bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Two Exercise Programs on Bone Strength and Architecture
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      Bone responds according to the load placed on it. In this study, investigators want to know
      if exercise that loads the body in exercises, like walking or jogging (Ground Reaction
      Forces: GRF), affects bone differently than exercises that load the joints, like weight
      lifting (Joint Reaction Forces: JRF). Participants will exercise at least 3 times a week for
      6 months. Measures of bone strength and mass, muscular strength, and aerobic fitness will be
      taken at the beginning and the end of the 6 month program. Period blood samples will be taken
      for future analysis of blood markers.
    


Intervention name(s): Ground Reaction Forces; Joint Reaction Forces
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6 month exercise program that loads the body via gravitational forces.; 6 month exercise program that loads the body via loading the joints.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Neutrophilic Asthma Study With Navarixin (MK-7123, SCH 527123) (MK-7123-017)(COMPLETED)
Condition: Neutrophilic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      4-Week Safety Study in Subjects with Neutrophilic Asthma
    

Detailed description: 
      Effect of treatment with navarixin (MK-7123, SCH 527123) on sputum neutrophils and asthma
      symptoms
    

Intervention name(s): Navarixin; Placebo; Rescue medication
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Navarixin 30 mg capsule to be taken by mouth once daily in the morning for 4 weeks.; Placebo capsule to match navarixin to be taken by mouth once daily in the morning for 4 weeks.; Participant choice of short-acting beta-2 agonist (salbutamol/albuterol), anticholinergic, or combination medication as needed for asthma symptoms
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Using a State-wide Initiative to Disseminate Effective Behavioral Weight Loss Strategies: Study 5
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether providing additional intervention support to
      individuals with lower than expected weight loss within the initial stages of an
      internet-based behavioral weight loss program improves weight loss outcomes at Week 12,
      compared to the internet program alone.
    


Intervention name(s): Standard; Early Intervention
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effectiveness of Self-thoracic Spine Mobilization on Improving Sleep Quality in Patients Who Have Shoulder Pain
Condition: Shoulder Pain Chronic
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      This project aims to study the impacts of self-thoracic spine and rib mobilization on sleep
      quality in patients who present to UTSW physicians with shoulder pain. The investigators plan
      to randomize participants into treatment and control groups, but the investigators will
      provide education on sleep hygiene for each group. The treatment group will also receive
      instruction to mobilize their thoracic spine and ribs each night before going to sleep.
    

Detailed description: 
      Subjects with a chief complaint of musculoskeletal pain will be recruited from clinics in the
      Departments of Internal Medicine, Family Medicine, and Orthopedic Surgery. Subjects will be
      randomized into either the intervention or control group. The intervention group will receive
      education on sleep hygiene and instruction to use a foam roller to mobilize the thoracic
      spine and ribs just before the subject goes to sleep. The control group will receive
      education on sleep hygiene. Valid and reliable measures will be used to assess sleep quality
      (Pittsburgh Sleep Quality Index), pain (Numeric Pain Rating Scale), and function (SF-36 and
      ASES), as well as a sleep diary. Measures will be taken at baseline as well as two weeks
      after the subject's enrollment in the study.
    

Intervention name(s): Self-mobilization; Sleep Education
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects will mobilize thoracic spine and ribs with a foam roller every night before going to bed.; Subjects will be educated on sleep hygiene in order to improve likelihood of having good sleep.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
PET Imaging to Delineate Macrophage Activation in Diabetic Gastroparesis
Condition: Diabetes; Gastroparesis With Diabetes Mellitus
MeSH terms: Gastroparesis; Diabetes Mellitus
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Macrophage-driven immune dysregulation has been shown to be involved in pathophysiology of
      diabetic gastroparesis. Currently, there are no non-invasive ways to study macrophage
      activation in humans. The researchers are trying to determine the utility of 11C-ER176 based
      PET-CT scanning to determine pro-inflammatory macrophage activation in gastric wall of
      patients with diabetic gastroparesis.
    


Intervention name(s): PET/CT Scan with 11C-ER176; Core biopsy of gastric muscle
Intervention type(s): Drug; Diagnostic Test
Intervention description(s): Subjects will have a low-dose, non-gated, non-contrast-enhanced, free-breathing CT from the orbits to upper thigh for attenuation correction (CTAC) and anatomic co-localization. Immediately following the start of the PET scan, 518 MBq (14 mCi) (range 370-666 MBq; 10-18 mCi) of 11C-ER 176 will be administered intravenously followed by a saline flush. A whole-body PET scan from the orbits to upper thigh will then be acquired.; The echoendoscope (Aloka Arietta 850; Olympus, Center Valley, PA) will be advanced into the gastric lumen and a site targeted for EUS-guided core biopsies based on findings of the PET scan. Fine needle biopsy of the gastric wall will be performed.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Three groups of patients (diabetic; diabetic gastroparesis; healthy volunteers) will undergo PET-CT. The diabetic gastroparesis group will also undergo gastric muscle biopsy of the involved and uninvolved area to validate immune changes visualized on imaging.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: macrophages, immune cells, gastric emptying, gastroparesis, imaging
Validation of a CREATION Health Assessment Tool for Patients in a Diabetic Outpatient Population
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Participants will complete a survey before an educational session, during the "break" of an
      educational session, or after the session.
    

Detailed description: 
      Participants will be recruited from diabetes education sessions at selected locations and at
      FHMG physician practices. For the diabetes education setting, ta research team member will
      introduce this study to a group of patients before educational sessions, during "break" of
      the educational sessions, and after sessions. If the patient is interested, an envelope with
      the Invitation to Participant letter attached to it and the survey enclosed will be given to
      them. Also, a NOTE will be attached to the envelope with the instructions: "Please drop your
      completed survey in the drop-box at ___." The drop-box location will be identified within
      each setting and provided to the participants in the note or indicated verbally.

      For patients at physician practices, an envelope with the Invitation to Participant letter
      attached to it and survey enclosed will be given by a staff member. Invitation to Participant
      letter contains all portions of the consent process. A NOTE will be attached to the envelope
      with the instructions: "Please drop your completed survey in the drop box at____." The
      drop-box location will be identified within each setting and provided to the participants in
      the note or indicated verbally. If patient does not meet the inclusion criteria, they will be
      asked to return the envelope to the staff member who provided it.

      Patients will be provided with Invitation to Participate letter along with survey. The
      Invitation to Participate letter provides patients with study details including
      inclusion/exclusion criteria, duration of participation, procedures to ensure
      confidentiality, and an overview of voluntary participation conditions. Implied consent will
      be used. In addition to the Invitation to Participate letter, there is a statement at the top
      of the survey "return of completed surveys implies consent to participate in the study"
    

Intervention name(s): CHAT-P
Intervention type(s): Other
Intervention description(s): Survey
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with type 2 diabetes mellitus
      
Keywords: diabetes; type 2 diabetes; diabetes mellitus; type 2 diabetes mellitus; outpatient
Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule
Condition: Hepatitis B; Polio; Diphtheria; Pertussis
MeSH terms: Hepatitis B; Whooping Cough; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is
      non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three
      dose (2-3-4 month) primary series.

      Immunogenicity

        -  To assess pre- and post-primary series

        -  To assess pre- and post-booster series.
    


Intervention name(s): DTaP-IPV-HB-PRP~T vaccine; DTaP-IPV//PRP~T combined; Hepatitis B vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular (IM); 0.5 mL, IM; 0.5 mL, IM
Other intervention name(s): PENTAXIM™; ENGERIX B®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B; Polio; Diphtheria; Pertussis; H influenzae type b
Improving Quality of Life of Fibromyalgia Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Comparison of two treatments of fibromyalgia; the QOL score should improve rather and, twelve
      months after the end of the program, remain higher in "Plurifocal educational group" than in
      control group
    

Detailed description: 
      Comparing two forms of non-drug treatment of fibromyalgia: "Information" (an information
      group session on the fibromyalgia management modalities) versus "Plurifocal educational
      program " (intensive group program of 8 weeks, including, in addition to the briefing,
      measures and exercises for the implementation of the principles of managing fibromyalgia, and
      cognitive-behavioral therapy).
    

Intervention name(s): Plurifocal educational program
Intervention type(s): Behavioral
Intervention description(s): intensive group program of 8 weeks, including, in addition to the briefing, measures and exercises for the implementation of the principles of managing fibromyalgia, and cognitive-behavioral therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Cognitive behavioral; Long-term study; Education
Glycemic Responses of an Innovative Oat Porridge
Condition: Postprandial Glycemic Responses
Study type: Interventional

Summary: 
      The aim of this study is to investigate whether enzymatic modification of starch in a food
      product using amylomaltase induces a lower glycemic response in healthy subjects compared to
      its unmodified counterpart.
    

Detailed description: 
      A single-blind, randomized, cross-over study design will be applied. During each of the two
      study visits, healthy participants will consume an oatmeal porridge. One porridge will be
      treated will amylomaltase to modify the molecular structure of starch while the other
      porridge will serve as a control (unmodified counterpart). Blood glucose measurements will be
      taken postprandially at regular time points.
    

Intervention name(s): Oatmeal porridge
Intervention type(s): Dietary Supplement
Intervention description(s): Investigation of the impact of enzymatic modification of the molecular structure of starch by amylomaltase on the postprandial glycemic responses of an oatmeal porridge.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: enzymatic starch modification; postprandial glycemic responses
Safety and Efficacy of Edoxaban in Thoracoscopic Ablation
Condition: Atrial Fibrillation; Anticoagulants and Bleeding Disorders
MeSH terms: Atrial Fibrillation; Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional

Summary: 
      The aim of this study is to compare the safety and efficacy of edoxaban and warfarin for
      prevention of stroke during a 6-month follow up after total thoracoscopic ablation.
    

Detailed description: 
      In Korea, 5% of patients older than 65 years and 10% of patients older than 80 have a history
      of atrial fibrillation (AF), which is often associated with sudden death and stroke.
      Medication and percutaneous radiofrequency catheter ablation are commonly used treatment
      modalities. Pharmacotherapy is primarily symptomatic treatment; moreover, the effect of
      conversion to a normal rhythm is minimal, and mainly aimed at stabilizing heart rate.
      Catheter ablation is associated with a high incidence of recurrence in chronic AF, and it is
      difficult to treat left atrial appendage, thereby preventing discontinuation of
      anticoagulation therapy post procedure. Thoracoscopic ablation is known to be a less invasive
      and more effective modality to treat patients with chronic atrial fibrillation. However,
      anticoagulation therapy is mandatory in the early postoperative period due to intracardiac
      thromboembolism associated with atrial stunning despite conversion to a sinus rhythm and
      resection of the left atrial appendage. Further investigation would be required to assess the
      efficacy and safety of novel oral anticoagulants such as edoxaban compared to that of
      warfarin for stroke prevention during the early postoperative period (6 months) after a
      thoracoscopic procedure. The need to maintain a constant level of blood coagulation and the
      potential development of complications such as hemorrhages are drawbacks associated with the
      use of warfarin. While novel oral anticoagulants such as edoxaban do have a role in atrial
      fibrillation, data regarding their effectiveness and incidence of complications after
      arrhythmia surgery do not exist. In this study, we will compare warfarin and edoxaban with
      respect to safety and efficacy, after they are used for 6 months following thoracoscopic
      ablation in patients with chronic atrial fibrillation
    

Intervention name(s): Edoxaban; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): oral edoxaban 60mg once daily for 3 months; oral warfarin once daily for 3 months according to prothrombin time
Other intervention name(s): Savaysa; Coumadin
Intervention MeSH terms: Warfarin; Edoxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: atrial fibrillation; thoracoscopic ablation; anticoagulation
Comparing the Effects of Positional Release Technique Versus Myofascial Release Technique of Gluteus Medius
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome
Study type: Interventional

Summary: 
      Patellofemoral pain syndrome is a condition of misleading diagnosis. It mostly affects
      individuals with ages between 18-40 years. It is believed that much work has been done on the
      joint itself in treating the Quadriceps muscles and triggers related to it but now literature
      is focusing on the segmental involvement, where weakness of the hip abductors and lateral
      rotators play a major role. Therefore, interventions used for treating this syndrome should
      include on focusing the hip muscles for trigger point therapy as well as strengthening them
      in increasing the stability of the hip and pelvis to reduce excessive valgus forces on the
      knee.
    

Detailed description: 
      Literature regarding Gluteus Medius trigger point is quite scarce especially in alleviating
      the pain related to Patellofemoral Pain Syndrome. The management of Patellofemoral Pain
      Syndrome includes a segmental treatment, giving special focus to the lateral rotators and
      abductors of the hip especially Gluteus Medius muscle, rather than treating the
      Patellofemoral Joint itself. It will help in improving the pain of the subjects suffering
      from this syndrome effectively, and within a shorter duration of time. It will also provide
      the practicing physiotherapist with an insight for treating such patients with better
      outcomes. Myofascial Trigger Points of the Gluteus Medius are important contributing factors
      in the management of Patellofemoral Pain Syndrome which is identified in a single study as
      per author's knowledge. But the treatment used to release the trigger point of Gluteus Medius
      in managing this syndrome has not yet been explored. So, this study will compare two
      well-known treatments in comprehending which one of the two techniques have better effects on
      the population to be studied. Written consent will be taken from all the study participants.
      Simple randomization technique will be used through "Randomization Main" software and
      randomization sheet will be generated. 60 participants with patellofemoral pain syndrome
      having Gluteus Medius trigger point will be randomly allocated in two equal group.
    

Intervention name(s): Physiotherapy
Intervention type(s): Other
Intervention description(s): Treatment will be given in 3 sessions per week for 6 weeks with home exercise program and participants will be provided with exercises sheets to remember the exercises.
The selected outcome measure will be taken on baseline (initial visit) and 6th week (post intervention)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anterior knee pain; Gluteus medius; trigger point therapy
The Effects of Extraoral Photobiomodulation on the Rate of Orthodontic Alignment
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The aim of this study is to determine if extraoral OrthoPulse®, which emits extraoral LED
      (Light Emitting Diode) photobiomodulation (PBM), reduces the time it takes to complete
      orthodontic alignment.
    


Intervention name(s): Extraoral OrthoPulse® PBM; Fixed Orthodontic Appliance Treatment
Intervention type(s): Device; Other
Intervention description(s): Patients carry out daily extraoral OrthoPulse® PBM treatments at home.; Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alignment phase; Photobiomodulation; Orthodontic treatment; Malocclusion; OrthoPulse™
Energetics and Function in Older Humans
Condition: Aging; Erythrocyte Glutathione Deficiency; Muscle Weakness
MeSH terms: Muscle Weakness
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators have previously reported that older patients with HIV are deficient in
      glutathione (GSH) due to decreased availability of cysteine and glycine, and that oral
      supplementation with cysteine (as n-acetylcysteine) and glycine for 2-weeks corrects their
      own levels, and improves concentrations of red-cell GSH. The investigators also found that
      when GSH deficient, subjects had impaired mitochondrial energetics and this improved with an
      increase in intracellular GSH concentrations. The current proposal will investigate if
      cysteine and glycine supplementation for a duration of 24 weeks will result in changes in :
      (a) GSH levels; (b) body composition/anthropometry; (c) strength and function; (d) quality of
      life; (e) mitochondrial energetics; (f) biochemistry (including dyslipidemia and oxidative
      stress); (g) protein and glucose metabolism; (h) cognition and memory. 3 months after
      completing supplementation, measurement of GSH concentrations, strength, function,
      mitochondrial energetics and neurocognitive tests will be done to determine the effects of
      washout.
    

Detailed description: 
      Data not available at present
    

Intervention name(s): Cysteine (as n-acetylcysteine) and Glycine
Intervention type(s): Dietary Supplement
Intervention description(s): Older subjects will be studied before and after receiving cysteine and glycine
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine; Glycine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pos -Extubation High Flow Nasal Cannula
Condition: Respiratory Insufficiency
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      comparing high flow nasal cannula & conventional oxygen tharapy in post-extubation period for
      patients mechanically ventilated due to respiratory failure regarding re-intubation rate, ICU
      outcome &28 days mortality
    

Detailed description: 
      patients with respiratory failure either type I or type II planned for extubation will be
      divided into 2 groups post extubation :

      Group I: will receive high flow nasal cannula giving oxygen 60 litres / minute group II: will
      receive nasal cannula up to 10 litres / minute

      Data of the patients will be collected for 28 days postextubation and analysed
    

Intervention name(s): High flow nasal cannula
Intervention type(s): Device
Intervention description(s): Device gives high flow oxygen comparable to non invasive ventilation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention