bioihbjkbjnl/mcl2 huggingface dataset:
Study to Compare the Efficacy and Safety of Oral AT1001 and Enzyme Replacement Therapy in Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to compare the efficacy and safety of migalastat and enzyme replacement therapy (ERT)
      in male and female participants with Fabry disease who are currently receiving ERT and who
      have an alpha galactosidase-A (α Gal-A) mutation that is amenable to migalastat, based on the
      clinical trial human embryonic kidney cell (HEK) assay.
    

Detailed description: 
      This was a Phase 3, randomized, open-label, active-controlled study to evaluate the efficacy
      and safety of 150 milligrams (mg) of migalastat hydrochloride (migalastat) (equivalent to 123
      mg of migalastat) once every other day (QOD) and ERT in male and female participants with
      Fabry disease who were receiving ERT and who have an α Gal-A mutation that is amenable to
      migalastat, based on the clinical trial HEK assay. This was a 2-part study. Part 1, the
      18-month randomized phase, evaluated participants who received either migalastat 150 mg QOD
      or ERT per prescribing physicians' instructions for efficacy and safety. Part 2, the optional
      12-month open-label extension (OLE) phase in which all participants received migalastat, also
      explored efficacy and safety. For Part 2, all participants who received ERT in Part 1 were
      given migalastat. Data presented in this posting include efficacy data from the 18-month
      randomized period and safety data from the entire study (18-month randomized period and
      12-month optional OLE [total of 30 months]).
    

Intervention name(s): migalastat hydrochloride; agalsidase
Intervention type(s): Drug; Biological
Intervention description(s): 150-mg capsule administered orally QOD; Agalsidase via intravenous infusion as prescribed by the participant's treating physician and in accordance with the approved prescribing information
Other intervention name(s): AT1001; Migalastat; Galafold; agalsidase beta; Fabrazyme; agalsidase alfa; Replagal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amicus Therapeutics; Galafold; AT1001; Migalastat
Mitochondrial Dysfunction and Oxidative Stress in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: COPD Patients
Study type: Interventional

Summary: 
      The purpose of this study is to understand the underlying mechanisms of improved exercise
      tolerance in COPD patients after training program.
    

Detailed description: 
      Training protocol used is based on recommendations (Nici et al., 2006) and was previously
      used in our group (Varray et al., 1991; Vallet et al., 1997). A minimum of 20 sessions in 4-6
      weeks were proposed. The exercise intensity of exercise corresponds to target heart rate at
      ventilatory threshold measured during incremental exercise test. Training at this intensity
      allowed us to individualize effort for each patient.
    

Intervention name(s): Training
Intervention type(s): Other
Intervention description(s): 20 sessions of training
Other intervention name(s): CT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: COPD; exercise tolerance; oxidative stress
Comparison of the Effects of Dexmedetomidine and Propofol on the Cardiovascular Autonomic Nervous System During Spinal Anesthesia
Condition: Spinal Anesthesia; Autonomic Nervous System
Study type: Interventional

Summary: 
      Spinal anesthesia induces bradycardia and hypotnesion, because itself decreases
      parasympathetic activity and increases sympathetic activity. These imbalance of autonomic
      nervous system can be measured by heart rate variability. Propofol and dexmedetomidine, which
      are used for sedation during spinal anesthesia, also affect autonomic nervous system, but the
      exact effects are not well known. The purpose of this study is measuring the effects of
      propofol or dexmedetomidine on autonomic nervous system in spinal anesthesia.
    

Detailed description: 
      Spinal anesthesia induces bradycardia and hypotnesion, because itself decreases
      parasympathetic activity and increases sympathetic activity. These imbalance of autonomic
      nervous system can be measured by heart rate variability. Propofol and dexmedetomidine, which
      are used for sedation during spinal anesthesia, also affect autonomic nervous system but the
      exact effects are not well known. Moreoever, the effect of spinal anesthesia combined with
      sedation agent on autonomic nervous system has not been evaluated. The purpose of this study
      is measuring the effects of propofol or dexmedetomidine on autonomic nervous system in spinal
      anesthesia. The current study is prospective randomized pilot study. Patients are assigned to
      propofol group and dexmedetomidine group. Using electrocardiaogram analysis, the change of
      autonomic nervous system will be measured from preoperative to end of surgery.
    

Intervention name(s): Propofol; Dexmedetomidin
Intervention type(s): Drug; Drug
Intervention description(s): Propofol as a sedation drug; Dexmedetomidine as a sedation drug
Other intervention name(s): FRESofol MCT inj 1% 500mg/50ml, Fresenium Kabi; Medex inj, 200mcg/2ml, ILSUNG
Intervention MeSH terms: Dexmedetomidine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Propofol group: propofol infusion as sedation drug Dexmedetomidine group: dexmedetomidine infusion as sedation drug
Masking: None (Open Label)
Primary purpose: Other
Keywords: spinal anesthesia; autonomic nervous system; dexmedetomidine; propofol
Effects of Therapeutic Exercises in Elderly Women With Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Knee Osteoarthritis is a degenerative disease associated with muscle weakness, arthralgia,
      rigidity and postural instability. Therapeutic exercise can reduce pain and improve muscle
      strength and postural balance, however benefits from association with pompage is not known.
      This study aims to evaluate the effects of therapeutic exercise on pain, muscle strength and
      postural balance in elderly women with knee osteoarthritis. Methodology: Almost randomized
      controlled trial, in which were included elderly between 60 and 80 years diagnosed with knee
      osteoarthritis, randomized into two groups with 11 participants each. Intervention group held
      strengthening exercises for flexors and knee extensors, balance training, and manual knee
      pompage for 12 weeks. Control Group received educational lectures. Arthralgia was estimated
      by pain subscale of the questionnaire Western Ontario McMaster Universities Osteoarthritis
      Index and (WOMAC); muscle strength was assessed by the isokinetic dynamometer HUMAC® NORM
      Testing & Rehabilitation System and the postural balance by the Biodex Balance SD postural
      stability protocol (Biodex Medical Systems, Inc. New York, USA). The Student t test was used
      for statistical analysis.
    


Intervention name(s): Therapeutic exercise and Pompage; Educational lectures
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Strengthening exercises for flexors and knee extensors, balance training, knee's pompage twice per week for 12 weeks.; Educational lectures in four meetings for 12 weeks (Control Group)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Osteoarthritis; Therapeutic exercises; Pain; Muscle strength; Postural balance
Effects of Phenylephrine on Cardiac Preload
Condition: Arterial Hypotension; Anaesthesia
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      In patients under general anesthesia, episodes of hypotension are often treated with
      phenylephrine. The effect of phenylephrine is conventionally attributed to afterload
      increase.

      The aim of the study is to describe the time course of the effects of phenylephrine on the
      cardiac preload and cardiac output, and to evaluate whether phenylephrine, as an exclusive
      alpha-mimetic, could be beneficial for preload optimisation.
    

Detailed description: 
      In consecutive patients scheduled for laparoscopic sigmoidectomy, all hemodynamic and
      respiratory variables are recorded electronically for subsequent offline analysis.

      All patients are ventilated in volume control mode with a tidal volume of 8 ml/kg ideal body
      weight.

      During steady-state Target Controlled Infusion (TCI) propofol/remifentanil anesthesia, when
      the Mean Arterial Blood Pressure (MAP) dropped below 80% of the awake state for at least 5
      minutes, a phenylephrine bolus of 2 μg/kg is administered. If necessary this is repeated, or
      a continuous administration of phenylephrine is started at a rate of 10-30 μg/kg/u.

      All patient manipulations during the procedure are electronically recorded and time stamped
      for subsequent off-line data analysis.

      The first episode in each patient where phenylephrine is administered and in a period of at
      least 10 minutes when minimal or absent patient manipulation occurred, the hemodynamic
      variables are analysed to describe the effects of phenylephrine administration on the dynamic
      preload parameters and macro-hemodynamics.
    

Intervention name(s): Phenylephrine
Intervention type(s): Drug
Intervention description(s): Intravenous administration
Other intervention name(s): Phenyl
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: phenylephrine; alpha mimetics; pulse pressure variation; venous return
Pharmacokinetics Ertapenem Burns
Condition: Burn Patients
MeSH terms: Burns
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine the pharmacokinetics of ertapenem in ventilated badly (> 30% SCT)
      burn patients.
    


Intervention name(s): Ertapenem
Intervention type(s): Drug
Intervention description(s): The patient received two injections of ertapenem, at a dose of 1g.j-1 by intravenous injection of 30 minutes, separated by 24 h.
Intervention MeSH terms: Ertapenem
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Burns; Ertapenem; Pharmacokinetics
Management of Grades 3-5 Renal Trauma in Pediatrics
Condition: Renal Trauma
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      comparing conservative management versus interventional management in hemodynamically stable
      paediatric patient with blunt renal trauma, evidence suggests that there is a reduced rate of
      renal loss and blood transfusion in patients managed conservatively.
    


Intervention name(s): Surgical
Intervention type(s): Other
Intervention description(s): Minimal: Such as PCN insertion Endosopic: Such as DJ insertion Surgical: Repair, Partial or total nephrectomy Angioembolization
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        60 children (age group 0-18 years) will be added to my study divided into two groups
        regardless of sex
Bioequivalence Study of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg +
      Pseudoephedrine HCL 30 mg under fed conditions.
    

Detailed description: 
      This study assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets
      of Dr. Reddy's and Advil® Cold and Sinus Caplets of Wyeth Consumer Healthcare in healthy
      human adult subjects with the single oral administration under fed conditions with a washout
      period of 7 days.
    

Intervention name(s): Ibuprofen + Pseudoephedrine Hydrochloride
Intervention type(s): Drug
Intervention description(s): Ibuprofen 200 mg + Pseudoephedrine Hydrochloride 30 mg Tablets
Other intervention name(s): Advil® Cold and Sinus
Intervention MeSH terms: Ibuprofen; Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Crossover; Ibuprofen and Pseudoephedrine
Compare the Effect of Aliskiren Plus Valsartan Versus Angiotensin-Converting Enzyme Inhibitor (ACEi) Plus Angiotensin Receptor Blocker (ARB) [Ramipril Plus Telmisartan] on the Renin-Angiotensin-Aldosterone System (RAAS) in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed as a mechanistic study to compare the effect of two different
      combinations of anti-hypertensive treatments (aliskiren and valsartan vs. telmisartan and
      ramipril) on the renin-angiotensin-aldosterone system (RAAS) in patients with moderate
      hypertension.
    


Intervention name(s): Aliskiren/ Valsartan; Telmisartan/ Ramipril
Intervention type(s): Drug; Drug
Intervention MeSH terms: Valsartan; Telmisartan; Ramipril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Aliskiren,; hypertension,; renin-angiotensin-aldosterone system
Effect of Natalizumab on Infarct Volume in Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to determine whether one 300 mg dose of intravenous
      (IV) natalizumab reduces change in infarct volume from Baseline to Day 5 on magnetic
      resonance imaging (MRI) in participants with acute ischemic stroke when given at ≤6 hours or
      at >6 to ≤9 hours from when they were last known normal (LKN).

      The secondary objectives of this study in this study population are as follows: to assess the
      efficacy of natalizumab on change in infarct volume from Baseline to Day 30; to assess
      efficacy of natalizumab on change in infarct volume from 24 hours to Day 5 and Day 30; to
      assess the efficacy of natalizumab on clinical measures of stroke outcome; to assess the
      safety of natalizumab in participants with acute ischemic stroke.
    


Intervention name(s): natalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as described in the treatment arm; Matched placebo
Other intervention name(s): Tysabri; BG00002
Intervention MeSH terms: Natalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prolutex in Frozen Embryo Transfer Cycles at the Blastocyst Stage (PROGEX)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this proof of concept clinical trial is to evaluate the impact of two
      different progesterone treatments for endometrial preparation (25 mg/twice-a-day,
      subcutaneous injection, and 200 mg/three times a day, vaginal administration) on the clinical
      pregnancy rate in women undergoing frozen embryo transfer (FET) at blastocyst stage.
    


Intervention name(s): Progesterone subcutaneous; Progesterone Vaginal Product
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg/twice a day.; 200 mg three times a day.
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Myofascial Release and Kinesio Taping on Autonomic Nervous System in Low Back Pain
Condition: Low Back Pain; Chronic Disease
MeSH terms: Back Pain; Low Back Pain; Chronic Disease
Study type: Interventional

Summary: 
      The purpose of this current randomized clinical trial is to determine the effects of
      myofascial soft tissue release and kinesio taping on disability, pain, quality of life,
      autonomic nervous system and oxidative stress indicators in chronic low back pain.
    

