bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness Of Therapy With A Thermal Water Nasal Aerosol In Children With Seasonal Allergic Rhinitis
Condition: Allergic Rhinitis (Disorder)
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate the effects of Ischia thermal waters nasal
      irrigation on allergic rhinitis and airway inflammation during the period of natural exposure
      to parietaria pollen in children with allergic rhinitis and intermittent asthma.
    

Detailed description: 
      The study was conducted on the island of Ischia - Naples from April to June 2009, during the
      natural exposure period to parietaria pollen. The treatment started just before the pollen
      season, when all the children were asymptomatic, not treated with any drug and not affected
      by respiratory tract and systemic diseases. All the children were randomly divided into two
      homogeneous groups by sex and age. The first group has practiced crenotherapy with
      "hyper-mineral chloride sodium water" aerosol by nasal adapter for 15 days per month, for
      three consecutive months, at thermal spa services of Lacco Ameno, while the control group was
      treated, in the same period, daily, by a micronized nasal douche with 0.9% NaCl (isotonic)
      solution. Before the treatment (T0), at the end of the treatment (T1) and again 2 weeks after
      the end of the treatment (T2), all the children have performed spirometry (Pony FX Cosmed),
      and exhaled nitric oxide (FeNO) (NIOX MINO analyzer COSMED), to assess their airway
      inflammation. At the time of recruitment, the parents of the children were instructed to fill
      a specific diary-card (TSS) at home, to assess rhinitis symptoms and possible drug use during
      all 3 months of treatment. The parameters considered in the TSS were: nasal obstruction,
      sneezing, nasal discharge and itching. These symptoms were scored: 0 = symptom absent, 1 =
      mild (symptoms present but not annoying), 2 = moderate (frequent and offensive symptoms but
      do not interfere with sleep or normal activities) 3 = severe (symptoms that interfere with
      sleep or normal activities).

      Every two weeks, at the end of each cycle of therapy the children underwent a general
      clinical control with nasal endoscopy, spirometry and monitoring the completion of diary
      cards and the possible use of drugs.
    

Intervention name(s): thermal waters nasal irrigation
Intervention type(s): Other
Intervention description(s): The first group (group 1) has practiced crenotherapy with "hyper-mineral chloride sodium water" aerosol by nasal adapter for 15 days per month, for three consecutive months, at thermal spa services of Lacco Ameno, while the control group (group 2) was treated, in the same period, daily, by a micronized nasal douche with 0.9% NaCl (isotonic) solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study of VIS410 to Assess Safety and Pharmacokinetics
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, immunogenicity and
      pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.
    


Intervention name(s): VIS410; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Influenza; Monoclonal antibody
Anti-hyperglycemic Effect of Short-term Arginyl-fructose Supplementation in Subjects With Pre-diabetes and Newly Diagnosed Type 2 Diabetes: Randomized, Double-blinded, Placebo-controlled Trial.
Condition: Pre-diabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      In this double-blind, placebo-controlled study, subjects with prediabetes and type 2 diabetes
      were randomly assigned to the placebo control group or the test (Arginyl-fructose: AF) group.
      We determined fasting serum levels of glucose, hemoglobin A1c (HbA1c), insulin, and free
      fatty acids (FFAs), were measured by 2-h oral glucose tolerance tests (OGTTs) at baseline and
      after the 6-week intervention.
    


Intervention name(s): Arginyl-fructose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anti-hyperglycemic effect
A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability and pharmacokinetics of sitagliptin in 10 to
      17 year old diabetic patients.
    


Intervention name(s): Sitagliptin phosphate; Comparator: matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of sitagliptin 50 mg tablet, sitagliptin 100 mg tablet, or sitagliptin 200 mg.; Participants will fast 8 hours prior to dosing. All doses will be given with 240 ml of water. Participants received either a single oral dose of matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
Other intervention name(s): MK-0431; Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of
      concept in subjects with PD treated with a stable dose of levodopa who are experiencing both
      end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)
    


Intervention name(s): Placebo oral capsule; PXT002331 - dose 1; PXT002331 - dose 2
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BID; Oral; Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Levodopa-Induced Dyskinesia (LID); Wearing-off; Foliglurax; Parkinson's Disease; mGluR4 PAM
Study of Blood Parameters of the Malnourished Children: Before and After Giving Nutritional Biscuit's Treatment
Condition: Undernutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Present study was designed to evaluate the efficacy of the nutritional intervention, in the
      SAM (Severe Acute malnutrition)children by monitoring various Anthropometric,Biochemical
      ,Hormonal and Enzymatic parameters before and after the nutritional intervention
      treatment.This study was also intended to study possible functional role of gene HRI (heme
      regulated inhibitor) as a molecular marker for the early detection of iron deficiency anemia
      in malnourished children similarly present study has also tried to find anthropometric marker
      and different correlations among study parameters.
    

Detailed description: 
      In India, child malnutrition is responsible for 22% of the country's burden of disease.
      Development of local therapeutic nutritional intervention is highly recommended by WHO.
      Present study was designed to evaluate the efficacy of the nutritional intervention, as well
      as to study HRI (heme regulated inhibitor) gene expression, to suggest it as a molecular
      marker for the early detection of iron deficiency anemia in malnourished children also to
      find anthropometric marker and different correlations of study parameters.

      105 test and 100 control SAM (Severe Acute malnutrition) children without infection, of 1 to
      5 years of age and either sex were enrolled. Test group was given treatment of nutritional
      intervention therapy (NIT), providing 2.5 to 3gm Protein and 90-100kcal/kg body Weight/day,
      for the three months period. Their Anthropometric, Enzymatic, Biochemical and Hormonal
      parameters were measured before and after the NIT. Correlation of serum triglyceride with
      weight for height% , as well as correlation of HRI with Mean corpuscular hemoglobin,(MCH) was
      studied. Similarly status of Hairs, Skin, oedema, WHO z- score,and BMR was also studied
      before and after the NIT.
    

Intervention name(s): Nutritional biscuits and khichadi; Khichadi
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Nutritional biscuits and Khichadi.; Khichadi.
Other intervention name(s): Khichadi means Rice cooked with lentiles and spices.; Khichadi means Rice cooked with lentiles and spices.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nutritional intervention; iron deficiency anemia
Cystogram Before Removal of Foley Catheter After Repair of Colovesical Fistula
Condition: Colovesical Fistula
MeSH terms: Intestinal Fistula; Fistula
Study type: Observational

Summary: 
      Colovesical fistulas are well-recognized but relatively uncommon pathology to both the
      general and colorectal surgeon. It is a complication arising from an underlying primary acute
      to chronic inflammatory process. Although colovesical fistulas are uncommon, they are
      associated with significant morbidity, affect quality of life, and may lead to death, usually
      secondary to urosepsis. Early diagnosis and management is essential.

      The purpose of the study is to determine the objective use of cystographic evaluation on
      postoperative day two to guide early Foley catheter removal post colovesical fistula
      takedown. The hypothesis is that a cystogram showing no extravasation of contrast on
      postoperative day two will predict safe removal without increased morbidity.

      This is an uncontrolled, single arm trial. Patients who meet criteria to undergo either
      minimally invasive or open colovesical fistula takedown with sigmoid colectomy, without
      evidence of the need for bladder repair will be eligible to participate. An indwelling Foley
      catheter is placed intraoperative and continued postoperative. All patients who consent to
      participate would undergo a cystogram on postoperative day two. The cystogram will be
      conducted by a radiologist and technician well-trained in the techniques and interpretation
      of the study. The colorectal surgery enhanced recovery protocol will be followed on all
      patients with the exception of the cystogram being conducted on post-op day two. If there is
      no evidence of extravasation of dye is seen on the cystogram the Foley catheter will be
      removed. Patients will be monitored closely following catheter removal to ensure
      self-diuresis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients meeting all inclusion and no exclusion criteria being cared for at Mount Carmel
        Health System
      
Keywords: cystogram; Foley catheter
Omega-3 Fatty Acids to Combat Sarcopenia
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how omega-3 fatty acids influence muscle protein
      metabolism and mitochondrial physiology in the context of human aging.
    


Intervention name(s): Omega-3 fatty acids
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Vantictumab (OMP-18R5) in Combination With Docetaxel in Patients With Previously Treated NSCLC
Condition: Solid Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label Phase 1b dose-escalation study to assess the safety, tolerability, and
      PK of vantictumab when combined with docetaxel.
    

Detailed description: 
      Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been determined,
      up to 10 patients may be enrolled in the cohort-expansion phase to better characterize the
      safety, tolerability and PK of vantictumab combined with docetaxel. Up to approximately 34
      patients may be enrolled into the study.
    

Intervention name(s): Docetaxel; vantictumab
Intervention type(s): Drug; Drug
Intervention description(s): Docetaxel will be administered IV.; Vantictumab will be administered intravenously
Other intervention name(s): (OMP-18R5)
Intervention MeSH terms: Docetaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase 1; dose escalation; histologically confirmed; malignancy metastatic
Shock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain
Condition: Tendinopathy
MeSH terms: Tendinopathy; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of this randomized controlled study in to investigate if a shock wave treatment
      extended to the gastrocnemius-soleus trigger points (TrP) is more effective than a standard
      treatment exclusively targeted at the plantar fascia in a population affected by unilateral
      plantar fasciitis with concomitant sural myofascial pain syndrome.
    


Intervention name(s): Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points; Shock wave therapy on plantar fascia only
Intervention type(s): Other; Other
Intervention description(s): Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia and the gastrocnemius-soleus trigger points were clinically targeted and treated with a perpendicular technique.; Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia was clinically targeted and treated with a perpendicular technique.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myofascial pain syndrome
ANTEAB: a Study of Early Antibiotherapy in the ICU Management of Acute Exacerbations of COPD
Condition: Chronic Obstructive Lung Disease (COLD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung
      disease (COLD) is a major cause of morbidity and mortality in such patients. Although
      bacterial of mortality in such patients. Although bacterial and or viral infections are
      considered as the major precipitating factor, the antibiotic strategy in this setting is
      unclear. The absence of overt infection remains controversial, and has not been adequately
      studied in patients admitted to the ICU. To assess the benefit ( or lack thereof ) of routine
      early systemic antibiotic therapy in patients with COLD admitted to the ICU.

      The primary objective of the essay is to evaluate the effectiveness of the precocious
      antibiotic therapy on the length of the respiratory symptoms with the admitted patients in
      polyvalent medical intensive care of chronic obstructive lung disease ( COLD )
    

Detailed description: 
      This is a multicenter, randomised, double-blind controlled trial, comparing
      amoxicillin-clavulanic acid administered for 7 days to a placebo.
    

Intervention name(s): Amoxicillin-clavulanic
Intervention type(s): Drug
Intervention description(s): Amoxicillin-clavulanic
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Lung Disease (COLD); Randomized Clinical Trial; Antibiotics; Acute Exacerbation; Mechanical; Ventilation; Intensive Care; Length of Stay; Mortality
Trial of Dronabinol and Vaporized Cannabis in Chronic Low Back Pain
Condition: Cannabis; Low Back Pain; Neuropathic Pain
MeSH terms: Neuralgia; Back Pain; Low Back Pain; Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will involve treating low back pain associated with nerve injury with oral
      delta-9-tetrahydrocannabinol (Δ9-THC) or whole plant cannabis for eight weeks. Research
      subjects will consume either oral Δ9-THC (dronabinol), vaporized 3.7% Δ9-THC/5.6% CBD, or
      placebo. An analysis will then be determined to assess the risk--benefit ratio of dronabinol
      and vaporized 3.7% Δ9-THC/5.6% CBD .
    

Detailed description: 
      The present study is designed to assess whether treatment with vaporized cannabis or
      dronabinol (oral Δ9-THC) reduces spontaneous and evoked pain more than placebo, and whether
      there are any differences between the two active treatments in terms of interference with
      activities of daily living. This study also aims to examine the effects of vaporized whole
      plant cannabis and dronabinol on mood, neuropsychological function, and psychomimetic
      side-effects (high, stoned, etc.) compared to placebo and to each other. In addition, we plan
      to examine the acute effects (after receiving stable treatment for 4 weeks) of vaporized
      cannabis and dronabinol compared to placebo and each other on driving skills.
    

Intervention name(s): Placebos; dronabinol; Vaporized Cannabis 3.7% THC/5.6% CBD
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of vaporized cannabis plus either dronabinol or placebo pill; Administration of vaporized cannabis plus either dronabinol or placebo pill; Administration of vaporized cannabis plus either dronabinol or placebo pill
Other intervention name(s): sugar pill; Marinol; marijuana
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Iron-fortified Pea Powder on Exercise Performance
Condition: Iron-deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      Female endurance athletes are susceptible to iron deficiency and this can impact their
      exercise performance. This study assesses the impact of an pea protein supplement with high
      iron bio-availability on iron status and exercise performance.
    

Detailed description: 
      Female endurance athletes are susceptible to iron deficiency due to poor iron intake from
      diets or possibly because of destruction of red blood cells during foot-strike hemolysis.
      This study will evaluate the impact of 8-weeks of iron supplementation through consumption of
      a pea-protein power that has high iron bio-availability due to low phytate levels. This will
      be compared to consumption of regular iron protein powder and maltodextrin placebo by
      randomizing participants to three groups. Participants will be assessed at baseline and after
      8 weeks of supplementation for exercise performance (maximal aerobic capacity and a 5 km time
      trial running test), blood levels of ferritin and hemoglobin, and body composition (fat mass
      and lean tissue mass).
    

Intervention name(s): Low phytate pea powder; Regular pea powder; Placebo (maltodextrin)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Exercise performance with low phytate pea powder; Exercise performance with regular pea powder; Exercise performance with placebo (maltodextrin)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are being randomized to three groups for the 8-week intervention:
Pea power with high iron bio-availability
Regular pea powder
Placebo (maltodextrin)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
TMS Modulation of Insula-related Brain Networks.02
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the modulatory effects of repetitive transcranial
      magnetic stimulation (rTMS) on functional connectivity with the insula. Functional
      connectivity (FC) measures the interaction between brain regions, and recent neuroimaging
      studies have used FC to investigate how addiction affects FC among pertinent brain regions.
      rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain
      connectivity and could be used therapeutically to treat addiction. However, investigators
      first need more information on brain FC and how it relates to behavior, in order to guide
      rTMS target selection.
    


Intervention name(s): transcranial magnetic stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      "This is a randomised, double-blind, placebo-controlled multi-centre study to investigate
      safety and tolerability and to provide pharmacokinetic and pharmacodynamics information of
      orally inhaled multiple doses (80 mg, 160 mg or 320 mg) of the nebulised neutrophil elastase
      inhibitor POL6014 in patients with Cystic Fibrosis. The controlled inhalation will occur via
      the eFlow® nebuliser system (manufacturer: PARI Pharma GmbH, Germany)".
    


Intervention name(s): POL6014; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DL1 80 mg cohorts 1A and 1B (80 mg QD and 40 mg BID) DL2 160 mg cohorts 2A and 2B (160 mg QD and 80 mg BID) DL3 40 mg QD cohort C
DL = dose Level QD= quaque die (once daily) BID= bis in die (twice daily); Placebo will be administered orally at a dose and frequency matched to POL6014
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CF; cystic fibrosis; POL6014; neutrophil elastase inhibitor; anti-inflammatory