bioihbjkbjnl/mcl2 huggingface dataset:
Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate if patients who had a serious cardiovascular event upon initiation
      of fingolimod are at risk to delevop long term other cardiovascular events
    

Detailed description: 
      This was a multi-national, long-term safety study. Patients enrolled in study FTY720D2406 who
      experienced a cardiovascular event within 24-hours of fingolimod treatment initiation which
      led to overnight monitoring or met serious adverse event criteria, were eligible to
      participate in this study.

      Patients who experienced a qualifying event in study CFTY720D2406 started study CFTY720D2409
      approximately 6 months after the occurrence of the CFTY720D2406 qualifying event.

      Patients underwent mandatory assessments on a 6-monthly basis including 12-lead ECG, vital
      signs. Other assessments were performed as per routine practice.

      The primary objective of the study was to estimate the long-term cardiovascular risk of
      fingolimod in patients who experienced a cardiovascular event during treatment initiation.

      The study has no stand-alone secondary objective. However data from the CFTY720D2409 and
      CFTY720D2406 studies will be pooled to supplement CFTY720DD2406 study and support its primary
      and secondary objectives of evaluating the safety profile of fingolimod.

      The pooled data will be appended to this result upon completion of FDA submission.
    

Intervention name(s): Fingolimod
Intervention type(s): Drug
Intervention description(s): Fingolimod 0.5 mg tablet
Other intervention name(s): FTY720
Intervention MeSH terms: Fingolimod Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: multiple sclerosis, fingolimod, adult, FTY720, inflammatory disease, demyelination, auto-inflammatory disease, relapsing-remitting MS, CFTY720D2406
Propofol in Emergence Agitation
Condition: Emergence Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to see if a small dose of propofol given intravenously (through a
      needle into a vein) at the end of anesthesia can make it less likely that children will be
      agitated as the come out of the anesthetic.
    

Detailed description: 
      Emergence agitation is defined as a mental disturbance during the recovery from general
      anesthesia. It consists of confusion, disorientation, delusions, and hallucinations. It
      manifests in children as some combination of restlessness, moaning, inconsolable crying,
      involuntary physical activity, and thrashing about. This puts patients at risk of injuring
      themselves or their caregivers, causing bleeding or disruption of their surgical repair, and
      pulling out IVs and drains. It can be difficult to maintain necessary vital sign monitoring
      in these agitated patients, and constant one-on-one nursing is often required. When emergence
      agitation occurs, all members of the healthcare team, and the parents report dissatisfaction
      with the quality of the child's recovery from anesthesia.

      Propofol is a commonly used intravenous anesthetic agent. Studies have compared continuous
      infusions of intravenous propofol versus inhalational sevoflurane for the maintenance of
      anesthesia. These have shown a significant decrease in the incidence of emergence agitation
      in the patients who received the propofol infusions. This proposed study will investigate the
      effects of a single bolus dose of propofol at the conclusion of a sevoflurane inhalational
      anesthetic.
    

Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): IV, single bolus at completion of anesthetic, 0.1 ml/kg
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Study of Ingrezza (Valbenazine) for the Treatment of Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 4

Summary: 
      Study of Ingrezza (Valbenazine) for the treatment of cervical dystonia.
    

Detailed description: 
      The study will be an open-label, prospective study. Patients with a diagnosis of cervical
      dystonia will undergo 4 weeks of baseline evaluation, followed by a 12-week treatment period.
      Subjects will be evaluated in-clinic every 4 weeks. Standardized assessments will be
      performed at these visits. Data will also be collected from wearable IMUs (inertial
      measurement units) and analyzed for improvements in involuntary, repetitive movements and
      postures.
    

Intervention name(s): Ingrezza Pill
Intervention type(s): Drug
Intervention description(s): Participants will receive Ingrezza 40 mg and 80 mg tablets for 12 weeks.
Intervention model: Single Group Assignment
Intervention model description: Experimental
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation the TECNIS IOL in Both Eyes VS the ReZoom IOL in One and TECNIS IOL in the Opposite
Condition: Cataract
MeSH terms: Cataract
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the visual performance of two cohorts of patients
      who received multifocal intraocular lenses following cataract and clear lens extraction
      surgeries. Comparing visual outcomes of patients who were implanted with TECNIS Multifocal
      IOLs in both eyes versus patients implanted with TECNIS Multifocal in one eye and ReZoom
      Multifocal IOL in the opposite eye.
    

Detailed description: 
      Stable post operative cataract and clear lens extraction patients who have been implanted
      with either the TECNIS Multifocal IOL in both eyes or TECNIS Multifocal IOL in one eye and
      theReZoom Multifocal IOL in the opposite eye.

