bioihbjkbjnl/mcl2 huggingface dataset:
Enhancing Adaptations to Exercise
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      Researchers are trying to understand how chronic inflammation affects muscle function and
      responses to exercise.They are also trying to determine if suppressing chronic inflammation
      using omega-3 fatty acids (n3-PUFA) restores skeletal muscle function and exercise
      responsiveness in older adults.
    

Detailed description: 
      Participants will be divided into two groups. Men and women between the ages of 20-35 years
      and 65-85 years. Participants in the older age group will be randomly assigned to receive
      groups (n3-PUFA or placebo (soybean oil)) in a double-blind manner. Before and after the
      intervention, all participants will complete an outpatient study day (body composition, blood
      draw, treadmill test, strength test) and an inpatient study day (muscle biopsies, fat
      biopsies, indirect calorimetry, exercise test, mixed meal test). During the intervention
      phase of the study, participants will be instructed to swallow 2 softgels twice per day with
      meals (morning and evening) for a total of 4 softgels per day. Every 4 weeks, participants
      will report to the Clinical Research and Trials Unit (CRTU) to pick up a new prescription and
      return any remaining capsules from the previous prescription. On the day they pick up
      prescription refills, participants will report to the CRTU for a fasting blood sample. The
      duration of the intervention will be 6 months.
    

Intervention name(s): n3-PUFA; Placebo; Biopsy; Body Composition Scan
Intervention type(s): Drug; Drug; Procedure; Diagnostic Test
Intervention description(s): The DHA/EPA softgels will each contain ~465mg of EPA and ~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule will contain SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (~381 mg) and poloxamer 237, NF (~8.8 mg).; Looks exactly like the study drug but contains soybean oil with no active ingredient.; Two muscle biopsies from the upper part of one leg. A small (~1cm) incision will be made through the skin, and a needle will then be used to remove the muscle.; Measure of body fat percentage, skeletal muscle mass, body water, and visceral fat.
Other intervention name(s): DEXA (dual-energy X-ray absorptiometry) scan.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Exercise; muscle function
A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Disease Progression
Study type: Observational

Summary: 
      The purpose of this study is to observe how the inflammatory pathways differ in subjects with
      chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).
    

Detailed description: 
      This is an observational study in adult male and female subjects with COPD to collect blood,
      endobronchial tissues and BAL to investigate the inflammatory genes/pathways associated with
      AECOPD at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable
      disease).
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects referred to the hospital clinic with AECOPD
      
Biospecimen description: 
      Blood, Endobronchial tissues and Bronchoalveolar (BAL) samples
    
Keywords: Chronic Obstructive Pulmonary Disease; COPD; Acute Exacerbation of COPD; AECOPD
Panoramic Presentation and Tolerance Mechanism of Human Endometrium Based on Tiangui Theory
Condition: Endometrium; Senility
Study type: Observational

Summary: 
      Detailed Description:In the process of women's menstrual cycle, there are different
      physiology at different time points in a cycle.

      Change, investigators select women with a menstrual cycle of 28 days and take samples every 3
      days.

      Day 4, Day 7, Day 10, Day 13, Day 16, Day 19, Day 22, Day 25, Day 28 days, a total of 10 time
      points, 20 healthy women were selected, and the transcription, Protein and phosphorylation
      proteomics, systematically integrated analysis; at the same time, 20 subjects were classified
      by age group Divide into 4 groups, 21-year-old group, 28-year-old group, 35-year-old group,
      and 42-year-old group. At the same time, investigators then analyze the differences in the
      receptivity of the endometrium of different ages.

      The experimental design groups are: 21-year-old group, 28-year-old group, 35-year-old group,
      42-year-old group, Each group includes D1 group Vs D4 group Vs D7 group Vs D10 group Vs D13
      group Vs D16 group Vs D19 group Vs D22 group Vs D25 group Vs D28 group; in phosphorylation
      modification omics, different time points are compared with each other, Look for transcripts,
      proteins and phosphorylated proteins that change significantly during the cycle of change.
      Analyze phosphorylation modification An important role for changing proteins and an important
      role for cycle changes.

      The experiment quantified the proteome and protein acylation modification through TMT (Tandem
      Mass Tag), and passed GO, KEGG Pathway, Localization, Functional enrichment analysis, Cluster
      analysis Bioinformatics analysis
    


Intervention name(s): Endometrial biopsy
Intervention type(s): Procedure
Intervention description(s): Subjects need to collect 5ml whole blood (EDTA or heparin anticoagulant) once in the morning on an empty stomach. Endometrial tissue samples were taken during a complete 28-day menstrual cycle, a total of 6 times, and blood was taken to measure the level of gonadal hormones before each sampling.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subject is a healthy woman aged 21/28/35/42/49 years old, BMI=23～25kg/m2, and her
        menstrual cycle is 28+/-1 day (that is, 2-3 days in advance of each month) , And consistent
        for the past 6 consecutive months (no more than 1 day before and after, that is, 27-29
        days), no IUD was placed in the uterine cavity.
Exact CRC Screening Test: Stool Sample Collection Study to Support Assay Validation Testing
Condition: Colorectal Neoplasms; Digestive System Diseases; Colonic Diseases; Colorectal Cancer
MeSH terms: Neoplasms; Colorectal Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases
Study type: Observational

Summary: 
      The objective of this study is to confirm the sensitivity and specificity of a stool DNA test
      for detection of colorectal cancer and pre-cancer.
    

Detailed description: 
      Patients who have recently undergone a colonoscopy that resulted with normal findings will be
      asked to submit a stool sample (s) (at least 30 days AFTER colonoscopy).
    

Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        Patients are at average risk of developing colorectal cancer at the time of their
        colonoscopy and the colonoscopy resulted in normal findings.
      
Biospecimen description: 
      Provide anonymous, clinically characterized specimens for bio-repository for future
      colorectal cancer-related test development.
    
Keywords: Cancer; Colorectal Cancer; Neoplasm; Colorectal Neoplasm; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases
Gene Expression Profiles in Generalized Aggressive Periodontitis: A Gene Network-based Microarray Analysis
Condition: Generalized Aggressive Periodontitis
MeSH terms: Periodontitis; Aggressive Periodontitis; Aggression
Study type: Observational

Summary: 
      In this study, the investigators evaluated molecular biomarkers which play a role in the
      development of generalized aggressive periodontitis (GAgP) using gingival tissue samples
      through omics-based whole-genome transcriptomic while using healthy individuals as background
      controls.
    

Detailed description: 
      Aggressive periodontitis (AgP) is an inflammatory periodontal disease which is complex,
      multifactorial, and destructive. Progression and severity of the disease depend on
      interacting risk factors such as: immunological, microbiological, environmental, and genetic
      factors, as well as age, sex, and race.Some patients are genetically predisposed to AgP; they
      have immunological abnormalities, which are thought to be under genetic control. However,
      high susceptibility for periodontal destruction and the relationship between inflammatory
      changes, and genetic factors remain unclear.

      Gene expression profiling is a powerful means of generating comprehensive genome-level data
      sets on diseases such as cancer, asthma, rheumatoid disorders and periodontitis, and provides
      significant insight information for these diseases. Gene expression profiling may provide an
      evidence for involving genes in the pathogenesis of AgP and generate further information
      other than clinical signs and symptoms of AgP.

      The aim of this study was to identify gene-expression patterns of patients with generalized
      aggressive periodontitis by whole-transcriptome gene-expression analyses.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Aggressive periodontitis patients: The periodontal diagnosis of subjects with GAgP was
        established on the basis of clinical and radiographic criteria and was defined by the 1999
        International World Workshop for a Classification of Periodontal Diseases and
        Conditions.(Lang et al., 1999) Patients were included if they were between 18 and 35 years
        of age and otherwise healthy. The bone loss estimation was radiographically performed in
        each patient for the assessment of the extent and severity of alveolar bone loss.
      
Biospecimen description: 
      Biospecimens were kept for analysis
    
Keywords: generalized aggressive periodontitis; microarray analysis
Modulation of Cognitive Flexibility by Tyrosine Depletion and Transcranial Direct Current Stimulation
Condition: Cognitive Flexibility
Study type: Interventional

Summary: 
      The dorsolateral prefrontal cortex (dlPFC) and dopamine (DA) have been implicated in the
      control of cognitive flexibility. However, while a great deal of what it is know regarding a
      causative relationship between cognitive flexibility and its neuronal underpinning comes from
      animal studies, human data have largely been correlational (i.e. imaging investigations). In
      a recent study, the current research group examined whether putative increases in dopamine
      levels through tyrosine administration and blockage of these by cathodal (i.e. inhibitory)
      transcranial direct current stimulation (tDCS) of the dlPFC could be causally related to
      cognitive flexibility as measured by task switching and reversal learning.

      The next step involves finding a way of lowering dopamine concentrations while anodal (i.e.
      excitatory) stimulation of the dlPFC is applied and cognitive flexibility measured. One
      experimental approach to reduce global DA synthesis and transmission is through acute
      phenylalanine and tyrosine depletion (APTD). This dietary intervention involves the
      administration of an amino-acid mixture lacking in tyrosine and phenylalanine, which can be
      used to selectively lower DA synthesis in humans.
    


Intervention name(s): Sham tDCS and tyrosine depleted drink; Anodal tDCS and tyrosine depleted drink; Sham tDCS and balanced drink; Anodal tDCS and balanced drink
Intervention type(s): Combination Product; Combination Product; Combination Product; Combination Product
Intervention description(s): Transcranial direct current stimulation (sham) of the dlPFC in combination with a tyrosine and phenylalanine free product.; Transcranial direct current stimulation (anodal) of the dlPFC in combination with a tyrosine and phenylalanine free product.; Transcranial direct current stimulation (sham) of the dlPFC in combination with a drink containing both tyrosine and phenylalanine.; Transcranial direct current stimulation (anodal) of the dlPFC in combination with a drink containing both tyrosine and phenylalanine.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Comparison of Immunogenicity and Reactogenicity of INFANRIX™ HEXA and HEXAVAC™ Vaccines as a Primary Vaccination Course
Condition: Hepatitis B; Poliomyelitis; Diphtheria; Acellular Pertussis; Tetanus; Haemophilus Influenzae Type b
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will compare the immunogenicity and the reactogenicity of INFANRIX™ HEXA and
      HEXAVAC™ vaccines in a 3, 5 and 11 - 12 month vaccination schedule.
    


Intervention name(s): DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA); DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)
Intervention type(s): Biological; Biological
Intervention description(s): Three doses administered intramuscularly; Three doses administered intramuscularly
Intervention MeSH terms: Edetic Acid; Vaccines; Pentetic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: HEXAVACTM; InfanrixTM HEXA; DTPa-HBV-IPV-Hib; DTPa-HBV-IPV/Hib
Clinical and Electrophysiological Evaluation of the Effectiveness for Manual Lymphatic Drainage
Condition: Carpal Tunnel Syndrome; Electrophysical Evaluation; Manual Lymphatic Drainage
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      When the other usage areas of the manual lymphatic drainage technique in the literature,
      except for the treatment of lymphedema, were examined recently, it was seen that it was also
      applied in orthopedic and neurological cases in a limited number of studies. The aim of our
      study is to investigate the effectiveness of manual lymphatic drainage on clinical and
      electrophysiological findings in carpal tunnel syndrome
    


Intervention name(s): manual lymphatic drainage (massage); Splint treatment
Intervention type(s): Other; Other
Intervention description(s): Patients will begin treatment with manual lymphatic drainage in the affected extremity. In this context, while the patients are in the supine hook position, lymph drainage will be applied first to the neck and then to the abdomen. After the stimulation of the central lymph nodes, the lymph circulation will be increased by stimulating the axillary lymph nodes of the relevant region. First, the proximal part will be drained and it will be advanced towards the distal. Drainage will be repeated depending on the edema at the distal forearm-wrist level.; The splint routinely given to patients diagnosed with mild to moderate carpal tunnel syndrome will be given to both groups in these patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Respiratory Rate After Cesarean Delivery
Condition: Cesarean Delivery; Neuraxial Opioids
Study type: Observational

Summary: 
      The study proposal summarizes aspects related to respiratory rate in women who undergo spinal
      anesthesia for cesarean delivery who receive or do not receive neuraxial opioids
    

Detailed description: 
      Respiratory monitoring device will be used to count respiratory rate continuously, as opposed
      to the intermittent nursing respiratory rate (RR) counts once per hour. The device counts
      respiration (RR) using a sticker placed by on the neck to detect vibrations made by
      respiration. This overcomes the specific limitation of capnography that requires wearing the
      nasal cannula.

      Prospective, observational study with institutional review board (IRB) approval. Women who
      undergo elective cesarean delivery under neuraxial block receive neuraxial opioids for
      postoperative analgesia.

      Potential study recruits will be approached prior to the cesarean delivery anesthesia
      assessment. Suitable women will be informed that neuraxial morphine is the gold-standard
      analgesia, however many women suffer nausea, vomiting and pruritus (itching) and may prefer
      an alternative analgesic or a lower dose of morphine. All women will receive intrathecal
      fentanyl as an adjuvant to the bupivacaine anesthesia. This fentanyl may also cause pruritus
      however this is limited to the 2-hour duration of the effect of the fentanyl.

