bioihbjkbjnl/mcl2 huggingface dataset:
Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis
Condition: Rectal Neoplasm With Metastasis to the Liver
MeSH terms: Neoplasm Metastasis; Rectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the safety and efficacy of simultaneous liver
      resections compared to staged hepatectomies of rectal cancer with liver metastasis and to
      compare the short and long-term survival between the two groups.
    

Detailed description: 
      The optimal surgical strategy for treatment of patients with resectable synchronous rectal
      liver metastases remains controversial. To answer whether synchronous rectal cancer liver
      metastases (SLM) should be resected simultaneously with primary cancer or should be delayed,
      We conducted a randomized, controlled trial to compare the safety and efficacy of
      simultaneous versus delayed resection of the rectum and liver. Patients with rectal cancer
      and resectable SLM were randomly assigned to either simultaneous or delayed resection of the
      metastases. The primary outcome was the rate of major complications (Clavien-Dindo grade≥III)
      within 30 days following surgery. Secondary outcomes included disease-free and overall
      survival. A consecutive patients of rectal cancer with liver metastasis from ZhongShan
      hospital, Fudan university were enrolled and randomly assigned to simultaneous liver
      resections and staged hepatectomies. Post-operative complications, peri-operative mortality,
      long-term survival were compared.
    

Intervention name(s): simultaneous resection of liver metastasis and the rectal primary tumor; staged resection of liver metastasis and the rectal primary tumor
Intervention type(s): Procedure; Procedure
Intervention description(s): simultaneous resection of liver metastasis and the rectal primary tumor; Patients received resection of the rectal tumor. 1 months later received resection of liver metastasis
Intervention MeSH terms: Liver Extracts
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Rectal cancer patients with synchronous resectable liver metastasis were randomized to simultaneous resection of primary and metastatic lesions or staged resection
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rectal neoplasms; liver metastasis; surgery; simultaneous resection; staged resection
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Condition: Epilepsies, Partial
MeSH terms: Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in
      Japanese pediatric patients with partial seizures
    


Intervention name(s): gabapentin
Intervention type(s): Drug
Intervention description(s): Orally administered gabapentin
Intervention MeSH terms: Gabapentin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pulmonary Function at High-Altitude
Condition: Pulmonary Edema
MeSH terms: Pulmonary Edema; Edema
Study type: Interventional

Summary: 
      Based on the findings of decreased vital capacity, decreased FEV1 and increased closing
      volume after ascent to high altitude, some investigators suggest the presence of a
      subclinical high altitude pulmonary edema (HAPE). Since these parameters are only indirect
      measures of pulmonary interstitial fluid accumulation, the aim of this study is to examine
      the effects of broncho-constriction on the increase of closing volume by extensive lung
      function testing in healthy mountaineers at low altitude and on the Margherita Hut (4559 m).
      As has been done in earlier studies, conventional thorax radiographs are used for
      verification of HAPE. In this study, the determination of the thoracic fluid quantity will be
      completed by measurements of thoracic impedance. In addition markers of pulmonary endothelial
      function will be assessed to get further insight into the regulation of pulmonary vascular
      tone at altitude and in particular into the pathophysiology of HAPE.
    


Intervention name(s): Hypoxic Exposure
Intervention type(s): Other
Intervention description(s): ascent to 4559 m within 24 h without prior acclimatization
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: high altitude pulmonary edema; pulmonary interstitial fluid; pulmonary function testing; hypoxia; pulmonary endothelial function; high altitude exposure without prior acclimatization
The Effect of Specific Strength-Training on Tension-Type Headache in Children 9-17 Years
Condition: Tension-Type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional

Summary: 
      This study aims at examining muscle strength capacity in neck and shoulder muscles in
      children and adolescents with and without tension-type headache, and furthermore examining
      the effect of a 10 week specific strength training programme for neck and shoulder muscles
      compared to a multi-disciplinary approach in 10 weeks.
    

Detailed description: 
      Frequent and chronic tension type headache are the most frequent pain illnesses in children
      with a prevalence of 0.5-7,6%. Frequent or daily headache leads to constraints in the child's
      life in relation to school and social activities.

      The underlying pathophysiological mechanisms are not yet fully examined. In several studies
      in adults and in children it is found that the shoulder muscles are tense and tender, but it
      is not known whether this phenomenon is primary or secondary to tension-type headache. A
      decrease in muscle capacity is furthermore found in studies. We therefore aim at examining
      parameters for muscle function in order to compare the differences between children with and
      without headache, and at examining the effect of a 10 week progressive specific strength
      training programme on headache compared to an in time comparable multidisciplinary
      intervention based on lifestyle counseling.
    

