bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster; Hepatitis A
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a randomized and controlled Phase IV clinical trial.The purpose of this study
      is to evaluate the immunogenicity and safety of combined immunization with live attenuated
      varicella vaccine and inactivated hepatitis A vaccine in children aged 12-15 months.
    

Detailed description: 
      This study is a randomized and controlled phase IV clinical trial in children aged 1 year old
      (12-15 months).The purpose of this study is to evaluate the immunogenicity and safety of live
      attenuated varicella vaccine co-administration with inactivated hepatitis A vaccine .The live
      attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co.,
      Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd.A total
      of 450 subjects aged 1 year old (12-15 months) were be enrolled.Subjects were be randomly
      divided into 2 groups in a ratio of 1:1.Subjects in the combined immunization group received
      one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A
      vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.Subjects
      in the Non-combined immunization group received one dose of live attenuated varicella vaccine
      on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of
      inactivated hepatitis A vaccine on day 222.
    

Intervention name(s): The live attenuated varicella vaccine and the inactivated hepatitis A vaccine
Intervention type(s): Biological
Intervention description(s): The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd.
The live attenuated varicella vaccine:live varicella-zoster virus in 0.5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection.
The inactivated hepatitis A vaccine:250 U inactivated virus in 0.5mL of aluminium hydroxide solution per injection.
All subjects received hepatitis A vaccine in the upper left arm and varicella vaccine in the upper right arm.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study to Evaluate the Interaction Between Vicodin® CR and Ethanol in Healthy Male and Female Moderate Alcohol Drinkers
Condition: Drug Interactions
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research study is to determine if varying strengths of ethanol affect the
      drug level and safety profile of Vicodin® CR.
    


Intervention name(s): Vicodin® CR (extended-release hydrocodone/acetaminophen)
Intervention type(s): Drug
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Comparison Between Pioglitazone and SES With type2 DM
Condition: Coronary Artery Disease; Type 2 Diabetes Mellitus
MeSH terms: Coronary Artery Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Drug-eluting stents have been shown to decrease restenosis, but were associated with an
      increased rate of death, as compared with bare-metal stents. Recently, thiazolidinediones
      effectively reduced restenosis and the risk of repeat target vessel revascularization. We
      conducted a study to compare the performance of a drug-eluting stent with that of a
      bare-metal stent with pioglitazone in patients with type 2 diabetic mellitus.
    

Detailed description: 
      The study is a prospective cohort trial involving 38 type 2 diabetic patients referred for
      coronary stenting who were assigned to either the sirolimus-eluting stent group or the
      pioglitazone group. Quantitative coronary angiography will be performed at study entry and at
      six months follow-up to evaluate in-stent late luminal loss and the percentage of the luminal
      diameter and the rate of restenosis. We also analyze major adverse cardiac events at 12
      months.
    

Intervention name(s): Pioglitazone
Intervention type(s): Drug
Intervention MeSH terms: Pioglitazone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bare metal stent; Major adverse cardiac events; Pioglitazone; Restenosis; Sirolimus eluting stent
Amtolmetin Gaucil in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      This study is conducted to study the efficacy and safety of Niselat in patients with
      osteoarthritis.
    

Detailed description: 
      Osteoarthritis is the most common rheumatic disease. Knee OA (KOA), gonarthrosis (GA), is
      characterized by high prevalence, progressive course with early disability of the subject,
      persistent pain syndrome for the treatment of which non-steroidal anti inflammatory drugs
      (NSAIDs) are actively used in clinical practice. It was revealed that NSAIDs may cause
      gastrointestinal adverse effects (AEs), from mild dyspepsia to bleeding and perforation as
      well as cardiovascular effects. Gastroprotection with misoprosol, Н2-receptor antagonists and
      proton pump inhibitors (PPI) is not always effective. NSAIDs with the lowest gastrointestinal
      toxicity with efficacy adequate to suppress joint pain is justified and reasonable.

      Amtolmetin guacil (AMG) is a new NSAID which proved to be the least gastrointestinally toxic
      in experimental studies in vivo, in vitro and in comparative clinical studies. AMG does not
      have selectivity towards COX-2 or NO. AMG exerts gastroprotective effect due to stimulation
      of capsaicin receptors (vanilloid receptors) in gastrointestinal wall. To assess tolerability
      of amtolmetin guacil, it is first necessary to obtain data on potential reduction of
      dyspeptic symptoms including in subjects with these signs of NSAIDs intolerability.
    

Intervention name(s): NISELAT
Intervention type(s): Drug
Intervention description(s): NISELAT 600MG BD
Other intervention name(s): AMTOLMETIN GAUCIL
Sampling method: Non-Probability Sample
Study population: 
        Subjects with knee osteoarthrosis (KOA)
Vascular and Metabolic Effects of Vytorin
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigator hypothesize that vytorin may improve vascular and insulin resistance in
      hypercholesterolemic patients
    


Intervention name(s): placebo; vytorin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ezetimibe, Simvastatin Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: statins, insulin resistance
Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to investigate if low doses of prednisone MR formulation,
      given at night and, with active drug release at 2 am, are more effective in controlling joint
      stiffness, and other disease symptoms of rheumatoid arthritis than standard IR prednisone
      given in the morning.
    


Intervention name(s): MR Prednisone; IR Prednisone; Placebo - MR Prednisone; Placebo - IR Prednisone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive tablets containing MR prednisone (to achieve the appropriate dose of 3-10 milligrams [mg] prednisone per day) at bed time.; Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning.; Participants will receive placebo matching to MR prednisone tablet at bed time.; Participants will receive placebo matching to IR prednisone tablet in the morning.
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: active disease; morning stiffness of joints; nighttime application of prednisone; modified release prednisone
Hearing Aids With "Notched Amplification" for the Treatment of Chronic Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Pilot study on safety, tolerability and clinical performance/randomized double-blind
      active-controlled pilot-study. Patients are being recruited from patients of the Tinnitus
      Center of Regensburg and groupwise randomized. Control groups are being treated with hearing
      aids without notch-filter. Patients and raters are blinded, only the coworker, who is
      programming the hearing aids, is informed about the group assigned.

      A Hearing aid with notched amplification filters frequencies in a specific manner, depending
      on the individual tinnitus frequency. Through this special filtering the neuronal functional
      changes of the auditory cortex are supposed to be affected therapeutically.
    


Intervention name(s): Notched filtering (verum); No filtering (placebo)
Intervention type(s): Device; Device
Intervention description(s): Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 The Hearing aid with notched amplification filters frequences in a specific manner, depending on the individual tinnitus frequency. Through this special filtering the neuronal functional changes of the auditory cortex are supposed to be affected therapeutically.; Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3
No notched filtering
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cervical Activation During Elastic and Manual Resistance
Condition: Cervical Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Cervical pain is a condition that affects 14.6% of all adults annually. Of this annual
      prevalence, 37.3% experience persistent neck pain with periodic recurring episodes. The
      purpose of this study is to compare muscle activation patterns of the cervical musculature
      during exercises with elastic versus manual resistance in a neck pain and asymptomatic
      populations. Methods: A convenience sample of 15 healthy, physically active participants and
      15 current patients diagnosed with non-radicular cervical pain will be recruited.
      Exclusionary criteria will include: current cervical or upper extremity injury (healthy
      group), history of neck surgery, corticosteroid treatment within the last two weeks, and
      radicular signs or symptoms. Surface electromyography will be used to quantify the activity
      level of the bilateral SCM, AS, Cervical Paraspinal (CP), and the Upper Trapezius (UT)
      muscles while performing a series of 6 exercises with elastic resistance using Thera-Band®
      Resistance Bands and manual resistance. The area will be prepped and surface electrodes
      placed on the corresponding muscles. The movement will be standardized by using the peak
      activation (PA) of each muscle during full flexion-extension movement to create a percentage
      of peak activation (%PA). The testing battery will consist of 6 exercises with elastic
      resistance and manual resistance, totaling 12 different trials. Each trial will involve 5
      repetitions, each held for 5 seconds. The exercises will include cervical: extension,
      flexion, left rotation, right rotation, left side bending, and right side bending. The men
      will use the green and women will use the red Thera-Band® Resistance Band. The order of
      exercises will be randomized in to two parts to minimize the effect of fatigue. First,
      cervical flexion and extension with manual and elastic resistance will be randomized.
      Secondly, the remaining 8 exercises will be randomized. Following each exercise, the patient
      will rate their perceived level of exertion on the Thera-band® Resistance Intensity Scale for
      Exercise (RISE).
    


Intervention name(s): Neck exercises using both manual and Thera-Band elasatic resistance
Intervention type(s): Device
Intervention description(s): Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance
Other intervention name(s): Thera-Band
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sternocleidomastoid; Neck pain; EMG; Perceived Exertion; Thera-Band; Cervical Paraspinals
Treatment With Ziprasidone for Schizophrenia Patients With Obsessive Compulsive Disorder (OCD)
Condition: Schizophrenia; Obsessive Compulsive Disorder
MeSH terms: Schizophrenia; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Comparing schizophrenic patients with comorbid OCD and schizophrenic patients without OCD in
      response to Ziprasidone and in cognitive functioning as compared with OCD patients
    


Intervention name(s): Ziprasidone
Intervention type(s): Drug
Intervention description(s): 40-80 mg BID
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Exercise Versus Niacin in Patients With Coronary Artery Disease (CAD) and Low High-Density Lipoproteins (HDL)
Condition: Coronary Disease; Hypolipoproteinemia
MeSH terms: Coronary Disease; Hypolipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators want to study the relative effects of physical exercise vs.
      extended-release niacin (lipid-lowering drug) in patients with coronary heart disease and low
      HDL cholesterol ("good cholesterol") on

        -  lipid profile

        -  endothelial function as measured by ultrasound

      The endothelium is the inner part of the blood vessels. Impaired endothelial function is
      known to be associated with atherosclerosis which can ultimately lead to diseases such as
      stroke, heart attack and others. Endothelial function can be assessed non-invasively by
      ultrasound.

      Both interventions mentioned above have been shown to have a beneficial effect on lipid
      profile and endothelial function. However, the relative effects are unclear.
    

Detailed description: 
      Comparison of physical exercise vs. extended-release niacin in patients with CAD and low HDL
      cholesterol (< 1,03 mmol/L) on lipid profile and endothelial function as measured by
      flow-mediated dilatation of radial artery. Secondary goals are the assessment of biochemical
      markers of atherosclerosis, expression of monocyte surface markers, oxidative stress and
      thrombogenicity.
    

Intervention name(s): physical exercise; niaspan (extended-release niacin); niacin; control
Intervention type(s): Behavioral; Drug; Drug; Other
Intervention description(s): physical exercise; niaspan (extended-release niacin); niacin extended-release; control
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Psychological Morbidity and Facial Volume in HIV Lipodystrophy: Quantification of Treatment Outcome
Condition: HIV-Associated Lipodystrophy Syndrome
MeSH terms: HIV-Associated Lipodystrophy Syndrome; Lipodystrophy
Study type: Observational

Summary: 
      The hypotheses of this study were that:

        1. HIV lipodystrophy is associated with psychological morbidity relating to body image,
           anxiety and depression.

        2. Treatment of HIV lipodystrophy using autologous fat transfer, polylactic acid or
           Bio-alcamid, is associated with an improvement in psychological morbidity and anatomical
           volume of treated areas.

        3. The DI3D system is a valid and reproducible method of recording and measuring facial 3-D
           volume.
    

Detailed description: 
      as above
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        50 patients with HIV facial lipoatrophy
Compare the Tolerance of Clindamycin 1% /Benzoyl Peroxide (BPO) 5% Gel to Clindamycin 1.2%/ BPO 2.5% Topical Medications
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy
      volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test
      products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide
      2.5% and the other side of the face will remain non-treated to serve as a control.
    

Detailed description: 
      This is a single-blind (blinded expert grader), parallel group, randomized, half-face study
      being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the
      2 test products, clindamycin and benzoyl peroxide 5%) or clindamycin and benzoyl peroxide
      2.5%) and the other side of the face will remain non-treated to serve as a control.
      Approximately 25-30 male and female healthy subjects without facial acne, aged 18 to 45, will
      be randomly assigned to each product.

      The eligible subjects (screened 3 days prior to randomization) who qualify will be entered
      into a 2-week treatment phase. The once-daily applications for the clindamycin and benzoyl
      peroxide 5%and clindamycin phosphate and benzoyl peroxide 2.5%) will be supervised at the
      site, Monday through Friday of each week. Subjects will apply the study product at home on
      Saturdays and Sundays and record the times of application on a diary card.

      A blinded expert grader will rate comparative product tolerance in terms of erythema and
      dryness on each week day (excluding Saturdays and Sundays) during the study before study
      product is applied.

      Instruments will be used to measure transepidermal water loss (TEWL) to assess skin moisture
      in order to evaluate product mildness. Instrumentation measurements of skin surface
      conductance will be utilized to evaluate product performance in terms of level of skin
      hydration.

      Subjects will complete questionnaires and all adverse events will be recorded.
    

Intervention name(s): Clindamycin and BPO 5% gel; Clindamycin phosphate and benzoyl peroxide 2.5% gel.
Intervention type(s): Drug; Drug
Intervention description(s): Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel.; Once daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel
Other intervention name(s): Duac Topical Gel; ACANYA Gel
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers
E-support for Healthcare Processes - ASTHMA
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of the study is to establish and clinically evaluate a new approach to treating
      asthma by using information and communication technologies (ICT). A mobile environment, and
      organizational interventions to improve the process of an integrated treatment of people with
      asthma will be identified, developed, introduced and clinically evaluated.
    

Detailed description: 
      A mobile environment to improve the process of an integrated treatment of people with asthma
      will be identified, developed, introduced and clinically evaluated. The study will include
      120 patients diagnosed with asthma that is poorly managed. The study will use the ACT (Asthma
      Control Test) questionnaire and an evaluation questionnaire that will cover issues regarding
      the satisfaction of subjects with asthma care offered. Subjects with a PEF meter, will be
      able to enter the value of PEF (Peak Expiratory Flow).

      In addition to this, users can enter values (1) physical activity (type, duration,
      intensity), and (2) food (type, quantity).
    

Intervention name(s): Self management asthma plan indorsment.
Intervention type(s): Other
Intervention description(s): Subjects adherence to asthma self management plan will be monitored through web-based support.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Asthma; ICT Support; ACT; PEF
Improving Negative Symptoms of Psychosis In Real-world Environments
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study will compare Cognitive Behavioral Social Skills Training-Compensatory Cognitive
      Training (CBSST-CCT) to a goal-focused supportive contact group to see which intervention
      better improves symptoms and functioning in people with schizophrenia.
    


Intervention name(s): CBSST-CCT; Goal focused supportive contact
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): Cognitive Behavioral Social Skills Training-Compensatory Cognitive Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: negative symptoms; cognition; functioning; defeatist attitudes; psychosocial treatment
PK and PD of Single, Escalating Doses of PER977 Following Enoxaparin
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      PER977 administration following a single dose of enoxaparin
    

Detailed description: 
      Single escalating doses of PER977 from 100 to 300 mg, of 25 mg PER977 x 4 doses will be
      administered following administration of enoxaparin. Serial pharmacokinetic and
      pharmacodynamic assessments ( whole blood clotting time) will be performed. Adverse events
      will be monitored.
    

Intervention name(s): PER977; Placebo; enoxaparin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): reversal of edoxaban-induced anticoagulation; Reversal of edoxaban-induced anticoagulation
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: PER977; enoxaparin; anticoagulation reversal; whole blood clotting time