bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Effect of Levalbuterol on Allergen Induced Airway Inflammation In Subjects With Atopic Asthma
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer,
      albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol
      which are mirror images of each other i.e. R-and S- isomers. The investigational treatments
      are R-albuterol and S-albuterol.

      R-albuterol ( levalbuterol) has been shown to have a slightly better bronchodilator effect as
      compared to the racemic albuterol and is well- tolerated in patients. However it is still not
      clear whether the S-isomer has no effect or has a harmful effect on the airways.

      The purpose of this study is to compare the effects of the R- and S- isomers on allergen
      induced airway inflammation in subjects with mild atopic asthma. This will give us a better
      idea as to whether the routine use of levalbuterol is superior to racemic albuterol.
    

Detailed description: 
      The most commonly used drug for immediate relief of symptoms of asthma is the blue puffer,
      albuterol or salbutamol (Ventolin). Racemic albuterol is a mixture of two forms of albuterol
      which are mirror images of each other i.e. R-and S- isomers. The investigational treatments
      are R-albuterol and S-albuterol .

      R-albuterol ( levalbuterol) relieves the narrowing of the bronchial air passages in the lungs
      and has been approved by the U.S. FDA, but is not currently licensed for use in Canada. We
      have obtained approval from Health Canada to use these isomers for the purpose of this study.
      R-albuterol has been shown to have a slightly better bronchodilator effect as compared to the
      racemic albuterol and is well- tolerated in patients, with only a few mild to moderate side
      effects (such as palpitations, diarrhoea, abdominal pain, bodyache, leg cramps and headache).
      However it is still not clear whether the S-isomer has no effect or has a harmful effect on
      the airways.

      The purpose of this study is to determine the effect of this drug, levalbuterol, on the
      allergen-induced inflammatory response in adult subjects with asthma. Specifically, we want
      to look for changes in airway eosinophils by examining sputum samples and to compare the
      effects of the R- and S- isomers on airway inflammation. This will help us to understand
      whether the racemic albuterol could worsen inflammation because of the presence of the
      S-isomer, and this will give us a better idea as to whether the routine use of levalbuterol
      is superior to racemic albuterol.
    

Intervention name(s): R-albuterol, S-albuterol
Intervention type(s): Drug
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: levalbuterol; asthma; allergen provocation; airway inflammation; clinical trial
Pharmacological Effects of Neurapas® Balance and Pascoflair® 425 mg on Brain Activity in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance
      and Pascoflair 425 mg) in comparison to placebo on brain activity.
    

Detailed description: 
      Evaluation of the pharmacological effects of Neurapas® balance and Pascoflair® 425 mg by
      quantitative measurement of brain activity in 16 healthy volunteers.
    

Intervention name(s): Neurapas balance; Pascoflair 425 mg; P-Tabletten weiß
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 6 tablets single dose; 3 tablets , single dose; 3 tablets, single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: qEEG; herbal medicine; cognitive function; Neurapas balance; Pascoflair; hypericum; passionflower; valerian; Healthy volunteers; Influence on quantitative electro-encephalogram (qEEG).
Optical Transcutaneous Sensors of Capnia and Oxygenation
Condition: Blood Gas Monitoring, Transcutaneous
Study type: Interventional

Summary: 
      This study aims at validating new optical transcutaneous sensors to evaluate tissue capnia
      (CO2 partial pressure) and oxygenation (blood oxygen saturation) by comparing them to
      standard laboratory measurements (end tidal CO2 measurements and oxygen saturation by
      near-infrared spectroscopy).
    


Intervention name(s): Measurements of capnia and tissue oxygenation by optical transcutaneous sensors
Intervention type(s): Device
Intervention description(s): Capnia and tissue oxygenation will be measured by optical transcutaneous sensors
Intervention model: Single Group Assignment
Intervention model description: One single group will have simultaneous measurements of capnia and tissue oxygenation by the new sensors and by the standard laboratory sensors
Masking: None (Open Label)
Primary purpose: Diagnostic
Aerobic Exercise and Oxygen Uptake Efficiency Slope in Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Thus, the purpose of the present study was to evaluate the effects of continuos exercise
      training (CET) and interval exercise trainining (IET) on oxygen uptake efficiency slope
      (OUES) in patients with coronary artery disease.
    

Detailed description: 
      The oxygen uptake efficiency slope (OUES) is a submaximal index that incorporates
      cardiovascular, peripheral and pulmonary factors that determine ventilatory response to
      exercise. There is scarce information about the effects of the mode and intensity of exercise
      training on OUES in patients with coronary artery disease.
    

Intervention name(s): Aerobic exercise training
Intervention type(s): Other
Intervention description(s): The continuous exercise training was performed on a treadmill with a 50-minutes duration and intensity at ventilatory anaerobic threshold.
The interval exercise training consisted of 7 sets of 3 minutes at respiratory compensation point and 7 sets of 3 minutes of exercise at moderate intensity corresponding to the ventilatory anaerobic threshold totaling 42 minutes
Other intervention name(s): continuos training; interval training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise training
Meibomian Gland Dysfunction (MGD) and Tear Cytokines After Cataract Surgery According to Preoperative Meibomian Gland Status
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      To investigate the possible mechanisms by which cataract surgery aggravates meibomian gland
      dysfunction (MGD), the investigators evaluated the changes in tear cytokines and ocular
      surface parameters after cataract surgery according to the preoperative MGD grade.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 55 eyes from 55 patients who underwent cataract surgery were included.
      
Biospecimen description: 
      TEAR
Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
Condition: Metastatic Pancreatic Cancer
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III Metastatic Pancreatic Cancer
    

Detailed description: 
      A Phase III, open-label randomized, multicenter trial to compare ABI-007(Albumin-bound
      Paclitaxel)in combination with gemcitabine administered weekly to standard treatment
      (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and
      Progression Free Survival (PFS) in patients diagnosed with metastatic adenocarcinoma of the
      pancreas.
    

Intervention name(s): Albumin-bound paclitaxel (ABI-007); Gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): ABI-007 125 mg/m^2 administered by intravenous infusion; Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).
Other intervention name(s): Abraxane; Gemzar
Intervention MeSH terms: Paclitaxel; Gemcitabine; Albumin-Bound Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Erectile Dysfunction in Severe Obstructive Sleep Apnea: Effects of CPAP Therapy
Condition: Obstructive Sleep Apnea; Erectile Dysfunction
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Erectile Dysfunction
Study type: Observational

Summary: 
      Obstructive sleep apnea has been linked to erectile dysfunction. Furthermore, small studies
      suggest that treatment of sleep apnea by continuous positive airway pressure (CPAP) may
      reverse erectile dysfunction in affected patients. The present study aims to investigate in a
      larger cohort if severe sleep apnea is independently associated with erectile dysfunction and
      if 6-12 months of CPAP therapy lead to an improvement of erectile dysfunction.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        male patients with untreated severe sleep apnea (apnea-hypopnea-index > 30/h)
      
Biospecimen description: 
      blood specimens for the determination of lipids and glucose
Evaluation of an Oral Nutrition Supplement
Condition: Gastrointestinal Tolerance
Study type: Interventional

Summary: 
      The objective of this study is to capture gastrointestinal tolerance (GI) information on a
      nutrient dense oral nutritional supplement (ONS) in healthy elderly subjects.
    


Intervention name(s): Oral Nutritional Supplement
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Study of BCX7353 as a Treatment for Attacks of Hereditary Angioedema
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 2

Summary: 
      This 3-part study will evaluate the efficacy and safety of an oral kallikrein inhibitor,
      BCX7353, in the treatment angioedema attacks in subjects with Type I or II hereditary
      angioedema (HAE). In each study part, subjects will treat 3 attacks with BCX7353 (2 attacks)
      or placebo (1 attack), in a randomly allocated order. In Part 1, the dose of 750mg will be
      assessed relative to placebo in up to 36 patients. If this is shown to be effective, then a
      further 12 patients will be enrolled at a 500mg dose (Part 1), followed by a further 12 (if
      efficacy still shown) at a dose of 250mg (Part 3) to determine the minimum effective dose of
      BCX7353 compared to placebo for treating HAE attacks. Efficacy will be determined by subject
      diary entries completed at pre-defined times post-dose.
    


Intervention name(s): BCX7353; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral liquid formulation; oral liquid formulation to match BCX7353
Intervention MeSH terms: Berotralstat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HAE; hereditary angioedema; kallikrein inhibitor; plasma kallikrein
Developing an mHealth Application to Improve Cancer Chemotherapy Symptom Management
Condition: Colon Cancer; Rectal Cancer
MeSH terms: Rectal Neoplasms; Colonic Neoplasms
Study type: Interventional

Summary: 
      This research project addresses critical gaps in cancer symptom management through the
      creation of a mobile chemotherapy symptom management application. This application will
      assess for the presence and severity of common chemotherapy side-effects and provide
      personally tailored symptom-related video and narratives to enhance self-management of cancer
      and treatment-related symptoms. This study will examine patient acceptance and use of this
      mHealth application (called MyChemoCare) in a prospective trial of cancer patients (n=60) who
      are receiving chemotherapy for colorectal cancer at the University of Michigan Comprehensive
      Cancer Center.
    


Intervention name(s): MyChemoCare iPad application
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Attaining and Maintaining Wellness in Obsessive-compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The goal of this study is to understand whether patients with obsessive-compulsive disorder
      (OCD) on serotonin reuptake inhibitors (SRIs) who receive a type of Cognitive-behavioral
      therapy called Exposure and Ritual Prevention (EX/RP) can discontinue their medication if
      they first do well with EX/RP.
    

Detailed description: 
      This study begins with a Preparatory Phase, wherein all eligible participants receive up to
      25 sessions of Exposure and Ritual Prevention (EX/RP) therapy. At the end of the Preparatory
      Phase, those who have achieved wellness (mild to minimal symptoms) enter the Study Phase.
      Those who do not achieve wellness will not continue in the study and are referred for
      treatment elsewhere. Those who enter the Study Phase are then assigned by chance to one of
      two groups. One group will continue on the SRI medication and the other group will
      discontinue the SRI gradually over 4-6 weeks as it is replaced with a placebo (sugar pill).
      Neither patients nor study staff will know which group a participant is in. Both groups will
      continue to receive monthly sessions of EX/RP. The study will examine who has the best
      response to treatment in this study, including taking blood samples for genetic testing to
      see whether there are genes that can predict who will or will not benefit from EX/RP.
    

Intervention name(s): Monthly Booster Sessions of EX/RP; Visits with MD and independent evaluators
Intervention type(s): Behavioral; Procedure
Intervention description(s): 45 minute EXRP booster sessions each month; All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Anti-epileptic Drugs on Mitochondrial Activity
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      This study is based on the hypothesis that antiepileptic drugs (other than Valproic acid)
      have an effect on the mitochondrial oxidative phosphorylation.

      The objective of this study is to evaluate this effect in an accessible tissue-human
      peripheral white blood cells.
    

Detailed description: 
      Antiepileptic drugs adverse reactions, including hepatotoxicity, are rare but potentially
      fatal, especially among children. Although the mechanism of the liver toxicity remains
      elusive, mitochondrial oxidative stress, has been hypothesized to play a role.

      Most of the studies addressing antiepileptic drug effects on the mitochondria discuss the
      effect of valproic acid. The exact mechanisms involved in the drug-induced effects on
      oxidative phosphorylation are still far from being resolved. Most of the studies investigated
      the effect of valproic acid by using animal models or different in vitro
      methods.Mitochondrial diseases should be considered as a risk factor for valproic
      acid-induced hepatotoxicity, and there is a consensus for avoiding the administration of the
      drug for these patientsIs it possible that other antiepileptic drugs have similar effects?
      The knowledge regarding the effects of other antiepileptic drugs on the mitochondria is
      relatively scarce.
    

Intervention name(s): antiepileptic treatment
Intervention type(s): Biological
Intervention description(s): White blood cells from peripheral blood samples
Other intervention name(s): study group
Intervention MeSH terms: Anticonvulsants
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children, ages 3 to 18 years old who start new antiepileptic drug treatment for the first
        time for new onset epilepsy
      
Biospecimen description: 
      White blood cells from peripheral blood samples
    
Keywords: antiepileptic drugs; mitochondria
First-Time-in-Humans Study to Assess Safety, Pharmacokinetics & Pharmacodynamics of SB756050
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will use single escalating doses of SB756050 to assess safety, pharmacokinetics,
      and pharmacodynamics in healthy volunteers and in subjects with Type 2 Diabetes Mellitus.
    


Intervention name(s): SB-756050 immediate release capsule; SB-756050 modified release capsule; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SB-756050 immediate release capsules will be size 0, white, opaque capsules with no identifying markings, containing white to off-white drug layered pellets. Each capsule will contain 5, 25 or 100 milligrams of SB-756050.; SB-756050 modified release capsules will be size 0, white, opaque capsules with no identifying markings, containing white to off-white enteric coated drug layered pellets. Each capsule will contain either 25or 100 milligrams of SB-756050.; Subjects will also receive placebo capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: safety; pharmacodynamics; diabetes; pharmacokinetics
4 vs 7 Points Blood Glucose Monitoring in Gestational Diabetes on Dietary Modification
Condition: Gestational Diabetes Mellitus in Pregnancy
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional

Summary: 
      This study aims to compare between 4 and 7 points blood glucose monitoring in women with
      gestational diabetes on diet modification.
    

Detailed description: 
      All women with gestational diabetes on diet modification will be recruited and randomised to
      4 versus 7 points self monitoring blood glucose. They will be followed up 4 weekly and the
      pregnancy outcomes will be evaluated.
    

Intervention name(s): diabetic diet
Intervention type(s): Dietary Supplement
Intervention description(s): Patients with gestational diabetes will be seen by the dietitian to be taught diet modification
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All women with gestational diabetes are randomised to 4 or 7 points of self monitoring blood glucose.
Masking: None (Open Label)
Primary purpose: Other
Keywords: diet modification, 4 and 7 points monitoring
The Characteristics of Different Personal Lancets on Blood Volume and Perceived Pain in Patients With Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A randomized single-blind study with the use of different lancing devices equipped with
      personal lancets to determine and to compare the amount of capillary blood volume and
      perceived pain after a single lancing of the fingertip.
    


Intervention name(s): Droplet lancing device (HTL-Strefa S.A.); Microlet 2 lancing device (Bayer); OneTouch Delicia lancing device (LifeScan); ReliOn lancing device (ReliOn); Accu-Chek Softclix lancing device (Roche); BGStar lancing device (Sanofi Aventis); Ultra-Fine 33G lancets (BD); Droplet 33G lancets (HTL-Strefa S.A.); OneTouch Delicia Extra Fine 33G lancets (LifeScan); HaemoFine 33G lancets (HTL-Strefa S.A.); Softclix 28 G lancets (Roche); ReliOn Ultra-Thin Plus 33G lancets (ReliOn); GlucoJect Dual S lancing device (Menarini); Microlet 28G lancets (Bayer); BGStar Ultra-Thin 33G lancets (Sanofi Aventis)
Intervention type(s): Device; Device; Device; Device; Device; Device; Device; Device; Device; Device; Device; Device; Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: lancing device; lancet; fingerprick; capillary blood; self-monitoring of blood glucose
MyHealtheVet to Enable Shared Decision Making Regarding Menopausal in Postmenopausal Women Veterans (MEANS)
Condition: Menopause
Study type: Interventional

Summary: 
      The purpose of this research study is to examine the impact of educational secure messages on
      menopause. In particular, the investigators will examine whether the secure messages increase
      menopause knowledge and communication between patients and their providers.
    

Detailed description: 
      The overall goal of this project is to determine the effectiveness of the MEANS (MyHealtheVet
      to Enable And Negotiate for Shared decision making) intervention in improving women's
      self-reported knowledge and rates of diagnosis and appropriate management of menopause
      symptoms. The proposed intervention is an educational and shared decision making platform for
      menopause symptoms to improve communication between patients and their providers regarding
      menopause symptoms. MEANS combines educational secure messages through the Veterans Affairs
      online Personal Health Record called MyHealtheVet, along with face-to-face and print
      interventions.

      MEANS will be applied in target population consisting of postmenopausal women Veterans ages
      45 to 60 who receive primary care at the Miami Veterans Affairs Healthcare System. This
      project will enroll women in MyHealtheVet, develop a library of menopause symptoms material
      for distribution, and evaluate how useful of MyHealtheVet use for educating and tracking
      women regarding menopause symptoms.
    

Intervention name(s): Menopause educational secure messaging
Intervention type(s): Other
Intervention description(s): Participants read educational material about menopause and treatment option for menopause symptoms once a week using secure messaging on a electronic patient portal.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Shared decision making; Knowledge; Patient portal; Secure messaging