bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D Levels Following Topical Application of Vitamin D Ointment
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pre-post open label trial to assess the change in Vitamin D blood levels following
      treatment with three doses of topical Vitamin D3 in subjects with existing Vitamin D
      deficiency.
    

Detailed description: 
      The proposed study investigates safety and efficacy of a new topical vitamin D3 compound. The
      purpose of this Phase 1 trial is to determine whether topical application makes Vitamin D
      bioavailable to the systemic circulation in sufficient quantities to treat hypovitaminosis D.
      The study will assess the change in serum 25-hydroxy (25-OH) vitamin D concentrations
      following 3 doses of 100,000 IU or 3 doses of 300,000 IU of topical vitamin D3 ointment in
      volunteers with vitamin D deficiency. Adults with serum 25-OH vitamin D concentrations of <
      20 ng/ml will receive a total of 300,000 IU or 900,000 IU in divided doses of topical vitamin
      D once per week for three weeks. Two 0.75 ml applicators of ointment will be applied to each
      upper arm (50,000 IU or 150,000 IU per arm) by study staff. Blood will be drawn at baseline
      prior to the first dose (Day 0) and on Days 7, 14, and 21. Total serum 25-OH vitamin D will
      be assayed at each draw. Parathyroid hormone, a measure of clinical effects of low vitamin D
      levels, will be checked at baseline and on day 21. Serum albumin adjusted calcium levels will
      be checked with each draw to check for possible effects of too much vitamin D absorption. The
      study will determine whether the topical application of Vitamin D ointment is able to correct
      existing vitamin D deficiency.
    

Intervention name(s): Dose 1; Dose 2
Intervention type(s): Drug; Drug
Intervention description(s): Subjects with vitamin D deficiency will be given 100,000 units of topical vitamin D on days 0,7, and 14. Vitamin D levels will be checked on days 7, 14, and 21.; Subjects with vitamin D deficiency will be given 300,000 units of topical vitamin D on days 0,7, and 14. Vitamin D levels will be checked on days 7, 14, and 21.
Other intervention name(s): cholecalciferol; 25-OH Vitamin D; cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation
Condition: Cardiac Output; Sedation
Study type: Observational

Summary: 
      The aim of the study is to investigate the use of a new FDA-approved non-invasive
      bio-impedance cardiac monitor, ICON, to detect hemodynamic effects during sedation in
      children undergoing radiology procedures. The purpose of the study is to determine the
      ability of the ICON monitor to identify the anticipated and documented hemodynamic changes in
      children which occur in response to Dexmedetomidine sedation. The investigators postulate
      that if the ICON device can trend hemodynamic changes, if any, during dexmedetomidine (DEX)
      sedation in children the investigators can delineate changes in cardiac output, stroke
      volume, and systemic vascular resistance associated with observed changes in heart rate and
      blood pressure.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All pediatric patients (1 month to 18 years of age) eligible for Radiology Sedation Service
        for CT scan and Nuclear Medicine Scan procedure who agrees to participate in the study will
        have their vital signs and ICON measurements recorded continuously pre-sedation, during
        sedation and through recovery until discharge.
      
Keywords: Electrical Cardiometry; Dexmedetomidine; ICON; bio-impedance; cardiac monitor
Pedunculopontine Nucleus Stimulation for Gait Disorders in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The appearance of postural instability and gait disorders is a major turning point in the
      evolution of Parkinson's disease (PD). These axial symptoms are usually unresponsive to
      L-Dopa and represent a severe impairment for the patients due to frequent falls and reduced
      outside mobility. There is no effective pharmacological treatment available for these
      symptoms, and their pathophysiology is not well known : it is currently assumed that
      non-dopaminergic brainstem lesions participate to axial symptoms in PD. Surgically, these
      patients cannot benefit from high frequency deep brain stimulation (DBS) of the subthalamic
      nucleus (STN) since this operation tends to even aggravate axial symptoms unresponsive to
      L-Dopa in some patients. A dysfunction of the pedunculopontine nucleus (PPN) might be at the
      origin of these axial symptoms, since the PPN participates in the maintenance of posture and
      motion in primates. In PD patients, recent reports have suggested that low frequency
      stimulation of the PPN may equally improve gait and posture. However, these results are
      debatable due to methodological limitations, insufficient clinical evaluation and uncertain
      anatomical targeting. Thus, our aim is to propose a low frequency PPN stimulation to six
      advanced PD patients according to the usual criteria for STN DBS who are, however, unsuitable
      for this operation due to gait and posture disorders. We will perform a randomized,
      double-blind and cross over design (two months periods with and without DBS randomly assigned
      to each patient). The targeting will be allowed by a a three-dimensional and deformable atlas
      of the basal ganglia fusioned with the stereotaxic magnetic resonance imaging (MRI) of each
      patient. Evaluations will comprise 1 month before surgery and in "Off" and "On" stimulation
      condition:

        -  clinical motor assessment in both "Off" and "On" drug state, including cardinal
           parkinsonian signs, gait and balance

        -  gait initiation physiological evaluation

        -  cognitive and behavioral testing If our hypothesis is confirmed, low frequency PPN
           stimulation may well represent a substantial improvement of our therapeutic options for
           advanced PD patients suffering from debilitating gait and posture disorders unresponsive
           to L-Dopa.
    


Intervention name(s): Low frequency DBS of the pedunculopontine nucleus
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Observational

Summary: 
      The purpose of this study is to determine the extent to which vaginal microflora and immune
      profiles of patients with urinary tract infection (UTI) differ from healthy controls.
    

Detailed description: 
      Recurrent urinary tract infections, which occur mostly in the female population, can be
      potentially harmful if not treated and significantly reduce quality of life. By
      characterizing the vaginal microflora and immune profiles of women that suffer recurrent UTIs
      in contrast to a healthy age matched normal group of women (with no history of recurrent
      UTIs), we can better understand the differences. This in turn can lead to development of
      better quality probiotics that will be based on their scientific basis, clinical efficacy,
      and quality in terms of shelf life and delivery to target sites. The reduction in only one
      third of UTI cases seen each year would have a significant impact on reducing health care
      costs.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Severe Legionellosis Cases Admitted to Grenoble University Hospital, 2006-2011.
Condition: Legionnaires' Disease
MeSH terms: Legionnaires' Disease; Legionellosis
Study type: Observational

Summary: 
      The study aimed at further describing the epidemiological, clinical, diagnostic and
      prognostic features in legionellosis cases admitted to Grenoble University Hospital during
      the 2006-2011period. The investigators also tested lower respiratory samples collected from
      these patients during their routine medical care, using a number of molecular tools allowing
      determination of the involved Legionella species, the bacterial load, and the presence of
      antibiotic resistant mutants. Our primary goal was to define biological markers that could
      predict severity and outcome of infection in legionellosis cases requiring hospitalization.
    

Detailed description: 
      Patients admitted to Grenoble University Hospital between 2006 and 2011 for severe
      legionellosis were retrospectively included in the study.

      Clinical, epidemiological, diagnostic and prognostic data of these patients were recorded
      retrospectively.

      Lower respiratory samples collected from these patients on a routine basis for
      microbiological analysis, especially Legionella culture, were tested using traditional
      microbiological methods. The remaining part of these samples was stored at -80°C fur further
      molecular analyses.

      The molecular tools developed by our bacteriology laboratory included the following: a
      real-time polymerase chain reaction (qPCR) test allowing detection and differentiation of L.
      pneumophila and other Legionella species; a qPCR test allowing determination of the
      Legionella DNA load in lower respiratory samples; a qPCR allowing detection of gyrA (the gene
      encoding subunit A of DNA gyrase) mutations that the investigators previously determined to
      be correlated with fluoroquinolones resistance in L. pneumophila; a high-throughput
      sequencing approach allowing confirmation of gyrA mutations and determination of the
      percentage of mutated alleles.

      The microbiological data, especially those obtained with the developped molecular tools, were
      tentatively correlated with the severity and outcome of infection in our patients' cohort.
    

Intervention name(s): Real-time PCR testing of lower respiratory tract samples
Intervention type(s): Biological
Intervention description(s): qPCR and high-throughput DNA sequencing testing of lower respiratory tract samples collected routinely in patients with severe legionellosis
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        82 unrelated legionellosis cases 64 males, 18 females mean age: 55 years, range: 27-97
        years severe legionellosis requiring hospitalization
      
Biospecimen description: 
      Lower respiratory tract samples collected on a routine basis for microbiological analyses
    
Keywords: Legionella; Legionnaires' disease; Diagnosis; Prognosis
Time Restricted Feeding for Weight Loss and Cardio-protection
Condition: Coronary Disease; Weight Loss
MeSH terms: Coronary Disease; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Time restricted feeding (TRF) is a novel form of intermittent fasting that involves confining
      the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. TRF is
      effective for weight loss and cardio-protection in obese adults. It is of great interest to
      see whether subjects can adhere to TRF for longer periods of time, and to see what degree of
      weight loss that can be achieved with TRF. Accordingly, the aims of this trial are: Aim 1: To
      determine if TRF can be implemented to facilitate weight loss in obese adults, and Aim 2: To
      determine if TRF can produce clinically meaningful reductions in plasma lipids, blood
      pressure, insulin resistance, and inflammatory markers.
    

Detailed description: 
      Time restricted feeding (TRF) is a novel form of intermittent fasting that involves confining
      the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. Recent
      findings from short-term uncontrolled trials suggest that TRF is effective for weight loss
      and cardio-protection in obese adults. In view of these pilot findings, it is of great
      interest to see whether subjects can adhere to TRF for longer periods of time, and to see
      what degree of weight loss that can be achieved with TRF. Accordingly, the aims of this trial
      are: Aim 1: To determine if TRF can be implemented to facilitate weight loss in obese adults,
      and Aim 2: To determine if TRF can produce clinically meaningful reductions in plasma lipids,
      blood pressure, insulin resistance, and inflammatory markers. To test the study objectives, a
      14-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1)
      2-week baseline; and (2) 12-week weight loss, will be implemented. Obese subjects (n = 40)
      will be randomized to 1 of 2 groups: (1) TRF (n = 20), or (2) control (n = 20). This study
      will be the first randomized controlled trial of TRF, and will show that TRF can be
      implemented to help obese individuals lose weight and lower risk of coronary heart disease.
    

Intervention name(s): Time restricted feeding
Intervention type(s): Other
Intervention description(s): Time restricted feeding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Sensitivity of Fecal Immunochemical Test (FIT) for Colorectal Cancer (CRC) Screening
Condition: Colorectal Neoplasms Malignant; Colonoscopy; Early Detection of Cancer; Female; Mass Screening; Middle Aged; Occult Blood
MeSH terms: Colorectal Neoplasms; Neoplasms
Study type: Observational

Summary: 
      Fecal immunochemical test (FIT) was introduced in France late 2015, FIT has better diagnostic
      accuracy for colorectal cancers (CRCs) than previous screening tests. Our primary objective
      was to evaluate the sensitivity of FIT and the proportion of interval cancer.
    

Detailed description: 
      Fecal immunochemical test (FIT) aims to detect pre-symptomatic lesions, i.e., early stage
      colorectal cancers (CRCs) or pre-cancerous lesions such as colonic adenomas in order to
      reduce CRC mortality. FIT was introduced in France late 2015, FIT has better diagnostic
      accuracy for CRCs than previous screening tests. Determining the incidence of post-test
      interval CRCs, diagnosed after a negative FIT and before the recommended date of the next
      test (2-year interval), allows assessment of the sensitivity of the test. The primary
      objective of this study was to evaluate the performance of FIT during the CRC screening
      campaign in the Finistère department (France) from January 1, 2016 to December 31, 2017. Its
      secondary objectives were the evaluation of diagnostic circumstances and their impact on
      treatment and survival, and risk factors for interval cancer (IC).
    

Intervention name(s): Positive fecal immunochemical test (FIT); Negative fecal immunochemical test (FIT); Fecal immunochemical test (FIT) not performed
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.; We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.; We evaluated CRCs screening campaign from January 1, 2016 to December 31, 2017, and interval cancers within two years after a negative test, and five years for post-colonoscopy interval cancers.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This retrospective study evaluated the CRC screening campaign, which took place from
        January 1, 2016 to December 31, 2017 in the Finistère department.
      
Keywords: Screening; Fecal immunochemical test; survival; interval cancer
Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate changes in liver fat content following multiple oral doses of
      MK-4074 and Pioglitazone Hydrochloride in adult males and females with fatty liver disease.
      The primary hypothesis of the study is that a multiple-dose administration of MK-4074 200 mg
      twice daily for 4 weeks results in a decrease in hepatic fat content with respect to placebo
      in adult male and female participants with hepatic steatosis (i.e., on order of 50% reduction
      in hepatic fat with respect to placebo is expected).
    


