bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Cardiac Shockwave Therapy in Patients Undergoing Coronary Artery Bypass Grafting
Condition: Heart Failure Patients; Cardiac Ischemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Ischemia
Study type: Interventional

Summary: 
      This randomised, controlled clinical trial aims to evaluate the safety and efficacy of
      Cardiac Shockwave Therapy (CAST-HF) in patients with ischaemic heart failure requiring
      surgical revascularization. The main questions to answer are:

        -  Does cardiac shockwave therapy, in addition to CABG surgery, improve left ventricular
           ejection fraction?

        -  Is cardiac shockwave therapy in addition to CAGB surgery safe?

      Participants will be randomised into intervention (cardiac shockwave therapy) and control
      (sham treatment with an inactive applicator) groups.
    

Detailed description: 
      This study investigates the safety and performance characteristics of the Direct Epicardial
      Shockwave Therapy System (DESWT) as applied with the Cardiac Shockwave Probe (CSP).
    

Intervention name(s): Shockwave Therapy
Intervention type(s): Device
Intervention description(s): The cardiac shockwave system consists of a table-top device (Nonvasiv Medical GmbH, Konstanz, Germany) and a sterile single-use applicator releasing electrohydraulic shockwaves (Heart Regeneration Technologies GmbH, Innsbruck, Austria). Prior to use, the applicator is inserted into a sterile cover containing ultrasound gel. In order to ensure acoustic coupling between the applicator and the myocardium, continuous saline rinsing is applied throughout the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study investigates the safety and performance characteristics of the Direct Epicardial Shockwave Therapy System (DESWT) as applied with the Cardiac Shockwave Probe (CSP) vs. Sham treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
Condition: Lung Diseases; Medication Compliance
MeSH terms: Lung Diseases; Signs and Symptoms, Respiratory
Study type: Interventional

Summary: 
      The purpose of this study is to understand why patients in the World Trade Center program
      have continuing breathing problems. This study will improve investigators understanding of
      breathing problems among individuals with World Trade Center exposure by allowing them to
      review and monitor medication use, lung function, and examine other conditions that can
      contribute to problems with breathing. The findings from the study will help investigators
      understand why some people have persistent lower respiratory symptoms (breathing problems)
      after their exposure to World Trade Center dust and fumes, and may help guide better
      management and treatment of these symptoms.
    

Detailed description: 
      Investigators will conduct a clinical study with aggressive treatment for lower respiratory
      symptoms in patients in the World Trade Center Environmental Health Center. Patients in the
      WTC EHC with uncontrolled LRS at visit 1 will be identified and placed on high-dose inhaled
      corticosteroids and long-acting beta agonists for three months. Adherence will be assessed at
      monthly visits. Patients will perform spirometry and oscillometry at baseline and after 3
      months of treatment. They will also be assessed for markers of airway inflammation, bronchial
      hyperresponsiveness and co-morbid conditions including depression,anxiety,post-traumatic
      stress disorder, gastroesophageal reflux, paradoxical vocal cord motion and rhinosinusitis.
    

Intervention name(s): Fluticasone propionate 230mcg for 3 Months; Current Treatment or no treatment; Salmeterol 21mcg for 3 Months
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
Other intervention name(s): Advair HFA
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: World Trade Center Disaster; Environmental Exposure; Respiratory Physiology; Inflammation; Gastrointestinal Diseases; Sinus Symptoms; PTSD; Anxiety; Depression; Hypersensitivity; Spirometry; Oscillometry
A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet (Without Water) and Conventional Tablet
Condition: Healthy; Plasma Concentration of YM060
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare time-course changes of plasma concentration of YM060 after intake of
      conventional tablet and orally-disintegrating tablet. Orally-disintegrating tablets will be
      administered without water.
    


Intervention name(s): YM060
Intervention type(s): Drug
Intervention description(s): oral, without water
Other intervention name(s): ramosetron; Irribow
Intervention MeSH terms: Ramosetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: YM060; ramosetron; orally-disintegrating tablet; OD tablet; bioequivalence
tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects on pain of transcranial direct current
      stimulation combined with therapeutic exercise in fibromyalgia patients.
    

Detailed description: 
      Fibromyalgia is one of the rheumatic diseases with the greatest impact on the quality of
      life, whose etiology and pathophysiology is not yet fully demonstrated. Perhaps this is why
      its therapeutic approach is refractory to current treatments.

      Based on the theory that fibromyalgia is characterized by a sensitization at the level of the
      central nervous system that leads to an increase in the perception of pain, any therapeutic
      approach aimed at modulating the central nervous system may be beneficial. Electrical
      stimulation with transcranial direct current (tDCS) is among these techniques.

      In the same way, therapeutic exercise has shown to have, like the tDCS, a beneficial effect
      on pain in different chronic pathologies.

      The present study aims to investigate the effect on pain of a combination therapy of tDCS and
      therapeutic exercise in patients with fibromyalgia.
    

Intervention name(s): Real tDCS; Sham tDCS; Therapeutic exercise
Intervention type(s): Device; Device; Device
Intervention description(s): Real tDCS (STARTSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days.tDCS is a galvanic current applied by a cap for 20 minutes at an intensity of 2 milliamps.; Sham current (STARSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days. Sham tDCS will be applied for the same time than real tDCS.; The therapeutic exercise program will include aerobic exercise and muscle strengthening for five sessions on alternate days. The program will include exercises and will last 30-45 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tDCS; Therapeutic exercise; Referred pain; Central sensitization
Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects
Condition: Hypoparathyroidism
MeSH terms: Hypoparathyroidism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare how rhPTH(1-84) affects the body between healthy
      adults of Japanese descent and matched, healthy Caucasian adults.
    


Intervention name(s): rhPTH(1-84); rhPTH(1-84); rhPTH(1-84)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 mcg rhPTH(1-84) SC injection; 50 mcg rhPTH(1-84) SC injection; 100 mcg rhPTH(1-84) SC injection
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Escalation Study of UCART19 in Adult Patients With Relapsed / Refractory B-cell Acute Lymphoblastic Leukaemia
Condition: B-cell Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is in two parts: a dose escalation then a safety dose expansion. The purpose of the
      dose escalation part is to evaluate the safety and tolerability of ascending doses of UCART19
      (dose-escalation part) given as a single infusion in patients with relapsed / refractory
      (R/R) B-cell acute lymphoblastic leukaemia (B-ALL), to determine the maximum tolerated dose
      (MTD), the recommended dose and the lymphodepletion regimen. The purpose of the safety dose
      expansion is to assess the safety and tolerability of the RD for UCART19.
    


Intervention name(s): UCART19
Intervention type(s): Biological
Other intervention name(s): S68587
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Interest of Non Invasive Ventilation Versus Oxygen During the Intial Managment of Infant With Bronchiolitis
Condition: Bronchiolitis; Respiratory Distress
MeSH terms: Bronchiolitis
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate, in a prospective way, the clinical, the manometric
      an gazometric benefit of non-invasive ventilation (VNI), (INFANTFLOW [EME, Brighton,
      England]) during bronchiolitis of the infant compared to a conventional managment.
    

Detailed description: 
      1. Experimental plan: The infants (0 to 6 month) admitted in pediatric intesive care unit
           for respiratory distress with bronchiolitis but not requiring mechanical ventilation are
           randomized in two groups: group "A" is treated with a non-invasive ventilation
           device(Infantflow) during 6 hours, group "B" is treated conventionally by inhalation of
           a Air/O2 mixture during 6 hours.

        2. Outcome: Primary outcome: clinical score of respiratory distress at H0 and H6. Secondary
           outcome: respiratory and cardiac frequency, average blood pressure. Manometric:
           Variation of esophageal pressure at H0, H6. Gasometric: Minimal FiO2 necessary to reach
           an oxygen saturation between 94 and 98%, transcutaneus PCO2, PaO2/FiO2

        3. Analyze results: Intention to treat analysis after having checked the randomization by
           comparing clinical gravity in the two arms (clinical score).

        4. Calendar of the study: October 2006 at April 2008

        5. Follow-up of the patients: the study proceeds during the hospitalization of the infants
           during 6 hours and will not impose any specific follow-up.
    

Intervention name(s): Infantflow [EME, Brighton, England]
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bronchiolitis; Esophageal pressure mesurement; Clinical score; Citical care; Infant
Stevens-Johnson Syndrome Antimicrobial
Condition: Stevens-Johnson Syndrome
MeSH terms: Stevens-Johnson Syndrome; Syndrome
Study type: Observational

Summary: 
      Steven-Johnson's syndrome, or great multiform erythema, appears as a systemic disturbance,
      with skin involvement and mucous membranes, related to several factors, such as, viral or
      bacterial infections and mainly the administration of medicines, in general painkillers and
      antibiotics. The objective of this work is report the emergence of ulcerative vesicle -bubble
      chronic disease in areas of lips, gum, tongue and genital mucous membrane in a 26 year-old
      patient, leucoderma and masculine gender, in treatment of breathing infection with
      sulfametoxazol-trimetropima, having been diagnosed as syndrome of Steven-Johnson.
    

Detailed description: 
      Among the serious medicaments reactions, there are as great representative the Mucocutaneous
      Disorders immunological mediated. Steven-Johnson's syndrome, or great multiform erythema,
      appears as a systemic disturbance, with skin involvement and mucous membranes, related to
      several factors, such as, viral or bacterial infections and mainly the administration of
      medicines, in general painkillers and antibiotics. The objective of this work is report the
      emergence of ulcerative vesicle -bubble chronic disease in areas of lips, gum, tongue and
      genital mucous membrane in a 26 year-old patient, leucoderma and masculine gender, in
      treatment of breathing infection with sulfametoxazol-trimetropima, having been diagnosed as
      syndrome of Steven-Johnson.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        1
      
Keywords: Steven-Johnson syndrome; erythema multiform; autoimmune disease
Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.
Condition: Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Intranasal hydromorphone has been shown to be effective in reducing acute pain in adults. It
      has not been previously studied in children, but may be a viable option for effectively and
      safely reducing pain in children by administering an analgesic by the intranasal route.

      This study will be a prospective, open-label pilot study of intranasal hydromorphone in
      children with moderate to severe acute pain presenting to the pediatric emergency department.
      The investigators aim to describe the amount of pain reduction associated with intranasal
      hydromorphone, and to determine the optimal dose of intranasal hydromorphone associated with
      a clinically meaningful improvement in acute pain.
    

Detailed description: 
      Primary Aim: Determine the change in pain intensity in children with moderate to severe pain
      who receive intranasal hydromorphone one hour after administration.

      Secondary Aim(s): Describe the incidence of minor and major adverse events associated with
      intranasal hydromorphone in children with acute pain.

      The investigators will assess the patient's pain at baseline (prior to study drug
      administration), then after study drug administration: 5 minutes, 15 minutes, 30 minutes, 45
      minutes, 60 minutes, and then every 30 minutes thereafter until 6 hours; administration of
      non-protocolized rescue medication administration (i.e. administered after first two rescue
      doses of IN hydromorphone); or discharge from emergency department (whichever comes first).
      The pain score at 60 minutes will be the primary outcome.

      The investigators will evaluate qualitative improvement in pain intensity at 15- and
      30-minutes after study drug administration. If there is no improvement, or worsening of pain
      intensity, at each assessment, an additional rescue dose rescue dose of intranasal
      hydromorphone will be administered. After 60 minutes, the treating physician may administer
      any additional rescue medications at their discretion to treat the child's pain.

      The patient will be assessed for minor and major adverse events for the duration of the
      study.
    

Intervention name(s): Hydromorphone
Intervention type(s): Drug
Intervention description(s): To be administered by intranasal route using mucosal atomization device.
Other intervention name(s): Dilaudid
Intervention MeSH terms: Hydromorphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intranasal; Hydromorphone; Pediatric; Emergency department
Study of NPC-07 for Fluorescence-guided Resection of Malignant Gliomas
Condition: Malignant Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the present Phase III study is to assess the positive predictive value of NPC-07
      (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and
      pharmacokinetics following a single dose of NPC-07 orally, at a dose of 20mg/kg/body weight,
      3 hours prior to induction of anaesthesia for surgery of patients with newly or recurrent
      malignant glioma (WHO grades III/IV).

      Positive predictive value will be confirmed by percentage of patients showing positive tumor
      cell identification in all biopsies taken from areas of strong and weak fluorescence. This
      study will be divided into two stages. After reviewing of the result of safety and
      pharmacokinetics of NPC-07 in small number of subjects by independent safety monitoring
      committee, more subjects will receive NPC-07 in Step II.
    


Intervention name(s): NPC-07 for oral administration
Intervention type(s): Drug
Intervention description(s): NPC-07, containing 1.5g of 5-aminolevulinic acid hydrochloride per vial, is dissolved in 50 mL of water and will be administered orally 3 hours (range 2-4 hours) prior to induction of anesthesia at a dose of 20mg/kg body weight.
Other intervention name(s): 5-ALA, 5-aminolevulic acid hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: NPC-07, 5-ALA, photodynamic diagnosis, pharmacokinetics
HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles
Condition: Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing IUI
Study type: Interventional
Phase: Early Phase 1

Summary: 
      We recently reported the superiority of the natural cycle to a natural cycle controlled by
      the administration of human chorionic gonadotropin (hCG) for planning the frozen-thawed
      embryo transfer cycles, demonstrating a probable negative impact of exogenous hCG on
      endometrial receptivity.Based on the above findings we conducted the first prospective study
      that assesses whether there is a difference in pregnancy rate after intrauterine insemination
      (IUI) in a natural cycle with spontaneous luteinizing hormone (LH) rise compared to natural
      cycles controlled by hCG for final ovulation.
    


Intervention name(s): HCG
Intervention type(s): Drug
Intervention description(s): 5000 IU
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: IUI; HCG; Spontaneous LH; pregnancy
Autotaxin: a Potential Biomarker for Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The goal of this clinical trial is to test the efficiency of Autotaxin (ATX) as a biomarker
      for breast cancer patients.

      The main questions it aims to answer are;

        -  is ATX a reliable tumor marker for breast cancer patients in diagnosis

        -  can ATX differentiate cancer patients from non-cancer ones
    

Detailed description: 
      80 breast cancer patients and 30 normal patients with no known cancer history were enrolled
      in this study. All patients were female. The mean ages of cancer patients were 58.2 and 52.7
      consecutively for cancer and non-cancer patients. The mean serum ATX levels of cancer and
      non-cancer patients were 1570.72 and 121.86 ng/mL consecutively (p=0.001). The cut-off value
      of ATX serum level was 178.49ng/mL according to the ROC analysis. The area under the ROC
      curve was 0.901showing that ATX is very efficient in distinguishing between two diagnostic
      groups (diseased/normal). ATX also showed good correlations with known tumor markers (CEA,
      CA15-3, CA125 levels). ATX levels were still higher than the cut-off value even in cancer
      patients with normal or low classical tumor marker levels.
    

Intervention name(s): measurement of serum autotaxin serum level
Intervention type(s): Biological
Intervention description(s): autotaxin expression
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: breast cancer; autotaxin; tumor marker
Study Evaluating SCA-136 in Subjects With Acute Exacerbations of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a low dose and a high dose of the study
      drug SCA-136 are effective and safe in the treatment of schizophrenia requiring
      hospitalization.
    


Intervention name(s): SCA-136 (200 mg); SCA-136 (400 mg); olanzapine (15 mg); placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia
Study to Investigate the Safety and Efficacy of High Dose of Symbicort® SMART in Japanese Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to compare the tolerability of Symbicort® Turbuhaler®
      160/4.5 μg 10 inhalations with terbutaline Turbuhaler® 0.4 mg 10 inhalations for 3 days on
      top of Symbicort® Turbuhaler® 160/4.5 μg 1 inhalation twice a day (bid) in adult asthma
      patients.
    


Intervention name(s): Symbicort Turbuhaler; Terbutaline Turbuhaler
Intervention type(s): Drug; Drug
Intervention description(s): 160/4.5μg for 3 days; 0.4 mg for 3 days
Intervention MeSH terms: Terbutaline; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Symbicort Turbuhaler
Application of Linaclotide Capsule in Bowel Preparation for Colonoscopy
Condition: Bowel Preparation for Colonoscopy
Study type: Interventional

Summary: 
      The clinical purpose of this study was to investigate whether the adjuvant application of
      linaclotide in bowel preparation for colonoscopy could improve the quality of bowel
      preparation or reduce the dosage of laxatives.
    


Intervention name(s): 3L PEG + Linaclotide; 3L PEG; 2L PEG + Linaclotide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Before colonoscopy, particpant take linaclotide capsules for 3 days (1 tablet should be taken at least 30 minutes before the first meal every day). Particpant take 1500ml polyethylene glycol electrolyte solution within 1.5 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.; Particpant take 1500ml polyethylene glycol electrolyte solution within 1.5 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.; Before colonoscopy, particpant take linaclotide capsules for 3 days (1 tablet should be taken at least 30 minutes before the first meal every day). Particpant take 1000ml polyethylene glycol electrolyte solution within 1 hours from 20 p.m the night before the examination; and repeat the same dose of polyethylene glycol electrolyte solution 4-6 hours before colonoscopy.
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Linaclotide; Bowel preparation; colonoscopy