bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of the Effect of Intra Articular Steroid Injection and Pericapsular Nerve Group Block for Hip Osteoarthritis
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The most common cause of hip joint dysfunction in the elderly is degenerative osteoarthritis
      of the hip. Innervation of the hip joint capsule is provided by the obturator nerve, the
      accessory obturator nerve, and the femoral nerve. With pericapsular nerve group block (PENG),
      by blocking the femoral nerve and the accessory obturator nerve, analgesia is successfully
      provided for the hip joint. Intra-articular injection of corticosteroids; It is used as an
      alternative to surgical interventions because it reduces inflammation and short-term pain and
      is a minimally invasive method. The investigators aim to compare and report patients who
      underwent ultrasound-guided intra-articular steroid injection and PENG block in terms of
      post-procedural pain scores and patient satisfaction.
    


Intervention name(s): intraarticular injection; peng block
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound-guided intraarticular injection; Ultrasound-guided PENG block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Losartan and Losartan Plus Isosorbide Mononitrate on Central Blood Pressure Measurements (0954-317)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will qualify a functional model that can measure central blood pressure and
      vascular compliance effects through noninvasive means.
    


Intervention name(s): losartan potassium; Comparator: isosorbide mononitrate (ISMN); Comparator: losartan + ISMN; Comparator: losartan + ISMN; Comparator: Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single dose losartan 100 mg in one of five treatment periods; Single dose ISMN 60 mg in one of five treatment periods; Single dose losartan 100 mg and ISMN 15 mg in one of five treatment periods; Single dose losartan 100 mg and ISMN 60 mg in one of five treatment periods; Single dose placebo only in one of five treatment periods
Other intervention name(s): COZAAR; IMDUR
Intervention MeSH terms: Losartan; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Efficacy and Tolerability of an Intra-Nasal Testosterone Product
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial is being performed to compare the pharmacokinetic profile of testosterone
      after repeated intra-nasal administration of products of different strengths in subjects with
      hypogonadism.
    

Detailed description: 
      Primary Objective:

      The primary objective of this study was to determine the efficacy of Nasobol in the treatment
      of hypogonadal men requiring testosterone replacement therapy. Efficacy was determined by
      establishing a pharmacokinetic profile for serum testosterone levels following Nasobol
      treatment, and comparing it to that of the active control, Androderm®.

      Secondary Objective:

      To establish a safety profile for Nasobol.
    

Intervention name(s): Nasobol®; Androderm® (Positive Control)
Intervention type(s): Drug; Drug
Intervention description(s): Intra-nasal Testosterone (2 syringes), b.i.d.; QD administration
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Hypogonadism; Secondary Hypogonadism
A Study to Evaluate the Efficacy and Safety of CEP-33457 in Participants With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of a 200 micrograms (mcg)
      dose of CEP-33457 compared with placebo in participants with active systemic lupus
      erythematosus (SLE) as assessed by the proportion of participants achieving a combined
      clinical response using the SLE responder index (SRI) at Week 24.
    

Detailed description: 
      The study consisted of a 2-week screening period (visit 1), a 20-week treatment period
      beginning with a baseline visit in which randomization was completed and study drug treatment
      began (visits 2 through 7), and a final assessment was performed 4 weeks after the last dose
      of study drug (visit 8 [week 24 or early termination]). Participants were randomized to
      receive either CEP-33457 or placebo subcutaneously (SC) every 4 weeks. Plasma samples for
      measurement of study drug concentration were collected in a subset of participants and study
      drug was administered at each study visit until the final visit. The dose of background
      steroid medication may have been increased, if needed, to treat the participant for minor
      fluctuations in lupus disease activity. One interim analysis was conducted when at least 80
      participants completed Week 12 or had been withdrawn from the study. Participants who
      completed the treatment period returned to the study center 4 weeks after the last dose had
      been administered for final procedures and assessments. Final procedures and assessments for
      participants who withdrew from the study before 20 weeks of treatment were performed at the
      last visit. Final procedures and assessments for participants who participated in the study
      beyond week 24 were to be performed at the next regularly scheduled visit. Participants who
      complete the study will be eligible for participation in the 12-month open-label study (study
      C33457/3075; herein referred to as study 3075) to assess continued effectiveness and safety
      of the CEP-33457 treatment.
    

Intervention name(s): CEP-33457; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CEP-33457 will be administered per dose and schedule specified in the arm description.; Placebo matching to CEP-33457 will be administered per schedule specified in the arm description.
Other intervention name(s): Lupuzor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lupus
Comparison of Duac® Gel And Differin® Gel in Mild to Moderate Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparing the efficacy and safety of a gel formulation containing a combination of
      clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily
      with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to
      moderate severity.
    

Detailed description: 
      Title: A Multi-Centre, Single-Blind, Parallel Group, Clinical Evaluation of the Efficacy and
      Safety of Duac® Gel (a Gel Containing Clindamycin Phosphate [Equivalent to 1% Clindamycin]
      and 5% Benzoyl Peroxide) And Differin® Gel (a Gel Containing 0.1% Adapalene) in the Topical
      Treatment of Mild to Moderate Acne Vulgaris

      Objectives: To compare the efficacy and safety of a gel formulation containing a combination
      of clindamycin phosphate (equivalent to 1% clindamycin) and benzoyl peroxide (5%) once daily
      with a gel containing 0.1% adapalene once daily in the treatment of acne vulgaris of mild to
      moderate severity.

      Study methodology: Randomised, comparator-controlled, single-blind trial. The Investigators/
      Assessors will be blinded to the treatment received.

      Study population: Male and female patients, aged 12-39, with mild to moderate acne vulgaris.
    

Intervention name(s): Duac® Gel / Differin® Gel
Intervention type(s): Drug
Intervention MeSH terms: Adapalene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Mild to Moderate
Internal Carotid Artery Blood Flow in Robot-Assisted Laparoscopic Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the change of the internal carotid artery blood flow
      according to the steep trendelenburg position and pneumoperitoneum in patients undergoing
      robot-assisted laparoscopic prostatectomy.
    


Intervention name(s): Position
Intervention type(s): Procedure
Intervention description(s): Pneumoperitoneum with Steep Trendelenburg position
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer
Pulsed Electromagnetic Field Therapy Versus Transcutaneous Electrical Nerve Stimulation in on Post-herpetic Neuralgia of the Sciatic Nerve
Condition: Neuralgia,Postherpetic
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional

Summary: 
      Background and purpose: Post-herpetic neuralgia (PHN) is the most frequent chronic
      complication of herpes zoster, resulting in post- infectious severe neuropathic pain. Due to
      drug resistance severe pain; patients with PHN suffer from reduced physical activities,
      social and psychological manifestations as well as decrease in the quality of life. The
      purpose of this research was to evaluate the efficacy of pulsed electromagnetic field therapy
      (PEMFT) versus transcutaneous electrical nerve stimulation (TENS) in the treatment of
      post-herpetic neuralgia of the sciatic nerve.

      Methods: In an eight weeks period of treatemnt, 52 patients were randomly and equally
      assigned into two groups. Both groups received conventional physical therapy treatment
      protocol. Moreover, group (A) has an additional TENS application and group (B) had PEMFS
      application. TENS and the PEMFT were applied once daily, three times per week for 20 minutes
      for each session. Assessment performed pre and post intervention using visual analogue scale
      (VAS) and estimation of the carbamazepine intake (CMI).
    


Intervention name(s): Electromagnetic field therapy and transcutaneous electrical nerve stimulation
Intervention type(s): Other
Intervention description(s): Both groups received conventional physical therapy treatment protocol. Moreover, group (A) has an additional TENS application and group (B) had PEMFS application. TENS and the PEMFT were applied once daily, three times per week for 20 minutes for each session. Assessment performed pre and post intervention using visual analogue scale (VAS) and estimation of the carbamazepine intake (CMI).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
MR Spectroscopy and Disease Severity Score for Gaucher in Pediatric Population
Condition: Gaucher
Study type: Observational

Summary: 
      The bone status in Gaucher disease is very difficult to monitor precisely in children. This
      is a major problem because lack of optimal treatment, especially enzyme replacement, may
      cause irreversible severe bone damage that will impact an affected person's life. Currently,
      there are qualitative (subjective) methods, such as Magnetic resonance Imaging (MRI), to
      gauge the response to treatment. A quantitative (objective) measurement of Gaucher cell
      presence and activity in bone marrow could help with more precise and accurate monitoring of
      bone marrow disease in patients both treated and not (yet) being treated with enzyme
      replacement. The investigators will evaluate the efficacy of Magnetic Resonance Spectroscopy
      (MRS) as a quantitative assessment of bone marrow involvement in Children with Gaucher, and
      examine how this result correlates with semiquantitative MRI scales and overall disease
      severity.
    

Detailed description: 
      To quantify the amount of fat in the bone marrow of affected subjects and healthy controls
      the investigators will use Single voxel short, echo time(TE) proton spectroscopy. This MR
      Spectroscopy (MRS) will be conducted in the vertebral body of L5 and in the neck of the
      femur.

      To assess the qualitative scores and compare it to the quantitative MR Spectroscopy (MRS)
      results the investigators will use a series of Fluid sensitive and Fat sensitive conventional
      MR sequences that will allows us to determine indirectly the degree of glucocerebrosidase
      infiltration.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will enroll patients with a Diagnosis of Gaucher disease. Subjects will be between 5 and
        20 years of age. We will recruit an equal number of age and gender matched healthy
        volunteers.
      
Keywords: Lysosomal diseases; Magnetic resonance Spectroscopy; MRI
Osteocel® Plus in Anterior Cervical Discectomy and Fusion (ACDF)
Condition: Degenerative Disc Disease in Cervical Spine
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      This is a prospective, non-randomized multi-center study to compare the use of Osteocel Plus
      in subjects who receive ACDF surgery at one or two levels. These subjects will present with
      degenerative conditions in the cervical spine that are amenable to surgical treatment and
      will be screened prior to study enrollment. Subjects will receive Osteocel Plus, without any
      other biologic product, during their ACDF operation. The ACDF procedure will be conducted
      with a radiolucent graft containment device such that progression of fusion can be adequately
      assessed via radiograph. Subjects will be followed for 24-months following surgery to
      determine the number of study subjects that are solidly fused at or before 24 months
      postoperatively, and to determine the mean time to fusion. This data will be compared to
      published and/or retrospective data for autograft, synthetic ceramics and Bone Morphogenetic
      Protein (BMP).
    

Detailed description: 
      A total of 175 subjects will be selected for enrollment in this study from multiple centers.
      The subjects will have degenerative conditions in the cervical spine and will be undergoing
      ACDF surgery as treatment at one or two levels. The following eligibility criteria are
      designed to select subjects for whom protocol treatment is considered appropriate. All
      relevant medical and non-medical conditions should be taken into consideration when deciding
      whether this protocol is suitable for a particular subject.
    

Intervention name(s): Biologic - Osteocel Plus
Intervention type(s): Biological
Intervention description(s): Osteocel Plus
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Existing clinic patients
      
Keywords: cervical spine; ACDF; biologics; fusion rates
Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      Aims:

        -  To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD).

        -  To compare the results of capsule colonoscopy with conventional colonoscopy in assessing
           mucosal healing.

        -  To correlate the level of faecal calprotectin with the results of capsule colonoscopy
           and conventional colonoscopy.

        -  To document changes in clinical practice attributable to the capsule colonoscopy
           findings a) concordant with and b) in addition to the parallel findings at colonoscopy
           and ileoscopy.

      Project design: Cross sectional, prospective, comparative study

      Methodology: Patients of the Royal Melbourne Hospital (RMH) and other associated speciality
      clinics with an established diagnosis of CD who need assessment of mucosal healing and have
      consented to be part of the study will undergo capsule colonoscopy and conventional
      colonoscopy on the same day after undergoing bowel preparation. The images of both the
      conventional and capsule colonoscopies will be recorded. In addition calprotectin (an
      inflammatory marker in faeces) will be measured in a sample of faeces collected by the
      patients prior to the colonoscopy day.

      Professor Macrae and the scholarly selective student researcher will assess the recorded
      images obtained from capsule colonoscopies once the images have been deidentified.

      To assess the level of mucosal disease they will use the Simple Endoscopic Score for CD
      (SESCD).

      The results of the assessment of mucosal healing obtained from conventional colonoscopy will
      be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be
      correlated.
    


Intervention name(s): PillCam® COLON 2 Capsule Endoscopy
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Optimization of Vonoprazan--amoxicillin Dual Therapy for Eradicating Helicobacter Pyloriinfection
Condition: Helicobacter Pylori Eradication Rate
Study type: Interventional
Phase: Phase 3

Summary: 
      Helicobacter pylori infection is closely related to gastritis, peptic ulcer,
      mucosa-associated lymphoid tissue lymphoma and gastric cancer. Eradication of HP can
      significantly improve and reduce HP-related diseases. International and domestic guidelines
      recommend a 10-14 day quadruple regimen containing bismuth as first-line treatment, achieving
      an eradication rate of more than 80%. However, some disadvantages of these quadruple
      regimens, such as severe adverse reactions, high medical costs and low compliance, prevent
      their application in clinical practice. Studies at home and abroad have shown that high-dose
      proton pump inhibitors combined with amoxicillin can be used as the first-line treatment for
      HP eradication, with good efficacy and compliance and low rate of adverse reactions. And
      because it is a single antibiotic therapy, we do not expect this regimen to increase
      antibiotic resistance rates for HP. The maintenance of gastric PH > 6 is one of the key
      factors for HP eradication. The acid inhibition effect of proton pump mainly depends on the
      degree of individual metabolism of proton pump. Vonoprazan fumarate, a new competitive
      potassium acid blocker, is not affected by gene polymorphism, and has the advantage of
      stronger and longer inhibition effect on gastric acid compared with proton pump inhibitors.
      In most parts of China, HP is characterized by high infection rate and antibiotic resistance
      rate, requiring higher eradication rate and safety regimen.This study aimed to evaluate two
      different amoxicillin dosages

      (1 g b.i.d. vs. 0.75 g q.i.d.) and two different durations of therapy (14 vs.10 days) to gain
      insights of the effectiveness of VA dual therapy .
    


Intervention name(s): vonoprazan fumarate + high dose amoxicillin（H-10d）; vonoprazan fumarate + low dose amoxicillin（L-10d); vonoprazan fumarate + amoxicillin（H-14d)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral, for 10d; vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin1000mg/ time, 2 times/day, oral, for 10d; vonoprazan fumarate 20 mg/time, 2 times/day, oral Amoxicillin 750mg/ time, 4 times/day, oral, for 14d
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of PRP on Diabetes Wound
Condition: Diabetic Ulcers on Both Feet
Study type: Interventional

Summary: 
      The purpose of this study is to focus on the effect of platelet-rich-plasma on diabtic ulcer
      foot, as adjuvant treatment along with the standard care of chronic diabetic, and evaluate
      the efficiency and the clinical application of PRP on serious wound healing.
    

Detailed description: 
      Diabetes is a condition in which the body dose not effectively use sugar so that there is too
      much sugar in the blood. It is estimated that 15% of the diabetics suffer from diabetic food
      ulcers at some point. The healing process can be slow and easily to be infected with some
      pathogens so the patients are at risk in amputation. The wound healing process is a complex
      mechanism involves the interaction of molecular signals and different cell types. Platelets
      play important roles in wound healing. When injury occurs platelets are activated with
      thrombin and clot is formed. In addition to the function of hemostasis, activated platelets
      release many growth factors that trigger angiogenesis, extracellular matrix production and
      cytokine release, which is need for wound healing.

      Platelet-rich plasma (PRP) is a portion of plasma fraction of autologous blood having a high
      concentration of thrombocytes. Thrombin induces the activation of PRP and results in the
      release of multiple growth factors, including platelet-derived growth factor (PDGF), vascular
      endothelial growth factor (VEGF), epidermal growth factor (EGF), insulin-like growth factor
      (IGF), and transforming growth factor beta (TGF-β). PRP is known for the capacity to
      stimulate cell proliferation and differentiation. PRP can also interact with macrophage to
      improve tissue healing and regeneration, and exhibit potent activities against several kinds
      of pathogens.

      Our study will focus on the advantage of PRP for aiding wound healing for diabetes. PRP from
      autologous blood can be mixed with thrombin in appropriate ratio and inject into the sites
      around the wound, as adjuvant treatment along with the standard care of chronic diabetic. The
      wound will be checked 1 to 2 times each week for the evaluation of PRP on clinical
      application.
    

Intervention name(s): wound healing
Intervention type(s): Other
Intervention description(s): wound healing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment