bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic
Condition: Gastrointestinal; Colic
MeSH terms: Colic; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This protocol is a study of the effects of Lactobacillus reuteri in 45 healthy infants with
      colic. The study is being conducted in order to prove treatment dose with probiotic
      (Lactobacillus reuteri) in a clinical setting is safe in healthy infants with colic.
    

Detailed description: 
      This study will evaluate the safety and tolerability of Lactobacillus reuteri in healthy
      infants with colic. Patients will be randomized to receive either L. reuteri at one dose
      orally for a total of 42 doses. The doses will be 5x108 (5 drops) during a satisfactory
      assessment of safety and tolerability. The time on study treatment is 6 months, and the
      target sample size is 45 healthy infants.

      Secondly, the investigators aim to gather evidence supporting hypothesis of safety and
      tolerability of Lactobacillus reuteri by administering a physical examination and testing of
      complete blood count, liver tests, and serum electrolytes over a forty-two day period.
    

Intervention name(s): Lactobacillus reuteri; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment of a well-functioning gastrointestinal (GI) microbiota and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment.
The drug is a clear liquid when suspended in sunflower oil. The drug will be administered orally, 0.2cc once daily.; Placebo is sunflower oil (vehicle for LR). The placebo will be administered the same way as drug listed above.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Crying; Fussiness; Gas; Hydrogen Breath; Fecal Calprotectin
Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the pharmacokinetic (PK) interaction between tegoprazan and
      non-steroidal anti-inflammatory drugs (NSAIDs) after given each alone and in their
      combination in healthy male adults.
    

Detailed description: 
      A randomized, open-label, multiple-dose, 6-sequence-arm, 3-period cross-over study
    

Intervention name(s): Tegoprazan; Naproxen; Aceclofenac; Celecoxib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tegoprazan 50 mg tablet; Naproxen 500 mg tablet; Aceclofenac 100 mg tablet; Celecoxib 200 mg capsule
Other intervention name(s): K-CAB; Naxen-F; Airtal; Celebrex 200 mg
Intervention MeSH terms: Celecoxib; Naproxen; Aceclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug-drug interaction; pharmacokinetic
The Effect of Intravenous Lidocaine on Pain After Lumbar Spinal Fusion
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine
      injection on the relief of pain in patients undergoing 1-level posterior lumbar fusion.

      A total of 54 patients will be randomized into one of two groups (group C or group I) based
      on Excel number generation.

      Patients in group C will receive received normal saline intravenous injection, and patients
      in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a
      continuous lidocaine infusion of 2 mg/kg/hr.

      Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients
      pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12,
      24, 48 hours postoperatively.
    


Intervention name(s): Intravenous lidocaine injection; Intravenous normal saline injection
Intervention type(s): Drug; Drug
Intervention description(s): Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.; The patients in Group C (placebo control group) received normal saline intravenous injection
Other intervention name(s): IV lidocaine; IV saline
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Preemptive; Lidocaine; Intravenous; Lumbar fusion
Safety and Efficacy of 6% Hydroxyethyl Starch (HES) Solution Versus an Electrolyte Solution in Patients Undergoing Elective Abdominal Surgery
Condition: Hypovolaemia Due to Acute Blood Loss
MeSH terms: Hypovolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to investigate the safety of a 6% HES (Hydroxyethyl Starch) solution
      (Volulyte 6%) versus an electrolyte solution (Ionolyte) in patients undergoing elective
      abdominal surgery.
    


Intervention name(s): Volulyte 6%; Ionolyte
Intervention type(s): Drug; Drug
Intervention description(s): Solution for infusion; Solution for infusion
Other intervention name(s): Hydroxyethyl starch 130/0.4; Electrolyte solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HES; HES 130; Hydroxyethyl starch
A Comparison of Efficacy and Safety During Endoscopic Submucosal Dissection Between Dexmedetomidine-remifentanil and Propofol-remifentanil
Condition: Early Gastric Cancer Patients Who Were Scheduled for Endoscopic Submucosal Dissection
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Adequate, safe sedation is essential for Endoscopic submucosal dissection. Dexmedetomidine is
      a potent and selective a2-adrenoceptor agonist used for sedative and analgesic effects, but
      it is limited to use alone. The investigators designed this study to compare the effect and
      safety of two sedatives, dexmedetomidine and propofol in Endoscopic Submucosal Dissection
      (ESD), when sufficient analgesia-remifentanil is administered all throughout the procedure.
    


Intervention name(s): Dexmedetomidine - remifentanil group; Propofol - remifentanil group
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dexmedetomidine; Remifentanil; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Endoscopic submucosal dissection; propofol; remifentanil; dexmedetomidine; efficacy; safeness
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, randomized, double-blinded, placebo parallel controlled phase 1 study to
      evaluate the safety and pharmacokinetics/pharmacodynamics of multiple (6 days) ascending dose
      (20mg QD, 40mg QD, 20mg Bid) administrationof Anaprazole in healthy Chinese subjects. 36
      subjects, 12 subjects for each dose group. In each dose group, 10 subjects take anaprazole, 2
      subjects take placebo.
    


Intervention name(s): Anaprazole Sodium enteric-coated tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Multiple ascendinng dose, anaprazole 20mg QD(20mg QD group), 40mg QD(40mg QD group), 20mg Bid(20mg Bid group) , 6 days, fasting oral administration.; Multiple dose, 1 tablet QD (20mg QD and 40mg QD group), 1 tablet Bid (20mg Bid group), 6 days, fasting oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Biomarkers of Broccoli Intake: A Pilot Study
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The objectives of the study are 1) to characterize plasma and urinary metabolites that
      originate from glucobrassicin, 1-methoxyglucobrassicin, 4-methoxyglucobrassicin, and
      4-hydroxyglucobrassicin, which are the major indole glucosinolates found in broccoli, and 2)
      to identify novel plasma and urinary metabolites following broccoli consumption that may have
      roles in reducing the risk of cancer.
    

Detailed description: 
      Consumption of Brassica vegetables is inversely associated with incidence of several cancers,
      including cancer of the lung, stomach, liver, colon, rectum, breast, endometrium, and
      ovaries. Brassicas are a good source of many nutrients, but the unique characteristic of
      Brassicas is their rich content of glucosinolates. Breakdown products of indole
      glucosinolates in Brassica vegetables show promise for reducing the risk of cancer, but have
      received comparatively less research attention than those of aliphatic glucosinolates. The
      aim of this study is to investigate plasma and urinary metabolites of indole glucosinolates
      from broccoli and to identify novel metabolites that may have roles in reducing cancer risk.
    

Intervention name(s): Broccoli consumption
Intervention type(s): Other
Intervention description(s): All subjects will eat broccoli on day 11
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate the Effect of Activated Charcoal on the Absorption of LY2216684 in Healthy Subjects
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The study involves a single oral dose of 18 mg (2 x 9mg tablets) LY2216684 taken on 2
      occasions, once with activated charcoal and once without activated charcoal.

      The study will evaluate the effect of charcoal on the absorption of LY2216684. Side effects
      will be documented. There will be 2 study periods each lasting up to 5 days. There will be at
      least 7 days between the two doses and a follow up will occur at least 7 days after the last
      dose. Screening is required within 30 days prior to the start of the study.
    


Intervention name(s): LY2216684; Activated Charcoal
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Intervention MeSH terms: Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to compare the rate and extent of absorption of a single dose of nemolizumab
      administered with auto-injectors [AI] (test) versus dual-chamber syringes [DCS] (reference)
      under controlled conditions in healthy adult subjects.
    


Intervention name(s): Nemolizumab; Nemolizumab
Intervention type(s): Drug; Drug
Intervention description(s): Nemolizumab with Auto-Injector (AI).; Nemolizumab with Dual-Chamber Syringe (DCS).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Auto-Injector (AI); Dual-Chamber Syringe (DCS); Atopic dermatitis (AD); Prurigo nodularis (PN)
L-PRF in Alveolar Ridge Preservation
Condition: Bone Loss, Alveolar
MeSH terms: Alveolar Bone Loss
Study type: Interventional

Summary: 
      The effect of leucocyte- and platelet-rich fibrin (L-PRF) for enhancing the healing after
      dental extractions is still a matter of debate. The available literature suggests that L-PRF
      performs positive effect to improve alveolar preservation resulting in less bone resorption
      on extraction sockets. L-PRF is a second generation of platelet concentrate produced without
      biochemical blood manipulation. L-PRF is composed by three key parameters: first, the
      presence of platelets; second, the presence of leucocytes; third, the density and complex
      organization of the fibrin matrix architecture produced by a natural polymerization process.
      The theory is that this key parameters acts to produce a faster bone healing.
    


Intervention name(s): Platelet-rich fibrin
Intervention type(s): Procedure
Intervention description(s): The use of autologous platelet-rich fibrin after tooth extraction to promote bone healing and alveolar ridge preservation
Other intervention name(s): platelet concentrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Platelet-rich fibrin; Tooth Extraction; Alveolar Bone Grafting
Bioequivalence Study of Torrent Pharmaceutical Limited's Donepezil Hydrochloride Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      To compare the rate and extent of release of the drug substance from the two tablet
      formulation of Donepezil Hydrochloride Tablets 10mg of Torrent Pharmaceuticals Limited and
      the Aricept® Tablets 10mg of Eisai Inc., Dosing periods were separated by a washout period of
      at least 7 days.

      Study Design:

      Randomized, open label, two treatment, two period, two sequence, single dose, crossover study
      in healthy human adult subjects
    


Intervention name(s): Torrent's Donepezil Hydrochloride Tablets 10mg
Intervention type(s): Drug
Intervention MeSH terms: Donepezil
Evaluation of the Screening Effect of Artificial Intelligence Hand Activity Evaluation System for Cervical Spondylosis
Condition: 10-second G&R Test
MeSH terms: Spondylosis
Study type: Observational

Summary: 
      The purpose of this study:

        1. Build an artificial intelligence screening tool for cervical spondylosis based on hand
           function analysis;

        2. Verify the accuracy of cervical spondylosis screening tools.
    

Detailed description: 
      Cervical spondylotic myelopathy (CSM) has a high incidence in the middle-aged and elderly
      people. According to clinical research, the surgeon can makes a preliminary assessment of the
      severity of CSM based on a 10-second grip and release (G&R) test. The statistics of G&R test
      mainly rely on the surgeon's manual counting. When a patient's hand motion speed is too fast,
      the surgeon's manual counting is prone to error, leading to potential misdiagnosis. We
      construct and verify the intelligent video analysis system for Grip-&-release. The system has
      a high accuracy and inference speed that ensure the proposed model can be used as a screening
      examination tool for CSM and a medical assistance tool to help decision making during CSM
      treatment planning.
    

Intervention name(s): 10-second hand grip and release test
Intervention type(s): Diagnostic Test
Intervention description(s): To grip and release hand in ten seconds
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        1000 asymptomatic population in community; 200 cases of cervical spondylosis; Arthritis,
        Parkinson's disease, cerebral apoplexy 60 patients each.
      
Keywords: 10-second G&R test; cervical spondylotic myelopathy; hand motion analysis; video analysis
Echographic Measurement of Skin Thickness
Condition: Skin Thickness
Study type: Observational

Summary: 
      To optimize a medical device for intradermal injection, knowledge concerning the thickness of
      epidermis and dermis at the proximal forearm is required. Since scientific knowledge is
      lacking, the investigators will examine the skin thickness (epidermis and dermis) of adults
      using imaging technology (High Frequency Ultrasound). The investigators hypothesize that they
      are able to correlate the thickness of the (epi)dermis to a specific combination of
      parameters age, gender, and BMI.

      Based on these results, the investigators can define which needle type and length is needed
      to correctly perform injections into the dermal layer.
    


Intervention name(s): Echographic measurement of skin thickness
Intervention type(s): Other
Intervention description(s): (Epi)Dermal thickness at the proximal forearm and the deltoid region will be measured using imaging technology, more specifically high-frequency ultrasound (20-40 MHz) in B-mode (VEVO 2100®, Visual Sonics). This non-invasive measuring technique has already been proven to be accurate.
The echographic measurement will be performed on the left and right deltoid region and on two sides of the proximal forearm. Both the dorsal part and the volar/palmar part of the proximal forearm will be investigated. Ultrasound will be executed using gel (Aquasonic®) to optimize imaging.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants will be recruited in the vicinity of the university and its university
        hospital of Antwerp, in the period of January 2015 until April 2015.
      
Keywords: skin thickness; high-frequency ultrasound
Analyses of Interleukin-6, Presepsin and Pentraxin-3 in the Diagnosis and Severity of Late-onset Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      Introduction: The etiology/pathophysiology of preeclampsia remains an enigma. Cellular
      immunity is a key factor in the etiology of late-onset preeclampsia (L-PrE). Presepsin is
      split out from the phagocytes membranes after phagocytosis. To investigators knowledge, this
      is the first study in literature to investigate maternal blood concentrations of presepsin in
      preeclampsia and healthy pregnant women.

      Methods: The investigators examined maternal plasma interleukin-6, presepsin and pentraxin-3
      concentrations in pregnant women with (n=44) and without L-PrE (n=44). These three
      inflammatory markers concentrations measured using enzyme-linked immunosorbent assays were
      compared.
    

Detailed description: 
      This observational case-control study was designed at Cengiz Gokcek Women's and Children's
      Hospital, Gaziantep, Turkey, in the Department of Obstetrics and Gynecology between June 2018
      and January 2019. The protocol was approved by the Ethics Committee for Clinical Research of
      Gaziantep University (Reference number: 2018/393). The study strictly adhered to the
      principles of the Declaration of Helsinki. All subjects included in the study gave oral and
      written informed consent. Eighty-eight women were enrolled in the study in two groups. All
      participants will gave their oral and written informed consent before their inclusion in the
      study.
    

Intervention name(s): interleukin-6, presepsin and pentraxin-3
Intervention type(s): Other
Intervention description(s): measurements and compare
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators consecutively recruited 50 subjects with preeclampsia, and 50 healthy
        pregnancies selected for the control group.
      
Keywords: innate immunity; macrophage; toll-like receptors; trophoblasts; phagocytos
D-chiroinositol Administration in Hypogonadal Males
Condition: Male Hypogonadism; Sexual Dysfunction
MeSH terms: Hypogonadism
Study type: Interventional

Summary: 
      D-chiroinositol (DCI), is known as second messenger of insulin pathway, but recently several
      works have reported the influence of DCI on steroidogenesis. In particular, the DCI
      capabilities to regulate aromatase expression and testosterone biosynthesis are arising. In
      this regard, DCI administration in case of reduced levels of testosterone, could be a good
      therapeutic opportunity. For this reason, the treatment of Late-Onset Male Hypogonadism (LOH)
      in undoubtedly an interesting target. LOH is a reduction of testosterone level due to
      advancing age, currently treated with Testosterone Replacement Therapy (TRT). Unfortunately,
      there is a lack of information about TRT safety, especially in older men. For these reasons,
      the aim of this study is to evaluate the effect of DCI treatment on testosterone accumulation
      in LOH patient.
    


Intervention name(s): D-chiroinositol
Intervention type(s): Dietary Supplement
Intervention description(s): Supplementation with 600 mg of D-chiroinositol, two-times daily on an empty stomach, for 30 days.
Intervention MeSH terms: Inositol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Male Hypogonadism; Testosterone; Aromatase; D-chiroinositol; Sexual dysfunction
Optimizing the Beneficial Health Effects of Exercise for Diabetes: Focus on the Liver!
Condition: Diabetes Mellitus, Type 2; Non-alcoholic Fatty Liver Disease; Obesity
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Due to the western lifestyle, correlated with a high calorie intake and low physical
      activity, obesity is becoming a major health problem. All over the world obesity reaches
      epidemic proportions. Obesity is closely linked to type 2 diabetes, a multi-factorial disease
      that increases the presence of multiple health problems. Until now, exercise and dietary
      intervention seem to be the single most effective interventions to treat obesity and type 2
      diabetes mellitus. In obesity and type 2 diabetes, not only fat accumulation in adipose
      tissue, but also fat accumulation in the peripheral tissues occurs. Fat accumulation in
      peripheral tissues has been associated with insulin resistance. Exercise seems to have a
      positive effect on the accumulation of fat in the peripheral tissue and on the insulin
      sensitivity in type 2 diabetic patients.

      In this study we want to investigate if a prolonged exercise training program can lower the
      intrahepatic lipid content and can improve the metabolism of the liver in type 2 diabetic
      patients and patients with non-alcoholic fatty liver disease, and to examine if this leads to
      improvements in metabolic risk markers. To this end, we will include investigation of the
      effect of exercise on adipose tissue (inflammatory markers and adipocyte size) and skeletal
      muscle (ex vivo lipid metabolism) to incorporate the effect of exercise on liver, muscle and
      adipose tissue and to clarify the crosstalk between these tissues in the pathophysiology of
      type 2 diabetes.
    


Intervention name(s): Exercise intervention
Intervention type(s): Behavioral
Intervention description(s): Subjects will be training for 12 week, 3 times a week. Two times a week they will perform a 30 minutes bicycle training. Once a week they will perform a 30 minutes resistance training.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Magnetic Resonance Spectroscopy; Exercise