bioihbjkbjnl/mcl2 huggingface dataset:
Reliability and Validity of the Turkish Version of the Upper Limb Short Questionnaire in Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy; Upper Extremity Problem
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Observational

Summary: 
      Purpose: This study aimed to evaluate the construct validity and reliability of the Turkish
      version of the Upper Limb Short Questionnaire (ULSQ) in Duchenne muscular dystrophy (DMD).

      Materials and methods: A total of 41 children with DMD have participated in the study. Upper
      and lower extremities functional levels were assessed with Vignos Scale and Brooke Upper
      Extremity Functional Rating Scale, respectively. The construct validity of the questionnaire
      was determined using the correlation between the ULSQ and ABILHAND-Kids. The Cronbach alpha
      value was calculated to determine internal consistency. To determine test-retest reliability,
      17 randomly selected children were evaluated seven days after the first evaluation, and the
      "Intraclass Correlation Coefficient (ICC)" value was calculated.
    


Intervention name(s): Assessment
Intervention type(s): Other
Intervention description(s): The Upper Limb Short Questionnaire was administered by the researcher in face-to-face sessions with the children and their caregivers.
The lower extremity functions and ambulation levels of the children were evaluated by the researcher using the Vignos Scale.
The Brooke Upper Extremity Functional Rating Scale and ABILHAND-Kids were used to evaluate children's upper extremity functions.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This study was planned as a methodological research. A total of 41 children with DMD
        between the ages of 5-18 were included in the study.
Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine if glucocorticoids will change neural activation in
      regions of the corticolimbic-striatal system that regulate feeding.
    

Detailed description: 
      The primary hypothesis tested in this study will be to determine if that in response to food
      cues, glucocorticoids will change neural activation in regions of the corticolimbic-striatal
      system that regulate feeding. It is anticipate that these changes will correlate with hunger
      ratings and food intake. Further, this research will also examine if glucocorticoids will
      increase the basal metabolic rate and alter multiple systemic appetite-regulating hormones
      compared to saline. It is expected that these changes will correlate positively with hunger
      ratings and food intake as well.
    

Intervention name(s): hydrocortisone; saline
Intervention type(s): Drug; Other
Intervention description(s): Hydrocortisone will be used as the steroid of choice because it is bio-identical to cortisol and is subject to the same metabolism as cortisol.; Saline will be used as the placebo comparator. It will be administered in the same manner as the active drug.
Intervention MeSH terms: Hydrocortisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: fMRI obesity
Using the Drug Spironolactone to Test If It Reduces Protein Leakage From the Kidney
Condition: Kidney Disease; Diabetic Nephropathy; Glomerulonephritis; Proteinuria
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Proteinuria; Glomerulonephritis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine which combination of the tablets ramipril,
      irbesartan or spironolactone is best to lower protein leakage from the kidney.
    

Detailed description: 
      Protein leak from the kidney into the urine is an indicator of kidney damage. The higher the
      leak, the worse the damage and the more likely the patient will lose their kidney function
      long term. Interventions that lower protein leak make the kidneys last longer.

      There are 2 groups of medications, both blood pressure tablets, the ACEI (angiotensin
      converting enzyme inhibitors) and ATRB (angiotensin receptor blockers) which have shown to
      reduce the amount of protein leaking from the kidney and as a result lengthen the life of the
      kidney. There has also been evidence that using these 2 tablets in combination is better than
      using either one alone. In spite of these tablets, there still remain some patients that
      continue to leak protein in the urine.

      Recently there has been evidence that the tablet spironolactone, which is a fluid tablet,
      also reduces protein leakage from the kidney. In this study we look at various combinations
      of these tablets to see which works best to lower protein leakage from the kidney.

      Patients are divided into 4 groups. Each group will receive the tablet ramipril (an ACEI). In
      group 1, patients will be on ramipril and 2 blank tablets, group 2 will be on ramipril,
      irbesartan (an ATRB) and a blank tablet, group 3 will be on ramipril, spironolactone and a
      blank tablet and group 4 will be on ramipril, irbesartan and spironolactone. Protein leakage
      is measured at the beginning and after 3 months of treatment.
    

