bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Honey Supplementation on Serum Leptin in Malnourished Infants and Children
Condition: Malnourished Infants and Childern
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This study was a randomized single blinded case control prospective intervention study.
    

Detailed description: 
      Fifty infants and children of both sexes, aged 6 months to 3 years, with malnutrition were
      consecutively recruited from the Nutrition Clinic of the Pediatric Hospital, Ain Shams
      University.

      These patients were randomly assigned following a simple randomization procedure
      (computerized random numbers) to either the honey group (group 1) or the malnourished control
      group (group 2) with a 1:1 allocation ratio. Each group consisted of 25 patients.

      An additional 25 healthy infants and children with the same age range and of both sexes were
      recruited from the outpatient pediatric clinic of Ain Shams University, Egypt as a healthy
      control group (group 3).

      The inclusion criteria was in whom the under nutrition is caused by inadequate energy intake,
      while the exclusion criteria included markedly ill patients, and children with chronic or
      severe systemic illness or malabsorption disorders, chromosomal aberrations, inborn errors of
      metabolism and cerebral palsy.

      History taking with special emphasis on the dietetic history, history of any disease that
      might interfere with the nutrient intake or their use by the body and history of any acute or
      chronic illness. And full body Examination which include anthropometric measurements weight,
      height and mid arm circumference.

      Each patient in the intervention group or honey group or group 1 took oral honey in a dose of
      2ml/kg/day for 8 weeks; the calculated dose of honey was dissolved in water with a ratio of
      1: 3, respectively, and then ingested by the patient before breakfast.
    

Intervention name(s): honey supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): honey supplementation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Compassionate Use of Ceftriaxone in Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis; Cerebrospinal Fluid; Neurodegenerative Disease; Motor Neuron Disease
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases; Sclerosis
Study type: Observational

Summary: 
      Amyotrophic lateral sclerosis is a uniformly progressive and fatal neurodegenerative disorder
      for which there is no known cure. In a novel attempt to widen the search for potential
      therapeutic agents, a NINDS- led cooperative group performed an in-vitro screening program of
      1040 FDA approved drugs in over 28 assays relevant to various neurodegenerative disorders.
      Several cephalosporins showed hits in ALS relevant assays. Efficacy was noted in models
      suggesting increased expression of the astrocytic glutamate transporter, EAAT2, as well as
      models of superoxide dismutase mediated toxicity. Ceftriaxone is a third generation
      cephalosporin with good CNS penetration, a long half-life, and was effective in both types of
      ALS assays. Ceftriaxone has calcium binding activity, antioxidant properties, and rescues
      motor neurons in culture from chronic glutamate toxicity. Since completion of the original
      NINDS screen, Ceftriaxone has been shown to increase by three fold EAAT2 activity in rodent
      brains, due to ceftriaxone's ability to increase EAAT2 promotor activation This program is
      for the use of ceftriaxone in ALS for compassionate care. Currently ceftriaxone is approved
      by the U.S. Food and Drug Administration (FDA) for treating bacterial infections but not for
      treating ALS. However, there is an ongoing phase I study -by NEALS Consortium and the
      National Institute of Health- with three cohorts -a placebo group and two groups receiving
      either 2 or 4 grams of ceftriaxone daily-. Unfortunately there are only a limited number of
      patients being enrolled and the next phase of the project will not be undertaken until next
      year. At this point there are ALS patients unable to participate in this Phase I trial and
      unlikely to be alive when the next phase of study begins. Some of these patients want to
      receive the drug and are willing to pay for the drug and nursing care. We are therefore
      requesting a compassionate use protocol for these patients who request the medication and are
      willing to pay for the drug and nursing care to administer it. Dr. Terry Heiman-Patterson
      will supervise the administration and safety monitoring including labs for renal and hepatic
      function as well as IV site inspection.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ALS clinic patients at MDA/ALS Center of Hope.
      
Keywords: Amyotrophic Lateral Sclerosis; Cerebrospinal Fluid; Neurodegenerative Disease; Motor Neuron Disease; Autonomic Nervous System; Neurodegenerative Diseases; Movement Disorders
Talking Pictures Social Media Intervention in Reducing Depressive Symptoms and Improving Spiritual Well-Being and Quality of Life in Adolescent and Young Adult Cancer Patients
Condition: Malignant Neoplasm
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      This clinical trial studies how well Talking Pictures social media intervention works in
      reducing depressive symptoms and improving spiritual well-being and quality of life in
      adolescent and young adult cancer patients. Talking Pictures social media intervention may
      help doctors better learn how to most effectively provide psychosocial support to adolescent
      and young adult cancer patients.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the feasibility and acceptability of a 10-week application (app)-based
      intervention.

      II. To assess the impact of the intervention on depressive symptoms, spiritual well-being and
      quality of life.

      III. To examine the content of participants recorded narratives for salient themes related to
      weekly content areas (e.g. identity, meaning-making, hopes, fears) in order to better
      understand the unique experiences and challenges of adolescent and young adult (AYA)
      patients.

      OUTLINE:

      Participants undergo Talking Pictures social media intervention for 10 weeks, receiving
      weekly assignments via email with requirements to use the Pixstori app to take and upload
      photographs with verbal narratives attached to a website. Participants can then share their
      pixstories to a group page and view and respond to others' pixstories.

      After completion of study, participants are followed up at 2 months.
    

Intervention name(s): Internet-Based Intervention; Quality-of-Life Assessment; Questionnaire Administration
Intervention type(s): Other; Other; Other
Intervention description(s): Undergo Talking Pictures social media intervention; Ancillary studies; Ancillary studies
Other intervention name(s): Quality of Life Assessment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 in Healthy Adults
Condition: Cytomegalovirus Infection
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647
      and mRNA-1443 cytomegalovirus vaccines in healthy adults
    


Intervention name(s): mRNA-1647; mRNA-1443; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): Escalating dose levels; Escalating dose levels; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: cytomegalovirus vaccine; mRNA-1647; mRNA-1443; Moderna
Pethidine Analgesia on Labor Duration
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Observational

Summary: 
      Although opioid analgesics are used to treat labor pain, there are still concerns about their
      side effects.

      The researchers in this study; aimed to evaluate the effect of pethidine on active phase
      duration of labor, labor pain and maternal-neonatal.

      50 mg pethidine will be administered intramuscularly to the cases to be included in the study
      group. The patients in the control group will be given placebo injections.

      Vital signs of all cases included in the study will be checked at 0, 5, 15, 30, 45 and 60
      minutes. Pain will also be assessed by Visual Analogue Scale (VAS) before injection and at
      the 1st and 2nd hour after injection. Delivery times, maternal side effects, neonatal apgar
      scores and fetal findings will be recorded.
    


Intervention name(s): pethidine; Placebo - Concentrate
Intervention type(s): Drug; Drug
Intervention description(s): Pethidine 50 mg intramuscular (IM) injection was performed when cervical dilatation was at or greater than 4 cm and the cardiotocogram uterine contraction recordings of 200 Montevideo units was reached. Opioid analgesia (pethidine HCl - 50 mg I.M.) was given following amniotomy.; Intramuscular saline was administered to the control group as placebo. Salin intramuscular (IM) injection was performed when cervical dilatation was at or greater than 4 cm and the cardiotocogram uterine contraction recordings of 200 Montevideo units was reached. salon was given following amniotomy.
Intervention MeSH terms: Meperidine
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inclusion criteria were nulliparous and multiparous patients with singleton pregnancies
        between 37 and 41 completed weeks (according to last menstrual period).
      
Keywords: Analgesia; labor; pethidine; Active Phase
Effect of the Hands- on McKenzie Program on Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain (LBP) is one of most prevalent types of musculoskeletal pain and is strongly
      related to disability. The McKenzie method is one of most popular treatment options for LBP.

      The objectives of this study are to determine the effect of the hands-on McKenzie program on
      pain, disability, spine mobility, and posture deviations in subjects with derangement low
      back pain.
    

Detailed description: 
      Thirty eight patients with sub-acute and chronic LBP will be randomly assigned to the
      McKenzie group (MG) or the control group (CG). The MG will perform exercises with the
      hands-on procedure (three sessions per week) for two weeks, while the CG will perform only
      exercises for two weeks. Both groups will do a home exercise program. The outcome assessments
      will measure pain by the Pain Numerical Rating Scale (NPRS), the level of disability through
      the Oswestry Disability Index (ODI), spine mobility by range of motion (ROM) for the lumbar
      spine, and the centralization of symptoms and the postural alternation by postural analysis
      grid (PAG). By using SPSS version 20, a paired t-test will be use to study the effect of the
      McKenzie program before and after treatment. An independent t-test will be used to study the
      significance between the two groups.
    

Intervention name(s): McKenzie group; Control group
Intervention type(s): Other; Other
Intervention description(s): Mobilization for lumbar spine,TENS,Exercises,Postural education ,Home exercises program.; TENS,Exercises,Postural education ,Home exercises program.
Other intervention name(s): without any Hand -on Technique.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
OmniHeart Trial: Macronutrients and Cardiovascular Risk
Condition: Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Hypertension
MeSH terms: Cardiovascular Diseases; Heart Diseases; Atherosclerosis
Study type: Interventional

Summary: 
      To compare the effects on blood pressure and plasma lipids of three different diets--a
      carbohydrate-rich diet, a protein-rich diet, or a diet rich in unsaturated fat.
    

Detailed description: 
      BACKGROUND:

      While there is widespread consensus that the optimal diet to reduce cardiovascular risk
      should be low in saturated fat, the type of macronutrient that should replace saturated fat
      (carbohydrate, protein or unsaturated fat) is a major, unresolved research question with
      substantial public health implications. The study will evaluate these three dietary
      approaches by studying their effects on established coronary risk factors and a selected
      group of emerging risk factors.

      DESIGN NARRATIVE:

      The study design was a randomized, three period cross-over feeding study that compared the
      effects on blood pressure and plasma lipids of a carbohydrate-rich diet patterned after the
      DASH diet (CARB) to two other diets, one rich in protein (PROTEIN) and another rich in
      unsaturated (UNSAT) fat, predominantly monounsaturated fat. The DASH diet has been shown to
      reduce blood pressure and LDL-cholesterol substantially, and is currently recommended by
      policy makers. During a one week run-in, all participants were fed samples of the three study
      diets (CARB, PROTEIN and UNSAT). Using a three period cross-over design, participants were
      then randomly assigned to the CARB, PROTEIN or UNSAT diet. Each feeding period lasted six
      weeks; a washout period of at least two weeks separated each feeding period. Throughout
      feeding (run-in and the three intervention periods), participants were fed sufficient
      calories to maintain their weight. Trial participants were 30 years of age or older, with
      systolic blood pressure of 120-159 mmHg or diastolic blood pressure of 90-99 mmHg. Primary
      outcomes variables were blood pressure and the established plasma lipid risk factors (LDL-C,
      HDL-C and triglycerides). Secondary outcomes include total cholesterol, apolipoproteins
      VLDL-apoB, VLDL-apoCIII, apolipoprotein B, non-HDL cholesterol, and lipoprotein(a).
    

Intervention name(s): CARB
Intervention type(s): Other
Other intervention name(s): UNSAT; PROTEIN
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Individuals were randomized to a sequence of 3 diets (CARB, UNSAT, PROTEIN)
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
BALANCE Diet Implementation in Primary Health Care: a Cluster Randomized Type II Hybrid Implementation Study
Condition: Obesity; Hypertension; Diabetes; Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional

Summary: 
      This is an implementation type II hybrid study with randomisation in cluster, whose objective
      is to compare two strategies of implementation of the Brazilian cardioprotective diet
      guidelines in primary health care in two Brazilian cities. All health professionals from the
      health units (clusters) randomized to the intervention group will receive training on the
      subject. The health professionals from the health units randomized to the control group will
      follow the usual activities, receiving only the printed guidelines, as usually done. After 6
      months, the prescription rate of the Brazilian cardioprotective diet will be evaluated, as
      well as the quality of the diet of patients in both groups.
    


Intervention name(s): Training Group
Intervention type(s): Other
Intervention description(s): Training for prescribing the Brazilian cardioprotective diet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster-Randomized Trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Effects of Massage on the Immune System of Preterm Infants
Condition: Premature Birth; Stress
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Infants in the Neonatal Intensive Care Unit (NICU) are exposed to stressful stimuli such as
      loud noises, bright lights, blood drawing, suctioning, and intubation, and are frequently
      left in isolation with minimal proper interaction. Stress has been demonstrated to exert a
      negative effect on the immune system. Different psychological interventions, including
      relaxation, have been used in efforts to reduce stress, and several of these techniques have
      been shown to improve cellular immunity. Massage therapy (MT) has been used to reduce stress
      in premature infants and has been associated with weight gain, shorter hospital stay, and
      improvement in mental/motor development. While MT has been shown to increase the number and
      function of natural killer (NK) cells in healthy adults and in adults infected with HIV, the
      effect of MT on the immune system of children, including premature infants, has never been
      investigated. The investigators hypothesize that, in premature infants, MT will enhance the
      immune system. One hundred and twenty stable premature infants meeting selection criteria
      will be randomized to massage and sham treatment groups. Immunologic evaluation will be
      performed on both groups at baseline, midway and at the end of therapy. Physicians, nurses,
      and parents will be masked. The investigators' unique and innovative study will be the
      largest study in this area and will provide valuable information on potential immune
      parameters associated with stress reduction and improved development in premature infants
      undergoing massage therapy.
    

Detailed description: 
      Already contained in Brief Summary
    

Intervention name(s): massage therapy; Sham
Intervention type(s): Other; Other
Intervention description(s): massage therapy to stable preterm infants; Sham (placebo) provided to the control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Massage; immune system; preterm infants
Artificial Intelligence in Lung Ultrasound for Preeclampsia
Condition: Preeclampsia; Lung Edema
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      A total of eight quadrants of standard lung US examination was performed to all pregnant
      women with preeclampsia within the scope of the study by the same anesthesiologist, dividing
      each hemithorax into four regions through the parasternal, anterior axillary, posterior
      axillary vertical lines, and the horizontal line assumed to pass under the nipple. The
      resulting images were stored in digital media. A Lung US examination was performed once for
      an average of 5-10 minutes. The presence of B lines was investigated in the examination.

      The case was defined as interstitial edema when the B lines, which are defined as vertical
      linear hyperechoic reverberation artifacts representing the edematous interlobular
      septa/alveoli, extend posteriorly from below the pleural line and moving in sync with lung
      movements, are found in two or more lung areas. B-lines were determined for each case and
      reported in standard form in terms of number and morphology. The diagnostic accuracy of B
      lines was determined with the artificial intelligence supported SmartAlpha Rievi 1300
      software program. B-lines validated by artificial intelligence assisted algorithm in all
      stored digital images were reported blindly by another anesthesiologist experienced in lung
      US. The clinical features, laboratory parameters, and intraoperative hemodynamic data of the
      cases were recorded to be evaluated in terms of relationship with lung US data.

      We predict that the application of lung US with artificial intelligence software will provide
      an opportunity to quickly evaluate the clinic of preeclamptic pregnant women who are
      frequently operated on in emergency conditions.
    

Detailed description: 
      After ethics committee approval, standard lung ultrasound (US) examination in eight quadrants
      was performed to search presence of B lines in 35 ASA III-IV parturients with preeclampsia by
      the same anesthesiologist. Interstitial edema was defined by recognition of the B lines in
      two or more lung regions. The digital images of B-lines verified with artificial intelligence
      (AI) were evaluated blindly by another anesthesiologist experienced in lung US.

      After assigning preeclamptic patients as mild or severe; demographic, hemodynamic and
      labarotary results were compared. Then, lung US findings (A pattern, 3 B lines and 1 or 2 B
      lines) were documented. Additionally, amount of protein / 24 hr, amount of fluid infusion
      (crystalloid or colloid) and hemodynamic parameters acording to lung US findings were
      compared.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        35 parturients who diagnosed with preeclampsia
      
Keywords: preeclampsia; lung ultrasound; artificial intelligence
Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk
Condition: HIV; Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective cohort study focusing on HIV negative women. The investigators want to
      learn how the contraceptive methods of depot medroxyprogesterone acetate (DMPA), etonogestrel
      implant (Eng-Implant), levonorgestrel intrauterine device (Lng-IUD) and the ParaGard® T 380A
      Intrauterine Copper Contraceptive impact the vaginal immune environment.
    

Detailed description: 
      The three proposed aims will evaluate the effect of four contraceptive methods (depot
      medroxyprogesterone acetate (DMPA), etonogestrel implant (Eng-Implant), levonorgestrel
      intrauterine device (Lng-IUD) and ParaGard® T 380A Intrauterine Copper Contraceptive) on: (1)
      HIV target immune cells within the female genital mucosa; (2) markers of T-cell activation
      and trafficking within the female genital mucosa; and (3) secreted cytokines and chemokines
      within the female genital mucosa.
    

Intervention name(s): Depot medroxyprogesterone acetate (DMPA); Etonogestrel implant (Eng-Implant); Levonorgestrel intrauterine device (Lng-IUD); ParaGard® T 380A Intrauterine Copper Contraceptive
Intervention type(s): Drug; Device; Device; Device
Intervention description(s): DMPA will be administered every 12 weeks at the standard dose of 150 mg IM, beginning from week 3 of study enrollment and repeated at week 15.; A standard nexplanon rod implant will be placed at study week 3 by a trained clinician.; A standard Mirena IUD will be placed at study week 3 by a trained clinician.; A standard ParaGuard IUD will be placed at study week 3 by a trained clinician.
Other intervention name(s): Depo Provera; Nexplanon; Mirena; ParaGuard
Intervention MeSH terms: Copper; Medroxyprogesterone Acetate; Contraceptive Agents; Levonorgestrel; Medroxyprogesterone; Etonogestrel
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HIV-negative