bioihbjkbjnl/mcl2 huggingface dataset:
Preliminary Study of Safety and Efficacy of Policosanol
Condition: Dyslipidemia; HIV Infections
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      Lay Language Summary: High cholesterol levels are common in persons with HIV infection.
      However, conventional cholesterol-lowering medications may have harmful side effects when
      given to HIV-infected persons. Therefore, we plan to evaluate the safety and effectiveness of
      policosanol, a dietary supplement derived from sugar cane that has cholesterol-lowering
      properties, to lower cholesterol levels in persons with HIV infection. We hypothesize that
      policosanol will lower levels of LDL cholesterol ("bad" cholesterol) and raise levels of HDL
      cholesterol ("good" cholesterol).
    

Detailed description: 
      As per Brief Summary
    

Intervention name(s): Policosanol; Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 20 mg of policosanol in capsular form daily; Two capsules of 10 mg of microcrystalline cellulose daily
Intervention MeSH terms: Policosanol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HIV; lipids; dyslipidemia; policosanol; treatment experienced
Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a Phase IV, randomized, double-blind, parallel-group, multiple-dose, active
      comparator, multicenter clinical study to evaluate the pharmacokinetics, efficacy, safety,
      and immunogenicity of SB5 versus Humira in subjects with moderate to severe chronic plaque
      psoriasis.
    

Detailed description: 
      The primary objective of this study is to assess the pharmacokinetic similarity in subjects
      with moderate to severe plaque psoriasis who switch between Humira and SB5 to those receiving
      Humira continuously.

      All entered subjects will be treated with Humira during a lead-in period of 13 weeks. At Week
      13, subjects who achieved at least a 50% reduction in Psoriasis Area and Severity Index
      (PASI50) response will be randomized in a 1:1 ratio to either be switched between Humira and
      SB5 or continue on Humira.
    

Intervention name(s): Humira (Adalimumab); SB5 (Adalimumab Biosimilar)
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous (SC) injection; Subcutaneous (SC) injection
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; Adalimumab
Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is as an extension study of SD-004-0765, to assess the safety profile of long-term
      use of budesonide inhalation suspension in Japanese young children with bronchial asthma.
      Children completing study SD-004-0765 continued administration of budesonide inhalation
      suspension as judged by the investigator; the dose is adjusted as appropriate within the
      range of 0.25 to 1.0 mg per day administered once or twice daily, according to the symptoms.
    


Intervention name(s): Pulmicort (budesonide) Respules
Intervention type(s): Drug
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Vibrations on the Biceps Brachii Muscle and Grip Strength
Condition: Muscle Strength
Study type: Interventional

Summary: 
      It has been suggested that applying acute vibration exercises enhances muscle force, like
      several weeks of resistance training. The present study investigated the effects of local
      vibration with two different frequencies on biceps brachii isometric muscle strength and grip
      strength in healthy young men. Isometric strength of the biceps brachii muscle and grip
      strength were assessed at baseline and after vibration training (immediate, 10 minutes, and
      20 minutes post vibration training).
    


Intervention name(s): Vibration training with 42 Hz; Vibration training with 63 Hz
Intervention type(s): Other; Other
Intervention description(s): Vibration exposure was given using a handheld vibration device.; Vibration exposure was given using a handheld vibration device.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two group parallel design.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Vibration Training; Biceps Brachii; Muscle Strength; Handgrip
The Reduced Insulinotropic Effect of a Continuous Infusion Relative to a Bolus Injection of GIP
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      In patients with type 2 diabetes, the incretin hormone glucose-dependent insulinotropic
      polypeptide (GIP) has lost its insulinotropic activity, but more so after continuous versus
      bolus administration. The design was a two-way crossover design comparing repeated bolus
      injection and continuous infusion of GIP under hyperglycaemic clamp conditions. Patients were
      age- gender- and weight-matched with type 2 diabetes, first degree relatives of such
      patients, and healthy subjects. Investigators performed a:

        1. Oral glucose challenge;

        2. hyperglycemic clamp (8.5 mmol/l) with two repeated GIP bolus administrations (50 pmol/kg
           body weight at 30 and 120 min); and

        3. hyperglycemic clamp with continuous administration of GIP (2 pmol.kg-1.min-1 from 30-180
           min).

      To answer the question, whether rapid tachyphylaxis occurs with regard to the insulinotropic
      action of GIP, investigators studied type 2-diabetic patients, their first-degree relatives,
      and healthy controls under hyperglycaemic clamp conditions with two GIP bolus injections 90
      min apart, and compared this to a continued intravenous infusion of GIP.
    


Intervention name(s): GIP Bolus; GIP Clamp; Oral glucose tolerance test (OGTT); hyperglycemic clamp
Intervention type(s): Drug; Drug; Procedure; Procedure
Intervention description(s): bolus injections of synthetic human GIP (50 pmol/kg body weight) administered 30 and 120 min after commencing the hyperglycemic clamp; hyperglycemic clamp with the continuous intravenous infusion of 2 pmol.kg-1.min-1 synthetic human GIP between 30 and 180 min; an oral glucose challenge (75 g); a hyperglycemic clamp (capillary venous glucose concentration ~ 8.5 mmol/l)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glucose-dependent Insulinotropic Polypeptide (GIP); Glucagon-Like Peptide 1 (GLP-1); Incretin; Insulin secretion; Tachyphylaxis
Remotely Supervised tDCS for Persistent Post-traumatic Headache
Condition: Persistent Post Traumatic Headache; Mild Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Post-Traumatic Headache; Tension-Type Headache; Headache
Study type: Interventional

Summary: 
      This pilot study is designed to provide preliminary data for a large scale, randomized
      clinical trial to evaluate the efficacy of remotely administrated at home transcranial Direct
      Current Stimulation (tDCS) with real-time monitoring via VA Tele-health for persistent post
      traumatic headache associated with mild traumatic brain injury (mTBI). Participants will
      receive total of 20 sessions of tDCS over four weeks. The investigators anticipate that the
      results generated from the study will directly translate into immediate meaningful clinical
      application: not only in management of chronic post traumatic headache, but also in reduction
      of acute pain medication use, and improving quality of life for our veterans with this
      debilitating neurological disorder.
    

Detailed description: 
      The aim of this study is to evaluate the feasibility and efficacy of transcranial Direct
      Current Stimulation (tDCS) administered at home with real-time monitoring via VA Tele-health
      for persistent post traumatic headache (PTH) associated with mTBI, and the impact of this
      treatment on persistent PTH associated functional recovery. Total of 20 participants (10
      treatment group, 10 sham control) will be included in this study. The investigators will also
      evaluate recruitment strategies and participants clinical characteristics.
    

Intervention name(s): transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): Treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20minute treatment session, both treatment and sham groups will complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
Other intervention name(s): tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Transcutaneous Bilirubin Levels From Covered Skin
Condition: Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study was to evaluate the levels of total serum bilirubin and transcutaneous
      bilirubin in newborns, measured in both covered and exposed areas, before phototherapy, 24th
      hour of phototherapy and 8 hours after cessation of phototherapy. The study included term and
      preterm newborns that required phototherapy between postnatal days 0-28. Total serum
      bilirubin levels and transcutaneous bilirubin measurements were obtained using the MBJ20-2019
      Transcutaneous Handheld Bilirubinometer (Beijing M&B Electronic Instruments Co. Ltd. China,
      2019) from both exposed (sternal) and unexposed (forehead, covered with a radio-opaque patch)
      areas before, at 24th hours and eight hours after phototherapy.
    

Detailed description: 
      Aim: This study aimed to evaluate total serum bilirubin and transcutaneous bilirubin levels
      measured from covered and exposed areas in newborns before phototherapy, after 24 hours of
      phototherapy, and 8 hours after discontinuing phototherapy.

      Materials and Methods: Term and preterm newborns who needed phototherapy between postnatal
      days 0-28 were included in the study. Total serum bilirubin values and transcutaneous
      bilirubin measurements by MBJ20-2019 Transcutaneous Handheld Bilirubinometer (Beijing M&B
      Electronic Instruments Co. Ltd. China, 2019) from the exposed area (on sternum) and an
      unexposed area (forehead, covered with a radioopaque patch) were obtained before starting
      phototherapy, after 24 hours of phototherapy, and at 8 hours after phototherapy. The results
      were analyzed statistically using intraclass correlation coefficients (ICC).
    

Intervention name(s): covered or open skin
Intervention type(s): Device
Intervention description(s): transcutaneous mesarument of covered or open skin area
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Neonates with indirect hyperbilirubinemia were admitted to the NICU
      
Biospecimen description: 
      serum
Pharmacokinetics of Procaterol in Elite Athletes
Condition: Asthma
Study type: Observational

Summary: 
      The purpose of the study is to find blood and urine concentrations of procaterol
      administrated either by inhalation or by tablets in asthmatic and non-asthmatics males. We
      hypotheis that the concentrations of procaterol in the blood and serum is higher after tablet
      intake versus inhalation.
    

Detailed description: 
      Doping study
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Asthmatic and healthy volunteers
      
Biospecimen description: 
      PK study
    
Keywords: elite athletes
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
Condition: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b; Hepatitis B
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate that DTaP-IPV-HB-PRP~T combined vaccine does not induce a higher incidence
      rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the
      three vaccinations at 2, 4, and 6 months of age for each subject.

      To evaluate the overall safety in terms of:

      Any solicited adverse reactions in the first 7 days after each injection, Any adverse events
      and reactions in the first 30 days after each injection, Any serious adverse events during
      the trial.

      Immunogenicity:

      To document the immune response to Hepatitis B antigen of the three batches of the
      investigational DTaP-IPV-HB-PRP~T vaccine.
    


Intervention name(s): DTaP-IPV-HB-PRP~T; Tritanrix-HepB/Hib
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular (IM); 0.5 mL, Intramuscular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Recombinant Hepatitis B; Poliomyelitis; Haemophilus influenzae type b; Tetanus protein
G-PUR® for Reduced Lead Bioavailability
Condition: Lead Exposure
Study type: Interventional

Summary: 
      This is a prospective, randomized, placebo-controlled, double blind, parallel-arm study in a
      two-staged approach that will assess the effect of two different doses of G-PUR® on enteral
      lead absorption in healthy adults using a stable lead isotopic tracer (204Pb).
    


Intervention name(s): G-PUR® 2x 2.0 g oral suspension; G-PUR® 1x 2.0 g oral suspension; Placebo oral suspension
Intervention type(s): Device; Device; Device
Intervention description(s): Cohort 1: 2 g G-PUR® powder mixed with 100 ml water in an opaque drinking bottle will be orally administered before and immediately after 204Pb intake; Cohort 2: 2 g G-PUR® powder mixed with 100 ml water in an opaque drinking bottle will be orally administered before 204Pb intake and 100 ml water (placebo) in an opaque drinking bottle immediately after 204Pb intake; Cohort 3: 100 ml of water in an opaque drinking bottle will be orally administered immediately before and after 204Pb intake
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Blood/Urine/Hair lead; Lead uptake & Lead bioavailability
Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Nicotine replacement treatment (NRT) can be efficacious for smoking cessation, but used by
      only a minority of smokers in China. Pharmacogenetic matching may improve treatment outcomes
      for NRT in subgroups of smokers. The investigators evaluated the efficacy and safety of
      sublingual nicotine tablets (SNT) for smoking cessation and the association of
      catechol-O-methyltransferase (COMT) genotype with efficacy in this smoking cessation trial
      among Chinese smokers.
    

Detailed description: 
      All subjects provided written informed consent after a full explanation of the protocol
      design.
    

Intervention name(s): sublingual nicotine
Intervention type(s): Drug
Intervention description(s): The nicotine sublingual tablet is Smokers were recommended to use one or two tablets per hour, up to a maximum of 20 tablets per day. Subjects were advised to use the full treatment dose for 4 weeks. After this time-point, treatment could be tapered off up to the 8-week visit. During the next 4-week follow-up phase, no further medication was dispensed. Staff, who dispensed medications, were not involved in treating the subjects. During each patient visit, the importance of adequate dosing with study medication was emphasized. The medication was free of charge. In addition, all participants received six sessions of standardized behavioral group counseling focusing on self-monitoring and behavioral modification approaches.
Other intervention name(s): nicotine sublingual tablet
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the immunogenicity profile of ADACEL™, Tetanus and Diphtheria Toxoids Adsorbed
      combined with Component Pertussis Vaccine (TdcP Vaccine) one month after administration.

      To describe the safety profile of ADACEL™ (TdcP Vaccine) when given as a fifth dose.
    


Intervention name(s): Diphteria, tetanus, and Acellular Pertussis vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): ADACEL™
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ADACEL™; Tetanus; Diphteria; Acellular pertussis
Isopropyl Alcohol Against Chlorhexidine - Isopropyl Alcohol as Antiseptics to Prevent Hemoculture's Contamination
Condition: Infectious Diseases
MeSH terms: Communicable Diseases; Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determinate if 70% isopropyl alcohol is not inferior
      preventing contamination of peripheral hemocultures, compared with 2% chlorhexidine in 70%
      isopropyl alcohol.
    

Detailed description: 
      The develop of contaminants in blood cultures is a problem of great impact to health
      institutions and patients, as they represent a waste of resources, and additionally increases
      the patient's hospital stay. The principal source of contaminant is the bacteria in the skin
      flora, so the greatest way to improve the sensibility of this test is to do an optimal skin
      antisepsis. It has been reported that 2% chlorhexidine gluconate in 70% isopropyl alcohol is
      superior that other skin disinfectants, and that 70% isopropyl alcohol has a high efficacy
      reducing the presence of bacteria on the skin, so both antiseptics are good options for skin
      antisepsis.
    

Intervention name(s): chlorhexidine in isopropyl alcohol; Isopropyl alcohol
Intervention type(s): Biological; Biological
Intervention description(s): When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.; When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.
Other intervention name(s): Chloraprep, Enturia Inc., Texas.; BacT/ALERT FA, Biomérieux Inc., North Carolina.; Alcohol Swabs, BD, Madrid.; BacT/ALERT FA, Biomérieux Inc., North Carolina.
Intervention MeSH terms: Ethanol; Chlorhexidine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Antiseptics; Hemoculture contamination; Anti-infecting agents, local
Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia
Condition: Bipolar 1 Disorder; Schizophrenia; Mental Disorder; Nervous System Disorders
MeSH terms: Nervous System Diseases; Schizophrenia; Mental Disorders
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects
      with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are
      currently on treatment with oral aripiprazole.
    

Detailed description: 
      The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects
      with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are
      currently on treatment with oral aripiprazole. This will be an open-label observational pilot
      trial to compare the PK profile of aripiprazole at Visit 1 of subjects who are receiving oral
      aripiprazole and who have the potential for suboptimal adherent behavior with their assigned
      medication.

      Information obtained in the current trial will be used to inform the conduct of a randomized,
      open-label, parallel-group trial to assess between-group change from baseline adherence using
      PK sampling in subjects receiving oral aripiprazole with or without the MIND1 System
      (Protocol 316-13-211).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Biospecimen description: 
      Whole blood, Plasma
    
Keywords: Aripiprazole; Treatment Adherence