Intervention name(s): Specific Strength Training; Lifestyle Counseling
Intervention type(s): Device; Behavioral
Intervention description(s): 10 weeks of progressive specific strength training for neck and shoulder muscles.; 10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
Other intervention name(s): A; B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tension-Type Headache; Strength Capacity; Neck and Shoulder
Acute Effects of Whole Body Blue Light Exposure on Blood Pressure
Condition: Blue Light
Study type: Interventional

Summary: 
      Ultraviolet light exposure was shown to be able to release nitric oxide from the skin into
      the blood stream and lead to an acute decrease in blood pressure and increase in vascular
      function. Additionally, preliminary work indicates that UV free blue light also releases
      nitric oxide in the skin mediating similar effects as seen with ultraviolet light A(UVA). It
      is the goal of the present experimental study to investigate the hemodynamic effects of whole
      body blue light exposure including blood pressure, endothelial function and vascular
      stiffness. Therefore, healthy volunteers will be exposed to 30 minutes whole body blue light
      (453 nm wavelength) and the change in blood pressure and endothelial function (Flow mediated
      dilation (FMD)), heart rate, forearm-blood flow, forearm vascular resistance central blood
      pressure and vascular stiffness ( pulse wave analysis by sphygmocor) will be measured.

      In this randomized controlled cross-over study, 20 healthy subjects aged 30 to 60 years will
      participate.
    


Intervention name(s): Blue light; control exposure
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects will be exposed to blue light (453 nm wavelength) for 30 minutes; Subjects will get control exposure to 30 minutes of whole body, which causes only comparable warming of skin as with blue light exposure.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: blue light; blood pressure; vascular function; endothelial function; health volunteers
Multiple-dose Study of FOY-305 in Japanese Healthy Adult Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate safety, tolerability and pharmacokinetics in Japanese healthy adult male
      subjects when FOY-305 is administered as multiple-dose orally.
    


Intervention name(s): FOY-305
Intervention type(s): Drug
Intervention description(s): Multiple-dose of FOY-305 will be administered orally at 4 times/day.
Intervention MeSH terms: Camostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing OHRQoL: One or Two Sessions for Wisdom Teeth Removal
Condition: Impacted Third Molar Tooth; Impacted Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      This single-center prospective cohort study includes patients aged 18-30 years aimed to
      compare the effects of bilateral extraction of wisdom teeth at a single appointment (Group A)
      versus two separate appointments (Group B) on patients' oral health-related quality of life
      (OHRQoL). The primary outcome is Oral Health Impact Profile 14 score, while secondary
      outcomes included postoperative pain and maximum interincisal opening.
    


Intervention name(s): Single-Session Bilateral Mandibular Third Molar Extraction; Two-Session Bilateral Mandibular Third Molar Extraction
Intervention type(s): Procedure; Procedure
Intervention description(s): Participants in this group chose to have both of their lower mandibular third molars extracted during a single appointment. This group will be used to compare the impact of single-session extraction on patients' oral health-related quality of life, postoperative pain, and maximum interincisal opening.; Participants in this group chose to have their lower mandibular third molars extracted during two separate appointments. This group will be used to compare the impact of two-session extraction on patients' oral health-related quality of life, postoperative pain, and maximum interincisal opening.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Quality of Life; Oral health; Prospective Studies; Molar, Third; Tooth Extraction; Patient Preference
Iron Absorption in Haiti
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      The government of Haiti plans to introduce a flour fortification program. The aim of the
      project it to inform the authorities on the most suitable iron compound for this
      fortification program. For this purpose, iron absorption from wheat flour using different
      iron compounds will be investigated.
    


Intervention name(s): NaFeEDTA; Ferrous fumarate; NaFeEDTA + ferrous fumarate
Intervention type(s): Other; Other; Other
Intervention MeSH terms: Ferrous fumarate; Edetic Acid; Ferric Compounds; Fe(III)-EDTA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
A Long-term, Open-label, Uncontrolled Trial of YM443 (Z-338) in Patients With Functional Dyspepsia
Condition: Dyspepsia; Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 3

Summary: 
      To examine the safety and efficacy of Z-338 (YM443) after long-term administration in
      patients with functional dyspepsia, and also to examine the pattern of long-term
      administration.
    


Intervention name(s): YM443
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Z-338; acotiamide
Intervention MeSH terms: Z 338
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: YM443; Z-338; Acotiamide; Rome III; Signs and symptoms, digestive
Dose-finding Pharmacokinetic Study in Healthy Males
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I PK study in healthy males.
    

Detailed description: 
      This is a phase I, open, repeated dose, randomised PK study in healthy males. The study will
      consist of 4 parallel groups (Groups 1-4). All groups will have a crossover design with 4
      treatment periods, each lasting for 7 days.
    

Intervention name(s): Levodopa; Carbidopa; ODM-104
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Levodopa 50 mg or 100 mg or 150 mg; Carbidopa 12.5 mg or 25 mg or 65 mg; ODM-104 50 mg or 100 mg
Other intervention name(s): Sinemet
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vestibular Pain Interactions
Condition: Healthy
Study type: Interventional

Summary: 
      The goal is to establish the practical usefulness of vestibular stimulation for modulating
      pain perception and to describe the possible mechanisms that could underlie neural
      vestibular-somatosensory interactions.
    


Intervention name(s): Quantitative sensory testing; CHEPS; 3D Turntable; Vection stimulation
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Measurement of warm and cold detection and pain thresholds; Measurement of amplitude and latency of cortically evoked potentials
Other intervention name(s): QST; Contact heat evoked potentials
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: quantitative sensory testing; contact heat evoked potentials; vection stimulation; 3D-turntable; Volunteers
Work Package 2 Phase 1 - Beverages Study
Condition: Glycemic Index; Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Within the SWEET project (EU funded), in Work Package 2 there are two phases, this study
      refers to Phase 1 of the SWEET WP2 project, which will be a coordinated trial across 3
      intervention centres, University of Navarra (UNAV), University of Liverpool (ULIV) and
      University of Copenhagen (UCPH). It will involve an acute intervention in 120 individuals to
      explore initial acceptance, safety and post-prandial effects of 3 S&SE blends delivered in
      beverage format.

      The main endpoints of the SWEET WP2 Phase 1 study will be glycaemic and lipaemic responses;
      eating behavior (subjective appetite, food preference, cravings, reward), and health effects
      (rebound hunger, G.I. side effects and metabolic effects). This phase will be exploratory and
      will not involve any specific primary hypotheses.
    

Detailed description: 
      This protocol has the overall objective to evaluate the acute (short-term, 1 day) and
      repeated (medium-term, 2 week) effects of combinations of sweeteners and sweetness enhancers
      (S&SEs) on metabolic, sensory and neuro-behavioural processes involved in satiety, consumer
      preference and health, and to explore mechanistic processes, genetic background, safety
      issues and consumer perspectives.

      There are 4 products being tested in 4 different formulations (sucrose-sweetened beverage
      control vs. 3 reformulated beverages with S&SE). Each product will be tested at 3
      intervention sites in double-blind cross-over trials with 40 subjects per site, tested per
      product. Therefore a total of 120 subjects will take part across the 3 intervention sites
      (UNAV, ULIV, UCPH).

      Using identical procedures each trial will consist of 4 Clinical Investigation Days (CIDs)
      scheduled 7-11 days apart for each of the 3 product formulations.

      The total duration of WP2 Phase 2 per site is 6 months, including a minimum of 22 days and a
      maximum of 34 days for each participant.
    

Intervention name(s): Comparison of sweetener blends in liquid form (cross-over study)
Intervention type(s): Other
Intervention description(s): The aim is to compare the effects of different sweetener blends on glycemia, subjective appetite parameters and safety parameters when consumed in a beverage as part of a breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Multi-centre crossover study with 4 conditions using balanced block randomisation. The three centres will follow different randomisation sequences but will all test the same 4 conditions (University of Navarra, University of Copenhagen, University of Liverpool).
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Three Drugs in Advanced Gastric Cancer Neoadjuvant Chemotherapy for Stage Ⅲ Clinical Study
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the relationship of pCR rate and efficacy by comparing
      the two drugs and three drugs as neoadjuvant chemotherapy in advanced gastric cancer
      patients.
    

Detailed description: 
      Eligible patients will be randomly assigned by a randomisation system in a 1:1:1 ratio to
      three group. The group A wil receive four cycles of DOX (docetaxel 60mg/m2 on day
      1,oxaliplatin 130mg/m2 on day 1 and capecitabine 1,000 mg/m2 per day on days 1 to 14,
      repeated every 3 weeks) as neoadjuvant therapy and four cycles of Xelox (capecitabine 1,000
      mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as
      adjuvant therapy.The group B wil receive four cycles of Xelox (capecitabine 1,000 mg/m2 per
      day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1, repeated every 3 weeks) as neoadjuvant
      therapy and four cycles of Xelox as adjuvant therapy.The group C wil receive eight cycles of
      Xelox (capecitabine 1,000 mg/m2 per day on days 1 to 14 and oxaliplatin 130mg/m2 on day 1,
      repeated every 3 weeks) as adjuvant therapy.
    

Intervention name(s): docetaxel,0xaliplatin,capecitabine; oxaliplatin,capecitabine
Intervention type(s): Drug; Drug
Intervention description(s): docetaxel 60mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14; oxaliplatin 130mg/m2， ivgtt，2h，d1;q21d; oxaliplatin 130mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14;q21d
Other intervention name(s): AISU,AIHENG,AIBIN; AIHENG,AIBIN
Intervention MeSH terms: Docetaxel; Capecitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Resectable advanced gastric cancer
Caries Management by Risk Assessment in Children
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The goal of this study is to address the effectiveness of a modified cavity prevention
      protocol for 5-9 year-old children which emphasizes better diet modification, more frequent
      professional fluoride applications, and xylitol product usage based on individual risk status
      in a 1-year randomized controlled clinical trial in the University of California, San
      Francisco (UCSF) Tenderloin Community Pediatric Dental Clinic. The investigators hypothesize
      that the regimen will help to reduce new cavities in children who are at risk for dental
      cavities.
    


Intervention name(s): xylitol mints and fluoride varnish
Intervention type(s): Other
Intervention description(s): Subjects in the intervention group will receive additional diet, oral hygiene handouts, more frequent professional fluoride application, and xylitol mints based on their caries risk levels.
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dental caries; children; mutans streptococci; lactobacilli; cariogenic bacteria
MEOPA Breathing Analgesia for Oocyte Retrieval(KALOVAL)
Condition: Infertility; Pain
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess pain, at or after oocyte retrieval, the effectiveness
      of self-controlled inhalation analgesia by nitrous oxide (N2O of 50% and 50% O2) by the
      patient compared to a local anesthesia combined with a tablet of 0.5 mg of Alprazolam.
    

Detailed description: 
      Oocyte retrieval is a major event during in VITRO-fertilization, with or without sperm
      micro-injection. Initially done by laparoscopy with general anesthesia, the oocyte collection
      is now carried out by trans-vaginal controlled ultrasound puncture. This potential painful
      event, related to trans-vaginal puncture or mechanical movements of the stimulated ovary,
      requires analgesia or anesthesia. General anesthesia is certainly effective in terms of
      collected oocytes. It remains, however, a heavy time consumer, with personal risks and
      distributor of anesthetic agents in blood or follicular fluid. These products could have a
      deleterious effect on early embryonic development or implantation. Few data are available
      concerning these risks in the literature. General anesthesia is still essential for
      pusillanimous patients or for patients with a heavy surgical past. Nitrous oxide is an
      inhaled gas with properties widely used in obstetric during parturition. It is regularly used
      during general anesthesia performed for oocyte retrieval. With a gas composed of 50% N2O and
      50% O2, its main interest is to provide analgesia in a state of conscious sedation. The
      effects of nitrous oxide in this form had never been assessed on the clinical or biological
      Oocyte collection. We conducted a preliminary study to assess pain in patients receiving
      local anesthesia, according the current protocol. Thus, 44% of patients had severe pain (VAS>
      40/100) during or just after transvaginal oocyte retrieval. In our preliminary experience,
      immediate or distance post-operative pain was high and we plan to evaluate the benefit of
      analgesia with nitrous oxide in terms of immediate post-operative pain with a prospective,
      randomized and controlled study as compared with local anesthesia associated to Alprazolam.
    

Intervention name(s): MEOPA inhalation; xylocaine
Intervention type(s): Procedure; Procedure
Intervention description(s): N2O of 50% and 50% O2; Ampoule-bottle of 20 ml
Other intervention name(s): local anesthesia
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oocyte retrieval; pain; surgery; anaesthesiology; Assisted Reproductive Technologies