bioihbjkbjnl/mcl2 huggingface dataset:
Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining chemotherapy with autologous bone marrow transplantation
      or peripheral stem cell transplantation may allow the doctor to give higher doses of
      chemotherapy drugs and kill more tumor cells.

      PURPOSE: Randomized phase III trial to compare bone marrow transplantation with peripheral
      stem cell transplantation following carboplatin in treating patients with breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare engraftment rates using G-CSF primed autologous bone marrow vs PBCP as
      hematopoietic support following high dose CTCb for patients with poor prognosis breast
      cancer. II. Compare the complications of these two methods of hematopoietic progenitor cell
      collections. III. Compare Stage IV patients with bone or bone marrow involvement (assigned to
      PBPC collections) with Stage IV patients randomized to PBPC collections relative to the
      number of leukaphereses needed to collect the required number of progenitor cells as well as
      assess engraftment rates between these two groups. IV. Assess the response to high dose CTCb
      in this group of patients.

      OUTLINE: All patients will receive G-CSF priming therapy for 5 consecutive days. Patients
      will then be randomized into two treatment arms: Arm 1 consists of autologous PBPC collection
      Arm 2 consists of autologous bone marrow collection Within 2 weeks after progenitor cell
      collection, all patients will receive high dose CTCb therapy by continuous infusion for 5
      days, followed by autologous hematopoietic progenitor cell infusion at least three days
      later. G-CSF will also be given after infusion until ANC count is over 5,000 or over 1,000
      for 3 consecutive days.

      PROJECTED ACCRUAL: 66 patients will be accrued at a rate of 24 per year.
    

Intervention name(s): autologous bone marrow transplantation; peripheral blood stem cell transplantation
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; stage IIIB breast cancer
Pharmacokinetic, Pharmacodynamic and Tolerability Study of Otamixaban in Patients With Mild, Moderate and Severe Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

        -  To study effect of mild, moderate and severe renal impairment on the pharmacokinetics of
           Otamixaban.

      Secondary Objective:

        -  To assess the pharmacodynamic effects of Otamixaban on subjects with mild, moderate and
           severe renal impairment and in matched subjects with normal renal function.
    

Detailed description: 
      The study period for one subject is broken down as follows:

        -  2 to 28 days of screening,

        -  1 day of treatment,

        -  8 to 11 days of follow-up after start of infusion.

      There are 5 days in the unit starting the day before the start of infusion.
    

Intervention name(s): OTAMIXABAN (XRP0673)
Intervention type(s): Drug
Intervention description(s): Form: solution for injection
Route: intravenous
Intervention MeSH terms: Otamixaban
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational [Patient Registry]

Summary: 
      The aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and
      radiology methods in patients with chronic hepatitis B in mainland China.
    

Detailed description: 
      Up to Nov, 2015, total of 818 patients with chronic HBV infection had been enrolled in the
      study. Paired blood and liver biopsy specimen had been collected. The serum samples stored at
      -80 degree Celsius. All the liver biopsy samples were judged by three pathology experts,
      according to Ishak standard.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with chronic hepatitis B or compensated cirrhosis due to chronic hepatits B virus
        (HBV) infection
      
Biospecimen description: 
      liver biopsy samples and blood samples
Colchicine in Coronary Artery Bypass Graft (CABG)
Condition: Elective Coronary Artery Bypass Graft Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      There is evidence that inflammatory processes may play a key role during surgical myocardial
      reperfusion. The hypothesis of this study is that colchicine, an anti-inflammatory agent, may
      lead to reduction in periprocedural infarct size, when administered during elective coronary
      artery bypass graft surgery.
    


Intervention name(s): Colchicine
Intervention type(s): Drug
Intervention description(s): colchicine p.os 0.5 mg bid for two days before undergoing elective CABG surgery and eight days after the operation
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: reperfusion damage
Conservative Treatment and Ultrasound Guided Injection for Treatment Meralgia Paresthetica
Condition: Meralgia Paresthetica
MeSH terms: Femoral Neuropathy
Study type: Interventional

Summary: 
      Meralgia paresthetica (MP) is an entrapment mononeuropathy of the lateral femoral cutaneous
      nerve (LFCN), where conservative treatment options are not always sufficient.

      The aim of this study was to evaluate the efficacy of ultrasound (US) guided lateral femoral
      cutaneous nerve injection in the management of meralgia paresthetica by comparing with
      transcutaneous electrical nerve stimulation (TENS) therapy and sham transcutaneous electrical
      nerve stimulation therapy.
    

Detailed description: 
      In this prospective, randomized, sham-controlled study, fifty four patients (23 female and 31
      male, the mean age 53.61±11.99 years) with lateral femoral cutaneous nerve compression with
      clinical and electrophysiological findings were enrolled. Patients were randomly assigned to
      three groups: 1) Ultrasound-guided injection group, 2) TENS group, 3) Sham TENS group. The
      blockage of the lateral femoral cutaneous nerve was performed for therapeutic meralgia
      paresthetica management in group 1. Ten sessions of conventional TENS were administered to
      each patient 5 days a week for 2 weeks, for 20 minutes per daily session in Group 2, and sham
      TENS was applied to group 3 with the same protocol.

      Visual Analog Scale (VAS), painDETECT questionnaire (PD-Q), Semmes Weinstein monofilament
      test (SWMt), Pittsburgh Sleep Quality Index (PSQI) and health-related quality of life (SF
      36), at onset (T1), 15 days after treatment (T2) and 1 month after treatment (T3) were used
      for evaluation.
    

Intervention name(s): Ultrasound guided injection; Transcutaneous Electrical Nerve Stimulation (TENS); Sham Transcutaneous Electrical Nerve Stimulation (TENS)
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meralgia paresthetica; Ultrasound-guided injection; Transcutaneous electrical nerve stimulation
The Effect of Antecedent Hypoglycaemia on β2-adrenergic Sensitivity
Condition: Diabetes; Hypoglycemia Unawareness
MeSH terms: Unconsciousness; Hypoglycemia
Study type: Interventional

Summary: 
      Hypoglycaemia unawareness is a common complication in patients with type 1 diabetes and with
      insulin-treated type 2 diabetes of long duration. The loss of autonomic symptoms to
      hypoglycemia does not solely depend on loss of adrenaline responses.Differences in
      sensitivity to catecholamines may also be involved.

      Reconciling the data on β2-adrenergic receptor polymorphism to those on loss of β-adrenergic
      sensitivity in diabetic patients with hypoglycemia unawareness, we hypothesize that
      hypoglycemia unawareness is at least partly the result of desensitization of the
      β2-adrenergic receptor and that patients who are homozygous for arginine at codon 16 are
      particularly susceptible for this desensitization process, whereas patients who are
      homozygous for glycine at codon 16 are resistant for desensitization.

      Objectives

        1. To determine whether, and if so to what extent, antecedent hypoglycemia reduces
           β2-adrenergic sensitivity in healthy subjects with Arg16 homozygosity.

        2. To investigate whether or not healthy subjects with Gly16 homozygosity are resistant to
           desensitization

        3. To confirm that antecedent hypoglycemia reduces the heart rate response to isoproterenol
           and to assess to what extent this reduced response is mediated by impairments in
           baroreflex sensitivity.
    


Intervention name(s): Hypoglycemia
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Hypoglycemia unawareness; Diabetes; adrenal receptor; adrenerg respons; adrenergic beta-agonists; salbutamol
End-range Mobilization on Time Curve of Pressure Pain Threshold
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Pain in knee osteoarthritis (OA) represents increased pain intensity due to peripheral and
      central sensitivity. Pressure pain threshold (PPT) is a widely applied technique for
      measuring the magnitude of peripheral and central sensitivity in knee OA. Despite several
      manual therapy techniques has been proven to increase PPT in knee OA, the effect of end-range
      mobilization on the time curve of PPT has not been evaluated so far in knee OA. The aim of
      this study was to investigate the effect of end-range mobilization on the time curve of PPT
      and some function-related measures in knee OA.
    

Detailed description: 
      Knee osteoarthritis (OA) is the most common form of arthritis leading to a major disability
      worldwide. Although many mechanisms may contribute to knee pain severity, the
      patient-reported hyperalgesia can be attributed to peripheral and central sensitivity in knee
      OA. Amongst quantitative sensory testing methods, pressure pain threshold (PPT) measurement
      is a simple and commonly applied method for measuring somatosensory function in
      musculoskeletal disorders, just as in knee OA. Many trials have presented lower PPT in knee
      OA compared to healthy controls underlining the presence of peripheral and central
      sensitivity.

