bioihbjkbjnl/mcl2 huggingface dataset:
Pounds Off Digitally (POD): The Use of Podcasting and Mobile Media to Promote Weight Loss
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional
Phase: Phase 1

Summary: 
      Overweight and obesity play a role in both cancer incidence and survival rates. Many people
      have found attending weight loss support groups to be time-intensive. Past research has shown
      electronic media, particularly the Web, to be effective in producing weight loss. The Web,
      however, lacks portability, which prevents people from accessing the information when it is
      convenient for them. Providing weight loss information via podcasting (audio files that may
      be listened to on portable audio players) may allow people to receive weight loss tips
      anywhere. A previous research study showed that podcasts emphasizing healthy eating and
      exercise can help people lose weight. This study was short-term and did not include
      additional social support. The purpose of this research project is to assess the
      effectiveness of a weight loss intervention delivered through podcasts as compared to the
      same podcast with added mobile media such as self-monitoring software (such as a pedometer)
      and support delivered via a social networking site. For this research study, the
      investigators will conduct a 6-month study in 104 overweight adults to determine if a podcast
      plus mobile media support leads to greater weight loss than a podcast alone.
    


Intervention name(s): Podcasting + mobile media
Intervention type(s): Behavioral
Intervention description(s): Use of a weight loss podcast designed with health behavior theory
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vascular Implant Safety and Efficacy Study
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Assessment of the safety and clinical performance of a coronary stent system in de novo
      coronary artery lesions
    


Intervention name(s): Stent
Intervention type(s): Device
Intervention description(s): Implantation of coronary stent in de novo coronary artery lesions
Intervention model: Single Group Assignment
Intervention model description: consecutive enrolment of cohort 1 (primary endpoint at 1 month), and cohort 2 (primary endpoint at 9 months)
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Neprilysin on Glucagon-Like Peptide-1 in Patients With Type 2 Diabetes
Condition: Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Glucagon-like peptide-1(GLP-1) is secreted during a meal and increases glucose induced
      insulin secretion. The enzyme dipeptidyl peptidase 4(DPP-4) cleaves intact GLP-1 within
      minutes and DPP-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. A
      few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the
      degradation of GLP-1 but if this is the case in humans with type 2 diabetes is unknown.

      We therefore administered a NEP inhibitor, 194mg sacubitril, a DPP-4 inhibitor (sitagliptin
      100mg the night before and 100mg 2 hours before), both, or placebo, to patients with type 2
      diabetes during a standardized meal and measured plasma concentrations of GLP-1
    


Intervention name(s): Entresto; Sitagliptin; Valsartan; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose administration of entresto; Single dose administration of sitagliptin; single doses administration of valsartan; placebo day
Intervention MeSH terms: Sitagliptin Phosphate; Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GLP-1; Neprilysin; Diabetes
A Study of Azithromycin in HIV-Infected Patients
Condition: Bacterial Infections; HIV Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the dose proportionality of azithromycin concentrations and toleration when
      delivered in tablet formulation to HIV-infected patients.

      The need exists to further assess the antibacterial agent azithromycin at differing doses in
      an HIV-infected population.
    

Detailed description: 
      The need exists to further assess the antibacterial agent azithromycin at differing doses in
      an HIV-infected population.

      Patients are randomized to receive azithromycin at 1 of 2 doses in a two-treatment,
      two-period, cross-over study. Dosing visits are separated by at least 14-day wash-out
      periods.
    

Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention MeSH terms: Azithromycin
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Azithromycin; Bacterial Infections
Effect of Intravenous Immunglobulin (IVIG) After Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      The instigators hypothesize that IVIG, given in the acute phase following MI in patients at
      risk for developing HF, will improve cardiac performance, and by attenuating cardiac
      remodeling in this phase, such therapy will prevent the development of chronic HF resulting
      in long term beneficial effect also after the therapy has been stopped.
    

Detailed description: 
      This double-blind placebo-controlled study represents a new approach to cardiovascular
      disease. The project deals with unresolved issues in the intersection between cardiology,
      immunology and molecular biology.

      IVIG/placebo will be given as an induction therapy for 5 days and thereafter as monthly
      infusions for 5 months. Change in left ventricular remodeling will be assessed at baseline,
      and 6 and 12 months with MRI and echocardiography.

      The objectives are:

        1. The primary objective of this study is to evaluate the effect on IVIG on LV remodeling
           and function: LV remodeling will be evaluated with magnetic resonance imaging (MRI)
           which offers an unsurpassed precision in the measurements of heart volumes and function.
           End points will be LV-end systolic and diastolic volume (LVESV, LVEDV), regional wall
           motion score index (WMSI), and LV-ejection fraction (LV-EF).

        2. The secondary objective of this study is to evaluate the effect on IVIG on the
           myocardial marker B-Type Natriuretic Peptide (BNP). BNP is a sensitive marker of the
           degree of HF besides being a prognostic indicator 18-20.

        3. The tertiary objective of this study is to evaluate the effect on IVIG on:

           a. Quality of life. b. Effect on New York Heart Association (NYHA) functional class. c.
           Effect on immunological variables. i. Inflammatory cytokines such as TNF-alpha, IL-6,
           IL-18. ii. Anti-inflammatory cytokines such as IL-10 and transforming growth factor beta
           iii. Chemokines such as monocyte chemoattractant protein 1, IL-8 and CCL21. iv.
           Regulators of hypertrophy such as matrix metalloproteinases, their endogenous inhibitors
           (i.e., TIMPs) and procollagen III N-terminal.

           d. Effect on neurohormones. e. Withdrawals. f. Side effects.
    

Intervention name(s): Octagam (IVIG)
Intervention type(s): Drug
Intervention description(s): Intravenous immunoglobulin 0.4 g/kg given as infusion
Other intervention name(s): Intravenous immunoglobulin 0.4 g/kg given as infusion
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Heart failure; Myocardial infarction; Patients with acute myocardial infarction
A Study of Modified Stem Cells in Stable Ischemic Stroke
Condition: Chronic Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of the clinical study is to determine the safety of a modified stem cell
      SB623 when administered to chronic, stable ischemic stroke patients. A second purpose is to
      determine whether SB623 might improve stroke symptoms. Chronic, stable ischemic stroke
      patients must be between 6 and 60 months after their stroke, and with only this one prior
      stroke, and with no further improvement from physical therapy.
    

Detailed description: 
      Chronic, stable stroke patients have no existing alternative treatments after rehabilitation
      therapy. SB623, a modified stem cell preparation, has been shown to improve motor function
      when administered in animal models of stable stroke. Safety studies in animals have shown no
      adverse events attributed to SB623. Patients who meet the entry criteria for this study will
      have regular examinations, radiological evaluations (CT, MRI, PET), and be followed for two
      years. Regular neurological evaluations will also be done using standard questionnaires, with
      occasional video recording if improvements are evident. Key entry criteria for this study, in
      addition to 6-60 months post-ischemic stroke, include moderately severe symptoms--e.g.,
      difficulty standing or walking, and/or difficulty using arms or hands, and/or speech
      impediments.
    

Intervention name(s): SB623
Intervention type(s): Biological
Intervention description(s): SB623, a modified stem-cell product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Stroke; Stable Stroke; Ischemic Stroke; Fixed Motor Deficits
Neurotherapy to Promote Emotion Recognition in Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder, more prevalent than
      previously thought and heterogeneous in expression, though uniformly characterized by severe
      social disability. The social disability that defines ASD pervades other areas of adaptive
      behavior, is predictive of secondary mental health problems, and adversely affects long-term
      outcome. Although ASD is a chronic condition, there has been little research on interventions
      for adults with ASD. This study proposes to first establish the neural plasticity of specific
      brain mechanisms underlying difficulties with facial emotion recognition, a core deficit
      believed to be pivotal in the behavioral expression of ASD-social disability. The
      investigators will then develop a novel, computer-based intervention using real-time
      feedback, to the user, to ameliorate emotion recognition deficits.
    

Detailed description: 
      Individuals with autism spectrum disorder (ASD) are known to have difficulty in the
      recognition of facial emotion. Such deficits in facial emotion recognition (FER) are thought
      to cause or exacerbate social disability in ASD by preventing 1) accurate detection of
      social/emotional information conveyed through the face and, subsequently 2) the deployment of
      emotionally appropriate responses. Consistent with this model, FER deficits are correlated
      with social disability in ASD and confer morbidity above and beyond core symptoms.

      The long-term goal is to understand how FER networks can be manipulated for therapeutic and
      preventative purposes. In this trial, investigators are testing the feasibility of an
      intervention that capitalizes on our previously developed brain-computer interface (BCI) to
      promote FER in a mixed virtual reality world. The new "FER Assistant" tool (deployed on a
      tablet - iPad) is intended to aid users in detecting emotions and intents of 'avatars'
      inhabiting a virtual world, and will provide users with a highly realistic testbed for
      practicing FER skills in concert with BCI.
    

Intervention name(s): neurofeedback
Intervention type(s): Behavioral
Intervention description(s): real-time feedback on accuracy of emotion recognition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma.
Condition: Asthma, Allergic
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-centre, randomized, double-blind，placebo parallel-controlled phase III study
      to evaluate the efficacy and safety of CMAB007 (recombinant humanized anti-immunoglobulin
      E(IgE) monoclonal antibody for injection) to treat asthma patients who remain not adequately
      controlled despite Med/high ICS plus LABA in China. Following a screening period of up to 2
      weeks and run-in period of 4 weeks, randomized patients will enter a 24-week treatment period
      with CMAB007 or placebo. Efficacy and safety will be assessed at 4-week intervals during the
      treatment period.
    

Detailed description: 
      Approximately 400 asthma patients with an increased serum total IgE level(60-1500
      international unit(IU)/ml) and uncontrolled receiving medium to high dose inhaled
      corticosteroid (ICS) plus long-acting β2-agonist(LABA) will be randomised in about 43 sites
      in China. They will be administered CMAB007 or placebo at a ratio of 2:1 for 24 weeks. During
      the whole study, all subjects will be on regularly fixed combination of med/high ICS and LABA
      (budesonide and formoterol fumarate powder for inhalation or salmeterol xinafoate and
      fluticasone propionate powder for inhalation). They should complete PEF measurement and
      patient diary daily and be assessed every 4 weeks. Spirometry, questionnaires, laboratory
      tests and so on will be performed. At selected sites, about 45 patients will be enrolled in a
      sub-study to assess the pharmacokinetic and pharmacodynamic characterises of CMAB007.
      Anti-drug antibody (ADA) will be sampled at V1, V2 and V7 too.
    

Intervention name(s): CMAB007; Symbicort; Seretide; Ventolin; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): the study drug; asthma-controlled drug; asthma-controlled drug; asthma rescue drug; No active components
Other intervention name(s): recombinant humanized anti-IgE monoclonal antibody; budesonide and formoterol fumarate powder for inhalation; salmeterol xinafoate and fluticasone propionate; Salbutamol sulphate aerosol
Intervention MeSH terms: Fluticasone; Xhance; Budesonide; Albuterol; Formoterol Fumarate; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: placebo parallel-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
James EMBAR® Light Therapy in the Treatment of Burn Wounds of Intermediate Depth
Condition: Burns
MeSH terms: Burns
Study type: Interventional

Summary: 
      This will be a prospective, randomized, single blinded, controlled study in a single center
      setting to assess the effect of either phototherapy with the Embar® light therapy or sham
      irradiation.
    

Detailed description: 
      This will be a prospective, randomized, single blinded, controlled study in a single center
      setting. Patients with burn wounds will be screened for enrollment. All burn wounds that are
      not clearly full thickness on clinical assessment will be treated the first 48 to 72 hours
      with a hydrocolloid gel (Flaminal®) combined with Vaseline gauze. Wounds will be photographed
      on a daily basis. In order to obtain an optimal preparation for Laser Doppler imaging, the
      burn wounds will be meticulously debrided during dressing changes. Patients whose burn wound
      meet the inclusion criteria will be randomized to receive either phototherapy with the Embar®
      light therapy or sham irradiation. Disinfection and topical treatment of the wounds will be
      the same in both groups as well as the treatment regimen after wound closure with special
      pressure garments and hydration.

      Clinical wound assessments, wound tracings (if possible) and digital photographs will be
      conducted at least twice a week till wound healing. Swabs will be taken on admission, the day
      after laser Doppler imaging and from then on a weekly basis. Primary endpoint is complete
      epithelialization of the wound, secondary endpoint is maturation of the scar after one year.
      Follow-Ups will be performed one, three, six and twelve months after wound closure. The
      treatment regimen will consist of custom made pressure garments and hydration of the scar.
      Objective methods will be used during these follow-ups to evaluate elasticity and color of
      the scar, this by using the Dermalab and the Dermaspectrometer, as well as the Vancouver Scar
      Scale, a subjective method.
    

Intervention name(s): Phototherapy with the Embar® light therapy or sham irradiation
Intervention type(s): Procedure
Intervention description(s): Phototherapy with the Embar® light therapy or sham irradiation is followed.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Burn wounds, light therapy
Improving Adolescent Adherence to Hormonal Contraception
Condition: Contraception
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether contraceptive compliance by young women can
      be improved through expanded counseling by a health educator at the initial clinic visit as
      compared with standard care.
    


Intervention name(s): educational instruction and phone follow-up; educational instruction in clinic
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Educational instruction and phone follow-up.; Educational instruction in clinic.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: contraceptive compliance; educational intervention; oral contraception
Therapeutic Approach of Cardiovascular Risk Factors in T2DM by Gender
Condition: Type 2 Diabetes; Cardiovascular Risk Factor; Gender
Study type: Observational [Patient Registry]

Summary: 
      Background: Patients with type 2 diabetes mellitus (T2DM) are at 2- to 4-fold higher risk of
      cardiovascular mortality compared with non-diabetic subjects. Cardiovascular disease (CVD) is
      the main cause of death in almost half of diabetic population in Spain. Female patients with
      T2DM have up to 40% excess risk of CVD compared with men and the causes are still unknown. It
      is argued that a tight control of cardiovascular risk factors could improve the situation.

      Hypothesis: The cardiovascular risk factors management in women with T2DM is different than
      in men with T2DM.

      Aims: To assess the therapeutic approach of cardiovascular risk factors and the occurrence of
      cardiovascular events among women in comparison to men with T2DM.

      Methodology: Observational study based on clinical records of primary health care from T2DM
      patients in Catalonia (2007-2013).

      Source: SIDIAP database. Analysis: The two study groups (women and men) will be matched to
      ensure balance in terms of basal comorbidities and previous cardiovascular disease in order
      to describe the study group characteristics and to perform a multivariate modeling approach.

      Applicability and Relevance: This study is intended to serve to identify the points of
      improvement of the cardiovascular risk factors therapeutic approach in women.
    


Intervention name(s): Current clinical practice in primary care of patients with type 2 diabetes mellitus
Intervention type(s): Other
Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study population is selected from 5,8 million people from the 282 primary care centres of
        the Catalan Health Service identified with an anonymized personal identifier and included
        in a unique patient registry called "SIDIAP" for primary care in Catalonia
Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole
Condition: Neurocysticercosis
MeSH terms: Neurocysticercosis; Cysticercosis; Taeniasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the Phase I study are to evaluate the safety and tolerance of increasing
      single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the
      pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The
      description of agent used is single oral dose of an aqueous suspension of oxfendazole, a
      benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two
      week safety data for the preceding group have been reviewed. If a clinically significant AE
      is observed, and if this event is drug-related the safety monitoring committee will be
      convened to determine whether the study should continue.
    

Detailed description: 
      This Phase I study is a randomized, double-blind, placebo-controlled evaluation of the safety
      and pharmacokinetics of escalating single oral doses of oxfendazole (0.5 to 60 mg/kg) in
      healthy volunteers. Up to 70 healthy males and females (non-chldbearing potential), ages
      18-45 volunteers recruited from one site will participate in this study. The study duration
      is approximately 18 months with subject participation of 2 weeks. The primary objective
      assess the safety and tolerability of oxfendazole in healthy adults. The secondary objectives
      assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole.
      Two sentinel subjects will receive the study product (1 drug/1 placebo) in each group and be
      monitored 48 hours for adverse events prior to completing enrollment of the remaining 8
      subjects in the group.
    

Intervention name(s): Oxfendazole; Placebo
Intervention type(s): Drug; Other
Intervention description(s): A benzimidazole carbamate antiparasitic drug. Oral Dose levels of 0.5,1, 3, 7.5, 15, 30, and 60 mg/kg will be evaluated sequentially, the dose increasing with each new cohort Group 1 to Group 7.; Normal Saline administered with an oral dosing syringe. Group 1- Group 6
Intervention MeSH terms: Oxfendazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: neurocysticercosis; pork tapeworm; Taenia solium