bioihbjkbjnl/mcl2 huggingface dataset:
A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer
Condition: Gastric Neoplasm
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant
      chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and
      large type 3 tumor in comparison with surgery alone.
    

Detailed description: 
      A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a
      neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric
      cancer.A total of 300 patients will be accrued for this study from 35 institutions within
      five years. The primary endpoint is overall survival. The secondary endpoints are progression
      free survival (PFS), response rate, proportion of protocol achievement, proportion of
      curative resection, and adverse events.
    

Intervention name(s): Gastrectomy with more than D2 dissection; Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Intervention type(s): Procedure; Drug
Intervention description(s): Gastrectomy with more than D2 dissection; Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoadjuvant Therapy; Stomach Neoplasms; Cisplatin; S-1(combination)
Ketorolac in Breast Cancer Surgery
Condition: Curative Breast Cancer Surgery; Inflammatory Positive/Negative Status; Pre Surgical Incision Administration
MeSH terms: Breast Neoplasms; Surgical Wound
Study type: Interventional
Phase: Phase 3

Summary: 
      Do the use of Ketorolac in one intravenous injection at the moment of the operative incision
      reduce the number of recurrence in patient with advanced breast cancer without inflammation
      signs.
    


Intervention name(s): Ketorolac 30 mg IV; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Active drug; Placebo looking like the Active drug
Other intervention name(s): ketorolac tromethamine; NaCl 0.9%
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness
Condition: Excessive Sleepiness; Parkinson Disease
MeSH terms: Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a 4-week, multicenter, randomized, double-blind, placebo-controlled, ascending
      dose, 4-period crossover study designed to evaluate the safety, tolerability, efficacy, and
      PK of JZP-110 (75, 150, and 300 mg) in the treatment of excessive sleepiness in adult
      subjects with idiopathic PD.
    


Intervention name(s): JZP-110; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 75 mg, 150 mg, 300 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Glossopharyngeal Nerve Block on Post Tonsillectomy Pain Among Egyptian Children
Condition: Post Tonsillectomy Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Tonsillectomy is one of most common performed surgical procedure in children . tonsillectomy
      or adenotonsillectomy have high incidence of Post operative pain , it is very important and
      significant problem because it can lead to decrease oral intake and dehydration
    

Detailed description: 
      Tonsillectomy is one of the most common performed surgical procedure in children.
      Tonsillectomy or adenotonsillectomy have high incidence of Post operative pain incidence .
      There is still debate about the optimal analgesia for this common procedure , different
      methods have been described including intraoperative anesthetic pain regimens , adjustment of
      surgical technique , intraoperative local anesthetic injection and use of pharmacotherapy
      post operative .

      The main goal of the preventive analgesia is the pain releif with minimum side effect . The
      objective of this study is to investigate and compare the effect of Glossopharyngeal nerve
      block for relief of pain on children following adenotonsillectomy .

      This is prospective , double blinded , randomized study
    

Intervention name(s): Bupivacaine Hydrochloride 0.5% Injection Solution; Saline 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): Local anesthetic; Isotonic crystaloid
Other intervention name(s): Marcaine; Saline 0.9 %
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Glossopharyngeal nerve block
Pain Relief After High Thoracic Eretor Spinae Block
Condition: Pain, Chronic
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The primary endpoint of this study was to identify if the ESPB in the patients of cervical
      radiculopathy has the effect of pain relief. The secondary endpoint of this study was to
      identify the spread level in the craniocaudal direction when performed at the T2 level.
    

Detailed description: 
      The ESPB requires ultrasound guidance which enables visible local anesthetic spread
      underneath the erector spinae muscles. The spinalis, longissimus thoracis, and iliocostalis
      muscles comprise the ES muscles, which run vertically along both sides of the vertebral
      column from the sacrum up to the skull base (1,10). The ESPB can be performed in the
      cervical, thoracic, and lumbar regions. Among them, upper or mid thoracic ESPB has been used
      more widely compared to cervical and lumbar regions.

      Previous cadaveric studies on the ESPB at the T5 level using computed tomography (CT)
      reconstruction or direct dissection demonstrated the extensive craniocaudal distribution of
      methylene blue ranging from T1 to T8 vertebral segments deep to the ES muscles and variable
      involvement of epidural, paravertebral, and intercostal spaces. The ESPB performed at the T2
      level of the cadaver demonstrated an injected dye distribution ranging from C4 to T10. Also,
      36% of cadavers showed the spread of an injected dye to the ventral, dorsal ramus,
      paravertebral space, and even the contralateral side.

      The exact mechanism of action of ESPB remains unclear. A recent study suggested that the
      analgesic effect of ESPB could be obtained by blocking the ventral and dorsal ramus of the
      spinal nerves by passing through the costotransverse foramen. However, in clinical practice,
      we can encounter highly variable clinical outcomes or sensory block after the ESPB. The study
      of the physical spread of the injected agent can be used to predict the clinical result and
      elucidate the possible mechanism of action of ESPB.
    

Intervention name(s): Erector spinae plane block
Intervention type(s): Procedure
Intervention description(s): fascial plane injection guided by fluoroscopic device after ultrasound guidance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain, Cervical, Spread
Safety, Tolerability and Pharmacokinetics of BI 44370 TA Oral Drinking Solution in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability and pharmacokinetics of single rising oral doses of BI
      44370 TA in healthy male volunteers, to compare a drinking solution vs. a tablet formulation
      and to assess intra-individual pharmacokinetic (PK) variability by re-dosing two further
      doses.
    


Intervention name(s): BI 44370 TA solution; BI 44370 TA tablet; Placebo solution; Placebo tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study of no Pharmacokinetic Interaction Between Rosuvastatin 20mg and Ezetimibe10mg, Fixed Dose vs Individual Components
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Monocentric study of no pharmacokinetic interaction between rosuvastatin 20 mg and ezetimibe
      10 mg. An open design, randomized, single dose with three periods, six sequences and crossed,
      in healthy volunteers with fasting conditions, managed in fixed dose combination (Sponsor
      Laboratorios Silanes S.A. de C.V.) versus individual components managed by separated
      (Crestor®, product of Astrazeneca, S.A. de C.V and Ezetrol®. product of Undra S.A. de C.V.)
    

Detailed description: 
      To statistically compare the bioavailability of rosuvastatin 20 mg and ezetimibe 10 mg in a
      pharmacokinetic non-interference study, after single-dose oral administration of a product
      with the fixed combination of active ingredients with respect to the individual components
      administered separately in healthy volunteers fasting. In the same way, the safety of the
      presentations will be evaluated based on the registry of adverse events at the end of the
      three study periods. The classic 90% confidence intervals will be determined for the
      intra-individual ratios (test / reference) of the main parameters AUC0-t, AUC0-inf, Cmax for
      rosuvastatin and ezetimibe.
    

Intervention name(s): Rosuvastatin (20mg) /Ezetimibe (10mg) in fixed dose; Rosuvastatin 20mg; Ezetimibe 10mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Form: Tablets Dosage: 20 mg Adminstration way: Oral; Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration way: Oral; Pharmaceutical Form: Tablets Dosage: 10 mg Adminstration way: Oral
Other intervention name(s): ROSU/EZET; ROSU (Crestor®); EZET (Ezetrol®)
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dyslipidemia; Rosuvastatin; Ezetimibe; Cholesterol
European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study
Condition: Venous Insufficiency of Leg
MeSH terms: Venous Insufficiency
Study type: Interventional

Summary: 
      The primary objective for this clinical study is to assess the role of the CE Marked Sapheon
      Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical
      setting.
    

Detailed description: 
      This is a post market, observational study of closure of the great saphenous vein "GSV".
      Efficacy and safety (adverse events) will be compared to appropriate literature reports to
      determine if the results of the treatment of reflux disease with the Sapheon Closure System
      are consistent with or better than the expectations of the medical community for alternative
      treatments, specifically Laser Thermal Ablation and Radiofrequency Ablation. Additional
      comparison points may include measurements of pain and/or length of time to return to work.
    

Intervention name(s): CE Marked Sapheon Closure System
Intervention type(s): Device
Intervention description(s): CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Addressing Behaviour and Treatment Effectiveness Project (A.B.A.T.E. Project)
Condition: Disruptive Behavior Disorder
MeSH terms: Mental Disorders; Problem Behavior; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional

Summary: 
      This study investigates the effectiveness of a clinic-adapted version of the Coping Power
      program compared to individualized child and family treatment for children with disruptive
      behaviour and their parents.
    

Detailed description: 
      This project compares the short- and long-term effectiveness of a clinic-adapted manualized
      group treatment (i.e., Coping Power; CP) to individualized child and family treatment for
      children aged 9 - 12 with disruptive behaviour. Children and their parents who meet criteria
      and agree to participate in the project are randomly assigned to either the CP condition or
      the Individualized treatment condition. In the CP condition, children and caregivers are
      asked to participate in two separate but complimentary 15-session groups. Child groups target
      development of children's emotional and cognitive problem solving skills and caregiver groups
      facilitate cognitive and behavioural parenting skills. In the Individualized treatment
      condition children and caregivers are asked to participate in 15 one-hour individual and
      family treatment sessions tailored by the clinician to address the children and parent's
      presenting concerns. Measurement of behaviour and emotional functioning is done pre- post-
      and at 6-months following treatment.
    

Intervention name(s): Coping Power; Individualized Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 15 sessions of concurrent parent and child group treatment; 15 sessions of individualized child and parent treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Disruptive Behaviour Disorder; Psychosocial; Group Treatment
A Survey on Efficacy and Safety in Patients With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational [Patient Registry]

Summary: 
      This survey is intended to collect efficacy and safety data of Duphaston® Tablets in patients
      with endometriosis under actual condition of its use and to obtain data for effectively and
      safely utilizing this drug.
    

Detailed description: 
      In Japan, Duphaston® Tablets have appeared in 1965 for the treatment of endometriosis and
      been used at some medical institutions. However, after releasing of danazol in the early
      1980's and gonadotropin-releasing hormone (GnRH) agonists in the late 1980's, pseudomenopause
      therapy became mainstream because of its high efficacy. However, pseudopregnancy therapy was
      recognized again due to adverse reactions associated with pseudomenopause therapy. After
      2000, low-dose estrogen/progestin (LEP) combination drugs (as LEP products,
      ethinylestradiol/norethisterone combination drug and ethinylestradiol/drospirenone
      combination drug) and dienogest have been utilized as drugs that are safer and can be
      administered for a long time. In recent years, Duphaston® Tablets are increasing recognized
      again from the viewpoints of its efficacy and safety because the drug has no effect to
      inhibit ovulation or effect on basal body temperature, a diagnosis of ovulation and other
      conditions may be made by following up basal body temperature, and pregnancy may be achieved
      even during treatment with Duphaston. As previously mentioned, Duphaston® Tablets are an old
      drug, and there are only few clinical data from Japanese patients; thus, its latest clinical
      efficacy and safety data are being demanded again mainly by obstetrician-gynecologists.
    

Intervention name(s): Dydrogesterone
Intervention type(s): Drug
Other intervention name(s): Duphaston
Intervention MeSH terms: Dydrogesterone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The subjects of the survey will be patients with a diagnosis of endometriosis.
Effect of PlayStation Distraction in the Dental Setting
Condition: Global Behaviour Measure
Study type: Interventional

Summary: 
      The aim of the study was to assess whether the behavior, anxiety, and dental pain of
      pediatric patients during dental treatment improves when a video game is played as method of
      distraction.
    

Detailed description: 
      global behavior Parental perception of patients' anxiety Patient's anxiety dental pain Heart
      Rate
    

Intervention name(s): Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.
Intervention type(s): Behavioral
Intervention description(s): videogame can be considered as a method of distraction.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Audiovisual distraction; Pediatric dentistry
Safety and Efficacy Study of Adult Human Mesenchymal Stem Cells to Treat Acute Graft Versus Host Disease (GVHD)
Condition: Graft Vs Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To establish the safety and efficacy of two dose levels of ex-vivo cultured adult human
      mesenchymal stem cells (hMSCs) (Prochymal®) in participants experiencing acute GVHD, Grades
      II-IV, post hematopoietic stem cells (HSC) transplant.
    

Detailed description: 
      Protocol 260 - Participants will be randomized with equal probability to the treatment arms
      (2 million cells/kilogram (kg) of Prochymal® or 8 million cells/kg of Prochymal®) using a
      stratified block design. The stratification factor is acute GVHD grade. For the purpose of
      stratification, the GVHD grades are II and III-IV. Treatment with investigational agent will
      be administered on study Days 1 and 4. Participants will be followed for safety and efficacy
      until Day 28 after initiation of treatment with the investigational agent, or until
      withdrawal or death, whichever occurs first.

      Protocol 261- This study is designed as a long-term safety follow-up of participants who take
      part in the preceding clinical study of Prochymal® (Protocol 260) for the treatment of acute
      GVHD. Participants will be enrolled in Study 261 upon completion of the preceding Study 260.
    

Intervention name(s): Prochymal® - 2 Million cells/kg; Prochymal®- 8 Million cells/kg; Methylprednisolone; Prednisone; Cyclosporine; Tacrolimus; Mycophenolate Mofetil
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 2 million hMSCs/kg actual body weight, IV on study Days 1 and 4; 8 million hMSCs/kg actual body weight IV on study Days 1 and 4; Methylprednisolone 2 mg/kg administered intravenously.; Prednisone 2.5 mg/kg administered orally.; Administered as prescribed by the caregiver.; Administered as prescribed by the caregiver.; Administered as prescribed by the caregiver.
Other intervention name(s): Remestemcel-L; ex-vivo cultured adult human mesenchymal stem cells; hMSCs; Remestemcel-L; ex-vivo cultured adult human mesenchymal stem cells; hMSCs
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Remestemcel-l; Prednisone; Methylprednisolone; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Graft vs Host Disease; (GVHD); Graft Versus Host Disease; Bone marrow transplant; Stem cells; Mesenchymal stem cells (MSCs); Adult stem cells; Leukemia; Lymphoma
A Study to Evaluate the Drug-drug Interaction Between Telmisartan, Amlodipine and Hydrochlorothiazide
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single dose, 3-way crossover study to evaluate the drug-drugs
      interaction between Telmisartan, Amlodipine and Hydrochlorothiazide in healthy male
      volunteers
    


Intervention name(s): Telmisartan 80mg; Amlodipine10mg; Hydrochlorothiazide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Telmisartan 80mg; Amlodipine 10mg; Hydrochlorothiazide 25mg
Intervention MeSH terms: Amlodipine; Hydrochlorothiazide; Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Altitude, Exercise and Glucose Metabolism in Pre-diabetic Men
Condition: Diabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      Concentric (CE) and eccentric (EE) exercises may differently affect glucose metabolism which
      may be additionally modified when exercises are performed in hypoxia, e.g. at moderate (1500
      - 2500 m) or high (2500 - 3500 m) altitudes. However, data on the effects of glucose
      metabolism due to CE and EE in hypoxia are scarce but would be of utmost importance
      considering the increasing number of persons suffering from impaired glucose tolerance or
      diabetes and the unique opportunities provided by the mountainous regions of the Alps to
      perform CE (e.g. uphill hiking) and EE (downhill hiking, downhill skiing) at altitude between
      1500 - 3500 m. Metabolic responses to exercise may be largely mediated by interleukin 6
      (IL-6), which is predominantly derived from the contracting limbs and may support the
      maintenance of metabolic homeostasis during exercise. In addition, IL-6 is elevated with
      acute and chronic altitude exposure at least partly mediated via adrenergic stimulation.
      Thus, the type of exercise as well as hypoxia may contribute to IL-6 elevations and
      differences in serum IL-6 concentrations might help to explain distinctions between responses
      of glucose metabolism to CE and EE at low and moderate to high altitude.

      32 male subjects suffering from pre-diabetes will be randomly assigned to a downhill (EE) or
      uphill (CE) walking group performing 9 sessions at low altitude (860 - 1360 m) and 9 sessions
      at moderate to high altitude (2000 - 2500 m). Between normoxic and hypoxic condition will be
      a break of approximately 12 month. Measurements of glucose metabolism, IL-6 plasma
      concentration will be performed pre, mid (day 5) and post intervention. Moreover
      anthropometric, strength and exercise capacity characteristics will be performed pre and post
      intervention.

      We hypothesize that EE in hypoxia is more effective in the modulation of glycemic control in
      pre-diabetic men than CE in hypoxia as well as EE and CE in normoxia. It is suggested that
      effects on glucose metabolism are associated with changes in plasma IL-6 concentrations. EE
      in hypoxia is expected to result in a more persistent rise of plasma IL-6 concentration than
      CE in hypoxia and in normoxia and to a more pronounced rise in plasma IL-6 than EE in
      normoxia.
    

Detailed description: 
      Not desired.
    

Intervention name(s): Walking uphill; Walking downhill
Intervention type(s): Other; Other
Intervention description(s): ascending about 500 m; descending about 500 m
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: glucose tolerance, hypoxia, myokines, exercise