatment of relapsing/refractory myeloma. III. Assess the
      tolerability and toxicity of this regimen in patients with relapsing multiple myeloma. IV.
      Assess response rate and survival of relapsing/refractory patients treated with this regimen.

      OUTLINE: Prior to entry, patients will have received 3 monthly courses of standard VAD
      followed by PBSC collection on Regimen A; those who responded to VAD continue standard VAD to
      best response and upon relapse (on or off therapy) proceed to Regimen B. Patients with no
      response to 3 courses of VAD and those with no response to an alkylating-based regimen
      proceed immediately to Regimen B following PBSC collection. The following acronyms are used:
      CTX Cyclophosphamide, NSC-26271 G-CSF Granulocyte Colony Stimulating Factor (Amgen),
      NSC-614629 L-PAM Melphalan, NSC-8806 PBSC Peripheral Blood Stem Cells VAD
      Vincristine/Doxorubicin/Dexamethasone TBI Total Body Irradiation Regimen A: Stem Cell
      Mobilization/Harvest. CTX; G-CSF. Regimen B: Single-Agent Myeloablative Chemoradiotherapy
      with Stem Cell Rescue. L-PAM; TBI (Co60 or linear accelerators of 4 MV or greater); with
      PBSC.

      PROJECTED ACCRUAL: If 9 or fewer or 20 or more responses are seen in the first 50 patients
      treated, the study will be discontinued.
    

Intervention name(s): filgrastim; cyclophosphamide; melphalan; peripheral blood stem cell transplantation; low-LET cobalt-60 gamma ray therapy; low-LET photon therapy
Intervention type(s): Biological; Drug; Drug; Procedure; Radiation; Radiation
Intervention MeSH terms: Cobalt; Cyclophosphamide; Melphalan
Primary purpose: Treatment
Keywords: refractory multiple myeloma; stage II multiple myeloma; stage III multiple myeloma
Effects of Magnesium Sulphate on Sugammadex Reversal of Rocuronium Induced Blockade in Gynaecology Patients
Condition: Pre-eclampsia Aggravated
MeSH terms: Eclampsia; Pre-Eclampsia
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: The aim of this prospective study was to evaluate the effect of magnesium on the
      reversal of rocuronium-induced neuromuscular block by sugammadex.

      Methods: Eighty patients, aged 18 to 60 years, American Society of Anesthesiologists I-II,
      undergoing elective gynecological surgery were enrolled. Anaesthesia was induced with
      propofol and fentanyl and was maintained with 60% nitrous oxide and Oxygen in sevoflurane.
      The magnesium group received 50 milligram/kilogram (mg/kg) Magnesium intravenous (iv) as a
      bolus and 15 mg/kg/hour by continuous infusion until the completion of surgery. The placebo
      group received the equivalent volume of isotonic saline. For intubation, 0.6 mg/kg rocuronium
      was administered and 0.1 mg/kg was added when Train of four (TOF) counts reached 1 or more
      during the procedure. At the end of the surgery at a TOF count of 1, 4 mg/kg sugammadex iv
      was administered. Patients were observed until a TOF ratio of 0.9 was achieved.
      Patient-controlled analgesia with intravenous morphine was used postoperatively.
    

Detailed description: 
      Inclusion criteria:

        -  American Society of Anesthesiologists physical status I or II

        -  18-60 years of age

        -  undergoing elective gynecological surgery

        -  requiring endotracheal intubation

      Exclusion criteria:

        -  Patients who had body mass index > 35

        -  gastroesophageal reflux

        -  a history of allergy

        -  used medication known to interact with the drugs being used in this trial

        -  who experienced expected or unexpected difficulty during intubation or ventilation

        -  had neuromuscular disease

        -  hepatic or renal insufficiency

        -  pregnant

        -  were American Society of Anesthesiologists III or IV

        -  had a family history of malignant hyperthermia

        -  detection if low or high control plasma magnesium levels
    

Intervention name(s): placebo; Magnesium Sulphate; sugammadex
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion; Experimental :
50 mg/kg bolus plus 15 mg/kg continuous infusion; 4 mg/kg iv bolus at the end of the surgery
Other intervention name(s): %0.9 NaCl; isotonic saline; magnesium; bridion
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sugammadex; rocuronium; magnesium; female
The Healthcare Evaluation of Absolute Risk Testing Study
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The aim of this study is to demonstrate the integration and use of cardiovascular disease
      (CVD) integrated risk tool (IRT) in an environment as close to real-world as possible.

