bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2b Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Total Knee Arthroplasty
Condition: Venous Thromboembolism; Deep Vein Thrombosis; Total Knee Arthroplasty
MeSH terms: Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to assess the efficacy, safety and dose-response relationship
      of DU-176b compared with placebo for the prevention of venous thromboembolism in patients
      after elective total knee arthroplasty.
    


Intervention name(s): DU-176b; DU-176b; DU-176b; DU-176b; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): DU-176b 5mg tablets oral, once daily for 2 weeks; DU-176b 15mg tablets, oral once daily for 2 weeks; DU-176b 30 mg tablets, oral, once daily for 2 weeks; DU-176b 60 mg tablets, oral, once daily for 2 weeks; Matching placebo oral tablets, once daily for 2 weeks
Other intervention name(s): edoxaban; edoxaban; edoxaban; edoxaban
Intervention MeSH terms: Edoxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention; venous thromboembolism; edoxaban; factor Xa
Comparison of the Combination of Fenofibrate and 40 mg Simvastatin Versus 40 mg Simvastatin Monotherapy
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Mixed or combined hyperlipidemia is a common metabolic disorder characterized by both
      hypercholesterolemia and hypertriglyceridemia. Statins and fibrates have complementary
      mechanisms and can be coadministered to patients with mixed hyperlipidemia. The overall
      objective of the study is to evaluate the efficacy and safety of combining fenofibrate and
      simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.
    


Intervention name(s): Fenofibrate/Simvastatin; Simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): Combination of Fenofibrate and Simvastatin 40mg; Simvastatin 40mg
Intervention MeSH terms: Simvastatin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hyperlipidemia Combined; Combination of fenofibrate and simvastatin
Evaluating New Formulation of Therapeutic HSV-2 Vaccine
Condition: Genital Herpes Simplex Type 2
MeSH terms: Herpes Simplex; Herpes Genitalis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the reduction in viral shedding after vaccination with a new formulation
      of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will
      receive GEN-003, one-third will receive placebo.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled clinical trial of a new
      formulation of GEN-003 for treatment of HSV-2 genital infection.

      Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive
      days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals then
      complete a second set of anogenital swabs for 28 consecutive days after the third dose. Each
      subject will be followed for one year after the third dose.
    

Intervention name(s): Matrix-M2; GEN-003; Placebo
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.; HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D; 0.9% Normal Saline
Other intervention name(s): Adjuvant; HSV Therapeutic Vaccine; 0.9% Normal Saline
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HSV; Herpes; Genital Herpes; Vaccine
Ultrasound Epidural Technique
Condition: Pediatric- Epidural Analgesia -Palpation-ultrasound
Study type: Interventional

Summary: 
      Epidural analgesia for abdominal surgeries provides numerous advantages for both neonates and
      children. The anatomical identification of the intervertebral space to access the epidural
      space is not constantly easy this is due uncertainty of the direction of the needle angle and
      the difficulty to estimate the epidural depth in spite of the skill of the operator. This can
      lead to more puncture attempts, inducing more pain or discomfort and even failure of epidural
      access.

      Pre-procedure neuraxial ultrasound (US) imaging facilities the identification of the chosen
      intervertebral space, the depth of the epidural space and so the selection of best point and
      angle for the needle insertion
    

Detailed description: 
      The aim of this study is to evaluate the efficacy of prepuncture ultrasonography to
      facilitate epidural block in pediatric patients undergoing elective urological operations
      compared with the conventional anatomical landmark technique
    

Intervention name(s): ultrasound
Intervention type(s): Device
Intervention description(s): the efficacy of prepuncture ultrasonography to facilitate epidural block in pediatric patients undergoing elective urological operations compared with the conventional anatomical landmark technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study to Evaluate the Pharmacokinetic Comparability of CC-93538 From Two Different Drug Concentrations in Healthy Adult Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, parallel design study to evaluate the PK comparability,
      safety, tolerability and immunogenicity of a single SC dose of 360 mg CC 93538 using two
      different drug concentrations, 180 mg/mL and 150 mg/mL, in healthy adult subjects.

      A total of approximately 52 subjects will be enrolled and randomized 1:1 to receive a single
      360 mg SC dose of CC-93538 using either 180 mg/mL (1 injection of 2 mL) or 150 mg/mL (2
      injections of 1.2 mL each) drug concentrations.
    


Intervention name(s): CC-93538; CC-93538
Intervention type(s): Drug; Drug
Intervention description(s): one injection of 2mL; two injections of 1.2mL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: CC-93538; Healthy Subjects; PK comparability between two different dose concentrations
Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effects of nefazedone on cocaine
      self-administration in depressed and non-depressed female cocaine users.
    

Detailed description: 
      This study evaluated the effect of nefazodone on reducing cocaine use and craving in both
      depressed and nondepressed women and if there was a greater effect in depressed women.
    

Intervention name(s): Nefazodone
Intervention type(s): Drug
Intervention MeSH terms: Nefazodone
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence
Assessment of an Intervention to Prevent Obesity and Diabetes in Latino Farm Workers
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      This is a study to assess the effectiveness of a culturally appropriate behavioral
      intervention to reduce obesity levels and ultimately the risk of developing diabetes type II
      in immigrant Latino farm workers. Workers enrolled in a 2:1 ratio by random allocation into
      an intervention or control arm of the study. The intervention participants received weekly
      classes for 10 weeks with education on diabetes, diet and physical activity and practical
      exercises. Both control and intervention were measured for weight, waist circumference,
      fasting blood glucose and interviewed before and after the study intervention. The main
      hypothesis was that intervention, but not control participants, would experience reduction in
      body measurements after the intervention.
    

Detailed description: 
      A more detailed description is not desired as noted above.
    

Intervention name(s): Behavioral Intervention
Intervention type(s): Behavioral
Intervention description(s): Intervention participants attended up to 10 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions were conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support were also emphasized. The control participants like the intervention were measured and interviewed before and again after the intervention sessions, but received no educational instruction or materials.
Other intervention name(s): Healthy Lifestyle intervention; Diet and Physical Activity intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diabetes Type II,; Overweight,; Obesity,; Behavioral Intervention,; Latino, farm worker; randomized controlled intervention
Investigating the Role of Active Versus Chronic Coronary Artery Calcification on Acute Myocardial Infarct
Condition: Chest Pain
MeSH terms: Myocardial Infarction; Chest Pain
Study type: Observational

Summary: 
      The investigator aims to determine the feasibility of understanding the process of active
      versus chronic calcification using Na-F PET scan and contrast CT scan of the heart.

      The patient cohort will consist of patients diagnosed to have either acute coronary syndrome
      (ACS) (comprising of either unstable angina pectoris or acute myocardial infarction) or
      suspected coronary artery disease (CAD). The PET images will be compared to images obtained
      from standard contrast CT of the coronaries. This study will provide additional insights
      about active versus non-active calcification amongst patients with ACS or suspected CAD.
    

Detailed description: 
      Contemporary techniques used to visualize coronary artery calcification include standard
      non-contrast computed tomography (CT) of the coronaries measuring amount of calcium
      deposition in the coronaries, contrast CT and more recently, using sodium-fluoride (Na-F)
      positron emission tomography (PET) to image coronary and valvular calcification. Na-F has
      been shown to accumulate in areas of active calcification where contrast CT of the heart has
      been shown to accumulate in areas of chronic calcification. The investigator aims to
      determine the feasibility of understanding the process of active versus chronic calcification
      using Na-F PET scan and contrast CT scan of the heart.

      The patient cohort will consist of patients diagnosed to have either acute coronary syndrome
      (ACS) (comprising of either unstable angina pectoris or acute myocardial infarction) or
      suspected coronary artery disease (CAD). The PET images will be compared to images obtained
      from standard contrast CT of the coronaries. This study will provide additional insights
      about active versus non-active calcification amongst patients with ACS or suspected CAD.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        15 patients
Opioid Rotation From Morphine to Methadone in Treatment of Non-malignant Pain
Condition: Non-malignant Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with non-malignant pain are switched from morphine to methadone with a nine-months'
      follow-up.
    

Detailed description: 
      Twelve patients with poor pain control or unacceptable side effects during treatment with
      morphine were switched to methadone and followed for nine months in this open prospective
      study. Primary outcomes were patient preference for opioid and pain control while physical,
      cognitive and role functioning were secondary outcomes. The morphine dose was decreased by
      1/3 daily and was replaced with an equianalgesic dose of methadone over a three-day period.
      During switching and a one-week dose titration period, patients were given additional
      methadone if required. During dose titration one patient experienced sedation requiring
      naloxone. Four patients were switched back to morphine due to poor pain control, drowsiness
      or sweating. Seven patients preferred long-term (>nine months) treatment with methadone and
      reported reduced pain and improved functioning while cognition was not improved. This study
      brings novel information on the long-term consequences for pain control, health-related
      quality of life and cognitive functioning with a switch from morphine to methadone in the
      treatment of chronic non-malignant pain.
    

Intervention name(s): Methadone
Intervention type(s): Drug
Intervention MeSH terms: Methadone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study of the Rotavirus Vaccine in Infants With Intestinal Failure
Condition: Intestinal Failure; Rotavirus Vaccines
MeSH terms: Intestinal Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the safety and immune response of the rotavirus
      vaccine in infants who have undergone abdominal surgery.
    


Intervention name(s): Rotarix
Intervention type(s): Biological
Intervention description(s): A rotavirus vaccine (Rotarix) will be administered in two doses, 8 weeks apart, in infants between 6 and 14 weeks of age. The standard dosage is 1 mL administered orally or per gastrostomy tube.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intestinal failure; Rotavirus vaccine; Infants
Long-term Follow-up Study of Substance Abuse Screening and Intervention in Multi Primary Care Centers
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this research is to improve the ability of primary medical staffs in screening
      and intervention for alcohol, benzodiazepines, and other illicit drug use.
    

Detailed description: 
      In order to reduce the social and personal harm caused by drugs, it is urgent to strengthen
      the ability of the primary health institutions in screening and intervention the addictive
      substances use. Firstly, the investigators will invite 10 primary medical staffs and 10
      experts in addition to revise the manual of Alcohol, Smoking, and Substance Use Involvement
      Screening Test (ASSIST) and Brief Intervention (BI). Then, the investigators will recruit
      related medical staffs in five provinces to participate the training of ASSIST and BI.
      Secondly, the researcher will investigate the effects of BI technology in reducing the use of
      addictive substances, improve the addiction related knowledge of patients through randomized
      controlled study. Finally, the investigators will collect the research information, revise
      the manual, and promote the training.
    

Intervention name(s): Intervention Group; Control Group
Intervention type(s): Other; Other
Intervention description(s): The medical staffs who received the training will use the manual of brief intervention to deliver BI and other materials about the harm of substance use.BI refers to a standard 15-30 minute intervention that includes a series of standard models that stimulate knowledge, motivation and behavior that reduce substance abuse.the harm of substance use is a dedicated paper publicity handbook, written by the SHMC, detailing the hazards of substance abuse.; The participants only receive the materials about the harm of substance use.the harm of substance use is a dedicated paper publicity handbook, written by the SHMC, detailing the hazards of substance abuse.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Screening, Brief Intervention, and Referral to Treatment; Substance Use
Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance
Condition: Paracentesis-Induced Circulatory Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      Paracentesis-induced circulatory disturbance (PICD) is a very common cause of mortality and
      morbidity in patients undergoing large-volume paracentesis. Albumin is commonly used in
      decompensated cirrhosis during large-volume paracentesis. However, it may not be
      cost-effective and has side effects like volume overload and transfusion reactions.

      Therefore the investigator proposed to use midodrine which is a drug that increases the mean
      arterial pressure. The investigators hypothesized that midodrine may be effective in
      preventing PICD in acute on chronic liver failure patients requiring modest paracentesis.
      This has already been found to be effective in initial studies in decompensated cirrhosis
    


Intervention name(s): Midodrine Hydrochloride; Human Albumin 20%
Intervention type(s): Drug; Drug
Intervention description(s): Midodrine hydrochloride for PICD prevention; Human ALbumin 20% for prevention of paracentesis induced circulatory disturbance
Intervention MeSH terms: Midodrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Ascites; Paracentesis-Induced Circulatory Dysfunction; Paracentesis
Facilitating Positive Adaptation to Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effects of a 10-wk cognitive behavioral stress
      management (CBSM) intervention vs. a single-day psycho-educational seminar on psychosocial
      adaptation and physiological adaptation in women being treated for stage I-III breast cancer.
    

Detailed description: 
      The study tests the effects of a 10-wk group-based cognitive behavioral stress management
      (CBSM) intervention (relaxation, stress awareness, cognitive restructuring, coping skills
      training, interpersonal skills training) versus a single-day psycho-educational seminar
      (general information about stress and coping) in women who have recently had surgery for
      breast cancer but have not yet started adjuvant therapy. The study evaluates the effects of
      CBSM on psychosocial adaptation (includes measures of negative adaptation [distress and
      social disruption] and positive adaptation [benefit finding and positive affect]) at 6-month
      and 12-month follow-up. The study also evaluates the effects of CBSM on physiological
      adaptation (includes levels of PM serum cortisol and T-helper-type 1 (Th1) cytokine
      [interleukin-2, IL-2, and interferon-gamma, IFN-g, production after anti-CD3 stimulation of
      peripheral blood mononuclear cells (PBMC).
    

Intervention name(s): Cognitive Behavioral Stress Management; a psycho-educational control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 10 weekly 2-hour sessions of group-based cognitive behavioral stress management; a single-day psycho-educational seminar
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: stress management intervention; breast cancer; quality of life; psychosocial adaptation
A Study To Estimate The Time Course Of PF-00241939 Concentration In The Blood After Dosing With Oral Inhalation From Dry Powder Inhalers
Condition: Pharmacokinetics
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the time course of PF-00241939 concentrations in
      the blood following dosing by oral inhalation using dry powder inhalers.
    


Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F; Treatment G
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): PF-00241939 300 ug using inhaler A; PF-00241939 300 ug using inhaler A; PF-00241939 300 ug using inhaler A; PF-00241939 300 ug using inhaler B; PF-00241939 300 ug using inhaler B; PF-00241939 300 ug using inhaler B; PF-00241939 300 ug using inhaler B
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Intravenous Microdose Pharmacokinetic (PK) Study With [14C]-GSK2239633
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first administration to man microdose study to describe the pharmacokinetics
      of GSK2239633.
    

Detailed description: 
      The different shapes of the pharmacokinetic (PK) profiles following administration of
      GSK2239633 in rat and dog make it difficult to reliably predict the human PK profile. This
      microdose study will provide an early readout on the distribution and clearance profile of
      the drug in man and will be used to model potential clinical oral doses. The study will be
      conducted using an open-label, single dose design in one group of healthy male volunteers.
      Each subject will receive a single intravenous infusion of 100ug GSK2239633 (containing
      approximately 10kBq of [14C]-GSK2239633), administered over 15 minutes. Subjects will attend
      for a screening visit within 30 days prior to Day 1 and receive a single dose infusion of
      study drug on Day 1. Blood and urine samples will be taken over 48 hours for pharmacokinetic
      and total radioactivity analysis, and safety and tolerability will be monitored. Subjects
      will be discharged on Day 3 and a follow-up telephone call will be made 4-10 days post-dose.
    

Intervention name(s): GSK2239633
Intervention type(s): Drug
Intervention description(s): 100 ug GSK2239633 containing approximately 10kBq [14C]-GSK2239633
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: GSK2239633; RADIOLABEL; PHARMACOKINETICS; INTRAVENOUS; MICRODOSE