bioihbjkbjnl/mcl2 huggingface dataset:
Benefit of the Chalaxie Pedagogical Tool in the Management of Overweight or Obese Children With Intellectual Disability : a Pilot Monocentric Prospective Study.
Condition: Pediatric Obesity
MeSH terms: Intellectual Disability; Overweight; Pediatric Obesity
Study type: Interventional

Summary: 
      The main objective of this study is to determine the benefit of the Chalaxie pedagogical
      evaluation tool in the management of overweight or obese children with intellectual
      disability.

      Chalaxie is a software developped as a pedagogical evaluation tool. It is used in the
      therapeutic education of overweight and obese children and allow the clinican to explore
      several skills of the child, such as self-esteem.
    

Detailed description: 
      Secondary objectives

        1. To assess the feasibility of the Chalaxie tool use during a medical visit;

        2. To assess the relevance of the Chalaxie tool for the pediatrician;

        3. To describe the characteristics of the patients followed at the "Réseau ODE";

        4. To evaluate patient self-esteem.

      Conduct of research After receiving written consent from the study participant and parental
      authority, the patients will have two visits with the pediatrician during which they will use
      the Chalaxie pedagogical evaluation tool. At the first visit, they will use the self-esteem
      assessment module. At the second visit (i.e. final visit), which should take place between 3
      weeks and 2 months after the first visit, they will use a module of their choice.
    

Intervention name(s): Use of the Chalaxie pedagogical evaluation tool
Intervention type(s): Procedure
Intervention description(s): Use of the Chalaxie pedagogical evaluation tool during two visits
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: intellectual disability; patient therapeutic education; pedagogical evaluation
A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      JZP025-101 is an open-label, multicenter, multi-arm, nonrandomized phase 1b master trial to
      determine the recommended phase 2 dose (RP2D) of CPX-351 when administered in combination
      with various targeted agents in previously untreated subjects with Acute Myeloid Leukemia
      (AML) who are fit to receive intensive chemotherapy (ICT). Subjects will be assigned to
      treatment arms based on results of AML mutation testing.
    


Intervention name(s): CPX-351; Venetoclax; Midostaurin; Enasidenib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Up to 2 induction and 2 consolidation courses will be offered; Will be administered over specified duration during induction and consolidation courses; Will be administered over specified duration during induction and consolidation courses; Will be administered over specified duration during induction and consolidation courses
Other intervention name(s): Vyxeos; JZP351; Venclexta; Rydapt; Idhifa
Intervention MeSH terms: Venetoclax; Midostaurin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of 2 Doses of MAP0010 in Adult Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the blood levels of two doses of MAP0010 (a
      corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with
      twice daily dosing over 7 days.
    


Intervention name(s): MAP0010 low dose; MAP0010 high dose; Budesonide inhalation suspension 0.25mg; Budesonide inhalation suspension 0.5mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol; a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol; a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol; a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
Other intervention name(s): Pulmicort Respules®; Pulmicort Respules®
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult Asthmatics
Trial of Antroquinonol in Patients With Hypercholesterolemia and Hyperlipidemia
Condition: Hyperlipidemias
MeSH terms: Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2

Summary: 
      Identified the efficacy of Antroquinonol (Hocena 50mg) in triglyceride, lipid-lowering and
      fatty liver.
    

Detailed description: 
      The primary efficacy objective is to demonstrate the reduction of triglyceride (TG) by
      Antroquinonol, in comparison with placebo, after 12 weeks of treatment in patients with
      hypercholesterolemia and hyperlipidemia. Secondary objectives include the evaluation of the
      effects of Antroquinonol in comparison with placebo on other lipid parameters after 12 weeks
      of treatment and the effects of Antroquinonol on left ventricular diastolic function,
      arterial stiffness and fatty liver. The safety and tolerability of Antroquinonol will be
      monitored as well.
    

Intervention name(s): Antroquinonol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Antroquinonol will be provided as capsules of 50 mg; The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
Other intervention name(s): Hocena 50mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of
      Plavix with Astrix.
    


