bioihbjkbjnl/mcl2 huggingface dataset:
S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in
      different ways. Some block the ability of tumor cells to grow and spread. Others find tumor
      cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop
      the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving
      erlotinib together with bevacizumab may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab
      works in treating patients with stage IIIB or stage IV primary non-small cell lung cancer who
      have never smoked.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess overall survival of patients with stage IIIB or IV primary non-small cell lung
           adenocarcinoma who have never smoked and are treated with erlotinib hydrochloride and
           bevacizumab.

      Secondary

        -  Assess progression-free survival of patients treated with this regimen.

        -  Assess the response rate (confirmed and unconfirmed, complete and partial) in a subset
           of patients with measurable disease treated with this regimen.

        -  Evaluate the frequency and severity of toxicities associated with this regimen in these
           patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral erlotinib hydrochloride daily on days 1-21 and bevacizumab IV over
      30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression
      or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for up to 3 years.

      PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
    

Intervention name(s): bevacizumab; erlotinib hydrochloride
Intervention type(s): Biological; Drug
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung
Multi-slice CT Coronary Angiography in Patients With Stable Angina
Condition: Chronic Stable Angina
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Observational

Summary: 
      early identification of vulnerable plaques by remodeling index prior to rupture and
      development of acute event is of considerable importance especially by a reliable
      non-invasive method as CT coronary angiography.
    

Detailed description: 
      single-center, cross section, observational study included 150 patients with stable angina
      with normal resting ECG, negative markers, normal systolic function by 2D echocardiography
      (EF>50%) and without regional wall motion abnormality at rest who were referred to MSCT
      evaluation of the coronary artery tree.
    

Intervention name(s): multisclice CT
Intervention type(s): Radiation
Intervention description(s): assessment of the remodeling index by multisclice CT in patients with chronic stable angina
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        evaluation of coronary artery remodeling index in patients with low to intermediate risk
        stable angina by MSCT coronary angiography.
      
Keywords: chronic stable angina; multislice CT; remodeling index
Preference of Protein Intake and FTO rs1558902 Gene Polymorphism Among Women Obese
Condition: Obesity Adult Onset
Study type: Observational

Summary: 
      The concept personalized gene-based nutrition combines genetic information with specific
      dietary intake that is crucial in managing obesity. Obesity experienced by adult women is
      generally caused by inapproriate diet and sedentary lifestyle. Variations in the fat mass and
      obesity-related gene (FTO) has been linked with susceptibility to obesity, but diet seems to
      change the relationship. A single nucleotide polymorphism (SNP) in the fat mass and
      obesity-associated gene (FTO) is a potent predictor of human obesity. Higher protein diets
      were more appropriate than standard protein diets, and frequently recommended as a weight
      loss plan as it prevents the loss of lean tissue mass. Nevertheless, high intakes of proteins
      may adversely affect metabolic functions. Multi studies have explored associated FTO
      polymorphisms with obesity in different populations. However, the contribution of the FTO
      common variants to obesity is controversial in Asian people, some studies showed rs1558902
      was statistically associated with BMI, but other results reported FTO gene is not
      statistically associated with obesity. Given the diversity of Asian populations, the
      investigators generated a hypothesis whether relations between preference protein intake and
      FTO rs1558902 gene polymorphism exist in selected Indonesian obesity women
    

Detailed description: 
      The sample size was calculated based on the difference in the proportion of variation of the
      gene FTO rs1558902 allele A between obese participants, which previous study estimated to be
      approximately 6% for populations from Malaysia. Using a power of 80% and a level of
      significance of 5%, the investigators required 100 obese participants.

      BMI and body fat which were assessed by SECA body analyzer (SECA 201). Blood samples were
      collected after a 12-h minimum fast by Prodia Laboratory for DNA isolation and biochemical
      analysis
    

Intervention name(s): fto gene testing
Intervention type(s): Diagnostic Test
Intervention description(s): Blood samples were collected after a 12-h fasting by Prodia Laboratory for DNA isolation and biochemical analysis
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        healthy woman obese and pre menopause
      
Biospecimen description: 
      whole blood specimen intravenous 5ml
    
Keywords: woman Obese; fto-gen; rs1558902; protein intake
Exploring Voluntary Control of Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Observational

Summary: 
      This pilot study aims to increase the understanding of tinnitus through the identification of
      potentially altered brain networks in patients who are able to voluntarily control or alter
      their tinnitus. Upon completion of this study, new knowledge will be gained about the changes
      in brain activity in people who are able to modify their tinnitus.
    

Detailed description: 
      Certain patients report that they are able to modulate the loudness or pitch of their
      tinnitus temporarily through various means, including attention re-direction or somatosensory
      mechanisms such as oral facial movements or head turn. This subset of patients may represent
      a unique opportunity for the researcher to gain insight into the mechanisms responsible for
      tinnitus.

      Neural activity in the brain has been linked to increases in blood flow and blood
      oxygenation. These changes in the concentration of oxyhemoglobin versus deoxyhemoglobin alter
      the magnetic resonance signal of blood which may then be detected using an appropriate MR
      pulse sequence as blood-oxygen-level-dependent (BOLD) contrast. In addition to increases in
      blood flow due to evoked neural activity, the brain exhibits continuous low frequency
      spontaneous activity. These fluctuations tend to be synchronous in functionally related, but
      spatially distinct, regions of the brain even when not performing a prescribed task. The
      phrase functional connectivity has been used to implicate the neural activity that
      facilitates the coordinated activity of functionally related brain regions.

      This study will use functional connectivity magnetic resonance imaging (fcMRI) to measure the
      network of synchronous brain activity in patients with tinnitus. Several targeted networks
      are those linked to the auditory system, attention, and control systems and the emotion
      systems linked to prefrontal cortex. Previously, functional MRI (fMRI) used changes in blood
      flow and blood oxygenation within the brain to detect which isolated regions of the brain
      were active during a task. The goal of functional connectivity research is to describe a
      pattern of interactions or a picture of the connectivity that occurs within distinct regions
      of the brain when the individual is not involved in a task.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Speciality clinic Community health centers Solicitation of participants from American
        Tinnitus Association and Acoustic Neuroma Society Research database
      
Keywords: Tinnitus; Ringing in ears; Functional connectivity MRI; Voluntary control of tinnitus
Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler®. (Symbicort®)
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study was to compare the efficacy and tolerability of the fixed combination
      beclomethasone/formoterol pMDI with that of budesonide/formoterol dry powder via Turbuhaler.
    

Detailed description: 
      Asthma is a chronic disease that is estimated to affect over 25 million people both in the
      U.S. and in Europe (i.e. approximately 10% of the total population). Pharmacological therapy
      is used to treat reversible airway obstruction, inflammation and hyper-reactivity.
      Medications include preventive treatments in forms of antinflammatory/antiallergic agents
      (i.e. glucocorticosteroids, leukotriene antagonists, cromolyn sodium) and reliever
      treatments, in forms of bronchodilators (i.e. β-adrenergic agonists, anticholinergics). In
      patients treated with inhaled glucocorticosteroids whose asthma is not fully controlled,
      national and international guidelines recommend a stepwise approach. Recent evidence-based
      clinical trials show that the addition of a LABA to inhaled glucocorticosteroids is more
      beneficial in terms of asthma control than increasing the dose of corticosteroids alone.

      COMPARISONS: CHF 1535 (BECLOMETHASONE DIPROPIONATE 100 µg+ FORMOTEROL 6 µg) pMDI via HFA-134a
      compared to SYMBICORT (BUDESONIDE 160 µg + FORMOTEROL 4,5 µg).
    

Intervention name(s): beclomethasone dipropionate plus formoterol fumarate combination; budesonide plus formoterol combination
Intervention type(s): Drug; Drug
Intervention description(s): 100mcg beclomethasone diproprionate plus 6 mcg formoterol; 200mcg budesonide plus 6 mcg formoterol
Intervention MeSH terms: Budesonide; Beclomethasone; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; Combinations; Inhaled therapy; Corticosteroids; Long acting bronchodilators; Beclomethasone; Formoterol; Budesonide
Evaluation of Sleep Apnea Related Inflammation With CRP, ESR and Neutrophil toLymphocyte Ratio
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      There is some evidence suggesting that OSA is associated with low level of systemic
      inflammation and oxidative stress. Low level systemic inflammation and subsequent vascular
      damage has been implicated as the underlying mechanism responsible for comorbidities.
      Detection of altered inflammatory markers in OSAS patients may predict the degree of
      nocturnal sleep disturbance and associated systemic inflammation and presence of
      comorbidities. Recently, novel inflammatory biomarkers, such as neutrophil to lymphocyte
      ratio (NLR) have been proposed as an indicator of systemic inflammation. To our knowledge,
      NLR has not been studied in OSAS. We conducted the present study to evaluate the association
      between OSAS and inflammatory markers CRP, ESR and NLR.
    


Intervention name(s): Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratio
Intervention type(s): Other
Intervention description(s): CRP, ESR and Neutrophil toLymphocyte Ratio values of sleep apnea patients were evaluated with respect to apnea- hypopnea scores.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering from sleep apnea and were referred to perform polysomnoraphy constituted
        the study groups. There were grouped into 4 according to apnea- hypopnea scores: control,
        mild apnea, moderate apnea and severe apnea.
Vitamin D Supplementation for the Prevention of Cardiovascular Risk
Condition: Obesity; Overweight; Insulin Resistance
MeSH terms: Overweight; Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypovitaminosis D is highly prevalent in the general population, particularly in obese
      individuals. Besides being associated with obesity, vitamin D deficiency seems to be involved
      in the pathogenesis of insulin resistance and low-grade chronic inflammation. In addition, it
      has been reported that individuals with low vitamin D levels are at increased risk for
      cardiovascular diseases. A healthy diet and weight loss are cornerstones in the prevention of
      cardiovascular diseases. Vitamin D supplementation could increase the beneficial effects of
      these lifestyle interventions. The purpose of this study is to assess whether vitamin D
      supplementation in conjunction with a hypocaloric diet improves the cardiometabolic profile
      of overweight/obese subjects to a greater extent than diet alone.
    


Intervention name(s): Vitamin D; Placebo (for vitamin D)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Obesity; Insulin resistance; Vitamin D; Cardiovascular risk factors
A Long-Term Study of MP-214 in Patients With Receiving Multiple Drugs Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study is to evaluate the long-term safety, tolerability, and efficacy
      of MP-214 in patients with receiving multiple drugs schizophrenia.
    


Intervention name(s): MP-214
Intervention type(s): Drug
Intervention description(s): Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Antipsychotic Agents; Mental Disorder; Psychotropic Drugs; Dopamine Agents; Central Nervous System Agents
Lavender During Intrauterine Insemination
Condition: Infertility, Female; Anxiety
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      The Researchers hope to learn if by using lavender aromatherapy during an intrauterine
      insemination patients have decreased anxiety and pain at the time of the procedure.
    

Detailed description: 
      Infertility patients have a high level of anxiety before and during infertility treatments
      due to anticipated discomfort of a procedure and anticipation of a long awaited pregnancy.
      Aromatherapy with lavender, an essential oil, has been shown to be effective in reducing
      anxiety and pain in a variety of procedures such as Botox injections, cesarean delivery and
      intrauterine device placement.
    

Intervention name(s): Lavender; Water
Intervention type(s): Other; Other
Intervention description(s): Lavender aromatherapy; Water
Other intervention name(s): Lavandula angustifolia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 3

Summary: 
      The Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related
      Cataract (CTNS) is a 13-year study designed primarily to evaluate the safety and efficacy of
      a vitamin-mineral supplement (Centrum) containing recommended daily-allowance dosage (RDA) in
      preventing age-related cataract or delaying its progression in participants with early or no
      cataract at baseline.
    

Detailed description: 
      Despite dramatic increase in the rates of cataract surgery during the last decades,
      age-related cataract is still responsible for about 50% of cases of severe visual impairment
      in developing countries, and for high and growing health care costs in western countries.
      CTNS was designed to complement the U.S. Age-Related Eye Disease Study (AREDS) by evaluating
      a much broader spectrum of nutrients at RDA dosages. Whereas about 60% of the AREDS control
      group was taking RDA dose multivitamin supplements, none of the participants in CTNS had
      taken any type of nutritional supplement for at least one year before the qualification
      visit. Therefore, the CTNS will be able to evaluate the effect of RDA doses versus no
      supplementation at all. CTNS and AREDS will use similar procedures, including those for
      grading the presence and severity of lens changes.

      CTNS is a randomized,parallel group, placebo controlled, double blinded, single center,
      intervention trial.

      Primary Outcomes: photographic evaluation of a prespecified increase from baseline in
      nuclear, cortical, or posterior subcapsular cataract (PSC) opacity grades or cataract
      surgery.

      Secondary Outcomes: increase in type-specific opacity grade, cataract surgery, and visual
      acuity loss from baseline > or = 15 letters.

      Patients will be followed for a maximum of 10 years.
    

Intervention name(s): Centrum; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Multivitamin/mineral supplement containing US RDA levels of nutrients. 1 tablet a day for the expected duration of follow-up (on average 10 yrs).; placebo tablets manufactured to mimic Centrum tablets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cataract; Nutritional supplements
Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese PCOS Women
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Overweight; Syndrome
Study type: Interventional

Summary: 
      RCT to investigate whether metformin co-treatment would improve IVF outcomes in overweight
      and obese women with PCOS.
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The metformin-treated group received metformin (1000 mg per day) with the start of controlled ovarian stimulation (COH) until the day of the pregnancy check.; Placebo
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Radiolabeled Study to Determine the Mass Balance of [14C] MGL-3196
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is determine in healthy males how MGL-3196 is metabolized using a
      radio-labeled version of MGL-3196.
    


Intervention name(s): MGL-3196
Intervention type(s): Drug
Intervention description(s): oral, 100 mg
Other intervention name(s): VIA-3196
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Tolerability Study of Denufosol in 2-4 Year Olds
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of denufosol 60 mg TID
      in pediatric CF patients 2 to 4 years of age
    


Intervention name(s): denufosol tetrasodium Inhalation Solution; 0.9% w/v sodium chloride solution
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg by oral inhalation three times daily; 0.9% w/v sodium chloride solution by oral inhalation three times daily
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Multicenter Study Comparing the Analgesic Effects and Safety of ABT-639 Compared to Placebo in Subjects With Diabetic Neuropathic Pain
Condition: Diabetic Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      People with diabetes can, over time develop nerve damage throughout the body with symptoms
      such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
    


Intervention name(s): ABT-639; pregabalin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ABT-639 Twice Daily for six weeks.; pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.; Placebo twice daily for 6 weeks.
Other intervention name(s): Lyrica
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetic Asymmetric Polyneuropathy; Symmetric Diabetic Proximal Motor Neuropathy; Diabetic Mononeuropathy Simplex,; Diabetic Autonomic Neuropathy,; Diabetic Amyotrophy; Mononeuropathy; Diabetic Neuropathy; Asymmetric Diabetic Proximal Motor Neuropathy; Diabetic Polyneuropathy; Painful; Diabetic Mononeuropathy; Neuralgia