bioihbjkbjnl/mcl2 huggingface dataset:
Reamed Nailing Versus Taylor Spatial Frame in Tibia Shaft Fractures
Condition: Tibial Fractures
MeSH terms: Fractures, Bone; Tibial Fractures
Study type: Interventional

Summary: 
      This is a randomised, bi-centre, prospective, clinical trial in patients with closed tibia
      shaft fractures. The fracture should be fresh/acute and seen within 3 weeks after the injury.
      Patients will be randomised to surgery with either a Taylor Spatial Frame (Smith & Nephew,
      England) or a reamed intramedullar nail (according to local choice) with locking screws.
      Primary outcome measure is the physical component summary (PCS) of RAND Short form 36 (SF-36)
      after 2 years. Among secondary outcomes: Visual Analogue Scale (VAS) for pain, complications,
      healing, malunion, and resource use.
    

Detailed description: 
      Fractures of the lower leg (fractures of the tibia shaft with or without concurrent fracture
      of the fibula) are a common injury. According to our fracture register 95 patients with
      closed tibia fractures were operated the last 3 years at our department. Fractures with
      moderate or no displacement can be successfully treated with a cast and subsequent Sarmiento
      brace. Displaced fractures are commonly treated with an intramedullary nail. Intramedullary
      nailing yields a high rate of union. More than 50 % of operated patients do, however, develop
      chronic anterior knee pain and one third of the patients have pain at rest. This contributes
      a big problem for many patients both at spare time and at work. Another problem is
      significant rates of malunion.

      The use of ring fixators utilizing rings and 1,8 mm. wires was introduced by Gavril Ilizarov
      more than 50 years ago, and the technique has been further developed through the introduction
      of six adjustable struts (Taylor Spatial Frame). This hexapod circular frame allows accurate
      reduction as well as a high stability. The ring fixator is less invasive and allows early
      weight bearing, but may be cumbersome to the patient. There is also concern about pin-tract
      infection, osteomyelitis and joint contracture.

      Only one prior study has compared ring fixator (Ilizarov) and intramedullar nail in closed
      tibia fractures. The results showed significant less anterior knee pain in the patients
      operated with ring fixator, but the study design did not allow clear conclusion.
    

Intervention name(s): Taylor Spatial Frame; Intramedullary nail
Intervention type(s): Device; Device
Intervention description(s): Circular external fixator; Antegrade intramedullary nail
Other intervention name(s): Circular frame
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized two-group clinical trial with block randomization.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The DASH Diet for Adults With Uncontrolled Asthma
Condition: Asthma; Hypertension
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot
      study aims to provide effect size estimates and justification, clinical trial and
      intervention feasibility data, and procedural materials for a full-scale randomized
      controlled trial that will determine the efficacy and mechanisms of action of the Dietary
      Approaches to Stop Hypertension (DASH)-a recommended dietary pattern based on proven
      cardiovascular benefits-as adjunct therapy to standard care for adults with uncontrolled
      asthma.
    

Detailed description: 
      Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot
      study aims to provide effect size estimates and justification, clinical trial and
      intervention feasibility data, and procedural materials for a full-scale randomized
      controlled trial that will determine the efficacy and mechanisms of action of the Dietary
      Approaches to Stop Hypertension (DASH)-a recommended dietary pattern based on proven
      cardiovascular benefits-as adjunct therapy to standard care for adults with uncontrolled
      asthma. Eligible, consenting participants (n=90) will be randomized to receive usual care
      alone or combined with a DASH intervention. Follow-up assessments will occur at 3 and 6
      months. By evaluating a dietary pattern approach to improving asthma control, this study
      could advance the evidence base for refining clinical guidelines and public health
      recommendations regarding the role of dietary modifications in asthma management.
    

Intervention name(s): Dietary Approaches to Stop Hypertension dietary pattern
Intervention type(s): Behavioral
Intervention description(s): The intervention will employ a series of small group and individual sessions, followed by periodic telephone contacts, to help participants make appropriate dietary changes and develop the skills to maintain these changes over the long term. The initial 3 months of intensive intervention will involve 8 group and 3 individual sessions for 45-60 minutes each. During the next 3 months, participants will receive counseling phone calls once per month for 20-30 minutes each call. Group session sizes may range from 8-15 participants.
Other intervention name(s): DASH
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: DASH; diet; asthma; adults; asthma control
A Single and Multiple Oral Dose Study and a Treatment Schedule-finding Study in Non-elderly, Healthy Subjects
Condition: Pharmacokinetics of ASP3325 in Non-elderly, Healthy Adult Japanese Male and Female, and Caucasian Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to evaluate the safety and tolerability of a single and
      multiple oral dose of ASP3325 and to evaluate the effect of administration timing on the
      pharmacodynamics of ASP3325 orally administered three times a day.
    

Detailed description: 
      <Part 1: Single ascending dose> Primary objective

        -  To evaluate the safety and tolerability of a single oral dose of ASP3325 in non-elderly,
           healthy adult Japanese male and female, and Caucasian male subjects

      Secondary objectives

        -  To evaluate the pharmacokinetics and pharmacodynamics

        -  To evaluate gender differences in the pharmacokinetics and pharmacodynamics

        -  To evaluate ethnic differences in the pharmacokinetics and pharmacodynamics between
           Japanese and Caucasians

      <Part 2: Multiple ascending dose> Primary objective

        -  To evaluate the safety and tolerability of multiple oral doses of ASP3325 in
           non-elderly, healthy adult Japanese male and female subjects

      Secondary objectives

        -  To evaluate the pharmacokinetics and pharmacodynamics

        -  To evaluate gender differences in the pharmacokinetics and pharmacodynamics

      <Part 3: Evaluation of the effect of administration timing> Primary objective

        -  To evaluate the effect of administration timing on the pharmacodynamics of ASP3325
           orally administered three times a day at different administration timings of 30 minutes
           before a meal, during a meal, 30 minutes after a meal, and 2 hours after a meal in
           non-elderly, healthy adult Japanese male subjects in a crossover design

      Secondary objective

        -  To evaluate the safety and pharmacokinetics
    

Intervention name(s): ASP3325; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: ASP3325; pharmacokinetics; pharmacodynamics
Assessment of Efficacy and Safety of Front-line Fludarabine, Cyclophoshamide and Ofatumumab Chemoimmunotherapy in Young Patients With Chronic Lymphocytic Leukemia.
Condition: B-cell Lymphoid Leukemia; Young Patients
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Assessment of safety and efficacy of with fludarabine and cyclophosphamide (FC) combined with
      ofatumumab (FCO2) in previously untreated "young" patients with Chronic Lymphocytic Leukemia
      (CLL).
    

Detailed description: 
      Given that:

        -  rituximab, fludarabine and cyclophosphamide (FCR) front-line treatment was associated
           with a high OR rate, superior PFS and OS as compared to fludarabine and cyclophosphamide
           regimen;

        -  a direct relationship between the dose of rituximab and the response rate has been
           reported;

        -  ofatumumab, as single agent, proved activity in CLL patients with refractory disease;

        -  ofatumumab, fludarabine and cylophosphamide (O-FC) front-line treatment has been
           associated with a high complete response (CR) rate;

        -  the expected grade 3-4 granulocytopenia could led to reduce the dose intensity of study
           drugs (FC) and increase the infection rate; a schedule combining FC with an increased
           dose of ofatumumab associated to primary phrophylaxis of granulocytopenia could be
           associated with an improvement in the CR rate. The purpose of this study is to determine
           whether we could improve the CR rate of the golden standard treatment for fit patients
           with CLL , the FCR regimen, with a chemoimmunotherapy including FC combined with an
           increased dose of the monoclonal antibody ofatumumab, given every other week (FCO2)
           associated with a primary prophylaxis of granulocytopenia.
    

Intervention name(s): Cyclophosphamide; Fludarabine; Ofatumumab
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Fludarabine; Ofatumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CLL; Fludarabine; Cyclophosphamide; Ofatumumab
Evaluation of the Relationship Between Zinc Vitamin D and b12 Levels in the Covid-19 Positive Pregnant Women
Condition: COVID; Zinc Deficiency; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Observational

Summary: 
      Zinc d vitamin and b12 serum levels in covid-19 positive pregnants will be compared in terms
      of patients' responses to computed tomography and treatment.
    

Detailed description: 
      Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated
      together with the information of the patients.
    

Intervention name(s): Serum zinc, vitamin d vitamin b12 levels .
Intervention type(s): Other
Intervention description(s): Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.
Intervention MeSH terms: Vitamin D; Vitamins; Vitamin B 12; Hydroxocobalamin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant women between 18-45 years old with positive covid-19 pcr test results
      
Biospecimen description: 
      Serum zinc, vitamin d vitamin b12 levels
Time Effect on the Predictability of Different Grafting for Gingival Recession RT 1
Condition: Gingival Recession Types One(RT1)
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The primary objective of this study was to evaluate time effect on the clinical
      predictability of collagen matrix Xenograft (CMX) with melatonin gel versus connective tissue
      graft (CTG) and determine whether it is proposed to be an alternative in multiple adjacent
      gingival recession (MAGR) in recession type one (RT1)
    

Detailed description: 
      this study was conducted to evaluate time effect on the clinical predictability of collagen
      matrix Xenograft (CMX) with melatonin gel versus connective tissue graft (CTG) and determine
      whether it is proposed to be an alternative in multiple adjacent gingival recession
    

Intervention name(s): melatonin with collagen matrix; connective tissue graft (CTG)
Intervention type(s): Combination Product; Combination Product
Intervention description(s): (CMX) with melatonin in the esthetic zone using Modified Coronally Advanced Tunneling Technique (MCAT); control group connective tissue graft using Modified Coronally Advanced Tunneling Technique (MCAT)
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-cell Lymphoma
Condition: Lymphoma, B-Cell
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy of a four-month dosing period
      of intra-lesional injection of TG1042 in patients with relapsing CBCL.

      Patients will receive intra-tumoral injections of an adenoviral vector construct containing
      the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with
      anti-tumor activity. This local administration induces tumour cell killing at the injected
      tumour sites.
    


Intervention name(s): Adenovirus Interferon gamma
Intervention type(s): Genetic
Intervention description(s): intra-tumoral injections, 1 dose per lesion, up to 6 simultaneous lesions.
Intervention MeSH terms: Interferons; Interferon-gamma
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary CBCL including (WHO/EORTC classification 2005); Primary cutaneous marginal zone B-cell lymphoma; Primary cutaneous follicle center B-cell lymphoma; Primary cutaneous diffuse large B-cell other than leg type; Histologically consistent with primary CBCL; Relapse or active disease
Tranexamic Acid in Sleeve Gastrectomy
Condition: Tranexamic Acid Adverse Reaction
Study type: Interventional

Summary: 
      The effectiveness of Tranexamic acid use will be measured in cases of sleeve gastrectomy in
      bariatric surgery and in early postoperative bleeding.
    

Detailed description: 
      Prospective, comparative and double-blind study with patients aged 18-65 years admitted to
      bariatric surgery. Selected patients were given or not given venous tranexamic acid (TXA)
      during anesthesia induction (CG). Anesthesia and thromboprophylaxis protocols were similar
      between groups. For statistical analysis, χ2 and analysis of variance tests were performed
      using the SPSS 21.0 ® statistical program at a significance level of p < 0.05.
    

Intervention name(s): Transamine 200mg iv
Intervention type(s): Other
Intervention description(s): In the intervention group, intravenous TXA (Transamine) 1000 mg dissolved in 100 mL 0.9% sodium chloride was administered intravenously within 10 minutes as a loading dose within the first 30 minutes at the end of the surgery. After the end of the loading dose, a maintenance dose of 120mg/hour TXA was infused in 500ml (60ml/hour) SF. The placebo group was given 100ml of saline in the first 30 minutes, followed by a maintenance dose of 60ml/hour of saline for 8 hours.
Intervention MeSH terms: Tranylcypromine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: tranexamic acid; Sleeve gastrectomy; Postoperative bleeding
Kinesiophobia, Quality of Life, and Cognitive Functions in Fibromyalgia Syndrome
Condition: Fibromyalgia; Kinesiophobia; Cognitive Dysfunction
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Cognitive Dysfunction; Kinesiophobia
Study type: Observational

Summary: 
      Although one of the most evidence-based treatment protocols is based on exercise strategies
      in patients with Fibromyalgia Syndrome, fear and avoidance of physical activity; named
      'Kinesiophobia' may hinder the patients from the exercises. Cognitive dysfunctions are seen
      frequently in Fibromyalgia Syndrome. The aim of this study, to assess the relationship
      between kinesiophobia and cognitive functions, disease severity, quality of life, physical
      activity level, pain intensity, and anxiety/depression level in Fibromyalgia patients.
      Additionally, the investigators aimed to compare the kinesiophobia level and cognitive
      functions between patients with Fibromyalgia Syndrome and control subjects.
    

Detailed description: 
      Cognitive dysfunction, including learning difficulties, memory, attention, and executive
      dysfunctions are frequent in fibromyalgia syndrome. Kinesiophobia is defined as fear and
      avoidance of physical activities, and it can lead to increased disability in patients with
      chronic pain. Although there is a relationship between cognitive functions and physical
      performance in Fibromyalgia Syndrome, the relationship between kinesiophobia, fibrofog, and
      quality of life are required to be investigated.

      The aims of this study are:

        1. To compare the kinesiophobia and cognitive functions in Fibromyalgia Syndrome with
           healthy volunteers

        2. To examine the relationship between the severity of kinesiophobia, cognitive functions,
           disease activity, quality of life, physical activity level, depression and anxiety
           severity in Fibromyalgia Syndrome.