Intervention name(s): Spironolactone; Irbesartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Irbesartan; Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: spironolactone; proteinuria; angiotensin converting enzyme inhibitor; angiotensin receptor blocker; renin angiotensin aldosterone system; aldosterone
Pilot Study of Tocilizumab Monotherapy for Active Chronic Periaortitis
Condition: Chronic Periaortitis; Tocilizumab Monotherapy
MeSH terms: Retroperitoneal Fibrosis
Study type: Observational

Summary: 
      This is a prospective study to investigate the treatment response of Tocilizumab on patients
      with active chronic periaortitis (CP).

      Methods: patients with a definite or possible diagnosis of CP at acute active stage were
      enrolled for this study and accepted Tocilizumab monotherapy for 3 months.

      Endpoints: The primary endpoint is to investigate the treatment response of Tocilizumab; the
      secondary endpoints include the improvement of inflammatory markers, the frequency of adverse
      events.
    

Detailed description: 
      Patients enrolled received intravenous infusions of TCZ (8 mg/kg) at inclusion and then every
      4 weeks for at least 3 months. Demographic and clinical features, laboratory findings and
      imaging examinations were recorded at baseline and during 3-month follow-up. Imaging
      improvement was converted into the ratio of perivascular soft tissues shrinkage by evaluating
      2 dimensions of greatest change on computed tomography (CT) at baseline and after 3 months.
      Partial remission was defined as obtaining alleviation of symptoms and normalization of
      inflammatory markers including erythrocyte sedimentation rate (ESR) and high-sensitivity
      C-reactive protein (hsCRP), with shrinkage of soft tissue mass in imaging <70%. Further,
      complete remission was defined as normalization of inflammatory markers accompanied by
      shrinkage of soft tissue mass ≥70%.
    

Intervention name(s): Tocilizumab monotherapy
Intervention type(s): Drug
Intervention description(s): intravenous infusions of TCZ (8 mg/kg) at inclusion and then every 4 weeks for at least 3 months
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic periaortitis (CP) is characterized by the presence of mass that develops around the
        thoracic aorta, abdominal aorta or iliac arteries, with predominance in males of middle and
        elderly age.
      
Keywords: chronic periaortitis; Tocilizumab; treatment response; complete remission; partial remission
99mTc-ADAPT6 SPECT-based Non-invasive Quantification of HER2-expression in Breast Cancer With Metastatic Lymph Nodes
Condition: Breast Cancer; Female
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      An open-label, single center study with 99mTc-ADAPT6 SPECT and biopsies of primary tumour and
      metastatic lymph nodes in breast cancer patients, where the primary endpoint of the study is
      to find out the correlation between the HER2 expression measured by 99mTc-ADAPT6 SPECT and
      standard histopathology from relevant tumor and lymph node biopsies.
    

Detailed description: 
      Overall goal of the project: To determine HER2 expression level in primary breast cancer and
      axillary lymph node metastases before neoadjuvant targeted (trastuzumab or
      trastuzumab+pertuzumab) therapy.
    

Intervention name(s): ADAPT6-SPECT
Intervention type(s): Drug
Intervention description(s): Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes
Other intervention name(s): Diagnostic ADAPT6-SPECT injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Diagnostic Test: ADAPT6-SPECT Diagnostic SPECT for HER2 expression in primary tumour and metastatic lymph nodes
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 99mTc-ADAPT6; Breast Cancer; metastatic lymph nodes; HER2 expression
Fluoride Availability in Saliva After Use of Sodium Fluoride or Monofluorophosphate Toothpastes
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 1

Summary: 
      Considering the widespread use of sodium fluoride (NaF) and monofluorophosphate (MFP) based
      toothpastes, the present study aim to evaluate F availability in saliva after use of the
      top-selling Brazilian toothpastes. In a blind, crossover clinical trial study, volunteers
      will brush their teeth with one of the following toothpastes: 1) non-fluoride toothpaste
      (negative control group); 2) NaF/silica based toothpaste 3)MFP/calcium carbonate based
      toothpaste. After brushing, a rinse with purified water will be performed. Unstimulated
      saliva will be collected before and up to 60 min after brushing. Ionic fluoride and total
      soluble fluoride (corresponding to the sum of fluoride as ion and as MFP) will be determined
      after acid treatment of salivary samples to hydrolyze MFP. Fluoride will be determined using
      an ion selective electrode.
    


Intervention name(s): Toothpaste
Intervention type(s): Drug
Intervention description(s): 1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: toothpastes; saliva; dental caries; fluoride
Tongue Depressor-related Ischemia-Reperfusion Injury in Tongue
Condition: Side Effect; Ischemia Reperfusion Injury; Edema; Tongue Enlarged
MeSH terms: Reperfusion Injury; Ischemia; Wounds and Injuries
Study type: Observational

Summary: 
      This study aimed to detect tongue edema associated with the pressure exerted by a rigid
      direct laryngoscope by measuring the tongue area using USG in patients undergoing suspension
      laryngoscopy (SL) procedures.
    

Detailed description: 
      Suspension laryngoscopy (SL) is a surgical procedure for both diagnostic and therapeutic
      purposes. In this procedure, a rigid direct laryngoscope is inserted orally, and the tongue
      and the base of the tongue are compressed.The tongue is an ideal organ for evaluation with
      ultrasonography. This study aimed to detect the occurrence of tongue edema through
      ultrasonography examination due to the rigid direct laryngoscope in SL procedures.
    

Intervention name(s): Ultrasonography imaging
Intervention type(s): Diagnostic Test
Intervention description(s): This study aimed to evaluate the tongue areas and compare the tongue areas before the implementation of rigid direct laryngoscope and after the rigid direct laryngoscope.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 20 years or older who will undergo suspension laryngoscopy procedures or who
        did not need suspension larygoscopy procedures.
      
Keywords: tongue; ischemia-reperfusion injury; side effect; edema; suspension laryngoscopy
Comparison of Analgesic Efficacy of US Guided ESP Block With Port Site Infiltration Following Laparoscopic Cholecystectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      To compare the efficacy of ultrasonography (USG)-guided bilateral Erector spinae plane block
      (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after
      laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and
      port-site infiltration are effective in providing post-operative analgesia.
    


Intervention name(s): Erector spinae plane block; Port site infiltration; Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China); Bupivacaine 0.5%; Lidocaine 2%
Intervention type(s): Procedure; Procedure; Device; Drug; Drug
Intervention description(s): Patients will be placed on their right side. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10-cm needle will be inserted using an in-plane approach in a cranial to caudal direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.; After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of the LA mixture. The volume will be divided equally between port sites. A total of four ports-supraumbilical, subxiphoid and two ports in the right subcostal area at mid-clavicular and anterior axillary line will be made.; Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection.; Bupivacaine 0.5% will be included in the injected LA mixture.; Lidocaine 2% will be included in the injected LA mixture.
Other intervention name(s): ESP block
Intervention MeSH terms: Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cholecystectomy; ESP block; Port Site Infiltration
Study to Evaluate the Effect of Food Upon the Pharmacokinetics of Androxal
Condition: Normal Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, randomized, single-center, single-dose, two-way crossover study
      of the PK properties of Androxal in healthy male subjects. Twelve male subjects will each
      receive a single dose of Androxal 25 mg in both the fed and fasting state.
    


Intervention name(s): Androxal 25 mg Capsules
Intervention type(s): Drug
Intervention MeSH terms: Enclomiphene
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Magnesium and Vitamin D Supplementation and Cardiometabolic Outcomes
Condition: Overweight and Obesity; Vitamin D Deficiency; Magnesium Deficiency; Cardiovascular Risk Factor
MeSH terms: Obesity; Overweight; Vitamin D Deficiency; Magnesium Deficiency
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of a combined vitamin D and magnesium
      supplementation on parathyroid hormone and cardiometabolic health in persons living with
      obesity.
    

Detailed description: 
      Individuals living with obesity are at a higher risk of cardiometabolic abnormalities and
      high circulating parathyroid hormone. There is evidence suggesting that vitamin D may play a
      role in cardiovascular health outcomes; however, the research is currently inconclusive.
      Magnesium is a cofactor of vitamin D metabolism, and the prevalence of concurrent vitamin D
      and magnesium deficiency is high. This study aims to investigate the effect of vitamin D and
      magnesium supplements in individuals who are overweight and obese on parathyroid hormone and
      cardiometabolic health.
    

Intervention name(s): Vitamin D and magnesium; Vitamin D; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily vitamin D and magnesium supplements are given to participants daily for 12 weeks.; Daily vitamin D supplements are given to participants daily for 12 weeks.; Daily placebo are given to participants daily for 12 weeks.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive
Condition: Prehypertension
MeSH terms: Prehypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Prehypertension are associated with an increased risk of atherosclerosis and coronary artery
      disease, and often complicated with the metabolic disorder of glucose and lipid. The
      comprehensive prevention of hypertension is still an important and complex clinical issue.
      Taurine is one of the ingredients of Chinese medicine bezoar ,as an endogenous amino acids is
      central inhibitory neurotransmitter, can regulate the excitability of nerve tissue, regulate
      body temperature, therefore, antipyretic, sedative, analgesic, anti-inflammatory,the role of
      anti-rheumatic, anti-convulsant. In addition, Taurine inhibits platelet aggregation in the
      circulatory system, lower blood lipids, to maintain the body's normal blood pressure and
      prevent atherosclerosis; protective effect on myocardial cells, can be anti-arrhythmic;
      special efficacy to lower blood cholesterol, to treat heart failure. The effect of oral
      Taurine on blood pressure is not consistent, however, many animal study has shown that oral
      administration of Taurine, could reduce 24-hour mean arterial systolic and diastolic blood
      pressure in spontaneous hypertensive rats. Furthermore, Taurine interfere with calcium and
      low affinity binding of the calcium binding sites, decrease the voltage-dependent Ca2+channel
      in vascular smooth muscle relaxation, vasodilation, lower blood pressure.In a prospective,
      double-blind, randomized, and parallel-group study, we will evaluate the effects of Taurine
      granule on blood pressure and metabolic parameters in prehypertensive and mild hypertensive
      patients. This study will help develop future comprehensive prevention and treatment
      strategies for hypertension.
    


Intervention name(s): Taurine granule; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 package(1.6g taurine granule) once a day after meals, 12 weeks; Placebo: 1 package once a day after meals, 12 weeks
Other intervention name(s): Taurine granule, H20003861.; Placebo packaged similar to Taurine granule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hypertension; Taurine; Metabolism
A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)
Condition: Chronic Idiopathic Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled,
      parallel-group study to evaluate the efficacy and safety of omalizumab administered
      subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged
      12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite
      standard-dosed H1 antihistamine treatment.
    

Detailed description: 
      The trial incorporated a Type I error control plan, as follows:

      The testing of the primary endpoint was conducted in the following hierarchical order. A
      p-value that is less than 0.05 can only be claimed statistically significant if statistical
      significance has been claimed at the previous stage.

        -  Stage 1: Omalizumab 300-mg group vs. placebo

        -  Stage 2: Omalizumab 150-mg group vs. placebo

        -  Stage 3: Omalizumab 75-mg group vs. placebo

      A hierarchical analysis of the secondary endpoints was performed for each dose found to be
      significant in the primary endpoint. A p-value that is less than 0.05 can only be claimed
      statistically significant if statistical significance has been claimed at the previous stage.

        -  Stage 1: Change from baseline in Urticaria Activity Score (UAS7) at Week 12

        -  Stage 2: Change from baseline in the weekly number of hives score at Week 12

        -  Stage 3: Time to weekly itch severity score Minimally Important Difference (MID)
           response at Week 12

        -  Stage 4: Proportion of patients with UAS7 ≤ 6 at Week 12

        -  Stage 5: Proportion of weekly itch severity score MID Responders at Week 12

        -  Stage 6: Change from baseline in weekly size of the largest hive score at Week 12

        -  Stage 7: Change from baseline in overall Dermatology Life Quality Index (DLQI) score at
           Week 12

        -  Stage 8: Proportion of angioedema-free days from Week 4 to Week 12
    

Intervention name(s): Placebo; Omalizumab
Intervention type(s): Drug; Drug
Intervention description(s): Placebo was supplied lyophilized in vials.; Omalizumab was supplied lyophilized in vials.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment