bioihbjkbjnl/mcl2 huggingface dataset:
Information and Anaesthesia in Paediatrics
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study aims to investigate whether detailed and illustrated information (comics) about
      anaesthesia reduce preoperative anxiety in children being subjects to craniotomy.

      Children scheduled for craniotomy are randomized to groups receiving a comic leaflet
      explaining the course of anaesthesia before preanaesthesia visit or no intervention.

      Preoperative anxiety is assessed with anxiety scale STAIC for the two groups of participants.
    


Intervention name(s): Information with comics
Intervention type(s): Other
Intervention description(s): Information of children with comic leaflet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: anxiety; anaesthesia; child; RCT; Elective surgery
Efficacy and Safety of SH T00660AA in Treatment of Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate safety and efficacy of SH T00660AA compared to
      placebo in the treatment of endometriosis
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.

      Bayer Schering Pharma AG, Germany is the sponsor of the trial.
    

Intervention name(s): Visanne (BAY86-5258, SH T00660AA); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): orally once daily; orally once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Neurostimulator Usage on Block Success
Condition: PATIENTS WITH UPPER EXTREMITY SURGERY
Study type: Interventional

Summary: 
      The need of a neurostimulator for a successful nerve block was questioned in different block
      types after ultrasound has become standard. The aim of this clinical study was to determine
      the effect of neurostimulator use on block success in costoclavicular block
    


Intervention name(s): fentanyl will be added; general anesthesia
Intervention type(s): Drug; Procedure
Intervention description(s): If adequate anagesia is not provided with the block, 1 microgram/kg of fentanyl will be added; If adequate anagesia is not provided with the block, general anesthesia will be administered.
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Brachial Plexus Block; Nerve Block; Ultrasonography
Study of Cingal® for Symptomatic Relief of Osteoarthritis of Shoulder Joint
Condition: Osteoarthritis, Shoulder
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This Trial will obtain clinical data to support an expanded indication for a single injection
      of Cingal® used for the symptomatic relief of osteoarthritis in the shoulder joint.
    

Detailed description: 
      CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone
      Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe. Cingal will be injected
      into the intraarticular (IA) space of the index hip using an 18-21-gauge needle. It is used
      for the symptomatic relief of osteoarthritis in the shoulder joint.
    

Intervention name(s): Cingal
Intervention type(s): Device
Intervention description(s): CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sodium Hyaluronate; Triamcinolone Hexacetonide
Aging, Nitrate, Endothelial Function and Muscle Oxygenation
Condition: Aging; Hypertension; Dyslipidemia; Abdominal Obesity
MeSH terms: Dyslipidemias; Obesity, Abdominal
Study type: Interventional

Summary: 
      Aging has been associated with reduced bioavailability of nitric oxide (NO) and endothelial
      dysfunction. Beetroot consumption, a nitrate-rich food, has been associated with increased NO
      bioconversion, which may promote beneficial effects on vascular health. The present study
      evaluated the effects of a beetroot-based nutritional gel (BG) on vascular function, arterial
      stiffness and blood pressure in the elderly at cardiometabolic risk. Twenty elderly
      individuals were submitted to BG and nitrate-depleted gel (PLA) interventions. Brachial
      flow-mediated dilation (FMD), blood flow velocity (BFV), peak wave velocity (PWVβ),
      augmentation index (AI), stiffness parameter (β), pressure-strain elasticity modulus (Ep),
      arterial compliance (AC), muscle oxygenation and function were measured 90 min after
      interventions. Urinary nitrate, nitrite, systolic blood pressure (SBP), diastolic blood
      pressure (DBP) and heart rate (HR) were measured at baseline, 90 min and 150 min after
      interventions.
    


Intervention name(s): Beetroot-based nutritional gel; Placebo
Intervention type(s): Other; Other
Intervention description(s): 100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.; 100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Aging; Beetroot; Dietary Nitrate; Functional Food; Vascular Function
Study of MEDI-507 Administered by Intravenous Infusion to Adults With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      - The primary objective of this study is to compare disease activity, as measured by PASI
      score, of two MEDI-507 dose levels (0.012 and 0.04 mg/kg) versus placebo administered by
      intravenous infusion every 2 weeks for a total of 8 infusions.
    


Intervention name(s): MEDI-507
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Care Guides in the Primary Care Office (Phase II)
Condition: Diabetes; Hypertension; Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      Trained lay persons ("care guides") working with chronic disease patients and their providers
      can help outpatients with diabetes, hypertension, and congestive heart failure achieve
      standard clinical care goals
    

Detailed description: 
      In a randomized parallel group multi-site trial looking at achievement of standard
      recommended treatment goals at baseline and one year later by 2135 patients with diabetes,
      hypertension, and congestive heart failure, we tested the hypothesis that adding a lay person
      with brief training to usual care would improve clinical outcomes. These "care guides" were
      culturally matched to patients served, similar to community health workers, but were located
      in 6 diverse primary care health clinics where they could meet patients face-to-face. They
      were asked to assist communication in both directions between providers and patients, taking
      advantage of their status as non-authority figures. They were given two weeks' training about
      these diseases and behavior change theory. This intervention was designed to be low cost,
      easy to implement, and to integrate into rather than change clinic work flow.
    

Intervention name(s): education and care guide; education only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients receive education about care goals, and in-person and telephone counseling of unspecified frequency over one year to achieve goals; patients receive education about care goals
Other intervention name(s): Active care management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: care management; chronic disease; outpatient
Flupenthixol and Haloperidol for Treating Cocaine Abuse Schizophrenics - 9
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of flupenthixol and
      haloperidol for cocaine dependence in individuals with schizophrenia/schizoaffective illness.
    


Intervention name(s): Flupenthixol
Intervention type(s): Drug
Intervention MeSH terms: Flupenthixol; Flupenthixol decanoate
Primary purpose: Treatment
Keywords: cocaine dependence
Hand & Foot Nocturnal Enuresis TENS Study
Condition: Bedwetting
MeSH terms: Enuresis; Nocturnal Enuresis
Study type: Interventional

Summary: 
      The investigators believe in order to strengthen the evidence in support of transcutaneous
      foot stimulation in this population the investigators need to move forward with a randomized
      comparison study using the TENS device on the hand and foot as a control.
    

Detailed description: 
      Nocturnal enuresis is a common problem in children which can have a dramatic psychological
      and social impact on quality of life. Neuromodulation by transcutaneous foot stimulation of
      peripheral tibial nerve branches has been shown to produce a prolonged inhibition of
      micturition reflex contractions and significantly increase bladder capacity. The
      investigators primary goal was to evaluate the effect of foot stimulation on the frequency of
      nocturnal enuresis episodes in children.
    

Intervention name(s): TENS
Intervention type(s): Device
Intervention description(s): Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Assess the safety and performance of the Miami InnFocus Drainage Implant in patients
      suffering from glaucoma that is inadequately controlled on tolerated medical therapy with
      intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg.
    

Detailed description: 
      Unicentric, non-randomized, single arm safety and performance study which will be conducted
      in accordance with the applicable parts of CFR 21 and Standard EN-ISO 14155 I & II: 2003 on
      clinical investigations with medical devices on human subjects and recommendations guiding
      physicians in biomedical research involving human subjects adopted by the 18th World Medical
      Assembly, Helsinki, Finland, 1964 and later revisions
    

Intervention name(s): Glaucoma Drainage Device
Intervention type(s): Device
Intervention description(s): Insertion of MIDI Arrow subconjunctivally with a fornix-based incision after pretreatment of scleral surface with 0.4 mg/mL MMC and insertion of MIDI Arrow tube through sclera into anterior chamber of eye
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MIDI Arrow; Glaucoma Drainage Device; GDD; InnFocus; Glaucoma treatment
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry II
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of
      treatment in patients with Chronic Obstructive Pulmonary Disease.
    


Intervention name(s): Olodaterol (BI 1744); Olodaterol (BI 1744); Placebo; Olodaterol (BI1744); Olodaterol (BI 1744) placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Comparison of low and high dose on exercise endurance time in COPD patients; Comparison of low and high dose on exercise endurance time in COPD patients; Comparison of low and high dose and placebo on exercise endurance time in COPD patients; Comparison of low and high dose on exercise endurance time in COPD patients; Placebo that represents olodaterol
Intervention MeSH terms: Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Treatment of Idiopathic Pulmonary Fibrosis(IPF) by REGEND001
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Idiopathic pulmonary fibrosis (IPF) is a serious chronic (long term) disease with injury of
      lung tissues. REGEND001 Autologous Therapy Product, made from bronchial basal cells with
      ability to regenerate lung tissue, is promising to IPF treatment. In this study, a
      single-armed clinical trial is ongoing to assess the safety and tolerability of REGEND001
      Autologous Therapy Product in treatment of IPF. Different doses of REGEND001 Autologous
      Therapy Product is evaluated to establish a dose-response relationship and to recommend
      appropriate dose for subsequent clinical trials.
    


Intervention name(s): REGEND001 Autologous Therapy Product
Intervention type(s): Drug
Intervention description(s): Transplantation of REGEND001 Autologous Therapy Product for dosage re-escalation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Assessment for a New UV-protected Pump Infusion Line in Intravenous Infusion Therapy
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      To verify the efficacy and safety of Original Perfusor Line (Art.No.8723017) in infusion
      therapy in Patients with light sensitive drug infusion.

      Subjects who choose to use Original Perfusor Line for their planned infusion treatment
      (nimodipine injection) as per the study protocol will be enrolled. The 300 subjects will be
      1:1 randomized into the experimental group or the control group, using Original Perfusor Line
      (Art.No. 8723017) connected with an injection pump for infusion treatment with nimodipine
      injection or Original Perfusor Line (Art.No.8723010) connected with an injection pump for
      infusion treatment with nimodipine injection, respectively.Use of both the test product and
      the control product will be in strict accordance with their package insert.

      The primary endpoint is the percentage of products which successful infuse fluids or
      medications into patient's circulatory system without leakage of fluids or medications,
      visible catheter embolism, air embolism and micro embolism in the infusion system and the
      secondary endpoint is the quality assessment for the clinical application of the
      products,such as the percentage of products which are qualified for infusion administration
      including link and removal, transparence, and tenacity.
    


Intervention name(s): Nimodipine pump infusion
Intervention type(s): Device
Intervention description(s): Patients with nimodipine pump infusion with pump infusion line and other infusion equipments
Intervention MeSH terms: Nimodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Controlled, Parallel, Multi-center study
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: pump infusion; photodegradation; IV infusion therapy
Movement Control Exercises With and Without Specific Breathing Techniques for the Treatment of Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Chronic low back pain (CLBP) is a leading disability globally. Exercise therapies are one of
      the most commonly prescribed treatment options for CLBP. Specific breathing techniques have
      been shown to enhance brain-based pain modulation and autonomic nervous system balance; these
      changes have been shown to improve clinical effectiveness in terms of pain management and
      psychological factors compared to general exercise. However, no previous studies have added a
      specific breathing technique protocol to an evidence-based exercise program for CLBP.
    


Intervention name(s): Home exercise
Intervention type(s): Other
Intervention description(s): Movement control exercise with or without specific breathing techniques
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: An open-label feasibility study with study subject allocated to movement control exercise with specific breathing techniques (experimental group) or movement control exercise without specific breathing techniques (control group)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The StepSmart Project: A Pedometer Based Phased Intervention to Encourage Physical Activity in Schools
Condition: Physical Activity; Health Behavior; Competitive Behavior; Incentives
Study type: Interventional
Phase: Phase 1

Summary: 
      A school based pedometer competition among Year 9 pupils (12 - 14 years old) to promote
      physical activity (PA).
    

Detailed description: 
      The intervention is separated into three main phases.

      Phase One: A 10-week school competition using pedometers and a range of non-financial
      incentives e.g. t-shirts, pens, badges etc. (April - June 2015).

      Phase Two: End of school competition but participants will still keep the pedometers. We will
      set them various challenges over the summer to keep active (July - Oct 2015).

      Phase Three: Removal of all extrinsically motivation factors. Focus on PA maintenance.
    

Intervention name(s): The StepSmart Challenge
Intervention type(s): Behavioral
Intervention description(s): A six month pedometer based intervention designed to increase Physical Activity in school children
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Pilates and Myofascial Release on Flexibility
Condition: Health, Subjective
Study type: Interventional

Summary: 
      The aim of this study is to compare the short and long term effects of pilates and myofascial
      relaxation technique on flexibility, muscle strength, dynamic balance, neural tension and
      pain threshold. To evaluate the effects of myofascial release technique on neural tension. To
      evaluate the effects of pilates on neural tension. To evaluate the effects of the protocol
      applied in combination with pilates and myofascial release technique in healthy women.
    

Detailed description: 
      Pilates is a synthesis of balance, breathing and movement systems that predict the unity of
      mind and body developed by Joseph Pilates. Breathing correctly and adequately allows more
      oxygen to go to all the tissues in our body. Pilates; It includes 6 key principles: breath,
      concentration, control, precision / accuracy, centering, rhythm / fluency. It activates every
      muscle in the body, gives balance and flexibility, and shapes the posture by improving the
      body. By correcting the posture, it protects the musculoskeletal system problems caused by
      the posture disorder and helps the body to be more flexible and increase the strength and
      endurance of the muscles. It provides control over all joint movements, especially the spine.
      It improves balance and coordination. Fascia is a single, inseparable connective tissue that
      wraps, supports, protects, connects all tissues. It is a dynamic structure with many sensory
      receptors, constantly changing and adaptable, it is the largest system in the human body.
      Myofascial release technique can be defined as low-intensity, long-term mechanical force
      applied to the myofascial complex in order to dissolve fascial adhesions, reduce pain, ensure
      optimal length of the muscle, and increase functionality. It has been shown that myofascial
      release applied to the hamstrings in healthy individuals provides an increase in the normal
      range of motion of the hip. The effects of Pilates and myofascial release technique on
      flexibility, muscle strength, dynamic balance, neural tension and pain threshold will be
      evaluated.
    

Intervention name(s): Pilates exercise and myofascial release
Intervention type(s): Other
Intervention description(s): Pilates exercise and myofascial relaxation technique will be applied to the experimental group and pilates exercise will be applied to the control group.
Other intervention name(s): Pilates exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized prospective clinical trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pilates; myofascial release; flexibility; muscle strength