bioihbjkbjnl/mcl2 huggingface dataset:
Resistance Exercise to Improve Fatigue in Workplace (REW)
Condition: Fatigue; Musculoskeletal Diseases
MeSH terms: Musculoskeletal Diseases; Fatigue
Study type: Interventional

Summary: 
      Studies show that exercise resistance in workplace can reduce the symptoms of induced labor,
      however, the effectiveness of such programs depends on the characteristics of the training
      fatigue. Thus, it is expected that this study the intervention group with training heavy
      using progressive resistance exercise protocol will be better in reducing fatigue when
      compare with light training group.
    

Detailed description: 
      Background: This study is randomized clinical trial with double-blinded. The aim is evaluate
      the effectiveness the training heavy with resistance exercise program in the muscle fatigue
      control. Methods: This is a randomized controlled trial by cluster, in which workers who
      participate in the intervention group will perform resistance exercise protocols; and workers
      in the comparative group held only stretching exercises and light resistance training with
      elastic bands. Expected results: strong evidence that fatigue reducing after ten weeks in
      workers and improve in others outcomes. Not found in literature studies in occupational
      evaluating this aspect of training.
    

Intervention name(s): Compensatory Workplace Exercise (CWE) - Comparative Group; Individual Resistance Exercise (IRE) - Intervention Group
Intervention type(s): Other; Other
Intervention description(s): The comparative group will receive warming up and stretching and light resisted exercise with elastic bands. The exercise will realize three times per week, 20 minutes for day in total 60 minutes per week. With warming up for 5 minutes and 15 minutes of the specific training . The exercise will realize in 3 series with 10 repetitions and rest 30 seconds between series.; Intervention group will receive warming up and stretching, and a specific resistance training with increase progress load. The exercise will realize three times per week, 20 minutes for day in total 60 minutes per week. With warming up and stretching for 5 minutes and 15 minutes of the specific training. The exercise will realize in 3 series with 10 repetitions and rest 30 seconds between series.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Workplace; Industrial workers; Resistance exercise; Fatigue; Occupational risk; Physical therapy
Multi-Component Early Intervention for Socially Inhibited Preschool Children
Condition: Behavioral Inhibition; Anxiety
Study type: Interventional

Summary: 
      This project is intended to provide a rigorous test of the Turtle Program, an early
      intervention program for behaviorally inhibited preschoolers. The proposed project will
      extend promising pilot study findings by: (a) evaluating the integrated intervention in a
      larger sample (n = 150) of 45-64 month children and their parents, which will allow for an
      examination of mediators and moderators of treatment effects; (b) comparing the Turtle
      Program to the best available treatment for preschool behavioral inhibition, the Cool Little
      Kids (CLK) parent psychoeducation group; (c) examining heart rate reactivity and regulation
      as both baseline moderators of treatment response and as outcome measures; (d) examining
      parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment
      assessment and extending follow-up to one year.
    


Intervention name(s): Turtle Program; Cool Little Kids
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial to Assess the Effect of Food on the Pharmacokinetics of YHD1119 in Healthy Volunteers
Condition: Peripheral Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess
      the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.

      Hypothesis: "YHD1119" is showing equal equal pharmacokinetics in fasted and fed state.
    

Detailed description: 
      This is a phase 1, open-label, randomized, single dose, crossover clinical trial to assess
      the effect of food on the pharmacokinetics of YHD1119 in healthy male volunteers.

      Group 1: 12 subjects will be assigned and they will be administered YHD1119 in fasted state
      at Day 1 and in fed state at Day 8.

      Group 2: 12 subjects will be assigned and they will be administered YHD1119 in fed state at
      Day 1 and in fasted state at Day 8.
    

Intervention name(s): YHD1119 300mg; YHD1119 300mg
Intervention type(s): Drug; Drug
Intervention description(s): Period 1:a single dose of YHD1119 300mg is administered in fasting condition Period 2:a single dose of YHD1119 300mg is administered in fed condition; Period 1:a single dose of YHD1119 300mg is administered in fed condition Period 2:a single dose of YHD1119 300mg is administered in fasting condition
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, open-label, single dose, cross-over clincial trial
Masking: None (Open Label)
Primary purpose: Treatment
A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate impact of Obicetrapib on PK levels of Atorvastatin and Rosuvastatin
    

Detailed description: 
      A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics
      of Atorvastatin Calcium Tablets or Rosuvastatin Calcium Tablets in Healthy Adult Subjects
    

