bioihbjkbjnl/mcl2 huggingface dataset:
An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005
    

Detailed description: 
      This is an uncontrolled study without comparator. Subjects were followed up to 4 years on
      Technosphere Insulin. Of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥
      36 mo, 31 for ≥ 42 mo, & 2 for 48 mo.
    

Intervention name(s): Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler
Intervention type(s): Drug
Intervention description(s): Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Scalp Nerve Block on Emergence Agitation
Condition: Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      Emergence agitation is a common problem in children during recovery from sevoflurane
      anesthesia. Pain is considered as a cause of postoperative emergence agitation and
      compounding factor of agitation assessment in children. The purpose of this study was to
      investigate the effect of scalp nerve block on the emergence agitation in children undergoing
      nevus surgery during sevoflurane anesthesia.
    

Detailed description: 
      Forty-four children, 1-7 years old, undergoing nevus surgery on head were enrolled.
      Anesthesia was induced with thiopental sodium and rocuronium, and maintained with
      sevoflurane. Patients were randomly assigned two groups: the control group received IV
      remifentanil 1 μg/kg, and the block group received scalp nerve block with 0.25% ropivacaine
      2-3 ml. Time to tracheal extubation, recovery time, hemodynamic change, FLACC score, and
      Watcha behavior scale for emergence agitation were assessed.
    

Intervention name(s): Ropivacaine; Remifentanil; Sevoflurane
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.25% ropivacaine 2-3 ml was injected around the scalp nerves that are located on the head.; Remifentanil 1 μg/kg was injected before skin incision.; Anesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value.
Other intervention name(s): Ultiva
Intervention MeSH terms: Remifentanil; Ropivacaine; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)
Condition: Elevated LDL-Cholesterol (LDL-C)
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, pharmacokinetics and
      pharmacodynamics of a single dose of ALN-PCS02 in subjects with Elevated LDL-Cholesterol
      (LDL-C).
    


Intervention name(s): ALN-PCS02; Sterile Normal Saline (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): Dose levels between 15 and 400 μg/kg by intravenous (IV) infusion; Calculated volume to match active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Iron-fortified Whole Maize Flour Trial
Condition: Anaemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess whether NaFeEDTA and electrolytic iron improve iron
      status of young school children, when added as iron fortificants in whole maize flour.
    

Detailed description: 
      Fortification of staple foods with iron may be an effective method of addressing the problem
      of iron deficiency. Questions however remain of the type of iron fortificants to use, the
      appropriate fortification levels and suitable food vehicles. Cereals form attractive vehicles
      because they are widely consumed in parts of the world that bear a large burden of the iron
      deficiency problem. They are however high in phytates and would reduce the bioavailability of
      commonly used iron fortificants. Isotope studies have shown that even in the presence of
      phytates, iron from NaFeEDTA is relatively more bioavailable than that from other fortificant
      sources. Its efficacy has however not been assessed in human trials. Electrolytic iron, on
      the other hand is widely used and was legislated as the iron fortificant of choice in South
      Africa. Its efficacy in a high-phytate vehicle has also not been assessed. We have therefore
      undertaken to assess the efficacy of NaFeEDTA at two doses, as an iron fortificant in whole
      flour, and the efficacy of electrolytic iron at a dose similar to the high-dose NaFeEDTA. The
      results will contribute information on the suitability of these fortificants in whole maize
      flour, a food commonly consumed in sub-Saharan Africa.
    

Intervention name(s): NaFeEDTA, Electrolytic Iron
Intervention type(s): Drug
Intervention MeSH terms: Fe(III)-EDTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: NaFeEDTA; electrolytic iron; efficacy; whole maize flour; phytate; school-age children; controlled trial; Africa
Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Adolescent Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate
      (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia.
    


Intervention name(s): quetiapine fumarate tablets
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia
Paroxetine vs Placebo Combined With Aerobic Exercise or Relaxation in Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Efficacy and safety of a 10-weeks treatment protocol of paroxetine vs. placebo in combination
      with regular aerobic exercise (running) or regular relaxation training in the treatment of
      panic disorder.
    

Detailed description: 
      In continuation of prior work from our group (Broocks A, Bandelow B, Pekrun G, et al.
      Comparison of aerobic exercise, clomipramine, and placebo in the treatment of panic disorder.
      Am J Psychiatry 1998; 155(5):603-9.) it is the purpose of this trial to test the assumed
      superiority of a combined therapy of paroxetine and aerobic exercise compared to placebo or
      unspecific relaxation training in panic disorder. Participants were randomized to a 10 week
      treatment protocol of paroxetine 40 mg daily or placebo in combination with regular exercise
      or regular relaxation after having given informed consent and screening of in- and exclusion
      criteria.
    

Intervention name(s): paroxetine + aerobic exercise; Paroxetine + relaxation; Placebo + aerobic exercise; Placebo + relaxation
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): paroxetine, 40 mg once daily + regular aerobic exercise; paroxetine, 40 mg once daily + regular relaxation training; placebo pill once daily + regular aerobic exercise; placebo pill once daily + regular relaxation training
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: panic disorder; pharmacotherapy; non-pharmacological treatment; SSRI; paroxetine; exercise
Vascular Graft Storage Solution Preserves Endothelial Function
Condition: Vein Injury
Study type: Observational

Summary: 
      Since Saline is still the most widely used storage and flushing solution in cardiovascular
      procedures despite knowing evidence of its influence on the human endothelial cell function
      the main aim of this study was to assess the effect of DuraGraft©, an intraoperative graft
      treatment solution, on human saphenous vein segments 8 Remnants from the operation after
      trimming the bypass length), rat aortic segments and human umbilical vein endothelial cells
      (HUVECs) in comparison to saline.
    

Detailed description: 
      Saline is still the most widely used storage and flushing solution in cardiovascular
      procedures despite knowing evidence of its influence on the human endothelial cell function.
      Aim of this study was to assess the effect of DuraGraft©, an intraoperative graft treatment
      solution, on human saphenous vein segments, rat aortic segments and human umbilical vein
      endothelial cells (HUVECs) in comparison to saline. According to literature saline could have
      detrimental effects on the endothelium but data shows conflicting evidence. Duragraft a so
      called endothelial preservation solution should protect the human endothelium. Intent of this
      observational study was to study the effects of both solutions and compare them.

      Within 12 patients undergoing aortocoronary bypass surgery, left overs from saphenous vein
      graft segments were randomized to DuraGraft© (n=12/6) or saline (n=12/6) solution before
      intraoperative storage. These segments as well as rat aortic segments underwent assessment of
      vascular function in a multichamber isometric myograph system in comparison to
      Krebs-Henseleit solution (KHS), a physiologic organ buffer solution. Additionally, human
      umbilical vein endothelial cells (HUVECs) were used for cell viability tests.
    

Intervention name(s): ex vivo organ bath testing, preservation of vein sections without contact to patient
Intervention type(s): Other
Intervention description(s): 1 piece of vein is separated during surgical bypass procedure, then randomized and put ex vivo in two solutions: saline and specific solution, then tested in the organ bath
Other intervention name(s): organ bath ex vivo comparing saline vs specific solution
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients undergoing bypass surgery exluding emergency cases
      
Keywords: vein; preservation; endothelium
Evaluation Of Efficacy And Safety Of Norspan In Moderate To Severe Pain Due To Osteoarthritis, Rheumatoid Arthritis, Joint/Muscle Pain
Condition: Osteoarthritis; Rheumatoid Arthritis; Lower Back Pain; Joint Pain; Muscle Pain
MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Arthralgia; Myalgia; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy of the buprenorphine transdermal patch
      (Norspan® or Sovenor® transdermal patch) in patients with chronic non-malignant pain of
      moderate to severe intensity due to osteoarthritis, rheumatoid arthritis, lower back pain and
      joint/muscle pain, who are not adequately responding to non-opioid painkillers.
    

Detailed description: 
      Baseline assessment (Visit 1) includes medical history, physical examination, vital signs.

      At Visit 2 [7 days ( ± 3 days) after Visit 1] and subsequent optional titration visits up to
      (Visit 1 + 42 days) , patients will be titrated up to an effective and tolerated dose of
      Norspan® or Sovenor® transdermal patch and continue rescue analgesic, if necessary.

