bioihbjkbjnl/mcl2 huggingface dataset:
Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      An open-label randomized Phase II study in order to explore two different sequential
      anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable
      breast cancer (T2-T4/N0-2/M0).
    


Intervention name(s): pemetrexed; cyclophosphamide; doxorubicin; docetaxel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4); 600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4); 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4); 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
Other intervention name(s): LY231514, Alimta
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Changes in Anatomical Landmark Locations
Condition: Anesthesia, General; Intubation
Study type: Observational

Summary: 
      This study was performed to ultrasonographically demonstrate the changes in relationship
      between the right internal jugular vein (IJV) and an anatomical landmark in two different
      head positions: neutral and rotational.
    

Detailed description: 
      Background: This study was performed to ultrasonographically demonstrate the changes in
      relationship between the right IJV and an anatomical landmark in two different head
      positions: neutral and rotational.

      Methods: One hundred patients scheduled for elective surgery under general anesthesia with
      endotracheal intubation were enrolled in this study. The patients were placed in the supine
      position with a neutral head position and without a pillow. The apex of the triangle formed
      by the sternal and clavicular heads of the sternocleidomastoid muscle and clavicle was marked
      (anatomical landmark point: AL point). The ultrasonography of the neck anatomy was performed,
      and a mark was placed at the central point of the IJV to the skin (ultrasonography point: US
      point). The other investigator measured the distances from the AL point to the US point
      (AL-US distance). The patient's head was then turned 30° to the left; the same procedure was
      repeated and the AL-US distance was again measured. The changes in AL-US distance were
      calculated.
    

Intervention name(s): head position change
Intervention type(s): Behavioral
Intervention description(s): AL-US distance measure using the ultrasound in two different head position
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled for elective surgery under general anesthesia with endotracheal
        intubation, were enrolled in the study between May 2009 and February 2010.
      
Keywords: jugular vein; anatomy; ultrasonography
Consolidation & Interference in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this research study is to investigate whether minimizing interference improves
      memory in multiple sclerosis.
    

Detailed description: 
      The ability to form new long-lasting memories is important for successful independent living
      and a high quality of life. Roughly half of the individuals diagnosed with Multiple Sclerosis
      (MS) have difficulty remembering new information and this is likely associated with poor
      acquisition of new information. There are only a limited number of studies that have
      investigated memory consolidation in MS. The current study will investigate the role of
      interference during the consolidation time period of memory formation.
    

Intervention name(s): Interference onset
Intervention type(s): Behavioral
Intervention description(s): Temporal duration of interference onset.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Memory
Subcutaneous Drains And Cesarean Section
Condition: Cesarean Section
Study type: Interventional

Summary: 
      A randomized controlled trial that aimed at studying the values (if any) of subcutaneous
      drains use in lean women during Cesarean section.
    

Detailed description: 
      Cesarean section (CS) is one of the most common operative procedures performed in modern
      obstetrics. Despite being that, common, surgical techniques and steps do widely vary. These
      variations depend on many factors including surgeons preferences, patient s characteristics
      and available facilities and circumstances .

      The most common complications of Cesarean section are superficial surgical site complications
      including sepsis, seroma formation and breakdown.

      One of the common, yet debatable, practices in Cesarean section is to use a subcutaneous
      drain for the wound .The advantage of such a practice is to drain any blood or serous fluid
      that may accumulate in the subcutaneous space, which cause post-operative pain or provide a
      good medium for microbial growth and infection.

      Thus, it is assumed that drains can reduce the burden of surgical site infection. Some
      surgeons, however, have raised much argument about the value of subcutaneous drains and
      emerging evidence raised concerns about its effectiveness. Despite this, it is evident that
      it is still widely used in the clinical practice.

      Most randomized controlled trials on this issue, from which we draw the current evidence,
      were conducted in the developed countries, mainly the United States, with readily available
      facilities and optimum level of care. This fact raises concerns about how this evidence can
      be applicable in developing countries with weak health care systems and low level of
      awareness. In addition, Cesarean section rates are greatly higher in developing countries due
      to its abuse, which emphasize how the current evidence can't be applicable and in need for
      further updates .

      The current gap between the current practice and lack of evidence has to be filled. In this
      study, investigators aim at providing answers for this critical issue, thus investigators can
      ensure women's health and provide the best quality of care following Cesarean section.
    

Intervention name(s): Subcutaneous Drain
Intervention type(s): Procedure
Intervention description(s): A closed drainage system for the subcutaneous tissue was used (Redivac) through a separate stab wound. Drains were left in place for 24 h or until drainage was less than 50 ml.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Pilot Sugar Reduction Intervention in Kiritimati Teenagers
Condition: Type 2 Diabetes; Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Kiritimati is an isolated coral atoll in the Pacific Ocean, and is one of 32 islands that
      comprise the Republic of Kiribati. Obesity and type 2 diabetes rates are high in Kiribati,
      but the causes and rates of childhood obesity/diabetes are unknown. However, it has been
      hypothesized that high consumption of sugar-sweetened beverages on Kiritimati may be a
      contributing factor. The investigators therefore conducted a study in Kiritimati in September
      2018 with the aim of 1) quantifying obesity and diabetes rates amongst children on Kiritimati
      and 2) testing the feasibility of a sugar-reduction intervention in Kiritimati schools. The
      investigators randomized the two high schools on the island to either the control group or
      the intervention group. The investigators measured height/weight, continuous blood glucose
      (using flash glucose monitoring), and diet (using 24-hour diet recalls). One week into the
      study, the intervention school received an intervention, which consisted of installation of a
      water filter at the school, the provision of water bottles to each student at the school, and
      a 30-minute educational presentation on the link between sugar consumption and type 2
      diabetes. The investigators then measured how blood glucose and diet changed the week
      following the intervention, and compared this to the control school.
    


Intervention name(s): Sugar-reduction intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention consisted of a) installation of a water filter at the school. b) each participant received a metal water bottle. c) a registered dietitian gave a 30-minute presentation on sugar reduction for the purposes of type 2 diabetes prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Memory Enhancement by Gamma-hydroxybutyrate vs. Trazodone in Major Depressive Disorder.
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      30 healthy adults and 30 patients with major depressive disorder, will take part in three
      single-application pharmacological interventions (GHB vs. Trazodone vs. placebo p.o.) to test
      potential effects of these drugs on nocturnal memory consolidation. All participants will be
      assessed with mood state questionnaires, tests of emotional, procedural and declarative
      memory consolidation, polysomnography, EEG and neuroinflammatory biomarkers. At experimental
      nights, learning tasks are performed prior to sleep. The next morning, recalling tasks are
      performed. Each subject will pass through 5 study nights (1 screening, 1 adaptation and 3
      experimental nights).
    


Intervention name(s): GHB; Trazodone; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg/kg GHB at one experimental night; 1.5 mg/kg trazodone at one experimental night; placebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon)
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Pilot Weight Control Intervention at HPHC
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to examine how adults can improve their physical activity levels
      and eating habits using an interactive web-based weight control program and regular contact
      with a dietician.
    

Detailed description: 
      -  All study participants must have regular access to the Internet, however, the study will
           not provide this access. Participants will be randomly placed in one of two study groups
           (Group 1 or Group 2).

        -  Group 1 participants will be asked to make 3 in-person visits, each lasting 75-90
           minutes. The following information will be collected: name, mailing address, telephone
           number, and email address. During the study visit, the following measurements will be
           taken: height, weight, waist circumference, blood pressure and dietary patterns.

        -  Group 1 participants will also receive counseling around diet and physical activity from
           a registered dietician and be asked to use a specialized website that will allow them to
           track eating and physical activity patterns, learn new weight management skills,
           interact with the dietician, and receive support from other participants.

        -  Group 1 will also receive 5 telephone counseling calls with a health counselor. During
           the telephone calls, we will teach the participant new skills such as tracking diet and
           physical activity, goal-setting and staying motivated.

        -  Group 2 participants will be asked to make 2 in-person visits, each lasting 75-90
           minutes in length. The following information will be collected: your name, mailing
           address, and telephone number. During the study visit, the following measurements will
           be taken: height, weight, waist circumference, blood pressure and dietary patterns.
    

Intervention name(s): Counseling Sessions; Specialized Website; Telephone Counseling Calls
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Counseling Sessions at each study visit around diet and physical activity from a registered dietician; Specialized website that allows participants to track their eating and physical activity patterns, learn new weight management skills, interact with the dietician, and receive support from other participants; 5 telephone calls with a health counselor, lasting 15-20 minutes each.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: weight control
A Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated Poliomyelitis Vaccine in Healthy Infants
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the study is to evaluate safety and immunogenicity of inactivated
      poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose
      of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.
    


Intervention name(s): Inactivated Poliomyelitis Vaccine (Sabin strain); Inactivated Poliomyelitis Vaccine (Salk strain)
Intervention type(s): Biological; Biological
Intervention description(s): Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.; Commercialized IPV based on Salk strain (Imovax Polio). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      Structured transition program for adolescents and young adults with Type 1 Diabetes (T1D)
      improves diabetes clinic attendance as well as glycemic control after transition from
      pediatric to adult diabetes care.
    

Detailed description: 
      The purpose of this study is to determine if a structured transition program for adolescents
      and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance and
      management as well as glycemic control after transition from pediatric to adult diabetes
      care.
    

Intervention name(s): Transition Coordinator
Intervention type(s): Other
Intervention description(s): The Transition Coordinator is central to the intervention and will provide ongoing contact with the medical system as well as education and clinical support where appropriate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; 17 to 20 years of age
Healthy Oils for Women (HOW Study)
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to understand the role of a dietary oil to alter chronic disease
      risk factors in women who are at risk for heart disease and/or diabetes. The investigator's
      previous study showed that safflower oil reduced trunk fat mass in women with diabetes. The
      investigators believe safflower oil can also attenuate criteria of metabolic syndrome through
      reduction in trunk fat mass.
    

Detailed description: 
      The long-term goal is to develop effective and novel dietary and lifestyle strategies to
      reduce the progression of metabolic syndrome to chronic diseases such as coronary heart
      disease. The rationale for conducting this research study is that there are few effective
      strategies that target changes in body composition and metabolism as a means to attenuate
      metabolic syndrome. The investigators plan to test the central hypothesis and accomplish the
      overall objective of this research by pursuing the following three specific aims.

      Specific Aim 1: Quantify the extent that linoleic acid reduces trunk adipose mass in women
      with metabolic syndrome.

      Specific Aim 2: Measure changes in visceral adipose tissue

      Specific Aim 3: Determine the time-dependent effect of linoleic acid to increase adiponectin
      levels.
    

Intervention name(s): High Linoleic Safflower Oil
Intervention type(s): Dietary Supplement
Intervention description(s): 2 tsp per day (~10g of oil)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safflower Oil; Linoleic Acid; Dyslipidemia; Hypertension
Carbamazepine Extended-Release for the Treatment of Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      To study the efficacy and safety of beaded extended-release Carbamazepine (Equetro) in the
      treatment of patients with Bipolar Disorder with a Major Depressive Episode.
    

Detailed description: 
      Patients with Bipolar I or II Disorder with a Major Depressive Episode who sign informed
      consent and meet eligibility criteria will begin treatment with extended release
      carbamazepine (ERC-CBZ ). The dose of ERC-CBZ will be initiated at 200mg twice daily and
      increased as tolerated by 200mg/day every 3 days up to 1200mg/day by week 2 (target dose).
      Then the dose may be increased at the investigator's discretion, up to1600mg/day as tolerated
      by week 8, if needed for a greater therapeutic response. Efficacy will be assessed biweekly
      with the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global
      Impression-Bipolar (CGI-BP). Safety is assessed biweekly with adverse events self-reports and
      laboratory evaluations. ).
    

Intervention name(s): carbamazepine ER
Intervention type(s): Drug
Intervention description(s): Active study drug, no comparator
Intervention MeSH terms: Carbamazepine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bipolar depression; carbamazepine ER; Equetro
Efficacy of Low Dose Sugammadex in Reversal of NMB in Laparoscopic Barbaric Surgery
Condition: Bariatric Patients
Study type: Interventional
Phase: Phase 3

Summary: 
      the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2,
      and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in
      laparoscopic bariatric surgery.
    

Detailed description: 
      Patients were randomly assigned using a randomization-computer program into three groups
      according to the dose of sugammadex administrated (according to the IBW after T2 of TOF):

      Group I: patients were given 1.5 mg / kg. Group II: patients were given 2 mg / kg. Group III:
      patients were given 4 mg / kg.
    

Intervention name(s): sugammadex reversal of neuromuscular blockade
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Lithium Clearance in Patients With High Risk of Acute Kidney Injury
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Observational [Patient Registry]

Summary: 
      Renal lithium clearance is hypothesized to be a useful indicator of renal tubular function.

      In this study lithium clearance will be monitored in patients with sepsis associated acute
      kidney injury and in healthy controls.
    

Detailed description: 
      Lithium is almost completely reabsorbed in the proximal tubule in parallel with sodium and
      water. What is not reabsorbed here is assumed to be fully excreted in urine, giving a
      reasonably accurate measurement of sodium reabsorption in the proximal tubule. Endogenous
      lithium clearance will be measured by inductively coupled plasma mass spectrometry (ICP-MS).
      The Gomez equations will be applied to calculate efferent arteriolar resistance, afferent
      arteriolar resistance, glomerular hydrostatic pressure, glomerular filtration pressure, and
      glomerular oncotic pressure. N-acetyl-β-D glucosaminidase (NAG) and NGAL, markers of tubular
      injury, will be measured by a spectrophotometric method using a commercially available kit.
      Routine blood and urine analyses will be performed at the Diagnostic Clinic Laboratory,
      University Hospital of North Norway, Tromsø.
    

Intervention name(s): Lithium measures
Intervention type(s): Diagnostic Test
Intervention description(s): Measurements of lithium levels in blood and urine
Intervention MeSH terms: Lithium Carbonate
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Intensive care patients and healthy controls
      
Biospecimen description: 
      Urine and blood
Clinical Trial on Acupuncture Adjuvant Treatment in the Pain After the Surgery of Gastrointestinal Carcinoma
Condition: Gastrointestinal Carcinoma; Pain
MeSH terms: Carcinoma
Study type: Interventional

Summary: 
      Clinical trial on acupuncture adjuvant treatment in the pain after the surgery of
      gastrointestinal carcinoma. Gastrointestinal cancer patients are diagnosed by pathology or
      cell biology. Patients are randomized into 2 groups: The control group receive normal
      treatment only, the experimental group receive acupuncture therapy besides normal treatment.
      Clinical evaluation is based on the observation of the pain degree and life quality
      improvement. Blood biochemistry tests mainly include Prostaglandin
      E2(PGE2),5-hydroxytryptamine(5-HT), histamine(HIS), malondialdehyde (MDA), superoxide
      dismutase (SOD), glutathione peroxidase (GSH-Px), adrenaline, nor-adrenaline, tumor necrosis
      factor (TNF)-α, cell flow cytometry on Th1, Th2, Th17, Treg cytokines as well as serum
      cortisol, estradiol (female), progesterone (female), testosterone (male) etc.
    


Intervention name(s): Acupuncture therapy; Laparoscopic Surgery
Intervention type(s): Device; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acupuncture Therapy; Pain degree after surgery
Study to Assess the Distribution, Metabolism and Excretion of [14C]AZD6765 After a Single-Dose Intravenous Administration
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to assess the distribution, metabolism and excretion of [14C]AZD6765 after a
      single-dose intravenous administration.
    


Intervention name(s): 150 mg [14C] AZD6765
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Major depression disorder