bioihbjkbjnl/mcl2 huggingface dataset:
Soluble Corn Fiber on BMD in Pre-pubertal Boys and Girls (PREBONE-Kids)
Condition: Bone Health
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of soluble corn fiber (SCF) on bone
      mineral content (BMC) and bone mineral density (BMD) in pre-pubertal boys and girls. The
      hypothesis to be tested is: SCF will lead to greater increase of BMD, as measured with
      densitometry in both low calcium as well as high calcium intakes compared to placebo.
    

Detailed description: 
      Main objective To investigate the effects of soluble corn fiber (SCF) supplementation on bone
      mineral content (BMC) and bone mineral density (BMD) in pre-pubertal boys and girls.

      Secondary objectives

      The secondary objectives are:

      To investigate changes in bone formation and bone resorption markers in response to soluble
      corn fiber supplementation in the diet of prepubertal boys and girls consuming adequate
      calcium intake vs placebo To investigate changes in body composition in response to soluble
      corn fiber supplementation in the diet of prepubertal boys and girls consuming adequate
      calcium intake vs placebo

      Hypothesis Soluble corn fiber would lead to improved BMC and BMD accrual in pre-pubertal
      children compared to placebo.

      Study design The proposed study is a double blind, randomized, single center, parallel design
      trial

      Duration of study The duration of the study intervention would be 12 months
    

Intervention name(s): Usual intake + placebo fruit juice; Usual intake+SCF fruit juice; Adequate calcium + placebo fruit juice; Adequate calcium+ SCF fruit juice
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will consume 200 mls of placebo fruit flavoured juice; Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF); Participants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI; Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF) added with 600 mg calcium to meet RNI
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
RCT of Non-Invasive Vagus Nerve Stimulation (nVNS) With gammaCore®, for the Acute Treatment of Migraine Attacks
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      This study is a prospective, multi-centre, randomised, double-blind, sham-controlled
      investigation designed for comparison of two parallel treatment groups: gammaCore (active
      nVNS treatment) and a Sham device (control treatment), for the acute treatment of migraine
      attacks
    

Detailed description: 
      Period 1: 4-week observational run-in period; no stimulation treatment. Subjects use standard
      of care (SoC) medication to treat their migraine attacks, according to their individual
      prescriptions.

      Period 2: 4-week randomized/controlled period. After the run-in period, subjects are
      randomized (1:1) to receive either an nVNS device or a sham device to treat up to 5 migraine
      attacks.

      Period 3: 4-week open-label (active treatment) period. After the randomized period, subjects
      continue to the open-label period where all subjects receive an active gammaCore device to
      treat up to 5 migraine attacks.
    

Intervention name(s): gammaCore-S; gammaCore-S Sham
Intervention type(s): Device; Device
Intervention description(s): At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication.; At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication.
Other intervention name(s): nVNS; sham nVNS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Non-invasive vagus nerve stimulation; Vagus nerve stimulation; Vagal nerve stimulation; gammaCore; episodic migraine
US-guided Percutaneous Electrolysis (EPE®) in Shoulder Pain
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Scientific evidence of conservative management of subacromial pain syndrome is conflicting.
      There is evidence that eccentric exercise programs are effective at medium term for this pain
      condition. The inclusion of other therapeutic modalities is still controversial. A recent
      study suggests that the inclusion of US-guided percutaneous electrolysis combined with
      eccentric exercises can be effective at short-term for this condition. The objective of this
      randomized clinical trial is to determine the effectiveness at short- and long-term of the
      inclusion of US-guided percutaneous electrolysis (EPE®) into a eccentric exercise protocol
      for the management of patients with subacromial pain syndrome for pain, function, disability
      and pressure pain sensitivity.
    


Intervention name(s): US-guided percutaneous electrolysis; Eccentric exercise
Intervention type(s): Other; Other
Intervention description(s): US-guided percutaneous electrolysis consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the supraspinatus tendon.; An eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles will be learned by the patients allocated to this group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subacromial pain syndrome; Eccentric exercise; Pressure pain; US-guided percutaneous electrolysis
The Effect of BMS-986142 on the Pharmacokinetics of a Combined Oral Contraceptive (OC) Containing Ethinyl Estradiol (EE) and Norethindrone Acetate (NET) in Healthy Female Subjects
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, 2-cycle, multiple-dose, single-sequence study in women of
      child-bearing potential. The primary objective is to assess the effect of BMS-986142 on the
      pharmacokinetics (PK) of Combined Oral Contraceptive Containing Ethinyl Estradiol and
      Norethindrone Acetate.
    


Intervention name(s): OC containing EE and NET; BMS-986142
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid
The Effect of Acipimox on GLP (Glucagon-like Peptide)-1 Secretion
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Glucagon like peptide 1 is produced in enteroendocrine L cells in the small intestine
      stimulated by peroral food intake. GLP-1 induces insulin secretion, and analogues are used in
      the treatment of DM2 (type 2 diabetes mellitus). Recently it was found, that levels of GLP-1
      are increased in response to acipimox. The hypothesis is that G protein coupled receptors on
      enteroendocrine L cells bind acipimox and thereby induce GLP-1 secretion.

      In a controlled, open, randomized experiment, eight healthy, overweight men will be studied
      on an intervention day, where they receive acipimox, and on a control day. The study day
      includes an OGTT (oral glucose tolerance test), blood samples before and after the OGTT and a
      biopsy from adipose tissue.
    


Intervention name(s): Acipimox
Intervention type(s): Drug
Intervention description(s): P.o. administration of 250 mg acipimox
Other intervention name(s): Olbetam
Intervention MeSH terms: Acipimox
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Acipimox; GLP-1; Insulin secretion
The Lipid Profile of the Skin Surface in Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the differences in the skin lipid profile of
      patients with and without acne. Secondly, the goal is to learn more about what the effects of
      retinoinds (topical and systemic) are on the the skin lipid profile. We hypothesize that the
      skin lipid profile of subjects with acne will be lower in inflammatory lipids in comparison
      to subjects without acne.
    

Detailed description: 
      Skin lipid profile will be conducted via sebutapes- adhesive tapes that painlessly absorbs
      sebum from the face. These tapes will be placed on the face for 1 hour. A photograph of the
      face will be taken during each study visit. A sebumeter will also be used to measure skin
      sebum secretion rate.
    

Intervention name(s): Tretinoin or Adapalene; Isotretinoin
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will apply a pea sized amount of topical retinoid cream once daily at night for 30 days. Subjects will return for a follow-up visit.; Subjects will take one pill once daily for 5 months. Subjects will return after 1 month and after 4-5 months of treatment for skin lipid profiling.
Other intervention name(s): Retin A; Accutane
Intervention MeSH terms: Adapalene; Tretinoin; Isotretinoin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be from the UC Davis Dermatology Clinic, surrounding dermatology clinics,
        from the UC Davis undergraduate campus, and from the California State University Sacramento
        campus.
      
Biospecimen description: 
      Sebum collections from sebutapes
    
Keywords: acne; lipid; tretinoin; isotretinoin
Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether an occlusive antimicrobial barrier dressing
      or portable negative pressure wound dressing is superior in preventing wound complications
      and infection rates in obese patients undergoing total joint arthroplasty (TJA).
      Approximately 240 subjects (120 for total knee arthroplasty and 120 for total hip
      arthroplasty) will be enrolled to evaluate the outcomes associated with silver impregnated
      dressings and negative pressure wound therapy (NPWT) in treating this subset of patients and
      analyze the cost benefit of each.
    


Intervention name(s): Antimicrobial Barrier Dressing; Negative Pressure Wound Therapy (NPWT)
Intervention type(s): Combination Product; Device
Intervention description(s): Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver.; PICO provides suction known as negative Pressure wound Therapy (NPWT) which draws out excess fluid from a wound and protects the injured area from getting dirty to ultimately help promote healing. PICO consists of an nPwT pump connected to an absorbent gentle adhesive dressing
Other intervention name(s): AQUACEL Ag Hydrofiber Dressing; PICO
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, open-labelled, prospective 96-week study comparing the antiviral
      efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining
      lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine
      monotherapy.
    

Detailed description: 
      Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than
      Lamivudine in nucleoside-naïve CHB patients. The prompt switch from Lamivudine to Entecavir
      in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL by PCR)
      may lead to full viral suppression to undetectable level by PCR method. The prompt switch
      from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression
      (HBV DNA ≥ 60 IU/mL) may preclude development of drug resistance. The results of this study
      will provide a rationale for switch treatment from one antiviral to another one, especially
      from LAM to ETV.
    

Intervention name(s): Entecavir; Lamivudine
Intervention type(s): Drug; Drug
Intervention description(s): entecavir 1.0 mg QD; lamivudine 100 mg QD
Other intervention name(s): Baraclude 1.0mg; Zeffix 100mg
Intervention MeSH terms: Lamivudine; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis B; Lamivudine; Entecavir
Comparison of a Needle-free Injection Method With a Needle-syringe Injection Method
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to obtain psychological response and user preference information
      on the use of the T jet® device versus the traditional subcutaneous injection administration
      of Tev Tropin®.

      This study will compare subject-reported injection anxiety immediately before the
      administration of each dose of Tev-Tropin® between a needle-syringe injection method and a
      needle-free injection method (T-jet®)
    

Detailed description: 
      The primary efficacy endpoint was the difference in mean subject-reported injection anxiety
      between the two injection methods as recorded on a 5-point FIS immediately before
      administration. A higher score denoted greater anxiety.

      The injection anxiety score was to be reported by the subject from a row of five faces with
      values ranging from 5 (the face with the most negative affect) to 1 (the face with the most
      positive affect).
    

Intervention name(s): T-jet® containing TevTropin®; TevTropin® needle-syringe injection method
Intervention type(s): Device; Procedure
Intervention description(s): Needle-free delivery method for 14 days before cross-over to other arm; comparison of delivery methods for 14 days before cross-over to other arm
Other intervention name(s): T-jet®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Extracellular Vesicle Infusion Treatment for COVID-19 Associated ARDS
Condition: COVID-19; ARDS
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of intravenous administration of bone marrow derived
      extracellular vesicles, ExoFlo, versus placebo as treatment for moderate-to-severe Acute
      Respiratory Distress Syndrome (ARDS) in patients with severe COVID-19.
    

Detailed description: 
      This is a Phase II, double-blinded, placebo-controlled, randomized controlled trial that
      enrolled 102 subjects that were admitted with COVID-19 associated moderate-to-severe ARDS
      across 6 sites in the United States.
    

Intervention name(s): ExoFlo; Intravenous normal saline
Intervention type(s): Biological; Other
Intervention description(s): Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-center, double-blinded, placebo-controlled, randomized controlled trial.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COVID-19; ARDS; Extracellular Vesicles; Exosome
Efficacy of DNK333 in Patients With COPD and Cough
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the efficacy and safety of two weeks treatment of DNK333 in patients
      with COPD and cough.
    


Intervention name(s): DNK333 100 mg twice daily; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic obstructive pulmonary disease; Cough; DNK333
Establish Tolerance In MS With Peptide-Coupled, Peripheral Blood Mononuclear Cells
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Open-label, single center, phase I clinical trial to assess the safety, tolerability and
      preliminary efficacy and in vivo mechanisms of action of i.v. administration of autologous
      peripheral blood mononuclear cell (PBMC) chemically coupled with a cocktail containing seven
      immunodominant myelin peptides to which T cell responses are demonstrable in early RR MS
      patients.
    

Detailed description: 
      Open-label, single center, phase I dose-escalation study to assess the safety, tolerability
      and preliminary efficacy and in vivo mechanisms of action of a single infusion of autologous
      peripheral blood mononuclear cells chemically coupled with seven myelin peptides (MOG1-20,
      MOG35-55, MBP13-32, MBP83-99, MBP111-129, MBP146-170, and PLP139-154) in Multiple Sclerosis
      patients who were off-treatment for standard therapies. Neurological, magnetic resonance
      imaging, laboratory, and immunological examinations were performed to assess the safety,
      tolerability, and in vivo mechanisms of action of this regimen.
    

Intervention name(s): ETIMS
Intervention type(s): Biological
Intervention description(s): injection of peptide-coupled PBMC by i.v. infusion
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Approach to Predict Steroid Sensitivity in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Inhaled corticosteroids are widely used as the primary therapy for asthma, which affects
      approximately 20 million people in the United States. While many patients respond to
      corticosteroid therapy, as many as 25-30% of patients with severe asthma have asthma that is
      difficult to treat or steroid insensitive. Predictive biomarkers for the rapid identification
      of patients with asthma who will achieve adequate control of their symptoms with inhaled
      corticosteroids has the potential to significantly improve asthma management. This proposal
      is based on the hypothesis that alterations in gene expression in epithelial cells of the
      buccal mucosa can be used as a reliable biomarker to predict corticosteroid response in
      patients with asthma. The goals of this proposal will determine if gene expression in
      epithelial cells of the buccal mucosa from patients with asthma is in concordance with gene
      expression profiles that have been identified through more invasive sampling techniques of
      the airway epithelium of asthma patients. The Specific Aims of this proposal are to 1)
      investigate the level of variability in gene expression of a subset of inflammatory markers
      in buccal epithelium from adult patients with asthma. Aim 1 will be carried out by collecting
      buccal samples from three cohorts of subjects (18-55 years of age) from the Pulmonology and
      Allergy Clinics at Truman Medical Center during regularly scheduled outpatient visits as
      follows: 1) healthy control adult subjects (n=10), 2) patients with asthma treated only with
      a short-acting beta2-agonist (SABA, n=10), and 3) patients with asthma treated with low-dose
      ICS (n=10). Relative gene expression of inflammatory markers will be determined using
      quantitative RT (reverse transcription)-PCR and variability in gene expression will be
      determined within and between the three cohorts. Data from the pilot studies described in
      this proposal will aid in the determination of appropriate study population sizes for future
      investigations with the long-term objective to use changes in gene expression (in buccal
      epithelial cells) as a dynamic biomarker for determining corticosteroid response in patients
      with asthma.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients of the allergy and asthma clinics
      
Biospecimen description: 
      Whole blood, DNA, RNA
    
Keywords: inhaled corticosteroids
Effect on Dynamic Postural Stability After Application of Cryotherapy to the Knee Joint
Condition: Cryotherapy Effect; Balance; Disorder, Fluid
Study type: Interventional

Summary: 
      The purpose of this study will determine the effect of cryotherapy applied to the knee joint
      on static and dynamic standing balance. It is hypothesized that there will be no change in
      dynamic postural stability after cryotherapy application.Twenty four individuals (age 18 to
      30) participated in the study. They will be randomly divided into two groups, experimental
      and control group. Each participant, in the experimental group will be asked to perform star
      excursion balance test (SEBT) under two conditions, before and after the application of
      cryotherapy. The participants will receive ice pack wrapping of the knee for 10 minutes. The
      control group performed SEBT at room temperature in an interval of 10 minutes. The two group
      will be analysed and compared
    

Detailed description: 
      The cooling procedure for the knee joint was initiated by using a cryopack or cold-pack. On
      completion of the initial SEBT, the participant lied supine and the investigator applied the
      cryotherapy for 10 minutes. After the 10 minute period of cryotherapy, the cryopack was
      removed, and the participants performed SEBT for the second time.
    

Intervention name(s): Cryotherapy
Intervention type(s): Procedure
Intervention description(s): The cooling procedure for the knee joint will be initiated by using a cryopack or cold-pack. On completion of the initial SEBT, the participant will lie supine and the investigator will apply the cryotherapy for 10 minutes. After the 10 minute period of cryotherapy, the cryopack will be removed, and the participants will perform SEBT for the second time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: balance; college students; star excursion balance test