bioihbjkbjnl/mcl2 huggingface dataset:
Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501
      inhaled human insulin
    

Detailed description: 
      This study investigated the pharmacokinetic (PK) and pharmacodynamic (PD) properties of
      Dance-501, a novel inhaled human insulin liquid formulation (INH) and device. Twenty-four
      subjects with type 2 diabetes (T2DM) received 3 INH doses: low (69 units), medium (139 units)
      and high (208 units) and 1 equivalent medium dose (18 units) of subcutaneous insulin lispro
      (LIS).

      The medium dose was repeated to determine within subject variability. PD was investigated
      during a 12 hour euglycemic clamp.
    

Intervention name(s): INH 69 U (low); INH 69 U (high); INH 139 U; INH 208 U; LIS 18 U
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): inhaled human insulin; inhaled human insulin; inhaled human insulin; inhaled human insulin; subcutaneous insulin lispro
Other intervention name(s): Dance-501; Dance-501; Dance-501; Dance-501; subcutaneous insulin lispro
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Is There an Association Between Chronic Pancreatitis and Pulmonary Function
Condition: Chronic Pancreatitis; Respiratory Insufficiency; Cirrhosis, Liver; Lung Function Decreased; Healthy
MeSH terms: Pancreatitis; Pancreatitis, Chronic; Liver Cirrhosis; Respiratory Insufficiency
Study type: Observational

Summary: 
      To evaluate pulmonary function in chronic pancreatitis compared with healthy volunteers and
      patients with cirrhosis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We plan to include patients with chronic pancreatitis, cirrhosis and healthy controls
Study of NGX-4010 for the Treatment of Postherpetic Neuralgia
Condition: Peripheral Nervous System Diseases; Pain; Neuralgia; Herpes Zoster; Shingles
MeSH terms: Herpes Zoster; Neuralgia; Nervous System Diseases; Neuralgia, Postherpetic; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to assess the efficacy and safety of NGX-4010 applied for 60
      minutes for the treatment of postherpetic neuralgia (PHN).
    

Detailed description: 
      This study is a 12-week randomized, double-blind, controlled multi-center evaluation of the
      efficacy, safety and tolerability of NGX-4010 for the treatment of PHN. Eligible subjects
      will have pain from PHN, with average numeric pain rating scale (NPRS) scores during
      screening of 3 to 9 (inclusive). Painful areas of up to 1000 square centimeters will be
      treated during a single treatment administration in this study. Subjects will be randomly
      assigned to receive active NGX-4010 patches or low-concentration control patches that are
      identical in appearance, according to a 1:1 allocation scheme.

      Subjects may be on stable chronic oral pain medication regimens, but currently will not be
      using any topical pain medications on the affected areas. NPRS scores for the average pain in
      the past 24 hours will be recorded daily in the evening, beginning on the day of the
      Screening Visit (usually on Day -14). Subjects will continue to record NPRS scores in a
      take-home diary from the evening on the day of treatment through the evening before the
      Termination Visit at Week 12. Subjects will return for interim follow-up visits at Weeks 4
      and 8 following study treatment.
    

Intervention name(s): NGX-4010
Intervention type(s): Drug
Intervention MeSH terms: Capsaicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: dermal assessment; pain measurement; diary; PHN; shingles; neuropathy; analgesics; capsaicin; postherpetic neuralgia
Effect of Saline Irrigation in Reducing Choledocholithiasis Recurrence After ERCP
Condition: Stone - Biliary
MeSH terms: Choledocholithiasis; Cholelithiasis; Cholecystolithiasis; Gallstones; Recurrence
Study type: Interventional

Summary: 
      In this prospective study, the investigators assessed the utility of intermittent saline
      irrigation in reducing the recurrent rate of choledocholithiasis after the endoscopic
      extraction for common bile duct stones, and it does not increase the rate of
      procedure-related complications.
    

Detailed description: 
      In recent years, an endoscopic retrograde cholangiopancreatography (ERCP) is the golden
      standard procedure to remove the common bile duct stones(CBD). Nevertheless, it is reported
      that the recurrence rate of CBD stones is 4% to 24% after ERCP. The contributing factors were
      periampullar diverticulum, situ gallbladder, and incomplete CBD stone clearance. The main
      reason of stone recurrence is incomplete CBD stone clearance including remnant stone
      fragments themselves and tinny fragments can act as a nidus for further CBD stone growth. It
      is difficult to retrieve these fine fragments completely using conventional devices such as
      retrieval basket and ballon. Therefore, the investigators attempt to remove residual stone
      fragments by means of saline infusion. Saline irrigation has many advantages such as better
      effect and less side effect and no extra cost. It is reported that use intraductal
      ultrasonography (IDUS) to demonstrate residual CBD stones. However, IDUS has limited
      availability in clinical practice. The single-operator cholangioscopy (SOC)-system gains
      widespread acceptance because of its independent washing channels and direct viewing.

      The purpose of this study is to evaluate whether saline solution irrigation would decrease
      the recurrent rate of choledocholithiasis after endoscopy retrieval stones.
    

Intervention name(s): Saline irrigation
Intervention type(s): Procedure
Intervention description(s): 100ml saline irrigation after CBD stone removal with routine ERCP procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ERCP; Common bile duct stone; Cholangitis; Residual stone; Irrigation; Recurrence
Comparing Two Instrumentation Systems for the Treatment of Adolescent Scoliosis
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Idiopathic scoliosis affects 2-5% of adolescents. This study will compare the quality of
      life, functional outcome, cosmetic result, and the correction of spinal deformity of two
      instrumentation systems for the treatment of adolescent idiopathic scoliosis.
    


Intervention name(s): Moss Miami Spine Instrumentation System; Universal Spine Instrumentation System
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Scoliosis; spinal disease; pediatrics; Adolescents; Universal Spinal Instrumentation System; Moss Miami Spinal Instrumentation System; Orthopedic Surgery
Evaluation of the Effects of a Food Supplementation on the Improvement of Cognitive Functions in Healthy Seniors
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The hypothesis of this study is to evaluate the effect of supplementation for 8 weeks on the
      improvement of cognitive functions in healthy seniors with or without mild cognitive decline.
    


Intervention name(s): Verum; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): After randomization (visit V1), subjects will consume orally 2 capsules per day, during the breakfast, for 8 weeks (from visit V1 to visit V3).; After randomization (visit V1), subjects will consume orally 2 capsules per day, during the breakfast, for 8 weeks (from visit V1 to visit V3).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is designed as a multicentric, randomized, parallel arms, double-blind, placebo-controlled clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Effectiveness of Aligners Versus Rapid Maxillary Expansion
Condition: Maxillary Transverse Deficiency (MTD)
Study type: Interventional

Summary: 
      Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared
      to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using
      3D technology.
    

Detailed description: 
      Aim of the study is to assess the effectiveness of Invisalign® First clear aligners compared
      to tooth-borne Hyrax-type maxillary expander on palatal morphology in growing subjects using
      3D technology. This two-arm parallel-group randomized prospective clinical trial will include
      patients with: indications for maxillary expansion treatment, age between 6 and 10 years old,
      mixed dentition, good standard of oral hygiene, good compliance during treatment as assessed
      by the practitioner. Patients will be assigned to one of two expansion methods (arm A:
      Invisalign® First clear aligners, arm B: tooth-borne Hyrax-type maxillary expander) according
      to a computer-generated randomization list shortly before the start of expansion Primary
      outcome measure will be the change in palatal morphology (palatal volume and surface area
      variations). Secondary outcomes will be: arch dimensions (upper inter-canine width, upper
      inter-molar width, anterior segment length, posterior segment length), complications,
      patients' satisfaction and periodontal health. Due to the nature of the intervention blinding
      will not be possible. Potential statistical differences between the two intervention groups
      will be evaluated.
    

Intervention name(s): Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA); Tooth-borne Hyrax-type maxillary expander
Intervention type(s): Device; Device
Intervention description(s): Subjects in this arm will be instructed to wear aligners 24h/day for entire duration of the therapy. They will be asked to remove their retainers only while eating, drinking (except water), or cleaning. At the time of appliance delivery, both written and verbal oral hygiene instructions were given, including methods for cleaning appliances themselves. Also, written informed consent were obtained for each patient or the parents.; The expansion protocol was one quarter-turn twice a day (0.45 mm activation per day) until overcorrection with the maxillary lingual cusps contacting the mandibular buccal cusps. The expander was left passively for retention for a minimum of 6 months. At the time of appliance delivery, both written and verbal oral hygiene instructions were given, including methods for cleaning appliances themselves. Also, written informed consent were obtained for each patient or the parents.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bilateral Elective Neck Dissection in Salvage Total Laryngectomy
Condition: Neck Cancer; Larynx; Larynx Cancer; Neck
MeSH terms: Laryngeal Neoplasms; Laryngeal Diseases
Study type: Observational

Summary: 
      The aim of this study is to evaluate the role of elective bilateral neck dissection in
      patients with clinically negative lymph nodes (cN0) who underwent salvage total laryngectomy,
      by estimating the prevalence of histologically positive occult lymph nodes (pN+). Secondary
      objective will be the assessment of complication rate and the evaluation of 5-year Overall
      Survival (OS) and 5-year Disease-Specific Survival (DSS) in these patients.
    


Intervention name(s): Elective bilateral neck dissection in cN0 patients
Intervention type(s): Procedure
Intervention description(s): Radical modified type 3 selective bilaterale elective neck dissection
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient affected by recurrent laryngeal cancer, after failure of primary radiotherapy or
        conservative surgery, with clinically negative neck (cN0) and treated with salvage total
        laryngectomy and concomitant elective selective bilateral neck dissection (levels II-IV +
        VI).
      
Keywords: neck dissection; SALVAGE TOTAL LARYNGECTOMY
St. John's Wort Extract LI 160 for the Treatment of Atypical Depression
Condition: Atypical Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of tis study is to assess the efficacy and safety of Jarsin® 300 mg as an acute
      treatment in mild to moderate depression with atypical features.
    

Detailed description: 
      The general picture of depression is still that of the traditionally called endogenous type,
      which is also the form that was characterized extensively in clinical trials. Atypical
      depression with reversed vegetative signs, such as hyperphagia or hypersomnia, is
      traditionalla neglected, demonstrated by the fact that in the most widely used depression
      scales, such as the Hamilton Depression Scale, melancholic symptoms have a specific weight,
      while, by contrast, reversed vegetative signs are not included. This etablishes a tendency to
      underestimate the severity of atypical depression.
    

Intervention name(s): St. John's Wort extract; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Coated tablets (batch no. 02080277) containing 300 mg of St. John's Wort extract LI 160 (drug-extract ratio 3-6:1; extraction solvent: 80% Methanol in water; batch no. 02019073) administered orally twice daily (morning and evening) with some liquid for 8 weeks; Coated placebo tablets (batch no. 01010177) that were identical in shape, size, taste and color were administered orally twice daily (morning and evening) with some liquid for 8 weeks.
Other intervention name(s): Jarsin; LI 160
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mild to moderate depression with atypical features according to DSM-IV
Non-invasive Assessment of Skeletal Muscle Loss in Cancer Patients
Condition: Cachexia
MeSH terms: Cachexia
Study type: Observational

Summary: 
      The long-term objective of this research is to develop a non-invasive approach for early
      assessment of which patients are at high risk for future development of skeletal muscle
      atrophy. The investigators hypothesize that the rate constant for the terminal portion of the
      isotope decay curve following ingestion of a single oral dose of deuterated-3-methylhistidine
      (D-3MH) provides an accurate measure of this increased risk and that this rate constant can
      be measured non-invasively from timed spot urine samples.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample of healthy males
Comparison of Different Drilling Speed to Classify Bone Quality by Tactile Sensation on a Saw Bone Model
Condition: Missing Teeth; Dental Implant
MeSH terms: Tooth Loss; Anodontia
Study type: Observational

Summary: 
      Comparison of different drilling speed to classify bone quality by tactile sensation on a saw
      bone model
    

Detailed description: 
      Bone quality is one of the major factors influencing the dental implant survival rate. Bone
      quality is believed to have effects on initial implant stability and success of
      osseointegration. Different implant designs and surgical protocols were developed for
      improving the survival rate in different bone quality. Although bone quality can be partly
      diagnosed by radiographic images, lots of experienced surgeons also evaluate bone quality
      with tactile sensation when they drill the bone. However, variations in evaluation of bone
      density maybe exist among different surgeons. The drilling speed also may have effect on the
      outcome of evaluation. For less experienced dentists, it is difficult to diagnose bone
      quality with tactile sensation in the beginning. The purpose of this study is to find proper
      drilling speed to classify bone quality by tactile sensation on a saw bone model. Saw bones
      of variant densities are used as training & testing materials. The proper drilling speed to
      distinguish different bone quality will be evaluated and offered to junior dentists for
      better implant treatment outcome.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        junior residents in NTUH
      
Keywords: dental implant; bone quality; tactile sensation; drilling speed
Safety, PK and Antiviral Activity of PGT121 Monoclonal Antibody in HIV-uninfected and HIV-infected Adults
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral
      efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy.
    

Detailed description: 
      This is a Phase 1 study to evaluate the safety, tolerability, pharmacokinetics and anti-viral
      efficacy of the PGT121 monoclonal antibody for HIV prevention and therapy. PGT121 mAb is a
      recombinant human IgG1 monoclonal antibody that targets a V3 glycan-dependent epitope region
      of the HIV envelope protein. PGT121 mAb was chosen for this study because it is potent,
      neutralizes a wide array of HIV viruses, and can prevent and treat simian-human
      immunodeficiency virus (SHIV) in rhesus monkeys.
    

Intervention name(s): PGT121 3mg/kg IV; PGT121 10mg/kg IV; PGT121 30mg/kg IV; PGT121 3mg/kg SC; Placebo (0.9% Sodium Chloride Injection USP (Saline))
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 3mg/kg administered by IV Infusion; 10mg/kg administered by IV infusion; 30mg/kg administered by IV infusion; 3mg/kg administered by SC injection
Placebo: None
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study to Evaluate LY3154207 on the Brain of Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to learn more about how LY3154207 affects the brain of healthy
      participants by using magnetic resonance imaging. The study will last up to about nine weeks
      for each participant and may include up to four visits to the study center.
    


Intervention name(s): LY3154207; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LY3154207 administered orally.; Placebo administered orally.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Clinical Study for the Treatment of Peripheral Nerve Defects With Neuromaix
Condition: Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy
Study type: Interventional

Summary: 
      The aim of this study is the development and initial clinical application of the nerve guide
      Neuromaix in humans to provide evidence for the safety and performance of the device.

      Neuromaix is intended to be used as a guiding structure to bridge a peripheral nerve
      discontinuity, and to create a conduit for axonal growth across the nerve gap.
    

Detailed description: 
      The Neuromaix nerve guide is an absorbable implant composed of porcine collagen, used to
      bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the
      nerve gap. Neuromaix provides a protective environment for peripheral nerve regeneration
      after injury. Neuromaix connects the proximal and distal ends of a transected nerve, allowing
      regenerating axons to grow through the scaffold, into the distal nerve tissue towards the
      target muscle or skin.

      Neuromaix is composed of two parts. The Epimaix part provides the structural characteristics
      needed to suture the nerve guide in place and to prevent ingrowth of scar tissue. The
      Perimaix part provides a structure that mimics endoneurial tubes, providing guidance for the
      regenerating axons while bridging the nerve gap.
    

Intervention name(s): Neuromaix
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nerve biopsy; nerve regeneration; neuroma pain; loss of sensation
Effects of Myofascial Induction Therapy on Pressure Pain and Ankle Range of Motion.
Condition: Fascia; Trigger Point Pain, Myofascial; Range of Motion; Pain
MeSH terms: Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      In this study, it will be assessed if there are changes in ankle dorsiflexion and pressure
      pain after performing the myofascial induction technique in the calf.
    


Intervention name(s): Calf myofascial technique
Intervention type(s): Procedure
Intervention description(s): A 3-pass superficial leg glide technique was applied first and then 5 minutes of the deep calf myofascial induction technique as described by Pilat.
Intervention model: Single Group Assignment
Intervention model description: A pre-post study
Masking: None (Open Label)
Primary purpose: Treatment