bioihbjkbjnl/mcl2 huggingface dataset:
Study of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency
Condition: Immunologic Deficiency Syndromes
MeSH terms: Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety, efficacy and Pharmacokinetics of Immune
      Globulin Intravenous (Human) GC5107 in subjects with Primary Humoral Immunodeficiency (PHID).
    

Detailed description: 
      This was a prospective, open-label, single-arm, historically controlled, multicenter phase 3
      study measuring the safety, efficacy and pharmacokinetics and tolerability of GC5107 in
      subjects with Primary Humoral Immunodeficiency disease (PHID).

      Subjects received intravenous infusions of the investigational product at the same dose and
      interval as used for their previous Immunoglobulin intravenous (IVIG) maintenance therapy.
      GC5107 was administered every 21 or 28 days for a period of 12 months.
    

Intervention name(s): GC5107
Intervention type(s): Biological
Intervention description(s): GC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)
Other intervention name(s): IGIV; Immune globulin intravenous (human) solution, 10% liquid
Intervention MeSH terms: Immunoglobulins; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open Lung Strategy During Non-Invasive Respiratory Support of Very Preterm Infants in the Delivery Room
Condition: Respiratory Distress Syndrome in Premature Infant; Non-invasive Ventilation; Lung Injury
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Lung Injury; Premature Birth
Study type: Interventional

Summary: 
      The opening and aeration of the lung is critical for a successful transition from fetal to
      neonatal life. Early nasal CPAP in the delivery room in spontaneously breathing premature
      babies with a gestational age of 30 weeks or less is a standard treatment approach since it
      reduces the need for invasive mechanical ventilation and surfactant therapy. In respiratory
      distress syndrome (RDS) management, providing optimal lung volumes in the very early period
      from the beginning of delivery room approaches probably augments the expected lung protective
      effect. Although the benefits of CPAP support are well known, standart CPAP pressures
      recommended in the guidelines may not meet the needs of individual babies. Maintaining lung
      patency in the delivery room is the main mechanism of action of CPAP and the requirement may
      vary individually depending on lung physiology.

      In this multicenter randomized controlled study, we aimed to compare the effects of CPAP
      therapy applied with a personalized open lung strategy (openCPAP), and standard CPAP therapy
      (standardCPAP) on oxygenation, respiratory support need and surfactant treatment requirement
      in preterm babies with RDS in the delivery room.
    


Intervention name(s): openCPAP; standardCPAP
Intervention type(s): Procedure; Procedure
Intervention description(s): Randomized to : Individualized high level CPAP between 8-10 cmH2O pressure; Randomized to : Standard level CPAP between 6-8 cmH2O pressure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nasal CPAP; delivery room; open lung strategy; PEEP; Respiratory Distress Syndrome; Individualised ventilation
Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether use of blood pressure lowering drugs,
      Angiotensin converting enzyme inhibitors (ACEIs) and blood fat (lipid) lowering drugs
      (statins) may have a place in the treatment of adolescents with diabetes and can help reduce
      serious long-term health problems in this population.
    

Detailed description: 
      Subjects will be recruited from a pre-screened population of 3,000 young people with T1D aged
      10 to 16 years based on assessment of risk for future CVD and DN.

      They will be randomised to a 2 x 2 factorial design contrasting the effects of ACEI, statins,
      or combination therapy to placebo over a maximum four year treatment period. Minimisation of
      variation in albumin excretion rate, gender, age, diabetes duration, HbA1c, total cholesterol
      and centre site will be undertaken at randomisation.

      Analysis of the primary endpoint, change in albumin excretion will be undertaken on an
      intention to treat basis. Secondary analyses will be undertaken on the basis of 'as treated'
      allowing for variance in compliance and allowing for subjects who show substantial change in
      HbA1c levels. Additional analyses will be undertaken to assess changes in the secondary
      objectives and to assess the overall effect of the intervention on quality of life and health
      economics.
    

Intervention name(s): Statin; ACE inhibitor; Placebo; Combination therapy
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10mg daily for a minimum period of 2 years; Starting dose of 5mg daily rising after 14 days to 10mg daily providing it is well tolerated for a minimum period of 2 years.; Participants receive statin placebo and ACEI placebo; Participants receive both active statin and active ACEI. Dose for Statins is 10mg daily. Dosing for ACEI starts at 5mg daily rising to 10mg after 14 days providing it is well tolerated. Both interventions last for a minimum of 2 years.
Other intervention name(s): Atorvastatin; Quinapril; Atorvastatin; Quinapril
Intervention MeSH terms: Quinapril; Atorvastatin; Angiotensin-Converting Enzyme Inhibitors
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Adolescence
Navigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      Ischemic stroke (IS) causes high mortality and severe disability. To improve outcome it's
      very important to choose the right way of the management of the patient and an appropriate
      drugs.

      There is a large number of the so-called neuroprotective drugs, which were effective in
      laboratory, but didn't show positive results in clinical studies with using traditional
      clinical scales scores as a primary outcome measures.

      Specialists suggest, that the investigators could receive better results if the investigators
      change design of the studies, particularly if the investigators select more precise and
      sensitive method of assessment.

      Aim of this study: to determine the role of navigated brain stimulation (NBS) for evaluation
      of the changes in the motor centers and motor tracts after administration of different
      cerebroprotective drugs. (The substances won't be compared to each other).
    


Intervention name(s): citicoline; L-Alpha glycerylphosphorylcholine; cerebrolysin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): citicoline IV 2000 mg, then citicoline 900 mg/day (300mg*3 times per day) per os; choline alfoscerate IV 1000mg daily 10 days; Cerebrolysin IV 10 ml daily 10 days
Intervention MeSH terms: Cerebrolysin; Cytidine Diphosphate Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Navigation Brain Stimulation (NEXSTIM); cerebroprotective drug effectiveness; acute ischemic stroke
The Utility of Virtual Reality in the Management of Pediatric Functional Constipation With Pelvic Floor Dysfunction.
Condition: Functional Constipation; Pelvic Floor Disorders
MeSH terms: Pelvic Floor Disorders; Constipation
Study type: Interventional

Summary: 
      1. To determine if the adjunctive use of a Virtual Reality (VR) module on diaphragmatic
           breathing (DB) can improve the quality of life (QOL) and symptoms of children with
           functional constipation (FC) with pelvic floor dysfunction (PFD) who are receiving
           standard of care treatment.

        2. To assess if a VR module on DB can decrease healthcare utilization for children with FC
           with PFD.
    

Detailed description: 
      The investigators will assess if the use a Virtual Reality (VR) module on diaphragmatic
      breathing (DB) can improve quality of life, constipation symptoms, and decrease healthcare
      utilization for children with functional constipation (FC) with pelvic floor dysfunction
      (PFD). FC is a common pediatric condition with a high prevalence and $4.25 billion yearly in
      healthcare expenditures. FC is often complicated with PFD as seen through stool withholding
      behaviors. Children with FC with PFD are referred to occupational therapy for biofeedback and
      DB training as standard of care. Occupational therapy uses to teach children with FC with PFD
      to relax their abdominal muscles, and subsequently their pelvic floor muscles, facilitating a
      more complete bowel evacuation. VR is a technology currently employed in rehabilitation
      services, anesthesiology and surgery. VR can provide a fun, immersive environment with a
      feedback component for children with FC to learn DB effectively and build a positive
      association with toileting.

      The purpose of this study is to examine if a virtual reality module that teaches children
      diaphragmatic breathing through an immersive game can improve the quality of life and
      decrease health care utilization for children with functional constipation and pelvic floor
      dysfunction.
    

Intervention name(s): Oculus go headset/virtual reality headset; Diaphragmatic breathing
Intervention type(s): Device; Behavioral
Intervention description(s): 10 minute virtual reality tutorial on diaphragmatic breathing, a game in practicing diaphragmatic breathing, and two scenarios in which the patient can also practice diaphragmatic breathing.; 10 minute tutorial on diaphragmatic breathing by a medical professional.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Single (Care Provider)
Primary purpose: Treatment
Predicting Insulin Resistance in American Indian Youth
Condition: Insulin Resistance; Stress, Psychological
MeSH terms: Insulin Resistance; Stress, Psychological
Study type: Observational

Summary: 
      The purpose of this study is to identify risks that may contribute to increased insulin
      resistance which may help explain some of the increased incidence of type 2 diabetes in
      American Indian Youth, at the Rosebud reservation ages 5 to 18 years old. If specific
      positive indicators of insulin resistance are present, individuals are recruited back in one
      year for repeat of all measures.
    

Detailed description: 
      Type 2 diabetes is rapidly becoming more prevalent in the United States but especially among
      minority populations at a younger age. Identification of risk factors, including traditional
      risk factors such as increased BMI, lack of exercise, increased glucose in the diet, higher
      blood pressure and lipids, along with other factors such as chronic stress, use of alcohol or
      other drugs has not previously been done with minority youth. If risk factors can be
      identified, more strategies for prevention of diabetes can be developed that specifically
      target this population. This study will enroll 300 Native American Youth over a 4 year period
      and perform body measurements including height, weight, waist circumference, blood pressure
      and lab values including a 2hour glucose tolerance test, fasting lipids, and a urine albumin
      creatinine ratio test. In addition, subjects will be asked to identify behavior and feelings
      of stress in everyday lives. Subjects who are determined to be at increased risk of
      developing diabetes will be asked to repeat the tests in one year. The results will be
      reported to the tribal council to help determine prevention strategies.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Native American youth between ages of 5 and 18 who are eligible for health care at Rosebud
        Sioux Reservation (Rosebud, SD) and willing to be measured and participate in a 2 hour
        glucose tolerance test and who have parental consent.
      
Biospecimen description: 
      Samples are only retained until specific tests are completed. Some tests are done in the
      clinical lab and some tests are done in the research lab.
    
Keywords: Insulin Resistance; Stress, Psychological
Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis
Condition: Renal Osteodystrophy; End Stage Renal Disease
MeSH terms: Chronic Kidney Disease-Mineral and Bone Disorder; Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Evaluate the separate and combined skeletal effects of recombinant human
      growth hormone (GH) and calcitriol in patients with adynamic renal osteodystrophy.

      II. Assess whether calcium-regulated changes in parathyroid hormone secretion predict changes
      in bone formation.

      III. Characterize the response to GH in cancellous bone and in growth plate cartilage in
      patients with secondary hyperparathyroidism during calcitriol therapy.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by bone lesion turnover
      and secondary hyperparathyroidism.

      Patients in the first group are treated with recombinant human growth hormone subcutaneously
      every day for 8 months.

      Patients in the second group are treated with calcitriol for 8 months, administered as a
      daily oral dose or an intraperitoneal dose three times a week.

      Patients in the third group are treated with growth hormone and calcitriol (same dosages as
      above).

      A control group does not receive any hormonal therapy.
    

Intervention name(s): calcitriol; growth hormone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Calcitriol; Hormones
Allocation: Randomized
Primary purpose: Treatment
Keywords: end stage renal disease; rare disease; renal and genitourinary disorders; renal osteodystrophy
Electrical Stimulation in Patients With Prolonged Mechanical Ventilation
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Muscle atrophy and diaphragm dysfunction are common complication in patients with prolong
      mechanical ventilator (PMV) and is associated with increased rate of weaning failure and days
      of hospitalization. Electrical stimulation (ES) has been shown to be beneficial in patients
      with severe chronic heart failure and chronic obstructive pulmonary disease. The purpose of
      this study is to examine the effects of ES on skeletal muscle function, pulmonary mechanics
      and hospitalization outcomes in patients with PMV.
    

Detailed description: 
      BACKGROUND AND PURPOSE: Muscle atrophy and diaphragm dysfunction are common complication in
      patients with prolong mechanical ventilator (PMV) and is associated with increased rate of
      weaning failure and days of hospitalization. Electrical stimulation (ES) has been shown to be
      beneficial in patients with severe chronic heart failure and chronic obstructive pulmonary
      disease. The purpose of this study is to examine the effects of ES on skeletal muscle
      function, pulmonary mechanics and hospitalization outcomes in patients with PMV.

      METHODS: Patients who have been on mechanical ventilator for more than 21 days will be
      recruited from respiratory care center (RCC). All subjects will be randomly assigned into
      three groups: ES in abdominal muscles (ES-Abd, n=30),ES in brachial biceps (ES-bicep, n=30)
      and sham group(Sham). Subjects in both groups will receive ES in muscles for 30 min/session,
      2 sessions/day for 10 days with the same setting except area of ES. The muscle function will
      be assessed by skin-fold thickness and muscle strength. The pulmonary function will be
      assessed by: lung compliance, airway resistance, tidal volume, minute volume and maximal
      inspiratory pressure. The hospitalization outcome will be followed up until patients are
      discharged from RCC. The outcomes variables include: weaning rate and duration, mortality,
      days of ventilator, and length of RCC stay.
    

Intervention name(s): electrical stimulation (high frequency); electrical stimulation (low frequency); sham group
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days; Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.; Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Prolong mechanical ventilator,; Electrical stimulation,; Activities of daily life,; Hospitalization outcomes.
Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function
Condition: Hepatic Insufficiency; Healthy
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to assess the effect of mild, moderate and severe hepatic
      impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral
      administration of BI 10773 as a single dose.
    


Intervention name(s): BI 10773
Intervention type(s): Drug
Intervention description(s): 2 tablets BI 10773 25 mg single dose
Intervention MeSH terms: Empagliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Analgesics in Cesarean Section Elective
Condition: Anesthesia; Functional
Study type: Interventional
Phase: Phase 4

Summary: 
      Two approved treatments for spinal anesthesia will be compared in women undergoing cesarean
      section.

      It is usual to perform cesarean sections using spinal anesthesia with a local anesthetic
      (bupivacaine) plus some opioid, such as sufentanil or morphine. Both have been shown to
      decrease postoperative pain, but we try to check if one brings more benefit than the other.
    


Intervention name(s): Hyperbaric bupivacaine+Sufentanil; Hyperbaric bupivacaine+Morphine
Intervention type(s): Drug; Drug
Intervention description(s): To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: sufentanil (5 mcg); To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: morphine (0,01 mg)
Other intervention name(s): Sufentanil; Morphine
Intervention MeSH terms: Sufentanil; Morphine; Dsuvia; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized clinical trial, without masking techniques, is proposed in pregnant women who are to undergo elective caesarean section by subarachnoid anesthesia with hyperbaric bupivacaine associated with sufentanil or morphine
Masking: None (Open Label)
Primary purpose: Treatment
Sonographic Examination Cubital Tunnel Release
Condition: Ulnar Nerve Compression, Cubital Tunnel
MeSH terms: Ulnar Nerve Compression Syndromes; Cubital Tunnel Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators want to compare changes in cross-sectional area (CSA) of the ulnar nerve at
      the elbow after open release or endoscopic release.
    

Detailed description: 
      The investigators want to compare changes in CSA of the ulnar nerve at the elbow
      hypothesizing that US examination is a useful tool to detect unsuccessful release and
      defining which technique shows the best outcome in the first year postoperatively.

      The measurement of cross-sectional area (CSA) as a diagnostic tool to detect entrapments
      syndrome in upper limbs has already been described. US typically demonstrates an abrupt
      narrowing and displacement of the nerve within the tunnel, possibly in association with a
      thickened retinaculum or a space-occupying lesions. Previous studies prospectively compared
      sonographic outcomes after decompression of the median nerve at the wrist.
    

Intervention name(s): Cubital tunnel release
Intervention type(s): Procedure
Intervention description(s): The ulnar nerve is decompressed proximally at the intramuscular septum, decompressed more distally through the cubital tunnel and then exposed between the two heads of the flexor carpi ulnaris muscle. Care is taken to ensure that any point that might compress the ulnar nerve either proximally or distally is evaluated.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ulnar Nerve Compression, Cubital Tunnel