      The different joint-based mobilization techniques may not only alleviate pain, but also
      increase pain tolerance to the locally applied mechanical pressure. Positive results of these
      techniques on increase of PPT has been reported in knee OA; however, the time curve of PPT
      has not evaluated so far in knee OA. Therefore, the aim of this study was to investigate the
      effect of end-range mobilization on the time curve of PPT and some function-related measures
      in knee OA.
    

Intervention name(s): End-range mobilization; Non end-range mobilization; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension; Non end-range mobilization performed in tibiofemoral joints' loose position; Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Musculoskeletal Manipulations; Osteoarthritis, Knee; Pain Threshold
Comparison of the Efficacy and Tolerability of T1210 and Olopatadine Hydrochloride 0.1% in the Treatment of Seasonal Allergic Conjunctivitis
Condition: Seasonal Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to compare the efficacy and the safety of T1210 versus Olopatadine
      eye drops in the topical treatment of seasonal allergic conjunctivitis.
    


Intervention name(s): T1210; Olopatadine hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 2 drops T1210 once a day; 2 drops once a day Olopatadine
Intervention MeSH terms: Olopatadine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Melatonin Supplementation in Postmenopausal Women With H. Pylori-associated Dyspepsia
Condition: Melatonin Deficiency
MeSH terms: Dyspepsia
Study type: Interventional

Summary: 
      Background: The aim of the study was to assess the role of melatonin in chronic dyspepsia in
      this group of women, with consideration of Helicobacter infection. Methods: The study
      comprised 152 subjects Including 30 healthy women (group I), 60 women with asymptomatic
      H.pylori infection (group II), and 64 women H. pylori infected with chronic dyspepsia(group
      III). Endoscopic examination, histological assessment of gastric end duodenal mucosa, urease
      breath test(UBT-13C), and serum levels of 17-β-estradiol, follicle stimulating hormone,
      melatonin and urinary concentration of 6-sulfatoxymelatonin were determined by
      immunoenzymatic method. In group III - 14-day antibacterial treatment was introduced with
      pantoprazole, amoxicillin and levofloxacin. Afterward, in 32 women was administered
      placebo(group IIIa), and in 32 women (group IIIb) melatonin at a dose 1 m/morning and 3 mg/at
      bedtime, for six months.
    

Detailed description: 
      Background:Dyspeptic syndrome in the form of epigastric pain are particularly frequent in
      postmenopausal women. The aim of the study was to assess the role of melatonin in chronic
      dyspepsia in this group of women, with consideration of Helicobacter infection. Methods: The
      study comprised 152 subjects Including 30 healthy women (group I), 60 women with asymptomatic
      H.pylori infection (group II), and 64 women H. pylori infected with chronic dyspepsia(group
      III). Endoscopic examination, histological assessment of gastric end duodenal mucosa, urease
      breath test(UBT-13C), and serum levels of 17-β-estradiol, follicle stimulating hormone,
      melatonin and urinary concentration of 6-sulfatoxymelatonin were determined by
      immunoenzymatic method. In group III - 14-day antibacterial treatment was introduced with
      pantoprazole, amoxicillin and levofloxacin. Afterward, in 32 women was administered
      placebo(group IIIa), and in 32 women (group IIIb) melatonin at a dose 1 m/morning and 3 mg/at
      bedtime, for six months.
    

Intervention name(s): Melatonin; placebo; Pantoprazole 40mg; Amoxicillin; Levofloxacin 500mg
Intervention type(s): Drug; Other; Drug; Drug; Drug
Intervention description(s): pantoprazole 2 x 40mg; Amoxicillin 2 x 1000mg; Levofloxacin 2 x 500mg
Other intervention name(s): Pantoprazole; Amoxycillin; Levofloxacin
Intervention MeSH terms: Amoxicillin; Levofloxacin; Ofloxacin; Melatonin; Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Sexually Active Adolescent Focused Education
Condition: Health Risk Behaviors
Study type: Interventional

Summary: 
      SAAFE will be pilot tested in 2 geographically distinct areas (Washington, DC and Deep South)
      with 100 participants from each site to 1) primarily assess the efficacy of improved
      self-efficacy, knowledge about HIV/STIs and perception of sexual risks by AAAs, and (2)
      secondarily detect intention to be tested for STIs and to change sexual risk behavior (i.e.,
      use a condom).
    

Detailed description: 
      A total of 200 African American adolescents (AAA) males and females will be recruited from
      Washington, DC (n=100) and Birmingham, Alabama (n=100). At both data collection sites,
      participants will be randomly assigned to one of two groups during the pilot. The two groups
      are:

        1. Intervention group (n=100) - will consist of 50 AAA males / 50 AAA females randomly
           selected participants who will receive a download of the SAAFE game and play for at
           least 30 minutes and as long as an hour, if desired.

        2. Control group (n=100) - will consist of 50 AAA males / 50 AAA females randomly selected
           participants. This group will receive dating sim game (called Choices). They will also
           receive pamphlets that provide information on the testing location and care if they have
           HIV/STI.
    

Intervention name(s): SAAFE; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): After completing the pre-game assessment, participants will be asked to play the SAAFE game for at least 30 minutes and up to 1 hour . At the conclusion of the game, participants will be provided with a post-game assessment about their perception of risk, knowledge of specific protective behaviors, and whether they plan to change behaviors.; This group will receive dating sim game (called Choices). They will also receive pamphlets that provide information on the testing location and care if they have HIV/STI.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Mobile dating simulation game; Sexual education; HIV; STI; Consent
Atrial Fibrillation Stratification Based on the Arrhythmia Perpetuation Mechanisms
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Atrial fibrillation treatments have a limited efficacy and often cause long-term side
      effects. This study aims to develop and validate an ECGI system to risk stratification in
      patients with persistent AF, identifying the mechanisms responsible for the maintenance and
      the best treatment for ending it.
    

Detailed description: 
      The MAIN GOAL of this project is to clinically validate the technology for the noninvasive
      identification of the mechanisms responsible for maintenance of AF using ECGI. To achieve
      this goal, the investigators will analyze the efficacy of different treatment options in
      persistent AF patients as a function of the results of the ECGI. Mainly, patients will be
      evaluated attending to the complexity of the patterns obtained. Moreover, the investigators
      will evaluate the treatment benefit of performing guided-ablation in conjunction with
      pulmonary vein isolation as compared to pulmonary vein isolation only. These analyses will be
      performed in patients with persistent AF arriving at the clinic to determine treatment
      options. AF outcomes following the treatment assigned therapy will be evaluated at 6 months
      and 1 year after.

      These parameters are obtained from the ECGI map: histogram of rotors (number of rotors and
      location), Highest and Lowest Dominant Frequency (Hz), rotor duration (ms), simultaneous
      rotors (number of rotors) and signal entropy (normalized).

      Wide antrum circumferential pulmonary vein isolation with demonstration of bidirectional
      block will be performed using standard cooled-tip radiofrequency catheters or cryoballoon
      catheters.
    

Intervention name(s): diagnostic strategy using ECGI
Intervention type(s): Other
Intervention description(s): Procedure: Drug treatment, CVE, Pulmonary vein ablation isolation according to treatment guidelines and investigators discretion.
ECGI: customized body surface mapping (57 electrodes) at the inclusion in the study, after treatment assignment and prior to AF ablation procedure.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        AF patients manifesting atrial fibrillation at the AF clinic
Vitamin D Metabolism in Patients With Endocrine Disorders
Condition: Pituitary ACTH Hypersecretion; Acromegaly; Diabetes Mellitus, Type 1; Primary Hyperparathyroidism
MeSH terms: Acromegaly; Pituitary ACTH Hypersecretion; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hyperparathyroidism; Hyperparathyroidism, Primary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This prospective controlled interventional study aims to reveal the diversity of vitamin D
      metabolism in patients with certain endocrine disorders (Cushing's disease, acromegaly,
      primary hyperparathyroidism, diabetes mellitus type 1) compared to healthy adults. All
      patients will receive a single dose (150,000 IU) of cholecalciferol aqueous solution orally.
      Laboratory assessments including serum vitamin D metabolites (25(OH)D3, 25(OH)D2,
      1,25(OH)2D3, 3-epi-25(OH)D3, 24,25(OH)2D3 and D3), free 25(OH)D, vitamin D-binding protein
      (DBP) and parathyroid hormone (PTH) as well as serum and urine biochemical parameters will be
      performed before the intake and on Days 1, 3 and 7 after the administration.
    


Intervention name(s): Cholecalciferol 15000 UNT/ML Oral Solution
Intervention type(s): Drug
Intervention description(s): A single dose (150,000 IU) of cholecalciferol aqueous solution per os
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Vitamin D; Vitamin D deficiency; Chromatography, Liquid; Tandem Mass Spectrometry; Cholecalciferol