bioihbjkbjnl/mcl2 huggingface dataset:
Femoral and Epidural Block After Total Knee Arthroplasty
Condition: Acute Postoperative Pain; Chronic Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Total knee prosthetic replacement causes severe postoperative pain. Various analgesic
      techniques have been used in pain control. Comparison of epidural and femoral nerve block is
      lacking, furthermore effect on chronic pain is unclear. The investigators aimed to compare
      the effects of epidural and femoral block on acute and chronic postoperative pain.
    

Detailed description: 
      Background and aim Total knee prosthetic replacement causes severe postoperative pain.
      Various analgesic techniques have been used in pain control. Comparison of epidural and
      femoral nerve block is lacking, furthermore effect on chronic pain is unclear. The
      investigators aimed to compare the effects of epidural and femoral block on acute and chronic
      postoperative pain.

      Methods The study was of randomized, prospective, and double-blind design and was conducted
      with 80 patients who had undergone total knee prosthetic replacement surgery with the
      insertion of a femoral nerve block or epidural block catheter to initiate postoperative
      analgesia. One-sided spinal anesthesia was performed in all the patients. Postoperative pain
      control was achieved with the administration via catheter using bupivacaine for
      patient-controlled analgesia. Acute postoperative pain was evaluated in the first 24 hours
      and chronic postoperative pain in the 1st and 3rd months following surgery. The
      anxiety/depression scale was used to assess anxiety and depression, the SF 12 test was used
      to evaluate quality of life, and the DN4 test was employed at patient visits at the 1st and
      3rd months.
    

Intervention name(s): DN4 test; The SF 12 test; HAD scale; Visual analogue score; femoral block; epidural block
Intervention type(s): Other; Other; Other; Other; Procedure; Procedure
Intervention description(s): The DN4 test was used to evaluate neuropathic pain.; The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.; The anxiety/depression scale (HAD) was used to assess anxiety and depression.; Visual analogue score vas used to evaluate pain.
Other intervention name(s): SHORT FORM 12; The anxiety/depression scale; VAS score
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: chronic postoperative pain; total knee arthroplasty; femoral block; We aimed to compare the effects of epidural and femoral block on acute and chronic postoperative pain.
Effects of Low-Dose Doxycycline on Oral Bone Loss
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this clinical trial is to determine whether low-dose doxycycline can
      reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis and
      not on hormone replacement therapy (i.e., estrogen deficient).
    

Detailed description: 
      The primary purpose of this clinical trial is to determine whether low-dose doxycycline (LDD)
      can reduce alveolar bone density loss in postmenopausal osteopenic women with periodontitis
      and not on hormone replacement therapy (i.e., estrogen deficient). The effects of LDD on
      alveolar bone height loss, progressive periodontal attachment loss, systemic bone mineral
      density, gingival crevicular fluid biochemical markers of collagen degradation and bone
      resorption and serum biomarkers of bone formation, bone resorption and inflammation also will
      be assessed. In addition, another objective is to determine if the microbial effects obtained
      with LDD over two years are equivalent to a placebo control. This clinical trial involves two
      clinical sites: the University of Nebraska Medical Center College of Dentistry and Stony
      Brook University School of Dental Medicine. A total of 128 postmenopausal osteopenic women
      with periodontitis between the ages of 45 and 70 at the time of telephone screening will be
      randomized to LDD or placebo groups and subjects will be followed for two years.
    

Intervention name(s): 20 mg doxycycline hyclate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects in the LDD group took 20 mg doxycycline hyclate tablets twice daily for two years; Subjects in the placebo group took a placebo look-alike twice daily for two years.
Other intervention name(s): antibiotic; sugar pill
Intervention MeSH terms: Anti-Bacterial Agents; Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontitis, metabolic bone diseases, doxycycline
A Comparison of Collagen, Lidocaine and Saline, in Trigger Points in Masseter Muscle.
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      An intramusclular injection of three solutions were performed( collagen, lidocaine, saline)
      in musculoskeletal trigger points, in patients suffering from temporomandibular
      disorders(TMD). Best results were observed in collagen group: reduction of 59,2% sEMG
      activity of masseter muscles and 53,75% reduction of pain intensity in VAS scale.
    

Detailed description: 
      Collagen is an important component, building myocytes and extracellular matrix of skeletal
      muscles. The novel treatment option for trigger point therapy and muscle regeneration in TMD
      patients are intramuscular collagen injections. The aim of the study was to evaluate the
      efficacy of intramuscular injections of Collagen MD Muscle(Guna) 2 ml, 2 ml of Lidocainum 2%
      without vasoconstrictor and 2 ml of Saline (0,9 % NaCl). 43 patients were enrolled to the
      study (17 male and 26 female, 40 +/- 3,8 years old). The masseter muscle activity was
      measured with sEMG Neurobit Optima 4 (Neurobit System). Visual Analogue Scale was used to
      determine pain intensity changes between follow-up visits in each group. Trigger points were
      localized with palpation of masseter muscle. Electromyographic activity of masseter muscle
      was measured before injections on each visit: 0, 7,14 days. In our analysis sEMG masseter
      muscle activity was significantly decreased: in collagen group 59,2%, in lidocainum group
      39,3% and in saline group14%. Pain intensity reduction in VAS scale was 53,75% in collagen
      group, in lidocainum group 25% and in saline group 20,1%.
    

Intervention name(s): MD Muscle GUNA collagen; Lidocaine 2% Injectable Solution; Saline Solution, Hypertonic
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intramusclular injections of MD Muscle collagen; intramuscular Lidocaine 2% injection; intramuscular Saline injection
Other intervention name(s): intramuscular MD Muscle collagen injection; intramuscular Lidocaine 2% injection; intramuscular Saline injection
Intervention MeSH terms: Lidocaine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: patients were divided into the three groups and examination and therapy was performed after 7 and 14 days
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: TMD, collagen, intramuscular injection, trigger point
Oxidative Stress in Chronic Kidney Disease: Diet and Exercise
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The central aim of this study is to improve understanding of how metabolic pathways that
      contribute to adiposity also amplify risks of kidney disease progression and cardiovascular
      disease in subjects with moderate to severe CKD. In order to achieve this goal, we propose
      the following aims through a randomized 2x2 factorial design trial in subjects with moderate
      to severe CKD: (a) To assess the feasibility of implementing aerobic exercise and caloric
      restriction interventions, and (b) To examine the effects of aerobic exercise and caloric
      restriction on a metabolic risk profile, including systemic measures of oxidative stress,
      inflammation, insulin resistance, and endothelial dysfunction.

      Hypothesis: We hypothesize that implementation of caloric restriction and aerobic exercise is
      feasible and can improve the metabolic milieu (as assessed by measures of oxidative stress,
      inflammation, insulin resistance, and endothelial dysfunction) in subjects with moderate to
      severe CKD.

      Interim analysis may be performed (no specific plan at this time).
    


Intervention name(s): caloric restriction; aerobic exercise
Intervention type(s): Other; Other
Intervention description(s): 10 to 15% reduction in total daily calories (300 to 500 kcal reduction) from the usual daily energy consumption for 4 months duration; supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Comparison of the Analgesic Efficacy and Hemodynamic Effects of Paravertebral Block Compared With Paravertebral and Intercostal Nerve Block for Thoracotomy in Adults.
Condition: Pain, Postoperative; Nerve Block; Thoracotomy
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Thoracotomy is a surgical procedure associated with severe post operative pain during the
      first day of surgery and is responsible for prolonged hospital stay, patient dissatisfaction
      and delayed return to normal activities along with increased morbidity and mortality.
      Investigators intend to compare the efficacy of two analgesic interventions (continuous
      infusion of paravertebral block (PVB) after loading dose compared with intercostal nerve
      block and continuous infusion of PVB without loading dose) on postoperative thoracotomy pain.
      The results of this study will direct the investigators to find the best practice methods
      which will reduce the postoperative thoracotomy pain, the overall cost of pain management and
      length of patient's hospital stay.
    

Detailed description: 
      Objective To compare the safety, efficacy for pain relief and hemodynamic changes of two
      analgesic interventions(continuous infusion of Paravertebral block (PVB) after loading dose
      compared with intercostal nerve block and continuous infusion of PVB without loading dose)
    

Intervention name(s): Paravertebral block/Intercostal Block (PVB/ICB) group; Paravertebral Block (PVB) group
Intervention type(s): Procedure; Procedure
Intervention description(s): A paravertebral catheter will be placed by surgeon into pleural cavity and will not be loaded with bolus dose. At the end of surgery the (consultant anaesthesiologist) will perform intrathoracic unilateral intercostal nerve block two level above and two level below and at site of incision with 4 ml per level of 0.25 % bupivacaine followed by continuous infusion with 0.25 % bupivacaine at 6-8 ml/hour through catheter placed in paravertebral space.; A paravertebral catheter will be placed by the surgeon before closure of thoracotomy wound. The catheter will be introduced percutaneously through 18 gauge needle into the pleural cavity. The tip of catheter will be loaded by anaesthesiologist with 0.25 % isobaric bupivacaine with 20 ml followed by continuous infusion with bupivacaine 0.25 % at 6-8 ml per hour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Multiple Sclerosis and Progressive Resistance Training
Condition: Multiple Sclerosis (Relapsing Remitting)
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate underlying mechanisms possibly explaining the
      beneficial effects of progressive resistance training for people with multiple sclerosis.
    

Detailed description: 
      Exercise in general, and progressive resistance training (PRT) in particular, is regarded as
      an important tool in the rehabilitation of people with multiple sclerosis (MS).

      Previous studies have reported positive effects of PRT on muscle strength, functional
      capacity, fatigue and quality of life. Also, a possible disease modifying effect has been
      proposed. However, the underlying physiological mechanisms that might explain these
      beneficial effects and the possible effects on disease progression are unresolved.
      Additionally, none of the previous studies has been concerned with the possible impact of MS
      progression type, gender and/or medication.

      The purpose of this randomized, controlled, gender stratified trial is to investigate
      underlying mechanisms possibly explaining the beneficial effects of progressive resistance
      training for people with multiple sclerosis.
    

Intervention name(s): Training
Intervention type(s): Behavioral
Intervention description(s): Bi-weekly progressive resistance training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Resistance Training; Strength Training
The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.
Condition: Childhood Obesity; Body Composition; Resistance Training; Insulin Resistance
MeSH terms: Insulin Resistance; Pediatric Obesity
Study type: Interventional

Summary: 
      Impact of resistance training in prepubertal children with obesity focusing mostly in changes
      in body composition and markers of insulin resistance.

      Hypothesis is that this will show positive changes in this randomized controlled trial.
    

Detailed description: 
      24 obese prepubertal obese children randomized to either resistance training program or usual
      care for 12 weeks. Baseline blood profiles and DEXA scans done before and after 12 weeks of
      training with the help of kinesiology graduates from Concordia University kinesiology
      department.
    

Intervention name(s): resistance training
Intervention type(s): Behavioral
Intervention description(s): 2 times a week resistance training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Resistance; Training; Obesity; Children
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis (UC)
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy and safety of upadacitinib compared
      to placebo in inducing clinical remission (per Adapted Mayo score) in participants with
      moderately to severely active ulcerative colitis (UC).
    

Detailed description: 
      Study M14-675 consists of 2 parts, Part 1 and Part 2. Part 1 is a randomized, double-blind,
      placebo-controlled 8-week induction period. Part 2 is an open-label, 8-week extended
      treatment period for participants who did not achieve clinical response at Week 8 in Part 1.

      Eligible participants are randomized in a 2:1 ratio to one of the two treatment groups
      (upadacitinib 45 mg or matching placebo) for 8 weeks. The randomization is stratified by
      biologic inadequate responder (bio-IR) status (bio-IR vs non-bio-IR), corticosteroid use (yes
      or no), and Adapted Mayo score (≤ 7 or > 7) at Baseline. Within bio-IR, the randomization is
      further stratified by number of prior biologic treatments (≤ 1 or > 1). Within non-bio-IR,
      the randomization is further stratified by previous biologic use (yes or no).

      Participants who achieve clinical response defined by Adapted Mayo Score at Week 8 or Week 16
      and do not meet any study discontinuation criteria are eligible to enroll into Study M14-234
      Substudy 3 (NCT02819635; 52-week maintenance study) or Study M14-533 Cohort 1 (NCT03006068;
      long-term follow-up study).
    

Intervention name(s): Placebo; Upadacitinib
Intervention type(s): Drug; Drug
Intervention description(s): Tablet for oral administration; Tablet for oral administration
Other intervention name(s): ABT-494; RINVOQ®
Intervention MeSH terms: Upadacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Upadacitinib; ABT-494; Ulcerative Colitis
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers
Condition: Venous Stasis Ulcers
MeSH terms: Varicose Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and effectiveness of
      Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers
    

Detailed description: 
      The purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the
      safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in
      patients with Venous Stasis (VS) ulcers. VS ulcers develop on the ankle or lower leg in
      patients with chronic vascular disease. In these patients, blood flow in the lower
      extremities is impaired, leading to edema (swelling) and mild redness and scaling of the skin
      that gradually progress to ulceration. Tβ4 is a synthetically-produced copy of a naturally
      occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and
      can up-regulate the expression of laminin-5.
    

Intervention name(s): Thymosin Beta 4; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There were three concentrations of gel used for topical administration to the active groups: 0.01% weight/weight (w/w), 0.03% w/w, and 0.1% w/w thymosin beta 4 gel applied once daily for up to 84 days; There were 3 groups of patients with venous stasis (VS) ulcers. Each group included 18 patients receiving active drug and 6 receiving placebo. There was one concentration of placebo gel for topical administration to the placebo group. The concentration was 0.0% weight/weight (w/w) thymosin beta 4 gel applied once daily for up to 84 days
Other intervention name(s): Tβ4; RGN-137 (topical gel)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Venous Stasis Ulcers; venous insufficiency; leg ulcers; Thymosin Beta 4; Laminin-5
Study of Sildenafil Citrate on Insulin Resistance in African American
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome; Insulin Resistance
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Obesity has a greater detrimental impact on the health of African American women than on any
      other racial or gender group. Nearly 80% of African American women are overweight or obese in
      the United States. Hypertension and insulin resistance are more prevalent among African
      American women as compared to men and Caucasians. These conditions put them at increased risk
      for the development of diabetes mellitus and cardiovascular disease.

      Recent studies have reported that a substance named Nitric Oxide (NO)may have some beneficial
      effect on how the body handles blood sugar and blood pressure. Of interest,some studies have
      shown that African Americans have decreased function of NO in their blood vessels.

      In this study proposal the investigators will test if increasing NO function with a PDE-5
      inhibitor (sildenafil citrate) will improve pre-diabetes and the health of the inner layer of
      the blood vessels in obese African American women.
    


Intervention name(s): Sildenafil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg three times a day.; No active drug
Other intervention name(s): Revatio
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: African American; Women; Metabolic Syndrome; Endothelial function; Sildenafil citrate
Graves' Orbitopathy and Hypercholesterolemia
Condition: Graves' Ophthalmopathy; Hypercholesterolemia
MeSH terms: Eye Diseases; Graves Ophthalmopathy; Hypercholesterolemia
Study type: Observational

Summary: 
      The investigators have recently observed retrospectively that the occurrence of Graves'
      Orbitopathy in patients with Graves' disease is less frequent in patients with normal
      cholesterol levels, in line with another recent observation suggesting that statins play a
      protective role in Graves' patients from developing Graves' Orbitopathy. The present study is
      designed in order to investigate the possible association between Graves' Orbitopathy and
      high cholesterol level as well as the relation between Graves' Orbitopathy degree and high
      cholesterol level
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Consecutive patients with Graves' disease, with or without Graves' Orbitopathy, off
        methimazole since two days to perform radioiodine treatment
SMART Clinical Study: Surgical Multi-center Assessment of RF Ablation for the Treatment of Vertebrogenic Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of RF ablation using the Intracept Intraosseous Nerve
      Ablation System to ablate intraosseous nerves for the relief of chronic axial low back pain.
      This is a prospective, double-blind, randomized, sham-controlled clinical trial with an
      optional crossover component.
    


Intervention name(s): Intracept Treatment; Sham Treatment
Intervention type(s): Device; Device
Intervention description(s): Percutaneous transpedicular RF ablation of an intraosseous nerve within the lumbar vertebral body to treat chronic axial low back.; Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic axial low back pain; vertebrogenic pain; Radio frequency ablation