bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1 Study of ACE-083 in Healthy Subjects
Condition: Musculoskeletal Diseases
MeSH terms: Musculoskeletal Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of single and multiple doses of ACE-083
      as a local injection into selected skeletal muscles of healthy subjects. The study will also
      determine the amount of ACE-083 that reaches the systemic circulation following local
      administration. Additionally, the study will assess whether local administration into
      skeletal muscle results in an increase in the size and/or strength of the injected muscle.
    

Detailed description: 
      ACE-083 is a molecule that has been shown to increase skeletal muscle mass in animals and,
      therefore, has potential utility in certain diseases that affect skeletal muscle. This
      initial study in healthy human subjects will help determine the properties of ACE-083
      (safety, tolerability, drug absorption and biologic activity), following local administration
      into skeletal muscle, in advance of clinical trials in patients.

      The study will consist of up to 7 planned groups of 8 or 9 subjects each. Subjects in each
      cohort will be randomized to receive either ACE-083 or placebo. ACE-083 (or placebo) will be
      administered locally into the right quadriceps (thigh) muscle or right tibialis anterior
      (lower leg) muscle. Subjects will receive a total of either one dose (on Day 1) or two doses
      (on Day 1 and Day 22). Each dose administered could include up to 4 injections of study drug
      into pre-defined locations in the muscle.

      A Safety Review Team (SRT) will review blinded, preliminary data from each treatment group to
      make recommendations regarding escalation to the next treatment group. Subjects will be
      assessed for safety throughout the treatment and follow-up periods. Follow-up visits will
      occur over 12 weeks following the last dose of study drug.
    

Intervention name(s): ACE-083
Intervention type(s): Drug
Intervention description(s): recombinant fusion protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Outcomes of DFine StabiliT Kyphoplasty in Vertebral Compression Fractures Due to Osteoporosis
Condition: Osteoporosis; Vertebral Fracture
MeSH terms: Osteoporosis; Fractures, Bone; Spinal Fractures; Fractures, Compression; Osteoporotic Fractures
Study type: Observational

Summary: 
      This post-market surveillance research project consists of data collection at specified time
      points using standard questionnaire instruments to compare pain level, mobility and function
      pre and post procedure using the D-Fine StabiliT® Vertebral Augmentation System and StabiliT®
      Bone Cement, an FDA approved product used in the standard treatment of vertebral compression
      fractures.
    

Detailed description: 
      This is a single arm, post market surveillance pilot study of an FDA cleared product, to
      evaluate the procedural and clinical profile of an ultra high viscosity cement vertebral
      augmentation system for the treatment of vertebral compression vertebral fractures due to
      osteoporosis.

      Twenty (20) consenting evaluable adult male and female patients between the ages of 50 and 90
      who meet the inclusion criteria for the study and are treated using the D-Fine StabiliT®
      Vertebral Augmentation System and StabiliT® Bone Cement as part of their standard treatment
      for osteoporotic vertebral compression fractures will be enrolled in the study.

      The participants will be followed after the procedure for 3 months by telephone and/or mailed
      questionnaire by an IRB certified member of the research team. Information collected will
      include the patient's ability to ambulate independently and activity level pre and
      post-treatment, decrease or increase in pain level compared to pre-treatment, and monitoring
      adverse events. Data will be collected at enrollment, procedure, discharge (or 1 day post
      procedure), 1 week, 1 month and 3 months post procedure using the Visual Analog Scale (VAS)
      for pain score, Oswestry Disability Index. Standard of care radiographs and MRI or CT/bone
      scan are evaluated by a board certified radiologist. The data collected will be compared to
      measure outcomes.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients evaluated for vertebral compression fracture in clinic
      
Keywords: StabiliT; Kyphoplasty; Vertebral; Compression; Fracture; Osteoporosis
Text Messaging for Smoking Cessation in College Health Clinics
Condition: Cigarette Smoking
Study type: Interventional

Summary: 
      This study is a randomized-controlled clinical trial which evaluates the efficacy of
      physician brief advice, nicotine replacement therapy and a 6-week course of text messaging in
      promoting cigarette smoking in smokers enrolled in college.

      The primary hypothesis is that smokers receiving physician brief advice, nicotine replacement
      therapy, and text messaging will have higher quit rates that smokers receiving physician
      brief advice and nicotine replacement therapy alone.
    


Intervention name(s): Smoking counseling; Text messaging; Nicotine patch
Intervention type(s): Behavioral; Behavioral; Drug
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cigarette smoking; tobacco use cessation products
Effect of Probiotics Among Overweight and Obese Saudi Adults
Condition: Obesity; Adult
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      Obesity is classified as a low-grade chronic and systemic inflammatory disease and results
      from complicated interactions between genes and environmental factors, which leads to many
      diseases and affects the quality of life. There are growing interests in the effectiveness of
      probiotics as a supplementation to treat obesity through regulating microbiota host
      metabolism. Probiotics may influence the interplays among gut, brain, adipose, and liver in a
      way leading to weight. Since limited studies have been conducted on human subjects, more
      investigation is needed in this field. Therefore, this study sheds light on the investigation
      of the anti-obesity effect of probiotic supplementation.
    

Detailed description: 
      This study expects that the multi-strain probiotic product will induce beneficial changes in
      gut microbiota including reduction in weight, especially the visceral fat, which leads to
      reduction in systemic inflammatory state associated with fat accumulation. In order to
      evaluate the changes, ninety adult Saudi overweight or obese adult will be enrolled in this
      clinical trial and randomized to receive daily placebo or probiotics "MCP® BCMC® strains" for
      12 weeks in a double-blind study. Biochemical markers will be measured through blood samples
      analyzed. Measurements and samples will be obtained at baseline and by the end of the study,
      at 12 weeks of treatment.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): The probiotics sachet contains a granular powder with 6 microorganism strains (30 × 109 CFU/gram): Lactobacillus acidophilus BCMC®12130, Lactobacillus casei subsp BCMC®12313, Lactobacillus lactis BCMC®12451, Bifidobacterium bifidum BCMC®02290, Bifidobacterium infantis BCMC®02129, and Bifidobacterium longum BCMC®02120.
The drug is consumed orally, two sachets per day, by dissolving the sachet content in a glass of room-temperature water, one before breakfast and one before the last meal, for three months length.; Placebo:
Subjects in the placebo group will receive the placebo consisting of only the carrier of the probiotic product, that is maize starch and maltodextrins.
The sachet is consumed orally, two sachets per day, by dissolving the sachet content in a glass of room-temperature water, one before breakfast and one before the last meal, for three months length.
Other intervention name(s): (HEXBIO®) containing MCP® BCMC® strains
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a 12-week, a single center, double-blind, placebo-controlled, randomized, trial, 90 overweight or first-class obese subjects will be divided equally into two groups, a probiotics group, and a placebo group.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
High Density Lipoprotein Subspecies and Coronary Disease
Condition: Cardiovascular Diseases; Coronary Disease; Coronary Arteriosclerosis; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Arteriosclerosis; Myocardial Ischemia
Study type: Observational

Summary: 
      To investigate the relative contributions of high density lipoprotein-C (HDL-C) subspecies to
      risk for coronary heart disease (CHD) in two distinct existing populations (samples from the
      VA-HIT study and the Framingham Offspring Study [FOS]) as well as the response of these
      subfractions to gemfibrozil treatment.
    

Detailed description: 
      BACKGROUND:

      Coronary heart disease (CHD) continues to be a leading cause of death and disability in the
      United States. Information about the contribution of different subspecies of HDL-C to
      increased or decreased risk for premature CHD and the extent to which common lipoprotein
      lipase (LPL) mutations affect HDL-C composition and subspecies could contribute to an
      increased understanding of the role of HDL-C in determining CHD risk.

