bioihbjkbjnl/mcl2 huggingface dataset:
EVALUATION OF AN INNOVATIVE TREATMENT FOR RADIOCARPAL OSTEOARTHRITIS USING INTRA-ARTICULAR INJECTION OF A MIXTURE OF AUTOLOGOUS MICROFAT AND AUTOLOGOUS PLATELET-RICH PLASMA
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Recently, the emergence of biotherapies has allowed the use of intra-articular injections of
      autologous plasma rich platelet (PRP). Their use is widespread since 2010 and is based on the
      demonstration that platelets-enriched plasma, by virtue of its growth factors concentration,
      stimulates in vitro and in vivo cartilage regeneration in preclinical models. Recent
      literature highlights that these autologous products are very well tolerated by humans. PRP,
      as an intra-articular injection therapy, seems to be an autologous biological medicine,
      innovative for cartilage injury reparation and showing good primary results for this
      indication.

      Adipose tissue contains stromal-vascular fraction (SVF), in which are located a large
      proportion of mesenchymal multipotent stem cells (Adipose-derived stem cells, ADSCs) able to
      differentiate into several cellular lines in vitro and in vivo, including cartilage cells.

      The association of microfat and PRP is interesting in order to potentiate trophic and
      regenerative effects on damaged cartilage site. The combination of these two products,
      respectively rich in autologous multipotent stem cells and growth factors, aims to create an
      optimal environment for cartilage cells regeneration. Furthermore, microfat semi solid phase
      is playing the role of a nutritive support matrix which contains and limits the diffusion and
      resorption of PRP liquid while allowing progressive growth factors release on the injection
      site.

      The hypothesis of this project is that standardized injection of an innovative treatment
      (microfat and autologous PRP) should allow delay the use of invasive surgical therapy in the
      treatment of wrist osteoarthritis. This minimally invasive treatment could provide a curative
      second line treatment in case of medical treatment failure.
    

Detailed description: 
      Material and methods:

      This research protocol aims to evaluate the safety of intra-articular injection of a mixture
      of autologous microfat associated with autologous PRP for radiocarpal osteoarthritis
      resistant to medical treatment.

      This is a prospective, longitudinal, intrasubject, single-center clinical trial phase I-IIa
      evaluating the safety and feasibility of this innovative treatment.

      Twelve patients will receive an intra-articular injection of 4 ml of an homogeneous mixture
      of autologous PRP (2ml) and microfat (2ml).
    

Intervention name(s): injection of microfat and plasma rich platelet PRP; MRI
Intervention type(s): Drug; Device
Intervention description(s): intra-articular injections; MRI 3T
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reshaping Exercise Habits and Beliefs (REHAB)
Condition: Cerebrovascular Accident; Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Regular exercise has been demonstrated to improve muscle strength, balance, coordination as
      well as improve cardiovascular fitness levels and overall quality of life in stroke
      survivors. This study is designed to test the feasibility and effectiveness of a 12-week
      intervention to education and encourage stroke survivors to exercise following discharge from
      rehabilitation settings using a walking program and targeted functional activity homework.
    


Intervention name(s): Exercise; Stroke education
Intervention type(s): Behavioral; Other
Intervention description(s): Home-based exercise prescriptions with weekly motivational telephone calls.; Stroke education program with matched attention phone calls
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Exercise; Rehabilitation; Stroke
ER-One: A Double-blind Trial of Erector Spinae Block (ESP) Versus Paravertebral Block (PVB) Before Breast Cancer Surgery
Condition: Breast Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      The block (ESP or PVB) will be performed preoperatively in the recovery room under standard
      monitoring. After setting a peripheral venous access, patient will be installed on lateral
      decubitus position on the opposite side of the block.
    

Detailed description: 
      The block will be performed with IV Remifentanil sedation Target-Controlled Infusion mode at
      2ng/ml and oxygen therapy.

      For the erector spinae plane block:

      The puncture will be performed with ultrasound guidance. The ultrasound probe will be placed
      parallel to the spine parasagittally at the T3 transverse process level. The needle will be
      introduced and visualized to the plane of the ultrasound image ("in plane").

      The desired injection site is between the fascia of the erector muscle of the spine and the
      transverse process at the T3 level. The operator ensures the correct localization of the
      needle with saline solution. Then 0.50% Ropivacaine hydrochloride will be injected at a dose
      of 0.6 ml/kg of actual weight, without exceeding 30 ml.

      For paravertebral block:

      The T2 intervertebral space will be located by identifying compared to C7, a prominent
      cervical vertebra, or by ultrasound by counting the thoracic vertebrae from the first rib.
      The paravertebral space will be identified by placing the ultrasound probe in a parasagittal
      or transverse position. The needle will go through the paravertebral muscles and the
      costo-transverse ligament or by a latero-medial approach using ultrasound. The block will be
      performed using a 22-gauge 8cm long needle. When the paravertebral space has been reach, an
      aspiration test will be performed and then 0.6 ml/kg of solution (Ropivacaine hydrochloride
      solution at 5 mg/ml up to 30 ml) will be injected.
    

Intervention name(s): Ropivacaïne Hydrochloride by Erector Spinae block; Ropivacaïne Hydrochloride by Paravertebral block
Intervention type(s): Drug; Drug
Intervention description(s): Ropivacaïne Hydrochloride Erector Spinae puncture will be performed with ultrasound guidance. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml.; Paravertebral puncture will be performed with ultrasound guidance. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml.
Other intervention name(s): Naropin; Naropin
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Double-blind Randomized non-inferiority Trial of erector spinae block (ESP) versus paravertebral block (PVB)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Breast; Surgery; anaesthetics
Lofexidine for Adults Undergoing Lumbar Spine Surgery
Condition: Opioid Withdrawal
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to investigate the effects of lofexidine in adults undergoing opioid
      tapering prior to elective lumbar spine surgery.
    

Detailed description: 
      In this clinical trial, an open label design will be used to facilitate opioid tapering
      during a 12-day period prior to elective spine surgery. The primary outcome measure of this
      study is the number of patients who achieve a 50% reduction in daily opioid dose at day 12.
    

Intervention name(s): Lofexidine Oral Tablet
Intervention type(s): Drug
Intervention description(s): lofexidine 0.54 mg 4 times daily
Intervention MeSH terms: Lofexidine
Intervention model: Single Group Assignment
Intervention model description: Open label design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid tapering; Spine surgery
Pharmaceutical Follow-up of Coronary Heart Disease (CHD) Patients
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      Objectives To explore the impact of a clinical pharmacist-led 12 month lasting follow-up
      program for patients with established coronary heart disease (CHD) discharged from the North
      Norway University Hospital. Methods A total of 102 patients aged 18-82 years were enrolled in
      a non-blinded, randomized controlled trial. The intervention comprised medication
      reconciliation, medication review and patient education during three meetings; at discharge,
      after three months and after twelve months. The control group received standard care from
      their general practitioner. Primary outcomes were adherence to clinical guideline
      recommendations concerning prescription, therapy goal achievement and lifestyle education
      defined in the medication assessment tool for secondary prevention of CHD (MAT-CHDSP).
      Secondary outcomes included changes in the biomedical risk factors cholesterol, blood
      pressure and blood glucose. Key findings Ninety-four patients completed the trial, 48
      intervention group patients and 46 controls.

      Appropriate prescribing was high, but therapy goal achievement was low in both study groups
      throughout the study. Overall adherence to MAT-CHDSP criteria increased in both groups and
      was significantly higher in the intervention group at study end compared to the control
      group, 78.1% vs. 61.4%, P < 0.001. The difference was mainly due to an increased
      documentation of lifestyle advices in intervention group patients.

      No significant improvements in biomedical risk factors were observed in favor of the
      intervention group, possible due to an underpowered study. Conclusion The clinical
      pharmacist-led follow-up program significantly increased documented lifestyle advices defined
      in the MAT-CHDSP for the intervention group, but did not lead to significant improvements in
      biomedical risk factor measures in favor of the intervention group. Even if prescribing was
      high, therapy goal achievement was low in both study groups. Changes to the follow-up program
      are warranted, in addition to a larger, adequately powered study, before implementation in
      standard patient care can be recommended.
    

Detailed description: 
      Find published article in Pharm Pract (Granada). 2015 Apr-Jun; 13(2): 575.
      https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482847/pdf/pharmpract-13-575.pdf
    

Intervention name(s): Pharmacist follow-up
Intervention type(s): Other
Intervention description(s): Drug review, drug conversation and written drug information. Follow-up concerning therapeutic goals and cooperation with the patient and the patient's GP to achieve these.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Preventive Health Services
Internet-based Cognitive Behavioural Treatment for Chronic Back Pain
Condition: Back Pain Lower Back Chronic
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      The aim of this study was to investigate whether an Internet-based cognitive behavioural
      intervention would have an effect on the symptoms of chronic back pain.
    

Detailed description: 
      All participants were screened in a live, structured interview before inclusion. It´s a
      experimental design with a treatment and a control group measured before and after a
      treatment period.
    

Intervention name(s): Guided Internet-based cognitive behavioural treatment
Intervention type(s): Behavioral
Intervention description(s): Eight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic back pain; internet based treatment; pain management programme; cognitive behavioural therapy; minimal therapist contact
A Biospecimen and Clinical Data Study on Patients for Drug & Biomarker Discovery
Condition: Alzheimer's Disease; Multiple Sclerosis; Parkinson's Disease; Huntington's Disease; Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Parkinson Disease; Multiple Sclerosis; Alzheimer Disease; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Huntington Disease; Sclerosis
Study type: Observational

Summary: 
      The purpose of this research project is to collect and store blood samples and clinical data.
      Researchers can then use the stored samples in future studies. Through such studies, they
      hope to find new ways to detect, treat, and maybe even prevent or cure health problems.
    

Detailed description: 
      Blood samples are collected in the comfort and safety of your home by a certified medical
      professional. We have mobile phlebotomists located in major metropolitan areas around the
      nation for your convenience.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A diagnosis of Multiple Sclerosis, Alzheimer's, Huntington's, or Parkinson's Disease.
      
Keywords: Alzheimer's Disease; Multiple Sclerosis; Parkinson's Disease; Huntington's Disease; Amyotrophic Lateral Sclerosis (ALS)
Music Therapy for Pain Modification in Pediatric Palliative Care
Condition: Neurological Impairment
MeSH terms: Neurologic Manifestations
Study type: Interventional

Summary: 
      The purpose of this within-subjects randomized controlled trial is to determine whether two
      music therapy interventions are efficacious in reducing pain symptoms, in order to improve
      the quality of care for children in pediatric hospice. The investigators hypothesize that
      both music therapy interventions, live guitar and vocal intervention and vibroacoustic
      intervention, will reduce behavioural pain scores and that behavioural pain scores will
      correlate with physiological outcome measures.
    

Detailed description: 
      Effective pain management in pediatric palliative care is a quality of life issue for
      patients, families and professionals. Current research supports the use of music therapy to
      assist with pain management in pediatric medical settings. However, little research has been
      done to explore the use of music therapy for reducing pain in children with life-limiting
      neurological impairments or metabolic conditions.

      As the first known project to examine the effects of music therapy on pain symptoms with
      children who have life-limiting neurological impairments or metabolic disorders, this study
      will expand the evidence-base for practice with this population. It is imperative that an
      evidence base for music therapy in this area be established, so that the most effective
      interventions can be provided to these vulnerable children.
    

Intervention name(s): Live guitar and vocal music therapy; Vibroacoustic Music Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Live guitar and vocal music therapy. Subject is passive recipient for 30 minutes.; 30 minutes using vibroacoustic mat.
Other intervention name(s): Somatron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Music therapy; Infants; Children; Adolescents; pediatric; palliative care; neurological impairment; metabolic condition; pain management
Dietary Fiber and Hyperkalemia in Dialysis Patients
Condition: Hyperkalemia; Hemolysis
MeSH terms: Hyperkalemia; Hemolysis
Study type: Observational

Summary: 
      To analyze the dietary nutrition and dietary fiber (DF) intake of maintenance hemodialysis
      (MHD) patients, and explore the effect of dietary nutrition and DF intake balance on the
      nutritional status and pre-dialysis hyperkalemia of MHD patients.
    

Detailed description: 
      A total of 100 MHD patients were retrospectively enrolled, including 67 males and 33 females.
      The daily diet was recorded by 3-day dietary recording method. The daily average dietary
      nutritional intake and DF intake of MHD patients were calculated by professional software.
      Dietary guidance and analysis were conducted according to the Expert Consensus on Nutrition
      in Chronic Kidney Disease (2005) and the Dietary Guidelines for Chinese Residents (2016). Of
      the 100 patients, 37 had hyperkalemia (serum potassium > 5.5 mmol/L) before dialysis.
    

Intervention name(s): dietary fiber
Intervention type(s): Other
Intervention description(s): Retrospective analysis of the relationship between patient dietary fiber intake and hyperkalemia
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients undergoing hemodialysis
Minocycline and/or Omega-3 Fatty Acids Added to Treatment as Usual for At Risk Mental States
Condition: At Risk Mental State (ARMS); Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized double-blind placebo controlled trial which aims to evaluate the
      efficacy and tolerability of minocycline and Omega-3 fatty acids for patients with ARMS.
      Specifically to determine whether the addition of minocycline and / or Omega-3 fatty acids to
      Treatment as Usual in an operationalized ARMS population in Pakistan:
    

Detailed description: 
      Primary hypothesis is that the persons with ARMS who are prescribed minocycline and / or
      Omega-3 fatty acids will have reduced transition rates to psychosis over a one year follow up
      period (from baseline) compared with Treatment-As-Usual (TAU). The transition rates will be
      lowest in the group receiving minocycline and Omega-3 fatty acids in combination.

      Secondary objective is to determine that the Persons with ARMS who are prescribed minocycline
      and / or Omega-3fatty acids in combination will have greatest symptom reduction compared with
      TAU.

      This study will be a six-month intervention of minocycline and/or Omega-3 fatty acids added
      to TAU in patients with ARMS, using a randomised, placebo-controlled, double-blind factorial
      design.The study will be a four-arm trial: one arm will receive minocycline with TAU; the
      second arm will receive Omega-3 fatty acids with TAU; the third arm will receive both
      minocycline and Omega-3 fatty acids with TAU; the fourth arm will receive placebo with TAU.
    

Intervention name(s): Minocycline; Omega-3 fatty acids; Placebo; Minocycline Plus Omega-3 fatty acids
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Minocycline added to TAU Minocycline will be administered in 200mg once daily dose; Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2g once daily dose; Placebo added to TAU; Minocycline will be administered in 200mg once daily dose and Omega-3 fatty acid 1.2g taken as once daily dose
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: At Risk of Mental State; Prodromal Phase; Psychosis
Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy
Condition: Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients
      With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy
    

Detailed description: 
      Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and
      Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory
      Demyelinating Poly(radiculo)neuropathy ("ProCID trial")
    

Intervention name(s): NewGam
Intervention type(s): Drug
Intervention description(s): In the Dose-evaluation Phase, all patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5, 1.0 or 2.0 g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days). If a patient is randomized to receive the low or medium NewGam dose, the same volume with the same infusion rate as would have been applied in case the patient would have been randomized to 2.0 g/kg NewGam will be used, thus supplemented with an authorized 0.9% w/v isotonic sodium chloride solution as appropriate and detailed in the following infusion bag split to maintain the blinding
Other intervention name(s): Panzyga
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Inflammatory Demyelinating Poly Neuropathy (CIDP)
Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects
Condition: Immune System Disorder
MeSH terms: Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This healthy male volunteers study will evaluate 148 subjects who will receive a single
      sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or
      Adalimumab(Humira,China spourced,40 mg/0.8 mL injection with a single-use prefilled syringe).
      This study will involve sampling,pharmacokinetics, safety, tolerability and immunogenicity
      evaluation of drug levels following administration of HLX03 and the licensed adalimumab
      products.
    

Detailed description: 
      This is a randomized, doubl-blinded, parellel-controlled phase 1 PK, safety, tolerability and
      immunogenicitiy study to compare HLX03, designed as an Adalimumab biosimilar, with China
      sourced Humira in Chinese health volunteers. All enrolled subjects will receive a single dose
      of HLX03 (40 mg）or Humira(adalimumab, 40 mg) in subcutaneous injectioin after randomization.

      The purpose of this study to prove the similarity in PK, Safety, tolerability and
      immunogenicity beween HLX03（adalimumab biosimilar） and China sourced Humira and provide
      evidence for Phase III comparison study.

      The blood will be collected before drug administration, and at 1 hr、4 hr、8 hr、24 hr (1d)、48
      hr (2d)、72 hr (3d)、96 hr (4d)、、144 hr (6d)、192 hr (8d)、240 hr (10d)、 336 hr (14d)、504 hr
      (21d)、672 hr (28d)、840 hr (35d)、1008 hr (42d)、1176 hr (49d)、1344 hr (56d)、1680 hr (70d) after
      drug injection for PK, ADA, etc analysis. All subjects also will be followed up at 0,
      1,2,3,4,6,8,10,14,21,28,35, 42, 49, 56, and 70 days after drug administration for AE and
      other specified outcomes.

      The main endpoint is AUC from time zero to ∞. The second endpoints include Cmax, Tmax, T1/2,
      CL, Vd and AUC（0-last）.

      This is single center study in China.
    

Intervention name(s): HLX03; adalimumab
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 40 mg HLX03 in 0.8 mL in subcutaneous injection.; A single dose of 40 mg Humira in 0.8 mL in a pre-filled syringe
Other intervention name(s): adalimumab biosimilar; Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HLX03; adalimumab; pharmacokinetics; biosimilar