bioihbjkbjnl/mcl2 huggingface dataset:
Two Different Approaches During Fluoroscopically Guided Interlaminar Lumbar Epidural Steroid Injection
Condition: Unilateral Lumbosacral Radiculopathy Pain
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      The purpose of this study is to compare two different approaches (midline and parasagittal)
      during interlaminar lumbar epidural steroid injection (LESI), and to verify the role of
      concordant pressure paresthesia occurring during the LESI in determining outcome.

      The investigators are planning to include 100 patients, undergoing LESI for radicular low
      back pain. This will be single-blinded randomized study. Every patient will receive the same
      medication we would use regardless of participating in the study. The patients will be
      randomly assigned to one of two groups, based on the approach:

        -  Group I (50 patients) - will get LESI using midline (MIL) approach.

        -  Group II (50 patients) - will get LESI using parasagittal interlaminar (PIL) approach.
    


Intervention name(s): Midline vs Parasagittal Lumbar Epidural Steroid Injection
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Comparison of the OSHO Protocol to a Standard Arm Protocol of the German AML Intergroup in Patients With AML>60a
Condition: Acute Myeloid Leukaemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Improvement of the treatment-results in elderly patients with acute myeloid leukemia through
      intensification of consolidation chemotherapy and/or allografting as consolidative
      immunotherapy
    

Detailed description: 
      Measuring EFS depending on induction therapy
    

Intervention name(s): Cytarabine; human stem cells
Intervention type(s): Drug; Biological
Intervention description(s): Induction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5.; Induction chemotherapy (1 or 2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5+7, Mitoxantrone 10 mg/m² day 1-3 and Pegfilgrastim 6 mg s.c. day 10. Consolidation chemotherapy (1 course): AraC 500 mg/m² i.v. 1h-infusion a 12h day 1+3+5, Mitoxantrone 10 mg/m² day 1+2 and Pegfilgrastim 6 mg s.c. day 8. Allogeneic stem cell transplantation using reduced intensity conditioning: Fludarabine 30 mg/m² day -4 - -2, TBI 200 cGy day 0; GvHD prophylaxis: cyclosporine A and mofetil mycofenolate
Other intervention name(s): AraC
Intervention MeSH terms: Cytarabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML
Study of Single and Multiple Doses of PRS-220 Administered by Oral Inhalation in Healthy Subjects
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      A dose escalating study of PRS-220 administered by oral inhalation in healthy subjects
    

Detailed description: 
      PRS-220 is a new drug being developed for treatment of idiopathic pulmonary fibrosis (IPF).
      The main purpose of this study is to investigate the safety, tolerability, pharmacokinetics,
      and immunogenicity of single and multiple ascending doses of PRS-220 in healthy subjects.
    

Intervention name(s): Placebo; PRS-220
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; formulated as solution for inhalation without active substance.; PRS-220; formulated as solution for inhalation.
Other intervention name(s): Control; Active
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a phase 1, dose escalating study to assess safety, tolerability, and PK of single and multiple doses of PRS-220 administered by oral inhalation to healthy male and female subjects. This study will be conducted utilizing a blinded, randomized, dose-escalating design.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Idiopathic pulmonary fibrosis (IPF); Anticalin; PRS-220; Healthy Volunteers; Pieris; CTGF
Comparative Effectiveness and Cost-effectiveness of Chuna Manual Therapy for Chronic Neck Pain
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      A multi-center randomized controlled trial assessing the comparative effectiveness and
      cost-effectiveness of Chuna manual therapy for chronic neck pain
    

Detailed description: 
      A multi-center randomized controlled, parallel, assessor-blinded trial will be conducted to
      evaluate the comparative clinical effectiveness and cost-effectiveness of Chuna manual
      therapy for chronic neck pain patients compared to usual care as assessed using pain,
      functional disability, health-related quality of life, economic evaluation, and safety
      measures.
    

Intervention name(s): Chuna manual therapy; Conventional medication; Physical therapy
Intervention type(s): Procedure; Drug; Procedure
Intervention description(s): Chuna is a Korean manual therapy that has absorbed and incorporated aspects of osteopathic manipulative medicine. Chuna manual therapy utilizes spinal manipulation techniques for joint mobilization including high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement, muscle energy, and fascial techniques.; Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics.; Physical therapy will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics.
Other intervention name(s): Chuna manipulation; Conventional medicine; Conventional drugs; Physiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
High Versus Normal Protein Diet in Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objective of this study is to assess the effects of a high protein (HP) and a normal
      protein diet (NP) on patients with polycystic ovary syndrome (PCOS) and body mass index
      (BMI)-matched controls in a sample of southern Brazilian women.

      Patients will be randomized to receive high protein (30% protein, 40% carbohydrate, 30%
      lipid) or normal protein (15% protein, 55% carbohydrate, 30% lipid) during eight weeks.

      The investigators hypothesis is that a different diet composition may have influences in
      changes of the main characteristics of PCOS, like hyperandrogenism and metabolic syndrome.
    


Intervention name(s): High protein diet; Normal protein diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): High protein diet (30% protein, 40% carbohydrate, 30% lipid); Normal protein diet (15% protein, 55% carbohydrate, 30% lipid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; High protein diet
An Observational Study of People Who Have Recently Been Infected With HIV
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      This is a long-term follow-up study of people who are identified during acute or recent HIV
      infection and are being followed at clinical research sites associated with the Acute HIV
      Infection and Early Disease Research Program (AIEDRP). The purpose of this study is to
      collect data on the immunological and virologic responses that occur early in the course of
      HIV infection in treatment-naive and treatment-experienced HIV infected adults.

      Study hypothesis: This study will examine the immunological responses that occur early in the
      course of HIV infection in treated and untreated individuals. The long-term follow-up of
      these subjects will help identify host immunological and genetic factors along with
      therapeutic strategies associated with control of viremia and delayed disease progression. In
      addition, this cohort will provide the recruiting mechanism to support future trials of
      therapy to restore immune function. Furthermore, this cohort will provide a population
      suitable to monitoring changing patterns in the transmission of drug resistant viral strains
      while also evaluating ongoing behavioral risk factors associated with HIV transmission.
    

Detailed description: 
      This study will collect data on the immunological and virologic responses that occur early in
      the course of HIV infection in treated and untreated HIV infected adults to identify host
      immunological, virological, and therapeutic factors that influence disease progression. This
      study will also monitor changing patterns in the transmission of drug-resistant viral strains
      and evaluate ongoing behavioral risk factors associated with HIV infection.

      Participants in this study will be followed for up to 10 years. During the first year of
      participation, study visits will occur approximately every 4 weeks for the first 12 weeks,
      then every 12 weeks thereafter, with a minimum of 8 study visits during the first year.
      Participants will be asked to complete a behavioral questionnaire at Week 8. After the first
      year of participation, there will be 4 visits per year. Blood collection and vital sign
      measurement will occur at each study visit.

      Participants enrolled in this study are strongly encouraged to also enroll in the AIEDRP
      CORE01 study.
    

Intervention name(s): Questionnaire
Intervention type(s): Behavioral
Intervention description(s): A behavioral questionnaire will occur at Week 8
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Treatment-naive and treatment-experienced HIV-infected adults
      
Biospecimen description: 
      Blood collection
    
Keywords: Acute Infection; HIV; AIDS; Acute HIV; Early HIV
Effects of Vasopressor on the Graft Blood Flow in TRAM
Condition: Blood Flow; Anastomotic Failure of Flap; Flap Necrosis; Flap Ischemia
MeSH terms: Ischemia; Necrosis
Study type: Interventional

Summary: 
      The purpose of this pilot study is to investigate whether two major vasopressors
      (norepinephrine vs. phenylephrine) used for treatment of hypotension during breast
      reconstruction with free flap transfer surgery have different effects on blood flow of the
      flap vessel measured by transit time flowmetry. Since there are few prior studies that
      compared the effects of these two vasopressors on the blood flow of the flap, this study will
      be conducted in the form of a pilot study in order to establish the evidence for the future
      randomized controlled trial.
    


Intervention name(s): Norepinephrine; Phenylephrine
Intervention type(s): Drug; Drug
Intervention description(s): Continuous drug: norepinephrine 4mg * 1@ + D5W 200 mL (20 μg/mL)
Range: 0.03 ~ 0.09 μg/kg/min (= 0.1 ~ 0.3 mL/kg/h); Continuous drug: phenylephrine 10mg * 5@ + D5W 200 mL (250 μg/mL)
Range: 0.42 ~ 1.26 μg/kg/min (= 0.1 ~ 0.3 mL/kg/h)
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blood flow; Failure of Flap; Vasopressor; Phenylephrine; Norepinephrine
LY2189265 and Atorvastatin Interaction Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess if giving LY2189265 at the same time as atorvastatin affects how the
      body absorbs atorvastatin.
    


Intervention name(s): Atorvastatin; LY2189265
Intervention type(s): Drug; Biological
Intervention description(s): Administered orally.; Administered subcutaneously.
Intervention MeSH terms: Dulaglutide; Atorvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Characterize the Pharmacokinetics of DA-8031 in Healthy Male Subjects
Condition: Premature Ejaculatory Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose block-randomized, double-blind, placebo-controlled, single/multiple dosing,
      dose-escalation study. The study is designed to describe the relationship between multiple
      doses and pharmacokinetic parameters of DA-8031 as well as safety profile.
    


Intervention name(s): DA-8031; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males (MK-0000-170)
Condition: Healthy; Overweight; Obesity
MeSH terms: Overweight; Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate whether 30 mg of pioglitazone administered once
      daily for up to 28 days to healthy overweight and obese subjects will lead to a significant
      change in insulin sensitivity, measured in the setting of a hyperinsulinemic euglycemic clamp
    


Intervention name(s): Placebo; Comparator: Pioglitazone; Comparator: Hyperinsulinemic Euglycemic Clamp
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo (to match pioglitazone 30 mg) once daily; Pioglitazone 30 mg once daily; Infusion of Glucose (20% dextrose) to achieve a glucose concentration of 90mg/dL; Infusion of Insulin at a rate of 10 mU/m2/minute from 0 to 180 minutes and at a rate of 40 mU/m2/minute from 180 to 360 minutes; Saline infusion at 60 minutes before the insulin and glucose infusions to keep the antecubital vein open.
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Volunteers
Preliminary Study of Fish Oil and Dementia
Condition: Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This preliminary study is aimed to investigate whether it is feasible to conduct a study to
      use fish oil compared to the placebo(olive oil) in people with cognitive impairment. We will
      also explore whether fish oil has better efficacy in some clinical aspects in people with
      cognitive impairment during 24 weeks intervention. The major clinical outcome will be:

        1. general clinical impression

        2. cognitive function
    

Detailed description: 
      Despite some positive findings from observational and animal studies, the effects of n-3 PUFA
      administration on cognitive impairment in humans have received little evaluation to date.
      Although some clinical trials of fish oil have been reported, the results are inconsistent.
      Given these inconsistent findings, we carried out a preliminary study to investigate the
      effect of fish oil monotherapy on cognitive function and general clinical condition in
      patients with cognitive impairment.
    

Intervention name(s): omega-3 polyunsaturated fatty acids ( EPA+DHA)
Intervention type(s): Dietary Supplement
Intervention description(s): Group 1 received omega-3 PUFAs as 3 capsules twice daily (total daily omega-3 fatty acid dosage of 1080 mg of EPA and 720 mg of DHA). Group 2 received three identical placebo capsules twice daily which contained olive oil esters. Identical gelatin capsules were used. Both treatment and placebo capsules were vacuum deodorized and supplemented with tertiary-butyl hydroquinone, 0.2 mg/g, and tocopherols, 2 mg/g, as antioxidants. The source of the omega-3 fatty acids was menhaden fish body oil concentrate.
Other intervention name(s): fish oil; n3 fatty acids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: polyunsaturated fatty acids; Alzheimer's disease; mild cognitive impairment; fish oil; cognition
Impact of Low Dose Unfractionated Heparin Treatment on Inflammation in Sepsis
Condition: Severe Sepsis With Septic Shock; Severe Sepsis Without Septic Shock
MeSH terms: Sepsis; Toxemia; Shock, Septic; Inflammation; Shock
Study type: Interventional
Phase: Phase 3

Summary: 
      Sepsis is a clinical syndrome which infection trigger systemic inflammatory response.
      Uncontrolled inflammatory process leads to multiple organ dysfunction and cause early
      mortality in severe sepsis. Unfractionated heparin is an anticoagulant that widely used
      either for DVT prophylaxis or treatment of disseminated intravascular coagulation. Heparin
      also have an anti-inflammatory effect through downregulates nuclear factor kappa B and tumor
      necrosis factor alpha.

      Aim of this study is to determine effects of low dose unfractionated heparin treatment on
      inflammation in severe sepsis patient.
    


Intervention name(s): Unfractionated heparin
Intervention type(s): Drug
Intervention description(s): 10 unit/kgBW/hour continuous infusion for 72 hours
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heparin; sepsis; inflammation
Varenicline for Gait and Balance Impairment in Parkinson Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if varenicline is effective in improving gait and
      balance impairment in patients with Parkinson disease.
    

Detailed description: 
      Parkinson disease (PD) is a clinical entity characterized by bradykinesia, rigidity, tremor,
      and postural instability. Current treatments primarily focus on replacement of dopamine to
      compensate for the degeneration of the substantia nigra pars compacta dopaminergic neuronal
      population. Though dopamine treats many of the motor symptoms of PD, postural instability
      (which often leads to falls) typically is least responsive to therapy. More recently, the
      degeneration of the cholinergic system arising from the pedunculopontine nucleus (PPN) in the
      brainstem has been implicated in gait dysfunction in PD. Striatal cholinergic inputs are
      supplied from the PPN both via the intralaminar complex of the thalamus and through direct
      inputs. The primary subtypes of cholinergic receptors present in the striatum are nicotinic
      and include α4β2, α6β2, and α7 receptors. Varenicline (Chantix) is a novel partial α4β2
      agonist and full α7 agonist developed as an aid for smoking cessation and has been shown in
      initial studies to improve imbalance in patients with inherited spinocerebellar ataxia. The
      unique method of action of varenicline may make it an ideal drug for the treatment of balance
      impairment in PD.
    

Intervention name(s): Varenicline; Sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): Varenicline 1mg twice daily for eight weeks after a one week dose escalation period.; 1mg twice daily for eight weeks after a one week dose escalation phase.
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Balance; Postural impairment; Falls; Parkinson Disease
Laparoscopic Sentinel Node Navigation Surgery for Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      There are few reports on a dual dye and isotope approach using laparoscopy in gastric cancer
      sentinel node mapping.

      The aim of this study was to evaluate the feasibility of laparoscopic limited gastrectomy
      with sentinel basin(SB) dissection for gastric cancer using simultaneous indocyanine green
      (ICG) and 99mTc-antimony sulfur colloid (ASC) injections.
    

Detailed description: 
      Prospective phase II clinical trials for sentinel node navigation surgery(SNNS) in early
      gastric cancer.

      Laparoscopic SNNS:

        1. ICG and 99mTc-antimony sulfur colloid (ASC) submucosal injection under intraoperative
           endoscopy

        2. Sentinel node basin identification and dissection

        3. Sentinel nodes picking in back table

        4. Frozen biopsy of sentinel nodes(hematoxylin and eosin staining and immunohistochemistry
           for cytokeratin)

        5. If the sentinel node biopsy by frozen section is negative, limited gastrectomy will be
           performed or if positive, radical D2 gastrectomy will be performed.

      Sample size: 100 cases

      Study duration: 5 years( 2year enrollment, 3 year follow-up)
    

Intervention name(s): Laparoscopic sentinel node navigation surgery
Intervention type(s): Procedure
Intervention description(s): Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastric cancer; Sentinel node navigation surgery; Dual method; Recurrence