      The hypothesis is, the patients diagnosed with Fibromyalgia Syndrome have higher
      kinesiophobia severity and worse cognitive functions, and also that kinesiophobia severity is
      associated with cognitive dysfunction, disease severity, physical activity level, and
      psychiatric symptoms in patients with Fibromyalgia Syndrome.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Fibromyalgia Syndrome participants and healthy volunteers.
      
Keywords: Fibromyalgia; Kinesiophobia; Cognition; Quality of life
A Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability of TAK-788 Followed by Evaluation of the Effects of a Low-Fat Meal on TAK-788 PK and Evaluation of Relative Bioavailability of TAK-788 Capsules in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability of TAK-788 and to identify a
      tolerable single oral dose of TAK-788 administered as a drug-in-capsule (DiC) formulation, to
      characterize the effects of a low-fat meal on the PK of the TAK-788 administered as DiC
      formulation and to evaluate the bioavailability of a test (Process B) DiC of TAK-788 relative
      to a reference (Process A) DiC of TAK-788 in healthy participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-788. The study will assess the safety and
      tolerability of single oral dose of TAK-788, evaluate the effect of a low-fat meal on PK of
      TAK-788 and will assess the relative bioavailability of two DiCs of TAK-788.

      The study will enroll approximately 69 participants. The study is designed to consist of 3
      parts: Part 1- dose escalation phase, Part 2- low fat meal effect and Part 3 - relative
      bioavailability. The study population of Part 1 will consist of 40 participants enrolled into
      5 cohorts. Each cohort will have 8 randomized participants with 6 receiving a single dose of
      TAK-788, and 2 receiving matching placebo under fasted conditions. In Cohorts 1 to 5, safety
      of single-dose TAK-788 will be evaluated. For Part 2, the effect of a low-fat meal on a
      single tolerable dose of TAK-788 will be determined following review of safety and
      tolerability data from the previous cohorts in Part 1. The study population of Part 2 will
      consist of 16 participants enrolled into 2 cohorts of different doses, where participants
      will be randomized to a cross-over sequence of:

        -  TAK-788 Fed + TAK-788 Fasted

        -  TAK-788 Fasted + TAK-788 Fed

      The study population of Part 3 will consist of 13 participants enrolled into 1 cohort, where
      participants will be randomized to a cross-over sequence of:

        -  TAK-788 DiC (reference) + TAK-788 DiC (test)

        -  TAK-788 DiC (test) + TAK-788 DiC (reference) This single-center trial will be conducted
           in the United States. The overall time to participate in this study is approximately 7
           months. Participants will be contacted by telephone 30 days after the last dose of study
           drug for a follow-up assessment.
    

Intervention name(s): TAK-788; Placebo; TAK-788
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-788 capsules.; TAK-788 placebo-matching capsules.; TAK-788 DiC.
Other intervention name(s): AP32788; AP32788
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Drug Therapy
Role of Armeo-Power and Muscle Vibration in Upper Limb Rehabilitation
Condition: Stroke
Study type: Interventional

Summary: 
      Muscle vibration (MV) has been suggested as a useful non-pharmacological approach to control
      spasticity. Armeo Power® (AP) is a robotic exoskeleton for rehabilitation allowing early
      rehabilitation treatment. The objective of our study was to determine whether AP training
      coupled with MV applied on antagonist muscles of the spastic upper limb (UL) can reduce the
      spasticity of agonist muscles. We enrolled 20 chronic post-stroke patients, who underwent 40
      daily sessions of AP training. Ten subjects (group-A) received muscle MV (on triceps brachii,
      deltoid, and supraspinatus), whereas the other 10 (group-B) underwent a sham vibration.
    


Intervention name(s): ArmeoP+real MV
Intervention type(s): Device
Intervention description(s): All the subjects assigned to the experimental received a focal belly-muscle vibration on the spastic antagonist muscles (i.e. triceps brachialis-TB, deltoid-DE, and supraspinatus-SS) during shoulder abduction and elbow extension. MV was delivered by a pneumatic vibrator powered by compressed air (Vibraplus; @Circle, San Pietro in Casale, Italy) (fig. 2) wired to appropriate-muscle probe diameter (up to 2cm2). MV was set at a frequency of 80Hz and an individually adjusted vibration amplitude (approximately 2mm in indentation depth, mean pressure of 250mBar, which effectively induce inhibition of the monosynaptic reflex) so that it was just below the threshold for perceiving an illusory movement. We chose such set up to avoid any signs of muscle contraction potentially reflecting either possible voluntary movement or occurrence of the tonic vibration reflex (TVR).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: robotic rehabilitation; muscle vibration; combined approach