bioihbjkbjnl/mcl2 huggingface dataset:
The Management of Perceived Breastmilk Insufficiency
Condition: Breast Milk Expression; Breast Feeding, Exclusive
Study type: Interventional

Summary: 
      A randomized control trial was made to determine the effectiveness of structured education
      and follow-up in the management of perceived milk insufficiency among breastfeeding mothers.
    

Detailed description: 
      Mothers 'perception of breastmilk insufficiency are important conditions affecting babies'
      exclusively breastfeeding in the first six months.

      This study was made to determine the effectiveness of structured education and follow-up in
      the management of perceived breastmilk insufficiency among breastfeeding mothers. It was
      tested the hypotheses that there are no differences between mothers who have been provided
      with structured education and follow-up and those who have not received the education in
      terms of initiating breastfeeding in the first one hour, breastmilk insufficiency
      perceptions, the rate of exclusive feeding of breast milk to babies 0-2 months old, the
      baby's amount of milk intake and weight gain.
    

Intervention name(s): Structured education and follow-up
Intervention type(s): Behavioral
Intervention description(s): This structured educational material was developed by the authors on the basis of the literature. Interventions of the study were carried out in the 32nd-42nd week of pregnancy, 3rd-7th day postpartum, and at the 1st month. At first stage, a 15-20-minute education was given to the pregnant women in the study group in the breastfeeding room of the facility, educational booklets were distributed. The main emphasis parts of the education were repeated with a standard summary information form at each follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: breastmilk; breastfeeding; education; follow-up
A Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Clevudine and Adefovir Dipivoxil After Oral Administration in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open-label, three-sequence, three-period, three-treatment clinical
      trial to investigate the pharmacokinetic drug-drug interaction of Clevudin and Adefovir
      dipivoxil after oral administration in healthy male subjects.
    

Detailed description: 
      To evaluate the safety, drug-tolerance, pharmacokinetics of Clevudine or Adefovir monotherapy
      or Adefovir and Clevudine combination in healthy male subjects
    

Intervention name(s): Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil; Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil; Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Clevudine 20mg qd Days 1; Adefovir dipivoxil 10 mg qd Days 8;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 15; Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 1; Clevudine 20mg qd Days 8; Adefovir dipivoxil 10 mg qd Days 15;; Adefovir dipivoxil 10 mg qd Days 1;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 8; Clevudine 20mg qd Days 15
Intervention MeSH terms: Adefovir; Adefovir dipivoxil; Clevudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clevudine and Adefovir dipivoxil; pharmacokinetic drug drug interaction; oral administration; male subjects
Effects of Multimodal Analgesia on Serum MCP-1, BDNF, and MiRNA-124 in Hysterectomy Surgery
Condition: Inflammation; Inflammatory Response; Acute Pain; Chronic Pain
MeSH terms: Inflammation; Chronic Pain; Acute Pain
Study type: Interventional

Summary: 
      The inflammatory process is the main mechanism in the occurrence of acute postoperative pain.
      It is also the main risk for the development of acute pain into persistent pain. Inflammation
      occurs in the process of peripheral sensitization and central sensitization with various
      inflammatory mediators. Postoperatively, there will be proliferation and activation of
      microglia and astrocytes which will then activate inflammatory receptors and signaling
      cascades of neurotransmitters, cytokines, and chemokines. There has been a lot of clinical
      research evidence that multimodal analgesia can adequately treat acute pain and can prevent
      the development of acute postoperative pain into persistent pain and chronic postoperative
      pain, but the molecular mechanisms are not fully understood.
    


Intervention name(s): Multimodal analgesia; Conventional intravenous analgesia
Intervention type(s): Drug; Drug
Intervention description(s): Multimodal analgesia includes the combination of:
morphine given by PCA (patient-controlled analgesia) at 1 mg/dose
bupivacaine 0.25% and dexmedetomidine 0.5 mcg/mL (total volume of 10 mL) by epidural-catheter bolus given preoperatively
bupicavaine 0.125% and dexmedetomidine 0.5 mcg/mL at a 5 mL/hour rate per epidural-catheter given intraoperatively
bupivacaine 0.1% and dexmedetomidine 0.5 mcg/mL given by programmed intermittent epidural bolus (PIEB), set to be delivered every one-hour
etericoxib 90 mg per oral give two-hours before surgery and then continued until three days post-surgery
paracetamol 1 g (intravenously) given on the day of the surgery, continued at 10 mg/kg dose every 8 hours until three days post-surgery; Standard analgesia includes fentanyl 2 mcg/kg (bolus) and morphine given by PCA (patient-controlled analgesia) at 1 mg/dose
Other intervention name(s): Group M; Group C
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Randomized, Placebo-controlled Study Investigating the Effects of Moxaverine on Ocular Blood Flow After Oral Administration in Healthy Subjects
Condition: Effect of Orally Administrated Moxaverine on Ocular Blood Flow
Study type: Interventional
Phase: Phase 2

Summary: 
      A number of common eye diseases such as age-related macular degeneration and glaucoma are
      associated with ocular perfusion abnormalities. Although this is well recognized there is not
      much possibility to improve blood flow to the posterior pole of the eye in these diseases.

      For many years, moxaverine has been used in the therapy of perfusion abnormalities in the
      brain, the heart and the extremities. This is based on a direct vasodilatatory effect of the
      drug, but also on the rheological properties of red blood cells. In two recent studies the
      investigators have shown that intravenous moxaverine increases choroidal and retrobulbar
      blood flow in healthy young subjects, in elderly people with healthy eyes and in patients
      with eye diseases associated with hypoperfusion. The present study aims to investigate,
      whether ocular blood flow is also improved after oral administration of moxaverine.
    


Intervention name(s): Moxaverine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Moxaverine-hydrochloride, coated tablets containing 150 mg moxaverine (Kollateral forte, Ursapharm. Saarbrücken, Germany), dosage: 900 mg, administrated per os in three equal doses of 300 mg at two hour intervals; coated tablets identical in number and appearance as the study drug
Intervention MeSH terms: Moxaverine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: moxaverine; ocular blood flow
Cerebral Perfusion Associated With Postural Changes: an ASL MR Perfusion Study
Condition: Brain Ischemia
MeSH terms: Brain Ischemia; Ischemia
Study type: Interventional

Summary: 
      Postural changes are commonly used as therapeutic maneuver to enhance or reduce cerebral
      perfusion. For instance, in acute stroke, the patient can be positioned in head down tilt
      position so as to increase perfusion of cerebral tissues perfusion. In During stroke and in
      hypertensive patients and during stroke, varying degrees a various loss of cerebral
      autoregulation is loss are usually observed. The aim of this study is to assess cerebral
      perfusion with ASL perfusion in human subjects in different conditions: healthy, hypertensive
      and stroke.
    

Detailed description: 
      Material and methods:

      Eighteen stroke patients, eighteen hypertensive patients and eighteen healthy subjects (men
      and women) will be enrolled. The investigator will use a 1.5 Tesla MRI device with a large
      magnet bore (70 cm) allowing positions change. Two measures will be performed, one in supine
      position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired
      and Cerebral Blood Flow (CBF) maps will be reconstructed. Volume of interest (VOI) will be
      placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter
      (caudate nuclei, thalami) and subcortical white matter (semi oval centers). Differences in
      CBF values (in mL/100g/min) will be analyzed using SAS 9.3 software for Windows (SAS
      Institute, Cary North Carolina, USA).

      Expected results and hypothesis:

      CBF is expected to significantly vary between the supine and head down positions. It is
      expected to at least increase in the head down position, for stroke patients. For healthy
      subjects and hypertensive patients, cerebral autoregulation may limit CBF increase although
      an increasing trend for CBF is expected.
    

Intervention name(s): MRI
Intervention type(s): Procedure
Intervention description(s): A 1.5 Tesla MRI device with a large magnet bore (70 cm) allowing positions change will be used. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and CBF maps reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Stroke, Acute
The Effect of Dairy on Bone Mass and Body Composition in 4th-8th Grade Boys and Girls
Condition: Healthy
Study type: Interventional

Summary: 
      Building stronger bones during pubertal growth could reduce lifelong fracture risk. This
      project is an 18 month dairy intervention study for overweight and healthy weight 4th-8th
      grade boys and girls. Half of the girls will receive dairy products to add to their habitual
      diet (milk, yogurt, and cheese) to equal three products per day, while the other half will
      remain on their normal diet. All participants will attend four study visits, each 6 months
      apart. At these visits height, weight, bone density and geometry, and fat and lean mass will
      be measured. This study aims to show that meeting calcium requirements by eating dairy
      products builds bigger, stronger bones, and that this effect may be enhanced in overweight
      boys and girls. The effect of the dairy intervention on body fat, lean mass, and weight, as
      well as the mechanisms and predictors of changes in bone mass and size and body composition
      will also be evaluated.
    


Intervention name(s): Increased Dairy Consumption
Intervention type(s): Other
Intervention description(s): 3 additional servings of dairy (two of which must be milk or yogurt)
8 oz milk
6 oz yogurt
1.5 oz cheese
Other intervention name(s): Prairie Farms Milk; Prairie Farms Yogurt
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bone; Dairy Intervention; Girls; Boys; Calcium; Bone Mineralization; Peak Bone Mass; Bone and Bones; Female; Male; Adolescent; Healthy
Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Diseases.
Condition: Systemic Lupus Erythematosus; Idiopathic Juvenile Arthritis; Human Papilloma Virus
MeSH terms: Papilloma; Rheumatic Diseases; Arthritis, Juvenile; Lupus Erythematosus, Systemic; Collagen Diseases
Study type: Observational

Summary: 
      Patients with chronic inflammatory rheumatic disease (CIR) are at increased risk for
      infections. Vaccination is a powerful tool to prevent infections, even in immunocompromised
      patients. Low-risk types of Human papilloma virus (HPV) cause anogenital warts, while high
      risk types are strongly related to pre-malignant cervical abnormalities and cervical cancer.
      HPV vaccines have been developed to prevent these conditions. Human papillomavirus (HPV)
      infections are more prevalent in systemic lupus erythematosus (SLE) patients or other
      auto-immune diseases when compared to the healthy population. In France, despite a
      vaccination available since 2007, rate of vaccination remain low. Although little is known
      about HPV vaccination in SLE, few studies in patients with autoimmune rheumatic diseases
      (AIRDs) have shown that HPV vaccines are safe, and capable to induce an immunogenic response
      in this group of patients. To date, available data suggest that HPV vaccines can be given
      safely to SLE patients. Given the increased incidence of cervical abnormalities due to HPV in
      SLE patients, this vaccination should be encouraged.

      The aim of this study was to assess the vaccination coverage rate in chronically ill girls
      with SLE or idiopathic juvenile arthritis who require a close pediatric specialized follow-up
      vaccination and to understand barriers or motivations for it.
    


Intervention name(s): self-administred questionnaire
Intervention type(s): Other
Intervention description(s): On the occasion of a follow-up consultation with referent pediatrician, a self-administred questionnaire is distributed. It will take around ten minutes to the patient and her parents for completing the questionnaire. Questionnaire is anonymous. Participation is free and informed by an information notice. There is a list of items to complete by the patient and her parents. Most of questions are closed-ended. Clinical data are reported : age, level of education, principal disease (SLE or Juvenile arthritis), received treatments. In the questionnaire, it is asked if the patient is vaccinated or not for HPV, and reasons for it.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Investigators study a French sample of young girls follow-up for systemic lupus
        erythematosus or idiopathic juvenile arthritis. It's a multicenter design.
Prospective Study to Assess DES Re-endothelization in BMS Restenosis and De-novo Lesions
Condition: Stable Coronary Artery Disease; Silent Myocardial Ischemia; In-stent(BMS)Restenosis; De-novo, Atherosclerotic, Coronary Lesions
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Ischemia
Study type: Observational

Summary: 
      The hypothesis of this study is that strut coverage occurs earlier when a DES is implanted to
      treat a BMS restenosis compared with atherosclerotic de-novo lesion. This hypothesis is
      supported by two different observations: first, when a DES is implanted to treat a BMS
      restenosis, stent struts are deployed and drugs are eluted on a soft tissue mostly
      characterized by extracellular matrix with a regular surface. In this case stent malposition
      is less likely to occur compared to atherosclerotic lesion whose surface is often more
      irregular and rich in calcium. Second, patients who develop in-stent restenosis after BMS
      implantation are likely to show a more pronounced neointima hyperplasia and, when a DES is
      implanted to treat restenosis, reendothelialization is likely to occur earlier. If this
      hypothesis was verified, duration of dual antiplatelet therapy could be shortened after DES
      implantation on BMS restenosis with a clinical advantage in terms of bleeding risk.
      Furthermore, a higher bleeding risk is often a reason for choosing a BMS instead of a DES;
      thus, patients presenting with BMS restenosis are likely to have a higher bleeding risk and
      to benefit from a shorter period of dual antiplatelet therapy.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Paziente affected by either stable coronary artery disease or silent myocardial ischemia
Study of the Effect of 12-week Dietary Supplementation With a Multicomponent Nutritional Supplement on Nails and Skin
Condition: Nail Damage
Study type: Interventional

Summary: 
      A double-blind, randomized, placebo-controlled efficacy study in one period will include 34
      participants divided into two groups. One group will receive a test product (n = 22; test
      group; multicomponent dietary supplement including MSM and several vitamins and minerals);
      the other group received placebo capsules (n = 12; placebo group; only modified starch).
      Volunteers will take two capsules / day orally continuously daily for 12 weeks to assess the
      effect of these substances on nail growth and condition and skin.
    


Intervention name(s): Multicomp; Placebo
Intervention type(s): Other; Other
Intervention description(s): Daily dietary supplementation over 12 weeks with test product: food supplement - 2 capsules / day containing together: 20 mg coenzyme Q10,500 mg methyl sulfonyl methane (MSM), 100 mg L-proline, 10 mg L-cysteine (as HCl monohydrate), 2 mg thiamine , 2.4 mg riboflavin, 19 mg niacin, 8.5 mg pantothenic acid, 2.3 mg vitamin B6, 0.15 mg, biotin, 0.0125 mg vitamin B12, 80 mg vitamin C, 5.5 mg vitamin A , 22 mg vitamin E, 10 mg zinc, 0.07 mg selenium, 1.1 mg copper.; Daily dietary supplementation over 12 weeks with placebo product: dietary supplement - 2 capsules / day, containing only modified starch.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
The Interval Between the Time of Second PEG Dose and the Start of the Colonoscopy
Condition: The Timing of Bowel Preparation in Outpatient Colonoscopy
Study type: Observational

Summary: 
      As the duration of the interval between the time of last preparation-agent dose and the start
      of the colonoscopy is increasing, the quality of bowel preparation will be worse.
    

Detailed description: 
      The aim of the present studies is to determine how the duration of the interval of the time
      of last preparation dose and the start of colonoscopy affects the quality of the bowel
      preparation and when the proper timing of the colonoscopy is after completion of last
      preparation regimen
    

Intervention name(s): bowel preparation using split dose of polyethylene glycol
Intervention type(s): Drug
Intervention description(s): polyethylene glycol, split dose(2L/2L), each dose for 1-2hours
Other intervention name(s): Colyte
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult outpatients who undergo colonoscopy
      
Keywords: Bowel preparation; Polyethylene glycols; Colonoscopy; Outpatient
Effect of Massage Therapy on Muscle Fatigue
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The main objective of the current proposal is to investigate the clinical and physiological
      changes triggered by massage therapy in a group of individuals with chronic low back pain
      experiencing muscular fatigue.

      The investigators believe these objectives are in line with the "2014 Massage Therapy
      Research Fund research priorities", since the results produced by these investigations will
      generate knowledge with regard to the short term clinical efficacy of massage therapy and
      will provide critical information related to the physiological mechanisms underlying massage
      therapy clinical effects. Most importantly, the combined assessment of clinical and
      physiological outcomes will also yield key information to identify specific biological
      components of the massage therapy intervention. Determining the presence of a biological
      mechanism is, as for any treatment, considered one of the necessary criteria to declare a
      causal relationship between a specific intervention and its associated clinical effects. The
      investigators strongly believe that the proposed research will contribute to the
      identification of specific mechanisms that will complement the emerging clinical evidence
      supporting massage therapy in the treatment of chronic low back pain.

      The proposed research project will involve researchers and future practitioners of massage
      therapy. In conjunction with a high quality research environment, it is the goal of the
      investigators to create an educational environment for undergraduate and graduate students
      that will foster interdisciplinary collaboration in order to ensure a diversified; high
      quality training of young researchers and clinician scientists working in the field of manual
      therapies.
    


Intervention name(s): Massage
Intervention type(s): Other
Intervention description(s): Massage therapy localized to the back of the individuals for a duration of 30 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: repeated measures crossover
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: massage