bioihbjkbjnl/mcl2 huggingface dataset:
Altered MAstication Contribute to TMJ PAin
Condition: Temporomandibular Joint Disorders; Mastication Disorder
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Observational

Summary: 
      The cause of temporomandibular joint disorders remains unknown. It is considered
      multifactorial and includes physical (peripheral) and psychosocial (central) factors. It has
      been showed an association: a steeper condylar path, flatter lateral anterior guidance, and
      habitual chewing on the symptomatic side. This finding argues the possibility of causation of
      some of these characteristics. This double blind longitudinal study aims to assess if the
      presence of one habitual chewing side could contribute to temporomandibular joint disorders
      over time.

      Method. Young adults with no signs or symptoms of TMD will be assessed. Participants with one
      chewing side (observed and interview); with steeper condylar path and lower lateral guidance
      angles will be considered consistent one side chewers, and this side will be considered more
      susceptible to suffer TMD. Mouth opening, hemispheric dominance and hemimandibular
      retrognathia will be considered as secondary pre-specified outcomes. Four years later, both
      TMJs of each participant presenting signs and/or symptoms will be evaluated according to
      DC/TMD.
    


Intervention name(s): Diagnostic
Intervention type(s): Other
Intervention description(s): OBSERVATIONAL, DIAGNOSTIC PROCEDURES. Young adults with no signs or symptoms of TMD will be assessed. The chewing function, condylar path angles and lateral guidance angles will be recorded. Maximum comfortable and unassisted jaw opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. Three-Four years later, both TMJs of each participant presenting signs and/or symptoms will be evaluated according to DC/TMD. Same recordings as baseline will be carried out.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Medical or Dental School students. Healthy young adults with fully dentate normal occlusion
      
Keywords: occlusion; pain
Feasibility of Virtual Reality Delivery of Pain Neuroscience Education
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      Randomized Clinical Trail (RCT) for patients already planned to attend physical therapy for
      chronic low back pain. Patients will be randomized to receive Physical Therapy (PT) as usual
      or PT plus pain education delivered via virtual-reality headset.
    

Detailed description: 
      There is an increasing emphasis in physical therapy and healthcare in general on enhancing
      patients' ability to self-manage spinal pain as a strategy to reduce disability for impacted
      individuals and escalating healthcare costs. This change in emphasis requires a paradigm
      shift on the part of practitioners and patients alike in how they conceptualize and respond
      to pain. PNE is a promising education strategy that has been shown to influence
      patient-reported outcomes in those with chronic pain and has been shown to influence the
      provider's beliefs about pain. However, the delivery of this education has proven difficult
      for providers in terms of comfortability and time-efficiency. A standardized delivery a PNE
      by experts in the field could prove efficient and effective.

      STUDY DESIGN The investigators' overall goal is to determine the feasibility of VR-delivered
      pain neuroscience education (PNE). Secondarily, the investigators would like to see if these
      interventions are best targeted to specific individuals. To accomplish these goals, the
      investigators will conduct a randomized clinical trial, randomly assigning participants to
      receive virtual reality (VR) education in addition to usual care or usual care with no
      additional education.
    

Intervention name(s): VR Pain Education; Usual Care Physical Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): pain education delivered via VR headset, up to 12 sessions; Normal course of PT without influence by study team on frequency or duration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Development of Agents to Diminish the Risk of Hypoglycemia-induced Brain Injury in Type 1 Diabetes
Condition: Hyperglycaemia (Diabetic)
MeSH terms: Brain Injuries; Hypoglycemia; Hyperglycemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To determine the effect of re-activation of brain glucose metabolism induced by
      dichloroacetate (DCA) on cognitive function and counterregulatory hormone responses in
      patients with type 1 diabetes (T1DM) with recurrent hypoglycemia.
    

Detailed description: 
      This will be a single center, placebo-controlled, cross-over, randomized clinical pilot
      study. The screening will take place at the Yale New Haven Hospital Research Unit (HRU) 10th
      floor, East Pavilion at 20 York St., New Haven, CT. At the screening visit informed consent
      will be obtained. Medical history and documents will be reviewed to screen potential subjects
      by inclusion and exclusion criteria. Subjects will receive a physical examination and
      laboratory blood work (BUN/creatinine, electrolytes, lipid profile, liver function, and
      HbA1c) as well as urine toxicology screens (to confirm self-report of alcohol, and drug
      information) to ensure good physical health.
    

Intervention name(s): Dichloroacetate; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Dichloroacetate is an isoform-unspecific inhibitor of four regulatory pyruvate dehydrogenase kinases, which are able to reduce entry of substrates into mitochondria by reducing the conversion of pyruvate to acetyl-CoA. Drug will be administered to subjects with sever hypoglycemia as well as healthy non-diabetic subjects.; A Placebo oral capsule identical in shape and color to those with active ingredient.
Other intervention name(s): DCA; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This will be a single center, placebo-controlled, cross-over, randomized clinical pilot study.
At the screening visit informed consent will be obtained. Medical history and documents will be reviewed to screen potential subjects by inclusion and exclusion criteria. Subjects will receive a physical examination and laboratory blood work (BUN/creatinine, electrolytes, lipid profile, liver function, and HbA1c) as well as urine toxicology screens (to confirm self-report of alcohol, and drug information) to ensure good physical health.
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Efficacy of Two Doses of Anifrolumab Compared to Placebo in Adult Subjects With Active Proliferative Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of an intravenous treatment
      regimen of two doses of anifrolumab versus placebo in adult subjects with active
      proliferative lupus nephritis (LN).
    

Detailed description: 
      This is a Phase 2, multicentre, multinational, randomised, double-blind, placebo-controlled
      study to evaluate the efficacy and safety of two intravenous (IV) treatment regimens of
      anifrolumab versus placebo while taking standard of care (SOC) treatment with mycophenolate
      mofetil (MMF) and corticosteroids in adult subjects with active proliferative lupus nephritis
      (LN).
    

Intervention name(s): Anifrolumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112; Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lupus, nephritis, randomized, placebo, anifrolumab, safety, efficacy, adult
Effects of Periodontal Therapy in Patients With Metabolic Syndrome
Condition: Periodontitis; Metabolic Syndrome
MeSH terms: Periodontitis; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      A 6-month, parallel-arm, investigator-masked, randomized clinical trial was conducted in
      patients with MetS and severe periodontitis. Participants were randomly assigned to an
      Intensive Periodontal Treatment group (IPT; scaling and root planing and azithromycin
      capsules 500mg/24h/3days) or to a Minimal Periodontal Treatment group (MPT; professional
      plaque removal and placebo capsules). Blood and subgingival microbiological samples were
      collected at baseline, 3 and 6 months after therapy. The primary outcome was between-group
      difference in C-reactive protein (CRP). Secondary outcomes included HbA1c, lipids, α-1
      antitrypsin, fibrinogen levels and subgingival microbiota assessment.
    


Intervention name(s): Scaling and root planning; Supragingival Prophylaxis
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients received non-surgical periodontal therapy in the form of full-mouth scaling and root planing (SRP), in two sessions, 1 week apart, with the use of an ultrasonic scaler (Minipiezon Electromedical Systems EMS, Nyon, Switzerland) and hand instruments, under local anaesthesia.; Supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Prader-Willi Syndrome; Nutrition Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted globally. The aim of this trial is to investigate the effect of
      liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.
    


Intervention name(s): liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Injected s.c./ subcutaneously (under the skin) This trial consists of a part A and a part B. Part A of the trial is conducted in obese adolescents with PWS. Part B of the trial is conducted in obese children with PWS. Entry into part A and part B of the trial will be sequential.; Injected s.c./ subcutaneously (under the skin) This trial consists of a part A and a part B. Part A of the trial is conducted in obese adolescents with PWS. Part B of the trial is conducted in obese children with PWS. Entry into part A and part B of the trial will be sequential.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase III, double-blind, placebo and active-comparator controlled, multicenter study
      will investigate the efficacy and safety of etrolizumab in induction of remission in
      participants with moderately to severely active ulcerative colitis (UC) who are naIve to
      tumor necrosis factor (TNF) inhibitors and refractory to or intolerant of prior
      immunosuppressant and/or corticosteroid treatment. In addition to this study, a second Phase
      III trial with identical study design (GA28948; NCT02163759) was independently conducted.
    


Intervention name(s): Adalimumab; Adalimumab Placebo; Etrolizumab; Etrolizumab Placebo
Intervention type(s): Drug; Other; Drug; Other
Intervention description(s): Adalimumab 160 milligrams (mg) will be administered subcutaneously (SC) at Week 0; 80 mg SC at Week 2; 40 mg SC at Weeks 4, 6 and 8.; Placebo matching to adalimumab will be administered SC at Weeks 0, 2, 4, 6, and 8.; Etrolizumab 105 mg will be administered SC every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).; Placebo matching to etrolizumab will be administered SC once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
Other intervention name(s): Humira; PRO145223; RO5490261; RG7413
Intervention MeSH terms: Adalimumab; Etrolizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Hypoallergenic Infant Formula Containing Starch and the Probiotic: Effect on Gastric Emptying
Condition: Regurgitation, Gastric
MeSH terms: Laryngopharyngeal Reflux
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this trial is to show that an hypoallergenic infant starter formula
      containing starch and the probiotic L. reuteri decreases the severity of
      regurgitation/spitting-up in infants presenting regurgitation/spitting-up , and who have
      taken it for 4 weeks, in comparison with a standard infant starter formula.
    

Detailed description: 
      The primary objective of this trial is to show that the test formula (HA formula + starch +
      L. reuteri) decreases the severity (frequency + volume) of regurgitation/spitting-up in
      infants and ultrasound gastric emptying time, compared to a classical infant starter formula.
    

Intervention name(s): HA formula + starch + L. reuteri
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Add-on Low Dose Dextromethorphan and Memantine in Patients With Amphetamine-type Stimulants Use Disorder
Condition: Stimulants Use Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The current study will investigate whether add-on dextromethorphan (DM) and memantine (MM) is
      able to improve the treatment outcomes for ATSUD, and be associated with improvement in
      inflammatory markers, neurotrophic factors and neuropsychological tests.
    

Detailed description: 
      In current study, we will conduct a randomized double-blind placebo-controlled study. We will
      recruit 100-120 patients with ATSUD in three years and allocate them to add-on low dose
      dextromethorphan and memantine (DM 30mg/day+MM 5mg/day) or placebo group in a 1: 1 ratio
      (patients will also undergo usual psychosocial interventions). We will follow up the
      participants for 12 weeks and measure the treatment responses, urine drug tests, craving
      scales and side effects to evaluate the therapeutic effects of add-on DM+MM.
      Neuropsychological assessments and tests for inflammatory parameters and neurotrophic factors
      will also be measured during 12-weeks follow up. The study results will show that whether
      add-on DM+MM is able to improve the treatment outcomes for ATSUD, and be associated with
      improvement in inflammatory markers, neurotrophic factors and neuropsychological tests.
    

Intervention name(s): dextromethorphan and memantine (DM+MM); Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Patients of Amphetamine-type stimulants use disorder (ATSUD) will take dextromethorphan 30 mg/day and memantine 5 mg/day combination (DM+MM) daily for 12 weeks.; Patients of Amphetamine-type stimulants use disorder (ATSUD) will take placebos daily for 12 weeks.
Intervention MeSH terms: Memantine; Dextromethorphan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: amphetamine-type stimulants use disorder; dextromethorphan; memantine; inflammation; neurodegeneration
Trial to Assess Implementation of New Research in a Primary Care Setting (TRAINS)
Condition: General Practice (GP), Primary Care Settings
Study type: Interventional

Summary: 
      In England and Wales, unscheduled care for school-aged children with asthma significantly
      increases after their return to school in September, a trend linked with decreased asthma
      preventer prescriptions during the summer holidays. The PLEASANT study found that a reminder
      letter from GPs to parents of children with asthma led to a 30% increase in prescription
      uptake during August and reduced unscheduled medical visits from September to December.

      The TRAINS trial will now assess if informing GPs of PLEASANT findings would lead to its
      implementation. This pragmatic cluster randomised implementation trial will use routine data
      from Clinical Practice Research Datalink (CPRD).
    


Intervention name(s): Letter
Intervention type(s): Behavioral
Intervention description(s): Selected GP practices currently registered with CPRD will receive correspondence by both email and mail informing them about the result of the PLEASANT study and advising them how to implement what has been learnt. Included in the mailing would be a suggested letter and SMS text.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison Between Laparoscopic Ovarian Diathermy and Clomiphene Citrate in Women With Anovulatory PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome; Hyperthermia
Study type: Interventional

Summary: 
      Laparoscopic ovarian diathermy (LOD) is currently offered to infertile women with polycystic
      ovarian syndrome (PCOS) who fail to conceive on clomiphene citrate (CC). However, using LOD
      before CC may result in a better reproductive outcome since LOD may reduce risks associated
      with CC such as miscarriages and multiple pregnancies. The aim of the study is to evaluate
      the effectiveness of LOD and its potential value in improving the success rates in infertile
      women with PCOS. This study will recruit 72 women with PCOS suffering from infertility due to
      lack of ovulation from the infertility clinic. After initial assessment, patients will be
      given explanation about the study and will receive an information leaflet. They will then be
      randomized into two groups: Group1 (36 patients) will receive CC as per infertility clinic
      protocol to induce ovulation for up to 6 months. Group 2 (36 patients) will undergo
      laparoscopic ovarian diathermy under general anaesthetic. Blood samples will be taken from
      both groups before any treatment, shortly after treatment and at 3 and 6 months after
      treatment to measure various hormones. Patients will be contacted every month after treatment
      for follow up. The reproductive outcomes particularly the pregnancy and livebirth rates will
      be compared between the two groups.
    


Intervention name(s): Laparoscopic ovarian diathermy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic ovarY; Laparoscopic ovarian diathermy; Induction of ovulation; Clomiphene citrate
The Value of Integrated Pulmonary Index Monitoring in Detecting Respiratory Events
Condition: Monitored Anesthesia Care
Study type: Interventional

Summary: 
      Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10
      based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate,
      respiratory rate, end-tidal carbon dioxide (ETCO2). It is a valuable monitor for sedation
      procedures and can provide early warning during cardiorespiratory derangements.The aim of the
      study is to determine whether the Integrated Pulmonary Index (IPI) detects changes in
      ventilation status early in patients undergoing gastrointestinal endoscopy under sedation,
      and to determine the risk factors affecting hypoxia and severe hypoxia.
    

Detailed description: 
      A single-center and retrospective study was conducted in 154 patients who underwent upper and
      lower gastrointestinal system endoscopy in the endoscopy unit between October 2018 and
      December 2019. Patients who were monitored by capnograph in addition to routine monitoring
      (ECG, noninvasive blood pressure and pulse oximetry monitoring) during the procedure in the
      endoscopy unit were included in the study.

      Patients were administered 2 mg midazolam as premedication for 5 minutes before the procedure
      and propofol 1-1.3 mg/kg bolus for sedation, followed by repeated doses (10-30 mg) according
      to the Ramsey sedation score. All patients were given 2 lt/min oxygen via nasal cannula
      during the procedure. In pulse oximetry, oxygen saturation longer than 15 seconds was defined
      as less than 92% hypoxia, and below 85% was defined as severe hypoxia.

      IPI value was measured with Smart Capnography™, Microstream® Integrated Pulmonary Index
      device. According to the capnographic information obtained from the patients and preserved in
      the capnograph disc memory, the planned findings in the study are as follows:

        1. Number of hypoxic events observed in patients (SaO2 value below 92% over 15 seconds)

        2. Number of severe hypoxic events observed in patients (SaO2 value below 85%)

        3. Apnea episodes observed in patients (observation of a straight line longer than 15
           seconds on the capnograph, absence of respiratory activity)

        4. Time from apnea to development of hypoxia and severe hypoxia in patients who develop
           hypoxia and severe hypoxia following apnea

        5. Time between IPI=1, IPI<7, EtCO2=0 and hypoxia and severe hypoxia.
    

Intervention name(s): Smart Capnography™, Microstream®
Intervention type(s): Device
Intervention description(s): patients monitored by capnograph
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Integrated Pulmonary Index (IPI) monitoring; capnograph; endoscopy