bioihbjkbjnl/mcl2 huggingface dataset:
Neonatal Cerebral Oxygenation After Exposure to Oxygen Evaluated With the INVOS Oximeter
Condition: Response to Hyperoxia
MeSH terms: Hyperoxia
Study type: Interventional

Summary: 
      -  Due to the increased risk of brain damage, continuous monitoring of the cerebral
           oxygenation is interesting. The investigators will evaluate the capability of the INVOS
           Oximeter to detect induced changes in the cerebral regional saturation.

        -  The purpose of the study is to investigate our hypothesis that cerebral vasoconstriction
           after oxygen exposure is prolonged in preterm infants compared to term infants.
    

Detailed description: 
      Preterm infants are at increased risk of brain damage compared with term infants, and
      cerebral hypoxia is considered to have an important role. The preterm infants are at
      increased risk of respiratory distress, episodes with low oxygenation, mechanical
      ventilation, risk of hypocapnia and labile or low blood pressure. These conditions can affect
      the microcirculation and hence the oxygenation of the brain. Hyperoxia is also a point of
      interest, since high levels of oxygen can cause vasoconstriction.

      The investigators will examine the normal physiological cerebral response to exposure of
      oxygen in a group of preterm infants with a gestational age (GA) of 32-37 weeks and a group
      of term infants.

      The investigators will do dynamic research with continuously monitoring of the cerebral
      oxygenation using the INVOS® Cerebral/Somatic Oximeter (Near InfraRed Spectroscopy (NIRS)).
      Reproducibility is examined by repeated measurements.

      There will be no follow-up.
    

Intervention name(s): Oxygen
Intervention type(s): Drug
Intervention description(s): Oxygen exposure (100% oxygen) for 5 minutes, then 25 minutes with room air. Repeated twice. Continuously monitoring of the cerebral oxygen saturation (NIRS).5 replacements of sensor for reproducibility.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Preterm; Newborn; Neonate; Cerebral oxygenation; Oxygen
A Phase II, Adaptive Trial Design Examining the Pharmacokinetic and Pharmacodynamic Effects of Modified Release Amphetamine (HLD100, Formulations B, C and E)) in Adolescents and Children With Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main purpose of this study is to determine the rate and extent of absorption of one or
      more modified release formulations of amphetamine (HLD100) in both adolescents and children
      with ADHD.
    


Intervention name(s): HLD100-B; HLD100-C; HLD100-E
Intervention type(s): Drug; Drug; Drug
Intervention description(s): d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B); d-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, fast release; formulation E) - this intervention may be deemed unnecessary based on results from Intervention 1.; d-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, medium release; formulation E) - this intervention may be deemed unnecessary based on results from Interventions 1 and 2.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of AMG 557 in Adults With Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, placebo-controlled, double-blind, dose-escalation study of
      repeat SC doses of AMG 557 in adults with Systemic Lupus Erythematosus.
    


Intervention name(s): AMG 557
Intervention type(s): Drug
Intervention description(s): A total of 4 cohorts will be administered multiple doses of drug or placebo subcutaneously. Dose escalation will take place by cohort.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Systemic lupus erythematosus; ICOSL; B7RP-1; Costimulation
Copeptin in Differentiation of Polyuria and Polydipsia
Condition: Polyuria; Polydipsia
MeSH terms: Polyuria; Polydipsia
Study type: Observational

Summary: 
      The differential diagnosis of patients with polyuria/ polydipsia is often complex, but
      important for the therapeutic strategy.

      Challenging is in particular the clinical differentiation between patients with a partial
      Diabetes insipidus centralis and patients with primary polydipsia as underlying disease,
      because both groups are associated with similar urinary osmolalities.

      The determination of plasma arginine vasopressin is unusual in this context, since
      measurement of AVP is not reliably.

      C-terminal ProVasopressin (copeptin) is secreted stoichiometrically with AVP from the
      neurohypophysis, but has a longer half life in the circulation, and is thus easier to
      measure.

      Therefore, the investigators will analyze in that study the diagnostic utility of plasma
      copeptin in the differential diagnosis of polyuria and polydipsia.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy probands Patients with diabetes insipdus centralis totalis/ partials Patients with
        diabetes insipidus renalis Patients with primary polydipsia
      
Keywords: diabetes insipidus; primary polydipsia; copeptin; Utility of plasma copeptin in differential diagnosis of polyuria/ polydipsia while performing a traditional deprivation test
Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome
Condition: Obstructive Sleep Apnea Syndrome
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      During last years, numerous sleep trackers have been commercialized. They are intended to
      give indications about sleep quality/duration in order to give people an internet-based
      feedback about their own sleep.

      For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used
      routinely to assess objective sleep quality/patterns. Their use is also validated to estimate
      sleep in obstructive sleep apnea syndrome (OSA).

      The purpose of the present study is to compare the accuracy of consumer-level sleep trackers
      and validated tools to measure sleep in OSA patients.
    

Detailed description: 
      During last years, numerous sleep trackers have been commercialized. They are working on
      accelerometer-based technology. They are intended to give indications about sleep
      quality/duration in order to give people an internet-based feedback about their own sleep..

      For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used
      routinely to assess objective sleep quality/patterns. Their use is also validated to estimate
      sleep in obstructive sleep apnea syndrome (OSA).

      The purpose of our study is to compare the accuracy of consumer-level sleep trackers and
      validated tools to measure sleep in OSA patients.
    

Intervention name(s): Jawbone sleep tracker; Withings sleep tracker; BodyMedia Sense Wear accelerometer
Intervention type(s): Device; Device; Device
Intervention description(s): During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient; During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient; During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
Other intervention name(s): accelerometer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Central Venous Pressure Monitoring and Prognosis of High-risk Operating Patients
Condition: Central Venous Pressure
Study type: Observational [Patient Registry]

Summary: 
      While central venous pressure measurement is used to guide fluid management in high risk
      surgical patients during perioperative period, the relationship between the value of central
      venous pressure and organ dysfunction and prognosis of high-risk operating patients is
      unknow. In this study, we conducted a retrospective study of the relationship between the
      initial levels of CVP with organ dysfunction, the severity of illness, the length of ICU
      stay, and prognosis of critically ill patients.
    

Detailed description: 
      Although less than 15% of high-risk patients (elderly or with limited cardiopulmonary
      reserves) undergo surgery, these patients account for 80% of hospital deaths. The
      requirements for hemodynamic monitoring to critical patients during perioperative period
      reach are of maximal importance, for two major reasons: (i) absolute or relative volume
      deficiency often occurs in postoperative patients due to preoperative fasting, intraoperative
      bleeding and non-dominant fluid loss caused by vasodilation and fluid redistribution caused
      by anesthesia; (ii) insufficient fluid replacement may lead to increased postoperative organ
      complications and poor wound healing. Adequate and goal-oriented hemodynamic monitoring
      combined with early and appropriate treatment can improve the prognosis of high-risk surgical
      patients.

      Central venous pressure is a localized parameter of the superior vena cava or the right
      atrium and is closely related to the right ventricular end-diastolic pressure. With volume
      overload, CVP levels may be abnormally elevated. Maintaining central venous pressure as low
      as possible is conducive to the recovery of internal organs during haemodynamic treatment,
      especially for the kidney, intestine, and brain, etc. However, elevated central venous
      pressure (CVP) occurs frequently in critical care settings, including postoperative critical
      patients. In this study, we conducted a retrospective study of the relationship between the
      initial levels of CVP with organ dysfunction, the severity of illness, the length of ICU
      stay, and prognosis of critically ill patients.
    

Intervention name(s): no intervention measures
Intervention type(s): Other
Intervention description(s): Because this study was a retrospective study, no intervention measures were implemented for the patients enrolled.
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        This is a single-center, retrospective, observational study enrolled 196 patients
        undergoing high-risk surgery who admitted to surgical intensive care unit(SICU) directly
        after operation from Feb 1,2014 to Mar 31,2018.
      
Keywords: perioperative; central venous pressure; fluid management; acute renal injury
Three Anaesthesic Method in Electroconvulsive Theraphy
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the effectiveness of three different anesthetic regimens (propofol,
      remifentanil-propofol and sevoflurane in ECT.
    

Detailed description: 
      The purpose of this study is to compare the effectiveness of three different anesthetic
      regimens (propofol, remifentanil-propofol and sevoflurane) with respect to seizure duration,
      postictal suppression index, early and midictal amplitude, hemodynamic variables and recovery
      profiles in ECT.
    

Intervention name(s): Propofol; Remifentanil and propofol; Sevoflurane
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 mg/kg propofol IV (over 15 sec) during anesthesia induction; 1 µg/kg IV (over 60 sec)remifentanil and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction; Sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered
Other intervention name(s): Intravenous anesthetic agent; Opioid and intravenous anesthetic agent; Volatil anesthetic
Intervention MeSH terms: Remifentanil; Propofol; Anesthetics, Intravenous; Anesthetics; Sevoflurane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: electroconvulsive therapy,sevoflurane,propofol,remifentanil
The Short-Term Effect of a Technology Driven Weight Control (SMART) Program for Obese Adults
Condition: Obesity; Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the short-term effect of a technology based weight
      reduction program for obese (BMI > 30 kg/m2) adults in a primary care office.
    


Intervention name(s): SMART
Intervention type(s): Behavioral
Intervention description(s): Use of measured resting metabolic rate from indirect calorimetry for personalized diet program and use of a computer application for journalizing food and exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Sorting of Apoptotic Spermatozoa on the Outcome of Assisted Reproduction
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      In assisted reproductive technology (ART) semen needs to be processed. Commonly used methods
      rely on physical properties of the spermatozoa, such as the swim-up methods and density
      gradient centrifugation. It is now known that current processing of spermatozoa does not
      prevent the admixture of spermatozoa with damaged genetic material. The latter have a
      negative impact on the outcome of ART. The investigators developed a new method for the
      processing of spermatozoa with intact genetic material based on flow cytometry and sorting
      (FACS) and on staining using a deye, YoPro. The investigators aim at examining the effect of
      this novel method of sperm sorting on the outcome of ART.
    


Intervention name(s): Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS; Swim-up
Intervention type(s): Procedure; Procedure
Intervention description(s): Semen processing will be carried out with the conventional swim-up method.
Other intervention name(s): YoPro; FACS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: intracytoplasmic sperm injection; Male infertility; apoptosis; flow cytometry and sorting; DNA fragmentation
Zingiber and Acmella Against Knee Osteoarthritis
Condition: Pain; Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      One-group pretest-posttest quasi-experimental design in which primary outcomes were: a) the
      evaluation of pain intensity, by a 30-days Visual Analogue Scale (VAS) and b) the assessment
      of knee function by Western Ontario and McMaster Universities Arthritis Index and by Tegner
      Lysholm Knee Scoring collected at baseline, at 15 and 30 days after treatment. Secondary
      outcomes were the evaluation: c) of Health-related quality of life, by the ShortForm36, d) of
      inflammation by C-reactive protein and Erythrocyte Sedimentation Rate, and e) of body
      composition by dual-energy X-ray absorptiometry measured at baseline and 30 days after
      treatment.
    

Detailed description: 
      To evaluate the safety and the efficacy on pain and inflammation of a new food-grade lecithin
      formulation of standardized extracts of Zingiber officinale and Acmella oleracea.
    

Intervention name(s): Zingiber officinale and Acmella oleracea
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects were supplied for four weeks with two tablets/day and there was the evaluation of pain intensity, by a 30-days Visual Analogue Scale (VAS) and b) the assessment of knee function by Western Ontario and McMaster Universities Arthritis Index and by Tegner Lysholm Knee Scoring collected at baseline, at 15 and 30 days after treatment, Health-related quality of life, by the ShortForm36, inflammation by C-reactive protein and Erythrocyte Sedimentation Rate, body composition by dual-energy X-ray absorptiometry measured at baseline and 30 days after treatment.
Intervention model: Single Group Assignment
Intervention model description: One-group pretest-posttest quasi-experimental design
Masking: None (Open Label)
Primary purpose: Treatment
Persistence of Antibodies in Children Aged 7 to 15 Years Who Previously Received One Dose of Menactra® or Menomune®
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is designed to evaluate the persistence of bactericidal antibodies in subjects aged
      7 to 15 years (not yet 16 years) who had been vaccinated five years previously in Study
      603-02. In addition, the kinetics of the antibody response will be evaluated in a subset of
      participants who will receive a booster dose of Menactra® vaccine and children in the same
      age group not previously vaccinated with a meningococcal vaccine or had meningitis disease
      who will receive a dose of Menactra® vaccine.
    


Intervention name(s): Polysaccharide Diphtheria Conjugate Vaccine; Polysaccharide Diphtheria Conjugate Vaccine; Polysaccharide Diphtheria Conjugate Vaccine; Polysaccharide Diphtheria Conjugate Vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): Menactra®; Menactra®; Menactra®; Menactra®
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal infection; Neisseria meningitidis; Menactra®; Menomune®
The Glycemic Indices of Five Common Varieties of Dates in the Tested Among Healthy and Diabetic Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The main objectives of this study is to measure the composition of five common types of dates
      (Fara'd, Lulu, Abu ouma'n, Dabbas and Khalas) and to calculate their Glycemic Indices (GI) of
      these dates tested in healthy and diabetic subjects. Thirteen healthy volunteers and ten
      subjects with type 2 diabetes mellitus were enrolled in the study.

      The dates' flesh composition analysis showed that the dates contain a high percentage of
      carbohydrate (total sugars, 65-68%).

      The measured mean glycemic indices of the dates among healthy individuals were 54.0, 53.5,
      46.3, 49.1 and 55.1 for Fara'd, Lulu, Abu Ouma'n, Dabbas and Khalas, respectively.
      Corresponding mean glycemic indices among individuals with type 2 diabetes were very similar
      46.1, 43.8, 51.8, 50.2, and 53.0. Thus the tested five varieties of the dates are classified
      as low glycemic index food items.
    

Detailed description: 
      The United Arab Emirates (UAE) has transitioned rapidly over the last 40 years. This has lead
      to a dramatic increase in the prevalence of obesity, metabolic syndrome, dyslipidaemia,
      hypertension, prediabetes and diabetes. Daily consumption of dates is the norm.The main
      objectives of this study is to measure the composition of five common types of dates (Fara'd,
      Lulu, Abu ouma'n, Dabbas and Khalas) and to calculate their Glycemic Indices (GI) of these
      dates tested equally in healthy and diabetic subjects. Thirteen healthy volunteers and ten
      subjects with type 2 diabetes mellitus were enrolled in the study. The dates' flesh
      composition analysis showed that the dates contain a high percentage of carbohydrate (total
      sugars, 65-68%).

      The measured mean glycemic indices of the dates among healthy individuals were 54.0, 53.5,
      46.3, 49.1 and 55.1 for Fara'd, Lulu, Abu Ouma'n, Dabbas and Khalas, respectively.
      Corresponding mean glycemic indices among individuals with type 2 diabetes were very similar
      46.1, 43.8, 51.8, 50.2, and 53.0. Thus the tested five varieties of the dates are classified
      as low glycemic index food items with potential health benefits for healthy and diabetic
      individuals alike.
    

Intervention name(s): Glucose; Dates
Intervention type(s): Other; Other
Intervention description(s): Each healthy and Diabetic volunteers received 50 grams of glucose; Each healthy and diabetic volunteers received 50 grams equivalent of carbohydrates of each of the five selected dates, on five separate days.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Glycemic index; Dates; Blood glucose
Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSU
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a placebo and active-controlled phase 2b dose-finding study to evaluate efficacy and
      safety of QGE031 monthly subcutaneous injections as add-on therapy in patients with Chronic
      Spontaneous Urticaria.
    


Intervention name(s): QGE031; Omalizumab; Placebo
Intervention type(s): Biological; Biological; Other
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: QGE031; ligelizumab; omalizumab; chronic; spontaneous; urticaria; adults; CSU
Tolerability of Rivastigmine Before and After Switching From Oral Formulation to Transdermal Patch in Alzheimer's Dementia
Condition: Alzheimer's Dementia
MeSH terms: Dementia; Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This phase IIIb study is intended to implement a consistent treatment way for switching to
      Exelon transdermal patch from oral formulation of rivastigmine to stress the importance of
      (1) advantages of transdermal patch over conventional oral therapies: smooth drug delivery
      with reduced side effects;(2) encourage treatment compliance in the Alzheimer's dementia
      setting.

      This study is a single-arm, treatment-switched design. Eligible patients, who are under
      Exelon capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed
      by treatment switch from oral capsule to patch for 48 weeks maintenance treatment. During the
      maintenance period, the treatment will be initiated with Exelon Patch 4.6 mg/24 hours (Exelon
      Patch 5 cm^2) for the first 24 weeks and the dose will be escalated to Exelon Patch 9.5 mg/24
      hours (Exelon Patch 10 cm^2) for another 24 weeks if well tolerated. Visits to assess safety
      are scheduled at baseline, 3 days, 1 week and 2 weeks after the first treatment switch, every
      4 weeks until Week 40, and at the end of study (Week 52). The assessment to address the
      primary objective will focus on the safety of treatment switching (Week 0~28); however the
      safety assessment will be performed during the whole study period.
    


Intervention name(s): ENA713
Intervention type(s): Drug
Other intervention name(s): Rivastigmine
Intervention MeSH terms: Rivastigmine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's dementia, AD