bioihbjkbjnl/mcl2 huggingface dataset:
Integrated Microfluidic System for Oral Diagnostics
Condition: Healthy; Periodontitis
MeSH terms: Periodontitis
Study type: Observational

Summary: 
      This study is being conducted to test the ability and accuracy of a new instrument in the
      diagnosis of periodontitis (gum disease) by using fluids from the mouth. The diagnosis
      instrument will test two types of fluids, gingival crevicular fluid (GCF) and saliva. GCF is
      the fluid that accumulates between your teeth and gum tissue. The fluids will be collected in
      three ways: 1. Direct GCF sampling 2. GCF rinse sampling and 3. Whole saliva. A total of 100
      adult patients will participate in this study. These subjects will be of two patient
      populations: 1) diseased population, with active gum disease; and 2) a low-risk disease
      population, with no active gum disease. Patients will be seen 6 times over the course of the
      study over a period of approximately 12 months. At each visit the patient will undergo oral
      fluid collection, as previously described, and thorough examinations of the mouth, including
      the taking of measurements for study purposes. Patients will also have radiographs taken at
      baseline, month 6, and end of study visits.
    

Detailed description: 
      The ultimate goal of this investigation is to validate the ability of the prototype platform
      (miniaturized microfluidic device that can rapidly (within 15 minutes) measure small volumes
      of oral fluids (on the order of nanoliters of fluid) and identify biomarkers of disease such
      as mediators of inflammation (interleukins -1 and -6; C-reactive protein (CRP), and a marker
      of bone resorption (ICTP). This analysis will aid in the diagnosis of active periodontal
      (gum) disease as well as diseases involved in systemic inflammation (e.g., cardiovascular
      disease) or systemic bone loss (osteoporosis). This project will have two specific goals: 1.
      To validate the ability of the diagnostic to measure the designated mediators from oral
      fluids; and 2. Determine the ability of the multiplexed format of mediator analysis to
      predict disease activity (future bone loss) in patients at high and low risk for disease.
      This proposed feasibility study will then aid in providing the impetus for sample size and
      other design requirements for larger, more expanded human clinical trial testing and
      subsequent technology transfer.
    

Intervention name(s): miniaturized microfluidic system
Intervention type(s): Device
Intervention description(s): Subjects will provide appropriate periodontal treatment as needed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 Adult subjects comprised of two populations: 1) disease susceptible (n=50) and 2)
        low-risk disease (n=50)
      
Biospecimen description: 
      Saliva, serum, dental plaque and gingival crevicular fluid
    
Keywords: periodontitis; microfluidics; saliva diagnostics
Investigation of the Effect of E.-Coli-Nissle as Supporting Therapy to Standard Care of Diabetes Mellitus Type II
Condition: Diabetes Mellitus Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to
      antidiabetic standard care in patients with diabetes mellitus type II
    


Intervention name(s): e.-coli-nissle
Intervention type(s): Drug
Intervention description(s): 1 ml qd for 24 weeks
Other intervention name(s): Mutaflor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes
Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation in Congenital Cataract
Condition: Congenital Cataract
MeSH terms: Cataract; Astigmatism
Study type: Interventional

Summary: 
      This study was conducted to evaluate changes of reduction of corneal astigmatism with toric
      intraocular lens(IOL) in congenital cataract.
    

Detailed description: 
      This retrospective study included 6 eyes from 4 patients (mean age 7.2 years) with congenital
      cataract who had an astigmatism of 2.5 to 4.0 D prior to cataract surgery. Review of
      preoperative and postoperative visual acuity (UCVA), refraction, toric axis was performed.
    

Intervention name(s): Acrysof Toric IOL
Intervention type(s): Device
Intervention description(s): Lens implantation following cataract surgery
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Deep Tissue Massage in the Myofascial Pain Syndrome
Condition: Massage Therapy; Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      This study aims to examine the effect of deep tissue massage (DTM) on myofascial trigger
      point (MTrP) number, neck range of motion (ROM), pain, disability and quality of life in
      patients with Myofacial pain syndrome (MPS).
    

Detailed description: 
      A total of 88 patients with MPS were screened for eligibility. Of these patients, 80 who met
      the inclusion criteria were randomly divided into two groups using randomization with
      computer-generated random numbers as the control group (n=40) and DTM group (n=40).

      The patients were evaluated at baseline (Day 0), and the end of treatment (Week 4).
    

Intervention name(s): Deep tissue massage; Conventional physiotherapy
Intervention type(s): Procedure; Procedure
Intervention description(s): The amount of pressure during the massage was adjusted by the physiotherapist with reference to muscle tissue palpation in the patients. During the massage, olecranon, pisiform bone protrusion, metacarpophalangeal and proximal interphalangeal joint faces forearm, wrist and fingers were used during the massage to reach deep tissue. As a massage technique, compression and stretching techniques are used in combination.; For 4 weeks 20 session, this group were applied hot pack with 20 minutes of conventional TENS to back and neck region, followed by 4 minutes of ultrasound at a frequency of 3 MHz and at a dosage of 1 w / cm2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Myofascial pain syndrome; Neck disability; Pain; Quality of life
Quetiapine Related Neurochemical Changes as Measured by Magnetic Resonance Spectroscopy in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      we aim to examine whether a representative atypical antipsychotic, quetiapine, has different
      effects from conventional antipsychotics on the magnetic resonance spectroscopy (MRS) markers
      in schizophrenia patients.
    

Detailed description: 
      The impact of medications on MRS changes in brain of schizophrenia patients have rarely been
      studied through a well-controlled study. Most of the MRS studies in schizophrenia patients
      are cross-sectional and uncontrolled and devoid of any comparison between effects of
      different drugs. To date, only limited research has explored this issue and the results are
      conflicting. These conflicting results may be related to small sample size, different patient
      population and design in these studies. Thus, further studies are warranted. Besides, with
      the advent of new generation atypical antipsychotics, it will be important to know whether
      atypical antipsychotics exert different effects on neurons from conventional antipsychotics.
      If neuronal activity can be improved by atypical antipsychotics, the findings will have great
      clinical implications.

      Fifteen patients in the experimental group will receive MRS examinations (including bilateral
      frontal and temporal area) in two phases: baseline (when they are on a conventional
      antipsychotic) and 4 weeks after shifting from that conventional antipsychotic to quetiapine.
      Another 15 schizophrenia patients receiving conventional antipsychotics will serve as the
      control group. The control group will receive the MRS examinations twice (baseline and 4
      weeks later) without change of medications. In each phase, every patient will also receive
      the Positive and Negative Syndrome Scale (PANSS) assessment. The changes of the MRS markers
      will be analyzed and compared, both within and between the 2 groups, and their correlations
      with the PANSS scores will be explored.
    

Intervention name(s): quetiapine; no intervention
Intervention type(s): Drug; Other
Intervention description(s): quetiapine (with equivalent dose to original antipsychotic agent) would replace the original antipsychotic agent for 28 days; keep the original conventional antipsychotic agent for 28 days
Other intervention name(s): seroquel; typical antipsychotics
Intervention MeSH terms: Quetiapine Fumarate; Antipsychotic Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; quetiapine; conventional antipsychotics; magnetic resonance spectroscopy
Quantitation of Bacteria Associated With Severe Periodontitis by Real -Time PCR Following Application of Diode Laser
Condition: Periodontal Pocket
MeSH terms: Periodontitis; Periodontal Pocket
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      1. Primary objective To measure the gingival crevicular levels of A.actinomycetemcomitans
           and P.gingivalis after intra-pocket application of diode laser in severe periodontitis
           (stage 3 grade C) patients.

        2. Secondary objective To compare the levels of the same microorganisms as in cases of
           diode laser therapy to those after conventional treatment with systemic antibiotic
           administration in severe periodontitis (stage 3 grade C) patients.

        3. to measure clinical parameters probing depth,attachment loss and mobility grade
    


Intervention name(s): medency diode laser; spirazole forte
Intervention type(s): Device; Drug
Intervention description(s): intra pocket application of diode laser; adminstration of spirazole forte with a dose 17 mg per kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Influence of CYP2C19 Polymorphism on PK/PD of Omeprazole
Condition: Stomach Ulcer
MeSH terms: Stomach Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical trial to investigate the influence of CYP2C19 polymorphism on
      pharmacokinetic/pharmacodynamic characteristics of omeprazole in healthy Korean volunteers
    


Intervention name(s): Omeprazole
Intervention type(s): Drug
Intervention MeSH terms: Omeprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
Condition: Primary Sclerosing Cholangitis (PSC)
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a phase 2, double-blind (DB), placebo-controlled trial in participants with primary
      sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in
      particular, serum alkaline phosphatase; and, safety. The long-term safety extension (LTSE)
      phase was conducted to evaluate the safety, tolerability, and efficacy of long-term,
      open-label use of OCA in participants with PSC who had completed the DB phase of the study.
    

Detailed description: 
      This was a phase 2, randomized, double-blind, placebo-controlled, dose-finding evaluation of
      the efficacy and safety of OCA in participants with PSC. Approximately 75 participants who
      provided written informed consent and met all of the inclusion and none of the exclusion
      criteria were randomized to 1 of 3 treatment groups as follows: 1.5 milligrams (mg) titrating
      to 3 mg OCA, 5 mg titrating to 10 mg OCA, or placebo, in a 1:1:1 ratio. Participants
      self-administered investigational product (IP) orally, once daily for 2 consecutive 12-week
      periods.

      For the first 12 weeks, the participant's dose was 1.5 mg OCA, 5 mg OCA, or placebo. After 12
      weeks, the participant's dose was titrated as follows, providing there were no limiting
      safety or tolerability concerns in the opinion of the Investigator, while maintaining the
      trial blind: the 1.5 mg OCA treatment group titrated to 3 mg, the 5 mg OCA treatment group
      titrated to 10 mg OCA, and the placebo group remained on placebo. Double-blind treatment
      continued for a further 12 weeks at that dose.

      Any participant whose dose was not titrated, due to safety or tolerability concerns, remained
      on their starting treatment (1.5 mg OCA, 5 mg OCA, or placebo) for the remainder of the DB
      phase to Week 24.

      Randomization was stratified by the presence or absence of concomitant ursodeoxycholic acid
      (UDCA) use and total bilirubin level (≤1.5x upper limit of normal [ULN] or >1.5x ULN but
      <2.5x ULN).

      Following completion of the DB phase, participants were asked to reconfirm their consent for
      participation in the open-label LTSE phase (planned as a further 24 months).
    

Intervention name(s): Obeticholic Acid (OCA); Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): 6alpha-ethylchenodeoxycholic acid (6-ECDCA); INT-747
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PSC
AMZ001 for the Treatment of Knee Osteoarthritis Symptoms
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 4-week
      trial of a formulation of AMZ001 once or twice daily versus placebo twice daily, including a
      single-blind treatment group with a commercial gel four times daily.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel group, 4-week
      trial of a formulation of AMZ001 once or twice daily versus placebo twice daily, including a
      single-blind treatment group with a commercial gel four times daily. Participants will be
      evaluated for osteoarthritis by X-ray images of the knees and one knee will be selected for
      treatment as the target knee. The study gel will be applied directly to that knee throughout
      the 4 weeks of the study.
    

Intervention name(s): AMZ001; Placebo; Comparator
Intervention type(s): Drug; Drug; Drug
Intervention description(s): diclofenac gel; Placebo; diclofenac gel
Other intervention name(s): active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: placebo-controlled, double-blind, randomized, parallel study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: AMZ001
Management of Obstructive Sleep Apnea (OSA) in Children and Maxillary and Mandibular Development
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Assessment of the association of maxillary expansion using a rapid palatal expansion, use of
      a mandibular advancement appliance (MGA™) and of a device allowing sleep in a semi-seated
      position (Yoobreath™) in patients with Obstructive Sleep Apnea (OAS). MGA™ and YooBreath™
      constitute the Yookid system™.
    

Detailed description: 
      Obstructive Sleep Apnea syndrome (OSA) shows a 10% morbidity rate in children with a higher
      rate between the ages of 3 and 5. Generally speaking, its prevalence is underestimated.
      Furthermore, detecting OSA remains difficult due to its particular physiopathology. The
      decrease in nasopharyngeal airway dimensions is the most common etiology. This decrease is
      related to soft tissues as well as maxillomandibular abnormalities. The aim of the study is
      to show that reducing sleep apnea in children remains possible when inducing rapid palatal
      expansion and mandibular advancement using the Yookid™ system. The Yookid™ system associates
      a mandibular advancement appliance and repositioning of the patient during sleep.
    

Intervention name(s): Rapid palatal expansion; MGA™ system; Yoobreath™ system
Intervention type(s): Device; Device; Device
Intervention description(s): Fixation of rapid palatal expansion from day 0 to day 60; Use of a mandibular advancement Appliance during the night from day 60 to day 180 (end of treatment from day 120 if Angle Class I is obtained); Use of a device allowing sleep in a semi-seated position during the night from day 15 to day 180 (end of treatment from day 120 if Angle Class I is obtained)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OSA; Polysomnography; Rapid palatal expansion; Mandibular advancement; Sleep position
Core Training to Improve Abdominal Strength Strength and Ankle Proprioception in Basketball Players
Condition: Proprioceptive Disorders
MeSH terms: Somatosensory Disorders
Study type: Interventional

Summary: 
      Introduction. The prevalence of ankle injuries in basketball are high. The lack of balance in
      the ankle is one of the main causes that produces these injuries. The goal of core training
      is to increase the physical capacities of resistance strength in the abdomen and analyze if
      it produces improvement in proprioception in the ankle joint in basketball players.

      Objective. To evaluate the effectiveness of Core training to improve the strength of the
      abdomen and analyze if it produces improvement in proprioception in ankle of basketball
      players.

      Study design. Randomized, multicentric, single-blind clinical study with a follow-up period.

      Methods. The 30 participants recruited will be randomly assigned to the two study groups:
      experimental (Core training for strength in the abdomen) and control (without intervention).
      The treatment will last 4 weeks, with 3 weekly sessions, approximately 20 minutes each. There
      will be three evaluations (pre-intervention, post-intervention and follow-up). On the
      dependent variables: strength core resistance (evaluated with Trunk Flexor Test, Trunk
      Extender Test, and Side Bridge Test) and proprioception (measured with the Star Excursion
      Balance tests and Romberg test) With the Kolmogorov Smirnov statistical test we will
      calculate the normality and with the t-student test of paired data and an ANOVA of repeated
      measures, we will obtain the difference between the three evaluations and the intra and
      intersubject effect, respectively.

      Expected results. To observe improvement in strength in the abdomen and analyze if it
      produces improvement in proprioception in the ankle of basketball players.
    


Intervention name(s): Core training
Intervention type(s): Other
Intervention description(s): In the first week different types of abdominal exercises will be performed: standard, with trunk rotation, extension of the back raising the upper extremity of the body and legs, extension of the back raising one arm and the contralateral leg. In the same way, the subject will raise from the quadruped position one arm and the contralateral leg on each side, and we will ask for the exercise of the front plate, positioning itself in a position of four support points: feet and elbows. When performing the rear bridge exercise the subject will raise the trunk resting on both feet, while in the lateral bridge exercise will be done with support on the right and left side. All exercises will be done for 30 seconds, in 3 series).
During the next three weeks we will continue with the same training, but for each week we will increase 10 seconds per exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Core; Strength; Proprioception; Ankle; Basketball
Association of Oral Helicobacter Pylori Infection With Gastric Helicobacter Pylori Infection
Condition: Helicobacter Pylori
MeSH terms: Infections
Study type: Observational

Summary: 
      The aim of this study was to investigate the association between oral Helicobacter pylori
      infection and gastric Helicobacter pylori infection. Patients who were tested for gastric
      Helicobacter pylori were tested for oral Helicobacter pylori at the same time, and were
      divided into four groups according to the test results to compare the positive rate of oral
      Helicobacter pylori.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients are from Xijing Hospital.
      
Biospecimen description: 
      Saliva
    
Keywords: Oral Helicobacter Pylori; Helicobacter Pylori Gastric
Effect of Curcumin as Nutraceutical in Patients of Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to find the effect of commonly used nutraceutical curcumin (
      extract of Curcuma longa, commonly called 'Haldi' in Hindi) in patients of depression.
    


Intervention name(s): Curcumin; Fluoxetine; Curcumin and Fluoxetine
Intervention type(s): Dietary Supplement; Drug; Dietary Supplement
Intervention description(s): Curcumin 500 mg 12 hourly after taking food in morning and evening for 6 weeks; Fluoxetine ; 20 mg Once a day in morning after taking food for 6 weeks; Curcumin 500 12 hourly after taking food in morning and evening and Fluoxetine 20 mg Once a day in morning after taking food for 6 weeks
Intervention MeSH terms: Curcumin; Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression