bioihbjkbjnl/mcl2 huggingface dataset:
Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture
Condition: Achilles Tendon Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The aim of this study is to investigate the feasibility of an early progressive exercise
      program for patients with Achilles tendon rupture treated non-surgically. The outcomes will
      concern the patient's acceptability of the intervention, adherence to the intervention and
      safety of the healing tendon.
    

Detailed description: 
      Regardless of choice of either surgical or non-surgical treatment, long-term muscular
      deficits and a decreased function after Achilles tendon rupture is found up to 10 years
      later. The majority of the patients are of working age and a deficit in physical performance
      will have impact on returning to work and sports.

      There has been promising results in treatments using early functional rehabilitation during
      the first eight weeks of treatment after both surgical and non-surgical treatment, but few
      studies has examined the effect of the exercises on its own. In general, descriptions of the
      exercise programs are lacking important information such as type, time of application,
      frequency, intensity and progression of the exercises.

      The primary aim is to test the feasibility of an early progressive exercise program for
      patients with Achilles tendon rupture treated non-surgically. Feasibility in this study will
      be defined as successful patient acceptability and compliance of the exercise intervention.
    

Intervention name(s): Resistance training
Intervention type(s): Other
Intervention description(s): Weekly sessions introducing resistance exercises and monitoring the patients acceptability. The exercises are isometric contractions, seated heel-rise and elastic band. The patient register the amount of exercise in a home exercise journal. To protect the tendon while doing range of motion of the foot, dorsiflexion is restricted beyond neutral (0 degrees of dorsiflexion). The load on the strength exercises will progress from isometric contraction without external load to strengthening exercises with 10-20 RM (RM: Repetition Maximum). Each strength exercise can progress with added weight or stronger elastic band. The Borg scale is used to guide the patient to progress or regress the load in each exercise. The recommended level being "easy" to "hard" (2-5/10). It is emphasised that the exercises must not cause sudden or severe pain in the tendon, but muscle soreness is to be expected.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Supporting Decisions With Transcranial Direct Current Stimulation in Healthy Young and Elderly Individuals
Condition: Real tDCS; Sham tDCS
Study type: Interventional

Summary: 
      Decisions are part of the daily life. On the neuronal level, activity in the dorsolateral
      prefrontal cortex (dlPFC) is important during complex decisions (e.g., whether something is
      emotional for a person or not). We apply transcranial direct current stimulation (tDCS) with
      the aim to increase dlPFC activity and thereby modulate decisions towards emotional content.
    


Intervention name(s): real anodal transcranial direct current stimulation; sham transcranial direct current stimulation
Intervention type(s): Device; Device
Intervention description(s): A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.; A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are allocated to one of 2 groups: real tDCS or sham.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: tDCS
Young Goalkeeper's Fracture: Radiographic Findings
Condition: Radius Fractures
MeSH terms: Fractures, Bone; Radius Fractures
Study type: Observational

Summary: 
      The aim of this project is to evaluate retrospectively goalkeeper's fractures in children
      using the children fracture classification and to evaluate the distal radius tilt angle of
      the growth plate on plain radiographs of the forearm.

      Patients positive for goalkeeper's fracture will prospectively answer a questionnaire
      concerning risk factors and circumstances during the injury.
    

Detailed description: 
      Distal forearm or radius fractures in young goalkeepers have been named "the young
      goalkeeper's fracture" in the literature. While catching the soccer ball the child suffers a
      distal forearm fracture due to axial forces to the immature bone of the child. These
      goalkeeper's fractures on radiographs may be subtle or difficult to discriminate from normal
      radiographs.

      Retrospective study for the evaluation of radiographs of the forearm from 2005 - 2016 of
      children with history of catching a ball. Two radiologist are blinded for history, age, name
      and findings on final reports.

      First reading without measurement of distal tilt angle, second reading with measurement of
      distal tilt angle and after consensus meeting.

      Questionnaire: prospectively all patients with goalkeeper's fracture will answer a
      questionnaire concerning circumstances and risks during the accident.
    

Intervention name(s): Radius tilt angle
Intervention type(s): Other
Intervention description(s): Fracture classification in children. Tilt angle measurement of the distal radius growth plate.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Distal radius fracture in young goalkeepers (=young goalkeeper's fracture)
      
Keywords: goalkeeper's fracture
Pharmacokinetics of Micafungin During Continuous Venovenous Hemofiltration
Condition: Candida Sepsis
Study type: Interventional
Phase: Phase 4

Summary: 
      Micafungin is a cyclic lipopeptide antifungal agent of the echinocandin class. Members of
      this class of antifungal agents are known to inhibit the synthesis of glucan polymers in
      fungal cell walls. The spectrum of activity of micafungin includes Candida (all species,
      including strains resistant to fluconazole), Aspergillus, and Pneumocystis.

      In intensive care patients continuous venovenous haemodiafiltration (CVVHDF) is a
      well-established extracorporal renal replacement therapy with a high clearance rate.

      Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVHDF
      are rare. Elimination of any given drug by renal replacement therapy is determined by several
      major factors which are membrane specific, due to physico-chemical properties of the drug and
      characteristics of the renal replacement technique used.

      Ten intensive-care patients with acute renal failure and suspected or proven candida
      infection are included into the study.

      100 mg Micafungin will be infused over a period of sixty minutes via a central venous
      catheter, different from the venous catheter used for CVVHDF. Blood samples will be drawn on
      days 1 and 2 from the arterial and venous line of the extracorporeal circuit at 0, 2, 4, 6, 8
      and 24h after starting the infusion. Plasma and ultrafiltration samples, collected from the
      outlet of the ultrafiltrate compartment of the hemofilter, will be taken at corresponding
      times.

      The following pharmacokinetic parameters will be determined: area under the curve (AUC),
      half-live (t1/2), maximum plasma concentration (Cmax) and elimination fraction.
    


Intervention name(s): Micafungin
Intervention type(s): Drug
Intervention description(s): Measurement of PK
Intervention MeSH terms: Micafungin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effects of LCI699 on Cortisol in Participants With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study determined the maximum dose of LCI6999 with respect to effect on the
      ACTH-stimulated cortisol response in participants with hypertension.
    


Intervention name(s): LCI699-matching placebo; LCI699
Intervention type(s): Drug; Drug
Intervention description(s): LCI699-matching placebo oral capsules; LCI699 oral capsules
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Blood Pressure; Hypertension; Cortisol
Comparing Patient-Centered Outcomes After Treatment for Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Study type: Observational

Summary: 
      The purpose of this observational, retrospective database study of patients with uterine
      fibroids is to compare the durability of symptom relief after uterus-conserving treatments
      for symptomatic fibroids in terms of incidence of, and time to, new or recurrent symptoms and
      subsequent procedures and evaluate the effect stakeholder participation had on the research
      process.
    


Intervention name(s): myomectomy; endometrial ablation; uterine artery embolization; MRI-guided focused ultrasound ablation
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Myomectomy as part of routine clinical care; Endometrial ablation as part of routine clinical care; Uterine artery embolization as part of routine clinical care; MRI-guided focused ultrasound ablation as part of routine clinical care
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patient population for the retrospective data analysis was uterine fibroid patients who
        have a record of at least 1 of the procedures of interest occurring during the time period
        of January 1, 2005 - December 31, 2011, with the first instance being designated as the
        index date. The study time period spanned from January 1, 2004 - December 31, 2013 to allow
        for 12 months pre-index for evaluating baseline demographic and clinical characteristics
        and 24 months post-index, ensuring a minimum of 2 years follow-up.
A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine
Condition: Haemophilus Influenza
MeSH terms: Influenza, Human; Haemophilus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Haemophilus influenza type b (Hib) remains a serious global health threat associated with
      high mortality and morbidity in young children. In China, The overall impact of Hib-related
      infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally,
      vaccination has been considered the most effective way to prevent infection against Hib.In
      order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib)
      conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a phase III clinical
      trial is planned to conduct in healthy infants and children in China.
    

Detailed description: 
      Haemophilus influenza type b (Hib) remains a serious global health threat associated with
      high mortality and morbidity in young children. In China, The overall impact of Hib-related
      infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally,
      vaccination has been considered the most effective way to prevent infection against Hib.In
      order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib)
      conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a randomized,
      positive-controlled, non-inferiority phase III clinical trial is planned to conduct in
      healthy infants and children in China.
    

Intervention name(s): Hib conjugate vaccine
Intervention type(s): Biological
Intervention description(s): Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Management of Pes Planovalgus With Talocalcaneal Coalition ,Osteotomy vs Arthroereisis
Condition: Talocalcaneal Bar; Pes Planus
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      the investigators compare the corrective osteotomies vs arthroereisis in management of
      talcalcaneal coalition in adolescents as regard the outcome to provide the best intervention
      for the patient
    

Detailed description: 
      In talocalcaneal coalition management is controversial so in this study the invstigators try
      to compare techniques other than coalition excision only or fusion only by using two types of
      intervention including first coalition excision and multiple corrective osteotomies according
      to deformity as evans ,medial displacement calcaneal osteotomy and cotton osteotomy vs
      coalition excision and arthroereisis the investigators compare functional and radiological
      outcomes and complication to provide the best management for these patients .
    

Intervention name(s): Coaltion excision and arthroereisis; Coalition excision and corrective osteotomies
Intervention type(s): Procedure; Procedure
Intervention description(s): Both done to treat rigid flat foot with talocalcaneal coalition. Talocalcaneal coalition excision and management of rigid pes planovalgus in adolescent; Both done to treat rigid flat foot with talocalcaneal coalition. Talocalcaneal coalition excision and management of rigid pes planovalgus in adolescent
Other intervention name(s): Coalition excision and corrective osteotomies
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups one with the first intervention arthroereisis and bar excision the second with bar excision and osteotomies it may be one or multiple
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Two Methotrexate in Sync With the First Adalimumab to Prevent the Immunisation Anti Ada in Spondyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis
Study type: Interventional

Summary: 
      Preliminary report have demonstrated that methotrexate induces an anti bio-medicament
      tolerization whan administrated just before the first administration of the bio-medicament.
      Once this tolerization is obtained it seems useless to continue the methotrexate because this
      treatment has no efficacity in cases of spondyloarthritis.
    

Detailed description: 
      spondyloarthritis are treated in first intention by NSAIDs but in case of inefficacity
      biotherapies that inhib the TNF are used. Adalimumab is the most used anti TNF in this
      indication. Monoclonal antibody uses in therapy is immunogene, and there is a clear link
      between increase of anti drug antibody and in one hand decrease of drug serum concentration
      and in an other failure of the therapeutic response. With adalimumab there is an apparition
      of ADAb in 30%. There are reports suggesting that adding methotrexate to the therapy in a
      specific timeline allow to prevent the immunization. A previous study shows that association
      in long terms between methotrexate and adalimumab induce less immunized patients. The
      investigator's goal is to assess if two methotrexate subcutaneous injections at day 1 and 2
      could prevent anti adalimumab antibodies formation.
    

Intervention name(s): Methotrexate
Intervention type(s): Drug
Intervention description(s): Patients randomized in this arm will have one subcutaneous injection of methotrexate 15min before and one 24h after their first injection of adalimumab prescribed as usual
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: adalimumab; anti-drug antibodies; tolerization; methotrexate; spondyloarthritis
Evaluation of Immersion in Virtual Reality in the Management of Anxiety, Then Pain, of Patients in Interventional Imaging.
Condition: Interventional Imaging
Study type: Interventional

Summary: 
      Investigators propose to use static VR scenarios, adapted to the patient's preferences (sea,
      mountain, countryside…) to immerse them in an emotionally positive environment. The objective
      is to reduce the anxiety and pain associated with IR acts in the operating room.

      Hypothesis tested:

      The use of the 3D immersion of an oculus rift DK2 virtual reality headset during an
      interventional radiology intervention would reduce the anxiety felt by patients by 25%,
      evaluated by the STAI YB scale. The correlation between the STAI YB and the APAIS and HAD
      scales will also be tested.
    


Intervention name(s): Virtual Reality
Intervention type(s): Other
Intervention description(s): Immersion in Virtual Reality
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Change in Insulin Resistance and Systemic Inflammation on Brain Structure and Function
Condition: Obesity; Bariatric Surgery Candidate
MeSH terms: Insulin Resistance; Inflammation
Study type: Observational

Summary: 
      Obesity is associated with alterations in brain structure and cognitive impairment and is a
      risk factor for Alzheimer's disease and vascular dementia. The mechanisms underlying obesity
      related decline in cognitive function are not fully understood. The long-term goal of this
      project is to understand how obesity affects cognitive function, with the aim to develop new
      ways to prevent and treat obesity related cognitive decline
    

Detailed description: 
      A growing body of evidence suggests that obesity is associated with alterations in brain
      structure and cognitive impairment. Mid-life obesity is a risk factor for Alzheimer's disease
      and vascular dementia. The mechanisms underlying obesity related decline in cognitive
      function are not fully understood. The long-term goal of this research is to identify how
      obesity, insulin resistance (IR), and their treatment impact brain structure and function.
      The investigators propose that IR and obesity related inflammation are two modifiable factors
      that affect neuronal integrity and lead to cognitive dysfunction. In this proposal,
      investigators will test two hypotheses: 1) among obese patients planning to undergo bariatric
      surgery (specifically vertical sleeve gastrectomy), baseline IR and systemic and brain
      markers of inflammation will inversely correlate with performance on cognitive testing and
      correlate with abnormalities in brain structure and 2) following bariatric surgery subjects
      who experience the greatest reduction in IR and obesity related inflammation will have the
      greatest improvement in cognitive function and brain structure. To address these hypotheses,
      investigators will use a comprehensive battery of tests to evaluate cognition and state of
      the art magnetic resonance imaging (MRI) techniques to assess brain structure and
      neurochemistry before and six months after bariatric surgery.
    

Intervention name(s): bariatric surgery
Intervention type(s): Procedure
Intervention description(s): Obese patients will undergo brain imaging, neurocognitive function testing and measurement of insulin resistance and inflammatory markers pre- and post bariatric surgery
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Obese Group • Undergoing VSG-type bariatric surgery

        Non-Obese Group-healthy controls

        • BMI < 25
      
Biospecimen description: 
      serum sample to measure hormones and inflammatory markers
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512)
Condition: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the ability of injections of Ji Gami(TM) or Ji
      Gami(TM) DO in combination with minoxidil to induce hair growth in male and female subjects
      with hair loss.
    


Intervention name(s): Autologous cultured dermal and epidermal cells
Intervention type(s): Biological
Intervention description(s): A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness; Hair Loss Baldness