bioihbjkbjnl/mcl2 huggingface dataset:
MMP-9 Expression in Permanent Mature Teeth With Symptomatic Pulpitis
Condition: Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      Matrix metallopeptidase-9 (MMP-9) expression was compared in healthy and inflamed pulp and
      the outcome of coronal pulpotomy in teeth with symptomatic pulpitis was assessed. After
      procedure blood samples were examined using Elisa kit.
    

Detailed description: 
      Introduction: Widely used diagnostic tests do not provide information to distinguish the pulp
      inflammation stage while improvement of materials, techniques and vital pulp therapy have
      received a wider acceptance in symptomatic pulpitis treatment. The aim of this clinical study
      was to compare MMP-9 expression in healthy and inflamed pulp and to assess the short-term
      outcome of coronal pulpotomy in mature permanent teeth with symptomatic pulpitis.

      Methods: Patients diagnosed with symptomatic pulpitis were included in this clinical study.
      Coronal pulpotomy was performed using calcium-silicate based material and blood samples were
      taken. Initial and postoperative pain was recorded by Heft-Parker visual analog scale at 24
      hours and 72 hours after the procedure. In control group teeth with healthy pulp were used.
      During follow-up visits after three and six-months, patients were examined clinically and
      radiographically. The ELISA kit was used to determine the levels of MMP-9 in inflamed and
      healthy coronal pulp tissue.
    

Intervention name(s): Coronal pulpotomy
Intervention type(s): Procedure
Intervention description(s): Coronal pulpotomy was performed with a sterile high-speed round bur under water coolant. Pulp vitality was confirmed by the presence of bleeding pulp tissue from all of the canal orifices. Hemostasis was achieved through the application of a pellet moistened with 2.5% NaOCl for two minutes and was repeated as needed. Calcium-silicate based material was prepared ac-cording to the manufacturer's instructions and gently placed over the pulp to fill the entire cavity.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Calcium-silicate, coronal pulpotomy, MMP-9, symptomatic pulpitis.
Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery
Condition: Hypoplastic Left Heart; Tetralogy of Fallot; Tricuspid Atresia
MeSH terms: Tetralogy of Fallot; Hypoplastic Left Heart Syndrome; Tricuspid Atresia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to determine what dexmedetomidine does to the body and in turn,
      what how the body handles the medication. This medication, for the purpose of this trial, is
      used as a short-term sedative for infants who are immediately post-operative from cardiac
      surgery and have a breathing tube and are breathing with the assistance of a mechanical
      ventilator or breathing machine.
    

Detailed description: 
      This is a single center, dose escalation study of a single bolus dose of dexmedetomidine
      followed by a continuous infusion for up to 24 hours in infants who are immediately
      post-operative from cardiac surgery and require tracheal intubation with mechanical
      ventilation in the post-operative period. Three bolus doses and infusion doses will be
      administered to a total of 36 evaluable patients.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Dosage levels: Dose Level 1: Loading dose 0.35mcg/kg and CIVI 0.25mcg/kg/hr Dose Level 2: Loading Dose of 0.7mcg/kg and CIVI 0.5mcg/kg/hr and Dose Level 3: Loading Dose 1 mcg/kg and CIVI 0.75 mcg/kg/hr.
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postoperative from cardiac surgery; Dexmedetomidine
Dexamethasone and Post-tonsillectomy Pain in Children
Condition: Pediatric Post-tonsillectomy Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will use a prospective randomized, controlled design utilizing a single
      preoperative dose of oral dexamethasone or placebo to achieve these specific aims:

        -  Specific Aim 1: To evaluate the potential for a single preoperative dose of oral
           dexamethasone administered the night before surgery to reduce the incidence and severity
           of early post tonsillectomy pain (PTP) in children

        -  Specific Aim 2: To prospectively evaluate differences in early PTP experience between
           overweight/obese children and their lean peers.

        -  Specific Aim 3: To determine whether circulating inflammatory markers are strongly
           linked to PTP severity in children and whether they could be potential contributors to
           the higher pain experienced by overweight/obese children following Tonsillectomy and or
           Adenoidectomy.
    

Detailed description: 
      (See brief summary as well)

      The study will serve as a vehicle for a three-pronged approach (clinical observation,
      biological basis and therapeutic intervention) reflects the applicants professional interest
      in translational pediatric obesity research If the investigators find that BMI-dependent
      disparity exists in Post Tonsillectomy Pain (PTP) and that preoperative down regulation of
      inflammatory response with one preoperative dose of corticosteroids reduces PTP, our findings
      should ultimately lead to improved postoperative pain management of pediatric PTP especially
      in obese children.
    

Intervention name(s): Dexamethasone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral dexamethasone elixir (0.5mg/ml or 4 mg/ml) mixed with Ora-sweet or simple syrup to mask the taste. Or 1 mg or 4 mg dexamethasone capsules if age appropriate; Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule
Other intervention name(s): corticosteroid
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Different Regimens of Transarterial Chemoembolization for Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate efficacy, safety, and patient reported outcomes
      (PRO) of different regimens of transarterial chemoembolization (TACE) in patients with
      hepatocellular carcinoma (HCC).
    

Detailed description: 
      Transarterial chemoembolization (TACE) has been recommended as first line non-curative
      therapy for non-surgical patients with large/multifocal HCC who do not have vascular invasion
      or extrahepatic spread. There has not been any standardized protocol in the choice of
      chemotherapeutic agents, dosage, dilution, rate of injection, and time interval between
      treatments. Similarly, there is no agreement on the choice of embolizing agents, degree of
      embolization, and whether the chemotherapeutic agent should be given together, or before the
      embolizing agent.

      Comparison(s): In patients with HCC who underwent TACE therapy, stratified by whether they
      have vascular invasion and tumor size, we compare efficacy, safety, and patient reported
      outcomes (PRO) of different regimens of TACE.

      Regimen 1: lipiodol combined chemotherapy with embolization

      Regimen 2: lipiodol combined chemotherapy without embolization

      Regimen 3: lipiodol single agent chemotherapy with embolization
    

Intervention name(s): Transarterial chemoembolization (TACE); Transarterial chemoembolization (TACE); Transarterial chemoembolization (TACE)
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg, plus particle embolization.; drugs and dosage: chemotherapy with lipiodol mixed with EADM 50mg, lobaplatin 50mg, and MMC 6mg.; Drugs and dosage:chemotherapy with lipiodol mixed with EADM 50mg, plus particle embolization.
Intervention MeSH terms: Chlorotrianisene
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Antineoplastic Agents; administration & dosage; Carcinoma, Hepatocellular; Chemoembolization, Therapeutic; Humans; Liver Neoplasms; therapy
Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck (VIMS) - Industrial Workers
Condition: Non-specific Pain of the Neck and Shoulder
MeSH terms: Musculoskeletal Pain; Shoulder Pain
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of specific resistance training on
      neck/shoulder pain in industrial workers.
    


Intervention name(s): Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck
Intervention type(s): Other
Intervention description(s): Participants will be randomized at the cluster level to a control group or 20 weeks of specific resistance training for 3 x 20 min a week
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Sinonasal Gas Exchange Dynamics
Condition: Sinusitis
MeSH terms: Sinusitis
Study type: Observational

Summary: 
      Sinonasal gas exchange is facilitated by the unique anatomy and topography of the sinonasal
      interface that represents a collection of airfoils creating an aerodynamic structure. The
      airflow during respiration generates positive and negative pressures that power the gas
      exchange between the sinuses and the nose. Major surgical alteration of the interface reduces
      the rate and velocity of the exchange. Minimally invasive procedures aimed at preserving the
      natural anatomy, topography and aerodynamic configuration of the interface will have
      negligible effects on sinonasal gas exchange.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients who had balloon sinuplasty of traditional endoscopic uncinectomy for
        treatment of chronic maxillary sinusitis
      
Keywords: nitric oxide; sinuplasty
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics
      of CNTO 3649 following a single dose in healthy adults and following multiple doses in
      patients with Type 2 Diabetes Mellitus.
    

Detailed description: 
      This is a randomized (study medication assigned by chance), placebo controlled, double-blind
      (neither physician nor patient knows the name of the assigned study medication),
      ascending-dose study to assess the safety, tolerability, immune response, pharmacokinetics
      (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of
      CNTO 3649. The study population will consist of approximately 80 healthy participants (Part
      1) and approximately 36 type 2 diabetic patients (Part 2). All participants will be
      randomized to CNTO 3649 or placebo in the ratio of 3:1. Out of 80 healthy participants, 48
      participants will receive single doses of CNTO 3649 (6 dose levels) or placebo as an
      intravenous infusion (directly into a vein) and 32 participants will receive single doses of
      CNTO 3649 (4 dose levels) or placebo as a subcutaneous (under the skin) injection. All 36
      diabetic patients will receive multiple doses of CNTO 3649 (3 dose levels) or placebo as
      subcutaneous injections. There will be a screening period of 30 days and 45 days for healthy
      participants and diabetes patients, respectively. Healthy participants will be in the study
      for 9 weeks. Diabetic patients will be in the study for 12 weeks.
    

Intervention name(s): CNTO 3649 IV (Healthy participants); CNTO 3649 SC (Healthy participants); CNTO 3649 SC (Diabetic patients); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Healthy participants will each receive a single dose of CNTO 3649 (1, 3, 10, 30, 100 or 300 microgram per kilogram, subject to change) as a 2-hour IV infusion.; Healthy participants will each receive a single dose of CNTO 3649 (10, 30, 100 or 300 microgram per kilogram, subject to change) as a SC injection.; Diabetic patients will receive multiple doses of CNTO 3649 (30, 100 or 300 microgram per kilogram, subject to change) as subcutaneous injections once weekly for 4 consecutive weeks.; Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; CNTO 3649; safety; Phase I; healthy adults; Type 2 Diabetes Mellitus
The Effectiveness of Physical Therapy Modalities in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Carpal tunnel syndrome is considered to be the most common entrapment neuropathy.
      Conservative treatment is recommended in the mild and moderate stage of CTS. The aim of this
      trial is to evaluate the effectiveness of physical therapy modalities in carpal tunnel
      syndrome.
    

Detailed description: 
      Conservative treatment is recommended in the mild and moderate stage of CTS and should
      involve splinting, steroid injections, oral steroids and ultrasounds .

      However, the results of some research studies have showed the beneficial effect of
      photobiomodulation as well as nerve and tendon gliding exercises in non-operative treatment .

      Patients were divided into two groups. The one group received low-level laser therapy (LLLT);
      the other group underwent ultrasound treatment. Additionally, nerve and gliding exercises
      were administered in both groups.

      The purpose of this trial is to assess the therapeutic efficacy of ultrasound treatment and
      low-level laser therapy combined with nerve and tendon gliding exercises and to compare the
      two regimens.
    

Intervention name(s): Low-level laser therapy; Ultrasound treatment
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Cryo-Touch III Refinement Study Investigational Plan
Condition: Facial Wrinkles; Skin Aging
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a prospective, non-randomized study to evaluate the performance of the MyoScience
      Cryo-Touch III device for the treatment of glabellar and/or forehead wrinkles.
    


Intervention name(s): Cryo-Touch III
Intervention type(s): Device
Intervention description(s): Percutaneous treatment with the device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wrinkle rhytid aging
A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the potential PK interaction between ABT-335,
      atorvastatin 80 mg and ezetimibe 10 mg when administered concurrently.
    


Intervention name(s): ABT-335; Atorvastatin; Ezetimibe
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One ABT-335 135 mg capsule QD for 10 days; One 80 mg tablet of atorvastatin QD for 10 days; One ezetimibe 10 mg tablet QD for 10 days
Other intervention name(s): fenofibric acid; atovastatin
Intervention MeSH terms: Atorvastatin; Ezetimibe; Fenofibric acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Propafenone in the Treatment of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This is a open label randomized, multi-center study conducted in Taiwan. The study aims to
      evaluate the effectiveness and safety of oral Rhynorm (A drug) and Rytmonorm (B drug) for the
      conversion of paroxysmal AF and is designed to evaluate the improvement in sinus rhythm
      restoration after the treatment with Rhynorm (A drug) and Rytmonorm (B drug) for 24 weeks.
    

Detailed description: 
      This is a open label randomized, multi-center study conducted in Taiwan. The study aims to
      evaluate the effectiveness and safety of oral Rhynorm (A drug) and Rytmonorm (B drug) for the
      conversion of paroxysmal AF and is designed to evaluate the improvement in sinus rhythm
      restoration after the treatment with Rhynorm (A drug) and Rytmonorm (B drug) for 24 weeks.

      This study comprised of three phases: a screening phase, a washout run-in qualifying phase
      lasting about 7 days, and a treatment phase of 24 weeks. A total of 60 evaluable subjects is
      planned to be enrolled. With an estimation of 20% dropout rate, 72 patients will be enrolled
      to reach 60 evaluable patients at the end of study. After screening for eligibility, the
      eligible subjects will be randomly assigned to either of the two gruop. The two-group are
      shown in the following table.

      Group Treatment Drug Group A Rhynorm (A drug) Group B Rytmonorm (B drug) Patients with
      arrhythmia will be screened for eligibility after providing informed consent. Patients
      present with the symptoms of arrhythmia after withdrawn from other prohibited anti-AF agents
      for at least 7 days and completed run-in period event recorded will be qualified for entering
      this study and will be randomized to Rhynorm (A drug) treatment group or Rytmonorm (B drug)
      reference drud group in a 1:1 ratio.

      The clinical evaluation will be recorded during the study period. Before treating with
      Rhynorm (A drug) and Rytmonorm (B drug), the physical examination and condition will be
      tracked and recorded for at least 7 days as the historical data.

      During the treatment period, the subjects still had a routine OPD visit. Record symptom event
      and event recorder monitoring on OPD visit.

      Safety assessments on all randomized subjects include adverse events, vital signs, and
      laboratory tests (hematology and biochemistry). Any adverse events, symptom events and
      concomitant medications/therapies will be recorded on the CRFs throughout the study.
    

Intervention name(s): Propafenone
Intervention type(s): Drug
Intervention description(s): oral, TID
Other intervention name(s): A drug: Rhynorm; B drug: Rytmonorm
Intervention MeSH terms: Propafenone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A: Rhynorm (A drug) Group B: Rytmonorm (B drug)
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Long-term Transcranial Direct Current Stimulation (tDCS) on Appetite Control Related Brain Regions
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the long-term effect of Transcranial Direct
      Current Stimulation (tDCS) on appetite control related brain regions.
    

Detailed description: 
      Transcranial direct current stimulation (tDCS) is emerging tool for brain modulation in a
      variety of clinical conditions. In addition, recent neuroimaging studies suggest that
      modifying the activity of brain circuits involved in eating behavior could provide
      therapeutic benefits in obesity.

      The investigators aim to assess whether long-term modulation of the dorsolateral prefrontal
      cortex (DLFPC) using tDCS, modifies behavioral response and brain activity while watching
      visually presented food cues and taste cues in obese subjects.

      Subjects will be randomly divided into sham and real tDCS arms. Subjects will receive sham or
      real tDCS ten times. Subjects will be investigated before and after sham or real tDCS
      interventions. Subjects will perform functional MRI experiments with visual and taste food
      cues. Questionnaire with behavior measures, body compositions, blood tests will be performed.
    

Intervention name(s): real tDCS; sham tDCS
Intervention type(s): Device; Device
Intervention description(s): For active tDCS, a 2 mA current will be delivered for 20 minutes with 20 second up and down ramp times. The anodal electrode will be placed on the right DLPFC (F4; 10-20 EEG system), and the cathode electrode will be placed on the left DLPFC (F4;10-20 EEG system), which is known to be related to cognitive function. The electrodes used for tDCS are saline-soaked sponges (25 cm2).; Sham tDCS will be delivered for 20 minutes. The anodal electrode will be placed on the right DLPFC (F4; 10-20 EEG system), and the cathode electrode will be placed on the left DLPFC (F4;10-20 EEG system), which is known to be related to cognitive function. The electrodes used for tDCS are saline-soaked sponges (25 cm2).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Chronobiology, Sleep Related Risk Factors and Light Therapy in Perinatal Depression: the Life-ON Project
Condition: Depression; Depression, Postpartum; Depressive Disorder; Depressive Disorder, Major; Mood Disorders; Pregnancy Complications; Puerperal Disorders
MeSH terms: Pregnancy Complications; Depression, Postpartum; Puerperal Disorders; Depression; Depressive Disorder; Mood Disorders; Depressive Disorder, Major
Study type: Interventional

Summary: 
      In a 3 years longitudinal, observational, multicentre study, about 500 women will be
      recruited and followed-up from early pregnancy (10-15 gestational week) until 12 months after
      delivery. The primary aim of the present study is to systematically explore and characterize
      risk factors for perinatal depression (PND) by prospective sleep assessment (using wrist
      actigraphy, polysomnography and various sleep questionnaires) and blood based analysis of
      potential markers during the perinatal period (Life-ON study). Secondary aims are to explore
      the relationship between specific genetic polymorphisms and PND (substudy Life-ON1), to
      investigate the effectiveness of BLT in treating PND (substudy Life-ON2) and to test whether
      a short term trial of BLT during pregnancy can prevent PND (substudy Life-ON3).

      The characterization of specific predictive and risk factors for PND may substantially
      contribute to improve preventive medical and social strategies for the affected women. The
      study results are expected to promote a better understanding of the relationship between
      sleep disorders and the development of PND and to confirm, in a large sample of women, the
      safety and efficacy of BLT both in prevention and treatment of PND.
    


Intervention name(s): Philips EnergyUp EnergyLight HF3419/01; Philips EnergyUp EnergyLight HF3419/01
Intervention type(s): Device; Device
Intervention description(s): Bright light therapy (10'000 lux) for 60 minutes after wake-up; Placebo dim light (500 lux) for 60 minutes after wake-up
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment