bioihbjkbjnl/mcl2 huggingface dataset:
Detection of Patients With Abnormal Water Distribution Based on Bioelectrical Impedance Analysis (BIA)
Condition: Kidney Diseases
MeSH terms: Kidney Diseases
Study type: Observational

Summary: 
      The aim of this clinical investigation is to prove that the seca mbca detects dialysis
      patients with abnormal water distribution correctly. Abnormal high water distribution is
      defined as more than 2 liters of Total Body Water (TBW) above a normal value range. TBW and
      Extra Cellular Water (ECW) are calculated with prediction equations for healthy subjects
      generated in BCA-01. The results are compared with TBW and ECW ascertained by dilution
      methods as standard reference methods. The Bioelectrical Impedance Analysis (BIA) method
      should be evaluated to the accuracy of the absolute measurement of the volume state of
      dialysis patients (euvolaemic and hypervolaemic) based on a single measurement.
    


Intervention name(s): medical Body Composition Analyzer seca 514/515; Deuterium and Sodium Bromide dilution methods
Intervention type(s): Device; Procedure
Intervention description(s): Current of 100 µA; Orally administered to the subject in a solution with 100 ml tap water.
Intervention MeSH terms: Bromides
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Data of 50 patients suffering from kidney disease are planned to be collected.
A Study of Anlotinib in Subjects With Advanced Malignancy
Condition: Advanced Malignancy
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Anlotinib is a tyrosine kinase inhibitors (TKI) with high effective in inhibiting
      angiogenesis and tumor cell proliferation by targeting VEGFR, PDGFR, FGFR and c-Kit. Previous
      phase I trial has shown the potency of anlotinib in treating patients with various cancer
      types who failed in standard treatment or lack proper treatment regimen. Here, a single
      center, single-arm, phase II study was conducted to further validate the efficacy and safety
      of anlotinib in these patients.
    


Intervention name(s): Anlotinib
Intervention type(s): Drug
Intervention description(s): Anlotinib is a oral small molecule receptor tyrosine kinases inhibitor with the potency of inhibiting tumor angiogenesis as well as cell proliferation simultaneously and have been approved to treat advanced non-small cell lung cancer (NSCLC) in China. Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combining Neuro-Imaging and Non-Invasive Brain Stimulation for Clinical Intervention in Opioid Use Disorder
Condition: Opioid-Related Disorders; Heroin Dependence; Morphine Dependence
MeSH terms: Opioid-Related Disorders; Heroin Dependence; Morphine Dependence
Study type: Interventional

Summary: 
      The overarching goal of this project is to expand the traditional expertise in non-invasive
      neuromodulation at the University of Minnesota towards developing novel
      paired-neuromodulation approaches using transcrancial direct current stimulation (tDCS) for
      new addiction treatments that support long-term abstinence. This study will investigate
      whether the pairing of dorsolateral prefrontal cortex (DLPFC) stimulation and cognitive
      training can enhance functional connectivity between DLPFC and nucleus accumbens (NAcc). We
      have identified higher functional connectivity between DLPFC and NAcc in alcoholics that have
      successfully maintained abstinence for extended periods of time (7 years). This
      paired-neuromodulation approach can potentially be used as a therapeutic intervention to
      decrease substance use probability in addiction (e.g. opioid use disorder). The long term
      goal is to develop new addiction treatments that support long-term abstinence in opioid use
      disorder. The overall objective of this proposal is to enhance functional connectivity
      between DLPFC and NAcc as a therapeutic intervention to enhance cognition and reduce
      substance use rates in opioid use disorder.
    


Intervention name(s): Transcranial Direct Current Stimulation (tDCS); Sham Transcranial Direct Current Stimulation (tDCS); Cognitive Training
Intervention type(s): Device; Device; Behavioral
Intervention description(s): Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex); Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS); Executive functioning tasks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will investigate markers, mechanisms and define general predictors for
      immunological health by comparing influenza vaccine responses in monozygotic and dizygotic
      twins.
    

Detailed description: 
      The investigators plan to study the immune response to different influenza vaccines much more
      broadly and deeply across different age groups and with different vaccine modalities and to
      probe the influence of genetics on these responses using monozygotic and dizygotic twins. The
      investigators plan to compare various immunological responses, identify age-specific
      biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre-
      and post-vaccination, and determine the effective breadth of T-cell repertoire to an
      influenza vaccine within an individual as a function of age and to what degree this is
      genetically determined.

      The study will be conducted in healthy young identical and fraternal 1-8 year-old twins. All
      participants will be immunized with seasonal trivalent inactivated influenza vaccine (IIV3).
      Blood samples to conduct the assays described will be taken at pre-immunization, Days 6-8 and
      28 post-immunization for children requiring 1 dose of vaccine. For children requiring 2 doses
      of vaccine, a second immunization will be given at least 28 days after Dose 1 with responses
      measured on Day 6-8 and Day 28-32 post-second immunization.

      Children 35 months and under will receive Fluzone® standard IIV3 Pediatric Dose, while
      children 36 months and older will receive Fluzone® standard IIV3.
    

Intervention name(s): Fluzone® standard IIV3; Fluzone® standard IIV3 Pediatric Dose
Intervention type(s): Biological; Biological
Intervention description(s): Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection; Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Trivalent, inactivated influenza vaccine; Child identical twins; Child fraternal twins
Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two part study. The purpose of the first part (Part A) is the evaluation of the
      pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The
      second part (Part B) of this study will focus on the exploratory pharmacodynamics of
      PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses
      selected in Part B will have been administered previously in the Part A of the study.
    


Intervention name(s): PF-05105679; PF-05105679; PF-05105679
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679; Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679; Subject will be randomized to a treatment sequence, and assigned to placebo, 2 separate single doses of PF-05105679 in the fasted state and to controlled-release Oxycodone 20 mg (positive control) , with at least one week wash-out between doses.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics Safety Tolerability Pharmacodynamics
EVA: Evista Alendronate Comparison
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine how treatment with raloxifene compares to treatment
      with alendronate in postmenopausal women with osteoporosis on the chance of experiencing
      fractures
    


Intervention name(s): raloxifene HCI and alendronate Na
Intervention type(s): Drug
Intervention MeSH terms: Alendronate; Raloxifene Hydrochloride
Primary purpose: Treatment
A Study to Evaluate How a Drug That Alters Liver Enzymes (Rifampin) Affects the Metabolism of Enzalutamide in Men
Condition: Drug-Drug Interaction (DDI); Healthy Subjects; Pharmacokinetics of Enzalutamide
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates how a drug that alters liver enzymes (rifampin) affects the metabolism
      of enzalutamide in men by measuring concentrations of enzalutamide and its metabolites in
      plasma.
    

Detailed description: 
      The study consists of 2 randomized treatment arms. In both arms the subjects receive a single
      oral dose of enzalutamide.

      In Arm 1 the subjects are admitted to the clinic on Day -1 where they remain until Day 3.
      Each subject receives a single oral dose of enzalutamide, administered under fasted
      conditions on Day 1. Ambulant visits take place from Day 4 to Day 50. Full PK profiles are
      obtained for enzalutamide, Major Inactive Carboxylic Acid Metabolite (M1) and Active
      Metabolite N-desmethyl Enzalutamide (M2) from Day 1 up to Day 50 after intake of
      enzalutamide.

      In Arm 2 each subject receives a once-daily dose of rifampin on Days 1 to 21. On Day 8, a
      single oral dose of enzalutamide is administered under fasted conditions concomitantly with
      rifampin. Full PK profiles are obtained for enzalutamide, M1 and M2 from Day 8 up to Day 57
      after intake of enzalutamide.

      An End of Study Visit (ESV) takes place between 7 and 10 days after the last PK sample or
      early withdrawal.

      Safety assessments are performed throughout the study.
    

Intervention name(s): enzalutamide; rifampin
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): ASP9785,; MDV3100,; Xtandi
Intervention MeSH terms: Rifampin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; Pharmacokinetics; Safety; Drug-drug interactions; Enzalutamide; Rifampin; CYP3A4; CYP2D8; Enzyme induction
Study of DNA Samples From Patients With Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Observational

Summary: 
      RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
      doctors learn more about changes that may occur in DNA and identify biomarkers related to
      cancer.

      PURPOSE: This laboratory study is looking at DNA samples from patients with multiple myeloma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether there is an increased frequency of 1 or more polymorphic alleles that
           are associated with clinical endpoints using custom myeloma single nucleotide
           polymorphism (SNP) chip analysis of banked DNA samples from patients with multiple
           myeloma.

        -  Determine SNPs associated with toxicities caused, not by variations in tumor cell
           genetics, but by individual genetic variations affecting drug activation, distribution,
           metabolism, and export (ADME).

        -  Determine SNPs associated with response, influenced by the same ADME.

        -  Determine SNPs associated with bone disease (as a variable) among patients with multiple
           myeloma.

        -  Determine SNPs associated with epidemiology (i.e., risk factors for the development of
           multiple myeloma).

      OUTLINE: This is a retrospective, multicenter study.

      Banked DNA samples are analyzed using a custom single nucleotide polymorphism (SNP) chip to
      assess approximately 3,590 SNPs from 1,061 genes that are associated with myeloma growth and
      response.

      PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
    

Intervention name(s): polymorphism analysis
Intervention type(s): Genetic
Observational model: Other
Time perspective: Retrospective
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma; refractory multiple myeloma
Study on the Cardioprotection and Humoral Mechanism of Limb Ischemia Preconditioning
Condition: Ischemic Preconditioning
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      Numerous studies Have shown that limb ischemic preconditioning can protect vital organs
      (including the heart) from ischemia-reperfusion injury,which has a broad application
      prospect.But its mechanism is still unclear. Evidence showed that humoral mechanisms may play
      an important role. This study was carried out on the limb ischemic preconditioning in healthy
      volunteers, collected their serum at different time points before and after
      treatment,classified and identified the serum proteins during different periods of limb
      ischemic preconditioning,by using methods including high abundant protein
      removal,Two-dimensional electrophoresis chromatography and mass spectrometry,then analysed
      activation and synthesis of the proteins in order to search for the proteins or peptides
      whose synthesis was activated by ischemic preconditioning. This study will be the first
      systemic explore of the changes in serum proteins of limb ischemic preconditioning in human
      body,and lay theoretical basis for the clinical application of limb ischemic preconditioning
      and for further explore of its humoral mechanism,thus provide clues for searching for protein
      or peptide having protective effects for organs.
    

Detailed description: 
      We aim to assess whether limb ischemic preconditioning protects remote tissue or organs
      through a humoral mechanism.
    

Intervention name(s): limb ischemia preconditioning
Intervention type(s): Procedure
Intervention description(s): limb ischemic preconditioning consists of three 5-min cycles of left upper limb ischemia induced by a blood pressure cuff placed on the left upper arm and inflated to 200 mmHg,with an intervention 5-min of reperfusion during which the cuff was deflated.
Other intervention name(s): remote ischemia preconditioning
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ischemic preconditioning,serum proteins,human
Effect of Gymnema Sylvestre on Patients With Impaired Glucose Tolerance.
Condition: Impaired Glucose Tolerance
MeSH terms: Glucose Intolerance
Study type: Interventional
Phase: Phase 2

Summary: 
      Prediabetes (PD) was defined as an state in which glucose levels are above normal but not
      enough to meet criteria for the diagnosis of type 2 diabetes (T2D). PD can be presented as
      impaired fasting glucose (IFG), impaired glucose tolerance (IGT) and glycated hemoglobin A1c
      (A1C) altered. The International Diabetes Federation (IDF) reported that in 2013 the
      prevalence of IGT was 6.9% which is equivalent to approximately 316 million individuals with
      IGT, it is expected that by 2035 this number will increase to 417 million people affected.
      Many hypoglycemic effects attributed to Gymnema sylvestre have been reported, including:
      increase of insulin secretion, regeneration of pancreatic islet cells, increased glucose
      utilization in various ways and inhibition of glucose uptake in the intestine.
    

Detailed description: 
      The target is to evaluate the effect of the administration of Gymnema Sylvestre on glycemic
      control, insulin secretion and insulin sensibility on patients with IGT. The investigators
      will conduct a double-blind trial, randomized, placebo control group, each group 12 female
      and male patients, between 30 and 59 years old with IGT (2-h values in the oral glucose
      tolerance test, OGTT) from 140 mg / dL to 199 mg / dL), Body Mass Index (BMI) from 25 to 34.9
      kg / m2. Randomization will determine who will receive the intervention during the 9-week
      trial (Gymnema Sylvestre capsules, 300 mg 2 times daily with the first bite of breakfast and
      dinner or homologated placebo capsules). The clinical findings and laboratory tests include a
      metabolic profile and biosafety, which will be made at baseline and at week 9. Body weight,
      body fat, BMI and blood pressure will be determined during the initial and final visit.
      Adverse events and adherence to treatment will be documented. Statistical analysis:
      Mann-Whitney U test, Wilcoxon and Fisher exact test. It is considered with significance at p
      <0.05.
    

Intervention name(s): Gymnema Sylvestre; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner; Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
Other intervention name(s): Gurmar; Calcined Magnesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gymnema Sylvestre; Glycemic control
A Study to Evaluate the Safety and Efficacy of CCX140-B in Subjects With Diabetic Nephropathy
Condition: Diabetic Nephropathy; Type 2 Diabetes Mellitus
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of treatment with CCX140-B
      in subjects with diabetic nephropathy.
    

Detailed description: 
      The primary objective of this study is to evaluate the safety and tolerability of CCX140-B in
      subjects with diabetic nephropathy based on subject incidence of adverse events.

      The secondary objectives of this study include evaluation of the effect of CCX140-B on
      several measures of effectiveness commonly used in the evaluation of diabetes and renal
      medications.
    

Intervention name(s): Placebo; CCX140-B; CCX140-B
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo capsules once daily; CCX140-B capsules once daily (Group B); CCX140-B capsules once daily (Group C)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination
Condition: Infections, Papillomavirus
MeSH terms: Autoimmune Diseases
Study type: Observational

Summary: 
      The purpose of this post-marketing study is to evaluate the incidence of autoimmune diseases
      (AIDs) following females who have received at the least the first dose of Cervarix® as part
      of their routine health care.
    


Intervention name(s): Data collection
Intervention type(s): Other
Intervention description(s): New onset of cases for endpoints of interest in the targeted population will be identified from ambulatory and inpatient electronic administrative data and will be confirmed by blinded review of the medical record by an Endpoint Adjudication Committee (EAC) that will confirm the AID case and will assess whether the onset of disease falls within the observation period. Fibromyalgia and psoriasis, for which a high number of cases are expected, will be identified from the electronic administrative data only.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Females between the ages of 9-25 years
      
Keywords: autoimmune diseases; HPV vaccine; papillomavirus; human papillomavirus; HPV
Study to Evaluate the Efficacy of Bite's Natural Deodorant
Condition: Sweat; Underarm Odor
Study type: Interventional

Summary: 
      This is an open-label observational single-arm clinical trial to study the efficacy of a
      commercial deodorant and its effect on odor, clothing (stains), and quality of life. It is
      hypothesized that the deodorant marketed as Bite deodorant will mask bodily odor in
      participants, will not stain clothes, and improve the quality of life in trial participants.
    


Intervention name(s): BITE Deodorant
Intervention type(s): Other
Intervention description(s): BITE natural Deodorant
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Primary purpose: Other
Keywords: sweat; underarm odor; perspiration
Study to Investigate the Safety and Efficacy of 3 Dosing Regimens of ABP-700 for Procedural Sedation in Adult Participants Undergoing Colonoscopy
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase II, two-part, multiple-dose, dose-finding, single-blind study in adult
      participants undergoing elective colonoscopy for screening or diagnostic purposes. This study
      is designed to test various ABP-700 infusion regimens for rational selection of one or more
      dosage regimen(s) to be used for future clinical development of ABP-700 in procedural
      sedation.
    

Detailed description: 
      In Part 1, three ABP-700 two-stage infusion regimens will be evaluated. A sample size of 75
      evaluable participants will be randomly assigned to dose regimens in a 1:1:1 ratio. Following
      the completion of Part 1, a Data Review Committee (DRC) will review the dose-response,
      efficacy, and safety data and provide recommendations on whether to continue the study to
      Part 2 and the number of ABP-700 infusion regimens to be included in Part 2. The Sponsor
      (MDCO) will make the final decision to proceed with Part 2 (whether to conduct Part 2 and
      number of dose regimens if the study continues to Part 2) based on the recommendation from
      the DRC.
    

Intervention name(s): ABP-700
Intervention type(s): Drug
Intervention MeSH terms: Abp-700
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Adult participants; Sedation; elective