bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study Comparing Budesonide/Formoterol Easyhaler and Symbicort Turbuhaler Forte
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with
      the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
    


Intervention name(s): Budesonide/formoterol Easyhaler; Symbicort Turbuhaler; Charcoal and Budesonide/formoterol Easyhaler; Charcoal and Symbicort Turbuhaler
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Budesonide/formoterol Easyhaler; Symbicort Turbuhaler; Charcoal and Budesonide/formoterol Easyhaler; Charcoal and Symbicort Turbuhaler
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination; Charcoal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Efficacy Study of Stain Control of a 67% Sodium Bicarbonate Containing Toothpaste on Chlorhexidine Tooth Staining
Condition: Oral Hygiene
MeSH terms: Tooth Discoloration
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare the stain effect on teeth of twice daily brushing with a
      67% sodium bicarbonate containing toothpaste versus standard toothpaste (not containing
      sodium bicarbonate) for six weeks whilst using a chlorhexidine digluconate 0.2% mouthwash.
    


Intervention name(s): Sodium bicarbonate/ Sodium Fluoride; Sodium fluoride; Chlorhexidine digluconate
Intervention type(s): Other; Other; Drug
Intervention description(s): Toothpaste containing sodium bicarbonate and sodium fluoride as cosmetic; Toothpaste containing sodium fluoride as cosmetic; Mouthwash containing chlorhexidine digluconate
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Phase 2, Multicenter, Open-Label Extension Study With ABT-122 in Rheumatoid Arthritis Subjects Who Have Completed the Preceding M12-963 Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, multicenter, 24-week OLE study to assess the safety and tolerability of
      ABT-122 in participants with rheumatoid arthritis (RA) who had had an inadequate response to
      methotrexate (MTX) therapy and who completed the preceding Study M12-963 randomized
      controlled trial, in which participants had been randomized to receive 1 of 3 doses of
      ABT-122 (60 mg every other week [EOW], 120 mg EOW, or 120 mg every week [EW]) or adalimumab
      40 mg EOW given on background methotrexate.
    


Intervention name(s): ABT-122
Intervention type(s): Drug
Other intervention name(s): Remtolumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tolerability; Methotrexate; Safety
Adjuvant Pazopanib in Stage I NSCLC
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study is to evaluate the efficacy and safety of pazopanib compared with
      placebo in patients with T < or = 5 cm, N0 (stage I according to TNM 2009) completely
      resected NSCLC.
    

Detailed description: 
      The study will be conducted in two phases as follows:

        -  The Phase II component of the study will be a randomized, double-blind,
           placebo-controlled, multi-centre study performed in France only. After undergoing NSCLC
           resection, 140 patients will be randomized to receive either pazopanib 400 mg per day or
           placebo for 24 weeks.

        -  The Phase III component of the study will be a randomized, double-blind,
           placebo-controlled, multi-centre study performed internationally. Patients who have
           completed the Phase II component of the study will be followed and included in the Phase
           III. Additional patients will also be recruited to a planned total of 355 patients per
           treatment arm. New patients will be randomized to receive either pazopanib 400 mg per
           day or placebo for 24 weeks.
    

Intervention name(s): PAZOPANIB; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg/day (24 weeks); Placebo 400 mg/day (24 weeks)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-small cell lung cancer; Stage I; adjuvant therapy; Adjuvant Drug Therapy
Vitamin D Supplementation in Crohn's Patients
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of vitamin D supplementation in Crohn's
      disease patients. Patients will be evaluated for increases in circulating vitamin D levels
      and effects on health benefits including improved bone markers, Crohn's disease activity
      scores, and inflammatory markers.
    

Detailed description: 
      The incidence of autoimmune diseases like inflammatory bowel disease (IBD) has increased in
      developed countries over the last 50 years. We propose that decreased outdoor activity and
      increased pollution and diets that lack adequate vitamin D have combined to create large
      fluctuations in vitamin D status in developed countries and especially in populations that
      experience winter. Experimentally we've shown that changes in vitamin D status results in
      more severe forms of experimental IBD. In addition, active vitamin D (1,25(OH)2D3) completely
      blocks the development of experimental IBD. The vitamin D hypothesis proposes that vitamin D
      regulates the development and function of the immune system and that changes in vitamin D
      status affect the development of the resultant immune response and the development of
      diseases like IBD. Our hypothesis is that because of low dietary vitamin D intakes and
      malabsorption of many nutrients, Crohn's patients will have low circulating vitamin D levels
      that are detrimental for their health. We plan to give Crohn's patients 1000 IU of vitamin
      D/d and determine whether this dose is well tolerated, induces an increase in circulating
      vitamin D levels and has any additional health benefits (improved bone markers, Crohn's
      disease activity scores, inflammatory markers).
    

Intervention name(s): Vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): Oral supplementation daily with up to 5000 IU over 6 months.
Other intervention name(s): Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Crohn's; vitamin D
The Use of RF in Premature Jowl and Neck Laxity Following Facialplasty
Condition: Premature Jowl and Neck Laxity Following Facialplasty
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Study is to evaluate the efficacy of treatment Radio Frequency in premature jowl and neck
      laxity following facialplasty
    


Intervention name(s): AccuTite/FaceTite
Intervention type(s): Device
Intervention description(s): Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
Other intervention name(s): Morpheus8
Intervention model: Single Group Assignment
Intervention model description: Subjects will receive the treatment and outcome will be followed
Masking: None (Open Label)
Primary purpose: Treatment
Adolescent Responses to Varying Environments in Virtual Reality Simulations
Condition: Residential Characteristics; Emotions; Stress, Psychological; Stress, Physiological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The objective of this study, named THRIVE (The Research In Virtual Environments Study), is to
      test hypotheses for how neighborhood environments influence stress and emotion, as a
      mechanism by which they may influence health. Neighborhood environments may have both acute
      influences on stress-related processes, but also may have lifespan effects due to the
      chronic, cumulative effects of repeated exposures and the long-term toll of adapting to
      adverse neighborhood environments. However, assessing neighborhood influences on stress and
      emotion is methodologically challenging. This study develops such a novel, alternative
      approach to address these questions by deploying a virtual reality (VR) based model of
      neighborhood disadvantage and affluence that creates an immersive experience approximating
      the experience of being in different neighborhoods. In this study, this model will be applied
      to understand neighborhood effects in a diverse sample of adolescents (n = 130) from a range
      of disadvantaged and affluent neighborhoods. The proposed study will employ a randomized
      experiment (n = 65 per condition), with online questionnaires and a single study session, to
      determine (a) if virtual exposure to neighborhood disadvantage elicits differences in emotion
      and stress reactivity; (2) if growing up in a disadvantaged neighborhood results in
      habituation or sensitization to different neighborhood characteristics; and (3) if chronic
      stress results in habituation or sensitization to different neighborhood characteristics.
      This research will develop an innovative methodology that will help establish the role that
      neighborhoods may play in eliciting stress as well as the processes of adaptation to chronic
      stress and chronic neighborhood exposures. In addition, it will help establish a method that
      can be utilized more broadly to study contextual and social environmental influences on
      psychological and biological risk in adolescence.
    


Intervention name(s): Virtual reality
Intervention type(s): Other
Intervention description(s): Participants are immersed in a neighborhood environment in virtual reality
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Neighborhoods; Poverty Areas; Adolescent Development
RF Ablation of Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an early feasibility trial designed to demonstrate whether a new ablation device can
      be used safely and effectively in treating atrial fibrillation.

      This study is a prospective, nonrandomized, single-arm, multi-center trial to be conducted at
      a single study site
    

Detailed description: 
      This study is intended to evaluate the safety and preliminary effectiveness of the RFMesh BAS
      for electrophysiological mapping and radiofrequency ablation in the region of the ostium of a
      targeted pulmonary vein in the treatment of drug refractory paroxysmal atrial fibrillation.
    

Intervention name(s): RF catheter ablation
Intervention type(s): Device
Intervention description(s): RF ablation using mesh device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation
Primary Aldosteronism In Hypertensive Patients in China
Condition: Hyperaldosteronism; Primary; Hypertension Secondary
MeSH terms: Hypertension; Hyperaldosteronism
Study type: Observational

Summary: 
      To investigate the prevalence of primary aldosteronism (PA) in Chinese patients with newly
      diagnosed hypertension.
    

Detailed description: 
      This is a nationwide sampling study. To investigate the prevalence of primary aldosteronism
      (PA) in Chinese patients with hypertension, we will conduct a case detection of PA in Chinese
      hypertensive patients from 10 centers of China (including Beijing, Chongqing, Shanghai,
      Guangzhou, et al.); furthermore, a case confirmation of PA (captopril challenge test and
      saline infusion test) will be performed if the result of case detection is positive. This
      study will be completed in two years.
    

Intervention name(s): Aldosterone/renin ratio (ARR) testing; Confirmatory tests
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Plasma aldosterone concentration tests, Direct renin concentration tests; Captopril challenge test, Saline infusion test
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Sampling Design: hypertensive patients will be continuously sampled for case detection in
        each center. PASS 11.0 Software-Confidence Intervals for One Proportion was used to
        calculate the sample size. A sample size of 2928 produces a two-sided 95% confidence
        interval with a width equal to 0.02 when the sample proportion(prevalence of PA) is 0.080.
        Accounting for the 20% withdraw rate in the process of case detection, the final sample
        size should be 3635 (about 4000 cases).
      
Biospecimen description: 
      Some subtye of PA such as glucocorticoid remediable aldosteronism(GRA) should be diagnosed by
      DNA
    
Keywords: prevalence; primary aldosteronism; hypertension; nationwide
Open Label Study To Assess The Effectiveness Of Amlodipine-Atorvastatin Combination In Hypertension And Dyslipidemia.
Condition: Hypertension; Hyperlipidemia
MeSH terms: Hypertension; Dyslipidemias; Hyperlipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effectiveness of amlodipine/atorvastatin therapy by assessing the percentage
      of subjects who reach target blood pressure (BP) and LDL-C targets as defined by their
      governing guidelines.
    


Intervention name(s): Amlodipine/atorvastatin single pill
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine; Amlodipine, atorvastatin drug combination; Atorvastatin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clopidogrel Pharmacogenetics (PGX) Bench to Bedside
Condition: Metabolism of Clopidogrel
Study type: Interventional

Summary: 
      Clopidogrel (also known as Plavix) is used commonly in patients to prevent heart attacks and
      conditions caused by blood clots. Although clopidogrel works in many individuals, some people
      do not respond as well to this drug. The variation in treatment response may be linked to
      genetics. This study will examine the effects of clopidogrel in a population in which
      sequencing for certain genes has been performed in order to determine the role that genes
      play in the response to various clopidogrel maintenance doses.
    

Detailed description: 
      Clopidogrel is a prodrug with high inter-individual response variability. Clopidogrel is
      converted to an active drug in part through an enzyme encoded by the gene named CYP2C19.
      Individuals with genetically-impaired CYP2C19 metabolism have lower capacity to convert the
      prodrug to its active form. Consequently, these individuals have lower blood levels of the
      activated form of clopidogrel, diminished antiplatelet responses, and higher rates of
      cardiovascular events and stent thrombosis. Increasing doses of clopidogrel in such patients
      represents a possible approach to managing the gene-drug interaction.

      The purpose of this study is to evaluate whether increasing the dose of clopidogrel increases
      antiplatelet responses and active metabolite exposure in individuals with genetically reduced
      CYP2C19 metabolism relative to those with normal CYP2C19 metabolism.

      The primary objective is to assess changes in clopidogrel response and exposure at three
      clopidogrel dose levels and with coadministration of omeprazole.
    

Intervention name(s): Clopidogrel; Omeprazole/Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Over a 6 week period participants will be given: 75 mg of clopidogrel for 8 days, at least 1 week washout, 150 mg of clopidogrel for eight days, at least 1 week washout, 300 mg of clopidogrel for eight days.; After a washout of at least 1 week, participants will have the option to participate in a final intervention in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days.
Other intervention name(s): Plavix; Prilosec; Plavix
Intervention MeSH terms: Omeprazole; Clopidogrel
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clopidogrel; Pharmacogenetics; Platelets; Healthy Subjects
Corifollitropin Alfa Followed by hpHMG in a Long GnRH Agonist Protocol for the Treatment of Poor Ovarian Responders
Condition: Infertility; Poor Ovarian Response
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the present study is to examine the level of ovarian response and the
      pregnancy rates among poor ovarian responders treated with a novel treatment protocol with
      150μg corifollitropin alfa followed by 300IU hMG in a long GnRH agonist protocol.
    

Detailed description: 
      Corifollitropin alfa reaches maximum concentrations (Cmax), between 25 and 45 h after
      injection , a time interval which is significantly shorter as compared to treatment with
      rFSH. The investigators hypothesized that this rapid increase in the serum FSH concentration
      may result in a significantly higher exposure of the small antral follicles to constant high
      levels of FSH during the early follicular phase, securing not only the recruitment of the
      follicles, but also the continued growth.

      In the current study the investigators examine whether administration of corifollitropin
      followed by 300IU hMG in a long GnRH agonist protocol may result in acceptable pregnancy
      rates in poor ovarian responders fulfilling the "Bologna criteria"
    

Intervention name(s): Triptorelin; Corifollitropin alfa 150μg; hpHMG
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Triptorelin 0.1 mg/1 ml solution daily from day 21 of the cycle onwards; Corifollitropin alfa 150μg (single dose) 2 or 3 weeks after initiation of triptorelin; hpHMG 300IU daily from day 7 following Corifollitropin alfa onwards
Intervention MeSH terms: Triptorelin Pamoate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Poor ovarian response; Poor ovarian responders; Bologna criteria for poor ovarian response
MEMORA-Caregiver : Risk Factors of Caregiver Burden Among Patients With Neurocognitive Disorders or Subjective Cognitive Complaint
Condition: Neurocognitive Disorders
MeSH terms: Neurocognitive Disorders; Caregiver Burden
Study type: Observational

Summary: 
      The investigators will investigate which patients' characteristics are associated with
      caregivers burden and its evolution for outpatients visiting a memory clinic, in particular
      how functional autonomy, behavioral and psychological symptoms as well as patients
      comorbidities can influence caregiver burden.

      The study will be conducted among outpatients with progressive cognitive complaint followed
      in a Memory Clinic and their primary caregiver. The investigators hypothesis that caregivers
      experience a higher burden due to disease symptoms such as impairment of functional autonomy,
      behavioral and cognitive impairment, whatever the aetiology of the cognitive decline.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes a sample of consecutive dyads of patient-caregiver consulting
        a neurologist or a geriatrician for a cognitive complaint between November 2011 and
        December 2014 at the Memory Clinic of the Hospital Charpennes, Villeurbanne, France.
      
Keywords: Alzheimer's disease or related disorder; Comorbidity; Charlson comorbidity index; Caregiver burden; Cohort; Dementia; Behavioral disorders; Functional dependency
Research for Papillomavirus as the Examination of Orientation in the Organized Screening of the Cervical Cancer
Condition: Research Human Papillomavirus ( HPV) by Vaginal Auto-takings ( APV) and Urinary Test
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      Auto-takings by APU and vaginal APV during the consultations for FCU in the department of
      gynecology-obstetrics (Group 1) according to an instructions for use proposed to the
      inclusive women, with consent; the same proposal, APU and APV, is made for other
      consultations requiring a screening on the CHRU (Group 2: dermatology, endocrinology,
      ambulatory surgery, inner medicine, pneumology, oncology). Auto-takings transmitted in the
      laboratory of the CHRU of Brest for test HPV by quantitative real-time PCR. Results
      transmitted to the women and to the doctors of consultation. In case of positive test (15 %),
      the patients are directed to a gynecologist. Confrontation with the cytological data when
      available (Group 1) .
    


Intervention name(s): vaginal auto-takings and urinary test
Intervention type(s): Other
Intervention description(s): vaginal auto-takings and urinary test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Papillomavirus; Vaginal auto-takings; Urinary test
Effects of Exposed to Antipsychotics Throughout Pregnancy on Infants Development: A Prospective Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The primary aim of this prospective study is to evaluate the effect of antipsychotics on
      infant development especially neurobehavioral development which evaluated by the Bayley-III
      when mothers are treated with antipsychotics throughout their pregnancy.
    

Detailed description: 
      The neurodevelopmental effect of antipsychotics on fetus has always been a major concern for
      women who need antipsychotic treatments and are in their reproductive years. The fear of
      harmful effects from antipsychotic on fetus and unplanned pregnancy commonly causes
      non-adherence to treatments. Even for those who are willing to maintain their antipsychotic
      treatments during pregnancy, the fear of potential harmful effects from antipsychotic on
      fetus can still exist. It is well known that non-adherence to antipsychotic treatments in
      patients with schizophrenia can cause most to relapse and poor treatment response. The
      consequences of relapse not only increase personal suffering, but also increase family and
      societal burden.Clearly, it is important to evaluate the safety of antipsychotics during
      pregnancy. However, up to now, most information about antipsychotics on reproductive safety
      and the effects on infant development come from case reports, case series, and retrospective
      studies.So the study was to investigate the developmental effects of antipsychotics on
      infants who were exposed to as fetus.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        76 infants who were exposed to antipsychotics as fetus was compared to 76 matched control
        infants who were not exposed to antipsychotics as fetus.
      
Keywords: antipsychotic; schizophrenia; infant development