      Women will be offered standard neuraxial anesthesia for cesarean delivery (heavy bupivacaine
      10 mg; fentanyl 10-25mic; and low dose intrathecal morphine mic). Alternatively, women will
      be offered an alternative anesthesia option: 1) heavy bupivacaine 10 mg; fentanyl 10-15 mic
      with an ultra-low dose, 50 mic of morphine, or 2) heavy bupivacaine 10 mg; fentanyl 10-25 mic
      without intrathecal morphine + postoperative bilateral quadratus lumborum block (QLB),
      transversus abdominis plane (TAP) or erector spinus block (ESP). For patients who select
      block without intrathecal morphine, the choice of block will depend on anesthesiologist's
      decision.
    

Intervention name(s): Respiratory Monitor
Intervention type(s): Device
Intervention description(s): All women receive a respiratory rate monitor after cesarean delivery. We anticipate that at least 30 women will receive standard dose neuraxial block, and aim to have a cohort of 20-30 women who receive non-standard dose (Group 20 in order to compare respiratory rates.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women undergoing elective cesarean delivery under spinal anesthesia
To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis
Condition: Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Background and Aims: Liver transplantation is the only curative treatment modality for
      decompensated cirrhosis and is limited by donor organ availability and financial resources;
      thus many patients die while awaiting liver transplant. Granulocyte colony stimulating factor
      (GCSF) therapy can mobilize bone marrow stem cells for tissue regeneration, and has been
      shown to benefit patients with liver disease. The investigators evaluated the efficacy of
      GCSF therapy in decompensated cirrhosis in an open labelled randomized control trial.

      Patients and Methods: Consecutive patients with decompensated cirrhosis of mixed etiologies
      were randomized to receive either a 5-day course of GCSF (5 μg/kg/d) plus standard medical
      therapy for 6 months (Group-A); or standard medical therapy alone for 6 months (Group-B). At
      the end of 6 months their survival were compared.
    


Intervention name(s): Granulocyte Colony Stimulating Factor
Intervention type(s): Drug
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity of Fluzone HD,A High Dose Influenza Vaccine, In Children With Cancer or HIV
Condition: HIV; Cancer
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label-study of Fluzone HD, a high-dose form of trivalent, inactivated
      influenza vaccine (TIV), vs. Fluzone, a standard-dose form of TIV. Subjects with cancer or
      HIV will be vaccinated twice with one of the two vaccines and evaluated for development of
      immune responses.
    

Detailed description: 
      The primary objectives of this study are to compare the immune response of Fluzone HD, a
      high-dose, trivalent influenza vaccine (TIV), to Fluzone, a standard-dose TIV, in children
      with cancer and in children with HIV.

      The secondary objectives of this study are to:

        -  Describe the safety and reactogenicity of high-dose and standard-dose TIV.

        -  Compare the immunogenicity induced by 1 dose, compared to 2 doses, of high-dose and
           standard-dose TIV.

        -  Describe the relationship between baseline lymphocyte numbers/function and
           robustness/durability of the immune response.
    

Intervention name(s): Fluzone High Dose Vaccine; Fluzone Standard Dose Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.; Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
Other intervention name(s): Fluzone-HD; Fluzone-SD
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fluzone; Trivalent Influenza Vaccine
An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-arm, open-label study of Rabies Immune Globulin (Human),
      Caprylate/Chromatography Purified (RIG-C), in approximately 12 healthy subjects. The purpose
      of this study is to characterize the rabies virus-specific antibody titer after a single
      intramuscular injection of 20 IU/kg RIG-C and to evaluate the safety and tolerability of
      RIG-C.
    


Intervention name(s): RIG-C
Intervention type(s): Biological
Other intervention name(s): Rabies Immune Globulin (Human), Caprylate/Chromatography Purified
Intervention MeSH terms: Immunoglobulins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rabies; Rabies virus; Rhabdoviridae; Rabies immune globulin; Rabies antibodies; Passive rabies immunization
Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD)
Condition: Dementia; Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and efficacy of two dose
      levels of rasagiline mesylate versus placebo in patients with mild-to-moderate Alzheimer's
      Disease who are taking Aricept.
    


Intervention name(s): Rasagiline
Intervention type(s): Drug
Intervention MeSH terms: Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dementia, Alzheimer's Disease
An Investigational Study of Experimental Medication BMS-986278 Given With the Antibiotic Rifampin in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of experimental medication BMS-986278
      given with the antibiotic Rifampin in healthy participants.
    


Intervention name(s): BMS-986278; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration 30 mg; Oral administration 600 mg
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment