bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Outcomes of Robotic Versus Laparoscopic Distal Gastrectomy for Gastric Cancer
Condition: Stomach Neoplasm; Robotic Surgery
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to explore the clinical outcomes of the robotic distal
      gastrectomy for patients with gastric adenocarcinoma（cT1-4a, N-/+, M0）.
    

Detailed description: 
      Robotic surgery has been developed with the aim of improving surgical quality and overcoming
      the limitations of conventional laparoscopy in the performance of complex mini-invasive
      procedures. The study is designed to explore the clinical outcomes of the robotic distal
      gastrectomy by comparing short- and long-term outcomes including financial cost of robotic
      and laparoscopic distal gastrectomy in the treatment of gastric adenocarcinoma （cT1-4a, N-/+,
      M0）.
    

Intervention name(s): Robotic Distal Gastrectomy; Laparoscopic Distal Gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): After exclusion of T4b, bulky lymph nodes, or distant metastasis case, robotic distal gastrectomy will be performed in the experimental group.; After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic distal gastrectomy will be performed in the comparator group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stomach Neoplasm; Robotic Surgery; Distal Gastrectomy
Safety, Tolerability, PD & PK of Calcipotriene 0.005% Foam, Under Maximal Use in 12-16 Year Olds With Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects
      with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for
      the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a
      multicenter study in which adolescent subjects (ages 12 to 16 years, inclusive) or their
      primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer to treatment areas
      of the body and scalp, excluding the face, under maximal use conditions, twice a day for 14
      days and once on Day 15. The safety, tolerability, pharmacodynamics, and pharmacokinetics of
      calcipotriene will be evaluated
    

Detailed description: 
      This Phase 1 multicenter, open-label, repeat-dose study is designed to evaluate the safety,
      tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene foam, 0.005%, applied
      topically to adolescent subjects with moderate plaque psoriasis (defined as a score of 3 on
      the Investigator's Static Global Assessment [ISGA]) involving a minimum of 10% body surface
      area (BSA) excluding the face and scalp, and a minimum of 20% scalp involvement. Subjects
      will be enrolled no more than 2 weeks after Screening. Approximately 30 eligible subjects,
      ages 12 to 16 years, inclusive, will be enrolled to ensure 20 completing subjects.
      Calcipotriene foam will be applied as a thin layer twice a day for 14 days and once on Day 15
      on all treatment areas. Blood samples for the evaluation of albumin adjusted calcium, intact
      parathyroid hormone (iPTH), alkaline phosphatase, magnesium, and phosphorus will be taken at
      Screening and on Day 1 (before the first dose), Day 15 (3 to 9 hours after dosing), and on
      Day 22 if the results from Day 15 show any abnormalities. Serum 25-OH vitamin D
      concentrations will be evaluated on Day 1 (before the first dose). Safety and tolerability
      will be evaluated throughout the treatment period and a 7 day follow-up period. Blood samples
      for pharmacokinetic (PK) evaluation will be collected on Days 1 and 15. Urine samples for
      evaluation of calcium/creatinine ratio will be collected before dosing on Days 1 and 15.
    

Intervention name(s): Calcipotriene 0.005% Foam
Intervention type(s): Drug
Intervention description(s): Topical application applied twice a day for 15 days
Other intervention name(s): Sorilux
Intervention MeSH terms: Calcipotriene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: plaque psoriasis; pediatric; adolescent
mTOR and Adipose Tissue Inflammation
Condition: Obesity
MeSH terms: Inflammation
Study type: Observational

Summary: 
      The target of rapamycin complex 2 (TORC2) is an evolutionarily conserved serine/threonine
      protein kinase that controls growth and metabolism. In mammals (including humans), mammalian
      TOR complex 2(mTORC2) contains mammalian TOR (mTOR), RICTOR, mSIN1 protein, and mLST8 gene.
      In an animal model, the adipose-specific rictor knockout (AdRiKO) mouse, systemic insulin
      resistance, hepatic steatosis, and cardiovascular dysfunction develop upon high fat diet
      (HFD)-induced obesity or aging. To find a molecular link between adipose mTORC2 and systemic
      insulin resistance, investigators have already performed transcriptomics and proteomics
      analysis on visceral white adipose tissue in a mouse model. The aim of the study is to
      confirm a molecular link between adipose mTORC2 and systemic insulin resistance in humans.
    


Intervention name(s): Adipose tissue sampling
Intervention type(s): Other
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obese patients (BMI >35 kg/m2) with insulin resistance and lean controls (BMI < 27kg/m2)
        scheduled for elective surgery for non-inflammatory conditions such as gallstone disease,
        diverticular disease or - in the case of obese subjects - bariatric surgery
      
Biospecimen description: 
      Adipose tissue
A Preliminary Investigation of the Efficacy of Aromatherapy in Reducing Discomfort in Youth With Chronic Headache
Condition: Chronic Headache; Migraine Headache; Headache
MeSH terms: Migraine Disorders; Headache Disorders; Headache
Study type: Interventional

Summary: 
      The purpose of this study is to preliminarily establish the extent to which a brief
      aromatherapy intervention incrementally improves subjective and objective indicators of
      discomfort (pain, anxiety, and heart rate variability) beyond passive relaxation in youth
      with chronic headaches. A secondary objective is to establish the safety of using
      aromatherapy as a treatment strategy in youth with chronic headache. The investigators
      hypothesize that children randomized to the aromatherapy condition will demonstrate a greater
      improvement in pain, anxiety, and objectively measured distress (heart rate variability) than
      comparable children receiving only a passive relaxation treatment (a foot bath). The
      investigators further hypothesize that the aromatherapy intervention will be safe and
      well-tolerated by study participants.
    

Detailed description: 
      Complementary and alternative therapies play an increasing role in the multidisciplinary
      treatment of primary pediatric headache disorders. Every pediatric headache patient needs to
      have a personalized and tailored program of education, psychological strategies,
      pharmacotherapy and complementary medicine choices. This particular study may prove desirable
      for parents of children and adolescents with chronic headache. As documented by Termine, C.,
      Ferrari, Ginevra, O., D'Arrigo, S., Rossi, M., & Lanzi, G. (2005), parents are often
      uncertain and fearful of submitting their children to treatment with traditional drugs,
      adolescents can use alternative therapies as a way of affirming their independence, and there
      are fewer drugs available to treat headache in children. Moreover, there is a 30-40% placebo
      response in headache sufferers (Mauskop, 2001). Children and adolescents should not be
      prevented from using alternative treatments, specifically essential oils, provided that the
      intervention is not harmful or costly. It is hoped this study will contribute to the scant
      research that exists and help define the indications, effects and limitations of aromatherapy
      use.
    

Intervention name(s): aromatherapy; foot bath
Intervention type(s): Other; Other
Other intervention name(s): Mentha piperita
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: aromatherapy, peppermint
Pergolide Treatment for Substance Abusers - 4
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of pergolide for cocaine
      dependence.
    


Intervention name(s): Pergolide
Intervention type(s): Drug
Intervention MeSH terms: Pergolide
Primary purpose: Treatment
Keywords: cocaine dependence
First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasm, Residual
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to study the MRD status after VELCADE based induction therapy
      (VELCADE, lenalidomide, dexamethasone or VELCADE, liposomal doxorubicin, dexamethasone) in
      patients with previously untreated multiple myeloma and study the impact of HDC and ASCT on
      MRD status post-transplant. Our hypothesis is that MRD-status will continue to increase
      significantly at 3 months post-transplant and will validate that HDC and ASCT needs to be
      performed even when patients have achieved major response after induction therapy with novel
      agents.
    


Intervention name(s): VELCADE; Lenalidomide; Dexamethasone; DVT prophylaxis; Bisphosphonates; Liposomal doxorubicin; Dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle; 25 mg by mouth on days 1-4 of each cycle; 20 mg the day before and the day after receiving VELCADE; At least one asprin 81 mg per day. Other option per physician's choice; Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.; 30 mg/m2 on day 4 of each cycle; 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
Intervention MeSH terms: Diphosphonates; Dexamethasone; Dexamethasone acetate; Doxorubicin; Liposomal doxorubicin; Lenalidomide; Bortezomib; BB 1101
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
How Much Vitamin D is Needed in Milk Products to Support Vitamin D Intake and Bone Health in Children?
Condition: Healthy
Study type: Interventional

Summary: 
      The study is a parallel interventional randomized dose-response trial designed to improve
      vitamin D intakes through food in a group of healthy 2 - 7.9 year old children. Subjects will
      be recruited from the general population in the greater Montreal area. The study will be
      conducted at the Mary Emily Clinical Nutrition Research Unit of McGill University. Children
      will be required to attend two study visits. Some information will be collected through
      monthly telephone survey to the parents. The investigators will add vitamin D to cheese and
      yogurt for daily consumption at home over a three month period. All products will be provided
      to the parents in the form of coded containers that do not contain any labels aside from the
      group and expiration date. Ingredient lists will be provided upon consenting to the study. To
      better understand vitamin D status; dietary intake, hematology, serum biochemistry including
      25(OH)D, growth, and body composition will be measured at the beginning and end of the three
      month study period. In addition, bone mass at baseline will be assessed. Sun exposure will be
      documented and a skin pigmentation test will be used to more objectively assess chronic sun
      exposure. The investigators will also investigate the association between vitamin D intake
      and status with immune function.
    


Intervention name(s): Vitamin D fortified yogurt and cheese products; Control Group 1
Intervention type(s): Other; Other
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: childhood; healthy; vitamin D; bone; dairy products
Transoral Removal of Specimen During Laparoscopic Gastric Resection
Condition: Gastric Disease; Bariatric Surgery Candidate
MeSH terms: Stomach Diseases
Study type: Observational

Summary: 
      Investigators aimed to present the patients who underwent laparoscopic gastrectomy with
      transoral specimen extraction.
    

Detailed description: 
      Minimally invasive surgical procedures such as NOSE (Natural orifice spesmen extraction) and
      NOTES (Natural orifice translumenal endoscopic surgery) are gradually increasing. The
      transoral way is probably the least used for NOSE.
    

Intervention name(s): transoral specimen extraction
Intervention type(s): Procedure
Intervention description(s): transoral specimen extraction during laparoscopic gastric resection
Other intervention name(s): laparoscopic gastric resection
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients who underwent sleeve gastrectomy for morbid obesity, subtotal gastrectomy for
        pyloric obstruction, and extensive gastric resection for gastrointestinal stromac tumor
Intra-operative Variation in Size of Brain Tumors After Craniotomy
Condition: Brain Tumor, Primary
MeSH terms: Brain Neoplasms
Study type: Observational

Summary: 
      We planned to evaluate the change in tumor dimensions of intraaxial parenchymal tumors after
      craniotomy by comparing the tumor size on intraoperative ultrasonography (IOUSG) with
      pre-operative CECT and CEMRI brain.
    

Detailed description: 
      Background: No previous study to determine the intraoperative changes in the tumor dimensions
      had been undertaken previously. Objectives: We planned to evaluate the change in tumor
      dimensions of intraaxial parenchymal tumors after craniotomy by comparing the tumor size on
      intraoperative ultrasonography (IOUSG) with pre-operative CECT and CEMRI brain. Study Design:
      This was a prospective observational study. Participants: Patients aged 15-65 years
      undergoing surgery at SKIMS for intraaxial parenchymal intracranial tumors were included.
      Methods: Standard pre-operative CECT and CEMRI brain were done to measure tumor dimensions
      and compared with IOUSG.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients above the age of 15 years conferring to Grade I and II of American Society of
        Anesthesiologist (ASA) physical status classification system undergoing elective
        intracranial tumor surgery at our institute in the specified period.
      
Keywords: Parenchymal brain tumors; Intraaxial brain tumors; Gliomas; Glioblastoma multiforme; Low grade glioma; High grade glioma; Intraoperative Ultrasound (IOUS); Tumor Surfacing; Tumor expansion; Contrast enhanced magnetic resonance imaging (CEMRI) brain; Contrast enhanced computed tomography (CECT) brain
Safety of gpASIT+TM Subcutaneously Administered to Hay Fever Patients With or Without Immunoregulating Adjuvant
Condition: Hay Fever
MeSH terms: Rhinitis, Allergic, Seasonal; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to compare the safety, clinical tolerability, immunogenicity and
      efficacy of gpASIT+TM (grass pollen peptides) alone and combined with an immunoregulating
      adjuvant, in a short course administration (5 injections over 4 weeks).
    


Intervention name(s): gpASIT+TM; gpASIT+TM + adjuvant
Intervention type(s): Biological; Biological
Intervention description(s): 1 subcutaneous injection every 7 days during 29 days; 1 subcutaneous injection every 7 days during 29 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: seasonal allergic rhinoconjunctivitis; grass pollen; allergen specific immunotherapy
Lamictal As Add on Treatment in Mixed States of Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      -  To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the
           acute treatment of patients in a mixed state of bipolar disorder.

        -  To evaluate the efficacy and of a combination of LAM+existing regimen of mood
           stabilizers in the maintenance treatment of patients with mixed state of bipolar
           disorder
    

Detailed description: 
      1. To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the
           acute treatment of patients in a mixed state of bipolar disorder.

        2. To evaluate the efficacy and of a combination of LAM+existing regimen of mood
           stabilizers in the maintenance treatment of patients with mixed state of bipolar
           disorder
    

Intervention name(s): Lamotrigine
Intervention type(s): Drug
Intervention MeSH terms: Lamotrigine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mixed mania; lamotrigine
A Study of BIO-11006 in the Treatment of Advanced Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer Stage IIIB
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 is a randomized study in advanced Non-Small Cell lung cancer patients to
      evaluate safety and efficacy of aerosolized BIO-11006 in conjunction with chemotherapy.
    

Detailed description: 
      This randomized, open label, multicenter Phase 2 study is to evaluate safety and efficacy of
      BIO-11006 in Stage IIIB Non Small Cell Lung cancer (NSCLC) patients who are not candidates
      for curative surgery, radiation, or immunotherapy and who are also receiving Pemetrexed and
      Carboplatin as standard of care (SOC). This study will be conducted at ten clinical centers
      in India under an IND from US-FDA and an IND from Indian FDA.

      This is a parallel 2- Arm study in which a total of 60 patients will be randomized. One Arm
      of 30 subjects will receive aerosolized 125mg BIO-11006 BID using Pari eFlow nebulizer in
      conjunction with SOC chemotherapy (Pemetrexed plus Carboplatin). A second Arm of 30 subjects
      will receive only SOC chemotherapy (Pemetrexed plus Carboplatin). The treatment period will
      be three months and nine months survival follow up period (every three months).

      Primary efficacy endpoint will be Progression-free survival (PFS) in patients who receive
      BIO-11006 plus SOC compared to those who receive SOC alone. The secondary efficacy endpoints
      will include: a. Response rate at three months (4 cycles) per RECIST V1.1; (b) overall
      survival; and (c) patient body weight maintenance.
    

Intervention name(s): BIO-11006 plus standard of care; Standard of Care
Intervention type(s): Drug; Drug
Intervention description(s): BIO-11006 is administered 125mg BID plus standard of care.; Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months.
Other intervention name(s): Active drug plus standard of care; Active comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized in 1:1 ratio to either BIO-11006 plus Standard of Care (intervention) or Standard of Care (Pemetrexed plus Carboplatin) (intervention).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung cancer; non small cell; metastasis
Efficacy of Lactobacillus GG (LGG) in Children With Abdominal Pain
Condition: Functional Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      Probiotics play an important role in preventing overgrowth of potentially pathogenic bacteria
      and maintaining the integrity of the gut mucosal barrier. The beneficial effects of
      probiotics have been previously studied in adult patients with IBS. Even though most of the
      studies demonstrate efficacy, other studies do not support these observations. Few studies
      addresses the efficacy of probiotics in children with IBS. The goal of the present study was
      to determine whether oral administration of the probiotic Lactobacillus GG under randomized,
      double-blind, placebo-controlled conditions would improve symptoms of children with abdominal
      pain.
    


Intervention name(s): Lactobacillus GG (probiotic ); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): LGG capsules: each cp containing 3 × 109 colony forming units, CFU; placebo which consisted of capsules identical in taste and appearance to the active study product except for the absence of freeze-dried LGG (and cryoprotectants)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Transnasal Induction of Normothermia in Febrile Stroke Patients
Condition: Stroke, Ischemic; Stroke Hemorrhagic; Fever; Seizures; Metabolic Encephalopathy
MeSH terms: Stroke; Seizures; Brain Diseases; Ischemic Stroke; Hemorrhagic Stroke; Brain Diseases, Metabolic
Study type: Interventional

Summary: 
      The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal
      Thermal Regulating Device in reducing temperature in a population of febrile subjects who
      meet the inclusion/exclusion criteria.
    


Intervention name(s): Transnasal Thermal Regulating Device
Intervention type(s): Device
Intervention description(s): Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: shivering, fever, normothermia