Intervention name(s): MK-4074 200 mg; Placebo for MK-4074; Pioglitazone hydrochloride 30 mg; Placebo for pioglitazone hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 x 100-mg capsules, orally, twice-daily (BID) for 4 weeks; 2 x 100-mg capsules, orally, BID for 4 weeks.; 1 x 30-mg tablet, orally, once daily for 4 weeks; 1 x 30-mg tablet, orally, once daily for 4 weeks
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Imatinib in Subjects With Seasonal Allergic Rhinitis and Who Are Sensitive to Timothy Grass Pollen
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the effects of Imatinib on allergic inflammation following repeated
      nasal allergen challenge in subjects with seasonal allergic rhinitis sensitive to Timothy
      grass pollen.
    


Intervention name(s): Imatinib
Intervention type(s): Drug
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Imatinib, allergic inflammation, out of allergy season, repeated nasal allergen, seasonal allergic rhinitis, sensitive, Timothy grass pollen, c-kit inhibition
Creatine-Guanidinoacetic Acid Supplementation for Sarcopenia (CREGAAS)
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Sarcopenia-driven brain and muscle creatine deficit could be seen as a distinctive
      pathological facet of this condition, and this might be approached with targeted therapies in
      aim to restore creatine homeostasis in target tissues. Among potential therapeutic
      candidates, guanidinoacetate (GAA) appears recently as a direct precursor of creatine that
      may favorably upregulate muscle and brain creatine concentration. Interestingly, GAA-creatine
      mixture was found to be superior than creatine itself to effectively improves bioenergetics
      in the human brain and muscle in healthy humans, perhaps due to the unique transportability
      features of this combination. Here, we plan to evaluate does creatine-GAA supplementation
      affects various biomarkers of sarcopenia in elderly.
    


Intervention name(s): Creatine-guanidinoacetic acid; Inulin
Intervention type(s): Dietary Supplement; Other
Intervention description(s): A dietary supplement provided as powder dissolved in a glass of water; A dietary supplement provided as powder dissolved in a glass of water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Physical Activity, Fatigue, Sleep, and Inflammation
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of the study is to examine the benefits of physical activity for breast cancer
      survivors related to muscle strength, tiredness, and sleep quality. Also, the study will
      determine the potential role of inflammation in these benefits.
    

Detailed description: 
      Our previous research has shown that increases in physical activity can improve the health
      and well-being of breast cancer survivors. The current study will determine whether the
      physical activity increases are adequate for improved health by measuring physical activity
      (accelerometer and self-report), muscle strength, fatigue, and sleep. Moreover, few studies
      have examined cytokine changes in cancer survivors after participation in a physical activity
      behavior change intervention with a mechanistic focus on cytokines which may influence the
      muscle strength, fatigue, and sleep response to the intervention.

      Seventy-four female, breast cancer survivors are being recruited within a 50-miles radius of
      Springfield, IL. Participants will be in the study for approximately 5 months. Participants
      will be asked to complete a questionnaire at the beginning of the study and 3 months later. A
      blood sample will be drawn to determine serum cytokine levels.

      Volunteers will be randomly assigned to 1 of 2 study groups. The intervention group will
      participate in a 3 month physical activity intervention involving moderate intensity walking
      and strength training with resistance bands.

      This randomized controlled trial includes the following study aims:

      Study aim 1: The intervention group will be compared with the control group to examine the
      change in physical activity, muscle strength, fatigue, and sleep dysfunction before and after
      participation in a physical activity intervention.

      Study aim 2: To investigate mechanisms that may underlie the effects of the physical activity
      intervention on muscle strength, fatigue, and sleep, we will compare the intervention group
      with the control group in terms of changes in cytokine markers of inflammation and evaluate
      whether such changes are consistent with and may mediate changes in muscle strength, fatigue,
      and sleep dysfunction.
    

Intervention name(s): 3 month physical activity intervention
Intervention type(s): Behavioral
Intervention description(s): 3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
Other intervention name(s): exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: exercise; breast cancer; physical activity; fatigue; sleep dysfunction; cytokines; muscle strength; inflammation