      DESIGN NARRATIVE:

      The following parameters will be measured in blood samples collected from the VA-HIT study
      and the Framingham Offspring Study: apo A-I-containing HDL subspecies (prebeta, alpha, and
      prealpha) in plasma using two-dimensional gel electrophoresis immunoblot and image analysis,
      LpA-I and LpA-I/A-II in plasma using differential electroimmunoassay, and apo C-III in HDL
      using immunoturbidometric assay. The study hypotheses are as follow. a) Subjects from the
      placebo arm of VA-HIT will have significantly lower alpha l HDL subspecies, LpA-I, and apo
      C-III in HDL, and higher HDL/alpha l and apo A-I/alpha l ratios than subjects free of
      coronary heart disease from the Framingham Offspring Study. b) These parameters will also
      predict prospectively risk of coronary heart disease in both groups. c) In the VA-HIT study,
      treatment with gemfibrozil, which has been shown to be associated with a 22 percent reduction
      in myocardial infarction and coronary heart disease death, will be associated with increases
      in alpha l HDL subspecies, LpA-I, and apo C-III in HDL, as well as decreases in HDL/alpha l
      and apo A-I/alpha l ratios, compared to placebo. d) The hypothesis that subjects with
      specific mutations in the lipoprotein lipase gene have less beneficial changes in HDL
      subspecies with gemfibrozil than subjects with no mutations will also be tested.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        men with CHD and low HDL-C men without CHD
Pharmacological Properties of Salmeterol
Condition: Pharmacokinetics in Healthy Young Men
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to help establish a urinary threshold for salmeterol on the
      World Anti-doping Agency prohibited list, to avoid supratherapeutic of this substance in
      competitive sports.

      Hence, there is no hypothesis as such.
    


Intervention name(s): Salmeterol
Intervention type(s): Drug
Intervention MeSH terms: Salmeterol Xinafoate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: salmeterol; pharmacokinetics; doping; beta2-agonists; long-acting beta2-agonists
Impact of Anti-static Chamber/Mask
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare lung delivery of fluticasone propionate delivered by HFA-pMDI, using a
      conventional polycarbonate of anti-static chamber/mask in a randomized crossover design in
      1-6 year old children.

      Hypothesis: Anti-static chamber/mask would increase the amount of inhaled corticosteroid
      delivered to young children who passively inhale and cannot breath hold.
    

Detailed description: 
      Objective -- to determine whether an anti-static chamber increases the one-hour steady-state
      fluticasone plasma concentration, which is an indirect measure of airway delivery and direct
      measure of systemic exposure. Twelve children 1-6 yrs with well-controlled persistent asthma
      were treated with HFA-FP pMDI, 2 actuations of 110 µg twice daily. The drug was administered
      by conventional polycarbonate or anti-static valved-holding chambers with masks in an
      unblinded, randomized, crossover manner each for at least three days. A blood sample was
      collected one hour after the last dose when adherence documented by electronic monitor was
      100%. FP plasma concentrations were measured by liquid chromatography mass spectrometry
      assay. Results evaluated using regression analysis.
    

Intervention name(s): HFA FP MDI; conventional chamber/mask; anti-static chamber/mask
Intervention type(s): Drug; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fluticasone; asthma therapy; spacer inhaler; HFA-134a
A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-108 in Patients With Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and effectiveness of two concentrations of
      IDP-108 in treating patients with onychomycosis
    


Intervention name(s): Low Strength IDP-108; High Strength IDP-108; High Strength IDP-108 under occlusion; Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical application once a day for 9 months; Topical application once a day for 9 months; Topical application once a day for 9 months; Topical application once a day for 9 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
McKenzie Exercises for Chronic Neck Pain: Stabilization vs. Non-Stabilization
Condition: Neck Pain; Cervical Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      PURPOSE: To compare the effects of mckenzie exercises plus stabilization exercise to those of
      mckenzie exercises alone on disability, pain, range of motion (ROM) in patients with
      nonspecific chronic neck pain (NSCNP).

      BACKGROUND: Little is known about the efficacy of providing mckenzie exercises in addition to
      cervical and scapulothoracic stabilization exercises in people with NSCNP.

      HYPOTHESES We hypothesize that there will be no significant effect of adding stabilization
      exercises to mckenzie exercises than mckenzie exercises alone in patients with NSCNP.

      RESEARCH QUESTION: Is there a statistically significant effect of adding stabilization
      exercises to mckenzie exercises on outcomes of patients with NSCNP?
    


Intervention name(s): Mckenzie exercise for neck; Stabilization exercise
Intervention type(s): Other; Other
Intervention description(s): The McKenzie protocol will be used to manage extension, rotation, and lateral flexion dysfunctions in patients with non-specific neck pain. An experienced physical therapist will perform the protocol 3 times a week for 6 weeks, tailoring exercises to each patient's individual needs based on limited and painful directions of movement. Exercises include retraction, extension, rotation, lateral flexion, and overpressure techniques. Patients will receive education on posture and body mechanics, and exercises will be progressed over time as the patient improves.; Cervical and scapulothoracic stabilization exercises will be performed by an experienced physical therapist 3 times a week for 6 weeks, with each session including a warm-up, stabilization exercises, and cool-down and stretching exercises. Postural education will be provided using mirrors to find a neutral balanced position, and the cervical bracing technique with deep neck flexor activation will be used to stabilize the cervical spine. Upper extremity range of motion exercises and cervical dynamic isometric exercises with elastic resistive bands will also be performed. Scapulothoracic stabilization exercises will include specific exercises for muscles affecting scapular orientation related to neck pain, using latex bands with mild or medium tension.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Acceptability of a Fixed Combination of Fenofibrate and Metformin
Condition: Dyslipidemia/Glucose Metabolism Disorder
MeSH terms: Dyslipidemias; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to assess the acceptability of a 4-week treatment of 4 new
      fixed-dose combinations of fenofibrate and metformin, in patients with type 2 diabetes and
      dyslipidemia.
    


Intervention name(s): fenofibrate and metformin fixed combination (drug)
Intervention type(s): Drug
Intervention MeSH terms: Metformin; Fenofibrate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1

Summary: 
      This project aims to comparing the effectiveness of transcranial direct current stimulation
      with common pharmacological treatments on behavioral problems and cognitive deficits of
      children with autism spectrum disorder
    

Detailed description: 
      45 children with autism spectrum disorder are recruited in Fatemi Hospital at Ardabil
      University of Medical Sciences. The patients will be randomized into 3 Intervention groups of
      15 with tDCS stimulation, risperidone, and placebo medication as the interventions. The study
      will be a randomized double-blind controlled design. The experimenter and the patient are
      blinded and are not aware of the study. Intervention group 1: TDCS intervention protocol
      consists of 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days.
      Anodal electrode will be placed over the F3 and cathodal electrode will be placed over the
      Fp2. They will also receive a placebo tablet (Galenus pharmaceutical company) in each
      stimulation session. Intervention group 2: Participants in this group will receive two daily
      Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days.
      Intervention group 3: Participants in this group undergo 10 daily sessions of sham tDCS
      concurrent with a placebo tablet (Galenus pharmaceutical company) for 10 consecutive days.
    

Intervention name(s): RisperiDONE 1 MG/ML; transcranial direct current stimulation; Placebo; sham transcranial direct current stimulation
Intervention type(s): Drug; Device; Drug; Device
Intervention description(s): Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days; Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days; Patients will receive placebo tablet (Galenus pharmaceutical company); Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days
Other intervention name(s): tDCS
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by
      meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more
      than 60 countries.

      The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY
      vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by
      storage at 2-8ºC.
    


Intervention name(s): MenACWY liquid; MenACWY
Intervention type(s): Biological; Biological
Intervention description(s): At visit 1 (day 1), each subject will receive a single dose of the investigational MenACWY liquid vaccine (GSK3536820A) aged for approximately 24 months in Phase 1 of the study (subjects randomized to study arm ACWY_Liq24) or vaccine aged for 30 months in Phase 2 of the study (subjects randomized to study arm ACWY_Liq30), administered by intramuscular injection in the deltoid of the non-dominant arm.; At visit 1 (day 1), each subject will receive a single dose of the MenACWY vaccine in the Phase1 of the study (subjects randomized to study arm ACWY_1) or in phase 2 of the study (subjects randomized to study arm ACWY_2), administered by intramuscular injection in the deltoid of the non-dominant arm.
Other intervention name(s): Menveo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Meningococcal disease; Liquid formulation; Meningitis