bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to
      cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term
      efficacy of MMF compared to azathioprine in maintaining remission and renal function.
      Patients were randomized to receive either MMF (1.5 g twice daily [bid]) or cyclophosphamide
      (0.5-1.0 g/m^2 in monthly pulses) in the induction phase. Those patients meeting criteria for
      response were re-randomized for entry into the maintenance phase, to receive either MMF (1 g
      bid) or azathioprine (2 mg/kg/day).
    


Intervention name(s): Mycophenolate mofetil (MMF); Cyclophosphamide; Azathioprine; Placebo to Azathioprine; Placebo to Mycophenolate mofetil; Corticosteroid
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Supplied as 500 mg tablets taken orally twice a day (BID). Dose specific for each arm. Dosing started at 500 mg BID for the first week, increasing by 500 mg in subsequent weeks until the final target dose was reached.; Intravenous cyclophosphamide (IVC) was administered every four weeks (monthly) to a total of six infusions.
Dosing was started at 0.75 g/m^2 of body surface area for the first month, with subsequent doses at 0.5-1.0 g/m^2. The target dose was 1.0 g/m^2, but doses were titrated by 0.25 g/m^2 increments to maintain nadir leukocyte count between 2500-4000/mm^3.; 2 mg/kg/day orally, provided as 50 mg capsules to be taken after meals.; Placebo capsules matching Azathioprine taken orally once a day.; Placebo tablets matching Mycophenolate mofetil taken orally twice daily.; Oral prednisolone (or equivalent) starting at a dose of 0.75-1.0 mg/kg/day (maximum 60 mg/day) tapered to 10 mg/day.
Other intervention name(s): CellCept; Endoxan®; Imuran®
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Depression, Obesity and Inflammatory Markers
Condition: Bipolar Disorder; Depression; Obesity
MeSH terms: Obesity; Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to better understand the relationship between bipolar disorder,
      body weight, and inflammation in the body (N=180). People with bipolar depression (N =
      50)will be offered a place in a pilot study looking to see if the antibiotic minocycline
      added to current psychiatric medications has an effect on mood. A separate consent form will
      be provided for the pilot study. Numerous studies have documented the presence of altered
      immune function and elevation of inflammatory markers in patients with depression. Studies
      suggest that major depression is accompanied by immune dysregulation and activation of the
      inflammatory response system. While a small number of studies have found elevated
      inflammatory markers in bipolar mania, very little has been reported about inflammation in
      bipolar depression, and none of these studies have addressed the relationship of inflammatory
      markers with obesity in bipolar disorder.
    

Detailed description: 
      Aim 1 (N=180)will examine relationships between the levels of the inflammatory markers and
      current clinical state (depressed, manic or euthymic) with the hypothesis that Inflammatory
      markers will be higher in depression and mania relative to the euthymic state.

      Aim 2 (N=180)will examine relationships between inflammatory markers and BMI in bipolar
      patients with the hypothesis that inflammatory markers will correlate positively with BMI.

      Aim 3 (N=180)will examine the relationship between depression, obesity and inflammatory
      markers with the hypothesis that depressed (or manic) bipolar patients who are also obese
      will have higher inflammatory markers than either obese euthymic patients or non-obese
      depressed or manic patients.

      Aim 4. (N=50) The pilot study will be to conduct a proof of concept add-on treatment study of
      the antibiotic minocycline for bipolar patients who are depressed, likely to be obese and
      likely to have elevated inflammatory markers and increased risk of heart disease. This is a
      proposal to conduct a 2-site trial of 50 subjects to examine the value of minocycline
      augmentation in bipolar depressed patients who are incompletely responsive to initial
      treatment with anti depressants and/or mood stabilizers. The investigators will compare two
      subgroups of depressed patients, those who have high (N=25) versus those who have low (N=25)
      levels of C-reactive protein (CRP).
    

Intervention name(s): Minocycline
Intervention type(s): Drug
Intervention description(s): Minocycline 100 mg twice a day
Other intervention name(s): Minocin
Intervention MeSH terms: Minocycline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bipolar Disorder; Obesity; Depression
Biological Standardization of Poa Pratensis Allergen Extract
Condition: Allergy to Grass Pollen
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the biologic activity of a Poa pratensis allergen
      extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference
      preparation (IHRP).
    

Detailed description: 
      This is an open, unblinded and non-randomized biological assay. The study design is a slight
      modification of the recommendations proposed by the Nordic Guidelines.

      Four concentrations of Poa pratensis allergen extract, together with a positive and negative
      control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline
      solution, respectively, will be tested in every patient in duplicate on the volar surface of
      the forearm.
    

Intervention name(s): Four different concentrations of Poa pratensis allergen extract, positive control and negative control
Intervention type(s): Biological
Intervention description(s): Four concentrations of Poa pratensis allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Immunotherapy; Skin prick test; Standardization; Poa pratensis
Translating a Heart Disease Lifestyle Intervention Into the Community
Condition: Obesity; Hyperlipidemia; Hypertension; Pre-diabetes; Diabetes
MeSH terms: Heart Diseases; Diabetes Mellitus; Hyperlipidemias; Prediabetic State
Study type: Interventional

Summary: 
      Translating a Heart Disease Lifestyle Intervention in the Community study will evaluate the
      feasibility and initial effectiveness of a community-based, culturally-targeted, lifestyle
      intervention to improve the cardiovascular health of underserved South Asian (Indian,
      Pakistani, Bangladeshi, Nepali, and Sri Lankan) Americans. Participants in this study will be
      randomly assigned to either a group to receive heart disease prevention classes or to another
      group where they will receive written materials about heart disease prevention.
    

Detailed description: 
      South Asian individuals were recruited from a community based organization in Chicago and
      randomly assigned to the print health education group or the SAHELI intervention.
    

Intervention name(s): Lifestyle Intervention; Print Health Education
Intervention type(s): Behavioral; Other
Intervention description(s): Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.; Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: South Asians; Diabetes; Physical Activity; Coronary Heart Disease; Lifestyle
Onset and Duration of Forearm Nerve Blockade
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This pilot study will evaluate the latency of onset and duration of sensory-motor block in
      patients undergoing hand surgery. Patients will be randomized to receive nerve blocks of the
      distal forearm or of the distal and proximal forearm. Local anesthetic will be injected to
      anesthetise the median and ulnar nerves in the distal forearm (1-injection site group) or the
      median and ulnar nerves in the distal and proximal forearm (2-sequential injection sites
      group) to accomplish anesthesia for surgery on the hand.
    


Intervention name(s): Lidocaine; Bupivacaine; Lidocaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total; Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total; lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
Intervention MeSH terms: Lidocaine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and effectiveness of adding alogliptin,
      once daily (QD), compared to glipizide with metformin in diabetic patients.
    

Detailed description: 
      For patients diagnosed with type 2 diabetes mellitus, metformin is the usual first-line
      therapy in addition to diet control and exercise. For those patients with inadequate glycemic
      control with metformin monotherapy or experiencing serious side effects of metformin,
      sulfonylurea is a popular choice as a second-line oral antidiabetic treatment.

      Alogliptin is a dipeptidyl peptidase-4 inhibitor currently being developed by Takeda for use
      in patients with type 2 diabetes mellitus.

      This study is designed to further explore the durability of efficacy and safety of alogliptin
      compared to glipizide in type 2 diabetes mellitus patients whose blood sugar level is
      inadequately controlled with metformin therapy.

      The duration of this study will be approximately 2 years.
    

Intervention name(s): Alogliptin; Metformin; Glipizide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Alogliptin tablets; Metformin tablets; Glipizide tablets
Other intervention name(s): SYR-322; Nesina; Glucophage; Glucotrol
Intervention MeSH terms: Metformin; Alogliptin; Glipizide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Drug Therapy; Hyperinsulinism; Hyperglycemia; Glucose Intolerance
Liver Regeneration Therapy by Intrahepatic Arterial Administration of Autologous Adipose Tissue Derived Stromal Cells
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      Mesenchymal stem cells have capability to differentiate into hepatocyte and will be useful
      for liver regeneration. Adipose tissue is relatively enriched with mesenchymal stem cell
      compared to bone marrow tissue. In this trial, eligible liver cirrhosis patients will receive
      autologous adipose tissue derived stromal cells through intrahepatic arterial
      catheterization.
    

Detailed description: 
      The population of the liver cirrhosis patients is enormous in Japan and the only radical
      treatment for them is liver transplantation: however, the number of giving donor is extremely
      limited. Mesenchymal stem cells have been capable to differentiate into mesodermal-lineage
      cells as well as endodermal-lineage cells such as hepatocytes. They reside in the mesenchymal
      tissues such as bone marrows as well as adipose tissues. The latter tissues are relatively
      enriched with mesenchymal stem cells compared to bone marrow cells. In this study, the
      cirrhotic patients will undergo intrahepatic arterial administration of autologous adipose
      tissue derived stromal cells through catheter.
    

Intervention name(s): adipose tissue derived stromal cells dosage
Intervention type(s): Biological
Intervention description(s): single administration of autologous adipose tissue derived stroma cells via intrahepatic arterial catheterization
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver Cirrhosis
Pediatric Acute Kidney Injury (AKI) Retrospective, Real-Time and Repository Research
Condition: Acute Kidney Injury; Renal Injury; Kidney Disease
MeSH terms: Kidney Diseases; Acute Kidney Injury; Wounds and Injuries
Study type: Interventional

Summary: 
      This proposal will incorporate statistical models developed by the investigators to predict
      risk for acute kidney injury into our electronic medical record system, enabling an alert to
      notify providers of the risk status. Pediatric inpatients will be randomly assigned to be in
      the intervention group, for whom the notification will be implemented, or in the control
      group, who will receive usual care (no notification). The investigators believe the
      notification will increase appropriate screening for acute kidney injury and reduce the
      severity of acute kidney injury in the intervention group.
    

Detailed description: 
      This proposal will incorporate a logistic regression models developed by the investigators to
      predict risk for acute kidney injury in pediatric intensive care unit and pediatric ward
      patients into the electronic medical record system, enabling personalized decision support.
      Real-time surveillance using the risk prediction models will identify pediatric inpatients at
      increased risk for acute kidney injury. When patients exceed the threshold risk for acute
      kidney injury, the electronic medical record system will notify providers. Patients will be
      randomly assigned to be in the intervention group, for whom the notification will be
      implemented, or in the control group, for whom the notification will not display. The risk
      notification will be assessed for its impact on outcomes including rates of screening for
      acute kidney injury and the severity of acute kidney injury.
    

Intervention name(s): AKI Risk Notification
Intervention type(s): Other
Intervention description(s): When a patient's calculated acute kidney injury risk exceeds the threshold value, the electronic medical record will notify the provider of the risk and that appropriate screening (BMP including serum creatinine) may be indicated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Screening
Keywords: Pediatrics
A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      This is a randomized, within-patient controlled study to compare the clinical performance of
      the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second
      degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary
      efficacy endpoint defined as recipient site wound closure at week 4 follow-up visit of the
      ReCell-treated area as compared to that of the STMSG-treated area, and 2)superiority in the
      healing of the ReCell donor site as compared to the STMSG donor site at week 1.
    


Intervention name(s): ReCell and Split-thickness skin graft
Intervention type(s): Device
Intervention description(s): The surgeon will be required to select two similar non-contiguous injury areas with both areas being at least 100cm2 and second degree depth/severity. One area will be treated using ReCell and the second using Split-thickness Skin Graft.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Second Degree Burn Injuries
To Evaluate the Response to Glucagon During Hypoglycemia
Condition: Type 2 Diabetes
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the response to Glucagon versus the spontaneous
      hormonal response to low blood sugar levels in T2DM Patients treated with AZD1656 and
      Metformin
    


Intervention name(s): AZD1656; Glucagon
Intervention type(s): Drug; Drug
Intervention description(s): Dose titration of oral suspension during 2 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose for another 6 days. On day 5 and 8 the dose will be given as a single dose; 1 mg injected 3 hr post AZD1656 morning dose on day 5 alt. day 8
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type II Diabetes; Counter-regulatory response; Hypoglycemia
Optical Stimulation in Peripheral Nerves for Select Rhizotomy Procedures
Condition: Spasticity
MeSH terms: Muscle Spasticity
Study type: Observational

Summary: 
      The purpose of this study is to determine the safe and effective levels of optical
      stimulation in peripheral nerves of humans otherwise undergoing nerve lesioning in surgery.
    

Detailed description: 
      The purpose of this study is to determine the safe and effective levels of optical
      stimulation in peripheral nerves of humans otherwise undergoing nerve lesioning in surgery,
      namely children undergoing selective rhizotomy for treatment of medically refractory
      spasticity.
    

Intervention name(s): Rhizotomy for children with spasticity
Intervention type(s): Procedure
Intervention description(s): Optical Stimulation versus electrical stimulation in children who need Rhizotomy Surgery for spasticity
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children over the age of 3 and younger than 17 years who have failed appropriate medical
        therapy for spasticity and are recommended for Rhizotomy surgery
      
Biospecimen description: 
      abnormal spinal nerves that have been surgically removed
    
Keywords: spasticity; rhizotomy; surgery
Targeted Electrotherapy for Aphasia Stroke Rehabilitation (TEASER) - Phase II Multi-Center Study
Condition: Chronic Aphasia
MeSH terms: Aphasia
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II study aims to ascertain the effectiveness of HD-tDCS for adjunctive treatment
      of anomia in chronic aphasia post stroke. Furthermore, it will help explore factors such as
      alternate outcome measures, subject selection criteria, and benefits of extended treatment
      duration. These results will be compared to an existing trial using conventional non-targeted
      tDCS with the same design and outcomes. Patients will be treated with HD-tDCS while
      performing computerized anomia treatment. The basis behind this method is that language
      therapy is mediated by cortical areas that are most effectively activated during the training
      tasks, thus increasing electric stimulation in these areas may improve learning outcomes. To
      better understand the long term benefits of the adjunctive treatment, patients will be
      screened again four weeks and six months after study using the same anomia tests. If HD-tDCS
      shows promising results in increasing the learning outcomes of anomia treatment, a Phase III
      trial can be considered.
    


Intervention name(s): HD-tDCS (Soterix Medical, Active); HD-tDCS (Soterix Medical, Sham)
Intervention type(s): Device; Device
Intervention description(s): Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.; Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
Other intervention name(s): Soterix Medical High-Definition MxN stimulator; Soterix Medical HDTargets; Soterix Medical High-Definition MxN stimulator; Soterix Medical HDTargets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Anomia