bioihbjkbjnl/mcl2 huggingface dataset:
A Study Comparing the Effects of Epoetin Hospira and Epogen/Epoetin Alfa (Amgen) When Administered IV in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment
Condition: Chronic Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assessed the comparability of the pharmacokinetics (PK) of epoetin following
      intravenous administration of Hospira Epoetin and Epogen/Epoetin Alfa (Amgen) in patients
      with chronic renal failure receiving hemodialysis treatment.
    

Detailed description: 
      This is a multicenter, active-controlled, cross-over, evaluator-blind, Phase I study in
      patients with chronic renal failure requiring hemodialysis. The study comprises a 4-week
      Screening Period, a 1-week Pre-Treatment Period, a 1-week Treatment Period 1, a 1-week
      Treatment Period 2 and a Follow-up visit at Week 7.

      Subject eligibility will be determined during the 4-week Screening Period. All subjects must
      be optimally titrated and stable to qualify for entry into Pre-Treatment Period.

      During the 1-week Pre-treatment period the patients will continue on the same stable dose as
      they received during the Screening Period. Blood samples will be collected during the
      Pre-Treatment Period to assess pharmacokinetics of Epogen. Eligible subjects will be
      randomized at Day 1 of Treatment Period 1 to receive either Epoetin Hospira or Epogen (Amgen)
      by intravenous (IV) bolus injections administered three times a week for 1 week.

      Subjects will then be switched to receive the alternate study drug for three times a week for
      1 week in Treatment Period 2. Blood samples will be collected during Treatment periods 1 and
      2 to assess pharmacokinetics of Epoetin Hospira and Epogen.

      Primary endpoint, i.e. pharmacokinetics concentrations, will be evaluator blinded. After
      completing Treatment Period 2, all subjects will receive standard of care treatment and will
      undergo a Follow-up Visit at Week 7 (i.e., 28 days after Treatment Period 2).
    

Intervention name(s): Epoetin Hospira; Epogen
Intervention type(s): Drug; Drug
Intervention description(s): IV dose 3 times a week.; IV dose 3 times a week
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic renal failure requiring hemodialysis
Efficacy of Rectal Indomethacin in Prevention of Post-operative Pancreatitis After Pancreaticoduodenectomy
Condition: Pancreatoduodenectomy
MeSH terms: Pancreatitis
Study type: Interventional

Summary: 
      Pancreatico-duodenectomy is one of the commonly performed procedure for periampullary/distal
      cholangio/head of pancreas carcinoma. Post operative pancreatitis is an emerging concept,
      recently being studied as one of the most important contributing factor of Post-operative
      pancreatic fistula, which is one of the major complication of pancreatoduodenectomy. Rectal
      indomethacin, a type of non-steroidal anti-inflammatory drug, when given in a single dose has
      been shown to prevent pancreatitis in patients undergoing ERCP. In this study, we will be
      administering rectal indomethacin at the time of induction of anesthesia to the experimental
      arm of the study and compare the results in terms of incidence of post-operative pancreatitis
      in the two groups.
    


Intervention name(s): Indomethacin suppository; Standard Medical Treatment
Intervention type(s): Drug; Other
Intervention description(s): 100mg Indomethacin Suppository administered at the time of Induction; Standard Medical Treatment
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Parent Mentors to Improve Adherence to Type I Diabetes Care Regimen in Adolescents
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study aim is to determine if parent mentors can improve adherence to the intensive
      multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the
      frequency of blood glucose measurements. Researchers are also trying to determine if the
      parent mentors can improve glycemic control, which is measured through HbA1c. The study
      hypothesis is that trained parent mentors can help families with children who have poorly
      controlled T1DM improve adherence to their diabetes regimen and improve their metabolic
      control.
    

Detailed description: 
      The study aim is to determine if parent mentors can improve adherence to the intensive
      multiple daily injection regimen (MDI) or the insulin pump therapy, through monitoring the
      frequency of blood glucose measurements. Researchers are also trying to determine if the
      parent mentors can improve glycemic control, which is measured through HbA1c. Diabetic
      knowledge, responsibility for diabetes care, degree of diabetes related family conflicts, and
      major complications of diabetes will also be collected during the patient's routine clinic
      visit. The study hypothesis is that trained parent mentors can help families with children
      who have poorly controlled T1DM improve adherence to their diabetes regimen and improve their
      metabolic control.
    

Intervention name(s): Parent mentors
Intervention type(s): Other
Intervention description(s): Parent mentors are to meet up with their assigned intervention group 4 times in 1 year and call the families monthly to document any diabetic complications
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Platelet Rich Plasma Injection Into Ovary of Patients With Premature Ovarian Insufficiency
Condition: Premature Ovarian Failure
MeSH terms: Premature Birth; Primary Ovarian Insufficiency; Menopause, Premature
Study type: Interventional

Summary: 
      All encountered cases with POI will be assessed and examined then investigated. Eligible
      cases will be included in the study
    

Detailed description: 
      Patients will be subjected to injection of autologous PRP inside the ovary about 0.5-1 mml by
      laparoscopy
    

Intervention name(s): PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml
Intervention type(s): Procedure
Intervention description(s): intraovarian injection of 2 mml of PRP by laparoscopic guide
Intervention model: Single Group Assignment
Intervention model description: All eligible patient will recieve the treatment with PRP
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Premature ovarian insuffiency; Infertility; PRP
PEARL Schizophrenia Maintenance
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Lurasidone HCI is a compound that is FDA-approved for the treatment of schizophrenia. This
      clinical study is designed to test the hypothesis that Lurasidone is effective in the long
      term maintenance treatment of schizophrenia.
    


Intervention name(s): Lurasidone; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating; Matching placebo once daily in the evening with a meal or 30 minutes after eating
Other intervention name(s): Latuda
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Lurasidone; Latuda
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Metformin or Sulfonylureas and Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic
      (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control.
    


Intervention name(s): exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks; subcutaneous injection twice daily in volumes equal to exenatide
Other intervention name(s): Byetta
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: exenatide; diabetes; Amylin; Lilly; China
Clinical Trial for 'Shen Qu Xiao Shi' Oral Liquid in the Treatments of Children's Functional Dyspepsia
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 4

Summary: 
      With domperidone suspension as the control, the effect of shenqu xiaoshi oral liquid on
      functional dyspepsia in children was evaluated objectively through multi-center, randomized,
      double-blind and double-simulation experiment, which alleviated the clinical symptoms,
      restored and promoted the normal growth and development of children.
    


Intervention name(s): Shenqu Xiaoshi oral liquid; Domperidone suspension
Intervention type(s): Drug; Drug
Intervention description(s): Shenqu Xiaoshi oral liquid; Domperidone suspension
Intervention MeSH terms: Domperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: functional dyspepsia; children; Traditional Chinese Medicine
Measuring Erythrocyte Iron Incorporation From Different Dosing Regimens in Anemic Women
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Observational

Summary: 
      Iron-deficient anaemic subjects are likely to benefit most from oral iron supplements, but
      supplementation schedules vary widely in clinical practice, absorption is low and compliance
      is poor due to mild gastrointestinal side effects. The investigators will compare iron
      absorption from labeled oral iron doses of 100mg and 200mg administered either on two
      consecutive days or on alternate days in young anemic women.
    


Intervention name(s): Iron stable isotope labeled iron(II) sulfate
Intervention type(s): Other
Intervention description(s): Administration of oral stable isotope labels using different dosings and different regimens in women with iron deficiency anemia
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young women with iron-deficiency anemia
Multifactorial Approach Associated With Orlistat (Xenical) for 4 Years Weight Loss Maintenance in Obese Adults
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the efficacy of a multifactorial approach associated with orlistat
      (Xenical) in weight loss maintenance during 4 years. The effect of orlistat in combination
      with diet, physical activity, and/or cognitive behavioral therapy will be monitored.
    


Intervention name(s): Orlistat
Intervention type(s): Drug
Intervention description(s): Participants will receive orlistat on an intermittent basis as 120 milligrams (mg) three times a day: once with breakfast, once with lunch, and once with dinner. In case of weight relapse (increase 2.5 percent [%] or more from Baseline) orlistat will be administered for up to 2 months or until weight regain reaches 0% from Baseline. For special occasions (feasts, birthdays, anniversaries) orlistat will be given for up to 3 days.
Other intervention name(s): Xenical
Intervention MeSH terms: Orlistat
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Thromboelastometry Prediction Utility for Risk of Abortion
Condition: Pregnancy Trimester, First; Abortion, Threatened
MeSH terms: Abortion, Threatened
Study type: Observational

Summary: 
      This study will use thromboelastometry in ED patients with vaginal bleeding, as well as
      healthy pregnant controls, to determine if abnormal results are associated with the presence
      of vaginal bleeding as well as later complications during pregnancy.
    

Detailed description: 
      First, a case control study with samples collected from patients in the ED and OB clinic at
      Mount Sinai Hospital will be performed. Blood samples are being collected at time of study
      entry. Patient health history will be collected and blood samples will be tested using
      thromboelastometry in prospective fashion. Samples will be compared between groups.

      A prospective cohort will then be established using the subjects from the case control study.
      The purpose of this prospective cohort will be to collect outcomes of pregnancies to
      determine association with the initial thromboelastometry results.
    

Intervention name(s): Thromboelastometry testing
Intervention type(s): Diagnostic Test
Intervention description(s): Thromboelastometry testing - a form of testing in whole blood for coagulation abnormalities
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with known histories of recurrent miscarriage, previously diagnosed thrombophilia,
        or other coagulopathy will be excluded. Patients with ectopic pregnancies will also be
        excluded.
      
Biospecimen description: 
      Whole blood collected at time of subject enrollment for thromboelastometry testing
    
Keywords: Thromboelastometry; Vaginal Bleeding; Early Pregnancy
Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Relief After Cesarean Delivery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael
      Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local
      anesthetics close to the anterior border of the quadratus lumborum muscle. In our randomized,
      controlled, double-blinded study ultrasound-guided QL-blocks in 20 female patients after
      cesarean delivery will be compared with a placebo control group of 20 patients to investigate
      analgesic consumption, pain level, opioid related side effects and mobilization.
    


Intervention name(s): nerve block
Intervention type(s): Procedure
Intervention description(s): quadratus lumborum block
Other intervention name(s): quadratus lumborum block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional

Summary: 
      The study is a prospective, multi-center, stratified randomized, single-blind, parallel
      assignment, active control, non-inferiority trial. Patients are randomized 1 : 1 to either
      stent retriever(TonbridgeMT) or Solitaire™ for endovascular therapy for AIS. The study aims
      to evaluate the benefit and safety of stent retriever(TonbridgeMT) for AIS therapy, as
      compared to Solitaire™.
    

Detailed description: 
      The main objective is to determine whether stent retriever(TonbridgeMT) will have
      non-inferior successful recanalization rate compared to Solitaire™ when applied to
      endovascular therapy for AIS.

      The secondary objectives is to verify whether there isn't significant differences in time to
      achieve recanalization, NIHSS score, mRS score, and transportation performance between stent
      retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.

      The third objectives is to verify whether there isn't significant differences in the rate of
      symptomatic intracranial hemorrhage, subarachnoid hemorrhage, adverse event(AE), serious
      adverse event(SAE), actual condition of AE and device deficiencies between stent
      retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.
    

Intervention name(s): stent retriever(TonbridgeMT); Solitaire™
Intervention type(s): Device; Device
Intervention description(s): mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI); mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, stratified-randomized, single-blind, parallel assignment, active control
Masking: Single (Participant)
Primary purpose: Treatment
Effect of Ectoin® Inhalation Solution on Subjects With Mild Bronchial Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      In this single center, dose finding, safety study the effect of inhaled Ectoin® inhalation
      solution will be investigated in subjects with mild bronchial asthma. This dose-finding study
      will estimate the minimum effective dose and will assess the safe dosage, in terms of the
      quantity given to patients. The results will be compared to baseline measurements. The
      results regarding Sputum measurements will be compared to measurements after placebo
      administration.
    

Detailed description: 
      Based on the anti-inflammatory effects of inhaled Ectoin® shown in previous animal studies,
      this trial aims to investigate the effects in terms of a reduction of the unspecific
      bronchial hyperresponsiveness (BHR) to Methacholine challenge test on subjects with mild
      bronchial asthma. In addition, measurements of exhaled nitric oxide level as an indicator of
      bronchial inflammation will be investigated.

      This study will focus primarily on safety and dose finding in 12 to 18 subjects with mild
      bronchial asthma.

      After a screening visit, subjects will be treated with placebo, followed by increasing doses
      of Ectoin® (low, medium and high dose). All doses of Ectoin® inhalation solution and placebo
      will be administered for 5 - 7 days.
    

Intervention name(s): Drug-like Medical Device: Ectoin Inhalation Solution
Intervention type(s): Other
Intervention description(s): After baseline visit subjects will receive 0.9% saline inhalation solution for placebo. Patients will be instructed to inhale once daily with the AKITA2® APIXNEB® inhalation system for 5 - 7 days.
The treatment phase with low dose of Ectoin® will follow subsequently without any washout phase. This treatment phase will be repeated for medium and a high Ectoin® dose. All doses of Ectoin® inhalation solution will be administered for 5 - 7 days without any washout phase. To minimize circadian variations Methacholine challenge tests will be performed always at the approximately same time. Sputum inductions will be conducted on the last but one day of placebo treatment phase and on the last but one day of treatment phase with the highest Ectoin® dose.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Ectoin; Ectoine; FeNO; Metacholin; sRaw
Closed Suction Drainage After Revision Hip Arthroplasty
Condition: Hip Osteoarthritis; Bleeding
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      Prospective, randomized trial. 40 patients who underwent revision hip arthroplasty, divided
      in to two groups with or without drainage. All patients was assessed with ultrasonography on
      3rd day after surgery. Bleeding, need for blood transfusion and laboratory test was analyzed
      after surgery. Patients was assessed with Harris Hips Score and Visual Analog Scale after
      surgery.
    

Detailed description: 
      Inclusion criteria: aseptic loosening, head or insert damage, girdlestone hip. Exclusion
      criteria: septic loosening, primary or secondary coagulopathy, renal or hepatic failure,
      thromboembolism in past history. At the end of operation information of drainage was get out
      from the envelope. On 3rd day all patient get ultrasonography with level of fluid in the
      joint and hematoma in soft tissue measurement. We analyzed hemoglobin, C-reactive protein,
      erythrocyte sedimentation rate on 1st and 3rd day after surgery. Visual analog scale was
      taken on 3rd day after surgery and Harris Hip Score 6 weeks after.
    

Intervention name(s): Drainage; No-drainage
Intervention type(s): Procedure; Procedure
Intervention description(s): Use of the suction drainage after hip revision arthroplasty; Patients without drainage after surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hip; Revision; Arthroplasty; Drainage
Analysis of Stroke Rehabilitation Outcomes
Condition: Stroke
MeSH terms: Stroke
Study type: Observational [Patient Registry]

Summary: 
      Observe and describe the relationships between impairments and function, systematically
      characterize recovery patterns and examine short and long term rehabilitation outcomes. This
      project is purely observational, descriptive and non-experimental. N=273
    

Detailed description: 
      This project involves an interdisciplinary stroke database of demographic variables and
      clinical measures collected during routine acute care, inpatient rehabilitation admission and
      discharge as well as follow up questionnaires at 6 month and 12 months to examine stroke
      recovery.

      Our aim is to observe and describe the relationships between impairments and function,
      systematically characterize recovery patterns and examine short and long term rehabilitation
      outcomes.

      This project is purely observational, descriptive and non experimental. No rehabilitation
      interventions or treatment procedures are being introduced, modified or studied.
    

Intervention name(s): Observational - No intervention
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Only inpatients with a primary diagnosis of stroke who have been admitted to the inpatient
        rehabilitation unit (IRU) will be recruited for this study. Participants are medically
        stable (criteria for admission to the IRU) and have recently had a stroke.
A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2
      diabetes mellitus patients with normal renal function and those with mild or moderate renal
      impairment.
    


Intervention name(s): ASP1941
Intervention type(s): Drug
Intervention description(s): oral
Intervention MeSH terms: Ipragliflozin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Urinary glucose excretion; Diabetes mellitus; ASP1941