bioihbjkbjnl/mcl2 huggingface dataset:
AZD0914 Phase 1 ADME Study in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the metabolic fate and routes of excretion of 14CAZD0914 in six
      male healthy volunteers.
    

Detailed description: 
      This is an open-label, single dose study in 6 healthy male subjects aged 18 to 55 years. Each
      subject will be admitted to the clinical pharmacology unit on the day prior to dosing Check
      in (Day -1) and will remain in the clinical pharmacology unit until up to at least target Day
      8 (168 hours post-dose).

      All subjects will receive 3000 mg AZD0914 incorporating 18.5 MBq (500 Ci) of [14C]
      administered as a single oral dose following at least an 8 hour fast from food. Subjects can
      have water. For specific food and water restrictions.

      This study will investigate the metabolic fate and routes of excretion of AZD0914.
    

Intervention name(s): AZD0914
Intervention type(s): Drug
Intervention description(s): Radiolabelled AZD0914 for study of absorption, disposition, metabolism, and excretion in healthy volunteers.
Intervention MeSH terms: Zoliflodacin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Long Term Follow-up of a Study to Assess the Safety and Immunogenicity of a Hepatitis A Vaccine Administered With and in the Absence of DTPaHibIPV, OPV and MMR Vaccines
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study was to assess whether the protection afforded by Epaxal
      vaccine co-administered with diphtheria, tetanus, Bordetella pertussis, Haemophilus
      influenzae type b, and inactivated polio vaccine(DTPaHibIPV), oral polio vaccine (OPV) and
      (measles mumps and rubella) MMR vaccines against hepatitis A was not inferior to the
      protection afforded by Epaxal administered alone. The aim of the follow-up phase is to obtain
      information on the long term protection afforded by Epaxal, and to compare this with an
      alternative hepatitis A vaccine (Havrix).
    


Intervention name(s): Epaxal; Havrix 720
Intervention type(s): Biological; Biological
Intervention description(s): 0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV); 0.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis A Vaccine; Combined Vaccines; DTP Vaccine; MMR Vaccine
A Study of Injection HB002.1T in Subjects With Solid Tumor
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic
      profile of HB002.1T, a human immunoglobulin Fc fusion protein containing domain 2 and
      flanking sequence of vascular endothelial growth factor (VEGF) receptor-1 in subjects with
      solid tumor.
    


Intervention name(s): HB002.1T
Intervention type(s): Drug
Intervention description(s): HB002.1T is a Vascular Endothelial Growth Factor Receptor Decoy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Meloxicam Tablets on Bleeding Time in Healthy Subjects
Condition: Healthy
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study was to evaluate the effect of meloxicam tablets (7.5, 15 mg
      and 30 mg) with meloxicam placebo. Extended-release indomethacin capsules (75 mg) was an
      active control to assess trial sensitivity on bleeding time in healthy subjects. The
      secondary aim of this study was to assess effects of treatment on other platelet function and
      coagulation parameters.
    


Intervention name(s): Meloxicam - low; Meloxicam - medium; Meloxicam - high; Placebo; Extended-release indomethacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Indomethacin; Meloxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Fructan Prebiotics on the Intestinal Microbiota
Condition: Study Focus is to Define the Usual Gut Microbiota Following Prebiotic Feeding
Study type: Interventional

Summary: 
      Prebiotics are carbohydrate polymers believed to improve health by stimulating beneficial
      gastrointestinal microbial populations. Prebiotic health claims are currently not permitted
      in Canada due to a lack of validating scientific data. Currently, Health Canada considers
      'prebiotic' to imply a health benefit that must be substantiated. Our goal is to conduct a
      human clinical trial to define the impacts of fructans on the colonic microbiome as well as
      the physiological, psychological and immunological effects on the host.
    

Detailed description: 
      Current health claims for the fructan prebiotics focus on the bifidogenic properties of these
      substrates. While these claims appear to be widely accepted among nutritionists, the
      gut-microbiology community considers this an archaic view on these complex communities which
      contain in excess of 400 species of which the majority have yet to be cultivated or
      characterized. The bifidogenic effect associated with fructans also forms the basis of
      current prebiotic health claims in Canada, claims which up until now have not stood up to
      regulatory scrutiny The primary objective of this study is to assess the impact of frucans on
      the human microbiome, as well as the physiological, immunological health of the host.
      Information generated from this study will address both aspects of the current FOA definition
      of what constitutes a "prebiotic". New data generated from this study will be applicable for
      a new health claim for prebiotics and will provide a guide for industry demonstrating the
      requirements for a scientifically valid study for other submissions involving prebiotics.
    

Intervention name(s): Prebiotic; Prebiotic
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Inulin-fructan 15mg/day for 28days; Daily consumption of 15g inulin-fructan for 28 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: gut microbiome; prebiotics; immunological status; fructans
Clinical and Radiographic Evaluation of Indirect Pulp Capping in Primary and Permanent Teeth With Different Materials
Condition: Dental Pulp Capping
Study type: Interventional

Summary: 
      Indirect pulp capping (IPC) is a treatment that preserves pulp's vitality. Several materials
      have been used for this procedure. The aim of this study is to evaluate the radiographic and
      clinical outcomes of TheraCal LC (Bisco Inc., Schaumburg, IL, USA) and to compare it with
      mineral trioxide aggregate (MTA) (Pro Root MTA, Dentsply Tulsa, Johnson City, TN, USA) and
      calcium hydroxide [Ca(OH)2] (Dycal, Dentsply De Trey Konstanz, Germany) biomaterials in IPC
      treatment.
    

Detailed description: 
      A total of 295 teeth, including second primary molars and first permanent molars with IPC
      indications from healthy and cooperative children between the ages of 4-15, were included in
      this study. Teeth were divided into three groups according to the materials used for pulp
      capping. Indirect pulp treatment was applied using Dycal for 91 teeth, ProRoot MTA for 89
      teeth and TheraCal LC for 115 teeth. Primary molars were restored with the compomer material,
      and permanent molars were restored with the resin composite material. Restorations were
      evaluated with the Modified United States Public Health Service (modified USPHS) criteria.
      Clinical and radiographic findings were evaluated for 24 months at follow-up.
    

Intervention name(s): Calcium Hydroxide; Mineral Trioxide Aggregate; TheraCal LC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in the same session.; After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in in the same session.; After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity (2 milimeter layer) and polymerized and restoration was finished in in the same session.
Other intervention name(s): Dycal; Pulp capping agent; (ProRoot MTA); resin-based calcium silicate cement
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dental Pulp; calcium hydroxide; Dental Pulp Capping
Safety and Tolerability of ACU-4429
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of a new investigational
      drug (ACU-4429) in healthy human volunteers.
    


Intervention name(s): ACU-4429; matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): administered as a single dose, orally; administered as a single dose, orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Meat Derivative and Satiating Compound Effect on Satiety
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the satiating effects of a meat derivative and a
      satiating compound on overweight subjects (BMI ≥25 and <30 kg / m2).
    

Detailed description: 
      A randomized, parallel, controlled and double-blind pilot study with 3 study arms is being
      performed to evaluate the satiating properties of a meat derivate and a satiating compound in
      a group of healthy overweight subjects.

      The investigators included 20 participants between 18 and 65 years (BMI ≥25 and <30 kg / m2).
      All volunteers will be randomized into 3 study groups, and participants will receive the 2
      study products during the 3 experimental phases.
    

Intervention name(s): Placebo meat derivative + Placebo satiating compound; Placebo meat derivative + Satiating compound; Experimental meat derivative + Placebo satiating control
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound placebo diluted in water; Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water; Subjects will consume 60 g of the experimental meat derivative in a brunch type meal with 25 g of satiating compound placebo diluted in water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Satiety; Meat derivative; Fiber; Visual Analogue Scale; Parallel
Safety, Tolerability, and PK of Escalating Doses of Flufirvitide-3 Dry Powder for Inhalation in Healthy Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability and pharmacokinetics (PK) of single,and repeat
      escalating doses of FF-3 dry powder administered via inhalation in healthy adult subjects
    


Intervention name(s): Flufirvitide 3; Placebo for Flufirvitide-3
Intervention type(s): Drug; Drug
Other intervention name(s): FF-3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: antiviral, influenza
Absolute Bioavailability of a Single Oral Dose of Selexipag in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this phase 1 study is to investigate the absolute bio-availability of
      a single oral dose of selexipag, i.e., to assess the amount of selexipag which reaches the
      blood when administered as an oral tablet (ACT-293987) compared to an intravenous
      administration in healthy subjects.
    

Detailed description: 
      A pilot phase was conducted in 3 male subjects before the main phase for assessment of
      absolute bio-availability conducted in 16 other male subjects. The pilot phase aimed to
      determine the intravenous dose to be used in the main phase based on safety data and
      pharmacokinetics data.
    

Intervention name(s): Selexipag for intravenous use; Selexipag for oral use
Intervention type(s): Drug; Drug
Intervention description(s): Selexipag was reconstituted in sterile 0.9% w/v NaCl before infusion via an infusion pump at a rate of 2.5 µg/min.; Tablet containing 200 µg of selexipag
Other intervention name(s): ACT-293987; ACT-293987
Intervention MeSH terms: Selexipag
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: selexipag; bioavailability
Safety and Effectiveness of CATHTONG™ II PICC
Condition: Cancer
Study type: Interventional

Summary: 
      This clinical trial is a prospective, multi-centre, open, parallel and comparative
      non-inferior trial design.
    

Detailed description: 
      Four clinical trial institutions that meet the national qualification are selected as
      clinical research centers. After informed consent of the subjects and meeting the selection
      criteria, the subjects will be included in this clinical study. After the follow-up, all the
      data were sorted out and analyzed. Finally, the data of the two groups were compared to prove
      whether the high-pressure-resistant peripherally inserted central venous catheter developed
      by L&Z US, Inc. was not inferior to the control group.
    

Intervention name(s): PICC with high pressure tolerance; rontine central venous catheter
Intervention type(s): Device; Device
Intervention description(s): Subjects signed informed consent, meet the inclusion criteria and did not meet the exclusion criteria, and were randomly admitted to the experimental group and given the intervention.; Subjects signed informed consent, meet the inclusion criteria and did not meet the exclusion criteria, and were randomly admitted to the control group and given the intervention.
Other intervention name(s): Peripheral intubation of central venous catheter
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Case Managers for CVD Risk Reduction in HIV Clinic
Condition: Cardiovascular Disease; HIV
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of the study is to assess the efficacy of a case manager/social worker
      administered, telephone-based educational curriculum in improving cardiovascular disease
      related outcomes among HIV-infected clinic patients.
    

Detailed description: 
      Fifty high Cardiovascular Disease Risk (CVD) risk clinic patients will be randomized 1:1 to
      receive either a series of educational pamphlets on CVD risk reduction plus a telephone-based
      CVD risk reduction curriculum delivered over 24 weeks [intervention arm], or the educational
      pamphlets alone [control arm]. Anthropomorphic data, blood pressure and lipid profiles will
      be obtained from patients to assess the efficacy of the intervention in reducing blood
      pressure and serum low-density lipoprotein levels (LDL).
    

Intervention name(s): Telephone; Educational pamphlets
Intervention type(s): Behavioral; Other
Intervention description(s): A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.; A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Complementary Effect of Ear Acupressure on Older Patients With Chronic Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Ear acupressure is commonly applied to treat insomnia in Oriental clinical practice but
      lacking the evidence of the randomized controlled trial (RCT)of ear acupressure on insomnia.
      In this study, a RCT is conducted to investigate the complementary effect of ear acupressure
      on chronic insomnia in old adults.
    

Detailed description: 
      Even though there have been many advances in the pharmacological treatment of insomnia, many
      patients with insomnia visit complementary and alternative medicine (CAM) specialists for
      help due to fear of the side effects of long-term treatment with hypnotics. Acupuncture is
      commonly used to treat insomnia in the field of CAM. Among the different methods of
      acupuncture, it has been noted that ear acupressure (placing magnetic pellets on the
      auricular points), which has the advantage of being non-invasive and easily carried out,
      shows possible effects whereby there is improvement in the sleep quality of old adults.
      However, it is lacking of the evidence of the randomized controlled trial (RCT) of ear
      acupressure on insomnia.

      Insomnia is related to homeostatic dysregulation of autonomic nervous system (ANS). Ear
      acupuncture and its related techniques are believed to act through the reticular formation
      and the ANS may thus result in an amelioration of illness.

      In this study, a RCT is conducted to investigate the complementary effect of ear acupressure
      on chronic insomnia in old adults.Besides, the changes of ANS function (measured by heart
      rate variability) are recorded to evaluate the role of ANS in the treatment of insomnia.
    

Intervention name(s): ear acupressure; sham ear acupressure
Intervention type(s): Other; Other
Intervention description(s): The ear acupressure that is used involved a 0.3 cm-sized magnetic pellet on a 1 cm size sticky patch (Ching-Ming Co., Taiwan), which was placed on the bilateral ear Shenmen points; each of the points were pressed once a second for one minute (60 times) before sleep every night. The time period of the treatment course was four weeks.; The sham ear acupressure that was used involved a 1 cm size sticky patch placed on the bilateral ear Shenmen points. There was no magnetic pellet attached to the sticker and no need to press it.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insomnia; ear acupressure
Implementation and Evaluation of a Before School Physical Activity Program in Revere, MA
Condition: Overweight and Obesity; Physical Activity; Quality of Life; Fitness; Executive Function
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study evaluates the implementation of the BOKS program in three schools (K-8) in Revere,
      MA, and its effect on participating students with regard to BMI, cognitive, and quality of
      life outcomes. BOKS (Build Our Kids' Success) is a before-school physical activity program
      that has been implemented in over 2,000 elementary and middle schools. Two sessions will be
      held (Spring 2018 and Winter 2018. This is a cohort study evaluating the impact of program
      participation on child BMI, quality of life, and executive function.
    


Intervention name(s): BOKS Program
Intervention type(s): Other
Intervention description(s): 12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Quadratus Lumborum Block Type III Versus Type II Versus Transversus Abdominis Plane Block in Cesarean Section
Condition: Cesarean Section; Quadratus Lumborum Block; Transversus Abdominis Plane Block
Study type: Interventional

Summary: 
      Compare the type III and type II quadratus lumborum block (QLB) to transversus abdominis
      plane block (TAPB) regarding efficacy in CS
    

Detailed description: 
      The transversus abdominis plane block (TAPB) is administered between the internal oblique
      muscle and the transversus abdominis muscle in the fascial plane, directly pointing to the
      somatic nerves T6-L1 that run in this plane. In addition, meta-analyses demonstrate that it
      is an effective analgesic for somatic pain and diminishes opiate intake. It has been reported
      that TAPB is an efficient analgesic approach following cesarean section .

      The quadratus lumborum (QL) muscle block (QLB) is a fascial plane block as local anesthetic
      (LA) is introduced nearby to the QL muscle to numb the thoracolumbar nerves. QLB is
      categorized into four types according to drug administration location, I (lateral), II
      (posterior), III (anterior/transmuscular), and Intravenous, (intramuscular). QLB can
      effectively decrease both visceral and somatic pain by LA distribution to the thoracic
      paravertebral space (TPVS), as this block ensures effective pain control from the T7 to L1
      dermatomes. QLB is one of the regional techniques that provides the greatest benefit in
      post-CS pain control, as it is progressively applied in obstetric anesthetic precise to
      improve analgesic results.
    

Intervention name(s): Quadratus lumborum block typen II; Quadratus lumborum block III; Transversus abdominis plane block
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): A 22 gauge needle was positioned between the quadratus lumborum muscle posterior border and the erector spinae muscle in the thoracolumbar fascia's middle layer; A 22 gauge needle was positioned between the psoas and quadratus lumborum muscles at the anterior fascia lumbosacral; A 22 gauge needle was positioned between the internal oblique and transversus abdominis muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment