bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Two Injection Techniques on Success Rate of Inferior Alveolar Nerve Anesthesia
Condition: Failed Mechanical Induction
Study type: Interventional
Phase: Phase 2

Summary: 
      Forty healthy patients with including criteria who failed to infra alveolar nerve block
      injection (without lip numbness) have been randomly divided into two groups on a random basis
      and have received Gow-Gates or another inferior alveolar nerve block injection. Endodontic
      access cavity preparation has been initiated after complete anesthesia. If patients felt any
      pain during the steps of caries or dentin removal, Endodontic access cavity preparation or
      canal working length determination, treatment has been stopped and their pain has been
      measured by Heft Parker 170 mm Visual Analog Scale (Zero as no pain and 170 as maximum pain
      ).The data has been analyzed by Mann-U-Whitney and CHI- SQUARE tests.
    

Detailed description: 
      The aim of this study was to assess the efficacy of Gow-Gates and inferior alveolar nerve
      block on success rate of anesthesia in patients with irreversible pulpitis. In this
      prospective, randomized, double-blind study , forty healthy patients with symptomatic
      irreversible pulpitis and including criteria who failed to infra alveolar nerve block
      injection (without lip numbness) have been randomly divided into two groups on a random basis
      and have received Gow-Gates or another inferior alveolar nerve block injection. Their pain
      has been evaluated by electric pulp tester every 5 minutes for two times. Endodontic access
      cavity preparation has been initiated after complete anesthesia. If patients felt any pain
      during the steps of caries or dentin removal, Endodontic access cavity preparation or canal
      working length determination, treatment has been stopped and their pain has been measured by
      Heft Parker 170 mm Visual Analog Scale (Zero as no pain and 170 as maximum pain ). The
      patients have been instructed to rate any pain during each of the mentioned steps. The data
      have been analyzed by Mann-U-Whitney and CHI- SQUARE tests.
    

Intervention name(s): Injection technique
Intervention type(s): Other
Intervention description(s): One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Local Fields Potentials Recorded From Deep Brain Stimulating Electrodes
Condition: Parkinson's Disease; Essential Tremor; Dystonia
MeSH terms: Parkinson Disease; Tremor; Dystonia; Dystonic Disorders; Essential Tremor
Study type: Observational

Summary: 
      Deep Brain Stimulation (DBS) is an FDA approved, and widely used method for treating the
      motor symptoms of Parkinson's Disease (PD), Essential Tremor (ET) and Dystonia. Over 100,000
      patients worldwide have now been implanted with DBS devices. The DBS target regions in the
      brain are the Subthalamic nucleus (STN), the Internal Segment of Globus Pallidus (GPi), or
      the Ventral Intermediate Nucleus of the Thalamus (VIM). In order to place the DBS electrode
      in the target location, a combination of two 3D imaging techniques; 3D MRI and CT, are used.
      Data are also collected from individual nerve cells to help find the best location for the
      DBS electrode in each patient. This electrode recording takes place during the standard
      surgical implantation of the DBS electrode, and is part of the standard clinical technique.
      The investigators plan to collect additional data from populations of neurons during the DBS
      surgery in an effort to further improve the placement of the DBS electrode. These "Local
      Field Potentials", LFPs, represent the activity of the collection of neurons surrounding the
      tip of the electrode, and will be measured during surgery along the path used for the
      placement of the DBS electrode. The goal of this project is to determine whether this
      additional data from surrounding neurons will help with optimal placement of the DBS
      electrode.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Movement disorder patients from primary care clinic.
      
Keywords: Deep Brain Stimulation; Local Field Potential; Subthalamic Nucleus
Purified Anthocyanins Supplementation and High-Density Lipoprotein (HDL) Function
Condition: Diabetes Mellitus，Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      HDL function is impaired in patients with type 2 diabetes mellitus. Anthocyanin, a
      water-soluble compounds,is beneficial for vascular function by increasing nitric oxide (NO)
      bioavailability and decreasing oxidative stress. This study was designed to evaluate whether
      anthocyanin supplementation might improve cardiovascular function in diabetic patients.
    

Detailed description: 
      The study is designed as a randomized, double-blind label, interventional study on patients
      with T2DM. The eligible participants are randomly assigned to control and anthocyanins group.
      During the 24 weeks trial period, the participants are instructed to consume two anthocyanin
      capsules or placebo capsules twice daily (30 minutes after breakfast and supper).
    

Intervention name(s): Anthocyanin; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): anthocyanin 320 mg daily for 24 weeks; placebo 320mg daily for 24 weeks
Other intervention name(s): MEDOX (natural purified anthocyanin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Trilogy Comparison Study - Adults
Condition: Respiratory Insufficiency; Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      The objective of this study (Part II) will be to compare the performance of the Trilogy
      device and a conventional ventilator (participant's current device). Both devices will be set
      to the participants' current mode and prescription settings.
    

Detailed description: 
      A. Primary Hypothesis and end-point In patients with respiratory insufficiency, when compared
      to conventional ventilators, the Trilogy device achieves comparable level of gas exchange
      (measured as partial pressure of CO2 in arterial or venous blood)and SpO2 levels during
      various modes of ventilation.

      B. Secondary Hypothesis and end-points In patients with respiratory insufficiency, when
      compared to conventional ventilators, the Trilogy device achieves comparable breathing
      pattern (tidal volume, respiratory rate, minute ventilation), hemodynamics (heart rate), and
      subjective measures of breathing comfort (measured by modified Borg dyspnea scale).
    

Intervention name(s): Trilogy; Standard of Care
Intervention type(s): Device; Device
Intervention description(s): Exposure for one hour on the Trilogy ventilator; Exposure to participants current ventilator
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
First-in-man Trial Evaluating the Safety and Efficacy of the NOVA Intracranial Stent (NOVA Trial)
Condition: Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional

Summary: 
      Prospective, multi-center, randomized 1:1 single blind trial using NOVA sirolimus eluting
      stent versus Apollo bare metal stent conducted in approximately 15 interventional neurology
      centers in China. The study was sponsored by Sino Medical Sciences Technology Inc.
    

Detailed description: 
      The study will enroll 264 subjects overall in two groups (randomized 1:1). The study
      follow-up will occur at 1, 6 and 12 months post-stent implantation. All patients will undergo
      angiography assessment (DSA/CTA) at 12 months follow-up. Angiography assessment will be
      performed at baseline (pre- and post-procedure) and 12 months follow-up.
    

Intervention name(s): NOVA Intracranial Sirolimus Eluting Stent System; Apollo Intracranial Stent System
Intervention type(s): Device; Device
Intervention description(s): A sirolimus eluting intracranial stent system with polylactic-co-glycolic acid (PLGA) biodegradable drug carrier and electro-grated polybutyl methacrylate (PBMA) base coating. The stent platform is made of 316L stainless steel.; A 316L stainless steel balloon-expandable intracranial stent system
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ischemic Stroke; Intracranial Stenting
Phase 1 Study of BXQ-350 in Adult Patients With Advanced Solid Tumors
Condition: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to characterize the safety profile and determine the maximum
      tolerate dose (MTD) of BXQ-350, when given as a single agent at escalating doses, according
      to the investigational product (IP) related dose-limiting toxicities (DLTs) in patients with
      advanced solid tumors. Secondarily to assess the preliminary antitumor activity of BXQ-350 in
      solid tumors and recurrent high grade gliomas.
    

Detailed description: 
      This is a first in man study of BXQ-350, a novel anti-neoplastic therapeutic agent composed
      of two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the
      phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes.
      When both the components are assembled together forming stable SapC-DOPS nanovesicles
      (clinical formulation BXQ-350), the agent exhibits the propensity to enter the body and
      brain, target cells in the tumor mass, and induce cell death.

      The study is divided into 3 parts:

        1. Dose Escalation Scheme Sequential cohorts of adult patients with advanced solid tumors
           and recurrent high-grade gliomas will be treated with escalating doses of BXQ-350 until
           the MTD is established, or in the absence of a MAD, the highest planned DL.

        2. During Part 2, patients with advanced solid tumors and recurrent high-grade gliomas will
           be enrolled and administered BXQ-350 at the MTD determined in Part 1 or at the highest
           planned DL, if the MAD is not reached.

        3. During Part 3, patients with either ependymoma, GI tumors , or advanced solid tumors
           other than HGG, will be enrolled and administered BXQ-350 at the 2.4 mg/kg dose level.
    

Intervention name(s): BXQ-350
Intervention type(s): Drug
Intervention description(s): BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes. When both the components are assembled together stable SapC-DOPS nanovesicles are formed(clinical formulation BXQ-350).
Other intervention name(s): SapC-DOPS
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glioblastoma Multiforme; Solid Tumors; Ependymoma
A Study Investigating the Safety, Recovery, and Pharmacodynamics of Multiple Oral Administrations of SNIPR001 in Healthy Subjects
Condition: E.Coli Infections; Bloodstream Infection
MeSH terms: Infections; Communicable Diseases; Sepsis; Escherichia coli Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose, dose
      escalation study in healthy participants, investigating the safety, tolerability, recovery,
      and PD of multiple oral administrations of SNIPR001.
    

Detailed description: 
      Approximately 36 healthy male and female participants will be randomized to one of 3 active
      oral doses of SNIPR001 or matching placebo, administered twice a day (BID) for 7 days.
      Subjects will be followed up until 6 months after receiving the last dose of SNIPR001.
    

Intervention name(s): SNIPR001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SNIPR001 is a live biotherapeutic product consisting of genetically modified bacteriophages specifically targeting Escherichia coli; Matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Dose escalation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Optimal Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension
Condition: Hepatocellular Carcinoma(HCC); Cirrhotic Portal Hypertension
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Hypertension, Portal; Hypertension
Study type: Interventional

Summary: 
      There is no consensus about the optimal treatment of hepatocellular carcinoma (HCC) with
      cirrhotic portal hypertension, While this group of patients are classified as hepatectomy
      contraindication according to guidelines from National Comprehensive Cancer Network (NCCN)
      and American Association for the Study of Liver Diseases (AASLD). With improvement of
      surgical technique, preoperative evaluation, and perioperative management,especially the
      Precise Hepatectomy Technique, more and more studies confirmed the safety of surgical
      intervention to hepatocellular carcinoma (HCC) patients with cirrhotic portal
      hypertension.However, most of the previous studies were either retrospective or with small
      samples.

      The investigators project is a prospective randomized controlled trial, planning to compare
      the safety, efficacy and quality of life between precise hepatectomy and combined
      interventional treatment on hepatocellular carcinoma (HCC) with cirrhotic portal
      hypertension, to make a further understanding of optimal strategy.
    


Intervention name(s): Precise hepatectomy; Combined intervention (chemoembolization/ablation)
Intervention type(s): Procedure; Other
Intervention description(s): Precise hepatectomy; transcatheter hepatic arterial chemoembolization and/or ablation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: transartery embolization chemotherapy, infusion of Chemoembolization was performed using 30 mg/m2 of epirubicin, 200 mg/m2 of carboplatin, and 4mg/m2 of mitomycin C (MMC), mixed with 2-5 mL lipiodol. Then up to 20 mL of additional pure lipiodol was injected into the tumor-feeding artery until stasis of blood flow in the target artery was observed
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: precise hepatectomy; hepatocellular carcinoma; cirrhotic; portal hypertension; safety; combined interventional treatment
Metabolic Profiling of Type 1 Diabetes Mellitus in Children and Adolescents
Condition: Type1diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The aim of this study was to look for discriminating variation in the concentrations of
      small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched
      controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics.
    

Detailed description: 
      Type 1 diabetes mellitus (T1DM) is one of the most common pediatric diseases and its
      incidence is rising in many countries. Recently, it has been shown that metabolites other
      than glucose play an important role in insulin deficiency and the development of diabetes.
      The aim of this study was to look for discriminating variation in the concentrations of
      small-molecule metabolites in the plasma of T1DM children compared with non-diabetic matched
      controls using proton nuclear magnetic resonance (1H-NMR)-based metabolomics.

      This cross-sectional study was set-up to examine the metabolic profile in fasting plasma
      samples from 7 T1DM children and 7 non-diabetic controls aged 8 to 18 years, and matched for
      gender, age and BMI. The obtained plasma 1H-NMR spectra were rationally divided into 110
      integration regions, representing the metabolic phenotype. These integration regions reflect
      the relative metabolite concentrations and were used as statistical variables to construct
      (train) a classification model in discriminating between T1DM patients and controls.
    

Intervention name(s): Blood sampling
Intervention type(s): Other
Intervention description(s): Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        from 7 T1DM children and 7 non-diabetic controls aged 8 to 18 years, and matched for
        gender, age and BMI
      
Biospecimen description: 
      Blood plasma for proton-NMR spectroscopy
    
Keywords: Type 1 diabetes; 1H-NMR spectroscopy; Metabolomics; Pediatrics
The Effects of Neuromuscular Electrical Stimulation in Older Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The aim of the randomized controlled study is to investigate the effects of NMES superimposed
      on voluntary contraction combined with patient education and exercise training program in
      patients with chronic obstructive pulmonary disease.
    

Detailed description: 
      When initial assessments will be completed, patients will be assigned to one of two possible
      sequences by simple randomization: Superimposed NMES group (SG) or control group (CG).

      All volunteers will receive an COPD patient education program for once and conventional
      physiotherapy exercise program for COPD with the duration of 8 weeks. Additionally,
      superimposed NMES will be applied on quadriceps muscle of both limbs at the same time with
      voluntarily contraction of quadriceps muscle in SG.

      All patients will be assessed in terms of functional capacity, pulmonary functions,
      quadriceps muscle endurance and strength, dyspnea, respiratory muscle strength and quality of
      life at the baseline and at the end of study. Data will be collected from all the patients at
      baseline and at the end of study (8 weeks) by the same physiotherapist who also will
      supervise the exercise sessions.
    

Intervention name(s): Superimposed Neuromuscular Electrical Stimulation; Quadriceps Strengthening; Patient Education Program; Aerobic Exercise Training
Intervention type(s): Other; Other; Behavioral; Other
Intervention description(s): NMES will be applied during each strengthening exercise session. A dual channel NMES stimulation device will be used with biphasic symmetric constant current impulses with a pulse width 300ms, a frequency of 50 Hz and a duty cycle of 10s on and 20s off protocol for 3 days a week for eight weeks.; Quadriceps strength training will be done with resistive elastics bands for 3 days a week for eight weeks.; The aim of patient education is to increase awareness of patients about COPD and develop skills to better manage their disease. The patient education will be performed at least once via face to face interview. Education topics will be covered basic information about COPD, environmental risk factors, monitoring and managing the signs and symptoms of their disease, energy conservation techniques and relaxation positions to reduce dyspnea and usage of a specific inhaler.; Exercise training will be comprised of cardiovascular endurance training with cycle ergometer and lower extremity strength training. The exercises will be done 3 days a week at the clinic under the supervision of physiotherapist. Total duration of exercise training will last for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Asthma; Neuromuscular Electrical Stimulation; Quadriceps Muscle Strength; Quality of Life
Effects of Sodium Intake on (PK/PD) Relationship of a Single Dose of a Renin Angiotensin System-Blocker
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The impact of sodium intake on plasma drug concentrations has previously been reported in the
      literature for verapamil and quinidine but, to the investigators' knowledge, never with
      renin-angiotensin system blockers such as AT1R antagonists and angiotensin converting enzyme
      inhibitors.
    

Detailed description: 
      The impact of sodium intake on plasma drug concentrations concentrations obtained after a
      single oral dose of RAS blocking drugs (ramipril 10 mg, valsartan 160 mg, candesartan 8 mg)
      or a blocker as control (ATENOLOL 50 mg) will be compared in healthy normotensive men
      randomly assigned to a 6-day replated-sodium diet or a sodium depletion.
    

Intervention name(s): high sodium diet; low sodium diet; ramipril 10 mg; valsartan 160 mg; candesartan 8 mg; atenolol 50 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): high sodium diet; low sodium diet; ramipril 10 mg; valsartan 160 mg; candesartan 8 mg; atenolol 50 mg
Intervention MeSH terms: Atenolol; Valsartan; Candesartan; Candesartan cilexetil; Ramipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: High sodium diet; Low sodium diet; Renin-angiotensin system blockers; AT1 receptor (AT1R) antagonist; ACE inhibition