bioihbjkbjnl/mcl2 huggingface dataset:
Probiotics in Prevention of Allergies, Obesity and Caries
Condition: Eczema; Allergy; Asthma; Obesity; Dental Caries
MeSH terms: Dental Caries; Eczema; Obesity; Hypersensitivity
Study type: Interventional

Summary: 
      During the period of 2000-2003, 179 healthy, term infants with no previous signs of allergic
      disease were recruited and randomized to daily intake of cereals with or without the addition
      of Lactobacillus paracasei subspecies paracasei strain F19 (LF19) from 4-13 months of age.
      The effects of LF19 on gut microbial composition, infections, allergies, immunological
      development, growth and blood lipids were monitored. Of 179 included infants, 171 completed
      the study. The study product was well tolerated with no observed side effects. Compliance was
      excellent.

      In a follow-up study, the aim is to investigate the long-term effects of feeding LF19 during
      weaning on allergies, immune programming, overweight, gut microbial composition and oral
      health in 8-year old children.

      The investigators' primary outcome will be to determine whether daily intake of LF19 during
      weaning results in less eczema at 8 years of age, and if the preventive effect encompasses
      also respiratory allergies and immunoglobulin E (IgE) - sensitization. The long term effects
      on gut microbial composition, overweight and metabolic markers will be investigated.
      Furthermore, the possible preventive effects of LF19 on caries will be assessed.
    


Intervention name(s): Lactobacillus F19; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Infant cereals with the addition of Lactobacillus paracasei subsp. paracasei strain F19 (LF19)10E8 CFU per serving; Infant cereals without any addition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention; Probiotics; Eczema; Allergy; Asthma; Obesity; Caries; Gut microbiota
Titrated Versus High and Low Dose Nebulized Morphine to Reduce Pain in Emergency Settings
Condition: Post-Traumatic Headache; Acute Pain
MeSH terms: Post-Traumatic Headache; Headache; Acute Pain
Study type: Interventional

Summary: 
      The investigators test a different technique using morphine to improve pain relief in patient
      visiting the emergency department with acute trauma pain, for this we are comparing three
      different methods of morphine administration:

        -  intravenous titrated morphine

        -  low dose nebulized morphine and

        -  high dose nebulized morphine
    

Detailed description: 
      Trauma patients are frequent in emergency department settings, and often require urgent care.

      taking care of this patients consists on taking care of their pain and then the specific
      treatment of their traumatic lesions.

      actually, the most used medicine and most efficient one in treating pain is morphine, it's
      mechanism of action is by acting on receptors located on neuronal cell membranes and inhibit
      neurotransmitter release.

      The most applied administration root of morphine is by intravenous (IV) titration or IV
      continuous perfusion, but until now, there is no clear recommendation concerning the
      superiority of this root over other administration techniques such as nebulization.

      In this study we aimed to investigate the efficiency, the feasibility and the tolerance of
      three morphine administration roots in patients with acute traumatic pain and to clarify the
      most adequate one to apply in emergency department settings.
    

Intervention name(s): IV titrated morphine; Low dose nebulised morphine; High dose nebulised morphine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous morphine : 2 mg every 5 minutes by IV root and nebulized placebo:
SS nebulised : 5 ml SS nebulised over 10 minutes and repeated 3 times; 10 mg morphine in 4 ml Serum Saline(SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes; 20 mg morphine in 3 ml serum saline (SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes
Other intervention name(s): IV morphine group; Neb10; Neb20
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: post traumatic pain; titrated morphine; nebulised morphine
The Effect of Metformin on the Correlation Between Hyperinsulinemia and Hypertension
Condition: Diabetes Mellitus; Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension; Hyperinsulinism
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effect of metformin on the correlation
      between hyperinsulinemia and hypertension.
    


Intervention name(s): Fosinopril; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Fosinopril group received fosinopril, 10mg, once per day.; Metformin group was treated with metformin hydrochloride, 500mg, three times per day
Intervention MeSH terms: Metformin; Fosinopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Insulin Resistance; Hyperinsulinemia; Metformin; Fosinopril
Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral
      Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used
      to support Linezolid OS NDA in China.
    

Detailed description: 
      To support Linezolid NDA in China.
    

Intervention name(s): Linezolid; Linezolid
Intervention type(s): Drug; Drug
Intervention description(s): Linezolid OS 600 MG
Linezolid Tablet 600 MG; Linezolid Tablet 600 MG
Linezolid OS 600 MG
Other intervention name(s): Zyvox; Zyvox
Intervention MeSH terms: Linezolid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bio-equivalence; Linezolid OS; Linezolid tablet
Effects of Exercise Therapy on Ventricular and Endothelial Function in Patients After Coronary Artery Bypass Surgery
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The purpose of this study was (1) to compare the peak exercise capacity and left ventricular
      diastolic function between patients with and without diabetes and (2) to investigate the
      interrelation among peak oxygen consumption, left ventricular diastolic function, blood
      sugar, and lipid profile.
    


Intervention name(s): exercise capacity test
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients after coronary artery bypass surgery
      
Biospecimen description: 
      fasting glucose
    
Keywords: coronary artery bypass graft; Diabetes mellitus, type 2
Precision Treatment With Angiotensin Converting Enzyme Inhibitor
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Angiotensin converting enzyme inhibitors (ACEI) are the first-line treatment for high blood
      pressure and congestive heart failure, and have excellent effects in improving the prognosis
      of cardiovascular diseases. However, ACEI is frequently discontinued due to its adverse
      reaction. The adverse reaction to ACEI is not uncommon, especially in Asians. Discontinuation
      of ACEI is known to increase the risk of poor prognosis of cardiovascular diseases.

      Biomarkers for predicting adverse reaction to ACEI have not yet been developed. Recently,
      genes related to adverse reaction to ACEI have been identified. This study is a randomized
      prospective study, in which the experimental group decides whether to administer the drug
      based on genetic information, and the control group decides whether to administer the drug
      without the information. In the experimental group, participants who are predicted to have a
      high risk of adverse reation to ACEI will receive angiotensin receptor blockers (ARB), and
      those who are predicted to have a low risk of adverse reaction will receive ACEI. Control
      group will receive ACEI. The frequency of adverse reaction will be investigated between
      control and experimental groups. In the genotyping and control groups, at least 45 and 31
      will be enrolled, respectively, and after drug administration, a phone follow-up will be
      conducted at 3 weeks, followed by a visit at the 6th week, and the study will be terminated.
    


Intervention name(s): genotyping and selection of renin-angiotensin system blocker; Perindopril
Intervention type(s): Drug; Drug
Intervention description(s): One of perindopril or candesartan was chosen based on genotyping results on two NELL1 variants.
perindopril 4 mg/d after genotyping
candesartan 8 mg/d after genotyping; perindopril 4 mg/d without genotyping
Intervention MeSH terms: Perindopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physical Exercise to Reduce Anxiety in Underserved Children With ASD
Condition: Physical Exercise Condition; Control Condition
MeSH terms: Disease
Study type: Interventional

Summary: 
      Anxiety is one of the most frequent comorbidities in children with ASD leading to poor
      clinical outcomes. Physical exercise has been shown to be a promising and easy to implement
      intervention for reducing anxiety. However, little is known about the feasibility and
      efficacy of physical exercise to reduce anxiety in children with ASD from underserved,
      low-income families. Children with ASD, ages 6 - 12 years old from low-income and Latino
      families will be recruited for the study and assigned to an exercise intervention group and a
      sedentary control group. The physical exercise program is an eight-week program, administered
      three times per week in small groups. Compliance, parent-rated anxiety, and salivary cortisol
      will be measured before and after completion of the exercise and control group interventions.
    


Intervention name(s): Physical Exercise; Control Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An eight week physical exercise intervention; An eight week sedentary control intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mi Band Step Challenge to Improve Body Composition in Overweight University Students
Condition: Intervention Study; Physical Activity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This is an eight-month research project using one group pretest-midst-posttest design. This
      study is based on self-efficacy and self-regulation of Social Cognitive Theory. The
      investigators will recruit 50 university students with a body mass index of 24 kg/m2 or above
      at one university campus. Participation is completely voluntary. After pretesting, a 12-week
      "Mi Band Step Challenge" will be launched immediately. Participants will be assessed with the
      validated instruments of International Physical Activity Questionnaire (IPAQ)-Taiwan
      short-form, Sedentary Behavior Questionnaire (SBQ), self-efficacy and self-regulation
      questionnaires. Mi Band activity trackers will be used to monitor step counts. An ioi 353
      body composition analyzer will be used to assess body composition. Data will be analyzed
      using generalized estimating equation (GEE).

      The expected outcomes of this study include: (1) "Mi Band Step Challenge" will be developed
      based on the theory, which is expected to be effective. If this is true, the intervention can
      be packaged and applied at different types of colleges and universities with overweight
      students. (2) "Mi Band Step Challenge" has the potential to be used for the reference of the
      healthy weight - physical activity, which is embedded in the School Health Promotion Program
      executed by the Ministry of Education. (3) The result of this study can serve as an example
      for the promotion of evidence-based health care.
    


Intervention name(s): Mi Band Step Challenge
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Intervention model description: One group pretest-midtest-posttest design
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: overweight; body mass index; university students; physical activity; sedentary behavior; body composition; Mi Band
Urdu Version of Northwick Park Neck Pain Questionnaire: Reliability and Validity Study
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      -  To adapt culturally Neck Pain Questionnaire in Urdu language.

        -  To check the reliability of Urdu version of Neck Pain Questionnaire

        -  To validate Neck Pain Questionnaire by Neck Disability Index and Visual Analogue Scale
           and Numeric Pain Rating Scale.
    

Detailed description: 
      The original English version of Northwick Park Neck Pain Questionnaire will be translated and
      culturally adapted as per previous recommendation. In patients with neck pain, Urdu Version
      of Northwick Park Neck Pain Questionnaire will be distributed among 70 participants choose a
      convenience sampling technique based on pre-defined inclusion and exclusion criteria. To test
      reliability of inter/intra observer of ultimate final Urdu Version of Northwick Park Neck
      Pain Questionnaire will be filled from patients on the equivalent day, by 2 different
      bystanders, and for inter observer valuation, with an interval of 30 minutes between the
      first and second application. Third assessment will be carried out after 7 days of the
      Observer -1, for intra-observer assessment. Data will be entered and analyzed Cronbach alpha
      value. Test-retest reliability will be assessed using an intraclass correlation coefficient.
      Urdu Version of Northwick Park Neck Pain Questionnaire will be evaluated for content
      validity, construct validity, criterion validity and responsiveness.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        People suffering from chronic neck pain with a working routine of more than 3 to 4 both in
        sitting and standing position.
      
Keywords: Northwick Park Neck Pain Questionnaire; Urdu Version; Reliability; Validity; Neck Pain
Pharmacodynamic Study of Two Lanthanum Carbonate Formulations in Healthy Adults
Condition: End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to assess any potential differences in the absorption and
      excretion between two lanthanum carbonate formulations. This study is also being done to
      assess the safety and tolerability of the two lanthanum carbonate formulations.
    


Intervention name(s): Lanthanum carbonate Granule Formulation; Lanthanum carbonate Chewable Tablets (Fosrenol)
Intervention type(s): Drug; Drug
Intervention description(s): 3x's per day for 3 days, 1 dose in the am for day 4. (A single dose equals 1000mg of lanthanum carbonate granule formulation. Dose is administered immediately after each meal.); 3x's per day for 3 days, 1 dose on day 4. (A single dose equals a 1000mg tablet of lanthanum carbonate. Dose is administered immediately after each meal.)
Other intervention name(s): Fosrenol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: End stage Renal disease
Photodynamic Therapy Associated With Full-mouth Ultrasonic Debridement in the Treatment of Severe Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      Background: Photodynamic therapy (PDT) is a method of microbial reduction which can benefit
      periodontal treatment in areas of difficult access, such as deep pockets and furcations. The
      aim of this randomized controlled clinical trial was to evaluate the effects of PDT as an
      adjunct to full-mouth ultrasonic debridement in the treatment of severe chronic
      periodontitis.

      Methods: Twenty-two patients with at least one pocket with probing depth (PD) ≥ 7 mm and one
      pocket with PD ≥ 5 mm and bleeding on probing (BOP) on each side of the mouth were included,
      characterizing a split mouth design. The control group underwent full-mouth ultrasonic
      debridement and test group received the same treatment associated with PDT. The following
      clinical parameters were evaluated: plaque index, gingival index, BOP, gingival recession
      (GR), PD, and clinical attachment level (CAL). All parameters were collected before, 1, 3 and
      6 months after treatment.
    

Detailed description: 
      The present study was a randomized, blinded, controlled clinical trial, which used a
      split-mouth design. Prior to commencement, the study design was approved by the Ethics
      Committee of Bahiana School of Medicine and Public Health (12/2008). All patients were
      informed individually about the nature of the proposed treatment, and informed consent forms
      were signed.
    

Intervention name(s): photodynamic therapy and periodontal debridement
Intervention type(s): Other
Intervention description(s): At least two teeth (one with PD ≥ 7 mm and another with PS ≥ 5 mm) were randomly assigned (by coin toss) to one of the treatments: with (test group) or without PDT (control group). After random allocation, all patients received full-mouth ultrasonic debridement using an ultrasonic scaler for 1 hour. Specific tips were used. PDT was performed on only one side of the mouth and the initial step was subgingival irrigation with 0.005% methylene blue dye. To avoid contamination of the control sites with the dye, the methylene blue was applied only inside the periodontal pockets and a high-powered suction device controlled the flow. Two minutes after applying the photosensitizer, the low power laser - AsGaAl was applied for 90 seconds.
Other intervention name(s): debridement using an ultrasonic scaler; Specific tips were used; 0.005% methylene blue dye; low power laser - AsGaAl
Intervention MeSH terms: Methylene Blue
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Laser; Clinical trial; Non-surgical periodontal therapy; Periodontitis; bleeding on probing and radiographic bone loss; minimum of 2 teeth with probing depth (PD) ≥ 7 mm and; 2 other teeth with PD ≥ 5 mm; mininum 16 teeth in both jaws
Study of Sulphoraphane in Chronic Kidney Disease
Condition: Chronic Kidney Disease stage3; Chronic Kidney Disease stage4
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test the safety of the compound sulforaphane that boosts the
      activity of antioxidant genes in the body to combat oxidative stress. Oxidative stress has
      been shown experimentally to play a role in kidney disease. This drug has been tested in
      patients with breast cancer who have normal kidney function, but has never been tested in
      patients with kidney disease.

      In this study, the investigators will establish a safe dose for patients with chronic kidney
      disease based on blood levels achieved in patients with normal kidney function.
    


Intervention name(s): Sulforaphane
Intervention type(s): Drug
Intervention description(s): This is an over-the counter nutritional supplement. Participants will be given the extra strength tablets.
Other intervention name(s): Avmacol
Intervention MeSH terms: Sulforaphane
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
24 Hrs Histamine Profile in Healthy Persons and Patients With Food Intolerance
Condition: Allergy; IBS
MeSH terms: Food Intolerance
Study type: Observational

Summary: 
      Over 24 hrs serum and plasma samples were collected every 3 hrs. With this a day histamine
      profile was created. 15 healthy persons with 20 patients with a high level of IgE in serum
      and 20 patients with afflictions but no high IgE level were compared. Measurment of histamine
      in plasma, urine and stool were realized. In addition to that Diaminoxidase, TNF alpha and
      IgE Antibodies were measured.
    


Intervention name(s): blood profile
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy subjects, patients with high IgE level and patients with afflictions, but no high
        IgE level
      
Keywords: histamine profile; IgE Antibodies
Study of the Effect of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability (2637-008)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess transcranial magnetic stimulation (TMS) as a biomarker and
      characterize TMS readouts of the activity of MK2637 and dextromethorphan. Resting
      quantitative electroencephalography(qEEG) readouts are also characterized with MK2637 and
      dextromethorphan.
    


Intervention name(s): MK2637; Comparator: MK2637; Comparator: Placebo; Comparator: Dextromethorphan; Comparator: Dextromethorphan
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose of 120 mg MK2637 capsules in one of five treatment periods.; Single dose of 50 mg MK2637 capsules in one of five treatment periods.; Single dose of placebo only in one of five treatment periods.; Single dose of 220 mg dextromethorphan capsules in one of five treatment periods.; Single dose of 110 mg dextromethorphan capsules in one of five treatment periods.
Intervention MeSH terms: Dextromethorphan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic