bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Mild Hypoglycaemia on Cognitive Function in Type 2 Diabetes
Condition: Diabetes Mellitus, Type II; Hypoglycemia; Cognitive Change
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Hypoglycaemia in subjects suffering from type 2 diabetes may have substantial consequences
      including a significant negative impact on quality of life. Further, repeated minor
      hypoglycaemias may result in significant productivity losses.

      Here, the investigators propose to provide quantitative results on cognition during an acute
      mild hypoglycaemic episode (target plasma glucose 3 mmol/L) in 28 subjects with type 2
      diabetes. Data will be provided on executive function, attention and memory.
    

Detailed description: 
      Hypoglycaemia in subjects suffering from type 2 diabetes may have substantial consequences
      including a significant negative impact on quality of life. Further, repeated minor
      hypoglycaemias may result in significant productivity losses. In healthy subjects a number of
      studies show that during a hypoglycaemic episode with plasma levels of 2.2 - 2.5 mmol/L
      (40-45 mg/dl) brain areas responsible for cognition have an altered neuronal function when
      measuring cerebral blood flow. This is accompanied by severely impaired cognitive function
      with a reduced ability to solve simple cognitive tasks. At higher levels of glucose (above 3
      mmol/L (54 mg/dl)), it remains to be settled whether cognitive functions are also affected
      negatively and whether this may be accompanied by changes in brain metabolism. Apart from
      raising the blood glucose directly or indirectly via glucagon, no treatment for hypoglycaemia
      exists, but since Glucagon-like peptide-1 (GLP-1) based therapies used in type 2 diabetes may
      affect brain glucose consumption, therapeutic interventions to prevent negative results of
      hypoglycaemia may eventually become clinically possible.

      Here, the investigators propose to provide quantitative results on cognition during an acute
      mild hypoglycaemic episode (target plasma glucose 3 mmol/L). Data will be provided on
      executive function, attention and memory.
    

Intervention name(s): Hypoglycaemic clamp; Euglycaemic clamp
Intervention type(s): Other; Other
Intervention description(s): The clamp is performed by insulin and adjustable 20% glucose infusions, with the aim to lower and keep plasma blood glucose levels at 3 mmol/L for outcome measurements.; The clamp is performed by insulin and adjustable 20% glucose infusions, with the aim to keep plasma blood glucose levels at 6 mmol/L for outcome measurements.
Intervention MeSH terms: Hypoglycemic Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Two Versus Four Implant-supported Fixed Full-arch Prosthesis
Condition: Prosthesis Durability
MeSH terms: Prosthesis Failure
Study type: Interventional

Summary: 
      The aim of this study will be the evaluation of patient satisfaction and oral
      health-related-quality of life (OHRQoL) of two versus four implants supporting fixed
      full-arch screw-retained metal acrylic hybrid mandibular prosthesis.
    

Detailed description: 
      -  Six completely edentulous patients will be selected for this study from the outpatient
           clinic of the prosthodontic department

        -  All patients will be informed about all surgical and prosthodontics procedures that will
           be done for them. All patients will sign the consent form of the ethical committee in
           faculty dentistry Mansoura University.

      The patients will be divided into 2 groups

        1. Control group: will receive implant-supported mandibular fixed metal acrylic prosthesis
           on 4 implants that were placed according to the "All on four concept".

        2. Study group: will receive implant-supported mandibular fixed metal acrylic prosthesis on
           two implants placed according to "All On two concept".
    

Intervention name(s): placement of four dental implants; placement of two dental implants; mandibular full arch prosthesis
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): placement of four dental implants according to the " All on four concept"; placement of two dental implants according to " All on two concepts"; loading of the mandibular fixed full-arch screw-retained metal acrylic prosthesis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
BENEFIT Extension Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      To assess the long-term effects of early therapeutic intervention, i.e. within two years
      following a first clinical demyelinating event suggestive of MS.
    


Intervention name(s): Interferon beta-1b (Betaseron, BAY86-5046)
Intervention type(s): Drug
Intervention description(s): Standard Therapy for Multiple Sclerosis
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1b
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This observational study may include all patients who were randomized into and treated at
        least once in the BENEFIT study 304747, inclusive of patients who prematurely discontinued
        study participation in either study 304747 or study 305207, and patients who did not
        transfer from study 304747 to study 305207.
      
Biospecimen description: 
      Population of Benefit Studies
Behavioral and Neuroimaging Changes After Cognitive Rehab in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment (MCI)
Condition: Mild Cognitive Impairment; Alzheimer's Disease; Traumatic Brain Injury
MeSH terms: Alzheimer Disease; Brain Injuries; Brain Injuries, Traumatic; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      Memory deficits are common after traumatic brain injuries (TBI) and are characteristic of
      various forms of dementia, such as Alzheimer's disease and its common precursor mild
      cognitive impairment (MCI). This project intends to assess the efficacy of cognitive
      rehabilitation in these patient populations. We will also use neuroimaging (functional
      magnetic resonance imaging - fMRI) to assess changes in brain activity that occur following
      cognitive rehabilitation.
    


Intervention name(s): Mnemonic strategy training (MST); Repeated exposure (XP); Subtracting Cues training
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: cognitive rehabilitation; explicit memory training; mild cognitive impairment; Alzheimer's disease; traumatic brain injury; veterans
Safety of Ibritumomab Tiuxetan (Zevalin®) in Combination With a Fludarabine-based Reduced Intensity Conditioning (RIC) Regimen (ZEVALLO 2007)
Condition: Diffuse Large B-Cell Lymphoma; Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced
      Intensity Conditioning regimen followed by allogenic stem cell support in patients with
      aggressive lymphomas who are responsive to a salvage chemotherapy regimen.
    

Detailed description: 
      The benefit of Zevalin® in the setting of autologous stem cell transplantation has been
      largely reported. The addition of Zevalin® to a fludarabine-based Reduced Intensity
      Conditioning regimen has been already evaluated in the setting of allo-SCT and the results
      reported so far seem to be promising without an overwhelming toxicity neither a delayed
      hematologic recovery. The assumption that the addition of Zevalin® to the conditioning
      regimen might improve lymphoma control and the demonstration that nucleoside analogs such as
      fludarabine synergize optimally with RIT led us to conduct this trial using the following
      preparative regimen: rituximab 250 mg/m² on days -21 and -14, Zevalin® 0,4 mCi/Kg body weight
      on day -14, fludarabine 30 mg/m² intravenously from days -6 to -2, Busulfan orally (4 mg/Kg
      body weight) or intravenously (0,8 mg/Kg body weight) on days -5 and -4 and ATG
      (Thymoglobulin®) 2,5 mg/Kg body weight intravenously on day -1. Cyclosporine A is
      administered at 2 or 3 mg/Kg body weight from day -1 to day 28 than followed by a dose
      reduction.

      The purpose of this study is to evaluate the safety and efficacy of Zevalin® in a Reduced
      Intensity Conditioning regimen followed by allogenic stem cell support in patients with
      aggressive lymphomas who are responsive to a salvage chemotherapy regimen

      Patients are followed from the beginning of the RIC regimen until day 365 for primary and
      secondary objectives of the study than on a regular basis depending on the practice of each
      centre. The evaluation includes physical examination (performance status, hematologic
      assessment, acute and chronic GVH disease), biologic tests (blood screening for blood count,
      renal and hepatic function, B and T-cell recovery, chimerism analysis, response assessment)
      and complementary examinations (marrow biopsies, tomography scan, positron emission
      tomography, …).
    

Intervention name(s): Ibritumomab Tiuxetan (Zevalin)
Intervention type(s): Drug
Intervention description(s): Conditioning regimen followed by allogeneic hematopoietic stem cell transplantation.
Ibritumomab Tiuxetan(Zevalin): 0.4 mCi/kg IV at day -14 (Day 0 is the transplantation)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Zevalin; Reduced intensity conditioning; Allogenic stem cell transplantation
Safety of Vitamin D Supplementation in Older Persons
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety over 6 months of two different doses of vitamin D
      (cholecalciferol) in men and women age 65 and older. It will also evaluate if supplementation
      with vitamin D improves physical performance.
    

Detailed description: 
      120 ambulatory men and women ages 65 to 95 will be enrolled in this study. Each subject will
      participate in the clinical trial for 6 months.

      Parathyroid hormone, vitamin D, and serum and urinary calcium will be measured periodically.
      Physical performance will be tested at baseline and throughout the study.
    

Intervention name(s): cholecalciferol (vitamin D); cholecalciferol (vitamin D)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 400 IU daily (low dose); 2000 IU daily (high dose)
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vitamin D; deficiency; elderly
Robot Assisted Total Hip Arthroplasties
Condition: Hip Arthropathy
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      This is a randomized controlled, multicenter study. According to the inclusion criteria,
      volunteers were recruited from patients undergoing total hip arthroplasty. After signing the
      informed consent, the subjects were assigned to the experimental group and the control group
      through the central randomization system. The researchers will complete the total hip
      arthroplasty for patients in the experimental group with the assistance of surgical robotic
      system. The patients in the control group do not use the surgical robotic system. The
      proportion of acetabular abduction angle and anteversion angle in the lewinnek safe area is
      the primary outcome measurement. The operation time, WOMAC score, Harris score, SF-36 and
      dislocation rate are the secondary outcome measurements. The incidence of complications,
      devices and other adverse events were recorded.
    


Intervention name(s): "VTS" surgical robotic system
Intervention type(s): Device
Intervention description(s): The"VTS" surgical robotic system can accurately match the preoperative and intraoperative image data with the patient's anatomical structure on the operating table, track and locate the surgical instruments during the operation. With the help of the robotic arm, the surgeon can make the operation procedure more accurate and safer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Iron Supplementation Outcome on Recurrent Upper Respiratory Tract Infections in 6-15 Years Old Egyptian School Children
Condition: Recurrent Upper Respiratory Tract Infections; Iron Deficiency Anemia
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Anemia, Iron-Deficiency; Iron Deficiencies; Recurrence
Study type: Interventional

Summary: 
      Recurrent upper respiratory infections ( RURTIs) are common in school aged children. An
      adequate iron status might reduce their prevalence. The aim of the study is to assess the
      percentage and type of RURTIs in Egyptian school children, assessing the percentage of iron
      deficiency anemia (IDA) and the effect of iron supplementation on the recurrence and severity
      of upper respiratory tract infections .
    

Detailed description: 
      This is a prospective interventional study in which 1000 Children (6-15 years) are recruited
      from two schools in urban Cairo; three months enrollment was done in early autumn ; students
      defined to have RURTIs were screened by Hemocue; if anemic (Hb < 11.5gm/dL),Complete blood
      picture and iron profile were done, they were enrolled into 2 groups: (A)children with IDA on
      oral iron fumerate therapy (6mg/kg/d) for 3 months, then maintained on oral iron (1mg/kg/d)
      for 12 months, and (B) Non anemic group; were randomly assigned in 1:1 ratio into: group
      (B1)children Received maintenance iron therapy for 12 months and group (B2) received placebo.
      Recurrence and severity of URTIs using (CARIFS score) throughout the study are recorded
    

Intervention name(s): iron fumerate
Intervention type(s): Dietary Supplement
Intervention description(s): iron fumerate supplementation (6mg/kg/d) for arm 1 iron fumerate supplementation (1mg/kg/d) for arm 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Iron; RURTIs; CARIFS; children
Exercise and Arterial Modulation in Youth
Condition: Cardiovascular Disease; Childhood Obesity; Hypertension; Endothelial Dysfunction
MeSH terms: Cardiovascular Diseases; Pediatric Obesity
Study type: Observational

Summary: 
      The project is designed as a large scale, cross-sectional study. The aim of the study is to
      investigate the association of micro- and macrovascular function with physical fitness and
      body composition in primary school children.
    

Detailed description: 
      The investigators will examine whether physical fitness, body composition and blood pressure
      differently affect large and small arteries in young children. Furthermore, the investigators
      will examine whether pulmonary dysfunction is associated with vascular disorders and if
      subcutaneous advanced glycation endproducts (AGE's) mediate some of the vascular alterations
      observed.
    

Intervention name(s): Physical Activity, 20-meter shuttle run
Intervention type(s): Behavioral
Intervention description(s): cross-sectional physical activity assessment and medical screeening
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ExAMIN YOUTH is a cooperative project between the department of sport, movement and health
        sciences (DSBG) of the University of Basel and the Cantonal Office of Sport of Basel-Stadt
        (COS-BS). Primary school children aged 6 to 8 years of the City of Basel are examined.The
        investigators expect to include n=1200 children in this cross-sectional study.
      
Keywords: arterial stiffness; retinal vessels; physical activity; children
A First-in-Human Study to Assess Single and Multiple Doses of NXC736 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo- controlled, single and multiple dosing,
      dose-escalation clinical phase 1 trial to investigate the safety, tolerability,
      pharmacokinetics and pharmacodynamics of NXC736 after oral administration in healthy male
      volunteers.
    


Intervention name(s): NXC736; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A 6-month Study to Evaluate Sulforaphane add-on Effects in Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the study is to investigate whether adding different doses of sulforaphane will
      benefit the clinical symptoms and cognitive function in individuals who have schizophrenia.

      This study will compare the sulforaphane with placebo. There is a thirty percent change (less
      than half) of receiving the placebo. The purpose of including placebo is to judge if the
      outcome is related to the study medication rather than other reasons.
    

Detailed description: 
      This study will be carried out in six mental health institutes in China and total of 180
      patients with first-episode or early onset schizophrenia will be enrolled into the study. The
      mental health institute at the Second Xiangya Hospital, Central South University.

      Individuals who participate in the study will be followed for 24 weeks. The changes in
      clinical symptoms and neurocognitive function will be assessed from baseline (week-2) to
      week-6 (acute phase), and week-12 to week-24 (maintenance phase).
    

Intervention name(s): sulforaphane; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.; Placebo is made of starch
Other intervention name(s): Nutramax
Intervention MeSH terms: Sulforaphane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; sulforaphane
Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid
Condition: Orbital Fat Prolapse
MeSH terms: Prolapse
Study type: Interventional

Summary: 
      Study title

        -  Safety and Efficacy Evaluation of UltheraTM in Treatment of Baggy Eyelid Study design

        -  single arm and Investigator Initiative pilot study
    


Intervention name(s): UltheraTM 100 shots
Intervention type(s): Device
Intervention description(s): UltheraTM 100 shots (infraorbital region 30shots, lateral orbital region 40shots, upper eyelid 30 shots) on the Rt, and Lt periorbital area, respectively using 1.5mm and 3.0mm probe
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: orbital Computed Tomography; baggy eyelids; orbital fat prolapse; UltheraTM; high intensity focused ultrasound
Thrombolysis and Deferoxamine in Middle Cerebral Artery Occlusion
Condition: Ischemic Stroke, Acute
MeSH terms: Stroke; Ischemic Stroke; Infarction, Middle Cerebral Artery; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Iron overload has been associated with greater brain injury in ischemia/reperfusion
      experimental stroke models and ischemic stroke patients, especially in those treated with
      thrombolytic treatment. Deferoxamine administration, an iron chelator, offers a
      neuroprotective action in ischemia/reperfusion animal models.

      Primary objective: To evaluate the security and tolerability of deferoxamine endovenous
      treatment in acute ischemic stroke patients treated with iv. tPA.

      Secondary objectives: To study pharmacokinetics of deferoxamine given by endovenous bolus (10
      mg/Kg) followed by 72-hour continuous intravenous infusion (20, 40 o 60 mg/Kg). To evaluate
      the deferoxamine effect in clinical outcome, infarct volume and hemorrhagic transformation
      and brain edema development.

      Methodology: Double-blind, randomized, placebo controlled, dose-finding phase II clinical
      trial. Study stages: 1st: bolus+20 mg/Kg/day vs. Placebo (n=15:5); 2nd: bolus+40 mg/Kg/day
      vs. Placebo (n=15:5); 3rd: bolus+60 mg/Kg/day vs placebo (n=15:5). These doses will be
      increased according to security results of the previous stage. Patients will be continuously
      monitored in stroke units. Laboratory parameters will be measured at baseline, 24h, 72h and
      30 days to evaluate adverse events related to the drug. Serum deferoxamine and feroxamine
      concentrations will be measured along time after the injection in a subgroup of patients to
      the pharmacokinetics study. CT scan will be performed at 24-36h to assess hemorrhagic
      transformation and brain edema. The NIH Stroke Scale will be evaluated during
      hospitalization, and the Rankin score at discharge and 3 months.

      If deferoxamine demonstrate to be secure and well tolerated treatment in acute stroke
      patients, it may be a new therapy option to lower the brain injury after ischemia and
      reperfusion.
    


Intervention name(s): Deferoxamine
Intervention type(s): Drug
Intervention description(s): Intravenous deferoxamine: bolus 10mg/Kg (initiated during thrombolytic infusion, iv tPA), followed by intravenous perfusion of 20/40/60mg/Kg during 72h. It's a dose-finding study with 3 different doses of deferoxamine, with 20 patients (15 active:5 placebo) in each step.
Bolus + 72h perfusion of saline solution for the placebo group.
Intervention MeSH terms: Deferoxamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Ischemic Stroke; Thrombolytic treatment; Middle cerebral artery occlusion; Deferoxamine; Iron chelator; Acute Ischemic Stroke treated with Intravenous Thrombolytic