bioihbjkbjnl/mcl2 huggingface dataset:
Familiar Fatal Insomnia: Preventive Treatment With Doxycycline in Subject With Disease Risk
Condition: Familial Fatal Insomnia
MeSH terms: Insomnia, Fatal Familial; Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The neurodegenerative disorders is a class o pathologies including very common diseases as
      Alzheimer or Parkinson or very rare as fatal familial insomnia (FFI), the progression of the
      disease with no therapeutic remedy is the common tract of these disorders. The aim of this
      project is to carry out a preventive treatment in subjects with genetic risk to develop FFI
      to avoid the establishment of the disease. FFI is a rare genetic neurodegenerative disease
      characterized by disrupted sleep, autonomic hyperactivation and motor abnormalities with
      fatal exitus. FFI is inherited in an autosomal dominant fashion and is linked to the D178N
      mutation in the prion protein gene (PRNP) in association with a methionine at the polymorphic
      codon 129 (D178N/M129). About thirty FFI pedigrees have been described worldwide, the mfirst
      case being reported in 1986 in northern Italy. This patient turned out to belong to large
      kindred, which spans 7 generations dating back to the eighteenth century. Many people
      belonging to this geneaology still live in the Veneto region of Italy, and they are part of
      an association. The genetic screening of 85 subjects belonging to this family permitted to
      identify the mutation carriers. Since the disease is aggressive and the affected people
      usually died within thirteen months from the onset, the possibility of an efficacious therapy
      when the disease become evident is unrealistic. This condition indicates in a preventive
      approach the better condition to affect the disease. Experimental studies and clinical
      observation indicated the antibiotic doxycycline (DOXY) as a potential candidate for a
      treatment in FFI subjects. The age with maximal risk to get the disease is between 50 and 55
      years old. Thus the carriers that were born between 1958 and 1969 will be recruited for a
      preventive treatment with DOXY for ten years, at the end of this period or before we can
      establish if DOXY can be useful to avoid the development of FFI.
    


Intervention name(s): Doxycycline Hcl; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablets of DOXY hydrocloride (Bassado); tablets of placebo
Intervention MeSH terms: Doxycycline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Development of a Multi-attribute Health Index: to Measure the Quality of Labour Analgesia: The QLA Index
Condition: Labour Pain
MeSH terms: Labor Pain
Study type: Observational

Summary: 
      The findings of this research will be used to develop a scale for measuring the quality of
      epidural pain relief achieved during labour and vaginal delivery.
    

Detailed description: 
      The current lack of a tool to measure the overall quality of neuraxial pain relief provided
      in labour analgesia trials has produced studies unable to provide clear direction to clinical
      care and research. Our previous work explored and described the underlying dimensions and
      attributes of quality neuraxial analgesia from the perspectives of labouring women as the
      initial phase of development of an Index to measure this as an outcome in research. We now
      seek to confirm our findings as well as to generate additional items (descriptors) of quality
      neuraxial analgesia from the perspectives of parturients and experts (obstetrical
      anesthesiologists and experienced labour nurses). Once generated, the full list of items will
      be used to in a subsequent study involving only parturients (Item Reduction phase) to develop
      a scale permitting global measurement of quality neuraxial labour analgesia. The resulting
      scale, once validated, will provide researchers with a simple global measure for quality in
      labour analgesia research. This scale will be used later in our program of research to assist
      with validation studies of the larger Multi-attribute Health Index we are developing.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who received neuraxial labour analgesia during the current pregnancy
      
Keywords: Women receiving labour epidural for most recent delivery
Relative Bioavailability of of Olodaterol and Ketoconazole
Condition: Healthy; Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is intended to investigate a possible effect of the p-gp inhibitor
      ketoconazole on the bioavailability of olodaterol
    


Intervention name(s): BI 1744; BI 1744; Ketoconazole; Ketoconazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mcg solution for oral inhalation; 10 mcg solution for oral inhalation; 400 mg tablet; 400 mg tablet
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Two Protocols for Patellofemoral Pain Syndrome
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The patellofemoral pain syndrome (PFPS) is defined as a painful complaint in the anterior
      aspect of the knee, although peripatellar pain and / or retropatellar are also common. In
      general, conservative treatment is the initial option of choice for patients with PFPS,
      however, the lack of a specific causal factor makes it difficult to choose the best treatment
      so early. This way, the purpose of this study is investigate the effects of the quadriceps
      femoris strengthening versus hamstring stretching in patients with pattellofemoral pain.
    


Intervention name(s): Stretching Hamstring; Quadriceps Strengthening
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pattelofemoral pain syndrome; Stretching; Strengthening
Short and Long Term Effects of IASTM and ESWT Therapy in Individuals With Lateral Epicondylitis
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Study type: Interventional

Summary: 
      Pain, decreased grip strength, and loss of function are observed in individuals with lateral
      epicondylitis. The aim of this study is to investigate the effects of ESWT and IASTM
      applications on pain, grip strength and function in individuals with lateral epicondylitis.
    

Detailed description: 
      The study will be carried out on volunteers after the approval of the ethics committee.
      Before the research, individuals and / or their relatives will be informed about the purpose
      and content of the study. Participants will be randomly divided into three groups: IASTM,
      ESWT and home exercise group. In addition to home exercise, IASTM and ESWT groups will be
      given 2 sessions per week for 4 weeks. Pain, grip strength and functionality of the
      participants will be evaluated before the application, after 4 weeks of application and 4
      weeks after the end of the application.
    

Intervention name(s): IASTM; ESWT; Home Exercise
Intervention type(s): Other; Other; Other
Intervention description(s): IASTM will be applied to the affected extremity twice a week for 4 weeks, in total 8 sessions. Participants will be asked to sit comfortably in a chair with back support. IASTM will be applied to the wrist extensor muscles of the participants for 90 seconds in the position where the muscle is tense, with a frequency of 60 beats per minute.; ESWT will be applied to the affected elbow two days a week for 4 weeks, a total of 8 sessions, each session 2000 shock 10 Hz frequency, 2.5 bar intensity point and circumferential application.; Special static stretching and eccentric strengthening exercises for the forearm muscles will be taught and they will be asked to perform 2 sets (morning-lunch-evening) 10 repetitions per day, 5 days a week, for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lateral epicondylitis; pain; function; grip strength
Influence on the Effect of an Oral Contraceptive Drug After Administration of Liraglutide in Postmenopausal Women
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 Europe. The aim of this trial is to investigate if liraglutide
      changes AUC (area under the curve) of ethinylestradiol and levonorgestrel administered as a
      combination contraceptive drug (Neovletta®).
    


Intervention name(s): liraglutide; placebo; levonorgestrel / ethinylestradiol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order; Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order; One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period
Intervention MeSH terms: Liraglutide; Levonorgestrel; Ethinyl Estradiol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
DAOIB Combined With tDCS for Early-phase Dementia
Condition: Transcranial Direct Current Stimulation; Dementia
MeSH terms: Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 24-week randomized, double-blind, placebo-controlled trial. We will enroll patients
      with aMCI or mild AD. All patients will receive 2 weeks of tDCS (5 sessions per week, 10
      sessions in total) during the first 2 weeks of the study, and will also be allocated randomly
      to either of 2 treatment groups for 24 weeks: (1) DAOIB group; (2) placebo group. We will
      assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We
      hypothesize that augmentation with DAOIB will yield better effect than tDCS alone in
      improving the cognitive function, global functioning and quality of life in patients with
      aMCI or mild AD.
    


Intervention name(s): DAOIB; Placebo; tDCS
Intervention type(s): Drug; Drug; Device
Intervention description(s): The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation.; placebo; tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long-Term Safety Performance of Fexofenadine in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the long-term safety performance of fexofenadine
      compared to montelukast in subjects with asthma
    

Detailed description: 
      The incidence of respiratory allergy in the US has increased gradually over the past several
      years, and current estimates suggest that allergic rhinitis and bronchial asthma affect
      approximately 20% and 5% of the population, respectively. Rhinitis and asthma frequently
      coexist, and large-scale population surveys indicate that up to 38% of subjects with rhinitis
      have asthma, and up to 78% of subjects with asthma have chronic nasal symptoms. Safety
      concerns with the increased use of inhaled corticosteroids, the heterogeneity of the disease,
      and poor compliance with asthma medication regimens, point to the need for the development of
      safe and convenient oral therapies for asthma. Oral leukotriene receptor antagonists (eg
      montelukast) are the latest class of inflammation-modulating asthma drugs and appear to cause
      fewer long-term side effects than systemic corticosteroids and reduce the need for
      shorter-acting bronchodilator reliever medicines. However variability in response between
      patients has been observed and clinical experience with these agents is still limited.

      Histamine is an important chemical mediator of inflammation in asthma. The benefits of
      antihistamine treatment in patients with mild to moderate asthma have been well documented,
      however their clinical use has been previously limited due to the high doses required for
      efficacy and their associated side effects including sedation and cognitive impairment.
      Recent evidence indicates that in addition to H1-receptor antagonism, some of the newer
      nonsedating, non-impairing antihistamines appear to possess various anti-inflammatory
      properties at concentrations achieved at therapeutic dosages suggesting an additional benefit
      of these drugs in the management of allergic diseases and asthma. The purpose of this study
      is to assess the long-term safety performance of fexofenadine compared to montelukast in
      subjects with asthma.
    

Intervention name(s): Fexofenadine, Comparator = Montelukast
Intervention type(s): Drug
Intervention MeSH terms: Fexofenadine; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Microencapsulated Sublingual Glycine (Bidicin) on Cognitive Performance in Healthy Men After an Acute Stressor
Condition: Healthy; Stress, Psychological; Cognitive Impairment
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The aim of this study is to assess whether intake of Glycine (MSG) leads to an increase of
      cognitive performance after an acute stressor compared to placebo. One group will receive
      verum, one group placebo and one group will not receive any intervention. Cognitive testing
      will be performed in connection with the Trier Social Stress Test (TSST).
    

Detailed description: 
      Stress can enhance or impair memory performances depending on the timing of the stressor and
      the timing of the memory processes in relation to the stressor. If stress occurs directly
      before or during the retrieval of information, the performance is impaired. Decreased
      performances using an acute stressor were also observed for other domains of cognitive
      functioning like working memory, interference control, cognitive flexibility and attention
      tasks.

      Glycine, the simplest of the amino acids, is an essential component of important biological
      molecules, a key substance in many metabolic reactions, the major inhibitory neurotransmitter
      in the spinal cord and brain stem, and an anti-inflammatory, cytoprotective, and immune
      modulating substance. Studies have found positive effects of Glycine on episodic memory
      retrieval and in a word retrieval task.

      To assess the effect of Glycine (MSG) on cognitive performance after an acute stressor,
      subjects perform baseline cognitive testing before intake of investigational products
      (Glycine (MSG), placebo or nothing) and participation in a stress test (Trier Social Stress
      Test - TSST). After the TSST stress-induced changes in cognitive performance are assessed. A
      second treatment intake takes place between the first and the remaining cognitive tests.
    

Intervention name(s): Microencapsulated Sublingual Glycine (MSG); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Glycine (MSG) tablet; Lactose tablet manufactured to mimic Glycine (MSG) tablet
Other intervention name(s): Bidicin
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Verbal Learning and Memory Test (VLMT); Stroop Test; Attention; Working Memory; Learning and recognition; CogTrack
A Study to Evaluate the Safety, Efficacy and Changes in Induced Sputum and Blood Biomarkers Following Daily Repeat Doses of Inhaled GSK2269557 in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Acute Exacerbation
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate specific alterations in immune cell mechanisms
      related to neutrophil function as detected by PI3Kdelta-dependent changes in messenger
      ribonucleic acid (mRNA) extracted from induced sputum in patients experiencing an
      exacerbation of COPD, with or without treatment with GSK2269557. The efficacy of treatment
      with GSK2269557 will also be measured using functional respiratory imaging (FRI) and
      spirometry. This is a randomised, double-blind, placebo-controlled, parallel-group study. The
      study consisted of Screening Phase (up to 3 days prior to Day 1), Treatment Phase (Days 1 to
      84) and Follow phase (7 to 14 days after last dose). The total duration of the study is 13-14
      weeks including the screening visit. DISKUS TM and ELLIPTA TM are registered trademark of GSK
      group of companies.
    


Intervention name(s): GSK2269557; Placebo; DISKUS; ELLIPTA
Intervention type(s): Drug; Drug; Device; Device
Intervention description(s): GSK2269557 500 mcg blended with lactose per blister and will be administered using a DISKUS dry powder inhaler device. Since GSK2269557 will no longer be manufactured for use with the DISKUS device, it will be replaced with ELLIPTA Device. Subjects will receive GSK2269557 700 mcg once daily for 84 consecutive days via ELLIPTA.; Lactose will be administered using a DISKUS and ELLIPTA dry powder inhaler device; It is multi-dose dry powder inhaler containing one foil strip of drug with 60 blisters; It is multi-dose dry powder inhaler containing one foil strip of drug with 30 blisters
Intervention MeSH terms: Nemiralisib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: double-blind; PI3Kdelta; GSK2269557; exacerbation; Chronic Obstructive Pulmonary Disease; randomised; placebo-controlled
Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase 3 study to evaluate the safety and efficacy of OmegaD softgels for the
      treatment of dry eye disease. A daily dose of 2 OmegaD softgels dosed orally BID will be
      compared to 2 placebo softgels dosed orally BID for 84 days. Approximately 164 subjects will
      be evaluated for their signs and symptoms of dry eye disease and for safety throughout the
      study.
    

Detailed description: 
      Inflammation is a key component of dry eye disease. Increasing the systemic levels of omega-3
      fatty acids relative to omega-6 levels can mediate immune responses. Evaluating whether
      omega-3 supplementation can improve dry eye disease signs, symptoms and associated measures
      of inflammation may present a new therapeutic option for dry eye disease.

      The primary objective of this study is to evaluate the safety and efficacy of twice daily
      (BID) dosing of OmegaD softgels in subjects with dry eye disease.

      Male and female subjects between 18 years and 90 years of age, with patient-reported dry eye
      symptoms and a clinical diagnosis of dry eye disease supported by global clinical assessment
      will be screened and enrolled. Each subject must have, in at least one eye, tear osmolarity
      of ≥ 312 mOsm/L and meibomian gland dysfunction as defined by a grade of 1 or 2 on the
      meibomian orifice size scale at both Screening and Baseline in at least one eye. In addition,
      Tear break up time (TBUT) must be ≤ 7 seconds in both eyes at both Screening and Baseline and
      the Schirmer's test score in both eye(s) must be ≥ 5 mm at Baseline.

      Approximately 164 subjects will be randomized (1:1) to 1 of 2 treatment arms and treated for
      84 days (12 weeks) with either OmegaD softgels; 2 softgels BID or placebo softgels; 2
      softgels BID. The study will be double-masked with OmegaD and placebo being
      identical-appearing softgels.

      Subjects will participate in safety and efficacy assessments throughout the study. Efficacy
      assessments will include, tear osmolarity, meibomian gland dysfunction grading, TBUT,
      Schirmer's Test, and dry eye symptoms based on the OSDI questionnaire, Safety assessments
      will include, slit lamp examination and adverse events.
    

Intervention name(s): OmegaD; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): OmegaD Softgels; Placebo Softgels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment