bioihbjkbjnl/mcl2 huggingface dataset:
Comparison Between aPDT and Systemic Doxycycline on Non-surgical Periodontal Therapy in Type 2 Diabetics
Condition: Periodontal Disease; Type 2 Diabetes
MeSH terms: Periodontal Diseases; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate Photodynamic Therapy (PDT) as adjunct on non
      surgical periodontal therapy in patients with type 2 diabetes. A total of 40 individuals will
      be selected and divided in two groups. On the treatment stage, the control group (Group C)
      will receive standard non surgical periodontal treatment. The Test Group (Group T) will be
      treated with PDT as an adjunct to non surgical periodontal treatment. The treatment will be
      repeated 4 times in two weeks, followed by dental prophylaxis every 15 days until accomplish
      3 months. The follow-up will be done for 6 months. The clinical parameters measured will be:
      plaque index, pocket depth, bleeding on probing, relative clinical insertion level and
      suppuration. In addition, the evaluation of crevicular fluid volume and the levels of IL-1,
      TNF-α, subgingival microbiota by the hybridization DNA-DNA Checkerboard technique. The
      investigators expect to find identical or better results for the test group.
    


Intervention name(s): Systemic Doxycycline and Sham aPDT; aPDT + Doxycycline Placebo
Intervention type(s): Drug; Drug
Intervention description(s): It will be prescribed a protocol of 100mg/day of Systemic Doxycycline for 14 days; The aPDT protocol will consist in 5 applications on the experimental time 0, 1, 5, 7 and 14 days.
Other intervention name(s): aPDT Sham
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Periodontal Diseases; Type 2 Diabetes Mellitus; hemoglobin A1c protein
Kinesthetic Ability Trainer for Peripheral Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      Objective: To determine the effectiveness of balance training with Kinesthetic Ability
      Trainer 2000 (KAT 2000) in patients with peripheral neuropathic pain related balance
      disorder.

      Methods: A total of 60 patients who developed peripheral neuropathic pain-related balance
      impairment in the chronic phase due to lumber disc herniation, lumber spondylosis and
      gonarthrosis were included into this randomized controlled prospective study and randomized
      into either balance exercises groups or KAT 2000 exercises groups. Balance exercises were
      given all patients in Group 1 (n=30). In addition to balance exercises, KAT 2000 balance
      exercises were given all patients in group 2 (n=30). All patients received 45-min
      individualized training session for three times a week for 4 weeks. Patients were evaluated
      according to pain, static and dynamic balance and quality of life (QoL).
    

Detailed description: 
      Neuropathic pain was determined by the Douleur Neuropathique 4 (DN4) questionnaire. Pain
      severity was assessed by using a visual analogue scale (VAS). KAT 2000 was used to evaluate
      static and dynamic balance. Dynamic balance and mobility also was assessed using the Berg
      Balance Scale (BBS) and Time Up and Go (TUG) test. QoL was assessed by using Nottingham
      Health Profile (NHP). Patients were evaluated at baseline and the end of the 4-week exercise
      program.
    

Intervention name(s): Kinesthetic Ability Trainer
Intervention type(s): Other
Intervention description(s): Kinesthetic Ability Trainer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neuropathic Pain; Balance; Kinesthetic Ability Trainer; Quality of Life
P3 Study Comparing Once Daily SB204 and Vehicle Gel in Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel
      group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
    

Detailed description: 
      This is a double-blind, placebo controlled study in subjects with moderate to severe acne.
      Subjects who satisfy the entry criteria will be randomized to SB204 4% QD or Vehicle Gel QD
      in a 1:1 ratio. Efficacy assessments will include Investigator Global Assessments (IGA) and
      inflammatory and non-inflammatory lesion counts. Subjects will return for post-Baseline
      evaluation at Weeks 2, 4, 8, and 12/Early Termination (ET).
    

Intervention name(s): SB204 4%; Vehicle Gel
Intervention type(s): Drug; Drug
Intervention description(s): Applied topically once daily; Applied topically one daily
Other intervention name(s): NVN1000; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
SYNERGY China: Assess SYNERGY Stent in China
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites
      across China, the primary endpoint is Technical success.
    

Detailed description: 
      The study is To evaluate clinical and peri-procedural angiographic outcomes for the SYNERGYTM
      MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of
      subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native
      coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).
    

Intervention name(s): SYNERGYTM Coronary Stent System
Intervention type(s): Device
Intervention description(s): SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.
Condition: Glaucoma, Open-angle
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Observational

Summary: 
      This study is designed to evaluate the safety and tolerability of Xalacom in patients with
      primary glaucoma
    

Detailed description: 
      according to physicians decision, patients who met inclusion and exclusion criteria and sign
      the ICD
    

Intervention name(s): Xalacom
Intervention type(s): Drug
Intervention description(s): Xalacom 1 drop into the affected eye daily
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients >18 years with primary open angle glaucoma or ocular hypertension
      
Keywords: glaucoma, open-angle, non-interventional study, safety, tolerability
Risk Factors for Development of Rapid Cycling in Bipolar Disorder Patients
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      In this study we tried to elucidate the factors associated with the development of a rapid
      cycling course in bipolar disorder patients, in a prospective and longitudinal design, and
      the role of antidepressants. The identification of risk factors is extremely relevant from
      the clinical point of view. We hypothesized that rapid cycling bipolar disorder is associated
      with more chronicity, poor outcome, and more antidepressant prescription.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Bipolar I and II disorder patients
      
Keywords: Rapid cycling
Chest Wall Deformities in Children - Epidemiological Data
Condition: Chest Wall Deformity; Funnel Chest
MeSH terms: Funnel Chest; Congenital Abnormalities
Study type: Observational

Summary: 
      Pectus excavatum (PE) or funnel breast is the most common congenital deformity of the chest
      wall, which occurs in about 1 in 400 births with a boy to girl ratio of 4: 1 to 3: 1. The
      etiology of PE is largely undefined, but there are numerous indications that genetic factors
      play a role in the development of PE. Up to 40% of patients report affected family members
      with similar congenital deformities. In many families, PE follows a pattern that would be
      compatible with an autosomal dominant or recessive pattern of inheritance. The data on the
      frequent occurrence of PE in family members fluctuate greatly and only a few genes associated
      with a PE have been identified so far.
    

Detailed description: 
      Previous studies suggest that sulfation of proteoglycans plays a crucial role in the normal
      development of cartilage and bone and could therefore be crucial in the genesis of the
      disease. The main catalytic machinery responsible for the biosynthesis and breakage of
      sulfate esters in the proteoglycans consists of various enzymes and transporters. Mutations
      in Sphingosine Kinase 1 (SK1) and Sphingosine Kinase 2 (SK2) genes that encode the
      transmembrane transporters of sulfate or enzymes that are involved in 3'-phosphoadenosine
      5'-phosphosulfate (PAPS) synthesis have been identified as the cause of several inherited
      diseases that all have skeletal system deformities.

      Connections between chest wall deformities with syndromes (e.g. Marfan, Noonan), anomalies
      (e.g. Poland, Moebius) or associations (e.g. Cantrell Pentalogy, PHACE) are well known. In
      contrast, there have so far been hardly any genetic studies of the isolated congenital chest
      wall deformities. Epidemiological data are insufficient and only a few groups deal with the
      inheritance and the incidence of this disease when it occurs in isolation.
    

Intervention name(s): Chest Wall Deformities Questionaire
Intervention type(s): Other
Intervention description(s): Questionaire about epidemiological data was sent to Patients and families
Observational model: Family-Based
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who presented themselves in the study hospitals with the diagnosis of a chest
        wall deformity (funnel breast, keel breast, sternum cleft)
A Study of LY2495655 in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of single and multiple
      doses of LY2495655 administered subcutaneously and intravenously in Japanese subjects.
    


Intervention name(s): LY2495655; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): administered intravenously or subcutaneously; administered intravenously or subcutaneously
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Symptom Evaluation After Cessation of a Proton Pump Inhibitor in Healthy Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether proton pump inhibitor (PPI) induced
      hypersecretion leads to acid related symptoms after treatment in healthy volunteers.
    

Detailed description: 
      Treatment with proton pump inhibitors (PPI) has been shown to cause rebound hypersecretion of
      gastric acid. The clinical significance of this phenomenon is however unclear. This study
      aims to examine whether or not healthy volunteers, who over a relatively short period of time
      treated with a PPI, develop dyspeptic symptoms after cessation of therapy. Dyspeptic symptoms
      will be measured subjectively using a validated questionnaire, which is filled out each day.
      Gastric acid will be measured indirectly with measurement of acid secretion markers (Gastrin
      and chromogranin-A).
    

Intervention name(s): Pantoprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg pantoprazole once daily for 28 days; identical placebo once daily for 28 days
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Basic Science
Keywords: volunteers
A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy
Condition: Gynecologic Surgery
Study type: Interventional

Summary: 
      Factors affecting to length of hospital stay after fast-track recovery program in
      laparoscopic hysterectomy compared to conventional recovery program
    

Detailed description: 
      Factors affecting to length of hospital stay after laparoscopic hysterectomy in fast-track
      recovery program group compared to conventional recovery group.

      The pimary outcome is time to discharge from the end of operation to discharge.

      The second outcomes are amount of opioid used and NSAID, postoperative paine, nousea and
      vomiting, patients satisfaction, anxiety and stress-coping test, operative bleeding,
      operative time, postoperative complications, the cost of the laparoscopic hysterectomy.
    

Intervention name(s): fast-track recovery program
Intervention type(s): Procedure
Intervention description(s): Pre-operative: fast-track management counseling, fast-track educational video,tobacco cessation, daily physical activity, light meal 6 hours and clear liquids up to 2 hours before surgery, no bowel preparation, a warm blanket, medication.
Intra-operative: vaginal wound infiltrative anesthesia, early remove of urine catheter.
Post-operative: early oral intake liquids and food, early mobilization, avoiding opioids by use of pregabaline for postoperative pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized superiority trial
Masking: None (Open Label)
Primary purpose: Treatment
Repeatability in Hyperpolarized 3-Helium With MRI
Condition: Radiation Exposure
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to assess and test the reproducibility and results of
      hyperpolarized 3-Helium gas as a contrast agent with Magnetic Resonance Imaging (MRI) of the
      lungs in healthy adult subjects.
    

Detailed description: 
      New CT imaging techniques often expose the patient to higher doses of radiation. There is a
      great deal of concern about effects of medical radiation exposure on the general public and
      regulations are becoming stricter on the radiation doses that are allowed.

      One novel procedure that has been developed to evaluate the function and structure of the
      lung is the use of hyperpolarized gases with MRI scanners. We want to compare the lung
      imaging techniques that we have developed in our lab to a technique that uses hyperpolarized
      3-Helium gas with MRI. This technique is free from radiation and less invasive than many lung
      imaging techniques.

      Hyperpolarized gas MRI is based on the introduction of spins into the lungs, allowing imaging
      to take place. The use of hyperpolarized 3-Helium has a few advantages:

        1. it allows us to see the microstructure of the lungs through diffusion imaging (apparent
           diffusion coefficient) which correlates with the size of airways and alveolar space.

        2. it allows us to see ventilation, or how air moves in the lungs, at a high resolution.

        3. it is capable of ultra fast imaging which will help us assess gas flow patterns within
           the airways.

      and 4) the speed of depolarization lets us measure the partial pressure of oxygen and
      associated gas exchange mechanisms.
    

Intervention name(s): Prone hyperpolarized 3 helium gas scan; Supine hyperpolarized 3 helium gas scan; Vitals; Pulmonary Function Tests; Initial protocol MRI scan
Intervention type(s): Drug; Drug; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.; Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.; Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes; Initial scan to determine placement
Other intervention name(s): Prone MRI scan with contrast; Supine MRI scan with contrast
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Single-Center 2-Arm Study for Lentigines on the Hands
Condition: Lentigines
MeSH terms: Lentigo
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of two laser systems
      for improvement of lentigines on the hands.
    

Detailed description: 
      The purpose of this study is to evaluate the effectiveness and safety in a clinic setting of
      two laser systems for the treatment of lentigines (liver spots, age spots, or dark sun spots)
      on the hands.
    

Intervention name(s): Enlighten Laser; Excel V Laser
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes
Condition: Type2 Diabetes; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      The aim of the study is to examine the health benefits of adding a concept in basic
      carbohydrate counting (BCC) to the routine outpatient nutritional education for adult
      patients with type 2 diabetes.

      The study hypothesis is that training and education in the BCC concept will improve glycaemic
      control either by reducing HbA1c or the average plasma glucose variability more than offering
      the routine dietary care as a stand-alone dietary treatment.
    

Detailed description: 
      The trial has a parallel-group design with a study duration of 48 weeks for each participant
      (a 6-month intervention period and a 6-month follow-up period). A total of 226 patients will
      be enrolled in the trial. Participants will be randomized to one of two arms: 1) Standard
      medical and dietary care (control group) or 2) Structured training and education in the BCC
      concept in addition to standard medical and dietary care.

      The primary objective is to evaluate the six months effect of structured training and
      education in the BCC concept compared to standard dietary care on glycaemic control as
      assessed by HbA1c or MAGE (mean amplitude of glycaemic excursions).
    

Intervention name(s): Standard nutritional education; Basic carbohydrate counting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Routine dietary care consists of three individual consultations with a trained dietitian. The individual guidance will be in accordance with the dietary guidelines in type 2 diabetes.; The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians.
Other intervention name(s): Routine dietary care in type 2 diabetes; Education in BCC in addition to standard dietary care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: carbohydrates; basic carbohydrate counting; diet; type 2 diabetes
Environmental Treatment for Seasonal Affective Disorder (SAD)
Condition: Seasonal Affective Disorder
MeSH terms: Mood Disorders; Seasonal Affective Disorder
Study type: Interventional

Summary: 
      The purpose is to study treatments of Seasonal Affective Disorder (SAD).
    

Detailed description: 
      This is a multicenter, randomized controlled trial of negative ion generation versus
      light-emitting diode phototherapy for seasonal affective disorder. Participants appropriate
      for the study are subjects with a DSM IV diagnosis of Major Depression, with seasonal
      pattern, winter type. Subjects were seen at Yale University,New Haven,CT University of
      British Columbia,Vancouver,BC Groningen University Hospital,Groningen, The Netherlands, Royal
      Ottawa Hospital, Ottawa,Ontario, McGill University, Montreal,Quebec, University
      Hospital,Saskatoon, Saskatchewan. The trial is 4 weeks in duration.

      This trial has now been completed.
    

Intervention name(s): Litebook treatment devices; Inactivated negative ion generator
Intervention type(s): Device; Device
Intervention description(s): Litebook LED phototherapy device used for 30 min before 8 am; Equivalent exposure to inactivated negative ion generator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depression; Seasonal Affective Disorder (SAD)
The Influence of Tantum Verde® on Recovery Following Tonsillectomy
Condition: Tonsillectomy; Adenoidectomy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of Tantum Verde® for improving recovery
      following tonsillectomy Study design: A prospective double-blined randomized trial. Sample
      size: Thirty patients undergoing tonsillectomy who will be treated with Tantum Verde® Mouth
      wash solution, and a control group of 30 patients that will undergo tonsillectomy and will be
      treated with a placebo.

      The study will be conducted in the Departments Otolaryngology - Head and Neck Surgery in the
      Western Galilee Medical Center, Nahariya, Israel. Patients who are scheduled for
      tonsillectomy with or without adenoidectomy will be recruited for the study. They will sign
      the inform consent in one of two places: in the departments before the surgery or in the
      clinic in the visit before the surgery. The patients will be evaluated for their ability to
      gargle and spit water before the surgery, after which they will be assigned to either the
      treatment group who will get a solution of Tantum Verde or the control group who will receive
      saline with mint flavor, both in identicle bottles. Randomization will be done using a random
      number generator program.

      The patients will be asked to gargle and spit the solution they received three times a day
      for 30 seconds, for the following week after surgery.
    


Intervention name(s): Tantum Verde® mouthwash; Placebo mouthwash
Intervention type(s): Drug; Other
Intervention description(s): Mouthwash with placebo solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Patients undergoing tonsillectomy with or without adenoidectomy