Intervention name(s): Closone; Plavix with Astrix
Intervention type(s): Drug; Drug
Intervention description(s): 75mg/100mg, 8weeks, PO; 75mg, 100mg a day, 8weeks, PO
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Traditional Chinese Medicine Intervention for Women With Menopausal Syndrome
Condition: Menopausal Syndrome
MeSH terms: Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this multiple-centered, randomized, controlled study is to investigate the
      efficacy and safety of a combination using herbs prescription and traditional Chinese
      medicine (TCM) emotion treatment in women with menopausal syndrome.
    

Detailed description: 
      Menopausal syndrome is a high incident disease which is associated with great influence in
      women's health and quality of life. It involves physical discomforts and emotional symptoms.
      Traditional Chinese medicine (TCM) theory emphasizes treating physical and emotional symptoms
      simultaneously viewing one person as an entirety. Herbs prescription and TCM emotion
      treatment is effective and safe to treat women with menopausal syndrome in clinical practice.
    

Intervention name(s): TCM intervention; Western intervention
Intervention type(s): Other; Other
Intervention description(s): Drug: Particle of compound Chinese herbs(produced by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months.
One tablet placebo of Tibolone (provided by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China, once every two days, taken orally, for two months.
Behavioral: TCM emotion treatment: made under the guide of TCM theory, administered by qualified TCM physician, for three times in two months.; Drug: Tibolone, (produced by Oujianong corporation, Nanjing, China), 2.5mg, once every two days, taken orally, for two months; Particle placebo of compound Chinese herbs (produced by San_jiu Medical & Pharmaceutical Limited Company, Guangzhou, Guangdong Province, China), mixing with boiled water, free of decoction, taken orally, twice a day, for two months.
Behavioral: supportive psychotherapy, administered by qualified physician, for three times in two months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: menopausal syndrome; TCM intervention
The Effect of Conbercept Injection Through Different Routes for Neovascular Glaucoma
Condition: Neovascular Glaucoma
MeSH terms: Glaucoma; Glaucoma, Neovascular
Study type: Interventional

Summary: 
      The neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to
      frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial
      growth factor (VEGF) in NVG. Conbercept is an anti-VEGF agent，its role in regression of other
      neovascular disorders such as wet-type age-related macular degeneration and diabetic
      retinopathy has been described. Investigators aim to evaluate the efficacy and safety of
      intracameral and intravitreal injection of conbercept for the treatment of NVG.
    

Detailed description: 
      The neovascular glaucoma (NVG) is a refractory type of secondary glaucoma and often lead to
      frustrated treatment and blindness. It has been confirmed high levels of vascular endothelial
      growth factor (VEGF) in NVG. Conbercept is an anti-VEGF agent，Its role in regression of other
      neovascular disorders such as wet-type age-related macular degeneration and diabetic
      retinopathy has been described. The intravitreal injection of anti-VEGF agent has shown its
      therapeutic potential for the early stage of NVG, but not for the late stage. Intracameral
      injection maybe used as an alternative way for administration. Investigators aim to evaluate
      the efficacy and safety of intracameral and intravitreal injection of conbercept for the
      treatment of NVG.
    

Intervention name(s): Intracameral injection; Intravitreal injection
Intervention type(s): Procedure; Procedure
Intervention description(s): Intracameral Conbercept injection for the treatment of NVG; Intravitreal Conbercept injection for the treatment of NVG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mulligan and Proprioceptive Neuromuscular Fasciliation Techiniques in Rotator Cuff Pathology
Condition: Rotator Cuff Injuries
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of Mulligan Mobilization techniques,
      Mobilization with Movement (MWMs) and Proprioceptive Neuromuscular Facilitation (PNF)
      techniques, Hold-Relax Active Movement Technique, on pain, normal joint range of motion,
      proprioception, scapular dyskinesia and functional status in individuals with rotator cuff
      syndrome.

      A total of 60 people were included in the study: 20 participants in the censervative
      rehabilitation group (Conservative Treatment), 20 participants in the Treatment A (Mulligan
      Mobilization Application) Group, and 20 participants in the Treatment B (PNF Application)
      Group. Individuals were treated for 5 days for 4 weeks. Pain before and after treatment with
      Visual Analog Scale; joint range of motion with goniometer; With proprioception Angle
      Repetition Test; Scapular dyskinesia with Lateral Scapular Slide Test; quality of life with
      SF-36; shoulder functionality was assessed with the Western Ontario Rotator Cuff Scale
      (WORC).
    


Intervention name(s): conservative rehabilitation; mullgan mobilization techniques; pnf
Intervention type(s): Other; Other; Other
Intervention description(s): Hotpack + TENS + streching exercises; Passive mobilization techniques during active movements; hold relax active movements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rotator cuff injuries; mulligan mobilization; proprioceptive neuromuscular fascilitation; pain; functionality; quality of life
Immunogenicity and Safety Study of Infanrix Hexa in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
Condition: Acellular Pertussis; Tetanus; Poliomyelitis; Diphtheria; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
MeSH terms: Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Hepatitis; Tetany
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      Infanrix hexa, given in the primary vaccination schedule to infants born to pregnant women
      who participated in study 116945 [DTPA (BOOSTRIX)-047]. This study will help us evaluate if
      the presence of transplacentally transferred maternal antibodies interfere with the immune
      response to primary vaccination with Infanrix hexa and a co-administered pneumococcal
      conjugate vaccine given as a part of this study in infants.
    


Intervention name(s): Infanrix hexa; Prevnar13
Intervention type(s): Biological; Drug
Intervention description(s): • All subjects will receive Infanrix hexa at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. Infanrix hexa is administered intramuscularly to the right thigh.; • All subjects will receive Infanrix hexa co-administered with Prevenar13* at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. *In some countries/regions with an Infanrix hexa 3-dose vaccination schedule, Prevenar 13 could be administered as 2-doses or 3-doses primary vaccination schedule (according to the routine national immunisation schedule). Prevnar13 is administered intramuscularly to the left thigh.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Efficacy of Adding Intravenous N-acetyl Cysteine in Colon Surgeries
Condition: Systemic Inflammatory Response Syndrome
MeSH terms: Systemic Inflammatory Response Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The use of antioxidant agents in the prevention or decreasing the severity of postoperative
      systemic inflammatory response syndrome after colonic surgeries adopted nowadays. Therefore,
      it is of interest to investigate safety and efficacy of administrating short term intravenous
      (IV) N acetyl cysteine as add on to l alany l glutamine and total parenteral nutrition on the
      marker of oxidative stress malondialdehyde and anti- inflammatory marker tumor necrosis
      factor alpha in patients undergoing colonic surgeries through a prospective, randomized,
      double blinded, controlled clinical trial
    

Detailed description: 
      A prospective, randomized, double blinded, controlled clinical trial will be carried out on
      60 patients, who will admit to the critical care unit, Ain Shams hospitals, Cairo, Egypt,
      following colon surgeries. Before the start of the study, eligible patients were randomized
      using computer generated list in order to allocate participants to either Group I (n acetyl
      cysteine group) or Group II (control group) in an equal manner No medication will take before
      the surgery and only oral fluids were allowed on the day before the operation. All eligible
      patients underwent bowel preparation with oral 1.745 g/ 30 ml magnesium citrate, and
      phosphate containing enema on the day before surgery. All patients received the general
      anesthesia with endotracheal intubation and muscle relaxant.

      Data management and analysis were performed using the Statistical Package for Social Sciences
      (SPSS) software for Windows version 18
    

Intervention name(s): N Acetyl L Cysteine; dextrose 5%
Intervention type(s): Drug; Other
Intervention description(s): 100 mg/kg n acetyl cysteine dissolved in dextrose5%
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety of Imovax Polio in Chinese Infants and Children
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To describe the tolerance in terms of occurrence of serious adverse reactions and severe
      adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX
      Polio™ administered in children and infants.
    


Intervention name(s): Inactivated Poliomyelitis vaccine; Inactivated Poliomyelitis vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, intramuscular (IM); 0.5 mL, IM
Other intervention name(s): IMOVAX Polio™ (IPV); IMOVAX Polio ™ (IPV)
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: IMOVAX;; poliomyelitis
Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of BI 1744 CL Plus BI 54903 XX Via Respimat® B Versus the Free Combination of BI 1744 CL Via Respimat® A and BI 54903 XX Via Respimat® B in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to compare the systemic exposure of BI 1744 BS and CD
      1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following
      inhalation of the fixed dose combination (FDC) BI 1744 CL plus BI 54903 XX (as ethanolic
      solution for inhalation, EIS) with the systemic exposure following inhalation of the free
      dose combination of BI 1744 CL (as aqueous solution for inhalation, AIS) and BI 54903 XX
      (EIS), respectively, when administered once-daily via Respimat® Inhaler (Respimat® A for AIS
      and Respimat® B for EIS) for 14 days in healthy volunteers. Secondary objectives were: to
      compare exposure to BI 1744 BS and CD 1857 XX after a single dose of the BI 1744 CL/BI 54903
      XX FDC and the free dose combination, respectively; to compare exposure to BI 54903 XX after
      a single dose and at steady state after multiple doses of the BI 1744 CL/BI 54903 XX fixed
      dose combination and the free dose combination, respectively; to compare the safety and
      tolerability of BI 1744 CL and BI 54903 XX when administered as BI 1744 CL/BI 54903 XX fixed
      dose combination and as the free dose combination, respectively.
    


Intervention name(s): BI 1744 CL; BI 54903 XX; BI 1744 CL + BI 54903 XX FDC; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Olodaterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Effect of Different Anesthetic Techniques for Isolated Systolic Hypertensive Patients of Abdominal Surgery on Postoperative Hospital Stay and Morbidity
Condition: Postoperative Complications
MeSH terms: Postoperative Complications; Systolic Murmurs
Study type: Interventional

Summary: 
      In General anesthesia, two main ways of pain control are used intra-operatively, one is
      opioids, the other is epidural. Many colleges prefer using epidural analgesia because it is
      potent and more effective , and also the benefits of stress block, less depression of breath.
      however, the epidural technique often causes more drop of blood pressure, especially in
      dehydrated patients. The investigators designed the trial to see if the benefit weigh out the
      potential risk of epidural in isolated hypertensive patients.
    


Intervention name(s): remifentanil(Ultiva); epidural infusing 2% lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): remifentanil (TCI, Ce 3 ng /ml)for intra-operative analgesia; epidural infusing 2% lidocaine 4ml bolus followed by 6-18ml/hr for intra-operative analgesia
Intervention MeSH terms: Lidocaine; Remifentanil
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: remifentanil; isolated systolic hypertension; morbidity; epidural combined general anesthesia
Efficacy of Vitamin C Injection on Fatigue in Workers After Work
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Fatigue is one of the most frequently observed symptoms for company workers, and oxidative
      stress is regarded as one of its cause. Vitamin C is a well-known antioxidant, and the
      investigators seek for evidence of the efficacy of high dose vitamin C parenteral supplement
      on fatigue symptoms of company workers after work.
    

Detailed description: 
      Previous studies dealing with vitamin C were focusing on terminal cancer patients or those
      with chronic fatigue syndrome. Since used drug dosage and the ways of administering vitamin C
      were not identical, the results were not consistent throughout those studies. This study is
      aimed to evaluate the efficacy of high dose vitamin C with parenteral supplement on relieving
      fatigue for apparently healthy volunteers.
    

Intervention name(s): Ascorbic acid (Vitamin C); Normal saline
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Single intravenous injection of vitamin C 10g(20ml) with 100ml of normal saline over 30 minutes; Single intravenous injection of 120ml of normal saline over 30 minutes
Other intervention name(s): Ascorbic acid; Merit C
Intervention MeSH terms: Ascorbic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: fatigue; ascorbic acid; oxidative stress
Utility of the Smart Pilot View in Clinical Practice: A Two Center Prospective Observational Study
Condition: Anesthesia,General
Study type: Observational

Summary: 
      Recently, a new software program for anesthesia has been developed, called Smart Pilot View.
      This program monitors the patient, the anesthetic drugs given, and the calculated depth of
      the anesthesia. The purpose of this study is to determine whether the use of this program
      improves the quality of anesthesia.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing surgery under general anesthesia scheduled for neurosurgery, gynecology
        and ear nose and throat surgery.
      
Keywords: Anesthesia; Smart Pilot View; Pain control; Recovery