      This study will recruit participants of both biological sexes and any ancestry or background
      who require and are eligible for a CVD risk assessment as part of the NHS Health Check. Those
      aged 45-64 years are most likely to benefit from CVD IRT and will be included in the study,
      as they are more likely to be asymptomatic but also derive most benefit from preventative
      measures.

      The study will be conducted in GP surgeries as the CVD IRT will have its greatest impact if
      incorporated into primary care practice for early identification of patients at highest risk.

      This study is a device performance evaluation.
    

Detailed description: 
      The aim of this study is to demonstrate the integration and use of a cardiovascular disease
      (CVD) integrated risk tool (IRT) in an environment as close to real-world as possible.

      In association with the routine healthchecks for CVD, the QRISK score will be integrated with
      the individuals polygenic risk score (from a blood sample) to produce the CVD IRT score, this
      score estimates the risk of CVD in the following 10years.

      This study will recruit participants of both biological sexes and any ancestry or background
      who require and are eligible for a CVD risk assessment as part of the NHS Health Check. Those
      aged 45-64 years are most likely to benefit from CVD IRT and will be included in the study,
      as they are more likely to be asymptomatic but also derive most benefit from preventative
      measures.

      The study will be conducted in GP surgeries as the CVD IRT will have its greatest impact if
      incorporated into primary care practice for early identification of patients at highest risk.

      This study is a device performance evaluation. 1000 participants are expected to be enrolled.
      Of this, it is expected that 200 surveys will be completed and from those surveyed 20-30
      interviewed. This would be considered an adequate determination of feasibility.
    

Intervention name(s): CVD Integrated Risk Test
Intervention type(s): Device
Intervention description(s): CVD IRT (IVD regulations with a software device)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Measurement of Retinal Blood Flow, Retinal Oxygenation and Retinal Oxygen Extraction in Healthy Subjects During Normoxia and Systemic Hyperoxia
Condition: Healthy; Normoxia; Systemic Hypoxia
MeSH terms: Hypoxia; Hyperoxia
Study type: Interventional

Summary: 
      The inner retina is crucially dependent on an adequate retinal blood supply. When the retina
      becomes ischemic and hypoxic this results in severe vision loss due to retinal
      neovascularization. Measurement of retinal blood flow and retinal oxygenation is, however,
      still a difficult task. Information on retinal oxygenation is almost unavailable from human
      studies. In the present protocol the investigators propose a procedure allowing for the
      measurement of retinal blood flow, retinal oxygenation and retinal oxygen extraction by
      combining a number of innovative techniques. Specifically, retinal vessel diameters will be
      measured with a Retinal Vessel Analyzer, retinal blood velocities with bi-directional laser
      Doppler velocimetry and retinal oxygenation with spectroscopic evaluation of retinal fundus
      images. This will allow for the calculation of retinal oxygen extraction, a fundamental
      parameter of retinal function. Up to now, no data for retinal oxygen extraction are available
      in the literature.
    


Intervention name(s): Oxygen
Intervention type(s): Drug
Intervention description(s): 100% Oxygen inhalation for 30 minutes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ocular physiology
Complications of Endocrine Surgery: Data From the United HealthSystem Consortium
Condition: Thyroid Disease; Parathyroid Disease; Endocrine Gland
MeSH terms: Thyroid Diseases; Parathyroid Diseases
Study type: Observational

Summary: 
      The goal of this study is to help better determine the complication rates for endocrine
      surgery across the nation for both benign and malignant disease. It is our hypothesis that
      the complication rates are low overall and that malignant disease results in a higher
      complication rate than benign disease. This study will do a database review from all
      University HealthSystem Consortium (UHC).
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study will be conducted through a United HealthSystem Consortium query of endocrine
        surgery done as a primary procedure for specific diagnosis.
Ultrasound-guided Regional Anesthesia vs Local Infiltration Anesthesia With Dexmedetomidine and Ropivacaine
Condition: Pain, Postoperative; Anesthesia, Local; Gonarthrosis
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia
      and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid
      need the first 48 hours after the total knee replacement operation.
    

Detailed description: 
      Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia
      and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid
      need the first 48 hours after the total knee replacement operation. Secondary objectives are:
      Pain assesment, Pain medication necessary, functionality of the prothesis, satisfaction,
      wellbeing, postoperative discomforts, complications (delirium, allergic reactions,
      cardiopulmonary decompensation), procedure specific time.
    

Intervention name(s): Ultrasound guided regional anesthesia; Local infiltration analgesia
Intervention type(s): Drug; Drug
Intervention description(s): Applied perineurally preoperatively ultrasound guided regional anesthesia; Applied in the wound intraoperatively from the orthopedics
Other intervention name(s): dexmedetomidine; Ropivacaine; dexmedetomidine; Ropivacaine
Intervention MeSH terms: Dexmedetomidine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Can 3D Ultrasound Be Used Reproducibly by Radiation Therapists in Partial Breast Image-Guided Radiation Therapy
Condition: Radiation Therapy for Primary Breast Cancer
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine if the Clarity 3DUS (3D Ultrasound) system can be used by multiple individuals
      to acquire 3DUS images and produce consistent TB (Tumor Bed) shifts for breast IGRT
      (Image-Guided Radiation Therapy).
    

Detailed description: 
      TB Contouring The CT1, CT2, and US1 tumor beds will be manually contoured on the RM
      workstation by one of the study radiation therapists. Contouring will be performed using
      previously defined contouring guidelines. Available automatic contouring tools, including the
      'interpolate' contouring function, may be utilized and contouring times will be recorded.

      IGRT Assessment The patient will be set up on the breast board in treatment position. The
      'ultra path' component of the Clarity system, which displays the path of the previous US
      acquired at CT simulation, will be used to guide the acquisition of US2. Although performed
      in the simulator room, the Clarity system will be used in 'treatment mode' thus simulating
      Clarity as it is used for IGRT. The study RT will first acquire the US2 scan. All steps
      following the acquisition of US2 will be performed off-line on the RM workstation without the
      need for further simulator or patient time.
    

Intervention name(s): Image-Guided Radiation Therapy using 3D Ultrasound Guided-Therapy; Ultrasound Guided Imaging; 3 DUS
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Subjects will have 3 x 3DUS during radiation therapy; Subjects will undergo a CT scan and an US of your breast for the planning of radiation therapy after a breast conserving operation.
About 1 week after the start of radiation treatment subjects will have a second CT and US. During this visit subjects will have one CT and three US's. These US's will be performed by 3 different radiation therapists. Part of the current study is to compare the similarity of the 3 US pictures taken by different individuals.; 3 DUS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Evacetrapib and Digoxin in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine how much digoxin gets into the blood stream
      and how long it takes the body to get rid of it when given with the study drug evacetrapib.
      This study will also look at the effect of evacetrapib on the removal of digoxin from the
      body by the kidneys. Information about any side effects that may occur will be collected.
      This study will last approximately 33 days for each participant, not including screening.
    


Intervention name(s): Evacetrapib; Digoxin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY2484595
Intervention MeSH terms: Digoxin; Evacetrapib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study of Chemoradiotherapy Combined With Cetuximab in Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open, multicenter phase Ⅱ clinical trial. The purpose of this study is to evaluate
      acute toxicity and efficacy of cetuximab (C225) combined with IMRT + neoadjuvant chemotherapy
      in advanced T stage of nasopharyngeal carcinoma. Besides, to figure out the relationship
      between patient outcome and EGFR gene copy number, expression and mutation.
    


Intervention name(s): Cetuximab
Intervention type(s): Drug
Intervention description(s): 400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy
Other intervention name(s): C225
Intervention MeSH terms: Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of the Combined Impact of Intermittent Preventive Treatment and Insecticide Treated Bednets in Reducing Morbidity From Malaria in African Children
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional

Summary: 
      An investigation will be made of the combined impact of insecticide-treated nets and
      intermittent preventive treatment with amodiaquine + sulfadoxine-pyrimethamine on malaria
      morbidity in children in Burkina Faso and Mali.Three rounds of treatment will be given during
      the malaria season in one year and the follow-up will be extended into the second year by
      passive surveillance.
    

Detailed description: 
      The trial will be conducted in 6000 children in Burkina Faso and Mali in 2008 and 2009. Each
      site will enroll 3,000 children. All children will be allocated a long lasting
      insecticide-treated net and randomized to receive to treatment (amodiaquine +
      sulfadoxine-pyrimethamine (AQ+SP)) or placebo (AQ-placebo + SP-placebo. Treatment will be
      administered over 3 rounds during the high malaria transmission season, with one month
      interval between rounds. Full course treatment of AQ and SP will be administered on each
      occasion. Treatment will not be given in the second year. Passive surveillance of malaria
      will be implemented for the monitoring of malaria morbidity and to assess whether children
      who received intermittent preventive treatment (IPT) are at increased risk of malaria.
      Adverse events will be monitored during each round of IPT administration. To assess the
      effect of IPTc on the prevalence of malaria infection, a random sample of 150 children will
      be visited every week during the high malaria transmission period. This number will be
      increased to 300 during the low transmission season, but the survey will be reduced to
      monthly visits. Baseline prevalence of genetic markers of resistance to SP and AQ will be
      estimated. A second cross-sectional survey will be conducted at the end of the malaria
      transmission season to assess the effect of IPT on the prevalence of genetic markers of
      resistance to SP and AQ, on the prevalence of anaemia and on nutritional indicators.
    

Intervention name(s): Intermittent preventive treatment with AQ+ SP
Intervention type(s): Drug
Intervention description(s): Amodiaquine (10 mg/kg over 3 days) and Sulfadoxine Pyrimethamine (25 mg of sulfadoxine + 1.25 mg of pyrimethamine per kg in a single dose) or placebo administered over 3 rounds of one month interval
Other intervention name(s): IPTc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Intermittent Preventive treatment; insecticide treated bednets; malaria
A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core
      study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute
      flares in chronic gout patients initiating allopurinol therapy. The core study was followed
      by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and
      efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout
      flare.
    


Intervention name(s): Canakinumab; Colchicine; Allopurinol; Placebo Matching Canakinumab; Placebo Matching Colchicine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Canakinumab was supplied in glass vials as a lyophilized powder.; 0.5 mg capsule orally once daily for 16 weeks.; 100-300 mg orally once daily for 24 weeks.; Subcutaneous injection.; Capsule orally once daily for 16 weeks.
Intervention MeSH terms: Colchicine; Allopurinol; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Gout; Chronic gout; Gouty arthritis; Gout flares
Reanimation in Tetraplegia
Condition: Spinal Cord Injury (Quadraplegia)
MeSH terms: Spinal Cord Injuries; Quadriplegia
Study type: Interventional

Summary: 
      The purpose of this clinical study is to allow the investigation of the Neural Bridging
      System for participants with tetraplegia to assess if the investigational device can
      reanimate a paralyzed limb under voluntary control by the participant's thoughts.
    

Detailed description: 
      This study plans to enroll participants who have been diagnosed with C4- C6 ASIA A spinal
      cord injuries (motor and sensory complete neurologic injuries), who are more than 1 year post
      injury, and who are neurologically stable.
    

Intervention name(s): Neural Bridge System
Intervention type(s): Device
Intervention description(s): Implanted device
Other intervention name(s): Blackrock Microsystems Neuroport; Neuromuscular Stimulator
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other