bioihbjkbjnl/mcl2 huggingface dataset:
Drug Interactions Between Paracetamol and Setrons in Pain Management
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to demonstrate that the association paracetamol / ondansetron is not
      as effective as the association paracetamol / droperidol in the treatment of pain in children
      following tonsillectomy. The secondary objectives are to compare opioid consumption (morphine
      / codeine) and the cumulated incidence of nausea and vomiting between the two groups of
      patients in the first 24 hours after
    

Detailed description: 
      Tonsillectomy is a common operation performed in children that is associated with marked pain
      and a high incidence of nausea and vomiting. Therefore, national and international guidelines
      have recommended the use of a setron as a prevention to nausea and vomiting and also the
      systematic administration of paracetamol to help in the control of postoperative pain.
      However, a potential interaction between setrons and paracetamol has been reported in
      different animal studies and in human volunteers although its existence has never been found
      in the clinic. Indeed, several hypotheses are proposed to explain the mechanism of action of
      paracetamol in the treatment of pain. However, a recent one involves the endocannabinoid
      system and spinal serotonin receptors. Serotonin receptors are also involved in the mechanism
      of action of antiemetics such as setrons. Indeed, these drugs are serotonin antagonists.
      Therefore, the investigators hypothesized that the concomitant administration of paracetamol
      and ondansetron leads to an interaction that will decrease the analgesic effect of
      paracetamol.

      Patients aged 2-7 years old and scheduled for a tonsillectomy will be recruited. They will
      all receive intraoperatively intravenous paracetamol together with either ondansetron or
      droperidol. Pain scores using the CHEOPS scale will be recorded for 24 hours. Furthermore,
      patients will receive i.v. morphine during the operation and in the recovery room if
      necessary and a non-steroidal anti-inflammatory drug for postoperative pain; on the ward,
      oral codeine will be administered when needed. Pain scores will be recorded regularly for up
      to 24 hours together with opioid consumption and the incidence of nausea and vomiting in the
      same period. Any adverse event will also be recorded.
    

Intervention name(s): paracetamol /droperidol; paracetamol / ondansetron
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetaminophen; Droperidol; Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Indirect Pulp Treatment of Young Permanent Molars Using Photo-Activated Oral Disinfection Versus Calcium Hydroxide
Condition: Deep Caries
Study type: Interventional

Summary: 
      This study aimed to assess the clinical and radiographic success for photo-activated oral
      disinfection (PAD) and calcium hydroxide in indirect pulp treatment (IPT) of young permanent
      molars.
    

Detailed description: 
      Indirect pulp treatment is a procedure in which pulp exposure is prevented by preserving the
      carious dentin bordering the pulp and sealing the pulp with a biocompatible material. .
      Calcium hydroxide is the gold standard for pulp capping, it permits reparative dentin bridge
      formation, maintains pulp vitality, protects the pulp against harmful stimuli and has
      antimicrobial effect. However, several disadvantages were reported with its use over time
      including poor seal, lack of chemical and mechanical adhesion, poor strength, long-term
      solubility, enhanced degradation after acid etching and tunnel defects in the dentin bridge .
      The operative tradition is to remove softened dentin to eliminate infected tissue; however,
      it is impossible to eradicate all the micro-organisms because few will persist although all
      soft dentin was excavated.

      Evidence suggest that for arresting caries lesions, it is not crucial to completely remove
      the infected dentin and that selective caries removal and composite restoration can yield
      better clinical results . For more conservative and effective treatment, disinfection instead
      of complete caries removal has been encouraged. . PAD is an advanced technology utilizing two
      non-toxic components, a photo-activating liquid and a LED light source that selectively
      target and abolish cariogenic bacteria and periodontal pathogens . The usage of PAD in caries
      management can eradicate residual bacteria in soft dentin, reassures rapid healing and
      improve the prognosis of treatment .
    

Intervention name(s): photo-activated oral disinfection; Calcium Hydroxide
Intervention type(s): Device; Drug
Intervention description(s): Application of PAD solution using disposable tip with agitation of the solution for 60 seconds using a brush; Placement of the light disposable tip in center of lesion and holding it just above the surface; Activation of the red light for 60 seconds; (h)Sealing the cavity with glass ionomer and then filling with composite resin as a final restoration; calcium hydroxide( Dycal ® Dentsply Caulk )was applied using calcium hydroxide applicator followed by glass ionomer and then composite resin as a final restoration
Other intervention name(s): PAD; Ca(OH)2
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Indirect pulp treatment; Photo-activated oral disinfection; Calcium Hydroxide
Prevalence of Tongue Anomalies in Egyptian Children
Condition: Tongue; Anomaly
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      The purpose of the study is to determine the prevalence of tongue anomalies in a group of
      Egyptian children and to relate the presence of malocclusion in cases of macroglossia, tongue
      tie and microglossia.
    

Detailed description: 
      The tongue is an important and accessible muscle in the oral cavity, it has many functions
      which includes speech, chewing, swallowing, sucking, control of breathing, growth and
      developments of the jaws and perception to pain.

      Also, many systemic disorders and diseases affect the tongue which makes it a great reflector
      of the general health.

      Tongue anomalies has different frequencies and prevalence between different countries, these
      differences may be due to geographic, ethnic, gender and age variability, for example a study
      in Iran in 2003 found that the prevalence of tongue anomalies 34.3%, while another study in
      Colombia in 2013 found that the prevalence of tongue anomalies on their study population was
      79.9%.

      The knowledge of the prevalence of tongue anomalies among Egyptian children is missing in the
      literature which could compromise the quality of dental care, increase the occurrence of
      orthodontic problems and decrease the chances of early detection of some systemic diseases,
      since tongue anomalies could help in early determination of some systemic diseases in cases
      of fissured tongue and geographic tongue as well as early prevention and early intervention
      of malocclusions and speech defects that might be caused in cases of microglossia,
      macroglossia and ankyloglossia.

      Hence, the knowledge of prevalence of tongue anomalies among Egyptian children can aid in
      setting a reference which will then help in public health planning and prevention policies.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): observational study, all data collected are binary
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        school children between six to twelve years old
      
Keywords: Tongue anomalies; ankyloglossia; Fissured tongue; Geographic tongue; macroglossia
A Study in Subjects With Recurrent Malignant Glioma
Condition: Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 2

Summary: 
      An open-label phase 2, multicenter study in participants with recurrent malignant glioma.
    


Intervention name(s): Lenvatinib; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): 24 mg lenvatinib capsules orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.; Bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.
Other intervention name(s): E7080
Intervention MeSH terms: Bevacizumab; Lenvatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glycaemic Index and Substrate Metabolism
Condition: Substrate Metabolism During Exercise
Study type: Interventional

Summary: 
      Substrate metabolism during exercise can be influenced by various nutritional regimes. The
      effectiveness of the different nutritional regimes, which differ in their carbohydrate
      content, will be investigated not only by functional tests but also the measurement of the
      mechanistic processes in the muscle will be explored.

      Magnetic resonance (MR), better known as magnetic resonance imaging (MRI), has been widely
      used in clinical practice as a non-invasive imaging technique. Importantly, in addition to
      producing anatomical images, an MR scanner also offers the possibility to measure the
      concentrations of a number of metabolic products. This is done through a technique known as
      magnetic resonance spectroscopy (MRS).

      This research project asks the following questions:

        -  Can a diet containing carbohydrates with a low glycemic index achieve the same
           adaptations in basic endurance/fat metabolism as a high fat, low carbohydrate
           (ketogenic) diet?

        -  Does a high-fat, low-carbohydrate diet, compared with a high-carbohydrate diet, prevent
           improvements in performance in the submaximal and maximal range?

        -  What is the effect of diets with different carbohydrate content and variable glycemic
           index on endurance performance in a half marathon and a time trial?

        -  How do the diets with different carbohydrate content and variable glycaemic index affect
           the energy and glycogen stores in the muscles?

      In active recreational athletes, the objectives are: (1) to investigate the effects of
      different diets with variable carbohydrate content and glycaemic index on substrate
      metabolism, (2) to determine the effects of the different diets on energy stores using
      multinuclear dynamic magnetic resonance spectroscopy, and (3) to measure the effects of the
      different diets on endurance performance.
    


Intervention name(s): Training intervention; High Glycaemic Index; LCHF; Low Glycaemic Index
Intervention type(s): Other; Other; Other; Other
Intervention description(s): The training intervention will be a 10 week training plan for endurance runners. The plan consists of five sessions per week (three basic endurance sessions and two interval sessions); The subjects eat 55-60 E-% carbohydrates with ≥ 65 % from high glycaemic index carbohydrates per day, the other E-% are fats and proteins.; The subjects eat ≥ 65 E-% fats and a maximum of 50 g carbohydrates per day.; The subjects eat 55-60 E-% carbohydrates with ≥ 65 % from low glycaemic index carbohydrates per day, the other E-% are fats and proteins.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Platelet Rich Plasma and Supraspinatus Tear
Condition: Supraspinatus Tear
Study type: Interventional

Summary: 
      Rheumatology and Rehabilitation Department, Mansoura University Hospital. Forty patients with
      chronic partial supraspinatus tears will be included in the study. The diagnosis of the
      supraspinatus tear will be made by ultrasound examination
    

Detailed description: 
      At inclusion in the study, demographic data (age, gender, duration of complaints, and body
      mass index) will be recorded.

      Randomization

      Patients will be randomized into two matched groups:

      A) PRP-Injection Group - Patients in this group will receive three ultrasound guided PRP
      injections in the supraspinatus tendon with one week interval (Ilhanli et al., 2015). After
      the injection, patients will be instructed to limit the use of shoulder for at least 24 hours
      and to use cold therapy for pain. After the third injection, ROM, and stretching exercises
      will be allowed and one month after the end of injections, patients will be recommended to
      begin the strengthening program as tolerated. Exercise is performed with 10 repeats five
      sessions per week.

      B) Physical Therapy Group - Patients in this group will be treated with hot pack for 15
      minutes, ultrasound in continuous mode (1.5 watt/cm2 for five minutes), trans-cutaneous
      electrical nerve stimulation in brief-intense mode for 15 minutes, range of motion (ROM),
      followed by stretching and strengthening exercises with 10 repeats 15 sessions (five sessions
      per week for three weeks). After the physical therapy, the exercise program will be continued
      as homework during the follow-up period.

      Patients in t
    

Intervention name(s): PRP; physiotherapy
Intervention type(s): Other; Other
Intervention description(s): Patients in this group will receive three ultrasound guided PRP injections in the supraspinatus tendon with one week interval (Ilhanli et al., 2015). After the injection, patients will be instructed to limit the use of shoulder for at least 24 hours and to use cold therapy for pain. After the third injection, ROM, and stretching exercises will be allowed and one month after the end of injections, patients will be recommended to begin the strengthening program as tolerated. Exercise is performed with 10 repeats five sessions per week.; Patients in this group will be treated with hot pack for 15 minutes, ultrasound in continuous mode (1.5 watt/cm2 for five minutes), trans-cutaneous electrical nerve stimulation in brief-intense mode for 15 minutes, range of motion (ROM), followed by stretching and strengthening exercises with 10 repeats 15 sessions (five sessions per week for three weeks). After the physical therapy, the exercise program will be continued as homework during the follow-up period.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Plasma Osmolality on Brain Glutamate
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to test the hypothesis that plasma osmolality is linked with cortical
      glutamate concentrations in the brain. It also investigates whether the glutamate response in
      schizophrenia is enhanced compared to healthy controls.
    


Intervention name(s): furosemide, Na supplements
Intervention type(s): Drug
Intervention description(s): furosemide 20 mg, Na supplements 8g in divided doses/day for 5 days
Intervention MeSH terms: Furosemide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: MRS, glutamate, osmolality
High-Dose Oral Ziprasidone Versus Conventional Dosing in Participants With Residual Schizophrenia Symptoms
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary aims of this study are to assess tolerability of ziprasidone dose escalation to
      320 milligrams per day (mg/d) compared to continued standard treatment (placebo) as measured
      by the Side Effect Checklist, Simpson Angus Scale for Extrapyramidal Symptoms (SAS), Barnes
      Akathisia Scale (BAS), serum prolactin concentrations, vital signs, electrocardiogram (EKG)
      and completion rates and to assess whether ziprasidone dose escalation improves overall
      psychopathology compared to continued standard treatment as measured by the change from
      baseline in the Positive and Negative Syndrome Scale (PANSS) total score and response rates
      as defined by a 20% or greater reduction in PANSS total score.

      The secondary aims of this study are to assess whether ziprasidone dose escalation improves
      psychotic symptoms compared to continued standard treatment as measured by the Positive
      Symptom Subscale of the PANSS, to assess whether ziprasidone dose escalation improves
      negative symptoms compared to standard treatment as measured by the Negative Symptom Subscale
      of the PANSS, to assess whether ziprasidone dose escalation improves depressive symptoms
      compared to continued standard treatment as measured by the Calgary Depression Rating Scale
      (CDRS), and to assess whether ziprasidone dose escalation improves overall functioning with
      the Clinical Global Impression - Severity (CGI-S), Clinical Global Impression - Improvement
      (CGI-I), Global Assessment of Functioning (GAF) and the Schizophrenia Cognition Rating Scale
      (SCoRS).
    


Intervention name(s): Ziprasidone 80-160 mg/d; Placebo; Ziprasidone 160 mg/d
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will be instructed to take one study capsule of ziprasidone orally twice daily (80 mg/d). After the first week, the study drug will be increased to two capsules twice daily (160 mg/d).; Participants will be instructed to take one study capsule of matching placebo orally twice daily. After the first week, the matching placebo will be increased to two capsules twice daily.; Participants will be taking open-label ziprasidone 80 mg orally twice daily for a total dose of 160 mg/d from at least 3 weeks before randomization to end of study 8 weeks after randomization.
Other intervention name(s): Geodon; Geodon
Intervention MeSH terms: Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia
Safety of Autologous Stem Cell Infusion for Children With Acquired Hearing Loss
Condition: Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To determine if autologous human umbilical cord blood infusion in children with acquired
      hearing loss is safe, feasible, improves inner ear function, audition and language
      development.
    

Detailed description: 
      There is currently no treatment available to repair/reverse acquired sensorineural hearing
      loss. Recent experiments using human umbilical cord blood treatment of a mouse and guinea pig
      models have demonstrated hair cell re-growth following acquired sensorineural loss as well as
      partial restoration of ABR. Autologous human umbilical cord blood therapy, which has been
      used for over twenty years, has an excellent safety record. This study will determine if
      autologous human umbilical cord blood infusion in children with hearing loss is safe and
      feasible, improves inner ear function, audition, and language development. The patients
      umbilical cord stem cells collected at birth and stored at Cord Blood Registry will be used
      for infusion.
    

Intervention name(s): Autologous Stem Cells
Intervention type(s): Genetic
Intervention description(s): The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
Other intervention name(s): Cell based therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Role of Nitric Oxide in Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Healthy Humans
Condition: Healthy
Study type: Interventional

Summary: 
      Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance
      to changes in perfusion pressure. In the eye, several studies have reported that retinal
      blood flow is autoregulated over a wide range of ocular perfusion pressures. The
      investigators recently showed that nitric oxide (NO) is a key metabolite in the regulation of
      vascular tone in the eye and plays an important role in the blood flow autoregulation of the
      choroidal circulation. However, no data is yet available for the optic nerve head. Thus, the
      present study is designed to test the hypothesis that NO plays also a role in optic nerve
      head blood flow autoregulation. Therefore, subjects will perform squatting to increase
      systemic perfusion pressure during administration of either a nitric oxide synthase inhibitor
      (L-NMMA), an α-receptor agonist (phenylephrine) or placebo. Optic nerve head blood flow will
      be continuously measured during the procedure to investigate optic nerve head autoregulation.
    


Intervention name(s): NG-monomethyl-L-arginine (L-NMMA); Phenylephrine; Physiological saline solution (as placebo); Laser Doppler Flowmetry; Goldmann applanation tonometer; squatting
Intervention type(s): Drug; Drug; Drug; Device; Device; Other
Intervention description(s): bolus 6mg/kg over 5 minutes followed by a continuous infusion of 60µg/kg/min over 15 minutes; 1μg/kg/min, infusion period 20 minutes; infusion period 20 minutes; blood flow measurements at the temporal neuroretinal rim of the optic nerve head; intraocular pressure measurements; Subjects will perform squatting for 6 minutes while blood flow is measured
Intervention MeSH terms: Phenylephrine; Oxymetazoline; omega-N-Methylarginine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: L-NG-Monomethyl Arginine; Optic Nerve Head blood flow; Intraocular Pressure; Regional blood flow; Ocular Physiology; Optic Disk
Safety and Efficacy of Vildagliptin Versus NPH Insulin add-on to Glimepiride in Type 2 Diabetes Mellitus Patients.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to evaluate safety and efficacy of vildagliptin versus NPH insulin
      add-on to glimepiride in patients with type 2 diabetes mellitus that do not reach adequate
      glycemic control on their current sulfonylurea monotherapy to give treating physicians a
      guidance which additional anti-diabetic treatment can be used if sulfonylurea monotherapy is
      not sufficient to reach glycemic control.
    


Intervention name(s): LAF237; Protaphane
Intervention type(s): Drug; Drug
Intervention description(s): Vildagliptin will be used as commercially available tablets of 50mg.; Protaphane will be used as commercially available injection pens
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes mellitus, diabetes