Detailed description: 
      Design: Randomized Clinical Trial. Objective: to determine the effects of myofascial soft
      tissue release and kinesio taping on pain, disability, quality of life, and autonomic nervous
      system indicators.

      Methods and Measures: sixty-four individuals will be randomly assigned to one of two groups.

      Intervention: For 10-week, the group 1 will undergo treatment comprising a myofascial soft
      tissue release protocol (1/week) and the group 2 will recieve a kinesio taping treatment
      (1/week).

      Main Outcome Measures: Intensity of pain, disability, quality of life, biochemical stimation
      intertitial fluid, body mass indicators, hormonal indicators, indicators of autonomic nevous
      system, and indicators of oxidative stress will be collected in both groups at baseline, 10
      weeks and 15 weeks after the last intervention. Baseline demographic and clinical variables
      will be examined between both groups with an independent Student t-test for continuous data.
      Separate 2x3 model ANOVA with time (baseline, 10 weeks and 15 weeks) as the within-subjects
      factor, group will be to determine the effects of the treatment.
    

Intervention name(s): Myofascial Soft Tissue Release; Kinesio taping treatment
Intervention type(s): Other; Other
Intervention description(s): Protocol: Myofascial release on thoracolumbar fascia, Myofascial release on diaphragm, Myofascial release in the psoas fascia, Indirect Myofascial release restrictions in the public area, Myofascial release in lumbo-sacral decompression, Myofascial release on sacrum, and Myofascial release on the lumbar fascia.; Two bands in "I", with anchor onset in sacrum, on paravertebral muscles. Furthermore a strip will be applies on correction space point of maximum pain.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Low Back Pain; Chronic Pain; Manual Therapy; Randomized Clinical Trial; Bandages
Circuit Training and Retina
Condition: Cognitive Impairment, Progressive; Cerebral Small Vessel Diseases
MeSH terms: Cerebral Small Vessel Diseases
Study type: Interventional

Summary: 
      The purpose of this research study is to see if high-speed weight training performed in a
      circuit (using one machine after another) can improve participant heart and brain function,
      strength, and power in older persons.
    


Intervention name(s): High-Speed Circuit Resistance Training; Lecture on Diet, Exercise and Cognition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Performance of 24 weeks of high-speed concentric and low-speed eccentric lift across three circuits on eleven pneumatic machines. Each training session will be in person and will last between 45 minutes and one hour.; Lectures on diet, exercise, and cognition. Lectures will be provided in person or online and will last approximately one hour.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Circuit Resistance Training; High-velocity Training; Retinal Microvasculature; Cognitive Function
Comparison of the Efficacy of Calcium-cholecalciferol Foodstuffs and Calcium-cholecalciferol Supplement
Condition: Vitamin D Status; Healthy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is conducted in two phases. At the first phase, the prevalence of vitamin D
      insufficiency in primary school-children in Tehran is determined during the cold seasons of
      2008. Then, the efficacy of calcium-vitamin D-fortified milk, -orange juice and supplement is
      compared in six selected primary schools.
    

Detailed description: 
      At the first step, serum 25-(OH)D, PTH(parathyroid hormone), osteocalcin, bone alkaline
      phosphatase, calcium, phosphorous, and magnesium is evaluated. Anthropometric and dietary
      intake data is also collected. In the second phase, we have 6 experimental groups: (1) plain
      milk; (2) calcium-vitamin D-fortified milk (containing 500 mg Ca and 100 IU vitamin D/200 mL
      package); (3) plain orange juice; (4) fortified orange juice containing equal amounts of
      calcium and vitamin D as fortified milk; (5) calcium-vitamin D supplement (500 mg calcium and
      200 IU vitamin D); and (6) placebo. Each group consists of 40-60 children (9-11 years) from
      both sexes. All above-mentioned biochemical, anthropometric and dietary intake data is
      collected both in the beginning and in the end of interventional period.
    

Intervention name(s): fortified milk; plain milk; fortified orange juice; plain orange juice; calcium-vitamin D supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 ml package for 10 weeks; daily intake of 200 ml plain milk; daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package; daily intake of 250 ml plain orange juice; daily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D); daily placebo
Other intervention name(s): FM; PM; FJ; PJ; SP; PL
Intervention MeSH terms: Vitamin D; Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: vitamin D fortification; milk; orange juice; supplement; efficacy