Intervention name(s): Obicetrapib; Atorvastatin Calcium; Rosuvastatin Calcium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): obicetrapib 10 mg daily; Atorvastatin 80 mg; Rosuvastatin 40 mg
Other intervention name(s): tablets; tablets; tablets
Intervention MeSH terms: Calcium, Dietary; Atorvastatin; Rosuvastatin Calcium; Calcium
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Open-label, two-cohort, fixed sequence, drug-drug interaction study
Masking: None (Open Label)
Primary purpose: Treatment
Compare Effects of Intensive Versus Conventional Lipid-lowering Therapy in Patients With Severe Atherosclerotic Renal Artery Stenosis Undergoing Stent Placement
Condition: Renal Artery Obstruction; Stents; Lipids; Glomerular Filtration Rate; Blood Pressure
MeSH terms: Renal Artery Obstruction
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Although expert consensuses recommend the use of statins in the treatment of atherosclerotic
      renal artery stenosis, in patients with severe atherosclerotic renal artery stenosis
      undergoing stent placement, the related investigation focused on renal protection by
      intensive lipid-lowering therapy is scant , and the optimal target level for lipid reduction
      remain uncertain. Therefore, we hypothesized that intensive lipid lowering could offer more
      benefits with respect to renal function in the patients with percutaneous renal artery
      stenting. We conducted the prospective randomized unblinded trial to compare the
      renal-protective effect of intensive lipid lowering with that of conventional lipid lowering
      in patients underwent renal artery stenting (75 patients in each study group)
    


Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): For patients who were assigned to receive intensive lipid lowering, 10 mg/d rosuvastatin was initially prescribed and target LDL-C was < 1.8mmol/L. For patients who were assigned to receive conventional lipid lowering, 5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, <3.3mmol/L.
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intensive lipid lowering gourp:10 mg/d rosuvastatin was initially prescribed and target LDL-C was < 1.8mmol/L; Conventional lipid lowering: 5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, <3.3mmol/L
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Artery Obstruction; Stents; Glomerular filtration rate
Lateral Mini Approach vs Anterior Approach for Plating of Proximal Humerus Fracture
Condition: Closed Fracture Proximal Humerus, Neck
MeSH terms: Fractures, Bone; Humeral Fractures; Fractures, Closed
Study type: Interventional

Summary: 
      A prospective randomized clinical trial is proposed to compare the plate fixation of proximal
      humerus fractures using a minimally invasive lateral approach and the traditional anterior
      approach.Forty five patients will be assigned to each approach (total of 90 patients) and
      will be assessed 7 times over a two-year period. The trial's primary objectives will be to
      demonstrate the efficacy of the plating technique in terms of speed of recuperation of
      function. The Quick DASH will be used for evaluation of function.The study will also examine
      secondary end-points of pain, range of motion, esthetic satisfaction and radiographic
      outcome, as assessed by the components of the Constant Score3,4, SF-12V2 Questionnaire, and
      Patient Scare Assessment Scale Questionnaire. Furthermore, the assessment of safety will be
      based on the rates of all reported complications and adverse events at 2 years
    


Intervention name(s): Lateral minimally invasive approach (plate fixation); Deltopectoral approach (plate fixation)
Intervention type(s): Procedure; Procedure
Intervention description(s): A longitudinally oriented, 4-cm incision will be made laterally starting at the acromion. The deltoid will be split proximally at the most strategic location (vis-à-vis the fracture), and after the deltoid is bluntly elevated from the humerus more distally the axillary nerve will be identified by digital palpation. The nerve is easily identified posteriorly as it emerges from the quadrilateral space. With a finger maintained on the nerve for protection, the plate will be inserted onto the lateral side of the proximal humerus and fixed according to the described technique. A second, 2-cm longitudinal incision will then be made further distally for diaphyseal screw placement. This incision is well distal to the course of the axillary nerve.; Anterior, Delto-Pectoral Approach - A 10-cm incision will be made over the deltopectoral groove, starting at the coracoid process proximally. As the clavipectoral fascia is incised, the cephalic vein will be identified and retracted laterally with the deltoid muscle. The pectoralis major as well as the conjoint tendon will be retracted medially, and the long head of the biceps tendon will be identified and used as a guide for achieving an anatomic reduction of the different fracture parts. Next, internally rotating the humerus will allow access to the lateral side of the proximal humerus, on which the plate will then be fixed according to the described technique.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: humerus fracture
Epidermal Grafting in Wound Healing
Condition: Ulcer; Skin Ulcer; Wounds and Injuries
MeSH terms: Skin Ulcer; Ulcer; Wounds and Injuries
Study type: Interventional

Summary: 
      Split thickness skin grafting is the normal standard of care for wound closure. However, this
      is an invasive procedure and associated with pain also there can be additional donor site
      morbidity. Epidermal grafting is an emerging clinical alternative that is gaining clinical
      practise. Epidermal grafting (EG) is an alternative method of autologous skin grafting that
      'harvests' a finer layer of skin than traditional Split thickness skin grafting (SSG). This
      potentially results in less pain and reduced donor site morbidity but only delivers several
      cell layers to the wound so may be less effective at healing a wound. It is not known if EG
      is an effective alternative to SSG.

      Further the mechanism to achieve wound healing may be different. EG promotes wound healing by
      expressing growth factors that accelerates wound healing and encourages keratinocyte
      migration. Whereas SSG is a transplant of several skin layers that integrated to the existing
      wound bed as a formal skin covering.

      The investigators wish to compare these two clinical practises; epidermal grafting and split
      thickness skin grafting in wound healing. Further to undertake a translational study to
      investigate the mechanism by which each technique achieves wound healing.
    

Detailed description: 
      This study evaluates the efficacy of EG, as an alternative to current wound management
      therapy, SSG. In a pilot study carried out in our centre (unpublished data), the
      investigators noted that this technique offers a method of autologous skin harvesting with
      minimal or no pain and a scar free donor site. Moreover, complete wound epithelialisation was
      achieved while maintaining patient independence. Therefore, this device has the potential to
      save healthcare resources, by eliminating the need for theatre space and a hospital bed, and
      result in better Patient Reported Outcomes Measures.
    

Intervention name(s): Epidermal grafting; Split thickness skin grafting
Intervention type(s): Device; Procedure
Intervention description(s): The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts.; Split thickness skin grafting will be performed as per normal clinical practice.
Other intervention name(s): CelluTome
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epidermal graft; suction blister; blister graft; suction graft; Epidermis/su, tr [Surgery, Transplantation]
FOLFOXIRI Compared With FOLFIRI for Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate if the exposure to all the three active cytotoxic
      agents (FOLFOXIRI regimen) is superior in terms of response rate to conventional chemotherapy
      with the FOLFIRI regimen as first-line treatment of metastatic colorectal cancer patients.
    

Detailed description: 
      Survival of patients with metastatic colorectal cancer is correlated with the proportion of
      patients who receive all the three active drugs in the course of the disease, but not with
      the proportion of patients who receive any second-line therapy. In a sequential strategy, not
      all patients who progress after first-line chemotherapy are able to receive second-line
      treatment. Moreover, there is a correlation between the response rate to chemotherapy and the
      postchemotherapy radical resection rate of metastases.

      Therefore, a way to improve the outcome of metastatic colorectal cancer patients could be to
      administer a first-line regimen containing the three active agents.
    

Intervention name(s): FOLFIRI; FOLFOXIRI
Intervention type(s): Drug; Drug
Intervention description(s): Irinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks; Irinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks
Other intervention name(s): Campto; l-lederfolin; 5-FU; Campto; Eloxatin; l-leucovorin; 5FU
Intervention MeSH terms: Leucovorin; Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic colorectal cancer; Phase III; FOLFOXIRI; FOLFIRI
Diagnostic Accuracy of CT-FFR Compared to Invasive Coronar Angiography With Fractional Flow Reserve
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Interventional

Summary: 
      Invasive coronary angiography is currently considered gold standard in the assessment of
      coronary artery disease although the method has limitations. Most importantly invasive
      angiography only depicts coronary anatomy without determining its physiological significance
      i.e the likelihood that the stenosis impedes oxygen delivery to the heart muscle. Fractional
      flow reserve (FFR) is a catheterization technique for assessing the physiological
      significance of a coronary artery lesion during invasive coronary angiography. Coronary
      computed tomographic angiography (CCTA) is a noninvasive imaging test that has become an
      alternative route to diagnosis for patients with suspected coronary artery disease.
      Computational fluid dynamics combined with anatomical models based on CCTA scans allows
      determination of coronary flow and pressure, and has emerged as a promising diagnostic
      modality called CT-FFR. In this Project New Mathematical algorithms are developed for
      computation of CT-FFR. The main objective of this study is to determine the diagnostic
      accuracy of CT-FFR values obtained by the new method compared with invasive coronary
      angiography with fractional flow reserve and state-of-the-art dobutamin stress
      echocardiography.
    


Intervention name(s): CT-FFR; Stress echocardiography
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Invasive FFR and CCTA With CT-FFR; Stress echocardiography and invasive FFR
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Diagnostic Techniques, Cardiovascular; Coronary Angiography; Fractional Flow Reserve, Myocardial; Echocardiography, Stress
Effect of Diode Laser on Sensitive NCCLs Prior to Composite Restoration
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This study will investigate the efficacy of three diode laser wavelengths 445 nm, 660 nm, 970
      nm when applied just before placement of composite restoration on reducing postoperative
      sensitivity from Non-carious cervical lesions (NCCLs) with class V cavity preparation.
    

Detailed description: 
      In this randomized clinical trial, patients with NCCLs will be included (four teeth in each
      participant). After class V cavity preparation in the NCCLs, the teeth will be randomly
      assigned into four groups according to diode laser irradiation wavelength Group 1 (placebo)
      laser simulation and Group 2 (445 nm) diode laser wavelength, Group 3 (660 nm) diode laser
      wavelength, and Group 4 (970 nm) diode laser wavelength. Following laser irradiation, the
      universal self-etch adhesive will be applied and all the cavities will be restored with the
      same resin composite. Tooth sensitivity to a cold stimulus will be recorded using a visual
      analogue scale (VAS) before treatment and on follow-up days 1, 14 followed by 1, 3, and 6
      month after treatment.
    

Intervention name(s): Placebo; 445 nm Diode Laser Wavelength; 660 nm Diode Laser Wavelength; 970 nm Diode Laser Wavelength
Intervention type(s): Other; Radiation; Radiation; Radiation
Intervention description(s): Laser Simulation; The Axial Surface of Class V Cavity will be Irradiated Using a 445 nm Diode Laser Wavelength; The Axial Surface of Class V Cavity will be Irradiated Using a 660 nm Diode Laser Wavelength; The Axial Surface of Class V Cavity will be Irradiated Using a 970 nm Diode Laser Wavelength
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In this randomized controlled clinical trial, patients with NCCLs will be included (four teeth in each participant). The teeth will be randomly assigned into four groups according to diode laser irradiation wavelength Group 1 (placebo) laser simulation, Group 2 (445 nm) diode laser wavelength, Group 3 (660 nm) diode laser wavelength, and Group 4 (970 nm) diode laser wavelength.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Biomarker Development in LGMD2i
Condition: Muscular Dystrophies; Limb Girdle Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophies, Limb-Girdle
Study type: Observational

Summary: 
      The overall goal of this natural history study is to define the key LGMD2i phenotypes as
      measured by standard clinical outcome assessments (COAs), and to validate a muscle biomarker
      for LGMD2i to support therapeutic development.
    

Detailed description: 
      Limb Girdle Muscular Dystrophy (LGMD) 2i is an autosomal recessive form of LGMD that is due
      to missense mutations in the Fukutin-related protein (FKRP) gene. Patients develop
      progressive proximal muscle weakness that leads to loss of ambulation. Patients will also
      commonly develop a cardiomyopathy and respiratory compromise.

      There are promising new therapies that have been developed and as a result therapeutic trials
      are approaching.

      The rationale for this study is to define appropriate COAs for LGMD2i, which will facilitate
      therapeutic development and ensure properly powered clinical trials. In addition, measurement
      of dystroglycan in muscles represents a potential muscle biomarker that could be used in
      early phase clinical trials as a measure of target engagement. The clinical utility of
      changes in dystroglycan has not been validated in human samples.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Study participants will be identified through self-selection and direct recruitment
        options. Participants will be identified from the population of individuals who are
        followed at the neuromuscular clinics. Participants will also be solicited from the Global
        FKRP registry.
      
Biospecimen description: 
      Blood and Tissue samples will be taken for biomarker development and retained for future
      research. No clinical diagnosis will be given to patients.
    
Keywords: LGMD; FKRP; Clinical Research; ML Bio Solutions; Limb Girdle Muscular Dystrophy; Limb girdle muscular dystrophy type R9 (LGMD R9); LGMD2i