      Titration period is dependent on time to achieving optimal pain control as determined by the
      investigator. The up-titration regime is planned on a weekly basis. Earlier dose titration
      (i.e. minimum 3 days after the patch application) is permitted at the investigator's
      discretion if the pain is uncontrolled. Effective and tolerated dose is assessed by data
      recorded in the case report form and patient diary.

      According to country label, all patients will begin treatment with Norspan® or Sovenor®
      transdermal patch 5mg and will then be up-titrated, if necessary, to a maximum of Norspan® or
      Sovenor® transdermal patch 40mg or according to country label to achieve stable pain control.
      Patients that require oral opioid at any time during the study should be discontinued from
      the trial.
    

Intervention name(s): Buprenorphine transdermal patch
Intervention type(s): Drug
Intervention description(s): Please see Arm Description.
Other intervention name(s): Norspan transdermal patch; Sovenor transdermal patch
Intervention MeSH terms: Buprenorphine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Norspan; buprenorphine; transdermal; patch; chronic pain; non-malignant; osteoarthritis; rheumatoid arthritis; lower back pain; joint pain; muscle pain; opioid; analgesic; painkiller; Mundipharma
Desaturation Validation of INVSENSOR00028
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to measure the trending accuracy of a noninvasive regional oximetry
      measurement of somatic oxygen saturation. Two large sensors (adult sensors) will be placed on
      the subject's forehead. Two investigational sensors (INVSENSOR00028) will be placed on the
      forearm of the volunteer. The values obtained by the INVSENSOR00028 will be compared to the
      reference value calculated from the arterial and venous blood measurements. Data will be
      collected from healthy adult subjects while undergoing a desaturation procedure wherein the
      concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen
      saturation is approximately 70%, while blood samples are drawn at prespecified reference
      points. The subject will then be returned to inhaling room air.
    


Intervention name(s): INVSENSOR00028
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Genetic Research in Schizophrenia Using DNA Markers and Clinical Phenotypes
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      Schizophrenia has long been known to be an illness with significant evidence for a genetic
      predisposition. The purpose of this study is to determine the genetic abnormalities that
      cause childhood and adult onset schizophrenia.
    

Detailed description: 
      It is known from genetic linkage and gene expression studies that the alpha 7 nicotinic
      receptor gene is abnormally expressed in people with schizophrenia. The immediate objectives
      of this proposal support the long-term objectives of a comprehensive description of the
      pathophysiology of schizophrenia and new drug treatments by carefully defining the
      physiological genotype-phenotype relationship for a single candidate gene. Subjects and
      family members with a mental illness or who appear to have a mental illness will be asked to
      undergo an interview, perform some mental tests and have a blood, urine, and saliva sample
      taken one time.
    

Intervention name(s): Diagnostic
Intervention type(s): Other
Intervention description(s): Diagnostic evaluation for schizophrenia. Schizophrenia includes schizophrenia and schizoaffective disorder.
Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons with schizophrenia, their relatives, and controls
      
Biospecimen description: 
      dna
    
Keywords: schizophrenia
Effect of Pneumoperitoneum on Cognitive Function and Regional Cerebral Oxygen Saturation
Condition: Pneumoperitoneum
MeSH terms: Pneumoperitoneum
Study type: Observational [Patient Registry]

Summary: 
      The investigators hypothesized that the pneumoperitoneum with reverse Trendelenburg position
      could alter the rSO2 and early postoperative cognitive function.
    

Detailed description: 
      Laparoscopic gastrectomy requires a reverse-Trendelenburg position and prolonged
      pneumoperitoneum and it could cause significant changes in cerebral homeostasis and lead to
      cognitive dysfunction. We compared changes in haemodynamic variables, regional cerebral
      oxygen saturation, and early postoperative cognitive function in patients undergoing
      laparoscopic gastrectomy in the reverse Trendelenburg position with those patients that
      underwent conventional open gastrectomy.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient who undergoing laparosopic or open gastrectomy patients who have respiratory and
        cardiovascular disorders were excluded
      
Keywords: pneumoperitoneum, cognitive function
D1 Receptor Occupancy (RO) Following a Single Dose of PF-06412562
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To assess the D1 receptor occupancy (D1 RO) in striatum after a single oral administration of
      PF-06412562.
    

Detailed description: 
      Primary Objectives:

        -  To assess the D1 receptor occupancy (D1 RO) in striatum after a single oral
           administration of PF-06412562

        -  To assess the relationship of D1 RO in the striatum versus plasma exposure of
           PF-06412562 after a single oral administration.

      Secondary Objective:

      • To evaluate the plasma exposure of PF-06412562for the duration of PET scan following a
      single oral administration of PF-06412562.

      Safety Objectives:

      • To evaluate the safety and tolerability of PF-06412562 of single oral doses of PF-06412562.
    

Intervention name(s): PF-06412562
Intervention type(s): Drug
Intervention description(s): Healthy Volunteers recruited for the study will undergo a single dose of PF-06412562 and will undergo two [18F]MNI-968 injections
Other intervention name(s): [18F]MNI-968 (PF-06730110)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HV
Clinical Effect of Platelet Rich Plasma Combined With Laser on Scar
Condition: Acne Scar
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      Investigation of Clinical Effect of Platelet Rich Plasma Combined With Laser on Acne Scar
    

Detailed description: 
      Platelet Rich Plasma may relieve the adverse effect of laser treatment. and it can be
      expected to improve acne treatment result.
    

Intervention name(s): fractional carbon dioxide laser with platelet rich plasma; fractional carbon dioxide laser with NS
Intervention type(s): Procedure; Procedure
Intervention description(s): fractional carbon dioxide laser followed by platelet rich plasma injection; fractional carbon dioxide laser followed by normal saline injection
Other intervention name(s): COFRAX with autologous PRP; COFRAX with normal saline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne scar; fractional carbon dioxide laser; platelet rich plasma
Progression to Impaired Glucose Tolerance and Type 2 Diabetes in the Korean People-based KNDP Study
Condition: Impaired Glucose Tolerance; Diabetes
MeSH terms: Glucose Intolerance
Study type: Observational

Summary: 
      Impaired glucose tolerance is a metabolic state between normal glucose homeostasis and
      diabetes. Previously, prospective studies have shown higher progression rates from IGT to
      diabetes in other country. But There is no prospective-multicenter based reports in Korea.
      Therefore, the purpose of this study is to estimate the progression rates to impair glucose
      regulation and diabetes in the Korean population-based Korea national Diabetes program.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients who vist the endocrinology department due to impaired fasting glucose or impaired
        glucose tolerance, or both.
      
Keywords: NGT, IGT, diabetes
Lifestyle Enriching Activities for Research in Neuroscience Intervention Trial: LEARNit Study
Condition: Aging; Cognitive Ability, General
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of modifiable lifestyle factors including
      exercise and healthy living on brain health. The investigators will compare 2 types of
      interventions, moderate aerobic walking vs. healthy living education, over 6 months to
      evaluate changes in brain health, cognition, and physical function in older adults with
      cognitive concerns.
    

Detailed description: 
      Cognitive decline in older adults is a major public health issue. The cost of caring for
      older adults with substantial cognitive impairment, like those with Alzheimer's Disease in
      the US is approximately $200 billion a year, causing major societal, economic, and caregiving
      burden. Despite great advances towards diagnosing these problems, the discovery of effective
      treatments has been minimal. Exploring non-pharmacological interventions, such as exercise
      and healthy living, have gained momentum. These promising, modifiable lifestyle interventions
      have the potential for delaying disease onset and slowing decline in cognition. However, the
      therapeutic effect of lifestyle interventions in patients with mild cognitive impairment, a
      prime intervention period for treatment, is not well understood. Therefore, in this study,
      the investigators will examine brain, body, and cognitive changes in older adults who engage
      in moderate-aerobic walking or healthy living education.
    

Intervention name(s): Moderate-aerobic walking; Positron Emission Tomography (PET) scan; Healthy living education; Physical activity monitor
Intervention type(s): Behavioral; Radiation; Behavioral; Device
Intervention description(s): Radioligand that binds to proteins using a PET/CT scanner.; Wrist device that will track daily physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; Mild Cognitive Impairment; Brain Imaging