bioihbjkbjnl/mcl2 huggingface dataset:
Single Dose Escalation Trial to Evaluate the Safety, Tolerability Pharmacokinetics and Pharmacodynamics of GSK3050002
Condition: Colitis, Ulcerative
MeSH terms: Colitis, Ulcerative
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety, tolerability and
      pharmacokinetics of GSK3050002 in humans. Subjects will attend the clinical unit for a
      screening visit and if eligible and consenting, will attend to participate in the study
      within 30 days. Subjects will be admitted to the clinical unit the evening prior to dosing
      when each subject will receive a single intravenous dose of GSK3050002 or placebo, then
      remain in house under supervision until discharged on Day 3. Subjects will then return for 7
      outpatient visits scheduled over the following 81 days. Finally, the follow-up visit will be
      7-14 days following the last visit.
    


Intervention name(s): GSK3050002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK3050002 is a white to off-white lyophilized powder that will be reconstituted with sterile water for intravenous infusion. It is available in the concentrations of 0.1 milligram (mg)/kg, 0.5 mg/kg, 1 mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg.; Placebo contains normal saline (0.9% sodium chloride) for intravenous infusion
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: safety; GSK3050002; CCR6 receptor; single dose escalation; Phase 1; CCL20
A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
Condition: Non-infectious Anterior Uveitis; Uveitic Glaucoma
MeSH terms: Glaucoma; Uveitis; Uveitis, Anterior; Iridocyclitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops
      compared to active comparator in subjects with active non-infectious anterior uveitis with or
      without uveitic glaucoma
    


Intervention name(s): TRS01; FDA approved steroid eye drop (masked)
Intervention type(s): Drug; Drug
Intervention description(s): TRS01 eye drops Dosed four times a day (QID); FDA approved steroid eye drop Dosed four times a day (QID)
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Neoadjuvant Erbitux Based Chemotherapy for Locally Advanced Oral/Oropharyngeal Cancer
Condition: Locally Advanced Malignant Neoplasm; Oral Cancer; Oropharyngeal Carcinoma; Effects of Chemotherapy
MeSH terms: Neoplasms; Mouth Neoplasms; Oropharyngeal Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      EGFR is a potential target for new anticancer therapy in head and neck squamous cell
      carcinoma, because blocking the EGFR by a monoclonal antibody results in inhibition of the
      stimulation of the receptor, therefore, in inhibition of cell proliferation, enhanced
      apoptosis, and reduced angiogenesis, invasiveness and metastases. The study hypothesis is
      that neo-adjuvant Erbitux-based chemotherapy followed by surgery and radiotherapy for locally
      advanced oral/oropharyngeal cancer could benefit the patients on prognosis. The endpoints of
      this study are the pathological complete response after neo-adjuvant Erbitux-based
      chemotherapy followed by surgery and radiotherapy, the survival rate, and the safety.
    

Detailed description: 
      The primary endpoint of this study is the pathological complete response after neo-adjuvant
      Erbitux-based chemotherapy followed by surgery and radiotherapy. The second endpoint of this
      study is the disease free survival rates (1, 2, 3, 5 years), locoregional control rates (1,
      3, 5 years), overall survival rate (3, 5 years), and the safety.
    

Intervention name(s): Neo-adjuvant Erbitux-based chemotherapy
Intervention type(s): Drug
Intervention description(s): Name/Substance: Erbitux Formulation: 2 mg/ml or 5 mg/ml Dose: 400 mg/m^2 initial, and then 250 mg/m^2 weekly Route: Intravenous infusion Frequency & treatment mode: Weekly Duration: 6 weeks
Name/Substance: Docetaxel Formulation: Liquid (20 mg/2 ml) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)
Name/Substance: Cisplatin Formulation: Powder (30 mg) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)
Other intervention name(s): Followed by surgery and radiotherapy
Intervention MeSH terms: Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral cancer; Oropharyngeal cancer; Induction chemotherapy; Targeted chemotherapy; Surgery; Radiotherapy
Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI
      201335 at a dose of 120 mg once daily, with a 24-week background of pegylated
      interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with
      hepatitis C virus (HCV) genotype 1
    


Intervention name(s): BI 201335; BI 201335; Pegylated Interferon-alpha (IFN); Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): BI 201335; BI 201335; Pegylated Interferon-alpha; Ribavirin (RBV)
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of the Enhanced Summer Food Service Program on Schoolchildren
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Convergent findings from several studies document that children, especially those who are
      already overweight or obese or from racial / ethnic minority groups, are at risk for
      accelerated weight gain during the summer months. Therefore, this project is comprised of
      three separate community-based interventions designed to increase access to healthy meals and
      physical activity opportunities to minimize excess summer weight gain in elementary school
      children from a diverse, low-income Rhode Island community. Specifically, we will complete a
      quasi-experimental study in which we will design and deliver a physical activity intervention
      in conjunction with the Summer Food Service Program (SFSP) to 50 children living in a
      low-income, urban community. We anticipate that the addition of physical activity programming
      to the SFSP, a federal program funded by the USDA which reimburses states for serving lunch
      meals to children during the summer in communities where at least 50% of students are
      eligible for free or reduced-price school meals, will increase both the acceptability and
      effectiveness of the SFSP and affect 1) physical activity levels, 2) sedentary behavior, and
      3) diet quality. The primary outcome (change in BMI z-score) will be compared between the 50
      kids enrolled in the active intervention and 50 children enrolled in the control condition,
      both recruited from the same community.
    


Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Physical activity programming in accordance with the SPARK - After School curriculum as well as engaging activities provided by local community partners. The intervention proceeded the SFSP lunch meal service, so that children received approximately three hours of physical activity programming daily.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Summer; Diet; Physical Activity; Sedentary behavior; Low-income
Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome
Condition: Obstructive Sleep Apnea; Sleep Hypopnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to determine whether treatment with Armodafinil
      (CEP-10953) is more effective than placebo treatment for patients with residual excessive
      sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring
      mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version)
      (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change
      (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit).
    


Intervention name(s): Armodafinil 150 mg/day; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Armodafinil 150 mg once daily in the morning; Matching placebo tablets once daily
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Excessive Sleepiness; Obstructive Sleep Apnea; Obstructive Sleep Hypopnea; nCPAP; Cephalon; Cephalon, Inc; Nuvigil
To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Forlax® is more effective than placebo in
      relieving chronic constipation in children who may also suffer from soiling or faecal
      incontinence.
    


Intervention name(s): PEG 4000 (Forlax®); Lactulose active and Lactulose placebo
Intervention type(s): Drug; Drug
Intervention description(s): Powder for oral solution. 2 sachets of 4g, from baseline every two weeks over a 4 week treatment period.; Powder for oral solution. 1 sachet of 3.3g lactulose active and 1 sachet of lactulose placebo. From baseline every two weeks over a 4 week treatment period.
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of High Speed Laser Doppler Imaging Technology
Condition: Hay Fever
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      Skin prick tests (SPT) are commonly used in daily allergological practice to assess skin
      reactivity to allergens. Multiple factors can contribute to non-optimal results of
      conventional wheal and flare measurement (CWFM) of SPT such as inaccurate measurements,
      observer-dependency and absence of traceability.

      This study aims to evaluate the quantification of SPT by a novel High Speed Laser Doppler
      Imaging (HSL-DI) and to compare it with CWFM. First, SPT with birch and/or grass pollen
      extracts as well as positive and negative controls will be performed in 20 volunteers (11
      atopics, 9 non-atopics) to establish the characteristics (cut-off, optimal reading time and
      allergen concentration) of HSL-DI analysis based on two parameters ("area" and "flow"
      measurement). In a second step, fifty patients will be tested with birch and grass pollen
      extracts at optimal allergen concentration and time window. Analysis of SPT by HSL-DI and
      CWFM will be compared.
    


Intervention name(s): Allergy test reading
Intervention type(s): Procedure
Intervention description(s): Reading of allergy skin tests (in response to allergen extracts or histamine or negative control) by HSL-DI versus direct observer evaluation (CWFM)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
fMRI of Vulnerable Brain Regions in Persons at Risk for Alzheimer's Disease
Condition: Magnetic Resonance Imaging; Alzheimer's Disease; Dementia; Adult Children; Risk
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      The purpose of this study is to investigate the organization of memory and develop future
      methods for early detection of AD. Using functional magnetic resonance imaging (fMRI), we
      examine the responsiveness of the brain to memory tasks, specifically focusing on regions of
      the brain (the mesial temporal lobe and posterior cingulate) that are known to be involved in
      early stages of Alzheimer's disease (AD). Of interest are differences in brain activation
      between people with and without a family history of AD and other risk factors.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons with a parent with Alzheimer's disease will be recruited from the Wisconsin
        Registry for Alzheimer's Prevention (WRAP). Persons with MCI will be recruited from the UW
        clinics and satellite clinics. Controls for the above study groups will be recruited from
        the WRAP and the local community.
      
Biospecimen description: 
      plasma and serum
Adipokines in Obese Adolescents With Insulin Resistance
Condition: Obesity
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare serum concentrations of inflammatory cytokines,
      interleukin 6 (IL-6), High-sensitivity C-reactive protein (hs-CRP), adiponectin, and tumour
      necrosis factor alpha (TNFα), before and after three months treatment with metformin in obese
      adolescents with insulin resistance (IR).
    

Detailed description: 
      The increased prevalence of obesity in pediatric patients is a public health problem
      particularly because of the difficulties involved with changing lifestyles. Current studies
      of obese children and adolescents show increased insulin resistance (IR) and chronic
      inflammatory states. These conditions increase the risk of disability and/or premature death.

      The current treatment schemes for obese children are conservative and are focused on changing
      their lifestyles (exercise and dietary plans). However, metabolic conditions, such as IR,
      dyslipidemia, and inflammatory processes, are perpetuated.

      Metformin is a biguanide that is used for adolescents with diabetes mellitus and polycystic
      ovarian syndrome. Several clinical trials with metformin for obese pediatric patients have
      observed decreases in IR, decreases in weight, and improvements in lipid metabolism.

      Adipose tissue is not only an energy repository, but also plays an immunological role by the
      secretion of cytokines. Both overweight adults and adolescents show decreases in adiponectin
      levels and increases in tumor necrosis factor alpha (TNFα) and interleukin 6 (IL-6). IL-6 can
      stimulate the production of high-sensitivity C-reactive protein (hs-CRP), which is considered
      to be a risk marker for the development of cardiovascular disease.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.; Tablet of 500 mg oral placebo every 12 hours for 3 months.
Other intervention name(s): Dabex
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metformin; Obesity; Insulin resistance; Interleukin six; Adiponectin; High sensitivity C reactive protein.; Tumour Necrosis Factor alpha
Role of the Orexin Receptor System in Stress, Sleep and Cocaine Use
Condition: Cocaine Use Disorder; Anxiety
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness of a medication called suvorexant
      in reducing anxiety, improving sleep, and reducing cocaine cravings or cocaine use.
    

Detailed description: 
      Preclinical research has established important functions for the orexin system in mediating
      arousal/sleep, stress, and cue-induced reinstatement of drug taking (e.g., relapse). The role
      of stress/anxiety and drug cue reactivity in human drug relapse is well established, but to
      date, the role of the orexin system in modulating these phenomena has not been examined in
      humans with substance use disorders (e.g., cocaine). The goal of the present first-in-human
      study will be to examine the effects of an orexin antagonist (suvorexant) on interactions
      among stress/anxiety, sleep, and drug-cue reactivity. The study will utilize a battery of
      highly sensitive, drug-specific, laboratory measures of drug cue reactivity (a relapse risk
      model), and well-established metrics of stress/anxiety and sleep. The hypothesis is that
      antagonism of the orexin system will attenuate the link between (1) stress/anxiety and drug
      cue reactivity, and (2) sleep and drug cue reactivity. These results will elucidate a unique
      biochemical mechanism for understanding relapse, and provide a potential medication target
      for relapse prevention.
    

Intervention name(s): suvorexant; Placebo (for suvorexant)
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM.; Subjects will receive placebo capsules once daily at 10 PM.
Other intervention name(s): Belsomra; corn starch
Intervention MeSH terms: Suvorexant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine; sleep; anxiety; craving; addiction; orexin; cue reactivity; suvorexant; Belsomra
Assessment of Potential Interactions Between Cocaine and RPR 102681 - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess Potential Interactions Between iv Cocaine and RPR
      102681
    

Detailed description: 
      Phase I, Double-Blind, Placebo-Controlled Dose Escalating Assessment of Potential
      Interactions Between Intravenous Cocaine and RPR 102681
    

Intervention name(s): Cocaine-Related Disorders
Intervention type(s): Drug
Intervention MeSH terms: Cocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: cocaine dependence
Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke
Condition: Ischemic Stroke; Cognitive Decline; Dementia
MeSH terms: Stroke; Dementia; Ischemic Stroke; Cerebral Infarction; Ischemia; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim of this randomized controlled study is to test if intensive polyintervention therapy
      including life style modifications targeting at reduction of modifiable risk factors of
      stroke can reduce the risk of post-stroke cognitive decline compared to a group of patients
      receiving standard care.
    

Detailed description: 
      Stroke is the second most frequent cause of death and cognitive deficits including dementia
      occur frequently following a stroke. The frequency of cognitive disturbances has been
      reported up to 30% and thus occurs three times more frequent than recurrent stroke (10%).
      Major attempts have been made to prevent the occurrence of new strokes by means of effective
      strategies including preventive drugs. In contrast, hardly any studies have been performed
      addressing the prevention of deteriorating cognitive function following a stroke. In spite of
      this high prevalence therapeutic possibilities are extremely limited. It must be expected
      that cognitive deficits become even a more frequent disability following stroke. This is
      caused by the increased aging of the population leading to further increase of incidence,
      furthermore that more people survive their acute stroke due to increased possibilities of
      acute treatment, and that frequent risk factors (e.g. hypertension, diabetes) are
      increasingly controlled, thus leading to less severe strokes with less severe and permanent
      motor deficits, but an increase of potentially disabling cognitive disturbances. The aim of
      this randomized controlled study is to test an intensive multiple intervention therapy for
      the first time in stroke and to add life style modifications targeting modifiable risk
      factors for cognitive deterioration.

      It is hypothesized that the risk of post-stroke cognitive decline can be significantly
      reduced compared to a control group with standard care when using polyintervention. These
      interventions will focus on nutrition, exercise, cognitive and social activity and monitoring
      and management of metabolic and vascular risk factors. Regular contacts with the subjects
      shall increase motivation and adherence to the study protocol.
    

Intervention name(s): Motivation and lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: prevention; cognitive decline; post-stroke dementia; life-style intervention; vascular risk factors; polyintervention; multifactorial treatment
Outcome Study of Complex Distal Radius Fractures
Condition: Distal Radius Fractures
MeSH terms: Fractures, Bone; Radius Fractures; Wrist Fractures
Study type: Observational

Summary: 
      The purpose of this study is to collect information about how people do after different
      treatments of a broken wrist to see if one treatment has better results.
    

Detailed description: 
      Complex distal radius fractures are a common problem treated by orthopaedic surgeons. The
      purpose of this study is to compare the outcome between complex distal radius fractures
      treated with open reduction and internal fixation using a volar fixed angled plate versus and
      external fixator versus DRV. The hypothesis is that the volar fixed angled plate will have a
      superior outcome both radiographically and clinically.
    

Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        Orthopaedic clinic
      
Keywords: distal; radius; fractures