bioihbjkbjnl/mcl2 huggingface dataset:
Exploring Advanced Imaging Techniques to Characterize Botulinum Toxin Diffusion in Human Muscle
Condition: Stroke; Muscle Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional

Summary: 
      Since the use of botulinum toxin in treating spasticity has already been proven effective, we
      are now using magnetic resonance imaging to examine the toxin diffusion within muscle (post
      injection) in order to determine the specific toxin dose required for an optimal treatment
      response.
    

Detailed description: 
      Over the past decade, botulinum toxins (BT) have been extensively used to treat any number of
      diverse disorders, including functionally significant, focal spasticity in the arm and leg of
      persons with injury/disease of the central nervous system. Spasticity is an involuntary
      muscle stiffness that limits movement of an extremity and often leads to pain, hygiene
      problems, difficulty in bed or wheelchair positioning, and functional deficits in self-care
      and mobility.

      There are three BT products on the market: MyoBloc®, Botox®, and Dysport®. FDA approval for
      use of Botox® in spasticity is anticipated sometime during 2010. In the Weill Cornell
      Division of Rehabilitation Medicine alone, nearly 50,000 units of Botox® were injected for
      the treatment of spasticity during the 2008-2009 academic year. (Note: The vast majority of
      the BT market share in the US rests with Botox®.)

      There is excellent evidence supporting the effectiveness of BT in decreasing tone and modest
      clinical evidence supporting functional improvement. Despite the frequent use, however, there
      is astonishingly little evidence delineating the impact on diffusion of dosing, dilution,
      approach to muscle localization, or serotype of BT. To better study these relationships we
      will be using advanced imaging to develop a model to characterize the physical
      characteristics of BT diffusion in human skeletal muscle.
    

Intervention name(s): Botox (botulinum toxin)
Intervention type(s): Drug
Intervention description(s): A series of three injections will be made simultaneously to the gastroc-soleus muscles of the affected lower limb; this will be the only drug intervention/injection session throughout the study, and occurs at baseline. The top injection site, closest to the knee, consists of 25 units of Botox and 0.25 cc saline. The bottom injection site, closest to the ankle, also consists of 25 units of Botox and 0.25 cc saline. The middle injection site will be considered the placebo injection, as it will not contain any Botox (0 units Botox) and 0.25 cc saline.
Intervention MeSH terms: Botulinum Toxins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: MRI; Magnetic Resonance Imaging; Botox; botulinum toxin; neurological; stroke; spasticity; muscle stiffness; diffusion; Weill Cornell; New York Presbyterian Hospital; O'Dell
Percutaneous Radiofrequency Thermal Ablation in Compressive Thyroid Nodules
Condition: Thyroid Nodule
MeSH terms: Thyroid Nodule; Thyroid Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Percutaneous radiofrequency thermal ablation (RTA) was reported as an effective tool for the
      management of thyroid nodules (TNs). This study aims to validate RTA as a valid approach for
      patients with compressive TNs for whom surgery is contraindicated or refused. Two groups of
      subjects with TNs (one group to treat with RTA and a matched untreated control group) will be
      evaluated in term of TN volume, thyroid hormones and clinical symptoms.
    

Detailed description: 
      Thyroid nodules (TNs) are very common in the general population, with a prevalence of about
      50% in subjects older than 60 years undergoing neck ultrasound examination.

      The great majority of TNs are benign, but they can be responsible for pressure symptoms in
      the neck and result in discomfort and decreased quality of life. Large compressive TNs may
      result in life-threatening conditions because of the potential acute onset of respiratory
      crisis. Percutaneous radiofrequency thermal ablation (RTA) is a minimally invasive procedure
      which has been firstly develop to treat patients with liver cancer and has been then used to
      treat both malignant and benign tumor nodules in many organs. RTA also represents a promising
      new approach for the management of TNs.The current prospective comparative study investigated
      the long-term effectiveness of RTA in patients with both toxic and non-toxic compressive TNs.

      Forty consecutive patients with TNs with pressure symptoms were prospectively enrolled in
      this study. Patients were randomised as follows: 20 patients were treated with a single RTA
      session (group A) and 20 patients did not receive any treatment and were only followed-up
      (group B).
    

Intervention name(s): Percutaneous Radiofrequency Thermal Ablation
Intervention type(s): Procedure
Intervention description(s): Percutaneous Radiofrequency Thermal Ablation (RTA) by using a RITA© StarBurst Talon needle (RITA Medical Systems, Fremont, CA). RTA is performed in each patient at Time 0.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thyroid Nodule; Radiofrequency Thermal Ablation; Pressure symptoms; Hyperthyroidism
Electrostimulation of Shoulder Girdle and Quadriceps Muscles in Facioscapulohumeral Muscular Dystrophy Patients
Condition: Facioscapulohumeral Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional

Summary: 
      The investigators evaluated clinical tolerance, biological tolerance, feasibility and
      efficacy of daily electrostimulation training of shoulder girdle and quadriceps muscles in 10
      patients with facioscapulohumeral muscular dystrophy, the third most common inherited
      myopathy.
    

Detailed description: 
      Autosomal dominant FSHD is characterized by selective pattern of muscle involvement. Weakness
      and atrophy typically involve facial and shoulder girdle muscles, and progressively anterior
      forearm and foreleg muscles and pelvic girdle muscles.

      The physiopatholgical mechanism of this disease, due to a deletion of repeated units named
      D4Z4 located on 4q35, is still controversial. Up to date, no curative therapy is available
      for these patients. We proposed in the present study to test feasibility, clinical and
      biological tolerance and efficacy of shoulder muscle training by electrostimulation in a
      group of FSHD patients. 10 patients displaying classical FSHD phenotype participate to this
      study consisting in daily session of shoulder girdle and quadriceps muscles
      electrostimulation of 23 minutes for a period of 5 months.

      We evaluated: clinical tolerance by daily pain and fatigue analogic scales, biological
      tolerance by measuring CK; feasibility: by measuring the monthly score of participation to
      sessions; the efficacy by manual muscle testing, quantitative muscle assessment, fatigue
      severity scale.
    

Intervention name(s): electrostimulation
Intervention type(s): Procedure
Intervention description(s): Electrostimulation of shoulder girdle and quadriceps muscles in facioscapulohumeral muscular dystrophy patients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: facioscapulohumeral muscular dystrophy; electrostimulation; training
Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy
Condition: Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the safety and clinical effectiveness of umbilical
      cord mesenchymal cells transplanted by intravenous infusion in patients with heart failure.
    

Detailed description: 
      Phase I-II Clinical Trial - Safety and efficacy of umbilical cord derived mesenchymal stem
      cells (ucMSC) in patients with heart failure Randomized, double blind, controlled prospective
      study in patients with compensated heart failure in dilated phase.

      Thirty patients will be selected, who will undergo a strict 3-month followup of ventricular
      function before being sequentially randomized into two groups: the first group of 15 patients
      will receive a sole injection of ucMSC and the remaining 15 patients will comprise the
      control group.

      Every patient will maintain their standard treatment of heart failure, with maximum tolerated
      dosage without side effects.

      The day of infusion will be considered day zero. From that moment, followup will be divided
      into 0-3, 3-6, and 6-12 months.

      Clinical results will be analyzed after completion of 12 months of followup.
    

Intervention name(s): ucMSC; Controls
Intervention type(s): Biological; Other
Intervention description(s): 1 million mesenchymal cells per Kg weight injected intravenously in allogenic AB plasma; Autologous Serum will administrated as placebo
Other intervention name(s): Umbilical Cord Mesenchymal Stem Cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; Coronary Heart Disease; Adult Stem Cells; Umbilical Progenitor Cells; Umbilical Cord Stem Cells Allogenic; Left Ventricular Function; Intravenous Injection
Topical DHEA Against Vaginal Atrophy
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the dose-response of vaginal mucosa parameters to
      the local action of DHEA (Dehydroepiandrosterone) in postmenopausal women suffering from
      vaginal atrophy.
    


Intervention name(s): Placebo; DHEA (0.25%); DHEA (0.5%); DHEA (1.0%)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.; Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.; Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.; Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
Other intervention name(s): Prasterone, Dehydroepiandrosterone; Prasterone, Dehydroepiandrosterone; Prasterone, Dehydroepiandrosterone; Prasterone, Dehydroepiandrosterone
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vulvar/vaginal atrophy; Atrophic Vaginitis; Dehydroepiandrosterone; DHEA; Prasterone; Vaginorm; Menopause; Intrarosa
Heparin Versus Normal Saline in Peripherally Inserted Central Catheter Lines
Condition: Cancer
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study team will be performing a study comparing the use of Heparin Flushes vs. Normal
      Saline Flushes in making sure central lines stay open. The participants will be placed in a
      group to receive the University of Texas Southwestern Medical Center (UTSW) Standard of Care
      (control group) for maintaining central lines, or a group to receive Normal Saline Flushes
      only (experimental group) to keep their central line open. The participants electronic
      medical record will be reviewed by study team members for the inclusion/exclusion criteria,
      the participants central line will be assessed by an 11 Blue BMT nurse every 12 hours, and
      they may be asked questions regarding their medical history during their stay on 11 Blue BMT.
      If a participant is discharged or transferred off of the 11 Blue BMT unit, they will no
      longer be included in the study and their central line maintenance will return to the UTSW
      Standard of Care. Participants in this study may be at risk for central line occlusion (a
      blood clot) which could require intervention to regain the free flow of fluids and use of the
      central line. The study team predicts there will be no increase in the rate of line occlusion
      when using Normal Saline Flushes only to maintain the free flow of fluids through
      participants central line. The study team also hopes the results of this study will help to
      improve patient outcomes by decreasing risk of infection, heparin associated complications,
      and costs.
    


Intervention name(s): Normal Saline Group; Heparin Group
Intervention type(s): Drug; Drug
Intervention description(s): A 10cc NS flush will be administered intravenously through the peripherally inserted central line catheter after administration of medication, blood products, and blood draws. In addition the peripherally inserted central line catheter will be flushed intravenously with 10cc Normal Saline every 24 hours.; All lumens of PICC line will be flushed w/ Heparin Flush every 8 hours. PICC line will be flushed with 10cc Normal Saline followed by 3cc Heparin Flush after administration of medication, blood products, or blood draws.
Other intervention name(s): NS Flush, Normal Saline Flush, 0.9% Normal Saline Flush; Heparin Flush
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Peripherally Inserted Central Lines; Heparin Flush
Multiple Dose FSH-GEX(TM) in Healthy Volunteers
Condition: Female Infertility
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the current study is the pharmacokinetic and pharmacodynamic characterization of a
      multiple dose administration of FSH-GEX™ in healthy pituitary-suppressed female volunteers,
      in comparison with two marketed comparator products or placebo.
    

Detailed description: 
      Healthy pituitary-suppressed female subjects received multiple doses of FSH-GEX at one of 2
      different dose levels (75 IU and 150 IU dosing once daily (QD), or 150 IU (dosing once every
      other day (QAD)) for maximal 7 Days. They were compared with subjects who received a urinary
      FSH or a recombinant FSH or placebo.
    

Intervention name(s): FSH-GEX™; recombinant FSH; urinary FSH; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): follitropin epsilon; Gonal-f; Bravelle
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: in-vitro fertilization; reproductive disorder
The Effects of BAY1193397 on Skin Capillary Blood Flow and Transcutaneous Oxygen Pressure
Condition: Diabetic Foot
MeSH terms: Diabetic Foot
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to analyse skin blood flow in diabetic patients. The patients
      receive a single dose of placebo, 1 mg BAY1193397, and 5 mg BAY1193397. The analysis of
      safety and tolerability are secondary objectives of this study.
    


Intervention name(s): BAY1193397; BAY1193397; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of 1 mg BAY1193397 given in the fasted state; Single dose of 5 mg BAY1193397 given in the fasted state; Single dose of placebo given in the fasted state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Adolescent Transition To Adult Care for HIV-infected Adolescents in Kenya
Condition: Adolescent Behavior; HIV; Transition; Adolescent Development; Disclosure
Study type: Interventional

Summary: 
      This study evaluates an adolescent transition package (ATP) to support HIV infected
      adolescents transitioning form pediatric/adolescent care to adult care. Ten clinics will
      receive the intervention and 10 will receive standard of care transition services.
    

Detailed description: 
      The Adolescent Transition Package (ATP) will include two components. The validated Namibia
      comic book for disclosure (to be used with children over 10 years of age) and transition
      booklet "Taking Charge" developed by stakeholders in Kenya.

      The disclosure tool includes a cartoon book, readiness and tracking tools used in clinic and
      health care worker training material. The intervention progresses from incomplete to complete
      disclosure using a narrative about soldiers fighting the battle of infection as the rationale
      for taking medicine. This tool has been validated for use in Namibia.

      The adapted transition toolkit includes a transition booklet, tracking tools to be used by
      health care workers and a readiness assessment checklist to be completed by study staff. The
      booklet has 4 chapters addressing key areas to support adolescents gain the knowledge and
      skills they need in adult care. The 4 chapters are: HIV treatment literacy, self management,
      communication and support.
    

Intervention name(s): Adolescent Transition Package
Intervention type(s): Behavioral
Intervention description(s): Clinic level intervention composed of an adolescent transition package with tools to support health care workers to disclose HIV status to adolescents and to track transition to adult care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An adolescent transition package composed of a disclosure booklet and transition tool
Masking: None (Open Label)
Primary purpose: Supportive Care
Are we Loading Our Patients With Sodium During Hemodialysis Treatments?
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Observational

Summary: 
      The objectives of the data search is to find out if there is correlation between pre, post
      serum sodium concentration, dialysate sodium concentration, interdialytic weight gain and
      associated changes in pre and post systolic and diastolic blood pressure, mean arterial
      pressure, number of blood pressure medications and adherence to 3 times per week dialysis,
      mortality.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Hemodialysis patients at Renal Research Institute and Fresenius clinics
A Study of Atomoxetine for Attention Deficit and Hyperactive/Impulsive Behaviour Problems in Children With ASD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity; Problem Behavior; Impulsive Behavior
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is to evaluate the tolerability and effectiveness of
      atomoxetine in the treatment of attention problems, hyperactivity, and impulsivity in
      children with ASD, and secondarily, to evaluate the possible response to atomoxetine on the
      core symptoms of ASD
    


Intervention name(s): Atomoxetine Hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy of Wet Cupping on Blood Pressure Among Hypertension Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This research proposal is submitted to fulfill the requirement of the PHD degree of Community
      Medicine Saudi Board at the Joint Program of Family and Community Medicine in Jeddah, Saudi
      Arabia.

      Background: Cupping is an ancient treatment remedy that has been used for many centuries in
      many parts of the world. In the Middle East, Wet cupping "Hijama" is still a popular
      treatment because of its religious background. Despite of that, it still has little
      scientific evidence that proves its efficacy. Many hijama healers claim that they have
      observed dramatic improvement in Blood pressure control of hypertension patients. Not many
      studies support that. This study should help to prove or disprove this hypothesis.

      Objectives:

        -  To determine the efficacy of wet cupping on blood pressure among high blood pressure
           patients.

        -  To assess the incidence of wet cupping side effects in the intervention group.

      Methods: The study design is a randomised controlled trial. There will be an intervention
      group of high blood pressure patients who will perform hijama in addition to their usual
      management, and a control group of high blood pressure patients who will receive their usual
      anti-hypertension management only. There will be 8 weeks follow up period. After that, data
      entry, analysis and interpretation will take place.

      Hypothesis: Wet cupping has an effect on blood pressure in adult hypertension patients
    


Intervention name(s): Wet cupping; Conventional treatment
Intervention type(s): Procedure; Other
Intervention description(s): Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.; According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital.
Other intervention name(s): Hijama; Anti-hypertension management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fexofenadine in Pruritic Skin Disease
Condition: Pruritus
MeSH terms: Pruritus; Skin Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

        -  To compare the efficacy and safety profile of Fexofenadine 180mg tablets plus
           prednicarbate(2.5mg/g) vs prednicarbate(2.5mg/g) alone in the treatment of pruritic skin
           disease

      Secondary objective:

        -  To evaluate patient's satisfaction of Allegra treatment
    


Intervention name(s): Fexofenadine
Intervention type(s): Drug
Intervention MeSH terms: Fexofenadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment