bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Breather on Hospital Stay in Patients With Acquired Pneumonia
Condition: Pneumonia Hospital Acquired
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      Acquired pneumonia is a sever medical condition that addressed as life-threatening issue
      require intensive care. Medical Breather device permits activating and strengthening of both
      inspiratory and expiratory musculatures; thus, it could be useful for pneumatic patients. The
      aim of the study is to investigate breather effect on hospital stay in pneumatic patients.
    

Detailed description: 
      Sixty participants diagnosed with acquired pneumonia '30 women, 30 men; selected from chest
      department of Kasr Alaini Intensive Care Unit (ICU) at Cairo University. They were randomly
      allocated into equal groups; Group A received respiratory training via incentive spirometer,
      and traditional chest physiotherapy; and Group B received respiratory training via Breather,
      and traditional chest physiotherapy. both received 3 session daily/2 weeks. Diaphragmatic
      excursion, Respiratory Distress Observation Scale, and ICU discharge were assessed pre and
      post treatment.

      Careful recruitment of participants based on the study criteria by both ICU resident and PT
      consultant. Identified inclusive criteria include conscious both genders aged 30- 40 years
      old with BMI ranged from 25 to5 29.9 Kg/m2 had an acquired pneumonia with a mild hypoxemia
      (O2 saturation was 90 - 95%). Aware participants whom cooperated through accurate understand
      and perform instructions. Excluding patients through identified inclusive criteria that if
      they had a history of any malignant tumors, hearing impairment or mental disorder,
      auto-immune diseases, a history of any surgical transplantation, unstable hemodynamics, rib
      fracture, a history of neuromuscular disease, spinal injuries, or BMI > 30 Kg/m2. Also,
      patients receiving mechanical ventilation, or whom require MV, but contraindicated for
      rehabilitation i.e., pulmonary emboli were excluded.
    

Intervention name(s): The Incentive Spirometer; The breather respiratory muscle training device
Intervention type(s): Device; Device
Intervention description(s): Tri-flow device flow-oriented incentive spirometer .; The breather respiratory muscle training device which allows for adjustable levels of resistance using easy-to-read dials, which allows to adjust the device to the settings require
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A (study group): 30 patients (15 males and 15 females) will receive respiratory training using incentive spirometer in addition to traditional chest physiotherapy, 3 sessions per day, for 2 weeks.
Group B (study goup): 30 patients (15 males and 15 females) will receive respiratory training using the breather in addition to traditional chest physiotherapy, 3 sessions per day, for 2 weeks.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Incentive spirometry,Breather, Acquired pneumonia, Arterial blood gases
A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the safety,
      tolerability, availability and distribution in the body of once-weekly long-acting growth
      hormone (NNC0195-0092, somapacitan) compared to once daily Norditropin NordiFlex® in adults
      with growth hormone deficiency (GHD).
    


Intervention name(s): somapacitan; Norditropin NordiFlex®
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous (s.c., under the skin) administration once weekly (Days 1, 8, 15 and 22) of 4 different doses of NNC0195-0092 (somapacitan) in an escalating order; Subcutaneous (s.c., under the skin) administration daily for 28 days. The daily dosing will be the same as the pre-trial daily dose of human growth hormone (hGH) taken by the adult with growth hormone deficiency
Other intervention name(s): NNC0195-0092
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Salivary miRNA Diagnostic Test for Autism
Condition: Autism Spectrum Disorder; Developmental Delay
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      The goal of this study is to validate a panel of miRNAs that distinguish children with autism
      spectrum disorder (ASD) from their non-ASD peers with a positive MCHAT-R. These biomarkers
      may allow earlier diagnosis of autism, allowing earlier service, and also help us to
      understand some of the changes in the brains of autistic children.
    

Detailed description: 
      The central aim of this project is to validate a panel of expressed microRNA (miRNA) in the
      saliva of children identified at risk for developing ASD by the MCHAT-R. Further, this study
      aims to assess the value of the current panel as an adjunctive test that may increase
      specificity of MCHAT-R positive results, or affirm clinical diagnoses alongside the ADOS or
      other objective assessments.

      The primary endpoints of this study are as follows:

        1. Evaluate the diagnostic ability (sensitivity and specificity) of the current a salivary
           microtranscriptome panel for distinguishing children with ASD from their non-ASD peers.

        2. Assess stability of the salivary microtranscriptome diagnosis over time, and interrogate
           longitudinal microtranscriptome levels relative to neuropsychological measures.

      Secondary endpoints are the identification of microtranscriptome features whose
      concentrations correlate with ASD endophenotypes.
    

Intervention name(s): Salivary collection; Vineland Adaptive Behavior Scale-III Assessment; Medical history questionaire; Autism Diagnostic Observation Schedule -2nd edition (ADOS-2); Mullen Scales of Early Learning
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Collection of saliva via swab for miRNA processing
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study will compare salivary miRNA in children between the ages of 24 months and 48
        months of age who are considered at risk for the development of autism spectrum disorder as
        identified by a score of 3 or greater on the MCHAT-R.
      
Biospecimen description: 
      Salivary RNA
    
Keywords: Autism; Asperger's Syndrome; microRNA; epigenetic; biomarker
Intravenous Remifentanil Patient-controlled Analgesia (PCA) and Epidural Patient Controlled Epidural Analgesia (PCEA) for Labor Analgesia
Condition: Labor; Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Women requesting analgesia do not always wish to receive a potent analgesic method, and may
      fear the risks of epidural analgesia.

      Study Aim: To determine whether remifentanil is effective for labor analgesia when compared
      with standard treatment (epidural analgesia).
    


Intervention name(s): Bupivacaine epidural; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): Bupivacaine 0.1%, fentanyl 1 mic/kg; 40-50 mic per 1-2 min via PCA
Intervention MeSH terms: Remifentanil; Bupivacaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epidural; Labor; Remifentanil
Drug-Drug Interaction Study: ASP2151 and Ritonavir
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      ASP2151 is an experimental treatment for herpes. HIV infected people are susceptible to
      contracting other infections because of their compromised immune system. As HIV patients will
      be taking drugs to treat the virus this study aims to see if ASP2151 would interact with one
      of the drugs that is commonly prescribed to HIV patients (ritonavir).
    


Intervention name(s): ASP2151; ritonavir
Intervention type(s): Drug; Drug
Other intervention name(s): Norvir
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HSV; HIV; Herpes; volunteers; drug-drug interaction
Evaluation of the Efficacy of Varenicline on Cognition, Safety, Tolerability and Pharmacokinetics in Subjects With Mild-to-Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      1. Assess the efficacy of varenicline, relative to placebo, on a performance based measure
           of cognition in patients with mild to moderate Alzheimer's disease

        2. Evaluate the effects of varenicline on clinically relevant measures including attention
           and executive function, behavior, and clinician rated global change.

        3. Evaluate the safety and tolerability of varenicline, relative to placebo, in patients
           with mild to moderate Alzheimer's disease

        4. Evaluate the pharmacokinetics of varenicline in patients with mild to moderate
           Alzheimer's disease.
    


Intervention name(s): Varenicline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mg once daily for 1 week followed by 0.5 mg twice daily for 1 week followed by 1 mg twice daily for 4 weeks; Placebo once daily for 1 week followed by placebo twice daily for 5 weeks.
Other intervention name(s): Chantix, Champix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Efficacy; Safety; Pharmacokinetics; Alzheimer's disease
A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)
Condition: Acute Coronary Syndrome; Type 2 Diabetes
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and feasibility of BXT-51072 as a
      cardioprotective agent in diabetics undergoing elective angioplasty / percutaneous
      intervention (PCI), a procedure to "open" coronary arteries.

      BXT-51072 belongs to a class of drugs called "glutathione peroxidase mimics." BXT-51072 works
      by imitating a substance produced in various tissues in the body, which prevents damage of
      the heart and blood vessels.
    

Detailed description: 
      Following screening, baseline measurements and informed consent, patients will receive
      BXT-51072 40 mg or placebo in a 2:1 ratio, 30 minutes before their scheduled PCI and then
      three times per day for 2 days. There will be 5 treatment visits and 3 follow-up visits.

      Blood samples will be obtained for CK-MB, troponin and routine chemistry. A 24-hour
      continuous electrocardiogram will be obtained following the PCI and regular
      electrocardiograms will be obtained during the study and follow-up period.
    

Intervention name(s): BXT-51072
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of ropinirole XR in the
      treatment of adults with Restless Legs Syndrome (RLS).
    


Intervention name(s): Ropinirole Extended Release (XR)
Intervention type(s): Drug
Intervention MeSH terms: Ropinirole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Restless Legs Syndrome; RLS
A Phase 3 Study of NE3107 in Probable Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      U.S. multicenter, parallel group study designed to evaluate the safety and efficacy of oral
      20 mg twice daily (BID) NE3107 vs placebo in 400 adult subjects with mild to moderate
      probable AD. Dual co-primary endpoints (Clinical Dementia Rating Scale Sum of Boxes, CDR-SB
      and ADAS-Cog12) will be evaluated as the change from Baseline to Week 30. Secondary endpoints
      include measures of cognition, neuropsychological deficits, functional performance, and
      glycemic control. A subset of patients may volunteer for exploratory magnetic resonance
      imaging (volumetric changes) and positron emission tomography (cortical glucose metabolic
      rate) scans at baseline and week 30.
    


Intervention name(s): NE3107; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NE3107 is an investigational orally bioavailable, blood-brain barrier permeable anti-inflammatory agent with a new mechanism of action targeting multiple mechanisms of pathology in Alzheimer's disease.; capsules that do not contain NE3107
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pseudophakic Accommodation
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Purpose:

      The aim of this study was to compare the effect of ciliary body training as proposed by
      manufacturers of accommodating IOLs and patient motivation on the pseudoaccommodative ability
      with a standard intraocular lens (SA60AT).

      Setting:

      Department of Ophthalmology, Medical University of Vienna.

      Methods:

      This randomized, controlled, examiner-masked study comprised 80 eyes of 40 patients that
      underwent standard cataract surgery. Patients were randomly assigned to a "motivated" or
      "non-motivated" (control) group. In the motivated group, subjects were told to take part in a
      special protocol to improve their near-reading ability after cataract surgery and were
      instructed not to use near adds for at least 3 months. Follow-up examinations included
      best-corrected distance visual acuity (VA), distance-corrected near VA, best-corrected near
      VA, defocus curve and reading speed, as well as pilocarpine-, cyclopentolate- and
      nearpoint-induced IOL shift assessed with partial coherence interferometry.
    


Intervention name(s): motivation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: pseudophakic accommodation
Ibuprofen Versus Mecillinam for Uncomplicated Cystitis
Condition: Acute Cystitis (Excl in Pregnancy)
MeSH terms: Cystitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Although uncomplicated cystitis is considered to be a mild condition and mostly self
      limiting, most patients who see a doctor will be treated with antibiotics. Antibiotics are
      known to give a quick relief of symptoms and shorten the course of the condition by a few
      days. The aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of
      uncomplicated cystitis in otherwise healthy, non-pregnant women. Our main objective is to see
      whether symptomatic treatment with ibuprofen is equally efficient as treatment with
      mecillinam in this group.
    

Detailed description: 
      The design of the study will be a double blinded randomized controlled trial (RCT). Half of
      the patients will receive treatment with mecillinam and the other half will receive treatment
      with ibuprofen. The study will follow the principles of Good Clinical Practice (GCP).

      Urine cultures will be obtained on day one and after two weeks. The patients will be given a
      diary where they daily will register symptom load, possible complications or adverse effects
      and on which day they feel completely cured. We will contact the patients after two weeks to
      make sure they have followed the study procedures. After four weeks we will perform a final
      interview with the patient.
    

Intervention name(s): Ibuprofen; Mecillinam
Intervention type(s): Drug; Drug
Other intervention name(s): Ibux; Selexid; Penomax
Intervention MeSH terms: Amdinocillin; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study intends to demonstrate bioequivalence of two formulations, the effect of food and
      water on one formulation and safety and tolerability of two formulations of lamotrigine in
      healthy male and female volunteers
    


Intervention name(s): Lamotrigine IR tablets; Lamotrigine ODT tablets
Intervention type(s): Drug; Drug
Intervention description(s): Lamotrigine IR tablets will be available in dose strength of 200 mg.; Lamotrigine ODT tablets will be available in dose strength of 200 mg.
Other intervention name(s): Lamotrigine
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food effect; Safety; Tolerability; Water effect; Bioequivalence
Use of Transcranial Direct Current Stimulation (tDCS) Coupled With Constraint Induced Movement Therapy in Stroke Patient
Condition: Stroke; Healthy
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether noninvasive brain stimulation associated
      with motor learning offers an additional benefit than motor learning alone in patients with
      stroke.

      The investigators hypothesis is that active transcranial direct current stimulation (tDCS)
      combined with constraint induced movement therapy (CIMT) will induce a greater motor function
      improvement as compared with sham tDCS combined with CIMT.
    

Detailed description: 
      In this 3 experiments study we will evaluate the effect of tDCS and constraint induced
      movement therapy (CIMT) in stroke patients (exp 1) as well as in healthy subjects (control
      population - exp 2). Finally we will investigate the effect of tACS - transcranial
      alternating current stimulation - as an alternative to tDCS, on motor function in healthy
      subjects (exp 3). The two experiments on tDCS are parallels (exp 1 & 2), while the experiment
      on tACS uses a crossover design (exp 3).

      For stroke patients (Exp1), our primary outcome measure is a clinical scale (Jebsen-Taylor
      Hand Function Test), while for healthy subjects (Exp 2) we investigate the effect of tDCS and
      CIMIT on cortico-spinal excitability using TMS - transcranial magnetic stimulation. Finally,
      for the third experiment using tACS, our primary outcome is cortical oscillation, as measured
      by EEG - electroencephalogram.
    

Intervention name(s): transcranial direct current stimulation (tDCS); constraint induced movement therapy (CIMT); transcranial alternating current stimulation (tACS)
Intervention type(s): Device; Procedure; Device
Intervention description(s): Subjects will be stimulated at 1 mA for 40 minutes.; Subjects will be stimulated at 15Hz for 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Transcranial direct current stimulation; Motor function
Fit Over 45 - a Health Promotion Project for Inactive Female Hospital Staff Age 45+ From the University Hospital of Zürich
Condition: Healthy
Study type: Interventional

Summary: 
      Background:

      Despite the well-known benefits of exercise, 64% of the Swiss population do not fulfill the
      public health recommendation of physical activity. A survey of female staff members over 45
      years of age from the University Hospital Zurich at the end of 2003 showed that physical
      inactivity is also prevalent in this population.

      Aim:

      To assess whether inactive women working at a large hospital centre prefer Nordic Walking
      (NW) or a Jogging (J) as a health promotion strategy. (2) To test whether the method chosen
      by the majority improves physical performance, physical activity, body weight and
      composition, and bone mineral density.

      Methods: The investigators will send out a questionnaire to all female staff members at a
      large hospital centre age 45 and older, ask whether they are inactive, and whether they
      prefer Nordic Walking or Jogging as a health promotion strategy. Depending on the preference
      of the majority of the women, the investigators will then ask inactive female staff members
      age 45+ to participate in a 12-months randomized controlled trial comparing training plus
      nutrition education to nutrition education alone. The training will have a 3-month
      building-up phase followed up by an in part unsupervised training of 9 months. All
      participants will receive a lecture on healthy nutrition once a months for 12 months. The
      investigators will assess diet with a food frequency questionnaire at baseline and after 12
      and 24 months.

      The primary endpoint is: physical performance, measured with the 12-minute Coopertest.

      The secondary endpoints are: level of physical activity, body mass index, body composition
      and bone mineral density at the spine and the hip.

      Importance: This project will address the questions which physical activities are preferred
      by inactive women and whether the preferred training improves physical performance, physical
      activity, body mass index, body composition and bone mineral density. In addition, our study
      will explore whether those women who changed their diet in addition to being randomized to
      the training group have an enhanced benefit.
    


Intervention name(s): Exercise and Nutrition Education
Intervention type(s): Behavioral
Intervention description(s): Guided nordic walking training and 12 presentations about diet and health.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: inactive; >45 years; female