bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Tysabri in Patients With Relapsing-Remitting Multiple Sclerosis: A Follow-up Magnetization Transfer Imaging (MTI) Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The primary objective of this study is to define the effect of Tysabri in patients with
      relapsing-remitting (RR) multiple sclerosis (MS) over 2 years. The investigators will also
      explore the extent of remyelination in MS patients treated with Tysabri over 2 years.

      A secondary objective of this study is to investigate differences in the capacity for
      remyelination between patients who do or do not respond to Tysabri monotherapy during the
      same 24 months.

      A tertiary objective of this study is to monitor Tysabri effect in MS antiphospholipid
      antibodies positive and MS antiphospholipid antibodies negative patients and to determine
      perfusion differences according to the antiphospholipid antibodies positivity status.
    

Detailed description: 
      Magnetization transfer imaging (MTI) is a widely used tool for characterizing the evolution
      of multiple sclerosis (MS) lesions and normal appearing brain tissue (NABT). As remyelination
      and demyelination are heterogeneous in each lesion and NABT, techniques such as voxel-wise
      based MTR dynamic mapping may help predict an individual's clinical course, as well as the
      effect of treatment, by revealing evidence of myelin repair and neuroprotection.

      Natalizumab (Tysabri) showed a robust effect on the decrease of inflammation in phase II and
      III clinical trials, as evidenced by the decrease in Gd enhancing and T2 lesions and on the
      decrease of clinical activity as measured by reduction of clinical relapses and progression
      of disability. The effect of Tysabri on non-conventional measures is only partially known.
    

Intervention name(s): Tysabri
Intervention type(s): Drug
Intervention description(s): Infusion of TYSABRI® 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP over approximately one hour at month 0 and 12 and 24 months. After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP.
Use of filtration devices during administration has not been evaluated. Other medications should not be injected into infusion set side ports or mixed with TYSABRI®.
TYSABRI® concentrate is supplied as 300 mg natalizumab in a sterile, single-use vial free of preservatives. Each package contains a single-use vial.
Other intervention name(s): Natalizumab
Intervention MeSH terms: Natalizumab
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        MS patients that are followed at the Jacobs Neurological Institute, University at Buffalo,
        Buffalo NY.
      
Keywords: Tysabri; VWMTR
Modified Surface of PLGA Nanoparticles in Smart Hydrogel
Condition: Antibiotic Resistant Infection
MeSH terms: Infections
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Nanoparticles containing antibiotic were prepared and incorporated in in situ gel to treat
      recurrent endodontic infections
    

Detailed description: 
      Enterococcus faecalis is the main cause of endodontic infections and form biofilm on dentin,
      resulting in treatment-resistant periradicular lesions. To overcome these problems,
      antibacterial nanoparticles were used because of their small size, sustained release and
      positive charge which interact with the negatively charged surface of bacterial cell causing
      its destruction. In this light, Ciprofloxacin hydrochloride (CIP) in chitosan coated PLGA
      nanoparticles (CIP-CS-PLGA-NPs) and free CIP were embedded in Pluronic® 407/188 to form
      thermosensitive gels(F1) and (F2) respectively, that were investigated in terms of viscosity,
      gelation temperature and in-vitro release. The antibacterial efficacy of F1 and F2 were
      clinically investigated on patients then compared to CIP and Ca(OH)2 pastes by determining
      bacterial reduction percent and biofilm inhibition assay
    

Intervention name(s): Ciprofloxacin
Intervention type(s): Drug
Intervention description(s): studying the effect of nanoparticles in controlling the release of the drug in addition to in situ gel
Other intervention name(s): device
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Fifty-five patients having single rooted teeth with signs and/or symptoms of post treatment disease that were indicated for non-surgical root canal retreatment were participated in this study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: nanoparticles; endodontics infection
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of MK-1064 (MK-1064-001)
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the
      safety, pharmacokinetics and pharmacodynamics of rising, single oral doses MK-1064 in
      healthy, young, male participants. The primary pharmacokinetic hypothesis is that at least
      one dose of MK-1064 that is generally safe and well tolerated produces an average MK-1064
      plasma concentration from 0 to 4 hours of ≥2.2 μM. Since this is an early Phase I assessment
      of MK-1064 in humans, the study protocol allows for modifications to the outlined dose,
      dosing regimen and/or clinical or laboratory procedures, if required to address study
      objectives and/or to ensure appropriate safety monitoring of participants.
    

Detailed description: 
      Two panels (Panels A and B), will receive alternating single rising oral doses of
      MK-1064/placebo (i.e., order of administration will be Panel A 5 mg, Panel B 10 mg, Panel A
      25 mg, Panel B 50 mg, and continuing in this alternating sequence). Following dosing for a
      given treatment period, a minimum of 3 days will elapse before administration of the next
      scheduled dose. After administration of each dose, safety and tolerability will be reviewed.
      The decision to proceed to the next Panel/Period in the alternating sequence will be
      contingent on acceptable safety and tolerability data from the preceding Panels/Periods.
    

Intervention name(s): MK-1064; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose for each period administered as oral MK-1064 tablets (1, 10 and 50 mg strengths); Dose for each period administered as oral placebo tablets matching active MK-1064 tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Raxibacumab on Immunogenicity of Anthrax Vaccine Adsorbed
Condition: Infections, Bacterial
MeSH terms: Anthrax; Bacterial Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This study, as a post-marketing commitment to the Food and Drug Administration, is designed
      to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a
      healthy volunteer population. This is a randomized, open-label, parallel group, two arm study
      to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is
      administered alone or concomitantly with raxibacumab. The study is planned to enroll
      approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be
      approximately 26 weeks. The dates reflect cohort 1.
    


Intervention name(s): AVA; Raxibacumab; Diphenhydramine
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Sterile, milky-white suspension with dosage level of 0.5 mL for SC administration; Sterile, liquid formulation with unit dose strength of 40 mg/ kg for IV administration; Depending upon the labelling of the specific product chosen, 25 - 50 mg will be administered orally or IV
Intervention MeSH terms: Diphenhydramine; Promethazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anthrax Vaccine Adsorbed; Raxibacumab; Immunogenicity
Dialectical Behavior Therapy Skills Group Pilot Evaluation
Condition: Suicidal Ideation; Emotions
MeSH terms: Suicidal Ideation
Study type: Interventional

Summary: 
      Uncontrolled pilot study examines feasibility, acceptability, and preliminary efficacy of
      Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion
      dysregulation.
    

Detailed description: 
      Uncontrolled pilot study to examine feasibility, acceptability, and preliminary efficacy of
      Dialectical Behavior Therapy skills group for Veterans with suicidal ideation and emotion
      dysregulation. Outcome measures will occur at pre-treatment, mid, end, and follow-up.
    

Intervention name(s): Dialectical behavior therapy skills group
Intervention type(s): Behavioral
Intervention description(s): Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Ranging Study of Glycopyrronium Bromide in Patients With Moderate or Severe Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an investigation of the beneficial effects, tolerability and safety of a range of
      single doses of orally inhaled glycopyrronium bromide (PSX1002GB pMDI) in male and female
      patients with moderate or severe chronic obstructive pulmonary disease (COPD). COPD is a long
      term and progressive disease of the lungs, generally caused by cigarette smoking, but other
      factors may be involved. Glycopyrronium bromide (GB) appears to be particularly useful in
      dilating the constricted airways of such patients, with a duration of action variously
      described as being between 12 and 24 hours.

      This study will investigate how well tolerated and safe this medication is at a range of
      doses. It will also help in the selection of a suitable dose for larger and repeat dose
      studies, based on measures of lung response. It will also help to determine how often the
      medication should be given; twice daily, or once daily.

      Up to 40 patients will be enrolled into the study, ranging in age from 40 to 75 years of age.
      Patients will be medically assessed before participation to ensure their suitability. The
      study will take place in one centre in the UK over five sessions; at each session one dose (2
      puffs) of GB or one dose (2 puffs) of placebo will be administered from a simple inhaler
      device. Neither staff nor patients will know which dose, or if placebo, is being taken. Lung
      function will be measured for up to 26 hours after the administration of each dose using
      standard spirometry equipment. Blood samples will be taken over a 24-hour period to check the
      blood levels of GB. There will be a period of about a week between each dosing session.
      Patients will be medically reviewed after the study to confirm that no untoward effects are
      present.
    


Intervention name(s): glycopyrronium bromide
Intervention type(s): Drug
Intervention description(s): glycopyrronium bromide suspension in HFA
Other intervention name(s): PSX1002-GB
Intervention MeSH terms: Glycopyrrolate; Bromides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glycopyrronium bromide; glycopyrrolate; oral inhalation; COPD; chronic obstructive pulmonary disease; lung function; pharmacokinetics; tolerability; safety; cross-over; single-dose; dose-ranging
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial is the first-in-human study of NO-13065. The purpose of this phase 1
      study is to assess the safety and tolerability of single and multiple ascending oral doses
      and food effect of NO-13065 in healthy and obese adult subjects.
    


Intervention name(s): NO-13065; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending doses of NO-13065 in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065.
Single ascending dose of NO-13065 with food effect arm. Multiple ascending doses of NO-13065 for 10 or up to 28 days in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065.; Two subjects per cohort will take a matched placebo.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Bioequivalence Study Of Ibuprofen 50mg/ml (laboratórios Pfizer Ltda) In The Oral Suspension Form.
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      An open label, randomized, 2x2 crossover, single dose, phase 4 study to determine the
      pharmaceutical bioequivalence of ibuprofen 50mg/ml (laboratórios pfizer ltda) oral suspension
      versus alivium ® 50mg/ml (mantecorp indústria química e farmacêutica ltda.) Oral suspension,
      in healthy fasting volunteers.
    


Intervention name(s): Alivium®; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): 400mg of Ibuprofen equivalent to 8mL (50mg/mL) oral suspension of the Reference Drug; 400mg of Ibuprofen equivalent to 8mL (50mg/mL) oral suspension of the Test Drug
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence Study; Ibuprofen; Alivium
The MOM Program at the Children's Hospital of Philadelphia
Condition: Child Development
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the MOM Program is to promote child development by helping families become
      more competent in accessing and using available resources. The program focuses are childhood
      immunizations, Early Intervention services, lead screening, Early Head Start and Head Start
      enrollment. The hypothsis is that children receiving the intervention will participate in
      more of the public services and primary healthcare activities which have been shown to be
      effective in improving their development.
    

Detailed description: 
      The MOM Program is a 3 year randomized controlled trial of mothers and newborns. At
      enrollment subjects are given a questionnaire to assess self efficacy and a non-verbal test
      of intelligence. Program personnel are blind to the results of this testing. Test results
      will be used in data analysis at the end of the study to compare outcomes of the intervention
      and control groups and to assess how mothers with impaired cognitive ability have benefited
      from participation in the study.The Intervention consists of frequent phone calls and home
      visits to encourage mothers to have their babies immunized on schedule and to participate in
      needed developmental and educational services. At 33 months of age all children receive a
      developmental assessment.
    

Intervention name(s): professional support model
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: child, preschool; environment; intelligence
Endothelial and Metabolic Effects of Glucagon-like Peptide-1 (GLP-1) in Coronary Circulation in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      GLP-1 is an incretin hormone which is discharged from the intestines after food intake. The
      hormone is known for its powerful insulinotropic and trophic effects on the beta cells in the
      pancreas and is currently used as an anti-diabetic agent in patients with type 2 diabetes
      (T2DM).

      GLP-1 receptors are widely distributed including on the endothelial cells in both coronary
      and skeletal muscle circulation and on the myocardium. GLP-1-receptor studies on knock-out
      mice have shown that they exhibit a reduced myocardial contractility and reduced diastolic
      heart function. GLP-1 also shows beneficial cardiovascular effects in patients with acute
      myocardial infarctions and dogs with dilated cardiomyopathy in that the left ventricle
      function and endothelial dysfunction improves after GLP-1 treatment via insulin-independent
      mechanisms. Preclinical studies indicate that exogenous administrated GLP-1 in physiological
      concentrations can improve perfusion but this has never been tested in humans. It is also
      unknown whether GLP-1 can directly increase the glucose/metabolite uptake across both cardiac
      and skeletal muscle in an insulin independent manner. Unpublished studies do however indicate
      that the improvement in the cardiovascular system is largely dependent upon a high blood
      glucose level and only partially dependent upon the antiglycemic effects of GLP-1.

      In the proposed studies the investigators wish to examine the physiological role of GLP-1
      receptor stimulation both with regard to perfusion, metabolic improvement as well as cardiac
      inotropic. These studies will be conducted in both healthy and in T2DM patients.
    


Intervention name(s): Glucagon like peptide-1; Adenosine
Intervention type(s): Drug; Drug
Intervention description(s): 0,1 pmol/kg/min; 20-40 microgram/minute
Intervention MeSH terms: Adenosine; Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Basic science; Type 2 Diabetes mellitus; Glucagon like peptid-1; Coronary Bloodflow; Metabolite uptake
Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A prospective, single-center, open-label, phase I study evaluating the pharmacokinetics (PK)
      of human parathyroid hormone (1-34) ("PTH") administered via the RaniPill™ capsule
      ("RT-102").
    

Detailed description: 
      The RaniPill device is a capsule-like ingestible device, which injects a microneedle
      containing a micro tablet (payload/drug) into the intestinal wall. This is a single-center,
      prospective, open-label, feasibility study being conducted in two parts.

      Part 1: Healthy women volunteers, 18-65 years of age, of any race, recruited from the general
      population and assigned to one of the following groups:

      RT-102:

        -  RT-102 Group 1: 20 µg (N=15)

        -  RT-102 Group 2: 80 µg (N=15)

      Subcutaneous (SC):

      • SC Group: 20 µg of Forteo (N=10)

      Part 2: Healthy women, 18-65 years of age, or healthy post-menopausal or surgically sterile
      with bilateral oophorectomy women of any race, recruited from the general population will
      have once-a-day repeat dosing with 20 μg dose of RT-102 for 7 days (N= up to 12):

        -  Healthy women: N = up to 12

        -  Post-menopausal or surgically sterile volunteers: N = up to 7
    

Intervention name(s): RT-102 (80 μg); Forteo; RT-102 (20 μg)
Intervention type(s): Combination Product; Drug; Combination Product
Intervention description(s): RaniPill capsule containing PTH with doses of 20 and 80 μg; A commercial formulation of PTH for SC control (20 µg); RaniPill capsule containing PTH with dose of 20μg
Intervention MeSH terms: Teriparatide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy women volunteers
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Forteo; Parathyroid Hormone; PTH
Monitoring of Multiple Sclerosis (MS) Participants With the Use of Digital Technology (Smartphones and Smartwatches) - A Feasibility Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This prospective pilot study will assess the feasibility of remote participant monitoring
      using digital technology in participants with MS and healthy controls. At the enrollment
      visit, the participants as well as the healthy controls will be provided with a remote
      patient monitoring solution which includes preconfigured smartphone and smartwatch. The
      configured smartphone and smartwatch pair will contain application software that prompts the
      user to perform various assessments, referred to as active tests and passive monitoring.
      Active tests will include Hand Motor Function Test (HMFT), gait test, static balance test,
      electronic version of the Symbol Digit Modalities Test (eSDMT), Mood Scale Question (MSQ), MS
      Impact Scale (29-item scale) (MSIS-29) questionnaire, MS Symptom Tracking (MSST). Passive
      monitoring will be done to collect metrics on gait and mobility throughout the daily life of
      participants in a continuous and unobtrusive manner.
    


Intervention name(s): Smartphone and Smartwatch
Intervention type(s): Device
Intervention description(s): Multiple sclerosis participants and healthy controls are required to wear the smartwatch; and to carry smartphone preferably in a median position in a belt bag, or alternatively in their pocket as they go about their daily routine.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other