bioihbjkbjnl/mcl2 huggingface dataset:
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in
      patients with nonalcoholic steatohepatitis.
    


Intervention name(s): NGM282; Placebo
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood
      glucose lowering effect and the safety profile of repaglinide given alone compared to
      gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated
      with oral anti-diabetic drugs (OADs). This study also investigates the augment effect of
      repaglinide on the phases of insulin secretion as a subgroup study.
    


Intervention name(s): repaglinide; gliclazide
Intervention type(s): Drug; Drug
Intervention description(s): Individually adjusted dose for 16 weeks; Individually adjusted dose for 16 weeks
Intervention MeSH terms: Repaglinide; Gliclazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Transcutaneous Electrical Nerve Stimulation in Patients With Acute Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Introduction: Low back pain is one of the most common complaints in doctors' offices, and
      acute low back pain is characterized by episodes of pain with less than three weeks duration.
      The transcutaneous electrical nerve stimulation (TENS), based on the gate control theory of
      pain proposed by Melzack and Wall in 1965, has been used as an adjunctive therapy in the
      control of back pain, being a non-invasive, low cost, safe and easy to apply. No studies were
      found regarding the effectiveness of TENS in acute low back pain.

      Objective: To evaluate the effectiveness of TENS in pain management of patients with acute
      low back pain.

      Material and Methods: A randomized clinical trial, double-blinded and placebo-controlled.
      Patients were selected in the clinics of Federal de University of Sao Paulo (UNIFESP)
      according to the following criteria: acute low back pain, both genders, aged between 18 and
      65 years, pain between 4 and 8cm in pain numeric scale (PNS) and who agreed to participate in
      the study. After signing the informed consent patients were randomly allocated into one of
      the groups: TENS group (TG) or Placebo Group (PG). In TG was applied conventional TENS with
      frequency and intensity variation (FIV) effect, frequency of 100 hertz, a pulse width of 60μs
      and intensity adjusted according to the individual baseline for each patient without causing
      muscular contraction. The electrodes were arranged in a cross shape in the paravertebral
      region (levels T12-L1 and L5 - S1). In PG the same procedures were adopted, but did not occur
      electrical stimulus. Patients were informed that they could or could not feel electric
      shocks. Treatment consisted of 10 sessions (2x / week / 5 weeks), with each session lasting
      30 '. Assessments were made at the following times: T0 (baseline), T1 to T10 (the beginning
      and end of each session), T11 (after the last session), T30 (30 days after the last session)
      and T60 (60 days after the last session). Assessment tools: PNS for pain, short-form 36
      (SF-36), Roland-Morris, self-assessment of improvement ("Likert" scale) and drug consumption
      (daily).
    


Intervention name(s): TENS
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transcutaneous Electric Nerve Stimulation; Pain
Low Intensity Shock Wave Therapy in the Management of Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      Researchers are evaluating the efficacy of low intensity shockwave therapy (LISWT) via
      MoreNova in the treatment of erectile dysfunction (ED).
    

Detailed description: 
      ED is broadly defined as the inability to achieve or maintain an erection sufficient for
      sexual intercourse or activity. Current treatment for ED consists of oral medications,
      intracavernosal injections and surgically placed penile prosthetics. In the literature this
      has been described as a Stepwise Approach, offering therapy beginning with the least invasive
      treatment option.

      The goal of LISWT is to restore natural erections and / or improve responses to oral
      medications (first line therapy).

      LISWT for ED is under evaluation in the USA. The European Association of Urology Guidelines
      on ED were recently updated to include LISWT for men with mild to moderate ED. The
      energy/pulse used in this application is approximately 10% of the energy used for
      disintegrating kidney stones; no serious side effects have been reported. Shock wave therapy
      for diabetic ulcers has recently been approved by the FDA.
    

Intervention name(s): MoreNova
Intervention type(s): Device
Intervention description(s): Shockwave therapy delivered to the genital area with low dose shocks
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Health Effects of Particulate Acids in Late Adolescence
Condition: Airway Obstruction; Cough
MeSH terms: Airway Obstruction
Study type: Observational

Summary: 
      This study was designed to follow a group of adolescents who were previously examined by
      questionnaire and pulmonary function tests when they were aged 8-10 years old. Approximately
      50% of the population in 10 towns were seen again at age 17-18. Questionnaires and pulmonary
      function were repeated. The hypotheses being tested related to whether the previously seen
      levels of pulmonary function that were related to pollution levels in the towns persisted as
      the lungs of these children grew and whether dietary antioxidants influences level of
      attained pulmonary function.
    


Observational model: Defined Population
Time perspective: Other
Keywords: FEV; Smoking; antioxidents; lung growth
A Double-Blind Comparison of Galantamine HBr and Placebo in Adults With Attention Deficit Hyperactivity Disorder
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This will be a double-blind, placebo-controlled, study using daily doses of up to 24 mg/ day
      Galantamine HBr in the treatment of adults who meet DSM-IV criteria for childhood-onset ADHD.
      Specific hypotheses are as follows:

      Hypothesis 1: ADHD symptomatology in adults with DSM-IV ADHD will be responsive to acute
      Galantamine HBr treatment.

      Hypothesis 2: Galantamine HBr -associated improvement in ADHD symptomatology in adults will
      translate into improved functional capacities (neuropsychological, social, and occupational)
      as well as an increased quality of life throughout acute treatment.

      Hypothesis 3: Galantamine HBr treatment will be safe and well tolerated as reflected by a low
      drop out rate and absence of major differences from placebo.
    

Detailed description: 
      Galantamine HBr, a tertiary alkaloid, is a competitive and reversible inhibitor of
      acetylcholinesterase that is indicated to slow the deterioration of cognitive impairment in
      Alzheimer's Disease. Initial anecdotal data suggest a promising role for Galantamine HBr in
      the treatment of ADHD. We propose to study to test the safety and efficacy of Galantamine HBr
      therapy in adults with ADHD. We will test if Galantamine HBr -associated improvements in ADHD
      symptomatology translate into improved cognitive and functional capacities (social and
      occupational) as well as increased quality of life.

      The proposed study includes 1) use of a 12-week design to document the response rate 2)
      assessment of the impact of Galantamine HBr on functional capacities (quality of life,
      psychosocial function) and cognition, 3) careful assessment of safety and tolerability.
    

Intervention name(s): galantamine HBr
Intervention type(s): Drug
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Adult; ADHD; galantamine; double-blind
Study to Evaluate GlaxoSmithKline (GSK) Biologicals' MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and
      reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C
      polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK
      Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different
      formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant
      vaccines were given to all children to complete the vaccination agenda.
    

Detailed description: 
      Five parallel treatment groups receiving a 3-dose primary vaccination course: MenC-TT vaccine
      (2 formulations, double-blind) + Infanrix hexa® OR Hib-MenC-TT (2 formulations double-blind)
      + Infanrix penta® OR Meningitec™ + Infanrix hexa® (control). Three blood samples taken,
      before dose 1 and one month after dose 2 and dose 3.
    

Intervention name(s): MenC-TT; Hib-MenC-TT
Intervention type(s): Biological; Biological
Other intervention name(s): MenC-TT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Haemophilus Influenzae type b/Meningococcal vaccine; Prophylaxis meningococcal serogroup C disease, Hib diseases
Comparison of Pediatric Septic Shock Treatment With and Without Central Venous Oxygen Saturation Monitoring
Condition: Severe Sepsis; Septic Shock
MeSH terms: Shock, Septic; Sepsis; Shock
Study type: Interventional

Summary: 
      The purpose of this study was to compare ACCM/PALS guidelines performed with and without
      central venous oxygen saturation monitoring on the morbidity and mortality rate of children
      with severe sepsis and septic shock.
    

Detailed description: 
      Background: ACCM/PALS guidelines addresses early correction of pediatric septic shock using
      physical examination supplemented by indirect measures of cardiac output such as central
      venous or superior vena cava oxygen saturation (ScvO2>70%) in a goal directed approach.
      However, these endpoints are based on unsupported evidence. The purpose of this study was to
      compare ACCM/PALS guidelines performed with and without ScvO2 on the morbidity and mortality
      rate of children with severe sepsis and septic shock.

      Methods: Children and adolescents with severe sepsis or fluid-refractory septic shock were
      recruited at two university-affiliated hospitals and randomly assigned to ACCM/PALS without,
      or with an ScvO2 goal directed (goal ScvO2 > 70%) resuscitation. Twenty-eight day mortality
      is the primary end point.
    

Intervention name(s): Central venous oxygen saturation continuous monitoring
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child; Septic shock; Resuscitation; Central venous oxygen saturation; Cardiac output; Goal-directed therapy
Effects of Tadalafil on LMR and MHR in Patients With ED
Condition: Erectile Dysfunction; Inflammation
MeSH terms: Erectile Dysfunction; Inflammation
Study type: Observational

Summary: 
      The aim of the study was to investigate whether daily 5 mg tadalafil over eight weeks affects
      to Lymphocyte/Monocyte ratio (LMR) and Monocyte/High-Density Lipoprotein ratio (MHR) in
      patients with erectile dysfunction (ED).

      Thirty-one patients with organic ED and 31 healthy controls between July 2017 and November
      2018 were included in this retrospective study. To avoid bias, the patients were randomly
      selected and the controls were also incorporated consecutively. The presence of ED was
      determined according to the International Erectile Function Index-5 (IIEF-5). The patients
      and the controls were evaluated in terms of IIEF-5, complete blood count, serum biochemistry,
      LMR, and MHR.
    

Detailed description: 
      The medical records of the heterosexual men treated with the diagnosis of organic ED in the
      Urology department of a private hospital between July 2017 and October 2018 were evaluated
      retrospectively. The number of samples to be included in the study was determined by the help
      of the computer-assisted power analysis. Random sampling was performed from all cohorts of
      patients with ED. Thirty-one male patients between the ages of 39-65 with organic erectile
      dysfunction more than one year and treated with OAD 5 mg dose of tadalafil for eight weeks
      were selected as the treatment group (group T)The patients in group T have been assessed both
      before (T1) and after (T2) the treatment.

      Between the ages of 39-65, thirty-one healthy men who were admitted to the internal medicine
      outpatient clinic for their annual follow-up were selected consecutively and the control
      group (group C) was formed. All subjects in the control group were sexually active men with
      regular monogamous heterosexual relationships during the last one year.

      .
    

Intervention name(s): Tadalafil 5mg tablet
Intervention type(s): Drug
Intervention description(s): Once-a-day 5 mg dose of tadalafil for 8 weeks
Other intervention name(s): phosphodiesterase type 5 (PDE5) inhibitor
Intervention MeSH terms: Tadalafil
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Between the ages of 39-65, thirty-one healthy men who were admitted to the internal
        medicine outpatient clinic for their annual follow-up were selected consecutively and the
        control group Thirty-one male patients with organic erectile dysfunction more than one year
        between 39 and 65 years of age which were treated with OAD 5 mg dose of tadalafil for eight
        weeks were selected as the treatment group
      
Keywords: Erectile Dysfunction; lymphocyte to monocyte ratio; monocyte to HDL ratio
Effect of Coconut Oil Application in Reducing Water Loss From Skin of Premature Babies in First Week of Life (TEWL)
Condition: Trans Epidermal Water Loss (TEWL)
Study type: Interventional

Summary: 
      The skin of newborn infants is immature and ineffective as a barrier. Preterm skin exhibits
      even more vulnerability to the environment due to poor self regulatory heat mechanisms,
      paucity of fatty tissue and its thinness. Most preterm babies lose up to 13% of their weight
      as water loss from their skin during the first week of life. Many strategies have been
      utilized by neonatologists to decrease this water loss. Oil application on the skin can act
      as a non permeable barrier and can help in reducing water loss from the skin. Edible coconut
      oil, often used for traditional massage of babies by Indian communities, is culturally
      acceptable and Hence the investigators decided to undertake this study to objectively assess
      the reduction in water loss from skin after oil application
    


Intervention name(s): Coconut oil application; No oil application
Intervention type(s): Other; Other
Intervention description(s): Four ml coconut oil application twice daily for first week; Oil application was not done
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Preterm; VLBW; Coconut Oil application; Trans epidermal water loss; Weight gain
FLAME: Airway Inflammation Monitoring in Asthma and Cystic Fibrosis
Condition: Asthma; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Asthma; Fibrosis; Inflammation
Study type: Observational

Summary: 
      Background By means of measurements of series of non-invasive inflammatory markers in exhaled
      breath (condensate), a reflection of inflammatory processes and oxidative stress, can be
      obtained. Thereby, these techniques could be important in monitoring asthma and CF lung
      disease in children. Fractional exhaled nitric oxide (FeNO) and inflammatory markers in
      exhaled breath condensate (EBC) reflect ongoing inflammation and oxidative stress in the
      airways. These markers have a promising capacity for monitoring diagnoses of CF and asthma
      lung disease.

      Aim To study the course of inflammatory markers in time in children with asthma and CF, in
      stable periods and during pulmonary exacerbations. In addition, we study the ability of
      inflammatory markers to predict safe tapering of medical treatment in both populations.

        1. To study the course of inflammatory markers in EBC during an exacerbation.

        2. To study which IM are already elevated before a clinical exacerbation is evident and can
           predict exacerbations in time.

        3. To study which inflammatory markers can predict safe discontinuation of antibiotics in
           children with CF, or tapering of inhaled corticosteroids in children with asthma.

        4. To study the relationship between inflammatory markers in EBC, the severity and control
           of CF and asthma, the symptoms and lung function within patients will be analysed.

      Methods Children with CF (n=30) and children with asthma (n=40) were recruited included from
      our outpatient clinic. During this longitudinal study patients visit the outpatient clinic
      were followed-up for 12 months; every two months during one year. patients visited our
      outpatient clinic. In addition to these standard visits, During exacerbations patients four
      extra visits were planned during an exacerbation. were asked to visit the University Hospital
      Maastricht four times. These additional visits were planned with a maximum of two times
      during the study. By means of a home monitor, children were asked to assess measurements of
      Besides measurements in the University Hospital, children measured forced expiratory volume
      in one second (FEV1) at home using a home monitor, to record medication use, and, to record
      presence and severity of pulmonary symptoms. Outcome parameters were: 1) FeNO assessment in
      exhaled air, 2) inflammatory markers in EBC, 3) lung function parameters, 4) specific
      questionnaires to assess asthma and CF control and severity, 5) data originating from the
      home monitor.
    


Time perspective: Prospective
Keywords: inflammometry; exhaled breath condensate; fractional exhaled nitric oxide; asthma; cystic fibrosis; monitoring; exacerbations; paediatric
Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines
Condition: Hepatitis B; Acellular Pertussis; Tetanus; Poliomyelitis; Diphtheria; Streptococcus Pneumoniae Vaccines
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis; Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety in terms of fever (rectal temperature)
      higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response
      following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of
      age in children previously primed with the same vaccines including a pneumococcal conjugate
      vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and
      meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus
      influenzae type b (Hib-MenC) vaccine.

      This protocol posting deals with objectives & outcome measures of the booster phase. The
      objectives & outcome measures of the primary phase are presented in a separate protocol
      posting (NCT number = NCT00334334).
    

Detailed description: 
      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Intervention name(s): Pneumococcal conjugate vaccine GSK1024850A; Prevenar; Infanrix hexa; Infanrix IPV Hib; Infanrix penta; Infanrix IPV; Meningitec; NeisVac-C; Menitorix
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 1 dose.; Intramuscular injection, 1 dose.; Intramuscular injection, 1 dose. In Germany and Poland.; Intramuscular injection, 1 dose. In Spain.; Intramuscular injection, 1 dose. In Germany and Poland.; Intramuscular injection, 1 dose. In Spain.; Intramuscular injection, 1 dose.; Intramuscular injection, 1 dose.; Intramuscular injection, 1 dose.
Other intervention name(s): Pneumococcal conjugate vaccine (Wyeth Lederle).; DTPa-HBV-IPV/Hib (GSK Biologicals).; DTPa-IPV/Hib (GSK Biologicals).; DTPa-HBV-IPV (GSK Biologicals).; DTPa-IPV (GSK Biologicals); Meningococcal C conjugate vaccine (Wyeth).; Meningococcal C conjugate vaccine (Baxter).; Combined Hib-MenC vaccine (GSK Biologicals).
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fever.; Meningococcal disease.; Pneumococcal disease.; Meningococcal vaccine.; Pneumococcal vaccine.; Immunogenicity.; Booster vaccination.; Safety.
Study of Escalating Doses of NRL001 Given in Slow-release Rectal Suppositories of Different Weights
Condition: Incontinence
Study type: Interventional
Phase: Phase 1

Summary: 
      Studies investigating single doses of different NRL001 formulations showed
      formulation-dependent differences in exposure, even though they had similar effects on mean
      anal resting pressure (MARP). This study is a first step in investigating the hypothesis that
      a better balance between desired anal effects and undesired systemic effects can be reached
      with a NRL001-slow release suppository than with previously studied formulations.

      To this purpose, single doses of 5 to 15 mg, administered as 1 g and 2 g suppositories, are
      being investigated with regard to their pharmacokinetics and systemic effects (blood
      pressure, pulse rate, electrocardiographic heart rate).
    


Intervention name(s): NRL001
Intervention type(s): Drug
Intervention description(s): Four single doses of NRL001 or placebo. NRL001 is administered at lower (5, 7.5 and 10 mg) or higher (10, 12.5 and 15 mg) doses in a slow release rectal suppository weighing either 1 g or 2 g.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment