bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Lovastatin on Human Platelet Proteome
Condition: Blood Platelets Proteome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects induced by the cholesterol-reducing drug
      Lovastatin on the platelet proteome of healthy volunteers. Our results may allow to recognize
      the cell signalling modifications induced by Lovastatin. Furthermore, the current study aims
      to characterize the biological and inter-individual variation of platelet's proteome as
      measured by liquid chromatography-tandem mass spectrometry. Lastly, the exploration of
      changes induced by Lovastatin on the platelet's proteome may allow the discovery of
      modifications relative to the effects of statins on hemostasis and the lipid profile.
    


Intervention name(s): Lovastatin
Intervention type(s): Drug
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Lovastatin; Proteome; Blood platelets
Study to Investigate the Effect of GSK1014802 on Ambulatory Blood Pressure
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study the investigators will determine whether there is any effect of GSK1014802 on
      ambulatory blood pressure. This will be a randomized, double-blind, placebo-controlled,
      repeat dose, 2 period cross-over study conducted in healthy male and female subjects.
      Approximately 60 subjects will be randomised to receive GSK1014802 400 mg bid and placebo for
      36 days with at least 1 week between treatment sessions. A follow-up will occur 7-14 days
      after the last dose.
    

Detailed description: 
      This study, previously posted by GlaxoSmithKline (GSK), was transitioned to Convergence
      Pharmaceuticals, Ltd., which spun off from GSK. Convergence Pharmaceuticals, Ltd., has now
      been acquired by Biogen.
    

Intervention name(s): GSK1014802; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets; Tablets
Other intervention name(s): BIIB074 and CNV1014802
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: sodium channel blocker; ambulatory blood pressure
Functional Dyspepsia Treatment Trial
Condition: Dyspepsia and Other Specified Disorders of Function of Stomach
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Functional dyspepsia is a common gastrointestinal disorder. Symptoms can include stomach pain
      or discomfort, bloating, fullness after eating meals, and nausea. These symptoms often
      interfere with school and work, and weight loss may occur due to dietary restrictions.

      The hypothesis of this study was that antidepressant therapy is more effective than placebo
      in relief of the symptoms of functional dyspepsia, adjusting for psychological and
      psychiatric co-morbidity. The study also examined if antidepressant therapy reduces
      disability and improves quality of life in functional dyspepsia.
    

Detailed description: 
      The aims of this study were to:

        1. Determine whether antidepressant therapy is more efficacious than placebo in relief of
           the symptoms of functional dyspepsia, adjusting for psychological and psychiatric
           co-morbidity. The investigators also planned to determine if antidepressant therapy
           reduces disability, improves quality of life and influences clinical response over 6
           months after ceasing medication.

        2. Determine if gastric emptying (motor dysfunction) and the nutrient drink test (a test
           that assesses gastric hypersensitivity and/or gastric accommodation) is altered by
           antidepressant therapy with a tricyclic or selective serotonin re-uptake inhibitors
           (SSRI), and whether subgroups with altered physiology are associated with treatment
           outcome.
    

Intervention name(s): Amitriptyline; Escitalopram; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 mg capsule by mouth at bedtime for two weeks, then 50 mg capsule by mouth at bedtime for 10 weeks. The drug will be provided in blister packs.; 10 mg tablets by mouth at bedtime for 12 weeks. The drug will be provided in blister packs.; Placebo escitalopram and placebo amitriptyline will be manufactured to ensure all tablets and capsules will be indistinguishable, and provided in blister packs.
Other intervention name(s): Elavil; Lexapro
Intervention MeSH terms: Amitriptyline; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Bloating; Early Fullness; Nausea; Upper Abdominal Discomfort; dyspepsia; stomach pain; stomach discomfort
Study of AZD9291 Plus MEDI4736 Versus AZD9291 Monotherapy in NSCLC After Previous EGFR TKI Therapy in T790M Mutation Positive Tumours
Condition: Locally Advanced or Metastatic EGFR T790M+ NSCLC
Study type: Interventional
Phase: Phase 3

Summary: 
      A Phase III, Multi-Centre, Open Label, Randomized Study to Assess the Efficacy and Safety of
      AZD9291 in Combination with MEDI4736 versus AZD9291 Monotherapy in patients with Locally
      Advanced or Metastatic Epidermal Growth Factor Receptor T790M mutation-positive Non-Small
      Cell Lung Cancer who have received Prior Epidermal Growth Factor Receptor Tyrosine Kinase
      Inhibitor Therapy
    

Detailed description: 
      This a phase III, Multi Centre, Open Label, Randomized, Study to Assess the Efficacy and
      Safety of AZD9291 (80 mg, orally, once daily) in Combination with MEDI4736 (10 mg/kg (IV)
      infusion q2w) versus AZD9291 Monotherapy (80 mg, orally, once daily) in patients with a
      confirmed diagnosis of Epidermal Growth Factor Receptor (EGFR) T790M mutation positive NSCLC,
      who have progressed following prior therapy with an approved Epidermal Growth Factor Receptor
      Tyrosine Kinase Inhibitor (EGFR-TKI) agent. The randomization will be stratified by previous
      lines of treatment (2nd or 3rd+) and ethnicity (Asian or Non-Asian). A mandatory biopsy will
      be needed for central testing of T790M mutation status following confirmed disease
      progression on the most recent treatment regimen. The primary objective of the study is To
      investigate the safety and tolerability profile of AZD9291 in combination with MEDI4736.

      350 patients were originally planned to be evaluated across the two below populations. The
      recruitment was stopped due to new information on safety of the combination, received from
      another trial in similar patient population

        1. 2nd line: patients who have progressed following an approved first-line EGFR-TKI
           treatment but who have not received further treatment.

        2. 3rd line or higher: patients who have progressed following prior therapy with an
           approved EGFR-TKI and an additional anti-cancer treatment. Patients may have also
           received additional lines of treatment.
    

Intervention name(s): AZD9291; MEDI4736
Intervention type(s): Drug; Drug
Intervention description(s): Once daily tablet 80 mg; 10mg/kg q2w (IV) infusion
Intervention MeSH terms: Durvalumab; Osimertinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase III Open Label Study; AZD9291 plus MEDI4736 versus AZD9291 Monotherapy; NSCLC After Previous EGFR TKI Therapy; T790M Mutation Positive Tumours.
Header Burden in Football (Soccer)
Condition: Header Frequencies, Head Injuries
MeSH terms: Craniocerebral Trauma
Study type: Observational

Summary: 
      To assess the realistic magnitude of the header burden in children's and youth' football in
      eight European countries. In a cross-sectional observational design, one match of 60
      different teams in each of the eight European countries were monitored via video recording
      throughout the second half of the regular season 2017/18 and the first half of the regular
      season 2018/19. Clubs with (female, male, or mixed) Under-10, Under-12 and female and male
      Under-16 teams were invited to participate. Header frequencies and types were analysed using
      standardized heading registration forms. Additionally, head injuries were recorded using
      standardized head injury registration forms.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): observational study
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Football (soccer) playing children and adolescents
Periostin Levels in Children With Adenoid Hypertrophy
Condition: Adenoid Hypertrophy
MeSH terms: Hypertrophy
Study type: Observational

Summary: 
      Periostin is a matricellular protein that has been shown to be a marker of Type 2
      inflammation associated with airway eosinophilia. Matricellular proteins are highly expressed
      at sites of injury or inflammation. Periostin involves tissue fibrosis and remodeling in the
      nasal mucosa in some of the otolaryngologic diseases. The up-regulation of periostin
      expression has been shown in allergic rhinitis, chronic rhinosinusitis with nasal polyps ,
      and aspirin intolerant asthma. In the light of these findings the investigators aimed to
      evaluate the relation between adenoid hypertrophy and periostin levels.
    

Detailed description: 
      A total of 40 patients-age ranged between 2 and 12 years- were planned to enroll in the study
      prospectively. Patients that were scheduled to undergo adenoidectomy were included in the
      study group (adenoid group). The control group comprised of 20 healthy children who had
      previously been treated for anemia in the out-patient clinic of the Pediatrics Department and
      were clinically healthy with normal complete blood cell counts at their follow-up visits.

      Serum samples were obtained from the two groups. The samples were centrifuged at 1500 g for 5
      minute and stored in -80 oC for later analysis of periostin levels. Adenoid tissue and normal
      mucosal tissue samples were obtained from the adenoidectomy patients and stored in -80 oC for
      later homogenization and measurement of periostin levels.
    

Intervention name(s): Periostin level
Intervention type(s): Other
Intervention description(s): The serum periostin levels were planned to compare between the serum samples that were obtained from the two groups. The evaluation of the periostin levels of adenoid tissue and normal healthy mucosa were also planned.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients that were scheduled to undergo adenoidectomy were included in the study group
        (adenoid group). The control group comprised of healthy children who had previously been
        treated for anemia in the out-patient clinic of the Pediatrics Department and were
        clinically healthy with normal complete blood cell counts at their follow-up visits.
      
Biospecimen description: 
      Adenoid tissue and blood samples were collected.
    
Keywords: Adenoid Hypertrophy; Periostin
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending and Multiple Doses of Eplontersen (Formerly Known as ION-682884, IONIS-TTR-LRx and AKCEA-TTR-LRx) in Healthy Japanese Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of single and potentially multiple doses of
      Eplontersen administered subcutaneously (SC) to healthy Japanese participants.
    

Detailed description: 
      This is a single-center, double-blinded, placebo-controlled study in up to 44 participants.
      Participants will be randomized to receive three subcutaneous single-ascending doses and
      potentially multiple doses of Eplontersen or placebo.
    

Intervention name(s): Eplontersen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eplontersen administered SC; Eplontersen-matching placebo administered SC
Other intervention name(s): ION-682884; AKCEA-TTR-LRx; IONIS-TTR-LRx
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Effectiveness of In-office Bleaching Activated With a LED/Laser Device
Condition: Tooth Discoloration
MeSH terms: Tooth Discoloration
Study type: Interventional
Phase: Phase 4

Summary: 
      There is a controversy in the dentistry literature about how the use of associated light to
      activate 35% hydrogen peroxide gel during in-office tooth bleaching may increase the
      bleaching effectiveness. The studies that demonstrated an increased level of bleaching using
      light activation employed lower hydrogen peroxide gels while the ones reporting no
      statistical difference employed higher hydrogen peroxide gels.

      The hypothesis of this study is that the effectiveness of light activation tooth bleaching in
      dependent on the hydrogen peroxide concentration employed.
    

Detailed description: 
      The aim of this study is to compare the color change and tooth sensitivity of in-office
      bleaching using different hydrogen peroxide concentrations and with or without light
      activation. Sixty patients will be enrolled in this trial and divide equally into 4 groups
      according to the combination of the main factors hydrogen peroxide concentration (35% or 20%)
      or LED/laser activation (yes or no). Three 15-min applications will be performed in each
      clinical appointment. A LED/laser device will be used in the respective groups for three
      1-min application with an interval of 2 min. The same procedure will be repeated one week
      later. The color change will be assessed after hte 1st and 2nd session, after 1 week and 6
      months of the end of the treatment using a value-oriented shade Vita Classical and a
      spectrophotometer Easy Shade. The tooth sensitivity will be reported by patients using a 0 to
      10 visual analog scale. The Student t test (α = .05) will be used to compare the tooth color
      changes and the intensity of tooth sensitivity between groups at baseline and immediately
      after the first and second bleaching appointments. The Fisher exact test and Student t test
      (α = .05), respectively, will be used to analyze the percentage of patients with tooth
      sensitivity and its intensity.
    

Intervention name(s): in-office bleaching with/without light
Intervention type(s): Procedure
Intervention description(s): Two clinical sessions of tooth bleaching will be performed in each patient with a 1-week interval between them. In each session, three 15-min applications of the gel will be done using one of the two concentrations under investigation. In half of the sample of each concentration, the gel will be activated with a LED/laser device for a total of 3 min, as specified by the DMC manufacturer.
Other intervention name(s): Tooth bleaching; Hydrogen peroxide; In-office bleaching; Light activation; Hydrogen peroxide concentration
Intervention MeSH terms: Hydrogen Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: tooth bleaching, bleaching agent, hydrogen peroxide
Apatinib and Irinotecan Combination Treatment in Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Esophageal cancer is one of the common malignant tumors. The annual incidence of esophageal
      squamous cell carcinoma is 260,000 with the mortality of 210,000 in China. Different from
      that in western countries, esophageal squamous cell carcinoma (ESCC) is still the dominant
      pathological type in China and account for more than 95% cases in clinic. The prognosis of
      ESCC is very poor. About 50% of patients have advanced disease at diagnosis with a 5-year
      survival rate of only 5-7%. Though esophagectomy is standard treatment, disease will relapse
      in many patients.

      For patients with unresectable or recurrent disease, chemotherapy is an important treatment
      alone or with radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported
      effective in ESCC and is popularly used in first-line treatment of ESCC. However, there is
      still no standard 2nd-line treatment for patients who fail in first-line treatment. Both
      irinotecan and taxane had been studied as 2nd-line treatment for esophageal cancer patients.
      But there are only a few of ESCC patients involved in those studies.

      Except for chemotherapy, targeting treatment is another promising treatment for esophageal
      cancer. In recent years, antiangiogenic treatment has been proved to be effective and
      tolerable in many cancers such lung, colorectal, and gastric cancer. Apatinib is an also
      known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical data has shown
      that it is effective in the treatment of a variety of solid tumors including esophageal
      cancer. And it was approved and launched in China in 2014 as a 3rd-line treatment for
      patients with advanced gastric cancer.

      Therefore, investigators initialize this dose escalation phase I study to explore the safety
      of irinotecan and apatinib combination treatment in ESCC patients with relapse disease after
      esophagectomy and failure in 1st-line chemotherapy. Investigators will analyze the maximum
      tolerated dose (MDT) and dose-limiting toxicity (DLT) in this study.
    


Intervention name(s): Apatinib; Irinotecan
Intervention type(s): Drug; Drug
Intervention description(s): 250mg p.o. qd in first cohort (3 subjects). 250mg p.o. bid in second cohort (3 subjects) 250mg p.o. tid in third cohort (3 subjects); 150mg/m^2 i.v. q2w
Other intervention name(s): YN968D1; Camptosar, Campto
Intervention MeSH terms: Irinotecan; Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal squamous cell carcinoma; Apatinib; Irinotecan
Respiratory Health of Elite Athletes
Condition: Asthma; Cardiovascular Diseases; Metabolic Diseases
MeSH terms: Cardiovascular Diseases; Metabolic Diseases
Study type: Observational

Summary: 
      Eleven National Sports Teams are located in the Quebec Metropolitan Area. In these groups,
      many athletes are aiming for Olympic medals in Beijing 2008 and Vancouver 2010 Olympic Games.
      A consultation of the coaches of these National Teams revealed that although a large
      proportion of these athletes present various cardio-respiratory symptoms, they do not have a
      rapid access to a systematic medical evaluation and follow-up. Furthermore, little is done in
      regard to prevention and optimization of treatment of pulmonary and cardiac conditions in the
      elite athlete's population of the Quebec area.

      Cardiorespiratory problems are therefore commonly found in high-level athletes. However,
      these pathologies are not well characterized in athletes and the associated symptoms often
      not well perceived. These problems can be serious and it is important to detect them before
      they appear1 while setting up a systematic medical follow-up. Health professionals should
      monitor health of the young athletes and help to reduce the risks associated with high level
      exercise. The following project is an evaluation and follow-up program of high-level
      athletes, aiming at gathering key-information on long-term effects of high-level training on
      cardio-respiratory and metabolic parameters. Our aims will be

        1. to establish a long-term program of systematic evaluation and follow-up of
           cardiorespiratory health and performance of high elite athletes.

        2. to evaluate the prevalence of respiratory, circulatory and metabolic problems among
           high-level athletes

        3. to evaluate the effects of treatments on cardiorespiratory conditions and exercise
           performance in athletes who need asthma medication.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Athletes training in the province of Quebec. Controls from Quebec schools and universities.
      
Biospecimen description: 
      Serum - plasma - sputum
    
Keywords: Asthma; Environment; Type of sport; Cardiovascular disease; Athletes
A Study to Investigate the Contraceptive Efficacy and Safety of a Subdermal Etonogestrel Implant (Implanon®)(P06473)(COMPLETED)
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is to investigate the contraceptive efficacy, safety and
      acceptability of Organon's subdermal etonogestrel implant in healthy female volunteers in
      various countries in order to obtain country-specific data.
    


Intervention name(s): etonogestrel implant (Implanon)
Intervention type(s): Drug
Intervention description(s): subdermal etonogestrel implant
Other intervention name(s): Org 3236
Intervention MeSH terms: Etonogestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Endometrial Injury and Single Embryo Transfer
Condition: Primary Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Endometrial injury increases clinical pregnancy rate in normoresponder patients undergoing
      long agonist protocol intracytoplasmic sperm injection cycles with single embryo transfer.
    

Detailed description: 
      Endometrial injury means endometrial biopsy on day 3 of menstrual cycle following down
      regulation in an IVF patient.
    

Intervention name(s): Endometrial injury
Intervention type(s): Device
Intervention description(s): Endometrial injury with Endometrial Suction Curette (pipelle) will be performed.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment