bioihbjkbjnl/mcl2 huggingface dataset:
Synaptic Injury and Functional Connectivity in Alzheimer's Disease
Condition: Alzheimer Disease, Late Onset
MeSH terms: Alzheimer Disease; Late Onset Disorders
Study type: Observational

Summary: 
      The purpose of this study is to examine cross-sectional associations between CSF markers of
      synaptic injury (Ng and SNAP-25) and functional connectivity in default and semantic memory
      networks using 3T- fMRI in individuals with MCI (i.e. the earliest clinically detectable
      stage of cognitive impairment) due to AD or mild AD dementia (CDR 0.5-1; n=20) and
      cognitively normal controls (CDR 0; n=20).
    

Detailed description: 
      SPECIFIC AIMS:

      Aim 1: Investigate correlations between CSF biomarkers of synaptic injury (Ng and SNAP-25)
      and functional connectivity (FC) within the default mode network (DMN) using resting-state
      fMRI (adjusting for age, gender, apolipoprotein-E4 [APOE4] genotype, task performance, and
      regional brain atrophy) in MCI/AD and controls.

      Aim 2: Examine correlations between CSF biomarkers of synaptic injury and functional
      connectivity (FC) within the semantic memory network on task-activated fMRI using the Famous
      Name Discrimination Task (FNDT) (adjusting for age, gender, APOE4 genotype, task performance,
      and regional brain atrophy) in MCI/AD and controls.
    

Intervention name(s): CSF analysis; Functional MRI
Intervention type(s): Diagnostic Test; Radiation
Intervention description(s): CSF analysis for tau, p-tau181, Abeta42, and CSF levels of markers of synaptic injury; Functional MRI during resting state and semantic memory task activation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Participants will be recruited from the community and the Memory Disorders Clinic of The
        OSU Wexner Medical Center Department of Neurology. This study will include cognitively
        normal individuals (CDR 0; n=20), individuals with a clinical diagnosis of single-domain or
        multi-domain amnestic MCI due to AD or mild AD dementia (CDR 0.5 or 1; n=20).
      
Biospecimen description: 
      Cerebrospinal fluid (CSF) and plasma
    
Keywords: Synaptic injury
Single-Dose Bioequivalence Study Comparing Two 4 mg Nicotine Lozenges
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess
      bioequivalence between a new nicotine lozenge and a reference nicotine lozenge in healthy
      smokers
    


Intervention name(s): Nicotine lozenge; Nicotine lozenge
Intervention type(s): Drug; Drug
Intervention description(s): Nicotine mint lozenge, 4 mg; NiQuitin mint lozenge, 4 mg
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
A Single-Dose Pharmacokinetics and Safety Study of Ceftobiprole in Pediatric Patients =3 Months to <18 Years of Age
Condition: Staphylococcal Skin Infections; Streptococcal Infections
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Streptococcal Infections; Staphylococcal Skin Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics (how drugs are absorbed, distributed in the body
      and removed over time) and safety of a single dose of ceftobiprole in pediatric patients
      undergoing treatment with systemic antibiotics and may be used to guide dosing
      recommendations for ceftobiprole in children.
    

Detailed description: 
      This purpose of this study will be to assess the pharmacokinetics (how drugs are absorbed,
      distributed in the body and removed over time) and safety of a single dose of ceftobiprole in
      pediatric patients undergoing treatment with systemic antibiotics and may be used to guide
      dosing recommendations for ceftobiprole in children. This study is an open-label (all
      patients will know the identity of the drug) single-dose, pharmacokinetic study in infants
      and children =3 months to <18 years of age who are medically stable as judged by the clinical
      investigator and require therapy with antibiotics. Patients will be given a 2-hour i.v.
      infusion (given directly into the vein) of 7, 10, or 15 mg/kg ceftobiprole. The study
      population will be grouped according to the following 4 age groups: =12 to <18 years of age;
      =6 to <12 years of age; =2 to <6 years of age; and =3 months to <2 years of age. Every
      attempt will be made to include patients of both sexes in each age group. Safety evaluations
      will include clinical laboratory tests (hematology, serum chemistry, and urinalysis),
      pregnancy testing, vital signs, physical examination, monitoring of adverse events, and
      recording of concomitant medications. Patients will be given a single 2-hour i.v. (given
      directly into the vein) infusion of ceftobiprole. The total duration of the study is
      approximately 18 days, including screening and posttreatment.
    

Intervention name(s): Ceftobiprole
Intervention type(s): Drug
Other intervention name(s): Ceftobiprole 7mg/kg - 15kg/kg per day as 2h infusion
Intervention MeSH terms: Ceftobiprole; Ceftobiprole medocaril; Cephalosporins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Staphylococcal Skin Infections; Skin Infections; Streptococcal Infections
Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Observational

Summary: 
      Severe acute respiratory coronavirus 2 (SARS-CoV-2) is a novel coronavirus and the causative
      agent of COVID 19 disease, whose presentation symptoms range from asymptomatic infection to
      mild flu-like symptoms to multi system failure and death, resulting in significant morbidity
      and mortality worldwide. Novel vaccines against the SARS-CoV-2 virus have very recently been
      developed; however, the effectiveness, immune response, and short- or long-term safety of
      these vaccines have not been tested in immunocompromised patients on anti-CD-20 therapy for
      multiple sclerosis (MS) or for other disorders.

      This study will examine the immune response of the Pfizer-BioNTech and Moderna messenger RNA
      (mRNA)-platform vaccines developed against SARS-CoV-2 virus given as standard of care (SOC)
      in MS patients on ocrelizumab.
    


Intervention name(s): SARS-COV-2 mRNA Vaccine
Intervention type(s): Drug
Intervention description(s): Pfizer-BioNTech and Moderna messenger RNA (mRNA)-platform vaccines developed against SARS-CoV-2 virus will be given as standard of care (SOC)
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COVID-negative Multiple Sclerosis patients treated with ocrelizumab
      
Biospecimen description: 
      Patients will have 5 blood draws in-person
    
Keywords: SARS-CoV-2 Vaccine; Ocrelizumab
Severe Anemia Treatment Trials, Pakistan
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the efficacy of two enhanced regimens (deworming and
      multivitamins) in the treatment of severe anemia in pregnant women and children 6-24 months
      of age in Karachi, Pakistan.
    

Detailed description: 
      Anemia continues to be a public health problem of global proportions. Severe anemia
      (hemoglobin, Hb< 70 g/L) is of special concern as it poses a significant health and mortality
      risk. Pregnant women and young children (6-24 months of age) are the two groups at highest
      risk. Severe anemia in pregnant women is associated with an elevated risk of maternal and
      perinatal mortality as well as case fatality. Pakistan, the country in which this study is
      ongoing, may harbor the highest prevalence of severe anemia in South Asia, with as high as
      15% being reported among pregnant women. Comparable rates (11-12%) are also seen among 6-24
      month old children. Iron deficiency is one of the major causes of anemia in young children
      and pregnant women in South Asia. In addition to iron, deficiency of vitamins such as folic
      acid, vitamin A, vitamin C, riboflavin and vitamin E can also inhibit erythropoiesis. Apart
      from these nutritional causes, two other infectious causes of severe anemia are malaria and
      geohelminths. The current international recommendation for treatment of anemia includes iron
      and folic acid but not other vitamins.

      Comparisons: Severely anemic pregnant women and children 6-24 months are randomized to
      receive enhanced treatment of deworming and multivitamins over and above the standard of care
      of iron-folic acid using a 2x2 factorial design.
    

Intervention name(s): Iron-folic acid and mebendazole; Mebendazole; Multivitamins; Mebendazole + Multivitamin
Intervention type(s): Dietary Supplement; Drug; Dietary Supplement; Drug
Intervention description(s): 100 mg iron for pregnant women, 25 mg iron for children
1 mg of folic acid for pregnant women, 100 ug folic acid for children 500 mg of mebendazole for both pregnant women and children; 100 mg twice a day for 3 days; Iron-folic acid also given; Iron-folic acid also given; Includes vitamins A, C, B12, E, and B2; Multivitamins + Mebendazole at 100 mg twice a day for 3 days; Iron-folic acid also given
Intervention MeSH terms: Folic Acid; Mebendazole; Piperazine; Piperazine citrate; DMP 777
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: severe anemia; anthelminthic; multivitamins; pregnancy; children; Pakistan
Safety and Efficacy Study of Intravenous Lidocaine After Colorectal Surgery: LIDOREHAB
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to check if lidocaine intravenous administration during surgery
      and 24 hours after surgery, associated with standardised management of the patient, helps to
      accelerate recovery and to improve the quality of recovery, after surgery for colic or rectal
      neoplasms.
    

Detailed description: 
      One of the purposes of postoperative care is to shorten the duration of recovery, in order to
      reduce the complications and to improve the quality of life. After abdominal surgery, two
      factors can be modified: early mobilisation, thanks to optimal pain control, and return to a
      normal feeding, permitted by transit recovery. Opioids, which are usually used for pain
      control, delay the intestinal transit and can be responsible for side effects like
      drowsiness, nausea, urine retention.

      Lidocaine is a local anaesthetic, which means that it can stop the pain if it is
      administrated around the nerves. It can also be used intravenously. In this way, it is
      supposed to decrease opioid consumption, accelerate intestinal transit and even decrease
      inflammation. Side effects of lidocaine appear at higher plasma concentrations than those
      considered in the study.

      After randomisation, the patient will receive either intravenous lidocaine during the surgery
      and 24 hours after the surgery, or physiological serum (like placebo). Every patient will
      dispose of patient-controlled-analgesia with morphine and of a standardised care management.
      Data will be collected concerning pain level, morphine consumption, psychomotor performances,
      duration of ileus, speed of activity recovery, quality of recovery, and side effects.
      Biological evaluation of lidocaine concentration and inflammation will also be done.
    

Intervention name(s): Lidocaine
Intervention type(s): Drug
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Double blind method; Prospective study; Lidocaine/administration and dosage/therapeutic use; Anaesthetics local/administration and dosage; Opioids/administration and dosage; Pain, postoperative; Perioperative care; Postoperative care; Analgesia, Patient-controlled; Length of stay; Survival analysis; Patient satisfaction; Surgery; Middle age; Adult; Aged
Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if an investigational treatment (teduglutide) is
      safe and effective in Japanese children (age 4 months through 15 years of age) with SBS who
      are dependent on parenteral support. This study will also evaluate how teduglutide moves
      through the body (pharmacokinetics) and how it affects the body (pharmacodynamics).
    


Intervention name(s): Teduglutide
Intervention type(s): Drug
Intervention description(s): 0.05 mg/kg/day SC injection once daily for 24 weeks.
Intervention MeSH terms: Teduglutide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Zidovudine in Infants Exposed to the HIV Before or Soon After Birth
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine if intravenous (IV) and oral zidovudine (AZT) can be safely given to children
      aged 1 day to 3 months who were born to mothers with an HIV infection. Also to determine the
      correct dose of AZT for young children. Of a total of 908 pediatric AIDS cases, 78 percent
      have acquired HIV infection from a mother with HIV infection or at high risk for acquisition
      of HIV, and the number of cases in children is expected to increase over the next several
      years. AZT therapy may be effective in altering the course of the disease and decreasing the
      high mortality in these children. It is also possible that early intervention with AZT may
      prevent the establishment of HIV contracted before, during, or just after birth.
    

Detailed description: 
      Of a total of 908 pediatric AIDS cases, 78 percent have acquired HIV infection from a mother
      with HIV infection or at high risk for acquisition of HIV, and the number of cases in
      children is expected to increase over the next several years. AZT therapy may be effective in
      altering the course of the disease and decreasing the high mortality in these children. It is
      also possible that early intervention with AZT may prevent the establishment of HIV
      contracted before, during, or just after birth.

      The children entered in this study receive oral and IV AZT. The first 6 children receive 2 IV
      doses and 2 oral doses over a 2-week period, then 4 weeks of continuous oral dosing (4 doses
      per day). The remaining 12 children receive

      1 IV dose and 1 oral dose followed by 6 weeks of oral AZT (4 doses per day) and a second IV
      dose at the end of the study. Each child is under the care of a specialist in pediatrics and
      has a physical examination and laboratory tests before starting AZT and 6 times while taking
      AZT to make sure the drug is not having a toxic effect on the child. A single cerebrospinal
      fluid (CSF) sample is taken from the last 12 children entering the study, so that the level
      of the AZT reaching the brain can be measured. The child returns to the hospital or clinic 4
      weeks after the end of therapy to make sure that there are no delayed toxic effects.
    

Intervention name(s): Zidovudine
Intervention type(s): Drug
Intervention MeSH terms: Zidovudine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pregnancy; Pregnancy Complications, Infectious; Infant, Newborn, Diseases; Infusions, Intravenous; Drug Evaluation; Administration, Oral; Acquired Immunodeficiency Syndrome; Zidovudine
Prophylactic Effects of Ondansetron, Ramosetron, and Palonosetron on Patient-Controlled Analgesia Related Nausea and Vomiting After Urologic Laparoscopic Surgery
Condition: Laparoscopic Marsupialization of Renal Cyst
MeSH terms: Vomiting
Study type: Interventional

Summary: 
      The aim of this prospective randomized controlled study was to compare the prophylactic
      effects of intravenous single dose of ondansetron, ramosetron, and palonosetron on
      PCA-related nausea and vomiting after urologic laparoscopic surgery.
    


Intervention name(s): Ondansetron; Ramosetron; Palonosetron; Normal saline inj
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ondansetron/single injection/4 mg/IV; Ramosetron HCl/single injection/0.3mg/IV; Palonosetron HCl/single injection/0.075mg/IV; normal saline injection 2ml
Other intervention name(s): ONSERAN; NASEA; ALOXI
Intervention MeSH terms: Ondansetron; Palonosetron; Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
PRAsugrel or clopIdogrel In Acute Coronary SyndromE With CYP2C19 GENEtic Variants
Condition: Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesize that reduced loading dose of prasugrel followed by reduced
      maintenance dose of prasugrel in acute coronary syndrome patients with CYP2C19 polymorphism
      undergoing percutaneous coronary intervention might exhibit lower platelet reactivity 24
      hours and 30 days later which is associated with major adverse cardiovascular events.
    

Detailed description: 
      Antiplatelet treatment is recommended worldwide for the secondary prevention and clopidogrel
      is an essential drug. But clopidogrel has limited value because of its pharmacodynamic
      interpatient variability and delayed onset time.

      It is well known that patients who carry a common reduced-function CYP2C19 allele have a
      lower level of active metabolite of clopidogrel, diminished platelet inhibition, and
      furthermore, higher rate of major adverse cardiovascular events than noncarriers.

      To achieve maximum plateau more rapidly and reduce the rate of high on-treatment platelet
      reactivity, higher loading dose of clopidogrel, up to 600 mg, is recommended. Although,
      however, the higher loading dose of clopidogrel, many patients still remain as non-responder.

      Incidence of patients with clopidogrel resistance, especially CYP2C19*2 and *3, which
      encounter loss function, is higher in Eastern Asian peoples than Western peoples. Some
      studies report incidence rate of clopidogrel resistance in Eastern Asian peoples up to 99%.

      However, the metabolism is not influenced by the presence of CYP2C19 genetic variation and
      prasugrel shows potent platelet inhibition. Although prasugrel exhibit potent platelet
      inhibition, recent reports describe the possible over inhibition of platelet especially in
      the East Asian people.

      The investigators are going to compare the efficacy and safety of loading dose of prasugrel
      30 mg which is lower than conventional loading dose followed by 5 mg/day which is also lower
      than conventional maintenance dose for 30 days and loading dose of clopidogrel 600 mg
      followed by 75 mg/day for 30 days.
    

Intervention name(s): Prasugrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Loading with prasugrel 30 mg followed by daily administration of prasugrel 5 mg; Loading with clopidogrel 600 mg followed by daily administration of clopidogrel 75 mg
Other intervention name(s): Effient; Plavix; Plavitor
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: reduced-function CYP2C19 allele; high platelet reactivity; clopidogrel; prasugrel
Effects of Extensive Abdominal Lavage on Postoperative Inflammation Following Full Thickness Excision of Deep Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      Surgical treatment of deep endometriosis with bowel involvement is widely accepted to require
      complete excision of all endometriosis also when invading the bowel. In case of opening of
      the bowel a subsequent inflammatory reaction follows the surgery, as demonstrated by the
      increase in blood levels of C-reactive protein during the first post-operative week.
      Furthermore it increases the risk of post-operative bowel complications. In case of
      peritonitis the general surgeons use extensive lavage in order to decreases mortality,
      morbidity and post-operative adhesions formation, as demonstrated in animal models and
      clinically in patients with peritonitis. Considering the efficacy of extensive lavage for
      peritonitis and the inflammatory reaction as judged by the increased C-reactive protein (CRP)
      following full thickness deep endometriosis resection from the bowel, the study aims to
      evaluate, in women undergoing this procedure, the effect of extensive abdominal lavage on
      abdominal inflammation and post-operative bowel complications.
    

Detailed description: 
      In a consecutive series 20 women with full thickness resection for deep endometriosis
      received randomly, at the end of the procedure, a standard abdominal rinsing (n=10) or
      extensive abdominal lavage with 8 Liters of saline (n=10). C-reactive protein and white blood
      cell count values were collected daily for 7 days. Women were observed for complications
      during the first post-operative week and during the follow up at 1 and 6 months.

      The primary end point was to evaluate the effects of extensive abdominal lavage on
      post-operative inflammation. Secondary end-point was to explore the potential protective rule
      against post-operative bowel complications.
    

Intervention name(s): Extensive abdominal lavage; Rinsing of the abdomen
Intervention type(s): Procedure; Procedure
Intervention description(s): Extensive lavage of the abdomen with 8 liters of saline at the end of the surgical procedure; Standard rinsing of the abdomen with some 0,5 liters of saline at the end of the surgical procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endometriosis; abdominal lavage; bowel perforation; discoid resection; laparoscopy