bioihbjkbjnl/mcl2 huggingface dataset:
Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)
Condition: Rectal Neoplasms
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the of international standard operation, mesorectal
      excision (ME alone) compared to Japanese standard operation, ME with lateral lymph node
      dissection for clinical stage II, III lower rectal cancer
    

Detailed description: 
      Total mesorectal excision (TME) or mesorectal excision (ME) with lateral lymph node
      dissection for advanced rectal cancer is widely performed in Japan. In other countries, TME
      or ME without lateral lymph node dissection is the standard. In order to determine which is
      the better rectal cancer surgery, relapse-free survivals of these are compared as the primary
      endpoint.
    

Intervention name(s): Mesorectal excision with lateral lymph node dissection; Mesorectal excision without lateral lymph node excision
Intervention type(s): Procedure; Procedure
Intervention description(s): Mesorectal excision with lateral lymph node dissection; Mesorectal excision without lateral lymph node excision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rectal Cancer; Lymph Node Dissection; Rectal Surgery; Autonomic Nerves; Stage II, III lower rectal cancer
Fixed Versus Flexible Dosing of Pregabalin in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      A 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week
      baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg BID for
      one week and increased to 150 mg BID for 7 weeks or flexibly dosed pregabalin given BID
      (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4
      weeks.It is proposed that use of flexible dosing combined with nightly dosing would have
      similar pain relief to fixed dosing, would improve adherence, would have less side effects
      and would be more likely to improve sleep.
    


Intervention name(s): Pregabalin
Intervention type(s): Drug
Intervention description(s): Fixed dosing of pregabalin: Week 1: 75 mg bid. Weeks 2 - 8: 150 mg bid. Week 9 (Days 57-60 and Days 61-63): 75 mg bid.
Flexible dosing of pregabalin: Week 1: placebo in the AM and 75 mg nightly; Week 2: placebo in the AM and 150 mg nightly.; Week 3 placebo in the a.m., 225 mg nightly; Weeks 4 - 8 placebo in the a.m., 300 mg nightly. Week 9 (Days 57-60) placebo in the a.m,, 150 mg bid nightly and Days 61-63: placebo in the a.m., and 75 mg bid nightly.
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: fibromyalgia; lyrica; pregabalin
Pazopanib in Advanced and Cisplatin-resistant Germ Cell Tumors
Condition: Germ Cell Tumors; Measurable Disease
MeSH terms: Neoplasms, Germ Cell and Embryonal
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label, single arm, single center, phase 2 study with the use of the
      antiangiogenic multikinase inhibitor pazopanib in a population of patients with germ cell
      tumors who are not cured following first or subsequent chemotherapy lines for metastatic
      disease, followed by eventual surgery.
    


Intervention name(s): Pazopanib
Intervention type(s): Drug
Other intervention name(s): Votrient
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Testicular Cancer; Germ Cell Tumors; Salvage Therapy; Pazopanib
Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity
Condition: Immunity
Study type: Interventional

Summary: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Cauliflower Mushroom extract on promotion of
      immunity. The investigators measured promotion of immunity parameters , including
      Cytotoxicity, Cytokine (IL-4, IL-10, IFN- γ, TNF-α), and CBC (WBC, RBC, Hb, Hct, MCV, MCH,
      MCHC, PLT), and monitored their blood pressure.
    


Intervention name(s): Cauliflower Mushroom extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Cauliflower Mushroom extract (1g/day); Placebo (1g/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Cauliflower Mushroom extract; immunity
A Naturalistic Study Investigating Sleep and Cognitive Learning in Children With and Without Tic Disorders
Condition: Tic Disorders
MeSH terms: Tics; Tic Disorders
Study type: Observational

Summary: 
      This study will explore the relationship between sleep, learning, cognition, mood and
      behaviour in children with Tic Disorders (Tourette Syndrome and Chronic Tic Disorder)
      compared to typically developing peers.
    

Detailed description: 
      This project explores the relationship between sleep and learning in childhood with tic
      disorders, such as Tourette syndrome (TS) and chronic tic disorders (CTD).

      TS/CTD are movement disorders characterized by repetitive involuntary movements and/or
      vocalizations called tics. Sleep related problems are commonly reported for children with
      TS/CTD and may include problems getting to sleep, waking up frequently during the night,
      early wakening and tic-related movements in sleep. For typically developing children, sleep
      disturbances have been linked to problems with mood, behaviour and learning. To date, the
      relationship between sleep and learning has not been explored for children with TS/CTD.

      The aim of this project is to investigate whether there is a relationship between sleep
      efficiency and learning in boys with and without TS/CTD aged 11-14 years.

      Sleep efficiency will be measured using a small actigraphy watch, which will collect
      information about movements during sleep, night time waking and light exposure. Children will
      be required to wear the watch for 14 days and nights. Before one night of sleep and again the
      next morning, children will be asked to complete some tasks on an iPad Air to assess
      learning. These include 1) 'popping' balloons with faces on them according to specific rules
      (e.g. boys faces, happy faces), 2) learning novel animal names, 3) navigating a 3D maze.
      Children will also be administered some standard tests to look at level of intellectual
      functioning, memory and other thinking skills that may contribute to performance on the
      computerized tasks. Additionally, children and their parents will be asked to complete
      questionnaires to assess tics, quality of life, mood and behaviour. The findings of this
      study will help improve understanding of sleep problems for children with tic disorders to
      aid the development of specific interventions for this group.
    

Intervention name(s): Actigraphy to measure sleep duration and efficiency; 'Sleepsuite' novel cognitive learning tasks
Intervention type(s): Other; Other
Intervention description(s): Actigraphy watch to be worn on participants' wrist for 14 days and nights; Novel iPad-administered learning tasks, to be completed one evening and the next morning during actigraphy monitoring period.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Students at mainsteam secondary schools, patients of the Tic and Neurodevelopmental
        (TANDeM) service at the Evelina Children's Hospital.
Monitoring of Adequate Course of General Anesthesia
Condition: Monitoring of Depth of Anesthesia; AAI Index
Study type: Interventional

Summary: 
      Clinical monitoring is the most common method of adjustment of the appropriate level of
      general anesthesia. However, the episodes of intraoperative awareness are still reported,
      suggesting that clinical observations may not be sufficient in some cases. The objective of
      the study was to compare the efficacy of clinical and instrumental neuromonitoring with
      auditory evoked potentials in intraoperative analysis of the proper level of general
      anesthesia.

      The patients scheduled for elective surgery were included into the study, and randomly
      divided into two groups. Patients in the first group (TIVA group) underwent intravenous, in
      the second group (VA group) underwent volatile anesthesia. The adequacy of anesthesia was
      analyzed with standard clinical parameters. All the participants were instrumentally
      monitored with AAI index. After the anesthesia patients received a questionnaire with the
      questions regarding possible intraoperative awareness.
    


Intervention name(s): monitoring of the proper level of general anesthesia
Intervention type(s): Other
Intervention description(s): The monitoring of the adequate level of general anesthesia was performed both clinically and instrumentally.
Other intervention name(s): clinical monitoring; instrumental monitoring
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are assigned to intravenous or volatile anesthesia. In both groups both the clinical and instrumental monitoring of the proper level of anesthesia was analyzed.
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Taurolidine in Haemodialysis Catheter Related Bacteraemia
Condition: Renal Dialysis; Catheter-Related Infections
MeSH terms: Bacteremia; Catheter-Related Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether taurolidine with heparin locking solution
      prevents recurrence of central venous catheter related blood stream infections in
      haemodialysis patients.
    

Detailed description: 
      Infections related to long-term haemodialysis catheters are associated with significant
      morbidity. A high proportion of those people initially treated with antibiotics to clear a
      catheter infection develop a second infection within six months, necessitating the removal
      and replacement of the dialysis catheter.

      This study will examine the efficacy of an antimicrobial catheter locking solution called
      taurolidine with heparin in preventing a second infection within six months of a significant
      infection. This solution will be compared with the solution used currently (heparin) which is
      left inside the catheter between dialysis sessions.

      This is a clinical study given that antimicrobial catheter locks are thought to reduce the
      risk of blood stream infections and the ultimate need for catheter change. However, there is
      concern that the absence of an anticoagulant in the lock solution increases the risk of
      catheter thrombosis, again requiring a change of catheter but for a separate reason. It is
      unclear therefore whether a solution containing both taurolidine (an antimicrobial) and
      heparin (an anticoagulant) will increase catheter survival.

      The results of this study will help guide the appropriate suse of locking solutions in the
      future.
    

Intervention name(s): Taurolidine with heparin (500 units/ ml)
Intervention type(s): Device
Intervention description(s): Central venous catheter will be locked (the designated volume required to fill the dead space) with taurolidine with heparin after each dialysis session. The control arm will be locked with heparin as is current practice.
Other intervention name(s): Taurolock Hep500
Intervention MeSH terms: Taurolidine; Heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Montelukast 10 mg Tablets
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of montelukast tablets are
      bioequivalent.

      Test product was Montelukast (10 mg tablets; GlaxoSmithKline) and reference product Singulair
      (10 mg tablets; Merck Sharp & Dohme). The single dosage was one tablet.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 32 healthy volunteers, both genders, adults between 18-50
      years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): Montelukast 10 mg; Montelukast 10 mg
Intervention type(s): Drug; Drug
Intervention description(s): Reference product; Test product
Other intervention name(s): Singulair; Merck Sharp & Dohme
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mexico; Montelukast; Pharmacokinetics; Bioequivalence
VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single-center, randomized, partially blinded study to determine whether 42-day old
      red blood cells (RBCs) deliver oxygen as effectively as 7-day old RBCs and also to determine
      whether transfusion with 28-day old RBCs is non-inferior to 7-day old RBCs with respect to
      oxygen delivery.

      In this study, subjects will be randomized to be transfused with 2 units of autologous (one's
      own) RBCs that are either 7-, 28-, or 42-days old. Endpoints include changes in exercise
      duration and VO2 max (test of oxygen consumption/delivery) between groups.
    

Detailed description: 
      The US Food and Drug Administration (FDA) regulations permit additive-containing RBCs to be
      stored for up to 42 days prior to transfusion. However, RBCs progressively develop
      abnormalities during storage. The efficacy of older stored blood, i.e., effective oxygen
      delivery, has not been established in rigorous controlled studies. Due to pragmatic reasons,
      a large clinical trial that randomizes patients to "old" blood may not be feasible.

      Every subject will have 2 phlebotomy visits at Stony Brook University Hospital. Subjects
      randomized to the 7- and 42-day old groups will have 2 units of blood removed at Week 0 and
      another 2 units removed at Week 5. However, the remaining 28-day group will have 2 units of
      blood removed at Week 2 and only 1 unit of blood removed at Week 5. During week 6, each
      subjects will have 3 study visits: 1) On Monday, a VO2 max test; 2) On Wednesday, a
      transfusion with 2 units of autologous RBCs (each over 1 hour), followed by a VO2 max test 2
      hours later; 3) On Friday, a VO2 max test will be done in order to calculate a delta VO2 max
      (Friday minus Monday results).
    

Intervention name(s): Transfusion of 7-day stored red blood cells; Transfusion of 28-day stored red blood cells; Transfusion of 42-day stored red blood cells
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 5 (7-day old) red blood cells.; Subjects will donate blood at Week 2 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 2 (28-day old) red blood cells.; Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week0 (42-day old) red blood cells.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
NEM® Versus Placebo on Exercise-induced Joint Pain, Stiffness, & Cartilage Turnover In Healthy, Post-Menopausal Women
Condition: Exercise-induced Joint Pain Stiffness and Cartilage Turnover
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      This study is intended to evaluate the effect of the dietary supplement NEM® brand eggshell
      membrane versus placebo in reducing exercise-induced joint pain & stiffness & cartilage
      turnover in healthy post-menopausal women. Half of the study participants will receive NEM,
      once daily, orally while the other half of the study participants will receive placebo, once
      daily, orally.
    

Detailed description: 
      Moderate exercise can induce discomfort in joints when done infrequently or when done too
      intensely or for too long a period. This discomfort is often realized as either pain or
      stiffness in the joint that was the focus of the exercise. For example, one's knees will hurt
      after jogging for several miles, particularly if jogging for the first time. This study is
      intended to evaluate whether NEM® brand eggshell membrane can alleviate joint pain or
      stiffness, either directly following exercise or 12 hours post-exercise versus placebo. The
      study will also evaluate NEM's effect, if any, on cartilage turnover via the cartilage
      degradation biomarker c-terminal cross-linked telopeptide of type II collagen (CTX-II).
      Participants will perform a minimum of 50 steps per leg utilizing an aerobics step at the
      clinical site. They will follow this exercise regimen on alternating days for 2 weeks.
      Changes in pain & stiffness (immediate & 12-hour) will be compared to both baseline and to
      the placebo group. Blood & Urine samples will also be collected at baseline and at the end of
      Week 1 & Week 2. The change in CTX-II will be compared to baseline.
    

Intervention name(s): NEM; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplement for the support of joint health.; Placebo
Other intervention name(s): Natural Eggshell Membrane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: exercise-induced; joint pain; joint stiffness; post-menopausal; women; cartilage turnover; CTX-II
Efficacy & Safety of Loratadine-Betamethasone Oral Solution for Treatment of Severe Perennial Allergic Rhinitis in Children (Study P03428)
Condition: Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

Summary: 
      This study attempts to document the therapeutic value of combining loratadine antihistamine
      action (no sedative) with anti-inflammatory effects of betamethasone at low doses, which may
      facilitate treatment adherence by patients whereas providing an effective and rapid perennial
      allergic rhinitis (PAR) symptoms relief.
    


Intervention name(s): Loratadine; Betamethasone
Intervention type(s): Drug; Drug
Intervention description(s): loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg; loratadine/betamethasone oral solution (1 mg/0.05 mg/1 mL), at a dose of 10 mg/0.5 mg
Other intervention name(s): SCH 029851; SCH 029851
Intervention MeSH terms: Loratadine; Betamethasone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Nucleotide Polymorphism (SNP) Panels and Risk Assessment in Women Undergoing Mammography
Condition: Mammography
Study type: Observational

Summary: 
      The primary objective is to compare the predicted lifetime risk values produced by SNP panel
      assessment to the risk values produced by the prediction models that are most commonly used.
      A second objective is to examine whether the incorporation of risk assessment panels
      (standard or SNP based) can improve the positive value of breast biopsies in women with
      BIRADS 4 mammograms.
    

Detailed description: 
      Calculating the risk that a woman will develop breast cancer in her lifetime can lead to
      decreased mortality rates as a result of increased screening and prevention methods when a
      person is known to be at high risk. Though there are several risk assessment models that are
      commonly used, it is important to continue to improve the process of calculating risk.
      Several genetic markers have been noted to potentially indicate risk of developing breast
      cancer. New tests, called SNP panels, can detect some of these genetic markers. This study
      aims to use both these SNP panels and the commonly used risk models to calculate risk and
      examine outcomes in women coming in to do screening mammography. This study will enroll women
      between the ages of 40-65 who are undergoing screening mammography (n=1000), in addition to
      women with BIRADS category 4 mammogram readings who are about to undergo biopsy (n=600), all
      with no personal history of breast or ovarian cancer, ductal carcinoma in situ (DCIS), mantle
      radiation, or known BRCA 1/2/mutation in self or family members. The participants will only
      be expected rto provide consent, swabs of the inside of the cheek of her mouth, and baseline
      questionnaire answers that will allow for a risk assessment to be performed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult women will be recruited for this study. Women undergoing screening mammography will
        be chosen if they are between the ages of 40 and 65. Women will be excluded if they have a
        personal history of breast or ovarian cancer, DCIS, or mantle radiation, or known BRCA 1/2
        mutation in self or in family members.
      
Keywords: Women undergoing screening mammography will be chosen if they are between the ages of 40 and 65.
A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy and safety/tolerability of 4 doses of Imeglimin versus
      placebo. The study will be performed in subjects with type 2 diabetes either naive of
      treatment or previously treated with an oral monotherapy excluding thiazolidinedione.
    


Intervention name(s): Imeglimin; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment