bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of FOLFOX4+Panitumumab vs.FOLFIRI+Panitumumab in Subjects WT KRAS Colorectal Cancer and Liver-only Metastases
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of the combination of
      Panitumumab with FOLFOX 4 Chemotherapy or Panitumumab with FOLFIRI Chemotherapy in Subjects
      with Wild- Type KRAS Colorectal Cancer and liver-only Metastases.
    


Intervention name(s): Panitumumab+FOLFOX-4; Panitumumab+FOLFIRI
Intervention type(s): Drug; Drug
Intervention description(s): Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes.
A cycle of panitumumab is defined as 14 days.
FOLFOX 4 chemotherapy will be administered on day 1 of each 14-day treatment cycle:
Oxaliplatin 85mg/m2 as a 120 minute infusion on day 1 of each cycle
Folinic acid 200mg/m2 as a 120 minute infusion on days 1 and 2
A bolus (2 to 4 minutes) of 5-FU at 400mg/m2 on days 1 and 2
5-FU at 600mg/m2 as a continuous infusion of 22 hour infusion on days 1 and 2; Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes.
A cycle of panitumumab is defined as 14 days.
FOLFIRI chemotherapy will be administered on day 1 of each 14-day treatment cycle:
Irinotecan 180 mg/m2 will be administered over 90 minutes ± 15 minutes on day 1 of each cycle
Folinic acid 400 mg/m2 will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing
A bolus (2 to 4 minutes) of 5-FU at 400mg/m2 on day 1
5-FU at 2400 mg/m2 continuous intravenous infusion over 46-hour ± 2-hour on day 1 of each cycle.
Intervention MeSH terms: Panitumumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal Cancer; Panitumumab; FOLFOX-4; FOLFIRI
Progression Evaluation and Genetic Determinants of Hypertension in Chinese - A Follow-up Study of Taiwan SAPPHIRe
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The purpose of this study is to determine the progression evaluation and genetic
      determinations of hypertension in Chinese
    

Detailed description: 
      Blood pressure is a quantitative trait affected by both genetic and environmental factors. It
      is known that human essential hypertension does not follow a simple Mendelian mode of
      inheritance. Stanford-Asian Pacific Program in Hypertension and Insulin Resistance (SAPPHIRe)
      is an international genetic study, which intends to map the major genetic loci underlying
      hypertension in sibpairs of Asian-Pacific Chinese and Japanese origin. Based on the data
      generated through year 1 to year 5, preliminary analysis has not shown positive results in
      the linkage analysis of genome wide scan data, although association studies of some candidate
      genes give promising results.

      Success in genetic studies may depend on many factors including the selection of the patient
      population, the identification of intermediate phenotypes, the disease subsets, and the
      genetic strategy and methodologies employed. According to our previous analysis, presented in
      SAPPHIRe Steering Committee meetings (twice a year), there is heterogeneity among Chinese and
      Japanese origins.

      In order to reduce heterogeneity of the genetic and environmental background, we will focus
      our investigation on the Chinese population. Furthermore, besides the variables associated
      with insulin resistance, which were collected and studied in year 1 through 5 of SAPPHIRe,
      some more variables will be collected and studied in order to identify most sensible
      intermediate phenotypes and more homogeneous disease subsets.

      Our general approach is to continue analyzing candidate genes as well as perform a complete
      genome search based on the exiting genome-wide scan data together with old and new phenotype
      variables.
    

Observational model: Family-Based
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A follow-up genetic study of Taiwan SAPPHIRe Cohort
      
Biospecimen description: 
      Plasma, serum, urine, and buffy coat
Study of Recombinant Human B Lymphocyte(RC18) Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to initially access the safety and effectivity of RC18 combined
      with standard treatment and Placebo combined with standard therapy in subjects with Moderate
      to severe SLE.
    


Intervention name(s): Placebo plus standard therapy; RC18 160 mg plus standard therapy
Intervention type(s): Biological; Biological
Intervention description(s): Standard therapy comprises any of the following (alone or in combination):
corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin ); Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )
Other intervention name(s): Standard therapy; Standard therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Encouraging Social Inclusiveness as a Means to Improving Academic Performance
Condition: ADHD
Study type: Interventional

Summary: 
      Children's peer relationships in elementary school are important to promote their academic
      learning and their social-emotional development. Many children with or at risk for
      Attention-Deficit/Hyperactivity Disorder (ADHD) have difficulty being accepted and getting
      along with their classroom peers. This study tested a classroom intervention that aimed to
      help improve the peer relationships of elementary school age children, with a particular
      focus on children with or at risk for ADHD.
    


Intervention name(s): Making Socially Accepting Inclusive Classrooms
Intervention type(s): Behavioral
Intervention description(s): Using a consultation model, study staff members met with teachers approximately twice per month and observed them an additional two times per month. The goal was to help teachers implement practices that create a socially accepting classroom climate for children.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: peer relationships
A Study to Compare Oral Absorption of YM060 Between Orally-disintegrating Tablet and Conventional Tablet Under With Water Intake
Condition: Healthy; Plasma Concentration of YM060
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to compare time-course changes of plasma concentration of YM060 orally-disintegrating
      tablet with those of conventional tablet. Tablets will be administered with water.
    


Intervention name(s): YM060
Intervention type(s): Drug
Intervention description(s): oral, with water
Other intervention name(s): ramosetron; Irribow
Intervention MeSH terms: Ramosetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: YM060; ramosetron; orally-disintegrating tablet; OD tablet; bioequivalence
Endodontic Root-canal Treatments Evaluated After Long-term Time
Condition: Root Canal Treatment; Endodontic Disease
MeSH terms: Dental Pulp Diseases
Study type: Observational

Summary: 
      The aim of the study was to evaluate the root canal treatments performed from 1989 to 1995.
      Type of complication, success, new endodontic diseases and number of success were reported.
      Mean clinical parameters were clinical symptoms and presence/absence of apical radiolucency.
    

Detailed description: 
      See previous papers (Pirani et al., Odontology, 2015)
    

Intervention name(s): Root canal orthograde treatment
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Similar geographic provenience
      
Keywords: Endodontology; Endodontics
Molecular Imaging With Erlotinib and Bevacizumab
Condition: Non-Small-Cell Lung Carcinoma
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The patients will be treated with erlotinib and bevacizumab for a six-week period. Imaging
      procedures will be performed at baseline, after one week of therapy and after the six weeks
      of treatment.

      The combination of erlotinib and bevacizumab represents an effective therapeutic strategy in
      NSCLC with the highest response rates ever reported for relapsed NSCLC having been observed
      recently in a phase II trial. Early differentiation of patients profiting and of patients not
      profiting from this therapy is of major relevance for further improving this targeted therapy
      approach and to develop more effective, personalized treatment strategies. We aim at this
      early identification by the combination of molecular and functional imaging tools (FDG-,
      FLT-PET, DCE-MRI), molecular marker analyses in tissue and peripheral blood (EGFR- and KRAS
      mutational status and high throughput mutational profiling in tumor tissue,
      angiogenesis-associated biomarkers and expression profiling in peripheral blood) and
      pharmokokinetic analyses. From the combined analyses of these tools we expect a better
      understanding of the host-drug interaction as a precondition for further improvement of
      erlotinib-bevacizumab combination therapy in NSCLC
    


Intervention name(s): Erlotinib, Bevacizumab; Fluoro-D-glucose; Fluoro-L-thymidine; Gadolinium-DPTA
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Erlotinib 150mg/d d1-d43 p.o. Bevacizumab 15mg/kg b. w. d1, d22, d43 i.v.; Tracer for PET imaging; FLT-PET tracer for imaging; Contrast agent for DCE-MRI imaging
Other intervention name(s): Tarceva; Avastin; FDG-PET; FLT-PET; Gd-DPTA; Magnevist
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NSCLC; Lung Cancer
A Phase I Study in Healthy Volunteers to Assess the Effect of Cytochrome3A4 (CYP3A4) Inhibitors (Diltiazem and Itraconazole) on the Pharmacokinetics (PK) of AZD3293 and the Effects of AZD3293 on the Pharmacokinetics of Midazolam, a Cytochrome 3A4 and Cytochrome 3A5 (CYP3A4/CYP3A5) Substrate
Condition: Healthy Volunteers; Pharmacologic Action
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, open-label, 3-group, fixed-sequence drug-drug interaction
      study to assess the effect of coadministration of multiple-dose itraconazole or diltiazem on
      the single-dose PK of AZD3293 and the effects of coadministration of single- and
      multiple-dose AZD3293 on the single-dose PK of midazolam. The study will also evaluate the
      safety and tolerability of single and multiple oral doses of AZD3293, alone and in
      combination with itraconazole, diltiazem, and midazolam in healthy young subjects.AZD3293 is
      being developed for the treatment of Alzheimer's disease
    


Intervention name(s): Group 1 AZD3293; Group 2 AZD3293; Group 3 AZD3293; Group 1 Itraconazole; Group 2 Diltiazem; Group 3 Midazolam
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): AZD3293 oral solution; AZD3293 oral solution; AZD3293 oral solution; itraconazole capsule; Diltiazem ER tablet; midazolam syrup
Other intervention name(s): beta secretase inhibitor; beta secretase inhibitor; beta secretase inhibitor; azole antifungal; calcium channel blocker; benzodiazepine
Intervention MeSH terms: Itraconazole; Diltiazem; Calcium Channel Blockers; Midazolam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: phase I; healthy volunteers; AZD3293; itraconazole; diltiazem; medazolam; drug interactions; Pharmacokinetics
Crossover Study to Evaluate the Efficacy of LED in Treating the Signs of Contact/Irritant Dermatitis of the Hand
Condition: Contact Dermatitis of Hand
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Irritant
Study type: Interventional

Summary: 
      This study is intended to be a cross over study. Subjects will treat one hand while the
      contralateral hand acts as a control. At the end of 6 weeks the subject will be instructed to
      cease treatment of the test hand and commence treatment of the control hand for 6 weeks.
      Efficacy will be evaluated at 6 weeks after the beginning of the treatment and 12 weeks (end
      of crossover).
    

Detailed description: 
      This is a single-center study intended to be a cross-over study. Subjects will treat one hand
      while the contralateral hand acts as a control. At the end of 6 weeks, the subject will be
      instructed to cease treatment of the test hand and commence treatment of the control hand for
      6 weeks. Efficacy will be evaluated at 6 weeks after the beginning of the treatment and 12
      weeks (end of crossover). There will be no wash-out period during the crossover as this is
      not a systemic drug that has a half-life, and we expect subjects to still be exposed to the
      contact irritants. A crossover trial was chosen since this makes more use of a smaller trial
      group and removes the need for a separate parallel control group, therefore reducing trial
      numbers and allowing all subjects to be given the active treatment.

      Since contact dermatitis is a chronic condition affected by external factors the skin
      condition should persist long enough for the investigator to expose the subject to the
      experimental treatment and measure the response. Since the subjects will still be exposed to
      their contact irritants as part of their daily life there should be no reason to introduce a
      washout period and since each subject acts as their own control, any systemic spread should
      be compensated for.
    

Intervention name(s): handLITE LED device
Intervention type(s): Device
Intervention description(s): handLITETM is a home use wearable LED phototherapy device. The device consists of a flexible silicone glove that contains red and near infrared light emitting diodes (LEDs) and a controller. The LEDs generate the light. The glove is worn on the hand and is held in place by an adjustable Velcro strap.
Intervention model: Single Group Assignment
Intervention model description: Subjects will treat one hand while the contralateral hand acts as a control. At the end of 6 weeks the subject will be instructed to cease treatment of the test hand and commence treatment of the control hand for 6 weeks. Efficacy will be evaluated at 6 weeks after the beginning of the treatment and 12 weeks (end of crossover).
Masking: None (Open Label)
Primary purpose: Treatment
Glucose, Whey Protein and Time to the Next Meal on Mealtime Food Intake in Children
Condition: Obesity
Study type: Interventional

Summary: 
      The investigators hypothesize that glucose and whey protein given 30 and 60 min before a
      pizza meal will exert different effects on food intake in adolescent children, and will
      depend on pubertal stage. Food intake will be measured at 30 and 60 min following a
      glucose(0.75 g of glucose/kg body weight), whey protein (0.75 g of glucose/kg body weight) or
      sweetened noncaloric beverage. Subjective appetite will be measured as well.
    


Intervention name(s): water with glucose; water and whey protein; water with noncaloric sweetener
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 0.75 g/kg body weight of glucose added to water; 0.75 g/kg body weight of whey protein added to water; 0.15 g of sucralose added to water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Clinical Trial of Exercise in Patients With Spinal Muscular Atrophy (SMA)
Condition: Spinal Muscular Atrophy; Neuromuscular Disease
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Neuromuscular Diseases; Atrophy
Study type: Interventional

Summary: 
      This study is being conducted to test whether exercise can be effectively used as an
      intervention to treat Spinal Muscular Atrophy (SMA). In order to answer this question, the
      investigators will enroll 14 subjects with SMA between ages 8 and 50 and ask them to complete
      an 18 month training schedule. At some points subjects will be asked to closely follow a
      specific training regimen and at other points they may be asked to exercise in the same
      manner they do normally. The exercises they will be asked to perform include biking on a
      stationary cycle and lifting hand weights. Subjects will be asked to come in to the clinic
      seven times over the course of the study to perform tests. These tests include motor function
      measures, a physical exam, questionnaires, a exercise capacity test which involves riding a
      stationary bicycle, and test where the subject is asked to walk as far as they can in six
      minutes. The main goal of the study is to see if the subjects who participate in the exercise
      protocol have larger increases in the distance they can walk in six minutes than those who do
      not.
    


Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): Muscle strengthening program using hand weights and resistance bands in combination with a home based cycle ergometry. This home-based exercise program will be performed up to 5 times weekly. Each session will consist of up to 30 minutes of cycling and 30 minutes of strengthening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal Muscular Atrophy; Exercise; Conditioning; Strengthening
Physical Activity and Leisure-time Study (PALS)
Condition: Physical Activity; Weight
Study type: Interventional
Phase: Phase 1

Summary: 
      Physical inactivity is a major public health problem and a primary contributing factor to the
      obesity epidemic. While most Americans do not meet the physical activity (PA) guidelines (30
      min/day, 5 day/wk), they do report watching several hours of TV each day, and frequently site
      "lack of time" as a barrier for engaging in PA. The Physical Activity and Leisure-time Study
      examines an approach convert sedentary TV watching into active TV watching time by having
      adults step in place during commercials (TV commercial stepping).
    

Detailed description: 
      This randomized controlled trial will examine the effects of a PA prescription of TV
      commercial stepping for at least 90 min/day of TV programming, with that of walking at least
      30 min/day (30 min walk) on daily step counts, TV viewing, and diet during a 24 week PA
      intervention. Sedentary, overweight or obese, adults will be randomly assigned to either the
      TV commercial stepping, or 30 min walk group during a 24-week behavioral PA intervention.
      Both groups will attend 8 sessions, but receive different PA goals. PA, TV watching time,
      diet, and anthropometric data will be collected at 0, 12, and 24 weeks. It is hypothesized
      that the TV commercial stepping condition will, show an equal increase in PA at 12 and 24
      weeks as compared to the 30-min walk condition. Neither group is hypothesized to demonstrate
      changes in TV viewing time, dietary intake, or weight.
    

Intervention name(s): TV commercial stepping; 30-min walk
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants were instructed to stand and "briskly" step in place, or "briskly" walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention; Participants were instructed to use "brisk" walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention
Other intervention name(s): novel exercise prescription; standard physical activity prescription
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Physical activity intervention; walking; TV; sedentary
The Role of Novel Organisms in Acute Endometritis
Condition: Pelvic Inflammatory Disease
MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection; Endometritis
Study type: Observational

Summary: 
      The goal of this project is to identify the microorganisms present in the endometrial samples
      obtained from women with or without evidence of endometritis using a combination of culture
      methods, rRNA sequencing and whole genomic sequencing. The overarching aim of these studies
      is to identify the etiology of endometritis. The investigators will define the role of
      fastidious anaerobic microorganisms in the etiology of PID, and assess whether antibiotic
      treatment regimens used for the treatment of PID have activity against the novel organisms
      linked with pelvic infections.
    


Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): Not Applicable- no intervention
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Endometrial biopsy samples from women participating in University of Pittsburgh IRB
        PRO10010112 and PRO10010159
      
Biospecimen description: 
      Endometrial biopsy specimens and isolates may be retained and stored in various registries
      such as:

        1. Human Microbiome Project

        2. J Craig Venture Institute

        3. PathoGene

        4. American Type Culture Collection

        5. CGS MindTouch Wiki hosted on Amazon's Elastic Compute Cloud
           (http://www.amazon.com/gp/browse.html?node-3435361)52 and will utilize MindTouch's
           Amazon Machine Image of their Wiki platform for rapid deployment