bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Effects of Age and Gender on the Pharmacokinetics of JNJ-42847922 in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics of single-dose evening
      administration of JNJ-42847922 in elderly non-Asian adults compared with weight- and
      gender-matched young healthy non-Asian adults and to assess the pharmacokinetics of
      single-dose evening administration of JNJ-42847922 in healthy Japanese adults.
    


Intervention name(s): JNJ-42847922 10 milligram (mg); JNJ-42847922 20 mg; JNJ-42847922 40 mg; JNJ-42847922 60 or 80 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): JNJ-42847922 will be administered as single tablet of 10 mg, orally, once on Day 1.; JNJ-42847922 will be administered as 1 tablet of 20 mg, orally, once on Day 1.; JNJ-42847922 will be administered as 2 tablets of 20 mg, orally, once on Day 1.; JNJ-42847922 will be administered as 3 or 4 tablets of 20 mg, orally, once on Day 1. Dose to be determined from Cohort 3, Period 1.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Non Invasive Brain Stimulation on Impulsivity in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder; Impulsive Behavior
Study type: Interventional

Summary: 
      A pilot study to examine the effects of Non-Invasive Brain stimulation on impulsive behaviour
      in patients diagnosed with Borderline Personality Disorder. patients who received the
      neurostimulation sessions will be enrolled in short term psychotherapy (3-month)
    


Intervention name(s): NeuroConn
Intervention type(s): Device
Intervention description(s): A neurostimulation decivse that works be generating weak electric current via Electrodes. These electrodes placed on a specific cerebral location, where the defect assumed to be there) to modulate the neuronal activity. This neuronal modulation does not induce or fire action potential but it facilitate action potentials and cerebral interconnection as well corticolimbic connection)
Other intervention name(s): tDCS; transcranial Direct Current Stimulation
Intervention model: Single Group Assignment
Intervention model description: we recruited 10 patients who attended a 10-session of tDCS stimulation. Each session lasted for 20 minutes in a 2-week.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: impulsivity; Non-Invasive Brain Stimulation; Psychotherapy
Probiotics as Adjuvant Therapy in the Management of Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      Studying the effects of adding probiotics to the drug regimen of patients with diarrhea
      predominant IBS
    

Detailed description: 
      Irritable bowel syndrome (IBS) is a common highly prevalent functional gastrointestinal (GI)
      disorder that places an enormous burden on resource-challenged healthcare systems. Although
      many drugs have been advocated in the treatment of IBS, including psychotropic agents,
      antispasmodics, bulking agents, and 5-HT receptor antagonists. However, in the vast majority
      of instances, these medications have failed to provide adequate symptom alleviation,
      presumably due to the disease's diverse pathophysiology. Probiotics are "live bacteria that
      confer a health benefit on the host when administered in suitable doses". In IBS, a decrease
      in Bifidobacterium and Lactobacillus species, as well as an increase in Gamma-proteobacteria
      species (a family of pathogens), has been described in IBS studies. Therefore, the ability of
      probiotics to repair dysbiosis (qualitative and quantitative changes in the microbiota) or
      stabilize the host microbiota is the reason for their use in the treatment of IBS.
    

Intervention name(s): Two probiotic strains (L. plantarum and L. acidophilus)
Intervention type(s): Dietary Supplement
Intervention description(s): A capsule containing the L. plantarum and L. acidophilus strains is to be administered twice daily for three months in addition to the standard treatment of IBS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: IBS; IBS-D; Abdominal pain; Abdominal distention; Probiotic; Lactobacilli; Mucus; L. plantarum; L. acidophilus
The Preventive Effect of Helicobacter Pylori Eradication on the Development of Gastric Cancer
Condition: Helicobacter Pylori; Eradication; Gastric Cancer; Medical Care Cost
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      Recently, the preventive effect of Helicobacter pylori (Hp) eradication treatment on the
      incidence of gastric cancer has been reported. By Hp eradication treatment being performed
      for Hp-infected people in Iijima town, we will evaluate whether the incidence of gastric
      cancer and/or the medical care cost can be reduced as compared with those in the previous
      years.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People who live in Iijima town
      
Biospecimen description: 
      serum
Buttonhole Versus Step Ladder Cannulation in High Dose Hemodialysis
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      The purpose of the pilot study is to determine: 1) Will patients agree to be randomized to
      two different methods of putting needles in their arteriovenous fistula and, 2) if we can
      adequately coordinate all of the sites to get useful multicentre trial data
    

Detailed description: 
      To determine the feasibility of 1) randomizing patients to step-ladder versus buttonhole
      cannulation techniques, and 2) coordinating the multiple Canadian sites that are required for
      the definitive study.

      Secondary Objectives: To determine 1) if buttonhole cannulation, compared to step-ladder
      cannulation is associated with reduced training time for high dose home hemodialysis
      patients, 2) if buttonhole cannulation, compared to step-ladder cannulation is associated
      with reduced overall cost, 3) if buttonhole cannulation, compared to step-ladder cannulation
      is associated with reduced complications (infection - local and systemic, radiologic/surgical
      interventions, re-trains for needle insertion difficulties, hematoma formation, aneurysm
      formation, missed insertions), and 4) if buttonhole cannulation, compared to step-ladder
      cannulation is associated with reduced patient discomfort with needling for intensive home
      hemodialysis patients
    

Intervention name(s): Buttonhole needling technique
Intervention type(s): Procedure
Intervention description(s): the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation
Other intervention name(s): Buttonhole canulation in home hemodialysis patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Renal failure; Hemodialysis; Canulation technique; Training time; Cost; Patient discomfort with cannulation technique
Multimodal Imaging-assisted Diagnosis Model for Cervical Spine Tumors
Condition: Spine Tumor
Study type: Observational

Summary: 
      Cervical spine tumor is a small sample of tumor disease with low incidence, great harm, and
      complex anatomical structure. It is very difficult to identify and classify benign and
      malignant cervical spine tumors clinically.

      The deep learning model we constructed in the early stage has a higher accuracy rate for the
      image diagnosis of cervical spondylosis with a large number of cases, and a better clinical
      application effect, but the accuracy rate for cervical spine tumors with a small number of
      cases is lower. The reason may be the amount of data. With limited tasks, the traditional
      deep learning model is difficult to play an effective role.

      Based on this, we propose to build a small sample-oriented deep learning model to assist
      clinicians in the diagnosis of cervical spine tumors with multimodal images, and to evaluate
      the benign and malignant tumors.
    

Detailed description: 
      Cervical spine tumor is a small-sample tumor disease with low incidence, great harm, and
      complex anatomical structure. It is very difficult to identify and classify benign and
      malignant cervical spine tumors clinically. The deep learning model we constructed in the
      early stage is suitable for the large number of cases. The imaging diagnosis of cervical
      spondylosis has a high accuracy rate and a good clinical application effect, but the accuracy
      rate is low for cervical spine tumors with a small number of cases. The reason may be that
      for tasks with limited amount of data, the traditional deep learning model is difficult to
      play an effective role. Based on this, we propose to construct a small sample-oriented deep
      learning model to assist clinicians in the diagnosis of cervical spine tumors in multi-modal
      imaging, and to evaluate the benign and malignant tumors. This research will not only improve
      the efficiency and efficiency of cervical spine tumor imaging diagnosis. Accuracy, to guide
      clinical personalized treatment, will also provide a basis for the clinical application of
      deep learning in the field of small samples, which has important clinical significance.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Inclusion criteria: clinically suspected cervical spine tumors, multi-modality (X-ray, CT,
        MR) imaging, followed by needle biopsy or surgery to confirm the tumor, and pathology
        report. Exclusion criteria: surgery or radiotherapy before imaging, cervical spine Those
        who have fractures, deformities, infections, etc. who cannot cooperate with imaging
        examinations, and those who have not signed an informed consent.
Effect on Bacterial Glycolytic Acid Formation on Plaque
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the effect of an amino acid on bacterial glycolytic acid formation in human
      interdental plaque.
    


Intervention name(s): Triclosan, Fluoride; fluoride; Fluoride, triclosan, amino acid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rinse 3 times daily with assigned toothpaste slurry; Rinse 3 times daily with assigned toothpaste slurry; Rinse 3 times daily with assigned toothpaste slurry
Other intervention name(s): Total+ Whitening toothpaste; placebo toothpaste (No triclosan, no amino acid)
Intervention MeSH terms: Triclosan; Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Sun Protection Factor Assay (316/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY 987516; SPF Control
Intervention type(s): Drug; Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z46-100); Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Does Ketamine Attenuate Depression of Respiratory and Cardiac Functions
Condition: Congenital Heart Disease; Sedated for Cardiac Catheterization
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      Normal cardiac and respiratory functions should be maintained during pediatric cardiac
      catheterization. Propofol has become a popular choice for sedation in children, however, it
      depresses cardiac and respiratory functions. Some investigators reported that ketamine
      attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac and
      respiratory depression caused by propofol in pediatric cardiac catheterization.
    


Intervention name(s): control; Ket10; Ket20
Intervention type(s): Drug; Drug; Drug
Intervention description(s): propofol 8mg/kg/h saline 0.24 ml/kg/h; propofol 6.4 mg/kg/h ketamine 10 microg/kg/min; propofol 4.8 mg/kg/h ketamine 20 microg/kg/min
Other intervention name(s): saline with propofol; ketamine 10 γ; ketamine 20 γ
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: children; sedation; propofol; ketamine
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of the ABT-333 Tablet
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
      escalating multiple doses of the ABT-333 tablet formulation in healthy adult subjects.
    


Intervention name(s): ABT-333; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): See arm description for more information; See arm description for more information
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: multiple ascending doses (MAD)
Clinical Efficacy of Tranexamic Acid and ε-Aminocaproic Acid in Reducing Blood Loss Following Total Knee Replacement
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Tranexamic acid (TXA) and ε-aminocaproic acid (EACA) are two drugs shown to limit blood loss
      following major surgery, from cardiac to orthopedic procedures. Yet compared to tranexamic
      acid (TXA), research on the clinical impact of ε-aminocaproic acid (EACA) in total knee
      arthroplasty (TKA) is limited. The primary aim of this study is to determine whether TXA and
      EACA provide similar blood decreasing effects following TKA or whether one drug provides a
      superior effect over the other in reducing patients' blood loss.
    


Intervention name(s): Tranexamic Acid (TXA); ε-Aminocaproic Acid (EACA)
Intervention type(s): Drug; Drug
Intervention description(s): 1g in 250cc of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 1g in 250cc of saline will be infused over 30 minutes beginning at the time of wound closure.; 7g in 250cc of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 7g of EACA in 250cc saline will be infused over 30 minutes beginning at the time of wound closure.
Other intervention name(s): Cyklokapron; Amicar
Intervention MeSH terms: Tranexamic Acid; Aminocaproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tranexamic acid; 6-Aminocaproic Acid; Arthroplasty; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Antifibrinolytic Agents; Fibrin Modulating Agents; Pharmacologic Actions; Coagulants; Therapeutic Uses
Drug-drug Interaction Study of Gepotidacin
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a drug-drug interaction (DDI), pharmacokinetics (PK), safety and tolerability
      study in adult healthy participants, including Japanese cohort. This study is designed to
      assess co-administration of probe substrates with gepotidacin in study cohorts 1 to 3 and
      establishing PK and safety in Japanese participants in cohort 4. Food effect will also be
      evaluated in cohort 4.
    


Intervention name(s): Gepotidacin; Cimetidine; Rifampicin; Midazolam; Digoxin; Placebo matching to gepotidacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.; Cimetidine tablets will be available as unit dose strength 400 mg and will be administered orally.; Rifampicin Capsules will be available as unit dose strength 300 mg and will be administered orally.; Midazolam oral syrup 2 milligrams per milliliter (mg/mL) will be available to be administered orally.; Digoxin tablets will be available as unit dose strength 0.25 mg and will be administered orally.; Placebo matching to gepotidacin tablets will be administered orally.
Other intervention name(s): GSK2140944
Intervention MeSH terms: Rifampin; Gepotidacin; Digoxin; Midazolam; Cimetidine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Cohort 1 and 2 are open-label, fixed sequence DDI cohorts. Cohort 3 is an open-label, 2-sequence, 2-period crossover randomized DDI cohort. Cohort 4 is a double-blind, placebo-controlled, randomized sequence study to investigate the safety and PK of gepotidacin.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gepotidacin; Drug Interaction; Pharmacokinetic; Safety; Bacterial Infection; Japanese Healthy Adults
Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of
      osteoarthritic knee patients.
    

Detailed description: 
      Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of
      osteoarthritic knee patients up to 6 months.
    

Intervention name(s): Hylan G-F 20; Corticosteroid
Intervention type(s): Drug; Drug
Intervention description(s): After full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle.; After full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle.
Other intervention name(s): Synvisc; Triamcinolone acetonide
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Hylan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee Osteoarthritis; Corticosteroid; Hyaluronic acid; Intra-articular injection
A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
Condition: Migraine With Aura; Migraine Without Aura; Migraine
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-center, single-dose, open-label, 2-part, 3-period crossover (in each part),
      pharmacokinetic and safety study.
    

Detailed description: 
      Phase 1, open-label, 2-part, single-dose pharmacokinetic and safety study of STS101 in
      healthy subjects. Part 1 was designed to identify a dose level of STS101 for administration
      in Part 2. Subjects in Part 1 received 3 ascending doses of STS101 in a 3-period crossover
      manner. During Part 2, subjects received the dose of STS101 selected from Part 1, 1.0 mg DHE
      mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 3 period crossover
      manner.
    

Intervention name(s): Dihydroergotamine
Intervention type(s): Drug
Intervention description(s): Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
Other intervention name(s): Dihydroergotamine Mesylate
Intervention MeSH terms: Dihydroergotamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dihydroergotamine; dihydroergotamine mesylate; migraine
The Efficacy and Safety of Ta1 for Sepsis
Condition: Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether thymalfasin is safe and effective in
      patients who have sepsis
    

Detailed description: 
      Our previous study reported that the 7-day treatment of Ta 1 demonstrated positive active
      effect as to the 28-day all-cause mortality and the augmentation of mHLA-DR (monocyte Human
      Leukocyte Antigen DR) at the secondary endpoint. Therefore, we intend to verify this finding
      through a randomized, double-blind and placebo-controlled clinical trial and the trail will
      include subjects with impaired immunologic functions.
    

Intervention name(s): Thymosin alpha 1; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subcutaneous injections of 1.6 mg thymosin alpha 1 every 12±2 hours for not more than 7 days depending on the change of the subjects' condition, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.; Subcutaneous injections of placebo every 12±2 hours for not more than 7 days depending on the change of the subjects' condition, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.
Other intervention name(s): thymalfasin
Intervention MeSH terms: Thymalfasin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: thymosin alpha 1; thymalfasin; sepsis; immunodepression