bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of IgM Rich Immunoglobulin With Antibiotics for Bacterial Sepsis in Very Low Birth Weight Preterm Neonates
Condition: Neonatal SEPSIS; Very Low Birth Weight Baby
MeSH terms: Sepsis; Toxemia; Neonatal Sepsis; Body Weight; Birth Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      Study comprises of giving IVIG to half of the septic VLBW preterm neonates along with ongoing
      antibiotics and placebo to the other half. The immunoglobulin will be given for 3 days and
      neonates will be monitored for the results. The data will be analysed on the basis of blood
      culture results and outcome of the patients.
    


Intervention name(s): IgM rich Immunoglobin
Intervention type(s): Drug
Intervention description(s): the 'IgM rich immunoglobn' is the normal human immunoglobin containing Human plasma protein 50mg/ml of which immunoglobin is atleast 95% Immunoglobin M (IgM) 6mg Immunoglobin A (IgA) 6mg Immunoglobin G (IgG) 38mg
Other intervention name(s): Pentaglobin®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: IgM; Immunoglobulin; Neonatal sepsis; very low birth weight preterm
A Dose Finding Study of AEB071 Assessing Psoriasis Area and Severity Index in Patients With Plaque Psoriasis
Condition: Moderate and Severe Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to provide efficacy and safety data of several doses of AEB071 so that
      the optimal dose and treatment duration can be chosen for testing in later studies in
      patients with plaque psoriasis (with a disease severity such that systemic treatment is
      justified). The treatment free Follow-up Period is designed to provide additional safety data
      and information on disease recurrence after the last dose of the study drug.
    


Intervention name(s): Placebo; AEB071
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Psoriasis; plaque psoriasis; inflammatory skin disease; scaly patches; AEB071
Transversus Abdominis Plane (TAP) Block for Cesarean Section
Condition: Hyperalgesia, Secondary
MeSH terms: Hyperalgesia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a transversus abdominis plane (TAP) block
      with Clonidine added to the injectate (Clo-TAP) performed approximately 2hrs after the
      cesarean section (CS) will decrease the amount of postoperative hyperalgesia and ultimately
      reduce post-CS chronic pain.
    

Detailed description: 
      Acute severe pain after cesarean section (CS) occurs more often than is thought and 10-15% of
      the women having a cesarean section develop chronic pain (Kehlet et al. 2006). With over 1.3
      million cesarean deliveries per year in the US, this is bound to create a significant health
      problem. One way to address this health burden is to refine techniques that may help control
      the pain women experience after CS and ultimately reduce the potential to develop chronic
      pain.

      The purpose of this randomized, double-blinded study is to evaluate the ability of an
      established anesthetic technique called the transversus abdominis plane (TAP) block to reduce
      the amount of hyperalgesia women develop around their incision after CS. Measuring the amount
      of punctuate mechanical hyperalgesia is used as a tool to assess postoperative central
      sensitization (Lavand'homme et al. 2005), which contributes to postoperative acute pain.
      Since postoperative acute pain has been shown to be predictive of developing postoperative
      chronic pain (Eisenach et al. 2008; Yarnitsky et al. 2008), an effective TAP block could help
      diminish the incidence of chronic pain after CS. In addition, blood samples will be collected
      for future genetic analysis and we will test preoperatively for mechanical temporal summation
      (mTS) to evaluate CNS (central nervous system) sensitization and nociceptive system
      hyperexcitability and see if this correlates with the amount of hyperalgesia women develop
      around their incision after surgery.

      The primary aim of this study is to evaluate the benefits of two different solutions injected
      by TAP block technique on postoperative peri-incisional hyperalgesia.
    

Intervention name(s): Bupivacaine Placebo; Clonidine Placebo; Bupivacaine; Clonidine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 x 20mL 0.9% NaCl; 2 x 1mL 0.9% NaCl; 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine; 2 x 1ml Clonidine = 150 µg Clonidine
Other intervention name(s): Bupi Placebo; Sodium Chloride; Sodium Chloride; Bupivacaine Hydrochloride; Clonidine Hydrochloride
Intervention MeSH terms: Clonidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: postoperative; hyperalgesia; pain; transversus abdominis plane block; TAP block; cesarean section
ToleroMune House Dust Mites (HDM) Exposure Chamber Study
Condition: Rhinoconjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and
      fabric. Like many other allergens, exposure to HDM allergens in sensitised patients is
      associated with poorer lung function, greater medication requirements and more asthma
      symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is
      evidence that HDMA leads to the development of asthma, in addition to exacerbating
      pre-existing asthma in HDM-sensitised patients.

      ToleroMune HDM is a novel, synthetic, allergen-derived peptide desensitising vaccine,
      currently being developed for the treatment of HDM allergy

      This study will look at the efficacy, safety and tolerability of three doses of ToleroMune
      HDM in HDM allergic subjects following challenge with HDM allergen in an Environmental
      Exposure Chamber (EEC)).
    

Detailed description: 
      This study is designed as a randomised, double-blind, placebo-controlled, parallel group
      study to evaluate the safety and tolerability of ToleroMune HDM in HDM allergic subjects with
      allergic rhinoconjunctivitis. The efficacy of ToleroMune Ragweed will be explored in subjects
      using an EEC.

      The study will consist of 3 study periods. In Period 1, Screening will be performed up to a
      maximum of 16 weeks before randomisation and may consist of one or two visits to the clinic,
      at the Investigator's discretion. Baseline Challenge will consist of 3 visits to the EEC.
      Eligible subjects will complete a daily diary card at home for two weeks following the final
      visit to the EEC.

      In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be
      randomised to one of four groups and will receive treatment over 11 visits in 3 dosing
      periods for each subject. Within each dosing period visits will take place at intervals of 4
      weeks (28±2 days). There will also be two EEC visits during the treatment period and one post
      treatment EEC visit. Following the final visit to the EEC, subjects will complete a daily
      diary card at home for two weeks.

      In Period 3, Follow-up will be conducted 16-21 days after the final EEC visit.
    

Intervention name(s): ToleroMune HDM; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intradermal injection 1 x 11 administrations 4 weeks apart; Intradermal injection 1 x 11 administrations 4 weeks apart
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HDM allergy; Rhinoconunctivitis; Environmental Exposure Chamber; Immunotherapy; ToleroMune HDM
Effects of Hemiplegic Shoulder Pain
Condition: Stroke; Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Observational

Summary: 
      The purposes of this study is to investigate the differences in upper extremity function,
      sleep quality, and functional independence between patients with and without hemiplegic
      shoulder pain (HSP).

      HSP is defined as musculoskeletal pain in the affected shoulders of individuals after
      stroke.Numerous studies have found an association between post-stroke shoulder pain and range
      of motion, sensory impairment, subluxation, spasticity, and complex regional pain syndrome.
      HSP is a problem that, starting from mild discomfort, leads to gradual functional impairment,
      ultimately resulting in increasing disability and decreased independence.In the literature,
      the relationship between HSP and upper extremity function, functional independence, and sleep
      quality has not been clarified.
    


Intervention name(s): Disabilities of the Arm, Shoulder, and Hand Questionnaire; Arm Motor Ability Test; Nine Hole Peg Test; Pittsburg Sleep Quality Index; Functional Independence Measure
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Upper limb function was assessed with the Turkish version of the Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH). The questionnaire DASH is a self-report instrument with 30 items. The total score ranges from 0 to 100, with higher scores indicating a worse upper limb function.; The test assesses hemiparetic upper extremity functional tasks.The increase in the scores of both subparameters of the scale, which is composed of the parameters of functional ability and quality of movement, indicates an improvement in the motor functions of the upper limbs.; Fine motor skills of the upper extremities were assessed.The patient was asked to insert the nine sticks in the box on the table into the holes in the other box as quickly as possible and then remove them immediately. As time increases, fine motor skills of the upper extremities decrease; Sleep quality was assessed using the this test.This scale, which provides a quantitative measure of sleep quality, is a 19-item self-report scale. The total score greater than 5 indicates "poor sleep quality".; This test assessed functional capacity in activities of daily living.The higher a person's score, the higher the level of independence.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Stroke patients
Vitamin D Needs of Early Adolescent Children
Condition: Healthy
Study type: Interventional

Summary: 
      While a large percentage of children have low blood vitamin D levels, the significance of
      these low levels and the impact on health is unclear. The purpose of this project is to
      determine the effects of varying doses of vitamin D supplementation over 12 weeks on blood
      indicators of health in white and black children, aged 9 to 13 years, from both the northern
      and southern US.
    

Detailed description: 
      Vitamin D intakes in children do not meet current US Dietary Reference Intake recommendations
      and emerging evidence suggests that a significant number of children, particularly those with
      darker skin pigmentation, have inadequate levels of serum 25-hydroxyvitamin D [25(OH)D]. The
      optimum level of circulating 25(OH)D has not been clearly defined in children, nor is it
      known what functional outcome measures are ideal for defining this level, or if these
      requirements would differ by race. Graded doses of vitamin D3 supplementation will be used in
      this dual-site, 12-week trial. The investigators hypothesize that a dose-response
      relationship will be observed between vitamin D supplementation and intermediate endpoints of
      skeletal health, and that race will modify these responses.
    

Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention description(s): vitamin D3 supplementation at 400 IU vs 1,000 IU vs 2,000 IU vs 4,000 IU vs placebo for 12-weeks
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Vitamin D; Adolescent; African American; White
LOMA: Long-Term Management of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study was to determine whether the use of induced sputum cell counts
      could guide treatment of asthma more effectively than the use of symptoms and breathing
      tests. The main outcomes where the time to the first exacerbation and the number of
      exacerbations.
    

Detailed description: 
      Airway inflammation is an important component of asthma. It influences other components which
      include symptoms and airway functional (physiological) measurements. It is the primary target
      of treatment. However, it does not correlate closely with symptoms, need for symptomatic
      bronchodilator relief, or the physiological abnormalities. Furthermore, it can be of
      different types. As a result, physicians are poor at recognizing its presence or type. This
      is important because eosinophilic inflammation is responsive to corticosteroid while
      non-eosinophilic is not responsive.

      The most comprehensive non-invasive or relatively non-invasive measurement of airway
      inflammation is by spontaneous or induced sputum cell counts. These are reliable, valid and
      responsive, the qualities of good measurements. They might therefore be clinically useful to
      guide individual treatment. In the present study we investigated this issue. We compared
      their use, in comparison with the use only of symptoms and spirometry, in preventing
      exacerbations of asthma. We chose prevention of exacerbations as the most important clinical
      outcome because these have the greatest impact on patient's quality of life, morbidity and
      healthcare utilization. The study comprised two Phases. In Phase 1, the minimum treatment to
      control sputum eosinophilia (as well as clinical criteria) in the Sputum Strategy, and
      clinical criteria in the Clinical Strategy, were established. In Phase 2, this minimum
      treatment was maintained and patients were seen every 3 momths and at exacerbations. The
      primary outcomes were the relative risk reduction for the occurrence of the first
      exacerbation and the length of time without exacerbation over 18-20 months in Phase 2 of the
      study.
    

Intervention name(s): Induced sputum cell counts; inhaled corticosteroids and other asthma drugs
Intervention type(s): Procedure; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: asthma treatment; induced sputum cell counts; asthma exacerbations; eosinophilic bronchitis; non-eosinophilic bronchitis
Efficacy Of Different Types Of Physiotherapy Approaches In Temporomandibular Disorders
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to investigate the efficacy of different types of physiotherapy
      approaches in cases with cervical myofascial painful TMD.
    

Detailed description: 
      59 persons with TMD diagnosed by the dentist and with cervical myofascial pain, aged 18-30
      years will be randomly allocated, 3 groups. The participants were randomly allocated only
      exercise group (EG) (n=20), low-level laser therapy plus exercise group (LLLT) (n=17) and
      manual pressure release plus exercise group (MPR) (n=22). The cases were evaluated and
      treated by the same physiotherapist for 4 weeks (12 sessions).

      Pain, pain pressure threshold, temporomandibular joint (TMJ) mobility and disability, forward
      head posture, head rotation, neck disability, psychological status and quality of life were
      evaluated. Evaluations were repeated before and after treatment.
    

Intervention name(s): Exercise; Low Level Laser Therapy; Manuel Pressure Release; Patient Education
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Exercise therapy intended in reducing muscle spasm, improving coordination of the mastication muscles and alter the jaw closure pattern.; LLLT (max output power: 1200mW, wavelength: 808 nm, dosage: 10j/ cm2 Electronica Pagani Laser Tower Light, Italy) 2.5-4j/TrP dosage was applied to MTrP or sensitive points.; MPR technique is a noninvasive method based on pressure on the trigger point in accordance with the patient's tolerance and technique applies supine position relax as much as possible, manuel pressure applied trigger point in neck and mactication muscles; Some suggestions were made to TMD people who should pay attention to in daily life. These suggestions were given in writing.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Temporomandibular disorders; Exercise; Low-level laser therapy
Study of Tissue Samples From Patients With Glioma or Other Brain Tumors
Condition: Central Nervous System Lymphoma
MeSH terms: Glioma
Study type: Observational

Summary: 
      RATIONALE: Studying the genes expressed in samples of tissue from patients with cancer in the
      laboratory may help doctors learn more about changes that occur in DNA and identify
      biomarkers related to cancer. It may also help doctors predict how patients will respond to
      treatment.

      PURPOSE: This research study is looking at tissue samples from patients with glioma or other
      brain tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To better understand the pathophysiology of gliomas and identify molecular markers that
           may predict prognosis and progression or that could identify new therapeutic approaches.

      Secondary

        -  To compare gene expression profiles, in terms of response to treatment, and attempt to
           isolate subgroups of patients with objective response to certain types of chemotherapy
           or radiotherapy.

      OUTLINE: This is a multicenter study.

      Biological samples are collected from patients at time of surgery for diagnostic and/or
      treatment purposes.
    

Intervention name(s): laboratory biomarker analysis; pharmacogenomic studies
Intervention type(s): Other; Other
Intervention description(s): laboratory biomarker analysis; pharmacogenomic studies
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Pathophysiology of gliomas and identification of molecular markers that may predict
        prognosis and progression or that could identify new therapeutic
      
Keywords: adult anaplastic astrocytoma; adult diffuse astrocytoma; adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma; adult pilocytic astrocytoma; adult pineal gland astrocytoma; adult subependymal giant cell astrocytoma; adult brain stem glioma; adult choroid plexus tumor; adult craniopharyngioma; adult ependymoblastoma; adult medulloblastoma; adult supratentorial primitive neuroectodermal tumor (PNET); adult anaplastic ependymoma; adult ependymoma; adult myxopapillary ependymoma; adult subependymoma; meningeal melanocytoma; adult meningeal hemangiopericytoma; adult grade I meningioma; adult grade II meningioma; adult anaplastic meningioma; adult papillary meningioma; adult anaplastic oligodendroglioma; adult oligodendroglioma; adult pineoblastoma; adult pineocytoma; adult mixed glioma; recurrent adult brain tumor
The Impact of Aromatherapy on Alleviating Dental Anxiety in Children
Condition: Pain Syndrome
Study type: Interventional

Summary: 
      Dealing with dental anxiety in children is the most problematic responsibilities for
      pedodontists in the dental office. Essential oils had been used for reducing dental anxiety
      in adults; this study is a challenge to understand their effects on children. Aromatherapy is
      considered as a reasonable, potent, safe, and non-pharmacological way, which has been taken
      into consideration, especially for children who are supposed to go through any dental
      procedure under local anesthesia. The aim of this study is to explore and compare the effect
      of Rosemary versus Lemongrass essential oils on dental anxiety levels and vital signs of
      children during dental anesthesia and extraction of a lower primary molar in a dental office.
      Forty-five children, aged between 4 to 7 years, who had a minimum of one mandibular primary
      molar with deep caries indicated for extraction were selected. Patients are divided,
      randomly, into three groups (15 children each): Group I (control group): with no interference
      before dental anesthesia and extraction, Group II (Rosemary group): children inhaled two
      drops of rosemary oil for 3 minutes before the procedures of dental anesthesia and extraction
      of a primary molar, Group III (Lemongrass group): children inhaled two drops of lemongrass
      oil, for 3 minutes before the procedure of dental anesthesia and extraction of a primary
      molar. Wong Baker Scale and the physiological measures of the children's anxiety will be
      evaluated and recorded for each child by measuring (pulse rate, oxygen saturation, and blood
      pressure) before, during and after the dental procedures.
    


Intervention name(s): Rosmary; Lemongrass Oil
Intervention type(s): Drug; Drug
Intervention description(s): inhale two drops of rosemary oil, from a gauze, for 3 minutes before the procedure of extraction of a primary molar; inhale two drops of lemongrass oil, from a gauze, for three minutes before the procedure of extraction.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Early Endoscopic Indicators for OACs After Lung Transplantation: Development of a Novel Mucosal Healing Score
Condition: Airway Complication Which Require Any Intervention
Study type: Observational

Summary: 
      Airway complications are a significant cause of morbidity after lung transplantation (LTx).
      Bronchoscopic evaluation may help to identify risk factors for requiring interventions later.
    

Detailed description: 
      The investigators evaluated lung transplant recipients prospectively. Adult patients
      surviving 90 day after LTx will be included. The investigators propose a classification of
      airway healing based on the endoscopic bronchial appearances at days 7, 14, 21, 90, 180 and
      365 after LTx. A score system including mucosal healing, full tissue necrosis (=dehiscence),
      lose sutures, fibrin plugs, polyps and malacia will be developed (max. score 8 points/date).
      Endoscopic findings will be correlated with the development of obstructive airway
      complications (OAC, requiring >1 intervention). Afterwards the new score system will be
      applied prospectively in the patients.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        LTx 01.2007-05.2009