bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Study of S-1 in Combination With Radiotherapy in Locally Advanced or Recurrent Gastric Cancer
Condition: Gastrointestinal Neoplasms; Gastric Cancer
MeSH terms: Stomach Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine maximum tolerated dose (MTD), dose limiting
      toxicities (DLT) and recommend a proper dose for our phase II study of S-1 when combined with
      radiation therapy for locally advanced or recurrent gastric cancer.
    

Detailed description: 
      This is a Phase I trial of S-1 given in treatment days with an oral dose from 30mg/m2/d to
      80mg/m2/d, concurrently with radiation in patients with locally advanced or locally recurrent
      gastric cancer. Patients will be treated with external beam radiation therapy in a standard
      manner. S-1 will be administered for 6 dose levels,30/40/50/60/70/80mg/m2/d. Patients will be
      assessed for acute toxicities according to Common Toxicity Criteria for Adverse Effects
      (CTCAE)3.0.
    

Intervention name(s): S-1; S-1; S-1; S-1; S-1; S-1
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): S-1,30mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.; S-1,40mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.; S-1,50mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner; S-1,60mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.; S-1,70mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.; S-1,80mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
Other intervention name(s): an oral fluorinated pyrimidine combination; an oral fluorinated pyrimidine combination; an oral fluorinated pyrimidine combination; an oral fluorinated pyrimidine combination; an oral fluorinated pyrimidine combination; an oral fluorinated pyrimidine combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Combined Modality; Gastric Cancer; Radiation Therapy; S-1
Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of high-definition transcranial direct
      current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The
      investigators hypothesize that subjects will show a decrease in pain symptoms in the active
      anodal stimulation group when compared to sham stimulation.
    


Intervention name(s): High Definition Transcranial Direct Current Stimulation (HD-tDCS)
Intervention type(s): Device
Intervention description(s): Subject will receive active anodal/cathodal and sham HD-tDCS in a randomized, counterbalanced order. Each stimulation session will be separated by at least one week to avoid carryover effects. For both active and sham HD-tDCS the electrodes will be placed over the primary motor cortex, at an intensity of 2mA.
For active anodal stimulation, the anode will be over the primary motor cortex, and the cathodal electrodes (4) will surround the anode in a 3 inch square, duration will be 20 minutes.
For active cathodal stimulation, the cathode will be over the primary motor cortex, and the anodal electrodes (4) will surround the cathode in a 3 inch square, duration will be 20 minutes.
For sham stimulation, the same procedure will be used, however, current will only be active for 30 seconds (current ramping up, then ramping down)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Device Feasibility
Keywords: High-Definition Transcranial Direct Current Stimulation
Randomized Trial to Evaluate the Effectiveness of X-22 as a Smoking Cessation Aid
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized, active controlled clinical trial in which a total of 216 healthy smokers will
      be enrolled and followed over approximately 19 weeks.

      The trial will evaluate the efficacy and safety of using X-22 as a smoking cessation aid.

      Healthy smokers who plan to quit smoking will be screened for eligibility. Subjects will be
      randomized in a 1:1 ratio to 1 of the 2 treatment arms:

        -  Group 1: X-22 Cigarettes (very low nicotine)

        -  Group 2: Active Control Cigarettes The randomization will be stratified by gender.
           Efficacy will be assessed by analysis of cigarette consumption using self-report diaries
           and measurement of exhaled carbon monoxide (CO) and cotinine concentrations.

      Safety will be assessed by evaluation of adverse events, physical examinations, clinical
      laboratory tests, and measurement of heart rate, blood pressure, and body weight at each
      study visit.
    


Intervention name(s): X-22 Smoking Cessation Product; Active Control Cigarettes
Intervention type(s): Drug; Drug
Intervention description(s): The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.; The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional "light" cigarette.
Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking; smoking cessation; quitting smoking
Neuro Imaging and Multimodal Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The present study aimed at measuring cerebral changes in Alzheimer Disease (AD) patients, who
      responded to strict physiological criteria typical of AD pathology. The objective of the
      present study was to identify the earliest alterations in cerebral connections that could
      contribute to the initial episodic memory impairment.
    


Intervention name(s): Neuroimaging
Intervention type(s): Radiation
Intervention description(s): AV45-positron emission tomography
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Oseltamivir Pharmacokinetics in Morbid Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      This trial asks the question: do people of much greater than average body weight need more of
      a drug called oseltamivir than current recommendations suggest. Oseltamivir is a drug given
      to people who have influenza, and currently is also being used to fight the new H1N1
      influenza. Some people of larger than average body weight require larger amounts of drugs to
      see the same effects as others of an average body weight. No studies have ever been conducted
      looking at the possibility of oseltamivir being one of those drugs. Our Study's hypothesis
      states that those of an above average body weight will have different amounts of drug in
      their blood than those of people of normal body weight if they are given the normal amount
      prescribed for influenza. Our study will give oseltamivir to twenty people for 7 days. Half
      of the people will be of normal body weight and the others will be of a much higher than
      normal body weight. Using blood samples the investigators will determine if the amounts of
      oseltamivir are significantly lower in the blood of patients in the above normal body weight
      group.
    


Intervention name(s): Patients with a BMI < 30 given Oseltamivir; Patients with a BMI > 40 given Oseltamivir
Intervention type(s): Other; Other
Intervention description(s): Patients with a BMI < 30 given Oseltamivir; Patients with a BMI > 40 given Oseltamivir
Intervention MeSH terms: Oseltamivir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oseltamivir Pharmacokinetics Obesity; Oseltamivir Pharmacokinetics in Obesity
A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate and compare the relative bioavailability, and
      therefore the bioequivalence of two formulations of Citalopram after a single dose
      administration under fasting conditions.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, 2-period, 2-sequence, crossover design.

      Official Title: Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg
      Tablets in Healthy Male Volunteers/Fasting State

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Citalopram HBr 40 mg tablets, single dose; CelexaTM 40 mg tablets, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Purepac formulated products under fasting conditions; B: Active comparator Subjects received Forest Labs formulated products under fasting conditions
Other intervention name(s): Citalopram; Citalopram
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Citalopram; Healthy subjects
Sunitinib Treatment on Tissue Sodium Accumulation (TSS2)
Condition: Renal Cell Cancer Metastatic; Hypertension; Sodium Imbalance
MeSH terms: Carcinoma, Renal Cell
Study type: Observational

Summary: 
      Here, it is investigated how sunitinib, a tyrosine kinase-inhibitor targeting vascular
      endothelial growth factor receptors, might influence sodium homeostasis in the skin and if
      this is related to a well-described treatment side-effect of sunitinib, hypertension.
    

Detailed description: 
      Tyrosine kinases-inhibitors targeting vascular endothelial growth factor (VEGF)-receptors
      (RTKIs) are increasingly used in oncology in several metastatic tumor types. These agents are
      featured by toxicities including hypertension. According to a new insight, sodium in response
      to a high dietary sodium intake, is accumulated in a hyperosmolar way in the interstitial
      compartment. In response to this high sodium concentration cells of the mononuclear
      phagocytic system (MPS) are activated resulting in an increased production of VEGF-C,
      activation of VEGF type 3 receptors and formation of a lymphatic capillary network, involved
      in clearance of interstitial sodium. Blockade of stimulation of VEGF-C receptors or depletion
      of MPS cells in rodents has been associated with salt-sensitive hypertension.

      Sunitinib is an orally-active, multitarget RTKI mainly used for the treatment of patients
      with metastatic renal cancer and imatinib-resistant gastrointestinal stromal tumors.
      Sunitinib blocks all three VEGF receptors subtypes, including VEGF-receptor type 3.

      The investigators hypothesize that treatment of patients with sunitinib is associated with
      tissue sodium accumulation and this accumulation contributes to the rise in blood pressure.
      Tissue sodium is measured by using a newly developed 23Na magnetic resonance-imaging (MRI)
      technique which allows a non-invasive and contrast agent-free sodium content measurement in
      the muscle and skin of the lower leg.
    

Intervention name(s): Sunitinib
Intervention type(s): Drug
Other intervention name(s): Diagnostic test: 23Na-MRI
Intervention MeSH terms: Sunitinib
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with metastatic renal cell carcinome in the primary care of the Charité -
        Universitätsmedizin Berlin as well as healthy subjects without known disease recruited in
        the Charité - Universitätsmedizin Berlin and healthy volunteers form the Max-Delbrück
        Center of Molecular Medicine
      
Biospecimen description: 
      Blood plasma
    
Keywords: Sunitinib; Tyrosine kinases-inhibitor; Sodium; MRI; Skin
Comparison of Anti-inflammatory Effects of Seroflo and Seretide in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test hypothesis if Sereflo (ICS/LABA) could reduce airway
      inflammation in asthmatic patients in the same as Seretide.
    


Intervention name(s): Sereflo; Seretide
Intervention type(s): Drug; Drug
Intervention description(s): Patients take sereflo (25/125) 2 puffs twice a day for 4 weeks; Patients will take Seretide (25/125) 2 puffs twice a day for 4 weeks
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma
Safety and Efficacy of an Allergen Vaccine in Grass-Pollen Allergy
Condition: Hypersensitivity
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate whether the use of a specific immunomodulatory
      principle (QbG10) together with conventional grass pollen allergen leads to a more rapid and
      more pronounced decrease of sensitivity against pollen than with the grass pollen allergen
      alone
    


Intervention name(s): CYT005-AllQbG10
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Allergy; Grass Pollen; Systemic Immunotherapy
Immune Response Study of Influenza Vaccine
Condition: Influenza Vaccine Allergy; Cell Mediated Reaction
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      An observational clinical study will be performed in subjects aged 12-60 years old to
      describe the dynamic changes of humoral immune/cellular immunity after vaccination of
      influenza vaccine, and to discuss the role of different antibodies against influenza virus
      infection, and to look for possible factors related to side effects with the vaccine.
    

Detailed description: 
      A randomized clinical trial will be conducted to describe immune response of seasonal
      influenza virus vaccine in a single center in China. 200 subjects aged 18-60 years will be
      enrolled under the premise of informed consent and receive one dose of vaccine. All
      vaccinations will be done by specific study personnel, who do not take part in the assessment
      of safety or immunogenicity. Adverse events will be recorded after vaccination and blood
      samples were collected at 0,7,14,28 days for antibody detection and split vaccine
      neutralizing antibody detection, determination of cellular immune function in the same time.

      The clinical program approved by the ethics committee will be performed by the researchers
      independently. Inspectors designated by the sponsor will take meticulous on-site audits to
      ensure the safety specifications during the whole process of research.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Biospecimen description: 
      blood
    
Keywords: influenza vaccine; immune response; dynamic changes
Evaluation of Transdermal Nicotine Replacement Therapy (NRT) Activity Through Metabolic Induction
Condition: Smoking; Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation to determine if auto-induction can be used as a surrogate measure of nicotine
      receptor up-regulation through an observational study using nicotine replacement therapy for
      two weeks and no intervention for two weeks.
    

Detailed description: 
      Studies have shown that prolonged exposure to nicotine reinforces addiction. The act of
      smoking delivers nicotine through lungs into the blood stream. As a result, during smoking
      nicotine levels peak and then when smoking stops levels progressively diminish to a base
      (trough) level. At the peak level a smoker feels rewarded, but at the trough level a smoker
      starts to experience negative withdrawal affects and a desire to smoke. Nicotine Gum and
      Inhalers mimic this smoking behaviour maintaining a peak and trough regime, but nicotine
      patches do not. Instead, nicotine patches deliver a constant base dose considered to be
      either above that of the smokers trough level or at a level where negative withdrawal effects
      are reduced.

      The question arises as to if nicotine levels delivered by a patch are constant and
      potentially above that of the baseline smokers level, does this reinforce the addiction and
      therefore contribute to the high long term relapse rate? To answer this question the
      investigators will be looking at metabolites which the body uses to breakdown nicotine and
      several other enzymes. These metabolites respond to the levels of nicotine in the blood
      stream by increasing or decreasing over time. By testing blood flow, blood and urine the
      investigators are able to gain an insight into how the body is dealing with a constant stable
      dose of nicotine rather than a peak and trough dose. In combination with the questionnaires
      the investigators will be able to determine the level of affect.
    

Intervention name(s): Nicabate 21mg transdermal NRT
Intervention type(s): Drug
Intervention description(s): Nicabate 21mg Transdermal NRT Patch applied daily for 14 days Testing at Baseline, Day 4, Day 14 and 14 days post.
Other intervention name(s): Nicotine replacement therapy
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: NRT; Patch; smoking; addiction
Delivering Geospatial Intelligence to Health Care Providers
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Physician counseling for physical activity, dental services, and academic support services
      such as tutoring could be improved through physician knowledge of local community resources
      and physician counseling directing patients to such services that are near the patient's
      residential address. This study will test the hypothesis that an electronic medical record
      enhanced with geographic information systems can improved physician counseling for physical
      activity, dental services, and academic support services by identifying services that are
      near the patient's residential address and informing MD's of such info at the point of care.
    


Intervention name(s): CHICA GIS (enhanced electronic medical record)
Intervention type(s): Other
Intervention description(s): An electronic medical record enhanced with geographic information systems will assist physicians in directing patients to community resources for increasing physical activity, preventing dental caries or addressing school problems
Other intervention name(s): CHICA GIS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: obesity; overweight; dental caries; school problems; school failure; child BMI > 85th percentile; Needing dental preventive services; Needing academic support for school problems
Growth Hormone, Cardiovascular Risk, and Visceral Adiposity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study will compare growth hormone levels and cardiovascular risk markers in normal
      weight and overweight women and men. In women and men with increased abdominal weight, growth
      hormone (GH) versus placebo will be administered and effects on cardiovascular risk, insulin
      resistance and body composition will be measured.
    

Detailed description: 
      The purpose of this study is to measure growth hormone levels in women and men who are normal
      weight, overweight, and obese. Growth hormone levels will be correlated with body weight,
      body composition, and markers of cardiovascular risk. In overweight or obese women and men
      with increased visceral adiposity and below average IGF-1 levels, growth hormone versus
      placebo will be given for 6 months. Effects of growth hormone treatment on weight, body
      composition, insulin resistance, lipids, and cardiovascular risk markers will then be
      assessed. Study subjects will be followed for an additional six months for these endpoints.
    

Intervention name(s): Nutropin AQ growth hormone; Placebo Growth Hormone
Intervention type(s): Drug; Drug
Intervention description(s): Participants will give themselves injections of growth hormone every night for 6 months.; Participants will give themselves injections of placebo growth hormone every night for 6 months.
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Visceral obesity; Growth hormone; Cardiovascular risk; Insulin resistance