bioihbjkbjnl/mcl2 huggingface dataset:
High Intensity Phototherapy: Double vs. Single
Condition: Hyperbilirubinemia
MeSH terms: Hyperbilirubinemia
Study type: Interventional

Summary: 
      Intensive phototherapy in form of double light is used worldwide in the treatment of severe
      neonatal hyperbilirubinemia. It has been debated if there is an upper limit on the efficiency
      of phototherapy. This study investigates whether double phototherapy reduces total serum
      bilirubin faster than single light during intensive phototherapy, using light emitting
      diodes, and whether there is an upper limit for the efficacy of phototherapy.
    

Detailed description: 
      Hyperbilirubinemia occurs in 60 - 80 % of newborns during the first days of life, among
      others because of immaturity of the enzyme uridin-glukuronosyl-transferase (UGT1A1) in the
      liver. In seldom cases with very high total serum bilirubin concentration (TsB), bilirubin
      can cross the blood-brain barrier and the deposition of unconjugated bilirubin in the central
      nervous system may cause acute bilirubin encephalopathy (ABE). This can progress to chronic
      bilirubin encephalopathy (CBE), a devastating condition, which unfortunately still occurs,
      even in industrialised countries.

      Hyperbilirubinemia gets severe for 2 - 6 % of infants born at term or late preterm, which
      means, they need treatment to prevent ABE and the treatment of choice is phototherapy due to
      its efficacy and safety. Hereby bilirubin in the skin and plasma is converted to
      photobilirubins; they are water-soluble and can be excreted through the liver without
      conjugation. They are presumably non-toxic. In most departments, single phototherapy is first
      choice. To avoid the above-mentioned damaging condition, it is very important to optimize
      phototherapy.

      Former fluorescent tubes were used as light source, but now light emission diodes (LED) are
      used.

      This study investigates whether double phototherapy reduces total serum bilirubin faster than
      single light during intensive phototherapy, using LED, and whether there is an upper limit
      for the efficacy of phototherapy.

      It is a prospective, randomised controlled study. The infants will be randomized to either 1:
      Conventional phototherapy with blue LED light from above and a distance from light source to
      mattress of 30 cm, giving a light irradiance of 66 µW/cm2/nm or 2: Conventional phototherapy
      combined with a light blanket (Bilisoft) with a light irradiance by the skin of 39 µW/cm2/nm.
      TsB will be measured at start and after 12 - and 24 h of treatment. Based on the calculation
      of strength 72 infants will be needed in this study. As statistical methods t-tests will be
      used and multiple linear regression models will be used to adjust for confounding.
    

Intervention name(s): Light irradiance
Intervention type(s): Other
Intervention description(s): Comparison of double vs. single phototherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Immunogenicity of GPO Seasonal Trivalent Inactivated Influenza Vaccine in Healthy Thai Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study is aim to evaluate the safety and immunogenicity of one dose (15 μg HA per strain
      per dose) of the GPO seasonal trivalent inactivated split virion influenza vaccine (Tri
      Fluvac) in healthy adults aged 18 to 49 years over 90 days post-injection.
    

Detailed description: 
      This is a double blind randomized study consisting of two phases - Phase I and Phase II. The
      same vaccine, a seasonal trivalent inactivated split virion influenza vaccine
      [A/California/7/2009, reassortant virus NYMC X-181 (H1N1), A/Victoria/210/2009, reassortant
      virus NYMC X-187 (H3N2), and B/Brisbane/60/2008, reassortant virus NYMC BX-35 virus strains]
      will be given in both Phase I and Phase II of the study.

      The vaccine will be administered via the intramuscular route; the preferred injection site
      will be the deltoid of the non-dominant arm. After vaccination volunteers will remain at the
      clinic for at least 30 minutes to observe for any reactogenicity after immunization. Total
      follow-up is 90 days.

      Blood specimens will be collected on Day 0 prior to vaccination, Day 21, Day 60, and day 90.
    

Intervention name(s): an inactivated influenza vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.; The placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: GPO Tri Fluvac Vaccine; Tri Fluvac Vaccine
The Effect of Radiation on Semen Quality and Fertility in Men With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      Many younger men are diagnosed with prostate cancer. These patients are often choosing
      radiation therapy as their primary treatment. The effect of this therapy on fertility will
      have a direct impact on their decision about therapeutic options and fertility preservation.
      The researchers hypothesize that when patients are treated with radiation for localized
      prostate cancer, infertility can occur due to direct damage to seminiferous tubules affecting
      sperm quality.
    

Detailed description: 
      Prostate cancer is the most common malignant disease among men. Many young men are diagnosed
      with localized prostate cancer. Some of these men are choosing to manage their prostate
      cancer with radiation therapy. The radiation therapy delivers minimal dose exposure to
      adjacent organs. We hypothesize that when patients are treated with radiation therapy for
      localized prostate cancer, decreased fertility can occur due to damage of seminiferous
      tubules, which may affect sperm quality. This study will assess the impact of radiation
      therapy on semen and seminal fluid.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Men being treated with radiation therapy for localized prostate cancer who consent to
        participate and provide a semen specimen for analysis following thereapy.
      
Keywords: Prostate; cancer; brachytherapy; radiation; semen; fertility
Long Acting Insulin Versus Multiple Dose Regimen for Control of Gestational Diabetes Mellitus
Condition: Long Acting Insulin in Control of Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      multiple dose regimen as a standard treatment for gestational diabetes will be compared to
      long acting insulin
    


Intervention name(s): Long acting insulin; multiple dose regimen
Intervention type(s): Drug; Drug
Intervention description(s): long acting insulin analogue once daily at bed time; intermediate and short acting insulin
Intervention MeSH terms: Insulin, Long-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
21 Day Comparison of Continuous Insulin Infusion Using HDV Insulin to Standard Insulin in Type 1 Diabetes Mellitus
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Single Center, Double Blind, Active Comparator Controlled 2-Way Crossover Multiple Dose
      Safety, Tolerability and Efficacy Study
    

Detailed description: 
      This is a single center, double blind, active comparator controlled 2-Way crossover multiple
      dose safety, tolerability and efficacy study.

      The study will consist of three periods. Total duration will be approximately nine weeks,
      including a screening period of up to 14 days, a 7-day run-in period and two 21-day treatment
      periods.

      Subjects will be screened and then they will undergo a week of baseline CGM. They will then
      be randomized to one of two treatment sequences: three weeks of treatment with HDV-lispro
      followed by three weeks of treatment with insulin lispro diluted with sterile water to match
      the insulin concentration in HDV-lispro, or the same treatments in the reverse order.

      A test meal study (standardized liquid test meal) is to be conducted at the beginning of
      treatment (baseline study) and at the end of each three week treatment period. As noted
      above, frequent blood samples will be collected for glucose and insulin levels during the
      first (baseline study) test meal; during the two test meals performed after the two treatment
      periods the same sampling for glucose and insulin will be performed, with the addition of
      collecting samples for glucagon levels.

      Subjects will also perform blinded continuous glucose monitoring throughout the entirety of
      the study (7 weeks).

      Throughout study, subjects will be asked to perform frequent self-monitoring of blood glucose
      (SMBG), at least 6 times per day (before and 60-90 minutes after each meal) during 3 or more
      days of each week. This will serve as data for therapeutic decision-making as well as for
      data collection.
    

Intervention name(s): HDV insulin lispro 100 UNIT/mL; Insulin Lispro 100 Units/mL
Intervention type(s): Drug; Drug
Intervention description(s): Hepatic Directed Vesicle (HDV) added to commercial insulin lispro; Sterile Water for Injection added to commercial insulin lispro
Other intervention name(s): HDV Humalog; Humalog
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a single center, double blind, active comparator controlled 2-Way crossover multiple dose safety, tolerability and efficacy study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CONCERTA Lab School Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial is to determine if the study medication, CONCERTA (methylphenidate
      HCl), is safe and effective in improving academic performance and behavior in children with
      Attention Deficit Hyperactivity Disorder (ADHD) when compared to placebo.
    

Detailed description: 
      The hypothesis is that CONCERTA (methylphenidate HCl) is safe and effective in improving
      academic performance and behavior in children with ADHD when compared to placebo as
      demonstrated using specified study measures. This is a double-blind (neither participant nor
      investigator knows the name of the assigned study drug), randomized (study drug assigned by
      chance), placebo-controlled, crossover study evaluating the academic, behavioral and
      cognitive effects of CONCERTA (methylphenidate HCl) on older children with ADHD This means
      that all eligible children will receive treatment with methylphenidate HCl throughout the
      study (the titration and assessment periods) and inactive pill (placebo) on 1 of the 2
      laboratory classroom days. On the other laboratory classroom day they will receive their
      regular dose of CONCERTA (methylphenidate HCl). The primary efficacy variable in this study
      is the Permanent Product Math Test (PERMP) attempted score. Secondary Measures include: SKAMP
      (Swanson, Kotkin, Agler, M-Flynn, and Pelham), tests of inattention, reading fluency and
      comprehension, and memory. Assessments will be completed during each of the laboratory
      assessment days (12.5 hours). Participants will be assessed for adverse events throughout the
      study. Patients will initiate treatment with oral CONCERTA (methylphenidate HCl) 18 mg at
      baseline and continue morning dosing with increases every 3 to 7 days until an optimal dose
      is achieved, up to the maximum of 54 mg/day. Eligible patients will remain in the study for a
      maximum of 8 weeks.
    

Intervention name(s): CONCERTA (methylphenidate HCl) or placebo; CONCERTA (methylphenidate HCl) or placebo
Intervention type(s): Drug; Drug
Intervention description(s): Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #1 with placebo on Day #2; Optimal Subject Dose (18mg-54mg) once daily during Lab School Day #2 with placebo on Day #1
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD; Attention Deficit Hyperactivity Disorder
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
Condition: Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, 3-period crossover phase 2 study in patients with
      documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics
      (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and
      PD as measured by reduction in serum uric acid levels.
    


Intervention name(s): Tranilast; Febuxostat; Combination - Tranilast and Febuxostat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tranilast tablets, 300 mg, QD; Febuxostat Tablets, 40 mg, QD; Tranilast, 300 mg QD; Febuxostat, 40 mg QD
Other intervention name(s): Uloric
Intervention MeSH terms: Tranilast; Febuxostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gout; Hyperuricemia
Does Optimal Control of Pre-operative Chronic and Acute Pain Predict Improved Function After Orthopedic Surgery?
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Despite the development of new pain medications, the prevalence of persistent postoperative
      pain (for more than three to six months) remains alarmingly high. Chronic pain and reduced
      function after surgery are of great concern since they have a significant impact on a
      patient's quality of life and are costly to society in terms of longer hospital stays and
      lost work days. An important risk factor for chronic pain and reduced function after surgery
      is the amount of pain patients experience immediately after surgery which is highly
      influenced by the amount of pain patients have preoperatively. For many patients,
      longstanding pain prior to surgery is common and thus can compromise the outcome of the
      procedure. Therefore, the aim of this study is to reduce the amount of pain patients have
      before they undergo surgery by administering a novel pain-relieving regimen in the weeks
      before surgery. Crucially, this treatment will be continued for three weeks after surgery to
      reduce pain that arises from the surgical trauma. The novel regimen will include a
      non-steroidal anti-inflammatory (celecoxib) and the alpha2 delta ligand, pregabalin. This
      drug combination will provide the best opportunity to target several key sites in the pain
      pathway. This regimen will be tested in patients with pain related to osteoarthritis and who
      are undergoing orthopedic (hip) surgery because chronic preoperative pain is common in these
      patients and is the main reason for undergoing surgery. The goal of this research proposal is
      to adequately manage pain before and after surgery in order to improve function weeks after
      surgery. If controlling pain in this way does lead to improved long term postoperative
      function the findings from this study may lead to the development of a standardized regimen.
      This is highly relevant not only for orthopedic procedures but following other common
      surgical procedures which would be of great benefit to patients and the entire healthcare
      system.
    


Intervention name(s): Pregabalin, Celecoxib
Intervention type(s): Drug
Intervention description(s): Pregabalin (75mg BID) and Celecoxib(100mg BID) two weeks prior to hip arthroplasty and 3 weeks postoperatively.
Intervention MeSH terms: Celecoxib; Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic pain; Preemptive analgesia; Pregabalin; Celecoxib; Hip Arthroplasty; Osteoarthritis
Effect of Policosanol as Monotherapy and Adjunctive to Statin Therapy
Condition: High Cholesterol
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      To determine the effects of policosanol on the cholesterol profile.
    

Detailed description: 
      The primary objectives of this study are to determine the changes in the lipid profile
      [LDL-C, HDL-C, triglycerides, total cholesterol] and the emerging risk factor, Lp(a), when
      policosanol is added to statin therapy. Additionally, one more primary objective is to
      evaluate the safety of the combination regimen.
    

Intervention name(s): Policosanol; Placebo; Policosanol Plus Already In Use Statin Therapy
Intervention type(s): Drug; Other; Drug
Intervention description(s): Policosanol 20 mg daily; Placebo daily; Policosanol 20 mg daily Statin Therapy
Other intervention name(s): Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol; Octacosanol, 1-Octacosanol, N-Octacosanol, Octacosyl Alcohol; Statin
Intervention MeSH terms: Ethanol; Policosanol; Hydroxymethylglutaryl-CoA Reductase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS
Condition: Cirrhosis
MeSH terms: Brain Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      TIPS has been used for 20 years, as a means of reducing portal pressure in patients with
      cirrhosis and portal hypertension related complications. TIPS proved more effective than
      alternative treatments in controlling or preventing variceal bleeding and refractory ascites.
      The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE).
      Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of
      previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of
      post-TIPS OHE in patients fulfilling these criteria remains close to 35 %.
    

Detailed description: 
      TIPS has been used for 20 years, as a means of reducing portal pressure in patients with
      cirrhosis and portal hypertension related complications. TIPS proved more effective than
      alternative treatments in controlling or preventing variceal bleeding and refractory ascites.
      The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE).
      Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of
      previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of
      post-TIPS OHE in patients fulfilling these criteria remains close to 35 %. Furthermore, the
      pathogenesis of HE in general but also in patients treated by TIPS is still not well
      understood. Therefore, there is a real challenge in discovering new molecular mechanisms
      involved in pathogenesis of OHE as well as new treatment to better prevent the risk of OHE in
      patients treated by TIPS. Observational and experimental studies suggest a microbiota's role
      in the mechanism of OHE and recently a non absorbable antibiotic has proven to reduce the
      risk of recurrence of OHE. However, the effect of this drug for the prevention of a first
      episode of OHE in patients treated by TIPS is not known. In addition, the mechanisms of the
      beneficial effect of rifaximin remain poorly understood.
    

Intervention name(s): Rifaximin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6 rifaximin caps of 200 mg morning and night, 15 days before and 6 months after TIPS
--------------------------------------------------------------------------------; 6 placebo caps per day morning and night, during 15 days before TIPS and 6 months after TIPS
Other intervention name(s): NORMIX
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: TIPS; portal pressure; rifaximin; overt hepatic encephalopathy; microbiota
CArdiovascular Risk Assessment STudy in Lupus Erythemathodes (CASTLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Observational

Summary: 
      The key of this prospective study is to identify a potentially increased cardiovascular risk
      in patients with systemic Lupus erythematodes, with and without renal affection. Three groups
      of patients will be compared.
    

Detailed description: 
      Key of this prospective study is to identify a potentially increased cardiovascular risk in
      patients with systemic Lupus erythematodes, with and without renal affection. Three group of
      patients will be compared as followed. First group are patients with known systemic Lupus
      erythematodes without renal affection, second group are patients with known systemic Lupus
      erythematodes with renal affection and the third group are patients with a non-autoimmun
      chronic kidney disease
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with or without systemic Lupus erythematosus
      
Biospecimen description: 
      Every participant will provide 20 ml Serum for further laboratory analysis
    
Keywords: lupus erythematosus; cardiovascular risk
Safety and Efficacy of High-dose Leukocytapheresis Using a Large Filter in Refractory Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Extracorporeal leukocytapheresis (LCAP) or granulocytapheresis (GCAP) has been used in the
      treatment of patients with rheumatoid arthritis and ulcerative colitis and has shown
      promising safety and efficacy. LCAP and GCAP seem to be effective for steroid-resistant
      inflammation. The investigators have already reported safety and efficacy of GCAP in
      refractory asthma and expect the beneficial effect of LCAP in refractory asthma. In this
      study, in order to improve the therapeutic effect of LCAP by increasing the quantity of
      leukocytes that were removed, the investigators conducted a clinical study to investigate
      safety and efficacy of high-dose LCAP performed using a larger filter and an increased dose
      of the blood volume per body weight treated, as an possible therapy for refractory asthma.
    


Intervention name(s): Leukocytapheresis
Intervention type(s): Procedure
Intervention description(s): 5000 ml, the blood volume per body, treated once. Twice at an interval of 6 days.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extracorporeal leukocytapheresis