bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Safety and Pharmacokinetics of Inhaled Doses of GSK233705 and GW642444 in Healthy Subjects.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GW642444 and GSK233705 are in development for treatment of Chronic Obstructive Pulmonary
      Disease. Development of these two inhaled drugs as a combination therapy would have potential
      for improved patient benefit as they both work through different mechanisms and the combined
      bronchodilatory effect might be additive. This study will look at the this combination, for
      the first time, in healthy subjects.
    


Intervention name(s): GSK233705; GW642444; GSK233705 and GW642444; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive 200 (mcg) microgram once daily as a single dose; Subjects will receive 50 mcg once daily as a single dose; Subjects will receive combination of GSK233705 200 mcg and GW642444 50 mcg as a single oral dose; Placebo matching study medication will be inhaled by subjects
Other intervention name(s): GSK233705
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: safety; pharmacodynamics; Muscarinic Receptor Antagonist; tolerability; healthy subjects; GS642444; GSK233705; Anticholinergic; ß2 agonist; pharmacokinetics
Advancement of Modified Bubble CPAP
Condition: Hypoxia; Respiratory Distress
MeSH terms: Hypoxia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to
      fit older children, will create a safe form of respiratory support that may help to decrease
      respiratory distress and thus mortality from pneumonia.
    

Detailed description: 
      This study proposes that modifying the current form of bCPAP by adjusting the nasal prongs to
      fit older children, will create a safe form of respiratory support that may help to decrease
      respiratory distress and thus mortality from pneumonia. Children age 1 month (mo) to 5 years
      (y) admitted to Gulu Regional Referral Hospital in Gulu, Uganda with respiratory distress
      will be evaluated for use of the modified bCPAP device as treatment for their respiratory
      distress (in addition to their routine care, i.e. antibiotics, nutrition support)
    

Intervention name(s): Bubble CPAP
Intervention type(s): Device
Intervention description(s): Respiratory assistance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoxia; Respiratory Distress
A NIS Evaluating the Treatment Patterns of Atypical Antipsychotics in Patients Diagnosed With Bipolar I or II Disorder
Condition: Bipolar Disorders
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      The purpose of this NIS is to obtain data on how AAPs are used in DSM-IV-TR Bipolar I and II
      Disorder, in the course of a major depressive episode. Both the parameters of use of AAPs and
      clinical evaluation will be recorded and potential differences that may exist due to
      epidemiological factors or comorbidities will be analyzed.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatients (male or female), diagnosed with Bipolar I or II disorder, having presented or
        presenting a major depressive episode (according to DSM-IV-TR) with starting date of 6
        months maximum before the inclusion.
      
Keywords: Antipsychotics; Bipolar Disorder; Depressive episodes; Bipolar I or II Disorders
Probiotics in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and
      gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI
      tracts is influenced by both genetic and environmental factors. Children with CF may harbor
      an abnormal intestinal microflora, because of altered cystic fibrosis transmembrane
      conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes
      and acid suppressors). The investigators have previously demonstrated that intestinal
      inflammation is highly frequent in CF children, being a major feature of intestinal
      involvement. In addition, specific probiotics significantly improved airway and GI
      inflammation in a preliminary trial. The investigators aim to characterize intestinal and
      respiratory microflora in CF patients and to investigate the effects of daily Lactobacillus
      GG (LGG) supplementation on both GI and airway microflora and the eventual relationship
      between probiotic assumption and clinical and inflammation markers. The investigators aim is
      to eventually improve the quality of life of CF patients, who often suffer from intestinal
      and respiratory progressive disease, through a non invasive intervention consisting in the
      supplementation of probiotic bacteria.
    


Intervention name(s): Lactobacillus rhamnosus GG; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsules containing lyophilized 6x10^9 Colony Forming Units (CFU)/die LGG, (60mg) maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg)
1 cps/die for 12 months; Capsules containing maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg)
1 cps/die for 12 months
Other intervention name(s): LGG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Pulmonary exacerbation; Inflammation; Intestinal microbiota
Single Dose Pharmacokinetics of Repaglinide, Metformin and Combination Tablet in Fed Healthy Volunteers
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      compare repaglinide and metformin as co-administered tablets and as a combination tablet.
    


Intervention name(s): repaglinide; metformin; repaglinide and metformin combination tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods; Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods; Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
Intervention MeSH terms: Metformin; Repaglinide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Safety and Immunogenicity Study of Inactivated Nasal Influenza Vaccine NB-1008
Condition: Healthy Adult Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and immune response of a new intranasal
      vaccine against influenza, called NB-1008. The vaccine is composed of a licensed vaccine that
      is normally given as an injection, called Fluzone, and an adjuvant (additive that helps a
      vaccine work better), called W805EC.
    


Intervention name(s): NB-1008; Control
Intervention type(s): Biological; Other
Intervention description(s): NB-1008 is composed of Fluzone containing 4 micrograms (mcg) or 10 micrograms of strain-specific hemagglutinin (HA) and 5%, 10%, 15%, or 20% W805EC adjuvant.; The controls include PBS placebo control as well as Fluzone IN and IM active controls.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Randomized Control Trials of Surgery for Pediatric OSA
Condition: Sleep Apnea, Obstructive; Otorhinolaryngologic Diseases; Pediatric Disorder
MeSH terms: Sleep Apnea, Obstructive; Otorhinolaryngologic Diseases
Study type: Interventional

Summary: 
      Randomized study on pediatric OSA with 2 groups: mild-moderate OSA and severe OSA.
      Mild-moderate are randomized to either expectancy or ATE. Severe are randomized to either ATE
      or APP. Pediatric age span of 2 until 4,9 years.
    

Detailed description: 
      Children who are referred to ENT clinic because of sleep-disordered breathing and fulfil the
      inclusion criteria undergo polysomnography (PSG) and fill in questionnaires. Depending on the
      outcome of the PSG, whether a) the child have mild to moderate OSA (AHI between 2-9.9) the
      family is asked to be in the study. If yes, the doctor take a sealed envelope and open it,
      either the child are randomized to adenotonsillectomy (ATE) or 6 months expectancy. Whether
      PSG shows b) severe OSA and the family accept participation the child is operated within a
      month. There is a straification beetween 2 groups, if AHI is 1) between 10 and 29.9 or 2)
      above 30. A sealed envelope is open in the operating room by the surgeon. The child is
      randomized to either ATE or ATE and suturing of the tonsillar pillars. The study is blinded
      for the family, who will not know which method the child has undergone. After 6 months all
      children will undergo follow-up with PSG and questionnaires. If the expectancy group will
      deteriorate during waiting time, or the child still has moderate to severe OSA, they will
      undergo ATE. Further follow-ups at three and ten years. Altogether 160 children should be
      evaluated with two PSG, 80 in each group.
    

Intervention name(s): ATE; APP
Intervention type(s): Procedure; Procedure
Intervention description(s): surgical removal of adenoids and tonsils; surgical removal of adenoids and tonsils and suturing of palatal pillars
Other intervention name(s): adeno-tonsillectomy; adeno-pharyngoplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tonsillectomy; Adenoidectomy; Adenoidpharyngoplasty; OSA
Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction
Condition: Contraceptives, Oral
Study type: Observational

Summary: 
      Prospective, non-interventional, multi-center study. Each subject will be followed for up to
      twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin
      Only Pill). For each subject demographic data and medical history will be documented at Visit
      1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and
      wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2
      (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.
    


Intervention name(s): EV/DNG (Qlaira, BAY86-5027); Progestin Only Pills
Intervention type(s): Drug; Drug
Intervention description(s): At the discretion of the attending physician; At the discretion of the attending physician
Intervention MeSH terms: Progestins
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women in gynecological practice
Metacognitive Therapy for Health Anxiety
Condition: Hypochondriasis
MeSH terms: Hypochondriasis
Study type: Interventional

Summary: 
      The study involves a comparing a new psychological treatment- Metacognitive Therapy (MCT)
      which has shown promising results in the treatment of health anxiety to no treatment at all-
      a waiting list.
    

Detailed description: 
      Hypochondriasis or severe health anxiety is characterised by excessive, disproportionate and
      persistent thoughts, behaviour and emotion focused on physical symptoms and/or fear of
      developing a serious illness. There is often excessive worry about illness or disease in the
      absence of supporting medical evidence and contrary to continual medical reassurance.

      The most effective psychological treatments are cognitive and behavioural therapies (CBT).
      However, CBT has failed to demonstrate consistent gains in the treatment of this disorder.

      A newer form of psychological therapy, Metacognitive Therapy (MCT) has shown to be more
      effective than CBT in the treatment of anxiety disorders and depression. MCT is based on the
      principle that health anxiety is caused by a pattern of extended thinking, this pattern is
      called the Cognitive Attentional Syndrome (CAS). The CAS is made up of chains of verbal
      thought in the form of excessive worry about having an illness; a pattern of focusing
      attention on threat, such as scanning the body for signs of illness and excessive body
      checking; and coping strategies that have negative effects, such as internet searching for
      illnesses or trying to block out thoughts of illness. Rather than stopping negative thinking
      the CAS extends it and leads to the belief that illness is present. To help reduce these
      symptoms MCT teaches specific techniques that help people develop new ways of experiencing
      negative thoughts about illnesses, allow them to abandon worry and learn to disengage from
      unhelpful coping attempts.

      A recent small study has provided some limited evidence that metacognitive therapy (MCT) can
      be applied to cases of hypochondriasis and demonstrated that the therapy was associated with
      improvement in symptoms.

      To provide future evaluation of MCT in this client group a more definitive trial will be
      carried out to ascertain the effects of MCT in a larger group when compared to a control
      group.

      If the results are positive this will provide a rationale for a larger research study, which
      will compare MCT with evidence based treatment such as CBT.
    

Intervention name(s): Metacognitive Therapy; Wait List
Intervention type(s): Other; Other
Intervention description(s): Participants will receive treatment which focus's on helping reduce excessive thinking about health,; Individuals are on a waiting list
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Core Muscles Activation for the Increase of Quality in Cardiopulmonary Resuscitation
Condition: Cardiopulmonary Resuscitation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether core muscle activation is effective in the
      increase of quality of cardiopulmonary resuscitation.
    


Intervention name(s): Core muscle activation
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Neural Mobilization and Conventional Physical Therapy After Laminectomy
Condition: Laminectomy
Study type: Interventional

Summary: 
      This study was conducted to evaluate the effect of addition of neural mobilization to a
      standard post-operative physical therapy program in patients with lumbar laminectomy.
    

Detailed description: 
      After Laminectomy, patients are suffering from many problems as pain, weakness. This study
      was conducted on two groups of patients who underwent lumbar Laminectomy as a surgical
      treatment for lumbar canal stenosis. The control group received TENS and strengthening
      exercises, while the study group received neural mobilization in addition to the program that
      was given to the control group. The outcome measures include pain intensity, nerve root
      compression and functional level which were measured pre-treatment and post-treatment through
      using visual analogue scale, H-reflex latency and Oswestry Disability Index (ODI)
      respectively.
    

Intervention name(s): Neural mobilization combined with conventional physical therapy program; Conventional physical therapy program
Intervention type(s): Other; Other
Intervention description(s): Neural mobilization of sciatic nerve combined with TENs and exercise program applied 3 times/week for successive 6 weeks.; TENs and exercise program applied 3 times/week for successive 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Comparative Efficacy of Tacrolimus and Clobetasol Propionate in Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 1

Summary: 
      Methodology: The 70 patients of age 20 to 50 years presented to the out-patient department of
      CMH Abbottabad suffering from alopecia areata were enrolled. The non-probability consecutive
      sampling technique was used. Patient in group-A applied clobetasol propionate 0.05% twice
      daily, whereas Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months. The
      Patients were assessed at baseline, 4th weeks, 8th week and 12th week after treatment of each
      session. Hair loss was calculated from SALT score at presentation and on follow-up after 3
      months. The degree of response was assessed on the basis of hair re-growth as excellent (>75%
      re-growth), Marked (51-75% re-growth), moderate (26-50% re-growth), or slight (≤25%
      re-growth). To determine statistical significance χ2-square test, taking p-value <0.05 as
      significant, was used.
    


Intervention name(s): Group A applied topical Clobetasol Propionate; Group B applied topical Tacrolimus
Intervention type(s): Drug; Drug
Intervention description(s): Patient in group-A applied clobetasol propionate 0.05% twice daily for upto 03 months; Group-B applied topical tacrolimus 0.1% twice daily for upto 3 months.
Intervention MeSH terms: Clobetasol; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Understanding Gastrointestinal Conditions in Children With Autism Spectrum Disorder (ASD)
Condition: Gastrointestinal Disorders; Autism Spectrum Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      The purpose of this research study is to help us learn if children with Autism Spectrum
      Disorder (ASD) have gastrointestinal (stomach and intestine) problems more frequently than
      children without ASD do. The investigators hope to learn if children with ASD and
      gastrointestinal (GI) disorders have certain Problem Behaviors (PB), such as self-injury and
      aggression, more than children with ASD but no GI disorders do. The investigators want to
      learn if the Gastrointestinal Symptoms Questionnaire (GIQ) can help us tell which children
      with ASD also have gastrointestinal disorders.

      Hypothesis 1: Children with ASD exhibit high rates of symptomatic GI dysfunction that are not
      identified by current diagnostic evaluation.

      Hypothesis 2: Painful or discomfort-causing gastrointestinal dysfunctions contribute to an
      elevated incidence or severity of PB in an identifiable subpopulation of PB-expressing
      children. The investigators anticipate that the proposed study will raise the standard of
      medical care for children with ASD by improving current methods of identifying GI dysfunction
      and determining whether there is a significant relationship between GI dysfunction and PB in
      this population.
    


Intervention name(s): evaluation visit by a pediatric gastroenterologist
Intervention type(s): Other
Intervention description(s): medical history, physical exam completed by pediatric gastroenterologist
Other intervention name(s): autism; ASD; pediatric; gastrointestinal
Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        131 nonselected subjects with ASD
      
Keywords: ASD; autism; gastrointestinal; gastrointestinal conditions in children with ASD
A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin
Condition: Chronic Kidney Disease; Tuberculosis
MeSH terms: Tuberculosis; Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the colchicine concentration before and after the
      administration of rifampicin.
    


Intervention name(s): Rifampicin
Intervention type(s): Drug
Intervention description(s): single arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration
Other intervention name(s): Rifampin
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Impaired Peripheral Endothelial Function and In-stent Restenosis
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational [Patient Registry]

Summary: 
      The investigators assessed the hypothesis that whether RH-PAT index (RHI) as a marker of
      endothelial dysfunction could predict occurrence of ISR after percutaneous coronary
      intervention (PCI).
    

Detailed description: 
      This is a prospective observational study of all consecutive patients with coronary artery
      disease (CAD) treated with PCI at Kumamoto University Hospital between January 2010 and
      September 2012. Inclusion criteria consisted of patients who were symptomatic for myocardial
      ischemia and who were undergoing stent implantation for significant CAD.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        consecutive patient sampling This is a prospective observational study of all consecutive
        patients with coronary artery disease (CAD) treated with PCI at Kumamoto University
        Hospital between January 2010 and September 2012. Inclusion criteria consisted of patients
        who were symptomatic for myocardial ischemia and who were undergoing stent implantation for
        significant CAD.
Study on Patterns of Care in Mild Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The PRIME study is an observational, Real World Evidence study designed to collect the type
      of treatments that are currently prescribed to patients with mild asthma and to collect
      relevant clinical data that could reflect the control of the disease over a 6-month
      observational period according to the standard clinical practice.
    

Detailed description: 
      Outpatients attending the hospital clinics/study centres will be recruited. Patients with
      mild asthma treated by Step 1 or step 2 treatments according to GINA report will be
      recruited. A total of approximately 1200 patients will be enrolled. Patients will be
      followed-up during a 6-month observational period according to standard practices.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Mild asthma patients treated by step 1 or 2 treatments according to GINA report