bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Botulinum Toxin Type A Associated With Physical Therapy on Children With Spastic Cerebral Palsy
Condition: Cerebral Palsy, Spastic; Physical Therapy; Botulinum Toxin
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional

Summary: 
      Purpose: The aim of this study was investigate the effects of botulinum toxin type A (BoNT-A)
      associated with physical therapy on the functional capacity of children with spastic cerebral
      palsy (CP). Material and methods: Twenty-four children with spastic CP were concealed and
      randomly assigned to the Experimental Group (EG) consisting of 12 patients treated with
      BoNT-A and physical therapy and Control with 12 patients treated only with physical therapy.
      All participants were assessed through motor and functional scales (GMFM-88, Ashworth, Berg
      Balance Scale, TUG test and Pediatric Evaluation of Disability Inventory) at three different
      times: before and after 30 days of treatment as well as 3 months after the end of treatment.
    


Intervention name(s): Botulinum toxin type A; Physical Therapy
Intervention type(s): Drug; Other
Intervention description(s): Botulinum Toxin type A The intervention with BoNT-A (Dysport®, Ipsen Biopharmaceutical, USA) was performed in the gastrocnemius and soleus muscles, bilaterally for diplegic children and unilaterally for hemiplegic children.; Physiotherapeutic intervention was performed twice a week, with duration of one hour per session for 4 weeks. To maintain standardization of treatment, physiotherapists received a booklet with instructions on what treatment they should do.
The intervention protocol consisted of:
Passive stretching of lower limbs,
Stretching associated with the functionality of the plantar flexor muscles, knee flexors, adductors and hip flexors;
Strengthening of the antagonist muscles with the application of BoNT-A;
Static and dynamic balance training;
Up and down stairs;
Functional walking training, prioritizing the initial contact of the heel and active and passive dorsiflexion.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized controlled clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Phase 1 Study of Epetraborole Tablets
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b double-blind, placebo-controlled, dose-ranging study to evaluate the
      safety, tolerability, PK, and food effect of epetraborole tablets administered to healthy
      adult subjects for up to 28 days.
    

Detailed description: 
      Up to 56 healthy male and female adult subjects will be enrolled into one of 7 Dose Cohorts
      (Dose Cohorts 1 to 7; n = 8 per cohort). Cohort 7 (n = 8) is a Food Effect Cohort and
      subjects will receive a single dose of epetraborole or placebo in a Fasted state (Period 1)
      followed by a second dose of the same Investigational Product (IP) in a Fed state (Period 2)
      after a washout period of at least 7 days (+3 days). The dose of IP to be administered in
      Cohort 7 will be determined based on the Safety Monitoring Group recommendation following
      evaluation of safety and available PK data (at least 14 days) in Cohort 1 through Cohort 6.
      Up to 16 additional subjects may be included for the purposes of cohort expansion or to
      explore a dose intermediate to previously evaluated doses.

      Subjects in each Dose Cohort (n=8) will be randomized 3:1 to receive epetraborole (n=6) or
      matching placebo (n=2) and will receive oral doses of epetraborole or placebo.
      Investigational product will be administered with approximately 240 mL (8 fluid ounces) of
      non-carbonated water to each subject following an overnight fast of at least 8 hours, except
      for Period 2 (Fed) of Cohort 7. Subjects will be required to fast for a minimum of 2 hours
      following administration of IP.
    

Intervention name(s): Epetraborole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Epetraborole hydrochloride 250 mg tablets for oral administration; Matching placebo for 250 mg epetraborole hydrochloride tablets for oral administration
Other intervention name(s): AN2-501971
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Does the Deep Layer of the Deep Temporalis Fascia Really Exist?
Condition: Anatomy; Temporal Region Trauma
MeSH terms: Craniocerebral Trauma
Study type: Observational [Patient Registry]

Summary: 
      It has been widely accepted that a split of the deep temporal fascia occurs approximately 2
      to 3 cm above the zygomatic arch, named the superficial and deep layers. The deep layer of
      the deep temporal fascia lies between superficial temporal fat pad and the temporal muscle.
      However, during the investigators' previous surgeries, the investigators did not find the
      deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal
      muscle. This study was conducted to clarify the presence or absence of the deep layer of the
      deep temporal fascia. And the investigators' clinical study has confirmed the absence of the
      deep layer of the deep temporal fascia between superficial temporal fat pad and the temporal
      muscle.
    

Detailed description: 
      The anatomic layers of soft tissues of the temporal region, with regard to the deep
      temporalis fascia, was investigated in 169 cases operated upon with zygomaticofacial or
      craniofacial fractures using the supratemporalis approach from June 2013 to June 2017. Among
      167 surgeries, this so-called "deep layer of the deep temporalis fascia" was not observed. In
      fact, the superficial temporal fat pad is closely attached to temporal muscle above the
      zygomatic arch.
    

Intervention name(s): The supratemporalis approach
Intervention type(s): Procedure
Intervention description(s): The incision differs according to specific fracture sites. It can be a hockey stick-shaped incision, hemicoronal incision, and full coronal incision. The first layer of dissection was just under the superficial temporalis fascia.Then, approximately at the level of 3-5cm above the zygomatic arch, our modified incision was carried through the deep temporalis fascia.Next, the superficial fat pad was encountered and retracted anteriorly, which was in close contact of the temporal muscle. Finally, a flap that included skin, subcutaneous tissue, the superficial temporal fascia, the areolar fat tissue, the deep temporalis fascia and the superficial temporal fat was reflected as a whole anteriorly, fully exposing the temporal muscle and zygomatic arch.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all patients diagnosed with zygomaticofacial fractures or craniofacial fractures and
        received surgical treatment from the Dr. Lei Liu
      
Keywords: Deep temporal fascia; Deep layer of the deep temporal fascia; Superficial layer of the deep temporal fascia; Temporal fascial layers; Temporal anatomy
A Study Designed to Determine if the Pharmacokinetic Disposition of Inhaled Insulin Exposure is the Same for Asthmatics and Non-asthmatics
Condition: Asthma; Diabetes Mellitus
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare the rate and extent of absorption of TI Inhalation Powder in subjects
      with asthma and subjects with normal lung function. 24 eligible subjects will be enrolled
      into the treatment phase of the trial.
    

Detailed description: 
      Visit 1 screening will determine eligibility and obtain informed consent. At visit 2, 3 and 4
      subjects inhale 1 dose of 45U TI Inhalation Powder. At visit 3 subjects inhale 2 puffs
      (200mcg) Albuterol prior to dosing. Only asthmatic subjects undergo visit 4 where a
      methacholine challenge test (MCT) is performed followed by inhalation of Albuterol then
      administration of TI Inhalation Powder. Each visit's dosing will occur during a
      hyperinsulinemic euglycemic clamp. Visit 5 is the follow up visit.
    

Intervention name(s): Technosphere Insulin Inhalation Powder; Salbutamol (Albuterol); Methacholine chloride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3.0 of human insulin. single dose cartridges filled with 5 or 10 mg of Technosphere Inhalation Powder, containing 15 or 30 u of insulin; 2 puff = 200 mcg total dose; 5mls of methacholine; diluent sodium chloride 0.9%; formulation methacholine chloride in sodium chloride 0.9%
Intervention MeSH terms: Albuterol; Methacholine Chloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthmatics and non-asthmatic male and female subjects
Study on Normal Ranges of Lipids in Breast Milk of Healthy Mothers
Condition: Healthy Mothers
Study type: Observational

Summary: 
      This trial is undertaken to better understand the ranges of functional components normally
      found in human milk. This will strengthen the scientific knowledge on breast-milk composition
      as a "gold standard".
    


Intervention name(s): minimum 4 months of breastfeeding
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy mothers
Mesenchymal Stromal Cells and Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      Osteoarthritis (OA) is one of the most frequent musculoskeletal disorders and represents the
      main indication for total joint arthroplasty. Multipotent mesenchymal stromal cells (MSCs)
      can be easily isolated and culture expanded from bone marrow aspirates and provide an
      excellent source of progenitor cells for cell-based regeneration strategies due to their ex
      vivo differentiation and proliferation capacity. Although there are hints that MSCs derived
      from OA patients may exhibit altered function the role of MSCs with respect to disease
      development and progression of OA is not clearly understood to date. To assess whether
      advanced-stage OA affects MSCs' suitability for musculoskeletal regenerative therapy, in the
      present study, we compare proliferation and differentiation potential of MSCs from
      osteoarthritic versus healthy donors.
    

Detailed description: 
      Clinical data (range of motion of lower limb joints, sociodemographic score dataset, WOMAC
      score, EQ-5D score, Harris Hip Score, radiological evaluation (OA group only), routine
      laboratory parameters, and bone metabolism parameters)

      Osteogenic, chondrogenic, and adipogenic differentiation is proofed qualitatively by cell
      staining

      osteogenic, chondrogenic and adipogenic marker gene expression analysis using quantitative
      real-time RT-PCR

      cell-specific alkaline phosphatase (ALP) activity assay

      large-scale gene expression profile

      Fluorescence-activated cell sorting (FACS)- CD44, CD105 (SH2; endoglin), CD106 (vascular cell
      adhesion molecule; VCAM-1), CD166, CD29, CD73 (SH3 and SH4), CD90 (Thy-1), CD117, STRO-1 and
      Sca-1 [%]
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        pelvic compartment advanced-stage (Kellgren and Lawrence grade 3 or 4, mean 67±6 years)
        osteoarthritic and age-matched healthy donors
      
Biospecimen description: 
      bone marrow aspirates
    
Keywords: osteoarthritis, mesenchymal stromal cells, proliferation
Evaluation of the Effect of Late Boost on HIV-uninfected Vaccines From EV06 Trial
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      EV07 is an open label phase I clinical trial to evaluate the effect of late boost on
      HIV-uninfected vaccinees from EV06 trial.

      The outcome of the EV06 trial has shown that the vaccine regimen is safe and well tolerated.
      Preliminary antibody immunogenicity analysis has demonstrated that the DNA/gp120 protein
      vaccine regimen induced strong gp120, gp140 and V1V2 region-focused binding IgG and
      neutralizing antibody responses. There is also preliminary evidence that S. mansoni infection
      may modulate antibody responses induced by vaccination1.

      Based on these preliminary immunogenicity results of the EV06 study, a study with an
      additional boost with DNA-HIV-PT123 and AIDSVAX®B/E (Late Boost) is warranted in order to
      better investigate and understand the effects of the late boost on the response rate,
      magnitude and durability of vaccine induced immune responses.

      The primary objective of EV07 is to evaluate the ability of the late boost combination of
      DNA-HIV-PT123 and AIDSVAX® B/E to enhance the pre-existing vaccine induced antibody
      responses.
    


Intervention name(s): DNA-HIV-PT123 & AIDSVAX B/E
Intervention type(s): Biological
Intervention description(s): DNA-HIV-PT123 encodes clade C ZM96 Gag and gp140, CN54 Pol-Nef; AIDSVAX®B/E is a subtype B (MN) and subtype E (A244) HIV gp120 glycoprotein adsorbed onto aluminium hydroxide gel adjuvant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients
Condition: Infertility; PCOS
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      In this study the investigators compare the traditional way of triggering with a new way in
      patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper
      Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/
      ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and
      pregnancy rate.
    


Intervention name(s): GnRh agonist +1500E hCG
Intervention type(s): Drug
Intervention description(s): ovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OHSS; mataphase II oocytes (MII); good quality embryo's; pregnancy
A Lifestyle Intervention for Type 2 Diabetes Patients in Kuwait and Its Impact on Glycaemic Control
Condition: Diabetes Mellitus, Noninsulin-Dependent; Diabetes, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This was an unblinded, randomised controlled study, the purpose of which was to investigate
      the impact of a structured health education intervention on the glycaemic control of Type 2
      diabetes patients within a Kuwaiti cultural context.
    

Detailed description: 
      The control group continued to receive routine clinical advice, in addition to the individual
      session. The intervention group was enrolled in a structured group-based educational program
      for the duration of the study (12 months). Physical, physiological and biochemical outcome
      measures were assessed at baseline and then at a 12-month follow up. The total duration of
      the study, including the recruitment, the screening, the pilot study, the educational
      sessions and the follow-up, was 14 months altogether, from December 2014 to February 2016.
      The study consisted of the following three phases.

        -  Phase 1: included the initial recruiting of diabetes patients at an Al-Rehab polyclinic
           and the baseline assessment of their medical, dietary and physical activity history, in
           addition to the biochemical assessment.

        -  Phase 2 (pilot study): Five patients were chosen from the recruited patients for a pilot
           study to be monitored for one whole month (30 days) in order to evaluate the lifestyle
           intervention's safety, its compliance to the educational sessions, and anticipated
           barriers and results. Recruitment continued during the pilot study.

        -  Phase 3 (main study): This phase was based on recommending lifestyle intervention to the
           intervention group of diabetes patients. The educational sessions were scheduled every
           two weeks and a total of four sessions was provided. Both intervention and control
           groups were received individual sessions at the beginning and at the end of the study.

      Later, there was a follow up of the intervention and the control groups at the end of the
      study, to measure the intervention's effectiveness and evaluate the results.
    

Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): The educational sessions and individual sessions including dietary management and physical activity advices.
Other intervention name(s): Dietary and physical activity advices
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Validation of Therapeutic Effects of Cefaly on Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The study aims to examine whether the Cefaly has a therapeutic effect on insomnia patients
      visiting a psychiatric clinic in Korea. The study design is a single site, single-armed
      exploratory study. Insomnia patients received a 20-minute daily sessions of the Cefaly for 4
      weeks. Primary endpoint was a reduction of scores in Pittsburgh Sleep Quality Index, Insomnia
      Severity Index, Epworth Sleepiness Scale, improvements in polysomnography measures, and
      changes in resting state networks, cortical thickness, fractional anisotropy and mean
      diffusivity
    

Detailed description: 
      Insomnia is well-known for its association with adverse health outcomes. Although insomnia is
      usually treated with hypnotics or cognitive behavioral therapy for insomnia, the need for
      novel nonpharmacological treatment for insomnia is increasing emphasized due to reports of
      side effects and detrimental consequences of hypnotics. Trigeminal nerve electrical
      neuromodulation has been suggested as a potential treatment modality through its modulation
      of noradrenergic activity that results in promoting relaxation and reducing hyperarousal.
      Insomnia patients enrolled in the study will go through a 20-minute daily session of the
      Cefaly device(originally FDA-approved device for migraine, which electrically modulates
      trigeminal nerve) for 4 weeks. The objective of this study is to test whether trigeminal
      nerve electrical neuromodulation has a therapeutic effect, validation measures involving
      subjective measures(Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth
      Sleepiness Scale), objective measures(Polysomnography measures) and neuroimaging(changes in
      resting state networks, cortical thickness, fractional anisotropy and mean diffusivity).
    

Intervention name(s): Cefaly
Intervention type(s): Device
Intervention description(s): Transcutaneous trigeminal nerve electrical neuromodulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of Obesity in Women Via Estradiol Regulation
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate potential mechanisms by which estradiol deficiency
      accelerates fat gain and abdominal fat accumulation in women.
    

Detailed description: 
      Many factors contribute to the current epidemic of obesity. Although estrogen status is not
      commonly recognized as a determinant of obesity risk in women, there is strong evidence from
      large randomized controlled trials that estradiol (E2)-based hormone therapy (HT) reduces
      weight gain by about 40% in postmenopausal women. Importantly, there is also strong evidence
      that E2 reduces abdominal fat accumulation, a fundamental component of the Metabolic
      Syndrome. Some studies suggest risks of HT outweigh the benefits for some women. However,
      this does not negate the importance of learning the mechanisms by which E2 influences energy
      balance and fat patterning.

      This study uses gonadotropin releasing hormone (GnRH) analog therapy to determine the effects
      of chronic (5-month) sex hormone suppression on resting energy expenditure (REE), altered
      hypothalamic-pituitary-adrenal (HPA) axis activity, and fat gain.

      It is hypothesized that REE will be reduced in response to chronic sex hormone suppression,
      promoting fat gain. It is also hypothesized that stress-induced
      hypothalamic-pituitary-adrenal (HPA)axis activity will be amplified during sex hormone
      suppression; altered HPA axis activity leading to cortisol excess causes abdominal fat
      accumulation. Finally, it is hypothesized that E2 add-back therapy will lessen these
      responses.

      Participants will be randomized so that half of the women in each treatment arm will
      participate in an exercise training program, consisting of progressive resistance exercise to
      prevent the decline in fat-free mass (FFM) and the increase in fat mass that has been
      observed in young women in response to GnRH analog therapy.
    

Intervention name(s): leuprolide acetate; Estradiol Transdermal; progressive resistance exercise training
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): 3.75 mg for depot suspension delivered by monthly intramuscular injection for 5 months; 0.075 mg patch per day for 5 months; 45 minute exercise sessions 4 times per week for 5 months
Other intervention name(s): Lupron; Climara
Intervention MeSH terms: Leuprolide; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hormone therapy; obesity; postmenopause; disease /disorder proneness /risk; insulin sensitivity /resistance; metabolic syndrome; women's health