bioihbjkbjnl/mcl2 huggingface dataset:
Anaesthetic Efficacy of 2% Mepivacaine Versus 4% Articaine With Symptomatic Irreversible Pulpitis
Condition: Symptomatic Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      The aim of this randomized, double-blinded, clinical trial was to assess the effect of 3.6 mL
      2% mepivacaine hydrochloride with 1:100,000 epinephrine compared to 3.4 mL 4% articaine
      hydrochloride with 1:100,000 epinephrine on the success of the inferior alveolar nerve block
      for patients with symptomatic irreversible pulpitis in mandibular molars.
    

Detailed description: 
      The aim of this randomized, double-blinded, clinical trial was to assess the effect of 3.6 mL
      2% mepivacaine hydrochloride with 1:100,000 epinephrine compared to 3.4 mL 4% articaine
      hydrochloride with 1:100,000 epinephrine on the success of the inferior alveolar nerve block
      for patients with symptomatic irreversible pulpitis in mandibular molars. Patients were
      clinically and radiographically examined and their eligibility assessed and preoperative pain
      was measured using the numerical rating scale (NRS). Patients were randomly assigned to one
      of 2 groups: experimental group (2% mepivacaine) and the control group (4% articaine). After
      15 minutes of the inferior alveolar nerve block (IANB), patients reporting lip numbness had
      their molars accessed. No-to-mild pain response was considered success during root canal
      preparation.
    

Intervention name(s): Mepivacaine; Articaine
Intervention type(s): Drug; Drug
Intervention description(s): IANB using 3.6 ml of 2% mepivacaine hydrochloride with 1:100,000 epinephrine.; IANB using 3.4 ml of 4% articaine hydrochloride with 1:100,000 epinephrine.
Intervention MeSH terms: Carticaine; Mepivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Endothelialized ePTFE Graft by Nanobiotechnology
Condition: The Apparatus for Processing the Tubular Graft Modification Will be Designed and Evaluated.; The On-site Capturing of the Endothelial (Progenitor) Cells by Peptide-mediated Selective Adhesion in Vitro and in Vivo Will Also be Elucidated.; The Patency Rate of ITRI-made Artificial Blood Vessels Will be Evaluated by the Porcine Animal Model.
MeSH terms: Tissue Adhesions
Study type: Observational

Summary: 
      The replacement of autologous blood vessels by artificial grafts is urgently needed in
      clinical applications. Expanded polytetrafluoroethylene (ePTFE) grafts are the most
      clinically used artificial blood vessels because of its chemical and mechanical stability.
      But, when used as arteriovenous (AV) grafts for haemodialysis, small diameter ePTFE grafts
      have a high failure rate of 40% in three years in vivo because of the functional lack of an
      intact endothelial cell layer. Here we developed a two-step modification including chemical
      etching and plasma activation to enhance the hydrophilicity of ePTFE. Peptide motifs (eg.
      cyclic RRE, RGD) known to bind integrins on the endothelial cells were immobilized on ePTFE
      grafts. Functional peptide immobilization significantly increased the adherence and growth of
      HUVEC cells on ePTFEs. Patch ePTFE implantation in the pig's descending aorta was used to
      evaluate the in vivo endothelialization of these modified ePTFE grafts. At 28 days
      implantation, newly formed endothelial layers on peptide-immobilized ePTFE grafts were
      demonstrated by SEM and histological analysis. These preliminary data showed the potential to
      grow an intact endothelial layer to improve the patency rate of the modified ePTFE grafts.
    


Sampling method: Non-Probability Sample
Study population: 
        Native arteriovenous fistulas are not available in up to 40 percent of patients with renal
        dialysis. Therefore, the replacement of autologous blood vessels by artificial grafts is
        urgently needed. Expanded polytetrafluoroethylene( ePTFE) grafts are the most clinically
        used artificial blood vessels.
      
Keywords: Expanded polytetrafluoroethylene( ePTFE)
A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP
Condition: Primary Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine safety, efficacy, tolerability and Pharmacokinetics
      of ARGX-113 in Patients with Primary Immune Thrombocytopenia.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled Phase II study in which approximately
      36 patients will be randomized in a 1:1:1 ratio to receive either ARGX-113 Dose A, or
      ARGX-113 Dose B body weight or placebo in 4 infusions administered 1-week apart in addition
      to Standard-of-Care (SoC) treatment. Patients aged 18 to 85 years (inclusive) with confirmed
      primary immune thrombocytopenia (ITP) who have a platelet count ˂ 30 × 109/L and who are
      receiving oral corticosteroids and/or permitted oral immunosuppressants and/or Thrombopoietin
      receptor (TPO-R) agonist as SoC which must be maintained on a stable dose and frequency for
      at least 4 weeks prior to Screening.

      The study will include a 2-week Screening, a 3-week Treatment period, and an 21-week
      follow-up (FU) period. The study is followed by an open label period where patients will be
      given the option to be treated with ARGX-113 Dose A in cycles of 4 weekly infusions with a
      minimum of 4 weeks apart. Patients may receive rescue therapy during the study at the
      discretion the investigator when deemed medically necessary.
    

Intervention name(s): ARGX-113; Placebo
Intervention type(s): Drug; Other
Intervention description(s): ARGX-113 (Dose A or Dose B) or matching placebo will be administered IV weekly; ARGX-113 (Dose A or Dose B) or matching placebo will be administered IV weekly
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Protocol designed to evaluate one or more interventions for treating a disease, syndrome or condition.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Immersion in 42℃ Thermal-mineral Water on Chronic Low-back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      In this controlled, follow-up study the effects of immersion in 42℃ radon, natrium, calcium,
      bicarbonate content thermal-mineral water on clinical parameters and quality of life of
      patients with chronic low-back pain is evaluated. The participants in the intervention group
      are treated with balneotherapy plus usual care, while in the control group only with usual
      care. The planned participants number is 120. Follow up period is 3 months.
    

Detailed description: 
      In this controlled, follow-up study the effects of immersion in 42℃ radon, natrium, calcium,
      bicarbonate content thermal-mineral water on clinical parameters and quality of life of
      patients with chronic low-back pain is evaluated. The participants in the intervention group
      are treated with balneotherapy plus usual care, while in the control group only with usual
      care. The balneotherapy takes place in Rudas Spa in Budapest, 15 times in 3 weeks. The
      intensity of pain in rest and during activity evaluated on Visual Analogue Scale (VAS), the
      Oswestry Disability Index and the Euroqol-5D is taken at week 0., at week 3. and at week 12.
      The planned participants number is 120. Follow up period is 3 months.
    

Intervention name(s): balneotherapy
Intervention type(s): Other
Intervention description(s): immersion in radon, calcium, natrium, bicarbonate content 42 ℃ thermal-mineral water 15 times in 3 weeks, plus usual care. The total mineral substance of the water is 1530 mg/l. The suggested daily time spent in water is 20 minutes altogether with breaks.
Other intervention name(s): no intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: immersion in radon, calcium, natrium, bicarbonate content 42 ℃ thermal-mineral water 15 times in 3 weeks, plus usual care. The total mineral substance of the water is 1530 mg/l. The suggested daily time spent in water is 20 minutes altogether with breaks.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: low back pain; Balneotherapy; spa therapy
A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)
Condition: Polysomnography
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study is
      to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS) as
      measured by polysomnography (PSG) in healthy young male participants, and to evaluate the
      safety and tolerability of single oral doses of MK-1064 and MK-6096 in healthy young male
      participants. The primary efficacy hypothesis is that at least one dose of MK-1064 is
      superior to placebo in decreasing LPS in healthy male participants as assessed by PSG.
    


Intervention name(s): MK-1064; MK-6096; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral MK-1064 tablets (10 and 50 mg strengths); Oral MK-6096 tablets (5 mg strength); Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessment of a New Surgical Smoke Clearing Technology in Laparoscopic Cholecystectomy
Condition: Focus: Surgical Smoke During Laparoscopic Surgery
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study will examine the safety and performance of a new surgical smoke clearance system
      designed for use during laparoscopic surgery.
    

Detailed description: 
      The study will examine the safety and performance of a new surgical smoke clearance system
      which has been developed to maintain a visually clear operative field during laparoscopic
      surgery by using electrostatic precipitation to clear, from the surgical field, smoke and
      plume produced by energy based surgical instruments e.g. electrocautery, laser tissue
      ablation and ultrasonic scalpel tissue dissection.
    

Intervention name(s): Innervision Surgical Smoke Removal System
Intervention type(s): Device
Intervention description(s): Smoke removal by electrostatic precipitation
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: surgical smoke; laparoscopic surgery; impaired vision
A Study to Test Whether ZS (Sodium Zirconium Cyclosilicate) Can Reduce the Incidence of Increased Blood Potassium Levels Among Dialized Patients.
Condition: Hyperkalemia
MeSH terms: Hyperkalemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of ZS in the treatment of hyperkalemia
      in patients on hemodialysis.
    


Intervention name(s): Placebo; Sodium Zirconium Cyclosilicate (ZS)
Intervention type(s): Drug; Drug
Intervention description(s): Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) .
Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days.; Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) .
Single dose contains from 1 to 3 sachets of ZS 5g depending on dose level assigned to a patient per non-dialysis days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Anti-Nephropathic Effects of Chronic Intermittent Intravenous Insulin Therapy (CIIIT)
Condition: Diabetic Nephropathy; Diabetic Retinopathy
MeSH terms: Diabetic Retinopathy; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 3

Summary: 
      Investigators with the goal of optimizing glycemic and blood pressure control saw type 1
      diabetic patients weekly. A control group received 3-4 subcutaneous insulin injections per
      day; an intravenous insulin pulsed infusion group received, in addition, three one hour
      infusions in a pulsatile fashion over one eight hour period each week. Patients were followed
      for 12 months with periodic testing of renal function by repeated blood and urinary analyses;
      diabetes control by blood testing and diabetes impact measurement score; cardiac and
      autonomic function by echocardiography, 24 hour electrocardiographic testing; and visual
      changes with repeated fundus photography. The study hypothesis was that correction of
      respiratory quotient would correct the defect leading to microvascular complications of
      diabetes (Type 1).
    


Intervention name(s): CIIIT
Intervention type(s): Drug
Intervention description(s): The intravenous infusion group received three one-hour courses of pulsed intravenous insulin infusion on a single day per week in addition to subcutaneous insulin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetic autonomic neuropathy
28-day Repeat Dose and Drug Interaction Study With Orvepitant (GW823296)
Condition: Depressive Disorder
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to obtain information on the safety and tolerability of
      repeated doses of GW823296 for 28 days in healthy male and female subjects. In addition, the
      pharmacokinetics of GW823296 will be evaluated to confirm the doses to be used in Phase II
      efficacy studies. The effect of repeat dose (RD) of GW823296 on CYP3A4 enzyme activity will
      be investigated evaluating the pharmacokinetics of midazolam and urine
      6-?-hydroxycortisol/cortisol ratio.
    


Intervention name(s): GW823296 tablet; GW823296 matching placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GW823296 immediate release tablets will be available as white film-coated tablets containing 5 milligrams (mg) and 20 mg of GW823296 for oral administration.; Matching placebo tablets will be identical in appearance to the GW823296 tablets.; Midazolam will be administered as 5 milliliter (mL) of an intravenous solution for oral application (5 mg/5 mL, Dormicum).
Other intervention name(s): Orvepitant
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: depression; NK1 receptor antagonists,
The Secondary Prevention Trial for Ischemic Stroke With DengzhanShengmai Capsule
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      In order to observe the secondary preventive effect of the Dengzhanshengmai capsule on
      ischemic stroke, the investigators hold the large randomized control trial (RCT). 3143
      subjects are included in 83 clinical research centers all over China. The subjects are
      randomly grouped into two groups. The basic therapy included antiplatelet aggregation, stroke
      health education, management of blood pressure, blood lipid and blood glucose, etc. The
      treating group will take the compound Chinese Medicine Deng Zhan Sheng Mai capsule and the
      contrast group will take the placebo for twelve months. Then all of the subjects are visited
      on the 30th, 90th, 180th, 360th day after inclusion. The recurrence of stroke, cardiovascular
      events, and peripheral arterial events are observed.
    

Detailed description: 
      Objective:To observe the secondary clinical effect of the Deng Zhan Sheng Mai capsule on
      ischemic stroke patients.

      Methods:3143 subjects suffering from acute ischemic stroke are included in 83 clinical
      research centers all over China. The subjects are randomly divided into two groups:The
      treating group and the placebo group.Both groups accept the basic therapy and test drug.The
      basic therapy included antiplatelet aggregation,stroke health education,management of blood
      pressure,blood lipid and blood glucose,etc.The patients in Dengzhan Shengmaigroup take Deng
      Zhan Sheng Mai capsule and the placebo group take the placebo drug for twelve months.Then all
      of the subjects are visited on the 30th,90th,180th,360th day after inclusion. Primary
      endpoints(cerebral infarction,intracerebral hemorrhage,subarachnoid hemorrhage) and secondary
      endpoints(cardiovascular events,peripheral arterial disease),functional disability are
      observed at each follow up.
    

Intervention name(s): Dengzhan Shengmai capsule; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule, 0.18g, 2#, Bid*1year; Capsule, 0.18g, 2#, Bid*1year
Other intervention name(s): DZSM; DZSMP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: recurrence of stroke; Dengzhan Shengmai Capsule; Traditional Chinese Medicine
Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical study is to assess the safety, tolerability and pharmacokinetics
      of repeat doses of IRL201104 given to healthy volunteers.
    


Intervention name(s): IRL201104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lyophilised powder for reconstitution for IV dosing; Matching placebo for IRL201104
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Proportion of Hysterectomy After Female Sterilization
Condition: Hysterectomy
Study type: Observational

Summary: 
      The objective of this study is to describe the proportion of hysterectomy in patients that
      had undergone sterilization through hysteroscopic device placement and the patients that had
      undergone sterilization through tubal ligation.
    


Intervention name(s): Hysteroscopic device placement including Essure (ESS305, BAY1454032); Tubal ligation
Intervention type(s): Device; Procedure
Intervention description(s): Essure is a permanent, minimally invasive, non-hormonal implantable device used for contraception and Adiana sterilization method is a combination of controlled thermal damage to the lining of the fallopian tube followed by insertion of a non-absorbable biocompatible silicone elastomer matrix within the tubal lumen; Tubal ligation or tubectomy is a surgical procedure for sterilization in which a woman's fallopian tubes are clamped and blocked, or severed and sealed, either method of which prevents eggs from reaching the uterus for implantation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women aged 18 - 49 at index date who underwent hysteroscopic device sterilization procedure
        or tubal ligation sterilization procedure.

        Index date: Date of sterilization procedure
      
Keywords: Sterilization; Hysteroscopic Device Placement; Tubal Ligation
A Study to Evaluate the Effects of Rifampin on Single-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate blood levels of canagliflozin in healthy volunteers
      before and after the administration of multiple-doses of rifampin.
    

Detailed description: 
      This is an open-label (volunteer and study staff will know the identity of study drugs
      assigned) study of canagliflozin and rifampin taken in a sequential order by healthy
      volunteers for up to 12 days. Healthy volunteers will take orally (by mouth) one 300 mg
      canagliflozin tablet and/or two 300 mg rifampin capsules daily in sequential order as
      follows: on Day 1 volunteers will take one 300-mg canagliflozin tablet, on Days 4 to 9
      volunteers will take two 300-mg rifampin capsules once daily, on Day 10 volunteers will take
      one 300-mg canagliflozin tablet + two 300-mg rifampin capsules, and on Days 11 and 12
      volunteers will take two 300-mg rifamplin capsules once daily.
    

Intervention name(s): Rifampin; Canagliflozin
Intervention type(s): Drug; Drug
Intervention description(s): Type=2, unit=mg, number=300, Form=capsule, route=oral use. Two 300-mg capsules once daily on days Days 4 through 12.; Type=1, unit=mg, number=300, form=tablet. Single dose of one 300-mg tablet on Day 1 and Day 10
Intervention MeSH terms: Canagliflozin; Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Canagliflozin; Rifampin; Pharmacokinetics