bioihbjkbjnl/mcl2 huggingface dataset:
Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to find out if Interferon-beta (IFN-beta) can recover its effectiveness after a
      washout period in patients with Multiple Sclerosis who have previously developed neutralizing
      antibodies to Interferon-Beta
    

Detailed description: 
      This is an explorative multi-centre, open label, non-comparative trial investigating whether
      it is possible to recover IFN-beta efficacy in breakthrough relapsing-remitting multiple
      sclerosis patients with high titres of neutralizing IFN-beta antibodies.

      Prior to enrollment, treated MS subjects must have been on interferon-beta-1a or
      interferon-beta-1b for a minimum of 12 months and have reduced bioavailability as defined by
      the relative expression of MxA mRNA/GAPDH.

      Subjects will complete a washout period with concurrent methylprednisolone 500mg PO daily for
      3 days every month until they become Neutralizing Antibody negative. Subjects will then be
      challenged with AVONEX 30mcg IM weekly. Bioavailability will be measured every three months
      to determine return of biological activity. Clinical and MRI parameters, safety and
      tolerability will be compared to baseline to determine efficacy.
    

Intervention name(s): Interferon-beta-1a; methylprednisolone
Intervention type(s): Drug; Drug
Intervention description(s): dosage and frequency as per Biogen Idec protocol; dosage and frequency as per Biogen Idec protocol
Other intervention name(s): Avonex
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Methylprednisolone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recovery of efficacy; MxA protein; neutralizing antibodies; Multiple sclerosis
A Study of Vestipitant (GW597599) in the Treatment of Breakthrough Postoperative Nausea and Vomiting (PONV)
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate single IV doses of Vestipitant (GW597599) compared to 4 mg IV
      ondansetron for treating breakthrough postoperative nausea and vomiting (PONV) after failure
      of PONV prophylaxis with a regimen that includes 4 mg IV ondansetron.
    


Intervention name(s): Ondansetron; Vestipitant
Intervention type(s): Drug; Drug
Intervention description(s): Single IV dose; Single IV dose
Other intervention name(s): Zofran; GW597599
Intervention MeSH terms: Ondansetron; Vestipitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Stomatognathic System Assesment, After Different Methods of Establishing the Centric Relation
Condition: Temporomandibular Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Observational

Summary: 
      Patients with complete dentures were examined after the prosthoddontic treatment with two
      methods of establishing a centric relation: wax rims and gothic arch tracing method. The
      effectiveness of establishing a centric relation was evaluated.
    

Detailed description: 
      In the study subjective experiences of patients, wearing complete dentures, were compared.
      Two different methods of determining a centric relation were performed: the traditional
      method using wax occlusal rims and the Gerber method, based on gothic arch tracings. The
      success rate of establishing a centric relation in both methods was evaluated
      (rentgenodiagnostics). The influence of the method used to obtain the centric relation on
      patients stomatognathic system (condyle centralization, pain) was also evaluated. The
      comparison between two methods was performed and results were analyzed. A centric relation
      was analyzed in temporomandibular joints and a corelation between TMD symptoms and centric
      relation was evaluated.
    

Intervention name(s): complete dentures
Intervention type(s): Procedure
Intervention description(s): therapy with maxilla and mandible dentures
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients attending dental office in Germany and in Poland, seeking for dental intervention:
        complete denture
      
Keywords: TMD, centric relation, complete dentures
Body Weight, Sleep, and Heart Health
Condition: Cardiovascular Risk Factor; Circadian Dysregulation; Obesity
MeSH terms: Chronobiology Disorders; Obesity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A multidisciplinary investigation examining the circadian mechanisms regulating
      cardiovascular (CV) risk in obesity. Specifically, in a valid circadian protocol, the
      investigators aim to study resting cardiovascular risk markers and the reactivity of
      circadian rhythms in these risk markers to standardized stressors in obesity. Furthermore,
      using an ingenious approach, the investigators propose to explore impairment in pre/post
      synaptic function in the cardiac left ventricle.
    

Detailed description: 
      Overall, these studies will help us answer whether CV rhythms predispose obese individuals to
      increased CV disease risk - particularly around the vulnerable morning period. The results
      will serve as a foundation for clinical trials of appropriately timed dosing of medications
      targeting aspects of the CV system in obesity that increase effectiveness while decreasing
      side-effects.
    

Intervention name(s): PET Imaging; Circadian Study Protocol; 11C-Meta-Hydroxyephedrine (mHED); 11C-CGP12177; O15-water
Intervention type(s): Radiation; Behavioral; Drug; Drug; Drug
Intervention description(s): Positron Emission Tomography (PET) imaging for research.; 5-day circadian study schedule; 11C-meta-hydroxyephedrine will be used during PET imaging to measure cardiac presynaptic norepinephrine transporter function.; Cardiac beta adrenergic receptor density will be measured via PET imaging with infusion of 11C-CGP12177.; Blood flow will be measured via PET imaging with infusion of O15-water.
Other intervention name(s): 11C-mHED
Intervention MeSH terms: CGP 12177
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Testosterone, Metformin, or Both, for Hypogonadism in Obese Males
Condition: Hypogonadism; Obesity
MeSH terms: Obesity; Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the effects of metformin, testosterone, or both, in
      males with obesity-related hypogonadism. This study will evaluate changes in insulin
      resistance, weight loss, body composition, testosterone levels,quality of life and erectile
      dysfunction.

      Obese men will receive diet and physical activity counselling, and be randomised to either
      testosterone, metformin, a combination of both or placebo
    


Intervention name(s): Placebo; Metformin; Testosterone Undecanoate; Metformin + Testosterone Undecanoate
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Glucophage; Dianben; Nebido; Reandron
Intervention MeSH terms: Metformin; Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypogonadism; Obesity; Erectile Dysfunction; Testosterone; Metformin; Weight Loss; Insulin Resistance
Optical Coherence Tomography Angiography Examinations in Chronic Retinal Artery Occlusion
Condition: Retinal Artery Occlusion
MeSH terms: Retinal Artery Occlusion; Arterial Occlusive Diseases
Study type: Observational

Summary: 
      Purpose of the study is to examine the retinal blood flow in chronic cases of retinal artery
      occlusion with non-invasive, non-contact optical coherence tomography angiography.
    

Detailed description: 
      Occlusion of the retinal arteries is an emergency which causes sudden, painless unilateral
      vision loss. Loss of blood flow causes ischemic damage to the retina. The extent of damage
      depends on the area affected.

      Following the acute phase of the disease re-canalization occurs and lesser blood flow can be
      detected usually without functional recovery.

      Purpose of the study is to examine the retinal blood flow in chronic cases of retinal artery
      occlusion.

      Standard procedures to examine this disease include retinoscopy following pupil dilation,
      fluorescein angiography and more recently, optical coherence tomography (OCT).

      The latest direction in OCT development was OCT angiography (OCTA) which is a software
      upgrade that allows detection of blood flow based on motion contrast. Similar to previous OCT
      machines OCTA is also non-invasive and non-contact and does not require any intravenous
      agents.

      OCT machines are approved in the EU and the US and are not experimental devices.

      The device used in this study is the commercially available Zeiss Cirrus HD OCT Angioplex
      5000 that operates with spectral-domain technology.
    

Intervention name(s): Optical coherence tomography angiography
Intervention type(s): Device
Intervention description(s): OCTA scans per built-in device protocol
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        White caucasias
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of
      IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with
      hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for
      future, longer term studies.
    


Intervention name(s): IDX184; Placebo; Peginterferon alfa-2a (Peg-IFN); Ribavirin (RBV)
Intervention type(s): Drug; Drug; Biological; Drug
Intervention description(s): IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.; Placebo white opaque capsules taken by mouth from Day 1 to Day 14.; Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.; RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
Other intervention name(s): Pegasys
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C; HepC; Hep C
A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The goal of this pilot study is to implement directly observed therapy with preventive asthma
      medications through a partnership with the school nurse (with input and direction from the
      primary care provider) to assure that the teen receives guideline based preventive
      medications, and provide a motivational interviewing intervention to help the teen transition
      to independence with their medical treatment plan. We hypothesize that this community-based
      pilot intervention will; 1) be feasible and acceptable among this population and among school
      personnel, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and
      emergency room / urgent care use for asthma care). We anticipate that enhancing preventive
      healthcare for urban teens with asthma through partnerships with schools will yield improved
      health, prevention of suffering, decreased absenteeism from school, and reduced healthcare
      costs. This new method of preventive care delivery could be sustained within the school
      nursing system, and could be implemented in schools nationwide. Further, it could be applied
      to other chronic illnesses affecting disadvantaged populations.
    


Intervention name(s): Intervention
Intervention type(s): Behavioral
Intervention description(s): Teens participating in this study will have:
directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study
three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Asthma
Vaccine for Recurrent Urinary Tract Infections in Women
Condition: Recurrent Urinary Tract Infections in Women
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is determine whether a vaginal mucosal vaccine given to women with
      a history of recurrent urinary tract infections can reduce the number of infections occurring
      in a six-month study period, as compared to placebo treatment.
    

Detailed description: 
      Recurrent urinary tract infections (UTIs) affect approximately 10% of women in the United
      States. Since antibiotic prophylaxis is not always effective, alternate treatments need to be
      developed. One such treatment would be immunization with a vaccine containing bacteria known
      to cause these infections. The objective of the study is to immunize susceptible women with
      inactivated bacteria contained in a vaginal suppository and to monitor the rates of
      reinfection compared to a group of women treated with placebo suppositories. Each group of
      patients will receive a total of six suppositories in the first four-months of the six-month
      study during which all UTIs and side effects will be recorded. The infection rates between
      vaccine- and placebo-treated women will be statistically analyzed to determine vaccine
      efficacy.
    

Intervention name(s): Immunization with inactivated bacteria
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Phase 2; Vaccine; Urinary Tract Infection; Vaginal Mucosal
Ocular Coil Drug Delivery Comfort Trial
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The Ocular Coil is intended to provide drug delivery to the ocular surface. This study will
      evaluate the safety and tolerability of the placebo Ocular Coil in healthy subjects.
    

Detailed description: 
      This study is designed to evaluate the safety and comfort of a placebo Ocular Coil for 28
      days in 40 healthy subjects.
    

Intervention name(s): Ocular Coil
Intervention type(s): Device
Intervention description(s): Non-invasive ocular device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Can we Reduce the Number of Vaccine Injections for Children?
Condition: Invasive Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This open label randomised controlled study will evaluate the induction of immunity following
      varying schedules of vaccination with glyco-conjugate Neisseria meningitidis serogroup C
      (MenC) vaccines in infancy. 498 infants will be enrolled in this multi-centre trial.
      Participants will receive either 0, 1, or 2 priming doses of a MenC-CRM197 conjugate vaccine
      or 1 priming dose of a MenC-TT conjugate vaccine in the first year of life, with all groups
      receiving a dose of a combination Hib-MenC-TT vaccine at 12 months, as well as all other
      concurrent routine vaccinations. All groups will also be further divided into 2 groups to
      receive their routine vaccines in either consistent or alternating limbs to assess the immune
      response to the concurrent infant routine immunisations administered in consistent versus
      alternating limbs. Immune responses will be assessed at 5, 12, 12months +6 days, 13 and 24
      months of age.
    


Intervention name(s): Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine; Routine schedule immunisations except monovalent MenC vaccine
Intervention type(s): Biological; Biological
Intervention description(s): In order to ensure proper intramuscular injection of the study vaccines, a 23G (0.5mm in diameter) needle of at least 1 inch (2.54 cm) length will be used. All vaccines will be administered intramuscularly.
Then MenC vaccine will administered either once (at 3 months) or twice (at 3 and 4 months) depending on treatment group to either the thigh, deltoid or a combination of the two.; Routine schedule immunisations will be given according to NHS guidelines.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: meningococcal serogroup C; vaccine; conjugate
The Relationship Between Hormone Sensitivity and Imaging of Idiopathic Interstitial Pneumonia by Artificial Intelligence
Condition: Idiopathic Interstitial Pneumonia
MeSH terms: Pneumonia; Lung Diseases, Interstitial; Idiopathic Interstitial Pneumonias; Hamman-Rich Syndrome; Pulmonary Fibrosis; Hypersensitivity
Study type: Observational

Summary: 
      Application of artificial intelligence deep learning algorithm to analyze the relationship
      between hormone sensitivity of idiopathic interstitial pneumonia and imaging features of high
      resolution CT.
    

Detailed description: 
      Methods: the medical records and chest high-resolution CT images of patients with idiopathic
      interstitial pneumonia admitted to the respiratory department of the Third Hospital of Peking
      University from June 1, 2012 to December 31, 2020 were retrospectively analyzed.Application
      of artificial intelligence deep learning neural convolution network method to create
      recognition technology of different imaging features.Including ground glass, mesh, honeycomb,
      nodule or consolidation, the model was established. IIP patients were divided into hormone
      sensitive group and hormone insensitive group according to whether the use of hormone was
      effective or not.Logistic regression analysis was used to analyze the correlation between
      statistically significant parameters and hormone sensitivity.Artificial intelligence was used
      to establish the correlation model between imaging features and clinical data and hormone
      sensitivity.
    

Intervention name(s): high resolution CT
Intervention type(s): Radiation
Intervention description(s): Ground glass，honeycomb，reticulation, consolidation
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From June 1, 2012 to December 31, 2020, all inpatients with IIP were admitted to the
        respiratory and critical care department of the Third Hospital of Peking University. Total
        patients are 150, 45 patients using hormone, average age 62 years old, 21 male.
      
Keywords: Hormone sensitivity; imaging features; artificial intelligence
Acamprosate: Genes Associated With Response
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Observational

Summary: 
      In 2004, acamprosate was approved in the U.S. for abstinence maintenance, by decreasing
      craving, in alcoholic patients who have undergone detoxification. while a new anti-craving
      drug was encouraging, only 36.1% of the subjects treated with acamprosate remained abstinent
      for 6 months. Having the ability to identify treatment responsive individuals would have a
      major impact on the use of acamprosate.
    

Detailed description: 
      The primary objective of this pharmacogenomic probe study of acamprosate is to identify
      genetic variations that predict response. Our hypothesis is that effective acamprosate
      response in alcohol dependent subjects may be influenced by genetically controlled variation
      in the functionality of the N-methyl-D-aspartate receptor (NMDA) and/or the type 5
      metabotropic glutamate receptor (mGluR5). Hypothesis confirmation could lead to development
      of effective individualized treatment recommendations for alcohol dependent patients based on
      pharmacogenomically relevant genetic variations.

      The general goal is to identify genetic polymorphic variants that differentiate subjects
      continuously abstinent for six months while taking acamprosate from relapsed subjects. The
      initial analysis will determine whether any of ten polymorphisms in four target genes (GRIN1,
      GRIN2A and GRIN2B that code for the NMDA receptor and GRM5 that codes for the type mGluR5
      receptor) are associated with successful abstinence. Subsequent analyses will examine whether
      variation in a comprehensive set of 383 linkage disequilibrium haplotype tagged single
      nucleotide polymorphisms of these four genes predicts successfully abstinent subjects.
    

Intervention name(s): acamprosate
Intervention type(s): Drug
Intervention description(s): acamprosate 333mg tabs, 2tabs 3times per day = 1998mg/day
Other intervention name(s): Campral is the brand name of acamprosate.
Intervention MeSH terms: Acamprosate
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects selected from Mayo Clinics Addiction programs.
      
Biospecimen description: 
      Samples obtained from study "Developing a DNA Repository for Genomic Studies of Addiction: A
      Pilot Study"
    
Keywords: nucleotide polymorphisms; disequilibrium haplotype; acamprosate; differentiate; pharmacogenomic; effective individualized treatment; alcohol dependent; N-methyl-D-aspartate receptor (NMDA); metabotropic glutamate receptor; decreasing craving; abstinence maintenance
A Study of LY3437943 in Chinese Participants With Obesity Or Overweight
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn about the safety and tolerability of LY3437943
      when given to Chinese participants with overweight body mass index (BMI) or obesity. Blood
      tests will be performed to investigate how the body processes the study drug and how the
      study drug affects the body. Each enrolled participant will receive injections of LY3437943
      or placebo given just under the skin. For each participant, the study will last about 20
      weeks excluding screening period and may include up to 20 visits to the study center.
    


Intervention name(s): LY3437943; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science