bioihbjkbjnl/mcl2 huggingface dataset:
Role of Nitric Oxide in Diabetic Patients With Erectile Dysfunction
Condition: Erectile Dysfunction; Diabetes Mellitus
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      Erectile dysfunction (ED) is defined as penile erection that is insufficient and
      unsustainable for a satisfactory sexual performance.

      The etiology of ED is multifactorial including chronic diseases such as hypertension,
      diabetes mellitus and coronary artery disease However, the main underlying cause is
      degenerative changes that result in endothelial dysfunction
    

Detailed description: 
      Diabetes leads to endothelial dysfunction and a pro-inflammatory state, which reduces the
      usability and activity of nitric oxide (NO). NO is a powerful force for sustaining penile
      blood flow.

      Diabetes is an estab¬lished risk factor for sexual dysfunction in men; a three-fold increased
      risk of erectile dysfunction (ED) was documented in diabetics compared with non-diabetic men.

      In smooth muscles, NO activates guanyl cyclase and increases cyclic guanosine monophosphate
      (cGMP) concentration. cGMP activates certain intracellular protein kinases that phosphorylate
      receptor proteins. Activated protein kinases open the potassium channels and increase the
      influx of potassium and block the influx of calcium by inhibiting calcium channels. This
      leads to hyperpolarization and relaxation of smooth muscle. Reduced arteriolar resistance
      leads to sinusoidal spaces filled with blood. These enlarged sinusoids further increase the
      intracavernosal pressure by blocking the venous return and producing a rigid erection. cGMP
      is converted to GMP by phosphodiesterase, which is inhibited by phosphodiesterase 5 (PDE-5)
      inhibitors.

      (NO) has vasodilatory properties and balances RhoA/Rho-kinase-mediated vasoconstriction,
      which is a predominant mediator of the physiologic induction and maintenance of erections.

      Evidences show that functional polymorphisms within endothelial NO synthase (eNOS) gene
      interfere with normal erectile function.

      In humans, the eNOS gene is located on chromosome 7q35-36 and consists of 26 exons spanning
      21 kilobases (kb). Several polymorphisms of eNOS have been investigated. More frequently,
      investigated regions of this gene include a variable number of 27 bp tandem repeats in intron
      4 (VNTR), G894T (rs1799983) polymorphism in exon 7 and a T-786C (rs2070744) polymorphism in
      the promoter region
    

Intervention name(s): Nitric oxide synthase gene
Intervention type(s): Diagnostic Test
Intervention description(s): Biochemical assessment of serum nitric oxide level pre and post 5 mg tadalafil therapy in diabetic patients with erectile dysfunction and in normal healthy controls.
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR FAILED BACK SURGERY SYNDROME
Condition: Failed Back Surgery Syndrome
MeSH terms: Syndrome; Failed Back Surgery Syndrome
Study type: Interventional

Summary: 
      Failed back surgery syndrome (FBSS) is the term of persistent back and/or leg pain after
      surgery for lumbar disk herniation (LDH). Repetitive transcranial magnetic stimulation
      (r-TMS) is a technique that allows non-invasive and relatively painless stimulation of
      cerebral cortex. It can reduce the experience of chronic pain by using magnetic field to
      produce small electrical currents in the cortex.The aim of this study is to determine the
      effectiveness of r-TMS treatment on patients with FBSS.
    

Detailed description: 
      Methods: In this double-blinded, randomized, placebo-controlled trial, 20 patients (aged
      34-65 years) clinically diagnosed as FBSS, who had a history of surgery for LDH with
      persistent back and leg pain. Patients in r-TMS group received 5 Hz of r-TMS, as a 20-min
      (1000 pulses) daily session, 5 days per weeks, for a total of 10 sessions. R-TMS applied with
      MagVenture device (MagPro X100, Denmark, 2009) and figure eight coil (MMC 140 parabolic,
      MagVenture). Control group received sham r-TMS with the same protocol. Patients were assessed
      at baseline,after 5th and 10th sessions and 1 and 3 months after treatment. Visual Analogue
      Scale (VAS), DN-4 (Douleur Neuropathique-4 Questionnaire), Oswestry Disability Index (ODI),
      Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI) were used for
      evaluation.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation; Sham Repetitive transcranial Magnetic Stimulation
Intervention type(s): Device; Device
Intervention description(s): Patients in r-TMS group received 5 Hz of r-TMS. R-TMS applied with MagVenture device (MagPro X100, Denmark, 2009) and figure eight coil (MMC 140 parabolic, MagVenture).; Control group received sham r-TMS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: repetitive transcranial magnetic stimulation; back pain; failed back surgery syndrome
Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With Dementia
Condition: Alzheimer's Disease; Dementia With Lewy Bodies; Parkinson's Disease Dementia
MeSH terms: Parkinson Disease; Alzheimer Disease; Dementia; Lewy Body Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study seeks to evaluate the effect of intepirdine (RVT-101) on gait and balance in
      patients with Alzheimer's Disease, Dementia with Lewy Bodies or Parkinson's Disease Dementia.
    

Detailed description: 
      To assess the effect of intepirdine (RVT-101) versus placebo on quantitative and qualitative
      gait and balance parameters.

      Each subject will be randomized 1:1 to one of the following sequences:

      Sequence 1: AB = RVT-101 35 mg during the early treatment period and Placebo during the late
      treatment period

      Sequence 2: BA = Placebo during the early treatment period and RVT-101 35 mg during the late
      treatment period

      Treatment A = RVT-101 35 mg once daily.

      Treatment B = Placebo once daily.
    

Intervention name(s): RVT-101 35 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RVT-101 once daily, oral, 35-mg tablets; Placebo once daily, oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RVT-101; intepirdine; Alzheimer's disease; Dementia with Lewy bodies; Lewy body dementia; Parkinson's Disease Dementia
Clearance of NRL972 in Patients With Cirrhosis, Nonalcoholic Steatohepatitis (NASH) and in Healthy Volunteers
Condition: Hepatic Cirrhosis; Nonalcoholic Steatohepatitis
MeSH terms: Liver Cirrhosis; Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study was conducted to describe and compare the plasma pharmacokinetics of NRL972
      administered after a standard meal and while fasted in patients with hepatic cirrhosis
      (Child-Turcotte-Pugh [CTP] class A-C), NASH, young and elderly healthy males, and young and
      elderly healthy females, to assess the effects of liver dysfunction, gender, age and prandial
      intestinal hyperaemia on the clearance of NRL972. In addition, the study was to provide
      information on the safety and tolerability of repeated intravenous doses of NRL972 in these
      populations.
    


Intervention name(s): NRL972; NRL972; NRL972; NRL972; NRL972; NRL972; NRL972
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal; Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal; Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal; Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal; Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal; Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal; Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety and Efficacy of NPS 1776 in the Acute Treatment of Migraine Headaches
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to evaluate the effectiveness and safety of a single oral dose
      of NPS 1776 in the acute treatment of migraine pain and associated symptoms.
    

Detailed description: 
      Migraine, the most common cause of recurrent severe or disabling headache, is diagnosed on
      the basis of a clinical history of intermittent headache with autonomic, constitutional, and
      neurologic disturbances.

      Many antiepileptic drugs (AEDs) have demonstrated efficacy as acute and/or prophylaxis
      therapy for migraine, even though the mechanism of action of the various AEDs is poorly
      understood.

      NPS 1776, isovaleramide, is a neutral aliphatic amide. The mechanism by which NPS 1776 exerts
      its therapeutic actions in nonclinical animal models of disease is unclear. The same is true
      for many antiepileptics on the market today. NPS 1776 does not appear to bind directly to
      various CNS receptor centers, although it shows a broad range of anticonvulsant activity in
      multiple animal models of seizures. This broad profile of anticonvulsant activity is similar
      to that of valproic acid (VPA), and may also predict NPS 1776 efficacy in the treatment of
      migraine.
    

Intervention name(s): NPS 1776 (800 mg); PLACEBO; NPS 1776 (400 mg)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NPS 1776 (800 mg) powder; Placebo in non-carbonated fruit flavored drink (150 ml); NPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink
Other intervention name(s): NPS 1776; NPS1776
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Migraine
Evaluation on the Efficacy of Bronchodilator Nebulization Via High Flow Nasal Cannula
Condition: High Flow Nasal Cannula
Study type: Interventional

Summary: 
      High-humidity nasal cannula (HFNC) has been shown to be effective in improving oxygenation
      and avoiding intubation in multiple randomized control trials, it is also suitable and
      feasible for long term use. Aerosol delivery via HFNC will minimize interruptions and improve
      patient compliance, bench study and radionuclide imaging study done in healthy volunteers
      demonstrated that aerosol can be effectively delivered using HFNC. This study aims to
      evaluate the efficacy of bronchodilator delivered via HFNC in chronic pulmonary obstructive
      disease or asthma patients.
    

Detailed description: 
      Chronic obstructive pulmonary disease or asthma patients who have positive response in
      bronchodilator test will be consented and enrolled, patients come back for the second
      bronchodilator assessment within one to three days after the initial bronchodilator test.
      Albuterol with different concentration will be provided to the patients via HFNC, patients
      will be assessed by spirometry after each concentration until bronchodilator response is
      positive and does not improve after the next dose.
    

Intervention name(s): High flow nasal cannula; Albuterol Sulfate
Intervention type(s): Device; Drug
Intervention description(s): High flow nasal cannula is a soft and flexible nasal prongs with adjustable head strap fits over the patient's ears, it delivers a broad variety of gas flows directly into the nares without gas jetting.; Albuterol is a short acting inhaled bronchodilator
Other intervention name(s): Optiflow, Fisher Paykel; Ventolin
Intervention MeSH terms: Albuterol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SILS Cholecystectomy: Cholangiography of the Biliary Tract
Condition: Cholecystolithiasis
MeSH terms: Cholecystolithiasis; Cholelithiasis; Gallstones
Study type: Interventional

Summary: 
      Single Incision Laparoscopic Surgery (SILS) can be performed for different standard
      operations such as appendectomy and cholecystectomy. During laparoscopic cholecystectomy
      sometimes a cholangiography (marking the biliary tract with contrast agent) is necessary to
      identify and preserve relevant structures. The investigators want to evaluate feasibility of
      performing cholangiography during SILS cholecystectomy.
    


Intervention name(s): SILS cholangiography
Intervention type(s): Procedure
Intervention description(s): intraoperative
Other intervention name(s): LESS; E-NOTES
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cholelithiasis
Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years
Condition: Upper Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional

Summary: 
      Acute upper respiratory tract infections are the most commmon infections in children and are
      associated with complications such as acute otitis media, sinusitis and pneumonia. Echinacea
      is widely used for treatment of upper respiratoty tract infections. The aim of this study is
      to evaluate its efficacy as prophilaxis in children 1-5 years old.
    


Intervention name(s): Echinacea; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old; Placebo (0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old) for 3 months
Other intervention name(s): American Cone Flower
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Upper Respiratory Tract Infections; Echinacea; viral infections
Effect of Aricept on Biomarkers (Acetylcholine, sAPP Alpha) In Cerebrospinal Fluid
Condition: Alzheimer's Disease; Dementia
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      It is hypothesized that the acetylcholinesterase inhibitor, donepezil, will increase acute
      cerebrospinal fluid (CSF) actylcholine levels in healthy volunteers following a 5mg single
      dose oral administration.
    

Detailed description: 
      Sampling method based upon estimates of intra-subject biomarker variability.
    

Intervention name(s): Placebo; donepezil (Aricept)
Intervention type(s): Drug; Drug
Intervention description(s): Oral; 5mg oral
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Young (18-55) male and female healthy volunteers.
      
Biospecimen description: 
      DNA, plasma, CSF
    
Keywords: CSF Biomarkers Acetylcholine
Drug-drug Interaction Study With GLPG3667 and Itraconazole in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine the effect of itraconazole on the amount of
      GLPG3667 that gets into the blood when the 2 drugs are administered together compared to when
      GLPG3667 is administered alone.
    


Intervention name(s): GLPG3667; Itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): On day 1 and day 8, participants will receive a single dose; On days 5 to 11, participants will receive itraconazole once daily
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Plaque Composition in Patients With ST-Segment Elevation Myocardial Infarction (MI)
Condition: Acute Coronary Syndrome
MeSH terms: Myocardial Infarction; Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      In patients with ST-segment elevation acute myocardial infarction (STEMI) increased
      LDL-cholesterol reduction (rosuvastatin 40 mg) will provide incremental plaque stabilization
      (changes in plaque composition) and plaque regression over 12 months beyond the benefit of
      moderate LDL-cholesterol reduction (rosuvastatin 5 mg) (assessed by IVUS and VH).
    


Intervention name(s): Rosuvastatin 5mg; Rosuvastatin 40mg
Intervention type(s): Drug; Drug
Intervention description(s): Rosuvastatin 5mg/day; Rosuvastatin 40mg/day
Other intervention name(s): Crestor; Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: ST-Segment Elevation Myocardial Infarction
Experimental Medicine in ADHD - Cannabinoids
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Adult patients with ADHD commonly report an improvement in behavioural symptoms when using
      cannabis with some reporting a preference towards cannabis over their ADHD stimulant
      medication. The EMA-C study aims to investigate the effects of a cannabis based medication,
      Sativex Oromucosal Spray on behaviour and cognition in adults with ADHD.

      This will be carried out by conducting a placebo controlled trial. 30 adults with ADHD will
      take Sativex or a dummy medication (a placebo) every day for 6 weeks. There is a 50% chance
      of receiving the Sativex or Placebo. Measures of behaviour and cognition will be taken before
      and after 6 weeks of treatment. We hypothesise that treatment with Sativex will result in
      improvements in behaviour and cognition above that of the placebo group.
    


Intervention name(s): Sativex Oromucosal Spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sativex Oromucosal Spray (GW Pharma Ltd, Salisbury. UK). Each 100 microlitre spray contains: 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD).
Other intervention name(s): Sativex
Intervention MeSH terms: Nabiximols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: ADHD,; Cannabis,; Sativex,; Endocannabinoid,; Cognition
Early Detection of COPD Patients in GOLD 0 (Smokers) Population
Condition: COPD; Smoking; Other Diagnoses, Comorbidities, and Complications
Study type: Observational

Summary: 
      Even though the main risk factor for the development of chronic obstructive pulmonary disease
      (COPD) is smoking only in less than one third of the smokers the clinically manifest COPD
      will develop. The disease progressive nature with high disability and mortality especially in
      the final stages makes it plausible to detect the disease as early as possible thus allowing
      for the early intervention. Major intervention trials in COPD, "Towards a Revolution in COPD
      Health" (TORCH), "Investigating New Standards for Prophylaxis in Reducing Exacerbations"
      (INSPIRE), and "Understanding Potential Long-term Impacts on Function with Tiotropium"
      (UPLIFT) have recently shown that the beneficial impact of intervention was larger in
      patients being treated in earlier stages of the disease development. Till now the only tool
      for an early diagnosis and early intervention that could be used on the global scale was
      spirometry even though symptoms and deprivation of quality of life (QoL) precedes clinically
      relevant spirometric changes. So there is a need for a new simple tool that would allow
      detection of patients in a very early stage of COPD.

      So the aim of this study is the development of diagnostic tools for an early detection of
      COPD, even before the significant change in spirometry.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Biospecimen description: 
      whole blood, serum, plasma
Dairy and Plant Amino Acid Uptake. An Explorative Study
Condition: Amino Acid Plasma Profile
Study type: Interventional

Summary: 
      To optimize the environmental sustainability, a protein transition to more plant-based
      protein sources is required. However, the protein quality of plant-based sources is lower
      than that of the dairy proteins casein and whey, which contain high levels of essential amino
      acids. The amino acid absorption characteristics of many plant-based proteins are unknown.

      The present study aims to estimate differences in postprandial plasma total essential amino
      acids (TEAA) profiles after protein consumption of different protein sources in blood of
      healthy participants. This explorative study has a randomized, cross-over, double-blind,
      controlled design.
    


Intervention name(s): Dairy protein; Plant protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.; During each visit, research subjects will receive the product dissolved in water, representing a 20g protein load.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Dairy protein; Plant protein; Postprandial plasma amino acid profiles; Essential amino acids (EAA); Total amino acids (AA)