bioihbjkbjnl/mcl2 huggingface dataset:
Umbilical Cord Blood Therapy for Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy of umbilical cord blood therapy for children with
      cerebral palsy.
    

Detailed description: 
      Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion
      or injury of the immature brain. It is a leading cause of childhood onset disability.

      Many experimental animal studies have revealed that umbilical cord blood is useful to repair
      neurological injury in brain.

      On the basis of many experimental studies, umbilical cord blood is suggested as a potential
      therapy for cerebral palsy.
    

Intervention name(s): Umbilical Cord Blood Administration; Active Rehabilitation
Intervention type(s): Procedure; Other
Intervention description(s): The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.; All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.
Other intervention name(s): Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Umbilical Cord Blood; Rehabilitation
Endothelial Injury Mechanism in Elderly Patients Undergoing Major Surgery
Condition: Endothelial Dysfunction; Blood Brain Barrier Defect; Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      The incidence of postoperative cognitive injury is high in elderly patients, especially after
      major surgery. The relevant pathophysiological mechanisms are still unclear, and the possible
      mechanisms that have been proposed so far include inflammation, neurotransmitter imbalance
      and metabolic disorders. In recent years, clinical studies of acute brain dysfunction after
      vascular endothelial injury have attracted attention.

      Degradation of the endothelial glycocalyx layer and subsequent shedding of its constituents
      is seen as an early marker of endothelial injury, and may increase vascular permeability.Many
      preclinical and clinical studies have demonstrated an association between inflammatory
      cytokines such as TNF-α, IL-1β, IL-6, and IL-10 and glycocalyx degradation biomarkers.

      The scholars found evidence of plasma endothelial injury after abdominal open surgery in the
      elderly. Dexmedetomidine could attenuate stress response such as TNF-α, IL-1β and IL-6. Based
      on the above evidence, we hypothesize that elderly patients experience inflammatory response
      secondary to surgical traumatic stress after major surgery, greatly increasing the degree of
      endothelial injury (heparan sulphate and syndecan-1), reducing brain perfusion while
      increasing Blood-brain barrier permeability (S100B level), promoting the release of cytokines
      Interleukin-2(IL-2), Interleukin-6(IL-6), tumor necrosis factor-alpha(TNF-α) ,and vascular
      endothelial growth factor (VEGF) while reducing brain-derived neurotrophic factor(BDNF)
      synthesis, then leading to postoperative acute spasm. We would test the hypothesis that can
      reverse these effects and improve cognitive deficits.
    


Intervention name(s): Dexmedetomidine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over.; 0.5μg/kg saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Azithromycin Combination Therapy for the Treatment of Severe Malaria
Condition: Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized controlled trial to assess the safety and efficacy of azithromycin combination
      therapy for use in severe malaria. This pilot trial will be conducted in uncomplicated
      malaria patients in southeastern Bangladesh.
    


Intervention name(s): Artesunate; Azithromycin + Artesunate
Intervention type(s): Drug; Drug
Intervention description(s): Artesunate alone; Combination of azithromycin + artesunate
Intervention MeSH terms: Azithromycin; Artesunate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reducing Recurrence of Symptomatic Atrial Fibrillation After Catheter Ablation by App-based Mental Training
Condition: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Meditation
MeSH terms: Atrial Fibrillation; Recurrence
Study type: Interventional

Summary: 
      Atrial fibrillation (AF) is one of the most common heart rhythm disorders and it is
      associated with a variety of symptoms leading to a considerable deterioration in quality of
      life. The Mental-AF trial is intended to inquire if an app-based mental training can reduce
      the occurrence of symptomatic AF episodes within the blanking period, i.e. the first three
      months after catheter ablation for AF.
    

Detailed description: 
      To explore the potential of a daily app-based mindfulness mental training in improving AF
      symptoms, assessed by self-reported outcome measures, i.e. the AF 6 questionnaire, AF Effect
      on QualiTy of Life (AFEQT) and Patient Reported Outcome Measurement Information System
      (PROMIS) Global Health questionnaires, as well as in reducing AF burden in 7-day-Holter,
      within the first 12 weeks following AF ablation.
    

Intervention name(s): Mental training
Intervention type(s): Other
Intervention description(s): App-based mental training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetic Study of ABT-126 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to investigate the process by which ABT-126 is absorbed, distributed,
      metabolized and eliminated by the body of a healthy volunteer.
    


Intervention name(s): ABT-126; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose administered twice daily on Study Days 1-10; Dose administered twice daily on Study Days 1-10
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Magnesium Therapy in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study is considered a pilot exploratory study. Intervention, prospective, double-armed,
      randomized, placebo-control clinical trial.

      The therapeutic effect of oral Magnesium sulfate on spasticity and constipation will be
      studied.
    

Detailed description: 
      Spasticity and constipation are major problems hindering improvement in motor development in
      children with cerebral palsy.

      Decreasing spasticity will have a positive effect on motor development and quality of life
      for the child and his family.

      The aim is to study the therapeutic and adverse effects of oral magnesium sulfate therapy on
      spasticity and constipation in infants and children with cerebral palsy.

      Hundred children with spastic cerebral palsy will be randomized to either intervention group
      n=50 will be treated with magnesium sulfate 4% orally for 28 days to treat spasticity and
      constipation in addition to their conventional treatment, or placebo group n=50 will receive
      conventional treatment and placebo.
    

Intervention name(s): Oral magnesium sulfate; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Magnesium sulfate 4% concentration in a dose of 65 mg/day for infants and children aged 1-3 years , 110 mg/day for those 3-8 years and 350 mg/day for those above 9 years .Each 1 ml of the magnesium sulfate used contains 0.325 mEq (milliequivalent) of elemental magnesium which equals to 4 mg elemental magnesium .
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: child
Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma
Condition: Malignant Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to test safety and efficacy of different doses of thymosin alpha
      1 (1.6 mg, 3.2 mg, and 6.4 mg) in combination with dacarbazine and with or without Interferon
      alpha in treating patients affected by stage IV melanoma.

      Primary end-point is Tumor Response evaluated according to Response Evaluation Criteria In
      Solid Tumors (RECIST). Secondary end-points are Overall Survival and Progression Free
      Survival.

      Ninety-five patients are allocated to each arm to test the hypothesis that P0 <= 0.05 vs the
      alternative hypothesis that P1 >= 0.15 (alpha = 5%, within-group statistical analysis beta =
      95%).
    


Intervention name(s): Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg; Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg; Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg; Dacarbazine + Thymosin-alpha-1 3.2 mg; Dacarbazine + Interferon alpha
Intervention type(s): Biological; Biological; Biological; Biological; Drug
Intervention description(s): Dacarbazine 800 mg/m2 IV on day 1;Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.; Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.; Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.; Dacarbazine 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.; Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
Other intervention name(s): Zadaxin; Thymalfasin; ST1472; Deticene; Roferon; Zadaxin; Thymalfasin; ST1472; Deticene; Roferon; Zadaxin; Thymalfasin; ST1472; Deticene; Roferon; Zadaxin; Thymalfasin; ST1472; Deticene; Deticene; Roferon
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Dacarbazine; Thymalfasin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Inhibitory Effect of Metformin on Gluconeogenesis in Relation to Polymorphisms in Organic Cation Transporter 1
Condition: Pharmacogenetics of Metformin
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to evaluate the pharmacodynamic impact of metformin in healthy
      Caucasian volunteers with and without single polymorphisms M420del or R61C in OCT1, thus the
      study hypothesis is that metformin only affect the hepatic gluconeogenesis in healthy
      volunteers with functional OCT1-transporters.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): The study was designed as a randomized, cross-over trial with a washout period of at least 4 weeks between the phases. In both phases, the volunteers fasted for 42 h. This was done in order to include an evaluation of the pharmacodynamic effect of metformin on the glucose production in fasting healthy volunteers.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Metformin; Hypoglycemic Agents; Diabetes Mellitus, Type 2; Gluconeogenesis; Pharmacodynamics; Pharmacogenetics
Study to Evaluate the Efficacy and Safety of Vibegron Administered Orally for 12 Weeks to Women With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of vibegron, a beta-3 adrenergic receptor
      (β3-AR) agonist, in the treatment of pain associated with irritable bowel syndrome (IBS) due
      to IBS with predominant diarrhea (IBS-D) or mixed episodes of diarrhea and constipation
      (IBS-M).
    


Intervention name(s): Vibegron; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral administration; oral administration
Other intervention name(s): RVT-901; MK-4618; KRP-114V; URO-901
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Irritable Bowel Syndrome with predominantly diarrhea (IBS-D); Irritable Bowel Syndrome with mixed episodes of diarrhea and constipation (IBS-M); Vibegron; Beta-3 adrenergic receptor (β3-AR); Pain
Maturation of the Autonomic Nervous System in Prematures
Condition: Analysis, Event History
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      The purpose of this study is to try to evaluate the maturation of the autonomic nervous
      system in prematures.
    

Detailed description: 
      To evaluate the maturation of the autonomic nervous system in prematures by using heart rate
      variability analyses.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Prematures
Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder
Condition: Bladder, Neurogenic
MeSH terms: Urinary Bladder, Neurogenic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin
      hydrochloride as treatment in children with an elevated detrusor leak point pressure
      associated with a known neurological deficit
    


Intervention name(s): tamsulosin hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): Flomax; Omnic
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tamsulosin; pediatric; neurogenic bladder
Efficacy of Tramadol With Levobupivacaine for Modified Pectoral Nerve Block
Condition: Breast Cancer; Radical Mastectomy Surgery
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the addition of tramadol combined with levobupivacaine
      in the reduction of postoperative pain, postoperative opioid consumption after modified
      radical mastectomy surgery.
    

Detailed description: 
      Breast surgeries are usually associated with sever postoperative pain ,good perioperative
      analgesic technique after breast surgery is always questionable Thoracic epidural and
      paravertebral blocks became the gold standard techniques for pain relief, however they may be
      associated with complications such as spinal cord injury, total spinal anesthesia
      ,inadvertent intravascular injection and pneumothorax.

      Pecs block is less invasive procedure involving ultrasound guided inter-fascial injections
      which has been suggested as potential alternative analgesic technique.

      The block produces excellent analgesia and can be used as a rescue block in cases where the
      analgesia provided by the paravertebral or epidural was patchy or ineffective .

      Different drugs, including opioids, non-steroidal anti-inflammatory drugs, ketamine,
      clonidine, and neostigmine, have been added to local anesthetics to improve the duration and
      quality of analgesia.Tramadol has also been used for pain management of patients.

      The power of this clinical trial was prospectively calculated using the G Power analysis
      program. Using a priory power analysis with accuracy mode calculations with visual analogue
      score (VAS) as the primary variant and assuming type I error protection of 0.05 and an effect
      size convention of 0.9, a total sample size of 54 patients (27 patients in each group)
      produced a power of 0.90. To protect against drop out cases we added 6 cases to the total
      number (total of 60 cases)
    

Intervention name(s): Levobupivacaine; Levobupivacaine and Tramadol
Intervention type(s): Drug; Drug
Intervention description(s): Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine; Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine in conjunction with tramadol
Intervention MeSH terms: Tramadol; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Treatment of Indolent Systemic Mastocytosis With PA101
Condition: Mastocytosis; Systemic Mastocytosis; Indolent Systemic Mastocytosis
MeSH terms: Mastocytosis; Mastocytosis, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo- and active-controlled, 2-period crossover, 2 cohort study in
      adult patients with indolent systemic mastocytosis (ISM).

      The purpose of the study is to determine the efficacy and safety profile of PA101 delivered
      via eFlow high efficiency nebulizer in patients with ISM who are symptomatic despite using
      standard treatments.
    

Detailed description: 
      The symptom scores for determining eligibility will be established during the 2-week Run-in
      Period using eDiary and the eligible patients will be randomly allocated in a 2:1 ratio to
      one of two treatment cohorts at the baseline visit.

      In Cohort 1 (n=24), patients will receive inhaled 40 mg PA101 three times daily and inhaled
      placebo three times daily via eFlow for 6 weeks each in a double-blind, 2-period crossover
      fashion with a 4-week washout period between the treatment periods.

      In Cohort 2 (n=12), patients will receive inhaled 40 mg PA101 three times daily via eFlow and
      oral cromolyn sodium 200 mg four times daily for 6 weeks each in an open label, 2-period
      crossover fashion with a 4-week washout period between the treatment periods.

      Patients will be allowed to use the same daily doses of pre-randomization H1 and H2
      antihistamines as well as the same daily doses of any other allowed medications during each
      treatment period.

      Visits during each treatment period will occur at the baseline Visit, and at the end of Weeks
      1, 2, 4, and 6.

      Blood and urine samples will be collected to test for various biomarkers. In a subset of
      patients, additional clinical assessments of the skin will be performed and blood samples
      will be collected for pharmacokinetic assessments. Clinical safety assessments will be
      performed in all patients at the start and end of each treatment period.
    

Intervention name(s): PA101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40 mg PA101 administered via inhalation three times daily for 6 weeks; matching placebo administered via inhalation three times daily for 6 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mastocytosis; cromolyn sodium
Effect of a Combination of Local Steroid Injection With Oral Steroid Administration for the Prevention on Esophageal Stricture After Endoscopic Submucosal Dissection for Early Esophageal Neoplasm
Condition: Esophageal Stricture
MeSH terms: Neoplasms; Esophageal Neoplasms; Esophageal Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      The method of esophageal endoscopic submucosal dissection (ESD) to remove superficial
      esophageal neoplasms has gained widespread acceptance as an alternative to surgery recently
      these years especially in Asian countries. However, besides of perforation and bleeding,
      another complication postoperative esophageal stricture is frequently observed after the
      removal of large-sized esophageal neoplasms by ESD. Dysphagia caused by postoperative
      stricture substantially decreases the patient's quality of life, requiring further therapy.
      Although the exact incidence is unknown, esophageal stricture is supposed to be related to
      the extent of the circumference being resected. In previous study by Ono et al，it is reported
      that 90% of patients with lesions of circumferential extension of more than three-fourths
      experienced postoperative stricture after esophageal ESD. There were some reported studies
      exploring new ways to prevent esophageal stricture after ESD, such as oral prednisolone and
      local corticosteroid injection. Corticosteroids can inhibit not only collagen synthesis but
      also enhance collagen breakdown, thereby inhibiting stricture formation. Some studies reveled
      that just oral prednisolone oral is effective option for the prevention of post-ESD
      stricture. However, most of the reported studies were non RCTs with small sample. In the
      primary study, the investigators search a new method of combination of both oral and local
      injection to prevent esophageal stricture，as a result，stricture at 8 weeks after ESD was
      found in 19 of 36 patients in the no corticosteroid group but only 4 of 34 in the
      corticosteroid group. Unfortunately，the study was also retrospective. So, the investigators
      plan to undertake a prospective, randomized controlled trial to evaluate the prophylactic
      effects of combination of local steroid injection with oral steroid administration for
      esophageal stenoses complicating extensive ESD.
    


Intervention name(s): combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）; oral steroid administration（prednisone）
Intervention type(s): Drug; Drug
Intervention description(s): local steroid injection and oral steroid; oral steroid
Intervention MeSH terms: Prednisone; Triamcinolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: esophageal stricture; endoscopic submucosal dissection; prevention