bioihbjkbjnl/mcl2 huggingface dataset:
Oral CF101 and Methotrexate Treatment in Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory
      agent, will improve the clinical condition of patients with rheumatoid arthritis who still
      have active joint inflammation despite taking methotrexate for at least 6 months.
    

Detailed description: 
      This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled,
      dose-finding study in which patients with active RA despite receiving methotrexate for at
      least 6 months (at unchanged doses for >=2 months) will be randomized to the addition of
      either CF101 0.1 mg, CF101 1 mg, CF101 4 mg, or placebo given orally q12h for 12 weeks.
      Screening examinations will occur within 1 month prior to dosing. Washout of other
      disease-modifying antirheumatic drugs (DMARDs) (with the exception of hydroxychloroquine),
      including biological agents, will occur prior to dosing; if washout is necessary, patients
      must re-qualify for inclusion following the washout. Doses of nonsteroidal anti-inflammatory
      drugs (NSAIDS) and corticosteroids must be stable for >=1 month prior to dosing and remain so
      during protocol participation. Disease activity will be assessed using swollen and tender
      joint counts, duration of morning stiffness, physician and patient global assessments (by
      visual analog scale, VAS), patient reported pain (by VAS), a Health Assessment Questionnaire
      (HAQ) Disability Index (DI), Westergren erythrocyte sedimentation rate (ESR, Screening, Weeks
      0 and12), and C-reactive protein (CRP) levels. Assessments will take place at Screening,
      Baseline (Week 0), and at Weeks 2, 4, 8, 12, and 14.
    

Intervention name(s): CF101
Intervention type(s): Drug
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; RA
Comparative Effectiveness of Muscle Energy Technique and Trigger Point Release in Plantar Fasciitis
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      Plantar Fasciitis (PF) causes heel pain in patients who have prolonged weight-bearing
      commonly, and it affects their ability to manage their routine work. By different physical
      therapy approaches like muscle energy technique (MET) and trigger point release, their pain
      and foot function would, might improve that would increase their work efficiency. This study
      aim towards better treatment option in treating PF. Therefore, the objective of this study
      was to compare the treatment effectiveness of MET and triggers point release in PF. A single
      blinded, randomized clinical design was conducted. Thirty patients was randomly allocated
      into two groups. One group received muscle energy technique and the other receive trigger
      point release, while both groups performed self-stretching exercises as a home plan. Their
      pain and foot function serve as outcome measure. Treatment was given for 4 weeks, 3 sessions
      per week.
    


Intervention name(s): Muscle Energy Technique; Trigger Point Release; Self-Stretching of Calf and Plantar Fascia
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Muscle energy technique (MET) is an active manipulative technique that requires patient active muscle contraction of a respective muscle from a specific position in a specific direction with 10-20 percent force exerted by the patient which is resisted by the therapist in an attempt to relax and lengthen the muscle.; In trigger point release, a vertical downward pressure toward the trigger point for 90 seconds is applied with the therapist's thumb. Three repetitions needed to be done with 30 seconds relaxation time. After that, 3 longitudinal strokes in caudal to cranial direction are given by therapist's thumb over the taut band.; Self-stretching will be done 5 times twice a day with 20 seconds of intermittent stretch and 20 seconds relaxation time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Muscle Energy Technique; Trigger Point Release
A Pilot Study of the Grapefruit Flavonoid Naringenin for HCV Infection
Condition: Hepatitis C Virus; HCV Infection; Chronic HCV; Hepatitis C
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Hepatitis C virus when it leaves the cells in the liver is bound to a type of fat. An
      component of grapefruit could block this fat and thus lower the amount of virus in the blood
      stream. We propose that treatment with this ingredient, called naringenin, could be used to
      block this fat and HCV in persons infected with hepatitis C.
    

Detailed description: 
      The hepatitis C virus is actively secreted by the liver of infected patients while bound to
      very low density lipoprotein (vLDL). The grapefruit flavonoid naringenin could be used to
      block vLDL secretion and lower the circulating viral titer.

      Hypothesis:

      Treatment with naringenin will block vLDL and HCV secretion in persons infected with HCV.

      Primary Objective

      To study the safety and pharmacokinetics of a single-dose of naringenin

      Secondary Objectives

        1. To study the changes in circulating HCV titers during the transition from a fasted to
           fed state.

        2. To study the changes in circulating HCV titers after administration of the grapefruit
           flavonoid naringenin.

        3. To study effects of naringenin on vLDL secretion.

      This is a single-arm, cross over study where placebo is administered during a transition from
      a fasted to a fed state, then the protocol is repeated with a single dose of naringenin plus
      cyclodextrin, using the previous measurements as his/her own control
    

Intervention name(s): Naringenin
Intervention type(s): Dietary Supplement
Intervention description(s): 1 gram of naringenin mixed with 16 grams of hydroxypropyl-β-cyclodextrin in 250 mL of water
Other intervention name(s): Grapefruit
Intervention MeSH terms: Naringenin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dietary supplement
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DWP14012 After Oral Administration in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a dose block-randomized, double-blind, placebo- and active-controlled, single and
      multiple dosing, dose-escalation clinical phase 1 trial to investigate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of DWP14012 after oral administration in
      healthy male volunteers.
    


Intervention name(s): DWP14012; Placebo; Esomeprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DWP14012 tablets; DWP14012 placebo-matching tablets, Active control placebo-matching tablets; Nexium®
Intervention MeSH terms: Esomeprazole; Fexuprazan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Predictive Objective Parameters for Outcome of the Treatment of Stress Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Observational

Summary: 
      To investigate the role of preoperative maximum urethral closure pressure and Valsalva leak
      point pressure in predicting outcome in patients who underwent trans-obturator tape for the
      treatment of female stress urinary incontinence.
    

Detailed description: 
      A prospective observational descriptive study conducted from May 2002 to November 2005 at a
      single tertiary urban teaching University Uro-gynecological Department. 65 patients affected
      by stress or mixed urinary incontinence (stress component clinically predominant), defined
      according to International Continence Society guidelines, associated or not with urethral
      hypermobility underwent surgery which consisted of a fusion-welded, non-woven, non-knitted
      polypropylene tape (Obtape® Mentor-Porges). Preoperative MUCP and VLPP, stratified as ≤ or >
      40 cmH20 and ≤ or > 60 cmH2O respectively, were separately or in combination correlated with
      primary (continence status: dry or wet) and secondary outcome variables (QoL questionnaires).
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Stress or mixed urinary incontinence (stress component clinically predominant), defined
        according to ICS guidelines, associated or not with urethral hypermobility
      
Keywords: Stress urinary incontinence; Mixed urinary incontinence; surgery; trans obturator tape; Maximum urethral closure pressure; Valsalva leak point pressure; outcome
Glioblastoma Platelet Activation Study
Condition: Glioblastoma; Circulating Platelet-monocyte Conjugates
MeSH terms: Glioblastoma
Study type: Observational

Summary: 
      Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the
      most frequent immune cells in glioblastoma are tumor associated macrophages, which find
      theirself in an anti-inflammatory (M2) phenotype.

      Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory
      status.
    

Detailed description: 
      Glioblastoma face an increased risk of venous or arterial thromboembolism. Furthermore, the
      most frequent immune cells in glioblastoma are tumor associated macrophages, which find
      theirself in an anti-inflammatory (M2) phenotype.

      Increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory
      status.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        consecutive patients with suspicious for glioblastoma
      
Biospecimen description: 
      blood
    
Keywords: platelet activation
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE II)
Condition: Dry Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      This LIGHTSITE II study is a double-masked, sham-controlled, parallel design, prospective
      multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry
      AMD.
    

Detailed description: 
      This study is a double-masked, sham-controlled, parallel design, prospective multi-site study
      for the use of PBM as a treatment for visual impairment in subjects with dry AMD. The target
      enrollment is 96 subjects in up to 10 centers in Europe, randomized at a 1:2 ratio into 2
      groups: Sham Treatment (S-1) and PBM Treatment (T-2). Once 96 subjects have been enrolled in
      the study, if there are less than 144 eyes that qualify for the study, additional subjects
      will be enrolled until 144 eyes have been included in the study.

      S-1 will receive 3 sham treatments per week over 3 to 5 weeks starting at Baseline and
      starting again at Months 4 and 8. T-2 will receive 3 PBM treatments per week over 3 to 5
      weeks starting at Baseline and starting again at Months 4 and 8. Each treatment series will
      total 9 treatments. Neither the subject nor the study staff will know which treatment the
      subject has been assigned.

      Subjects will receive standard visual outcome measurements including Early Treatment Diabetic
      Retinopathy Study (ETDRS) BCVA, CSV-1000E contrast sensitivity (CS) and the Radner Reading
      Test prior to and following each treatment series as well as eye exams, fundus photographs,
      Heidelberg OCT and FAF imaging and optional Optos Ultra Wide Field (UWF) imaging of the
      retina at selected time intervals. Subjects will also complete the Visual Function
      Questionnaire 25 (VFQ-25) at selected time intervals.
    

Intervention name(s): Valeda PBM treatment; Valeda Sham treatment
Intervention type(s): Device; Device
Intervention description(s): The Valeda Light Delivery System delivers 590, 660 and 850 nm wavelengths of light to the study eye. The Valeda Light Delivery System will treat through the open eyelid with the 590 nm and 850 nm wavelengths together. The 660 nm wavelength will be treated through the closed eyelid.; The sham mode emits an approximate 100x reduction in the highest dose for the 660 nm wavelengths as compared to the treatment mode, producing a slightly duller light. The 850 nm (NIR) wavelength (which is not visible light) is not provided in the sham treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Valeda Light Delivery System
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dry AMD; Photobiomodulation; Visual Acuity; Contrast Sensitivity; Optical Coherence Tomography; Drusen
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a proof of concept study to determine the efficacy and safety of a monoclonal
      antibody with three doses versus placebo. Subjects will be randomized to a treatment and the
      dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate
      to severe refractory Crohn's Disease.
    


Intervention name(s): PF-04236921 SC injection; PF-04236921 SC injection; PF-04236921 SC injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo delivered SC, 2 doses separated by 4 weeks; Drug dose level 1 delivered SC, 2 doses separated by 4 weeks; Drug dose level 2 delivered SC, 2 doses separated by 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Crohn's Disease; safety; efficacy; pharmacokinetics; pharmacodynamics; Crohn's Disease Activity Index (CDAI)
Phase I/II Study of Recombinant Human Interferon-gamma (rIFN-gamma) in HIV-Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      PRIMARY: To determine the safety and toxicity of recombinant interferon gamma-1b ( rIFN-gamma
      ) in HIV-infected children receiving ongoing zidovudine ( AZT ) or didanosine ( ddI )
      therapy. To document HIV-associated defects in neutrophil and/or monocyte function that are
      improved with rIFN-gamma.

      SECONDARY: To determine whether a change in CD4 cell count occurs and to assess virologic
      status and effects on AZT and ddI pharmacokinetics.

      It is likely that infants and children severely immunocompromised by HIV infection would
      respond to immunomodulators that augment different portions of the host defense system.
      Interferon-gamma has been shown to benefit children with severely compromised nonspecific
      immunity and may thus be of benefit to those with HIV infection.
    

Detailed description: 
      It is likely that infants and children severely immunocompromised by HIV infection would
      respond to immunomodulators that augment different portions of the host defense system.
      Interferon-gamma has been shown to benefit children with severely compromised nonspecific
      immunity and may thus be of benefit to those with HIV infection.

      Patients are treated with subcutaneous rIFN-gamma 3 times a week for 24 weeks and are then
      followed for an additional 12 weeks.
    

Intervention name(s): Interferon gamma-1b
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Interferon-gamma
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Interferon-gamma, Recombinant; Acquired Immunodeficiency Syndrome; AIDS-Related Complex
Glucocorticoids in COVID-19 (CORTIVID)
Condition: Covid-19 Pneumonia
MeSH terms: COVID-19; Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state
      whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the
      early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this
      setting remains controversial. This study aims to assess the safety and effectiveness of GC
      pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen
      inflammatory biomarkers.
    


Intervention name(s): Methylprednisolone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): -A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión; -An infusion bag of 100 mL of 0.9% saline
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Covid-19; pneumonia; Inflammatory phase; Glucocorticoids
Chronic Administration of Diosmectite (SMECTA®) in Subjects With Chronic Diarrhoea
Condition: Chronic Functional Diarrhea of Unknown Origin
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the concentration of elemental impurities in
      blood and urine after chronic administration of Smecta® in subjects with chronic functional
      diarrhoea. For exploratory purposes, the potential effects of diosmectite on bowel microbiote
      composition will be investigated.
    


Intervention name(s): Diosmectite (Smecta®)
Intervention type(s): Drug
Intervention model: Single Group Assignment
Intervention model description: The study is interventional Phase 1 without individual benefit.
Masking: None (Open Label)
Primary purpose: Other
ch14.18/CHO Bridging Study
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, pharmacokinetic and activity profiles of
      the ch14.18 antibody produced in cells of hamster origin (ch14.18/CHO).
    

Detailed description: 
      Anti-ganglioside GD2 antibody ch14.18 is a monoclonal antibody specifically recognizing the
      target antigen GD2, which is expressed on virtually all neuroblastoma tumours. This antibody
      is a chimeric protein and consists to 30% of mouse variable light and heavy chain and to 70%
      of human constant heavy and light chain. Ch 14.18 has already been tested in stage 4
      neuroblastoma patients in phase I/II clinical trials with encouraging response rates.
      Therefore, the European SIOP neuroblastoma group designed a Phase III protocol to test the
      efficacy of ch14.18 immunotherapy in a randomised trial.

      However, the ch14.18 antibody for this Phase III trial was recloned and produced in Chinese
      hamster ovary (CHO) cells in contrast to ch14.18 antibody used for previous clinical trials,
      which was produced in murine, non-secreting myeloma cells (SP2/0). Although the antibody-gene
      transfer into CHO and SP2/0 was done with exactly the same plasmid assuring an identical
      protein sequence, changes in the glycosylation of the final protein product may occur since
      the glycosylation pattern varies between different production cell lines. Glycosylation is
      important for the immunological effector function of the antibody and the pharmacokinetics in
      patients. Therefore, this change is considered to be a major change in production requiring
      the reassessment of the new product in a Phase I clinical trial.

      The primary objective of this trial is the re-evaluation of toxicity of the new ch14.18/CHO
      antibody. This is ultimately followed by the secondary objectives including the determination
      of pharmacokinetics and immunostimulation in patients receiving ch14.18/CHO therapy. This
      involves particularly the determination of activation of immune effector cells and complement
      during and after application of ch14.18/CHO. Subsequently, we will evaluate the clinical
      effect of this treatment on the course of the disease.

      The nature of this phase I trial is a bridging study for a medicinal product subjected to a
      major change in production according to the guidelines provided by the "Committee for
      Proprietary Medicinal Products" (CPMP) of the "European Agency for the Evaluation of
      Medicinal Products (EMEA) (Document Number CPMP/BWP/3207/00).
    

Intervention name(s): ch14.18/CHO
Intervention type(s): Drug
Other intervention name(s): Chimeric 14.18 anti-GD2 monoclonal antibody produced in Chinese hamster ovary cells
Intervention MeSH terms: Dinutuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuroblastoma; Refractory neuroblastoma; ch14.18/CHO
Docosahexaenoic Acid in the Treatment of Autism
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that dietary supplementation with the
      omega-3 fatty acid docosahexaenoic acid (DHA) improves the behavior of children with autism.
    

Detailed description: 
      Autism is a neurodevelopmental disability with an increasing prevalence. Traditional medicine
      does not offer any cures for autism; thus, many parents of children with autism are attracted
      to complementary and alternative therapies, one of which is dietary supplementation with the
      long chain polyunsaturated omega-3 fatty acid, docosahexaenoic acid (DHA). DHA is a critical
      structural lipid of brain cell membranes and differences in brain DHA content may influence
      synaptic function, particularly in nutritionally-sensitive areas of the brain, such as the
      cerebellum and hippocampus, which may be brain structures involved in the etiology of autism.
      This study is a randomized, double-blind, placebo-controlled trial investigating whether DHA
      supplementation is an effective treatment for children with autism. Eighty children with
      autism will be randomized to receive 200mg of DHA or placebo for 6 months. Outcome variables
      will include total plasma fatty acid patterns and scores on parent and investigator-completed
      behavioral and developmental rating scales at baseline and after 3 and 6 months of
      supplementation. Differences between groups after 6 months will be evaluated using regression
      methods. Regression analysis will be used to detect correlations between plasma total fatty
      acid DHA contents and scores on the various outcome measures. Results from this study will
      either provide evidence for a breakthrough biomedical treatment alternative for children with
      autism or evidenced-based advice to desperate parents in regard to their choices of potential
      treatments for their children with autism
    

Intervention name(s): docosahexaenoic acid (DHA); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Capsule containing 200mg of DHA; Placebo capsule containing corn and soybean oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: autism; omega-3 fatty acids; docosahexaenoic acid