bioihbjkbjnl/mcl2 huggingface dataset:
Sacroiliac Joint Injection: Comparison of Xray Versus Ultrasound
Condition: Sacroiliac Joint Arthritis Causing Low Back Pain
MeSH terms: Sacroiliitis; Low Back Pain
Study type: Interventional

Summary: 
      This project involves the assessment of the efficacy of two different image guided techniques
      in patients with low back pain due to arthritis of the sacroiliac joint (SIJ).
      Intra-articular injection of local anesthetics and steroids is performed to relieve pain
      originating from the SIJ. Fluoroscopy has been used traditionally for image guidance for this
      procedure but there is a growing interest in use of ultrasound (US) for this procedure. US
      avoids radiation exposure to the patient and the health care team (HCT) and is less
      expensive. We aim to compare procedural efficacy related outcomes for SIJ injections
      performed using these image-guided modalities.
    

Detailed description: 
      The study is a prospective, randomized trial. Patients with low back pain which is diagnosed
      secondary to SIJ disease will be identified beforehand in clinic and offered a therapeutic
      joint injection. Informed consent will be obtained. Patients will be randomized for SIJ block
      with 3 mL of 0.25% bupivacaine with 1:200,000 epinephrine and 40 mg depomedrol using guidance
      with ultrasound or fluoroscopy. In both groups, confirmation of needle placement will be
      obtained using contrast injection imaging before the injection is performed. Record will be
      made of the number of times the needle is correctly placed into the articular space, as well
      as the number of attempts to do so. The final position of the needle will be recorded. Pain
      scores will be assessed before the procedure, as well as post-procedure at 24 and 72 hours,
      as well as 1 week, 1 month, and 3 months. Patients will keep a pain diary and will be
      followed up at 3 months time in clinic.
    

Intervention name(s): Sacroiliac Joint Injection
Intervention type(s): Procedure
Intervention description(s): Medication injected into the sacroiliac joint: Bupivicaine 3ml 0.25% with epinephrine 1/200,000 and Depo-Medrol 40mg.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sacroiliac Joint; Ultrasound; Fluoroscopy; Chronic Pain
Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether in patients with early type 2 diabetes, a
      short-term intensive metabolic intervention comprising IDegLira, metformin, and lifestyle
      approaches will be superior to standard diabetes therapy in achieving sustained diabetes
      remission.
    

Detailed description: 
      This is a multicentre, open-label, randomized controlled trial in 160 patients with
      recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 16-week
      course of treatment with IDegLira, metformin and lifestyle therapy, and (b) standard diabetes
      therapy, and followed for a total of 68 weeks (1 year and 4 months). In all participants with
      HbA1C<7.3% at the 16 week visit, glucose-lowering medications will be discontinued and
      participants will be encouraged to continue with lifestyle modifications and regular glucose
      monitoring. Participants with HbA1C ≥ 7.3% at this visit or who experience hyperglycemia
      relapse after stopping drugs will receive standard glycemic management as informed by the
      current Canadian Diabetes Association clinical practice guidelines.
    

Intervention name(s): IDegLira; insulin degludec; Metformin; Lifestyle Therapy
Intervention type(s): Drug; Drug; Drug; Behavioral
Intervention description(s): Dose is titrated to achieve fasting normoglycemia; In those who need additional insulin or who cannot tolerate IDegLira, insulin degludec will be used. Dose is titrated to achieve fasting normoglycemia.; Dose is titrated to 2000 mg per day or maximal tolerated dose; Lifestyle intervention includes individualized dietary and exercise advice targeting at least 5% weight loss with frequent visits and coaching for goal reinforcement, behavior modification and problem-solving
Other intervention name(s): insulin degludec / liraglutide; diet and exercise
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Liraglutide; Insulin, Long-Acting; Xultophy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; IDegLira; Metformin; Insulin; Diet; Excercise; Lifestyle
MoKaRi II Intervention Study
Condition: Decreased Cardovascular Risk; Decreased Risk of Diabetes Mellitus Type II
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The proposed intervention study addresses the development and validation of nutritional
      concepts based on menu plans for patients with hypertriglyceridemia (triglycerides > 1.5
      mmol/l) and participants with impaired glucose tolerance/prediabetes (glucose > 5.6 ≤ 7
      mmol/l).
    

Detailed description: 
      The proposed intervention study addresses the development and validation of nutritional
      concepts for patients with hypertriglyceridemia (triglycerides > 1.5 mmol/l) and participants
      with impaired glucose tolerance (glucose > 5.6 ≤ 7 mmol/l).

      The randomized, controlled study will be conducted in a parallel design with four arms. In
      total, 120 participants (males, females; age: 30 - 80 years) will be randomized to one of the
      four groups: hypertriglyceridemia concept (group A), hypertriglyceridemia control (group B),
      prediabetes concept (group C), and prediabetes control (group D).

      The study participants in group A and C receive defined personal nutritional counselling
      every two weeks and they are provided with daily menu plans (isocaloric) with optimized
      nutrient profiles and chosen study products (e.g., fish or plant oil, nuts) over the study
      period of ten weeks. Participants in the control groups B and D are not provided with defined
      menu plans or study products.

      Blood samples will be taken at the beginning, regularly every two weeks of the ten-weeks
      intervention period as well as after the ten-weeks follow-up. Primary endpoints are
      triglycerides (group A, B), and fasting glucose (group C, D).

      The study design enables the comparison of the effectiveness of the developed nutritional
      concepts, which were adapted to the requirements of the target groups.
    

Intervention name(s): Menu plans
Intervention type(s): Dietary Supplement
Intervention description(s): The study participants in group A and C receive defined personal nutritional counselling every two weeks and they are provided with daily menu plans (isocaloric) with optimized nutrient profiles and chosen study products (plant oils, nuts mixture etc.) over the study period of 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel design
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: triacylglcerides, glucose, HbA1c, body weight
A Study to Evaluate the Pharmacokinetics Similarity of CBP-201 in Healthy Adult Chinese Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, open-label, single-dose, parallel-designed PK similarity
      study.
    

Detailed description: 
      A total of 324 healthy subjects are planned to be enrolled and randomized into 3 groups at a
      ratio of 1:1:1, with 108 subjects in each group. They will receive 2 doses of the test drug
      T1 (CBP-201 injection (pre-filled syringe, 150 mg/1 mL)), 1 dose of the test drug T2 (CBP-201
      injection (pre-filled syringe, 300 mg/2 mL)), and 2 doses of the reference drug R (CBP-201
      injection (vial, 150 mg/1 mL)), respectively.

      The study consists of a screening period (Day-28 to Day-2), a baseline period (Day-1), an
      administration and observation period (Day1 to Day6), and a follow-up period (Day7 to Day57).
    

Intervention name(s): Test drug (T1): CBP-201 injection (pre-filled syringe, 150 mg/1 mL); Test drug (T2): CBP-201 injection (pre-filled syringe, 300 mg/2 mL); Reference drug (R): CBP-201 injection (vial, 150 mg/1 mL)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): subcutaneous injection of 2 doses on Day 1; subcutaneous injection of 1 dose on Day 1; subcutaneous injection of 2 doses on Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Online Mindful & Resiliency Program Intimate Partner Violence
Condition: Mindfulness; Intimate Partner Violence
Study type: Interventional

Summary: 
      The purpose of this study is to explore the experiences and benefits of offering an online
      mindfulness program that integrates resiliency factors to women.
    

Detailed description: 
      The purpose of this study is to explore the experiences and benefits of offering an online
      mindfulness program that integrates resiliency factors to women. Investigators will recruit
      participants via email and social media flyers to local community sites as well as approved
      Loma Linda University affiliated sites. Participants who consent will then complete a
      Demographic Questionnaire(before initial session of program), Pre and Post Stress Surveys (at
      the start and end of each session), Five-Facet Mindfulness Questionnaire(before and after
      completion of the program), and a semi-structured interview after the completion of the
      program. The program will be done be 20-minutes sessions for 3x/week for 4 weeks.
    

Intervention name(s): Online Mindfulness Resiliency Program
Intervention type(s): Other
Intervention description(s): An approximate 20 minute online mindfulness resiliency program offered 3/wk x 4 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Mindfulness; Resiliency; Online; Domestic violence
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase I Study in Chinese Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of
      Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese
      healthy volunteers.
    

Detailed description: 
      This is an open-label study that will be conducted at a single site in China to characterize
      the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon
      alpha2a Fusion Protein in healthy subjects. Subjects will receive a single dose of
      Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein or active comparator
      Pegasys at Day 0. The total duration of study participation is up to 6 weeks for each
      subject. Subjects will complete a follow-up visit at Day 28 after the dosing.
    

Intervention name(s): Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.; Peginterferon 180 mcg single dose S.C.
Intervention type(s): Biological; Biological
Intervention description(s): Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0; Pegasys 180 mcg S.C. single dose on Day 0
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of a single
      intravenous (IV) and oral (PO) ascending dose of NRX-1074 as evidenced by the incidence and
      severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis,
      changes in physical examination findings and subject-reported symptoms.

      The secondary objectives of this study are to assess the plasma and cerebrospinal fluid (CSF)
      pharmacokinetics (PK), the oral bioavailability of experimental formulations and the renal
      elimination through urine concentration of NRX-1074 through 24 hours following dosing.
    

Detailed description: 
      Randomized, double-blind, placebo-controlled, single ascending dose level study. On Day 1,
      eligibility of each subject will be confirmed, physical examination will be performed, and
      blood and urine for laboratories will be obtained. Each subject will be randomized, then will
      receive either a single IV, SC or IN dose of GLYX-13 or placebo.
    

Intervention name(s): NRX-1074; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single IV or PO administration; Single IV or PO placebo administration
Other intervention name(s): NMDA receptor functional glycine-site partial agonist
Intervention MeSH terms: Glycine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: safety; tolerability; pharmacokinetics
Investigation Of Two Different İnterventions İn Hemiplegic Patients
Condition: Stroke; Physiotherapy and Rehabilitation
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Background: Our study aims to determine the effect of relaxation and breathing exercises in
      addition to the treatment procedure on depression level, sleep quality, and spasticity in
      hemiplegic patients.

      Methods: Thirty patients aged 40-70 years diagnosed with hemiplegia were included in the
      study. All patients received the same Bobath exercise three days a week for six weeks.
      Patients in Group 2 additionally received breathing and relaxation exercises. Sleep quality
      assessment by Pittsburgh Sleep Quality Index (PUKI), depression by Hospital Anxiety and
      Depression Scale (HADS), and spasticity by Modified Ashworth scale (MAS) were used. All
      assessments were made at baseline and six weeks after exercise treatments.
    


Intervention name(s): Bobath Exercises; Breathing Exercises,Breathing Exercises, Bobath Exercises
Intervention type(s): Other; Other
Intervention description(s): The Bobath approach aims to enhance postural and neuromotor control goal-directedly, leading to functional improvement. Our study selected the Bobath 30 exercises from the fundamental exercises to create a program specific to the goal and targeting functionality.
The ten Bobath exercises performed by all participants in the study are as follows: Bridging Exercise, Latissimus Stretch Exercise, Autoinhibition Exercise, Dorsiflexion Training, Sitting Balance Training, Upper Extremity Weight Shifting Exercise, Lower Extremity Weight Shifting Exercise, Oblique Abdominal Strengthening Exercise, Knee Control Training, and Walking Training.; The puckered lip breathing exercise aims to prevent the closure of the small airways by creating pressure during expiration. During the exercise, the individual is asked to follow these steps:
Breathe calmly and slowly through the nose.
Pucker the lips as if whistling or inflating a balloon.
Exhale the breath with puckered lips. Relaxation exercises Progressive Muscle Relaxation Technique: Progressive muscle relaxation is one of the easiest methods to learn and apply, developed by Jacobson. It involves voluntarily tensing and relaxing large muscle groups regularly and sequentially. The participant was encouraged to wear comfortable clothing, breathe deeply, and exhale. The technique can be performed in a sitting or lying position. Music can be played to contribute to the participant's relaxation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Depression; Exercise; Relaxation; Pain
Cardiometabolic Profiles of Boys With Klinefelter Syndrome
Condition: Klinefelter Syndrome; 47,XXY; Sex Chromosome Aneuploidy; XXY Syndrome
MeSH terms: Klinefelter Syndrome; Syndrome; Aneuploidy
Study type: Observational

Summary: 
      This study plans to learn more about how to measure the way the the body's energy system
      works in boys with Klinefelter syndrome, including the heart, lungs, muscles, and liver. This
      is important to know so that investigators understand how hormones and an extra X chromosome
      relate to diseases such as diabetes, extra weight gain, heart disease and liver diseases.
    

Detailed description: 
      Klinefelter syndrome (KS) is the most common chromosomal abnormality in males and is
      associated with primary gonadal failure in adolescence and a high morbidity and mortality
      from cardiovascular-related diseases (CVD) in adulthood. Recent studies in children and
      adolescent boys with KS have found a high prevalence of CVD risk markers, however the
      underlying mechanisms have not been explored. Our central hypothesis is that pubertal boys
      with KS have relative testosterone deficiency resulting in abnormal energy metabolism that
      predisposes them to later CVD, and that exogenous testosterone will modify these
      abnormalities.

      In this study, investigators will measure markers of cardiometabolic risk in pubertal boys
      with KS.
    

Intervention name(s): No intervention
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study will enroll 10 youth with 47,XXY who will be subdivided into 2 groups:

          1. Testosterone naïve (no exogenous testosterone within the past 5 years)

          2. Testosterone exposed (topical testosterone treatment for at least 1 year but no more
             than 2 years) Most subjects will be recruited at the completion of a monitored,
             double-blind randomized controlled trial ongoing at our institution. Additional
             subjects may be recruited to meet enrollment goals.
      
Biospecimen description: 
      Plasma
    
Keywords: Klinefelter syndrome; XXY; Sex chromosome aneuploidy; sex chromosome variation; hypogonadism; cardiometabolic; body composition; exercise capacity
Oral Chemotherapy And Platinum With Radiotherapy Followed Or Not By Consolidation With The Same Chemotherapy In Locally Advanced Non Small Cell Lung Cancer
Condition: NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, open-label, randomised, phase III study of 2 cycles of oral
      vinorelbine in combination with cisplatin concurrently with radiotherapy randomised to either
      two more cycles of consolidation therapy with oral vinorelbine and cisplatin plus Best
      Supportive Care (BSC) or BSC alone in patients with unresectable locally advanced non small
      cell lung cancer (NSCLC).

      The primary objective is to compare progression-free survival in both arms, the secondary is
      to evaluate the response rate, overall survival in both arms, to evaluate the safety profile
      in both arms and to assess quality of life by the LCSS questionnaire.
    


Intervention name(s): Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose); Oral Vinorelbine and cisplatin with concomitant radiotherapy 66 Gy (total dose)
Intervention type(s): Drug; Drug
Intervention description(s): q 28 days :
50 mg/m2 oral vinorelbine d1, d8, d15
20 mg/m2/d cisplatin from d1 to d4; q 21 days :
60 mg/m2 oral vinorelbine d1,d8 for cycle 1 or 80 mg/m2 oral vinorelbine d1,d8 for cycle 2
80 mg/m2 cisplatin d1
Intervention MeSH terms: Cisplatin; Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Untreated locally advanced inoperable stage IIIA or stage IIIB NSCLC amenable to radical radiotherapy to a dose of 66 Gy
Dapagliflozin Effects on Cardiometabolic Outcomes in Patients With an Acute Heart Attack.
Condition: Acute Myocardial Infarction; Heart Failure
MeSH terms: Heart Failure; Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effect of dapagliflozin versus placebo, given once daily in
      addition to Standard of Care (SoC) therapies for patients with myocardial infarction (MI),
      for hospitalisation for heart failure (HHF), cardiovascular (CV) death, and other
      cardiometabolic outcomes.
    

Detailed description: 
      This is a multicentre, parallel group double-blind, placebo-controlled phase 3 registry-based
      randomised controlled trial (R-RCT) in patients without diabetes presenting with myocardial
      infarction (MI) (ST segment elevation myocardial infarction (STEMI) or non-ST segment
      elevation myocardial infarction (NSTEMI)) and evidence of impaired regional or global LV
      systolic function or definite evidence of Q wave MI on ECG. In the study the effect of
      dapagliflozin versus placebo, given once daily in addition to SoC therapy will be evaluated
      for the hospitalisation for HF, CV death, and other cardiometabolic outcomes.
    

Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dapagliflozin 10 mg tablets given once daily, per oral use; Placebo matching dapagliflozin 10 mg tablets given once daily, per oral use
Other intervention name(s): Forxiga TM; Farxiga TM
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myocardial Infarction; Cardiovascular Outcome Trial