bioihbjkbjnl/mcl2 huggingface dataset:
Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis
Condition: Non-Insulin Dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      In most diabetic patients where low blood magnesium levels occur the important depletion of
      cellular levels is usually not measured. This study will measure both blood and oral mucosal
      cell magnesium levels before and after 3 months of supplementation with magnesium tablets
      (the recommended dietary amount of 336 milligrams per day). These magnesium levels will be
      correlated with blood levels of indicators of inflammation (eg C reactive protein) to see
      whether the cellular levels are more reliable than blood levels of magnesium for appropriate
      treatment of magnesium deficiency in diabetic patients.
    

Detailed description: 
      The anti-inflammatory effects of oral magnesium (Mg) supplementation of diabetic and
      metabolic syndrome patients with low serum Mg levels have been studied with increased
      interest in recent years. However, serum magnesium levels only represent less than one
      percent of total body magnesium; whereas cellular deficiency of Mg is a more reliable
      parameter to assess repletion of this essential mineral for correlation with indices of
      inflammation.

      The proposed research will compare the efficacy of a 3 month period of treatment with oral Mg
      of diabetic patients selected for elevations of CRP, TNFα and other markers of inflammation
      on cellular and serum levels of Mg.

      We anticipate that 50 hypomagnesemic diabetic patients will be selected for 3 months of
      supplementation with 336 mg of Mg lactate tablets. The repletion of serum and oral epithelial
      cell Mg levels will be correlated with responses of CRP, TNFα, substance P, HgbAIc and
      oxidative/nitrosative (ROS/RNS) stress parameters before and after treatment. Individuals
      will be selected from the Dasman Diabetes Institute in Kuwait. With completion of these
      analyses, a collaborative manuscript with joint authorship will be prepared and submitted for
      publication.
    

Intervention name(s): magnesium lactate
Intervention type(s): Dietary Supplement
Intervention description(s): Patient will be given 4 tablets a day of study supplement (Magnesium Lactate) for 3 months. Magnesium cellular and serum levels will be compared prior and post intervention.
Other intervention name(s): MagTabSR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypomagnesemia, Cellular Mg, Inflammation, Diabetes Mellitus
Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor,
      itraconazole, on the steady-state PK of AVP-923 and AVP-786.
    

Detailed description: 
      A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.
    

Intervention name(s): AVP-923; AVP-786; Itraconazole
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Sporanex
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Drug-drug interaction; Healthy Volunteers; Pharmacokinetics; deuterated dextromethorphan; dextromethorphan; dextromethorphan with quinidine; deuterated dextromethorphan with quinidine; itraconazole
Timing of Umbilical Cord Clamping in Term Cesarean Deliveries
Condition: Cesarean Delivery; Delayed Separation of Umbilical Cord
Study type: Interventional

Summary: 
      The aim of this study is to show that delayed umbilical cord clamping or milking of the
      umbilical cord in pregnant women undergoing elective cesarean delivery might have better
      effects than early clamping, on neonatal results without causing maternal hemorrhage or
      negatively affecting the neonatal outcome , and to compare the superiority of these three
      methods to each other.
    

Detailed description: 
      Late clamping of the umbilical cord has been shown to have positive effects such as higher
      neonatal hemoglobin level, higher iron stores in the newborn around three to six months, and
      better neurological development. In 2017, American College of Obstetricians and Gynecologists
      (ACOG) recommended a minimum 30-60 seconds delayed clamping of the cord after a minimum of
      30-60 seconds, regardless of the delivery method, in both term and preterm newborns. In
      addition, optimal placental transfusion can be achieved due to strong uterine tonus in
      vaginal delivery. However, this is not possible due to decreased uterine tonus and time
      constraint in cesarean delivery. The main concern in delayed clamping and milking of the
      umbilical cord is the possibility of maternal anemia due to excessive maternal blood loss in
      the short term, the need for maternal blood transfusion or maternal intensive care support,
      and the possibility of conditions such as hyperbilirubinemia, symptomatic polycythemia, and
      long hospital stay that may cause the need for phototherapy in the newborn. Although there
      are many studies in the literature regarding the neonatal results of the clamping timing of
      the umbilical cord, there are a limited number of articles regarding the results in patients
      who underwent term elective cesarean section. The aim of this study is to show that delayed
      umbilical cord clamping or milking of the umbilical cord in pregnant women undergoing
      elective cesarean delivery might have better effects than early clamping, on neonatal results
      without causing maternal hemorrhage or negatively affecting the neonatal outcome , and to
      compare the superiority of these three methods to each other.
    

Intervention name(s): Delayed umbilical cord clamping; Early umbilical cord clamping; Milking of the umbilical cord
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The umbilical cord will be clamped 60 seconds after the baby is born.; The umbilical cord will be clamped 15 seconds after the baby is born.; The cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cesarean delivery; Umbilical cord clamping; Delayed umbilical cord clamping
Variability of Daily Iodine Intake: The Effects of Intra- and Inter-individual Variability in Iodine Nutrition Studies
Condition: Iodine Deficiency
Study type: Observational

Summary: 
      Iodine status in populations is assessed using urinary iodine concentration (UIC) measured in
      spot urine samples. The iodine intake is classified as deficient, sufficient, or excessive
      iodine based on the median UIC (mUIC). However, this approach has limitations, as it does not
      quantify the prevalence of individuals with habitually deficient or excess iodine intakes.
      The EAR cut-point method has the potential to quantify prevalence of iodine deficiency and
      excess. However, little is known about the effects of the inter- and intra-individual
      variance of UIC.

      The aim of the study is to quantify the intra-individual variability in dietary iodine
      intake. The overall goal is to estimate the prevalence of iodine deficiency and excess in the
      study population and propose sample size recommendations for future iodine nutrition
      population studies. The results will provide evidence guiding international recommendations
      for iodine nutrition studies.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): This is an observational study and no interventions will be administered.
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy women of reproductive age and residents of Switzerland since at least 12 months
      
Biospecimen description: 
      Urine, Dried blood spot
    
Keywords: Iodine; Urinary iodine concentration
Insulin Glargine U300 vs Insulin Degludec U100 in Impact on the Glycaemic and Cardiovascular Factors
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the impact of insulin degludec (IDeg-100) and insulin glargine U300 (IGlar-300) on
      cardiovascular risk parameters - glycaemic variability (GV), oxidative stress, arterial
      stiffness and lipid parameters - in insulin naive patients with DMT2.
    

Detailed description: 
      We recruited a total of 25 patients (23 completed the study) with T2DM who had uncontrolled
      disease on two or more oral antidiabetic drugs. After the wash-up period, they were
      randomized alternately to first receive either IDeg-100 or IGlar-300 along with metformin.
      Each insulin was applied for 12 weeks. At the beginning and the end of each phase,
      biochemical and oxidative stress parameters were analysed and augmentation index was
      measured. On three consecutive days prior to each control point, patients performed a 7-point
      SMBG profile. Oxidative stress was assessed by measuring thiol groups and hydroperoxides
      (d-ROM) in serum. For augmentation index measuring, we used SphygmoCor (AtCor Medical,
      Sydney, Australia) which allow non-invasive measurement of AIx on radial artery using strain
      gauge transducer placed on the tip of a pencil-type tonometer. This method is based on the
      principle of applanation tonometry
    

Intervention name(s): Degludec; Glargine U300
Intervention type(s): Drug; Drug
Intervention description(s): treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles; treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus type 2; degludec; glargine U300; glucose variability; lipids; arterial stiffness; oxidative stress
Dose Range Study to Evaluate the Efficacy and Safety of AV5080 in Patients With Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      Assessment of the effect reached with the different doses of AV5080 on the duration and
      severity of influenza symptoms based on the incidence of their resolution within 96 hours
      from study treatment initiation compared to Placebo.

      The absence of influenza symptoms or their reduction to mild severity for at least 24 hours
      indicates the resolution of influenza.
    

Detailed description: 
      The study was a multi-center, double-blind, randomized, parallel- group clinical study to
      assess the efficacy and safety of different AV5080 doses as compared to placebo in patients
      with influenza during the 5-day treatment period.

      The study included only patients with influenza of mild and moderate severity, without
      complications, both outpatients and those hospitalized for epidemiological reasons. The study
      included three periods for each patient: Screening, randomization, and study treatment,
      follow up period.
    

Intervention name(s): AV5080; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Hard gelatin capsules with a white body; Hard gelatin capsules with a white body
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Influenza treatment in adults
Randomized Study to Compare the Bioavailability of Three Mometasone Furoate 0.1% Topical Lotions
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this study was to compare the relative vasoconstrictive effects of two test
      and one reference Mometasone Furoate 0.1% Topical Lotions in healthy, female subjects.
    


Intervention name(s): Mometasone Furoate 0.1% Topical Lotion-Reference Product; Mometasone Furoate 0.1% Topical Lotion-Test product 1; Mometasone Furoate 0.1% Topical Lotion-Test Product 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Small amount applied and evaluated over the course of two days. ChromaMeter used to measure response.; Small amount applied and evaluated over the course of two days. ChromaMeter used to measure response.; Small amount applied and evaluated over the course of two days. ChromaMeter used to measure response.
Intervention MeSH terms: Mometasone Furoate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Community Volunteers
      
Keywords: Bioequivalence; Mometasone Furoate
Influence of Ribavirin on the Initial Virological Response in Treatment Naïve Patients With Hepatitis C Genotype 1 Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study examined the influence of ribavirin on the initial virological response in
      treatment-naïve participants with chronic hepatitis C, genotype 1. Participants were
      randomized to 1 of 3 treatment groups to receive placebo, ribavirin monotherapy 1000
      milligrams (mg) to 1200 mg orally daily depending on body weight or pegylated interferon
      (PEG-IFN) alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously (SC) weekly, for 6 weeks.
      Following the initial 6 weeks, all participants received combination therapy with PEG-IFN
      alfa-2a plus ribavirin (Copegus®) for 12 weeks. If there was an initial virological response
      after 12 weeks of combination therapy, treatment could be continued for a further 36 weeks
      outside of the study.
    


Intervention name(s): Pegylated Interferon (PEG-IFN) alfa-2a; Placebo; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pegylated interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.; Ribavirin matching placebo orally (PO) twice daily for 6 weeks.; Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
Other intervention name(s): Pegasys®; Copegus®
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Extending Veteran Participation in the Validation of the SCI-QOL/CAT
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      The field of spinal cord injury rehabilitation medicine lacks a reliable, patient reported,
      health-related quality of life measurement tool. The National Institute of Health has
      provided funding to develop a spinal cord injury-specific, quality of life survey tool in
      non-Veterans with spinal cord injury called the spinal cord injury-quality of life (SCI-QOL).
      This quality of life survey asks questions regarding physical/medical, emotional, and social
      health as it relates to individuals with spinal cord injury.

      The purpose of this study is to include a Veteran population in the making of the quality of
      life survey. Each participant will be asked to complete a packet of quality of life
      questions. Participants will be given the opportunity to take the survey a second time,
      either 7-14 days or 5-7 months after the first survey. Taking the survey twice will allow the
      research team to test the reliability of the survey. Comparing the SCI-QOL with other legacy
      measures will allow the investigators to test the validity of the survey.

      Additionally, the investigators will be testing the SCI-QOL between Veterans and non-Veterans
      with SCI to determine if there are differences in their self-reported quality of life.

      This study will be recruiting participants at the James J. Peters Veterans Affairs Medical
      Center, Bronx, New York and the James A. Haley Veterans Affairs Hospital, Tampa, Florida.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Veterans at the James J. Peters Veterans Affairs Medical Center or the James A. Haley
        Veterans Affairs Hospital with spinal cord injury
      
Keywords: Spinal Cord Injuries; Quality of Life
Therapeutic Effectiveness of Different Machines in Intense Pulsed Light Treatment of Meibomian Gland Dysfunction
Condition: MGD-Meibomian Gland Dysfunction
MeSH terms: Meibomian Gland Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aimed to determine the therapeutic effectiveness of different machines in intense
      pulsed light (IPL) treatment of meibomian gland dysfunction (MGD). Subjects diagnosed with
      MGD underwent three sessions of IPL treatment in a control (M22) treatment group or
      experimental (OPL-I) treatment group and were followed up three to four weeks after each
      session. Tear breakup time (TBUT), meibomian gland secretion scores (MGSS), meibomian gland
      meibum scores (MGMS), corneal fluorescein staining (CFS) scores, and the Standard Patient
      Evaluation of Eye Dryness (SPEED) was used to assess eye dryness signs and symptoms at
      baseline and follow-up visits.
    


Intervention name(s): Intense pulsed light; 0.3% hyaluronic acid eye drops
Intervention type(s): Procedure; Drug
Intervention description(s): Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.; 0.3% hyaluronic acid eye drops (Hialid; Santen, Osaka, Japan) four times a day during the study, including the follow-up period.
Intervention MeSH terms: Ophthalmic Solutions; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The trial aimed to assess therapeutic effectiveness of the study treatment arm (OPL-I with the dual filter system; Miracle Laser systems, Wuhan, China) to the control treatment arm (M22 with a single filter; Lumenis, Yokneam, Israel). Each MGD patient underwent three treatment sessions at three-week intervals and three follow-up examinations over the course of treatment.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: MGD; IPL; Non-inferiority analysis
Ipratropium Bromide in Peri-Operative COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, multi-centre
      trial.The trial aims to evaluate efficacy of nebulized ipratropium bromide in Chinese
      peri-operative patients with COPD under general anaesthesia.
    


Intervention name(s): placebo; ipratropium bromide
Intervention type(s): Drug; Drug
Intervention description(s): normal saline; ipratropium bromide
Intervention MeSH terms: Bromides; Ipratropium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Relationship Between Post-ERCP-choledocholithiasis and Gallbladder Status
Condition: Cholecystitis
MeSH terms: Cholecystitis; Acalculous Cholecystitis; Choledocholithiasis
Study type: Observational

Summary: 
      In this retrospective study, the investigators evaluate the relationship of
      post-ERCP-choledocholithiasis(PEC ) and the gallbladder status as a risk factor.
    

Detailed description: 
      When patients have common bile duct(CBD) stones, ERCP is widely used for stone extraction
      instead of clinical operation. ERCP has many advantages like less injury or faster recovery.
      However, according to literature, ERCP will has a mostly 10% possibility to get an acute
      purulent cholecystitis, which often requires emergency intervention, therefore, it is
      necessary to know if the gallbladder status(chronic disease) is one of the important risk
      factors of PEC like the gallbladder wall thickness, chronic cholecystitis, polyps,crudely or
      calculus.

      .
    

Intervention name(s): ERCP
Intervention type(s): Procedure
Intervention description(s): Routine ERCP for CBD stone with the gallbladder in situ, the chronic gallbladder status was defined as gallbladder wall thickness≥4mm, chronic cholecystitis, polyps,crudely or calculus .
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Routine ERCP patients with CBD stones
      
Keywords: ERCP; Acute purulent cholecystitis; Bile duct stone; PEC(post-ERCP-choledocholithiasis)
A Study of OPC-262 in Patients With Type 2 Diabetes
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this clinical study is to evaluate the superiority of the efficacy of OPC-262
      (2.5 mg, and 5 mg) to placebo in patients with type 2 diabetes after 24 week treatment in a
      double-blind fashion and to evaluate the safety of OPC-262 to placebo.
    


Intervention name(s): OPC-262 2.5 mg; OPC-262 5 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): orally administered once daily for 24 weeks; orally administered once daily for 24 weeks; orally administered once daily for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment