bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of Electrocardiogram (ECG) Effects of Sancuso® (Granisetron TDS)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the electrocardiogram (ECG) effects of Sancuso® compared to
      placebo and moxifloxacin in healthy subjects.
    

Detailed description: 
      Granisetron is a well tested and established 5-HT3 receptor antagonist used in both oral and
      intravenous (IV) forms. A transdermal form of granisetron (Sancuso®) was approved by the
      United States (US) Food and Drug Administration (FDA) in September 2008.

      Many of the 5-HT3 antagonists were developed and approved before the adoption of the
      International Conference on Harmonisation (ICH) E14 standard on QTc and cardiac testing. The
      association of non-cardiac medicinal products with the potential to prolong the QT interval
      and induce torsades des pointes (TdP) has significant implications for the future development
      of medicinal products.
    

Intervention name(s): granisetron
Intervention type(s): Drug
Intervention description(s): Treatment A: Sancuso® patch (3.1mg/24 hours) on Day 1 and IV placebo (0.9% saline) on Day 3 Treatment B: Granisetron IV 10 mcg/kg over 30 seconds on Day 1 and placebo patch on Day 3 Treatment C: Placebo patch on Day 1 and IV placebo on Day 3 Treatment D: 400 mg oral moxifloxacin on Day 1 and placebo patch on Day 3
Other intervention name(s): Granisetron Transdermal System; Sancuso® patch; Kytril®; Granisetron Injection; IV Placebo (0.9% saline); Placebo patches; Avelox® Oral
Intervention MeSH terms: Granisetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Electrocardiogram; Effect on electrocardiogram; Granisetron; Moxifloxacin; Pharmacokinetic profile; Sancuso® patch; Transdermal
The Effect of Anesthetic Agents Management on ECG Changes of Patients Who Were Operated Under RIVA
Condition: Qt Interval, Variation in
Study type: Interventional

Summary: 
      IVRA can be performed with many local anesthetics and adjuvant agents. Investigators planned
      to compare cardiac effects and ECG changes by IVRA with lidocaine and lidocaine plus
      ketamine.
    

Detailed description: 
      Methods: Patients between 18-60 years, with score of ASA 1-2 and who were undergoing IVRA for
      short operations on arm and forearm were included. Systolic, diastolic and mean blood
      pressures, heart rate, SpO2, ECG, adverse effects during the operation were recorded. Double
      cuffed tourniquet were placed on the extremity to be operated to hinder nerve injuries.
      Venous blood in the extremity was purged with Esmarch bandage. Proximal cuff was inflated
      with a pressure 50-100 mmHg higher than systolic blood pressure and the bandage was
      displaced. Randomly patients were divided into 2 groups. Group 1: %0.5 Lidocaine+Ketamine 0.8
      mg/kg; 40 ml. Group 2: %0.5 Lidocaine 40 ml. Anesthetic agent was injected with a rate of 20
      ml/min. 20 minutes after injection the distal cuff was inflated and the proximal cuff
      deflated with a rate of 50 mmHg in every 3 minutes. 0,5,10,15,30,45,60 minutes after the
      beginning of deflation and 10 minutes after the deflation was completed ECG were recorded.
      PR,QT,QTc, RR were recorded.
    

Intervention name(s): Ketamine HCL
Intervention type(s): Drug
Intervention description(s): ketamine HCL is using as adjuvant agent with local anesthetic agent in regional intravenous anesthesia procedure routinely
Other intervention name(s): Include brande name: ketalar injectable
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: IVRA, ketamine, lidocaine, ECG
A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
Condition: Non-Alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether BMS-986036 is effective in the treatment of
      subjects with Non-alcoholic Steatohepatitis (NASH).
    


Intervention name(s): BMS-986036; BMS-986036; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: First Line Therapy; NASH
The Effects of Supervised Aerobic Training on Dyslipidemia Among Diabetic Older Patients
Condition: Diabetes Mellitus; Exercise
MeSH terms: Dyslipidemias
Study type: Observational

Summary: 
      In this study, we are trying to explore the potential effects of moderate aerobic exercise
      for six months on the severity values of blood sugar, HbA1c, insulin, lipid profile, and
      highly sensitive CRP (hs-CRP) in a total of 50 subjects diagnosed with diabetes for more than
      five years with an age range of 30-70 years.
    

Detailed description: 
      This study explored the influence of 6 months of moderate-intensity supervised aerobic
      training on diabetic control parameters, serum lipid profile, hs-CRP, and variable-related
      correlations in prediabetic and type 2 diabetic patients (T2MD). The patients were classified
      into two groups: the prediabetes group (HbA1c ≤ 6.5, n = 25) and the T2MD group (HbA1c ≥ 6.5,
      n = 25). The values of blood sugar, HbA1c, insulin, lipid profile, and highly sensitive CRP
      (hs-CRP) were measured in all subjects by using colorimetric and immunoassay techniques
      respectively at baseline and postintervention of moderate aerobic exercise for six months.
      Participants performed the exercise test three times per week for 6 months. The training set
      comprised of a warming phase by stretching exercises and walking for 5 to 10 minutes, the
      participants were allowed to reach their precalculated training heart rate (THR) in bout form
      with a total time of 45 to 60 minutes performed as circuit training using a treadmill,
      bicycle, and stair master. All patient groups were subjected to estimate diabetic control
      parameters such as FBS, FI, HbA1c, serum lipid profile, hs-CRP, and BMI as anthropometric
      changes before and after moderate aerobic exercise training for six month
    

Intervention name(s): moderate aerobic exercise
Intervention type(s): Other
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Fifty participants aged 30-70 years diagnosed with type 2 diabetes (DM2) for more than 5
        years according to the American Diabetes Association criteria were invited to this study.
        Based on ADA criteria, the subjects were classified according to the level of glycated
        hemoglobin (HbA1c) into two groups; the prediabetic group (HbA1c ≤ 6.5, n=25) and the
        diabetic group (HbA1c ≥ 6.5, n=25).
      
Biospecimen description: 
      For all participants, standardized physical examination and collection of serum samples were
      performed at week 0 (before the onset of the training program), 3 months, and after a 6-month
      program of moderate aerobic training
A Study of OCE-205 in Participants With Cirrhosis With Ascites Who Developed Hepatorenal Syndrome-Acute Kidney Injury
Condition: Cirrhosis; Ascites; Hepatorenal Syndrome; Acute Kidney Injury
MeSH terms: Liver Cirrhosis; Hepatorenal Syndrome; Acute Kidney Injury; Syndrome; Fibrosis; Ascites; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      OCE-205 is being tested to treat participants who have developed Hepatorenal Syndrome-Acute
      Kidney Injury as a complication of cirrhosis with ascites.

      The study aims are to evaluate the safety and efficacy of OCE-205 at various doses.

      Participants will receive treatment by intravenous infusion. Participants will continue with
      this treatment until participants meets primary endpoint or any discontinuation criteria.
    

Detailed description: 
      The study will include 5 treatment arms including 1 Placebo Arm and 4 active drug arms.
      Participants will be randomly selected to 1 of 5 arms.

        -  Placebo

        -  OCE-205 at 8 micrograms per hour (µg/hr)

        -  OCE-205 at 15 micrograms per hour (µg/hr)

        -  OCE-205 at 30 micrograms per hour (µg/hr)

        -  OCE-205 at 50 micrograms per hour (µg/hr)

      This multi-center trial will be conducted in the United States and Canada. If selected for
      the study, participants will be randomly assigned to 1 of the 5 treatment arms.
    

Intervention name(s): OCE-205; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The drug product, OCE-205, is a sterile solution to be used for intravenous infusion.; Placebo to match OCE-205 is a sterile solution to be used for intravenous infusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HRS-AKI
A Study of Subcutaneous KY1005 in Healthy Volunteers
Condition: Immune System Diseases
MeSH terms: Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Single centre, open-label, single dose, parallel group study to investigate the PK, safety
      and tolerability of KY1005 after subcutaneous (s.c.) and intravenous (i.v.) administration,
      with i.v. KY1005 as a reference treatment.
    


Intervention name(s): KY1005
Intervention type(s): Drug
Intervention description(s): A human anti-OX40 ligand monoclonal antibody
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after s.c. and i.v. administration, with i.v. KY1005 as a reference treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Pramipexole for Treatment-Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effectiveness of pramipexole (Mirapex) in managing
      treatment-resistant depression.
    

Detailed description: 
      Depression is a serious medical illness, for which various types of treatment have been
      developed. Both medications and therapies have proven effective in treating depression.
      However, some people with depression do not benefit from these treatments. New medications
      are needed for treating depression in those who have not responded to commonly used
      antidepressants. Pramipexole (Mirapex) is most often used for the treatment of Parkinson's
      disease, but has been reported to have antidepressant effects as well. This study will
      evaluate the effectiveness of pramipexole in treating depression in individuals that have not
      responded to other medications.

      Participants in this double blind study will be randomly assigned to receive either
      pramipexole or placebo, in addition to their current medications, for 8 weeks. Treatment
      response will be assessed at the end of this phase by measuring symptoms of depression. At
      this time, those individuals who have responded to treatment will have the option to continue
      in a 6-month follow-up study. Participants will be seen monthly throughout the 6 months to
      assess treatment response. Participants who do not exhibit a response to treatment will be
      tapered off the medication. All participants will receive 3 months of follow-up care,
      regardless of their response to the medication.
    

Intervention name(s): Pramipexole (Mirapex); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): pramipexole 0.5mg tablets qd and titrated per protocol; sugar pill
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression, Treatment-Resistant
Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to look at pharmacoeconomic data for subjects that have received
      either NicVAX or placebo in the Nabi-4514 or Nabi-4515 studies.
    


Intervention name(s): NicVAX vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): NicVAX vaccine given 6 times over 6 months; Placebo vaccine given 6 times over 6 months
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Pharmacoeconomic; Quality of Life; Health Outcomes; Smoking; NicVAX; Smoking vaccine; Smoking cessation
Assessment of Effectiveness and Safety of Dysport® for the Treatment of Hemifacial Spasm
Condition: Hemifacial Spasm
MeSH terms: Hemifacial Spasm; Spasm
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effectiveness and safety of Dysport® with the domestic Botulinum Toxin Type A
      (manufactured by Lanzhou Biologic Product Institute, P.R. China) for the treatment of
      hemifacial spasm.
    


Intervention name(s): Botulinum toxin type A
Intervention type(s): Biological
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Predictors of Motor Progression in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Treatment resistant motor features, such as postural instability and freezing of gait are
      common in people with Parkinson's disease and major contributors to morbidity and mortality.
      This project will use sleep studies, quantitative motor assessments and magnetic resonance
      imaging to examine the relationship between abnormally increased muscle activity during rapid
      eye movement sleep and the development and progression of treatment-resistant postural
      instability and gait disturbances. Specifically, the investigators will test the hypothesis
      that anticipatory postural adjustments (weight and pressure shifts) during gait initiation
      are significantly reduced in people with Parkinson's disease who have abnormally elevated
      muscle activity during rapid eye movement (REM) sleep compared to individuals will
      Parkinson's disease whose REM sleep muscle activity is normal. In addition, the investigators
      will test the hypothesis that the level of RSWA at baseline is predictive of measures of
      motor decline (postural stability and gait) and alterations in the structure and function of
      locomotor brainstem networks. Since sleep disorders can emerge years before a diagnosis of
      Parkinson's disease, establishment of a link between sleep and treatment-resistant posture
      and gait disorders will help identify individuals at risk of developing these disabling motor
      features of disease.
    


Intervention name(s): No intervention. Observational studies of sleep, movement and brain imaging
Intervention type(s): Other
Intervention description(s): Participants will be asked to visit the University for 3 baseline visits which include a screening visit & sleep study, movement tests and magnetic resonance imaging (MRI) scans. Three years later the participant will be asked to repeat the same visits.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parkinson's Disease
Tissue and Plasma Pharmacokinetics of Cefazolin in Antibiotic Prophylaxis in Bariatric Surgery
Condition: Bariatric Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      With 6.5 million obese recorded in France in 2009, obesity is a major public health: it is a
      chronic disease associated with many respiratory, cardiac, metabolic, musculoskeletal
      complications. The risk of mortality and morbidity are directly proportional to the
      importance of overweight and medical treatment alone is only moderately effective weight
      loss. Bariatric surgery is the only treatment with proven efficacy in patients with a body
      mass index above 40 kg/m2. As with any surgery, there is a risk of surgical site infection
      (SSI). The SSI are the third most common nosocomial infection after urinary tract infections
      and airway. The fight against the ISO requires the administration of antibiotic prophylaxis
      acting on the main bacteria found in bariatric surgery. There are several studies in the
      literature interested in the dose of cefazolin in bariatric surgery. However, no published
      pharmacokinetic studies defines an optimal dose to obtain tissue and plasmatic concentrations
      of cefazolin higher than minimum inhibitory concentrations of the main germs encountered in
      these surgery. Only empirical recommendations are published, including the SFAR and the
      National Institute of Health in 2010. This study aims to determine whether the dose of 4
      grams of cefazolin can achieve these goals of concentration and estimate an injection time of
      preoperative ideal for an adequate tissue concentration at the time of the incision.
    


Intervention name(s): Cefazoline
Intervention type(s): Drug
Intervention description(s): Injection of CEFAZOLINE (4 grams) 30-60 min before skin incision. A second injection will performed every 4 hours during the surgery
Intervention MeSH terms: Cefazolin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which
      are indicated for active immunization for the prevention of influenza disease.
    

Detailed description: 
      Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1. To assess the
      safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events
      for 28 days post-vaccination are assessed and reported. To assess the immunogenicity,
      antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at
      pre-vaccination and 21 days post-vaccination.
    

Intervention name(s): NBP607QIV; Agrippal
Intervention type(s): Biological; Biological
Intervention description(s): Purified inactivated influenza virus surface antigens of four strains(quadrivalent); Influenza virus surface antigens of three strains(trivalent)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
HPV Vaccination Study in Postpartum Women
Condition: HPV; Immunization; Human Papilloma Virus
MeSH terms: Papilloma
Study type: Interventional
Phase: Phase 4

Summary: 
      The human papillomavirus (HPV) is the most common sexually transmitted infection (STI) in the
      United States (U.S.) and is responsible for a wide range of conditions, including cancers
      within the anogenital tract and the oropharynx. In just the U.S. alone, it's estimated that
      HPV causes 330,000 cases of precancerous cervical dysplasia and 12,000 cases of cervical
      cancer. The investigators propose a 2-dose HPV vaccination study in women seeking postpartum
      care at Johns Hopkins University. The investigators will measure the immunogenicity and
      acceptability of the vaccine in the postpartum setting.
    

Detailed description: 
      This is a pilot, non-inferiority clinical trial using historical controls. Participants will
      have whole blood drawn at 0 months, 6 months, and 7 months and receive the HPV vaccine at 0
      months, 6 months, and 12 months. Each blood draw will consist of one 15mL red top tube to
      measure HPV serologies and hormone levels. All blood samples collected will be analyzed at
      the end of the study.
    

Intervention name(s): Gardasil9
Intervention type(s): Biological
Intervention description(s): Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Human Papilloma Virus; HPV; Immunization
A Study of Methods to Reduce Anxiety in Preoperative Elective Surgical Patients
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients are often anxious immediately before surgery. The investigators hypothesis is that a
      warming blanket is as effective as the sedative midazolam in allaying anxiety before surgery.
    

Detailed description: 
      The investigators are randomising patients aged 18-70 having elective surgery to 1) a cotton
      blanket and reassurance as required; 2) midazolam, a cotton blanket and reassurance as
      required; and 3) forced-air warming, a cotton blanket and reassurance as required. The
      primary endpoint is a visual analog scale of anxiety.
    

Intervention name(s): Midazolam; Normal Saline; Bair Hugger
Intervention type(s): Drug; Drug; Device
Intervention description(s): Intravenous midazolam 0.3 mg/kg; Normal saline injection will be given to groups not receiving midazolam; Forced air warming
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anxiety; midazolam; forced-air warming
Design and Verification of Individualized Smart Assistive Devices for Stroke Rehabilitation
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study aims to design and verify a multi-mode smart assistive device system for Stroke
      Rehabilitation by using EEG, fMRI, IMU and questioners
    


Intervention name(s): VR rehabilitation for motor function
Intervention type(s): Other
Intervention description(s): rehabilitation for motor function
Other intervention name(s): VR rehabilitation therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; rehabilitation
Spinal Manipulative Therapy for Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Context: Acute low back pain (LBP) is a common reason for consultations in primary care.
      Reducing the pain in the first hours and days and restoring the functional capacity of the
      lumbar spine may result in a decrease in medical costs and earlier return to work.

      Objective: To determine the impact of spinal manipulation on pain and analgesic use in acute
      low back pain.
    

Detailed description: 
      Design: Randomised controlled parallel-group trial comparing standard care plus spinal
      manipulative therapy with standard care alone. Intention-to-treat analysis.

      Patients: Outpatients with acute low back pain. Setting: Emergency Department of Bern
      University Hospital and a primary care practice network.
    

Intervention name(s): manipulative therapy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low back pain; Spinal manipulative therapy; Randomised controlled trial