      Study Design-A retrospective chart review to collect visual outcomes to determine lens
      performance. Patient satisfaction questionnaire will be administered to determine spectacle
      independence.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Stable post operative cataract and clear lens extraction patients who have been implanted
        with either the TECNIS multifocal IOLs in both eyes or TECNIS multifocal IOL in one eye and
        the ReZoom in the opposite eye
      
Keywords: Visual outcomes; Patient satisfaction
Oxygen Reserve Index (ORi) Validation of INVSENSOR00029
Condition: Healthy
Study type: Interventional

Summary: 
      ORi is a unitless index that could help clinicians with their assessments or normoxic and
      hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi
      of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to
      PaO2 values of 200mmHg and above. In this study, the PaO2 is varied by controlling the
      concentration of oxygen the study volunteer breathes. Changes in ORi values are analyzed by
      comparing it to corresponding changes in PaO2 measurements from blood samples.
    


Intervention name(s): INVSENSOR00029
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Comparison of Surveillance Colonoscopy Techniques in Patients With IBD
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      We propose a randomized controlled study to determine the detection rates of neoplasia with
      high definition colonoscopy alone, high definition dye spraying chromoendoscopy or High
      definition iSCAN virtual chromoendoscopy in patients with long standing colitis (8 years from
      diagnosis except primary sclerosing cholangitis when surveillance starts at diagnosis) CD or
      UC.

      We hypothesized that these novel endoscopic techniques using High definition colonoscopy with
      virtual chromoendoscopy -iScan 2 and 3 may be superior to high definition colonoscopy alone
      and similar to using dye spraying chromoendoscopy for detection of dysplasia and neoplasia in
      patients with long standing IBD.

      We will aim to demonstrate if we can avoid dye spraying during the procedure and save expense
      and considerable time.

      In addition, we can hope to produce evidence and inform the way in which we perform
      surveillance colonoscopy especially without large number of multiple random biopsies but only
      few targeted" smart and intelligent" biopsies using high definition colonoscopy with iSCAN
      technique as is already the European practice in several centres.
    


Intervention name(s): HD Colonoscopy; HD Colonoscopy + iSCAN; HD Colonoscopy + dye spray
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): High definition colonoscopy procedure in surveillance colonoscopy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inflammatory bowel disease patients undergoing surveillance colonoscopy
      
Keywords: Dysplasia, Inflammatory Bowel Disease
Clinical Validation Study in Allergic Conjunctivitis to Birch Pollen During Allergen Challenge in ALYATEC EEC
Condition: Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional

Summary: 
      This is a single center open study designed to determine the concentration of airborne birch
      pollen inducing an allergic conjunctivitis response in individuals allergic to birch pollen,
      during allergen exposures in the Alyatec environmental exposure chamber (EEC).
    


Intervention name(s): Exposure to birch pollen in EEC
Intervention type(s): Other
Intervention description(s): Patients are exposed to airborne birch pollen allergen. The duration of each exposure is 4h maximum.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Allergy; Conjunctivitis
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Treating Tremor of Unknown Cause.
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and effectiveness of topiramate as compared
      to placebo in treating patients with tremor of unknown cause.
    

Detailed description: 
      Essential tremor is a very common form of tremor, occurring in up to 5% of people. It may be
      inherited. In 90% of patients, the tremor is in the hands; however, it can also be in the
      head, voice, legs, jaw, and tongue. Essential tremor may be treated by the blood pressure
      medicine propranolol or the anti-seizure drug primidone. The drawbacks of these drugs are
      that they tend to lose effectiveness over time, and they may cause side effects. Researchers
      believe that topiramate, an anti-seizure drug, may be effective in treating essential tremor.
      In this double blind, placebo-controlled study, patients with essential tremor will start at
      a low dose of topiramate (25 milligrams) or placebo. The dose will be gradually increased
      over 12 weeks to a maximum of 400 milligrams daily, taken in two divided doses. Then, each
      patient will stay on the established dose for the next 12 weeks. During the next phase of the
      study, the patients will slowly reduce the dose until they stop taking the study drug, after
      which, patients have the option of taking up to 600 milligrams of topiramate (not placebo) in
      a 14-week extension of the study. This study was designed to investigate the hypothesis that
      topiramate will be more effective than placebo in the treatment of essential tremor as
      measured by the Clinical Rating Scale for Tremor (TRS) and is well tolerated. The TRS is a
      three part scale that measures tremor location/severity rating, specific motor tasks/function
      rating, and functional disabilities resulting from tremor. Safety evaluations are assessed
      throughout the study.

      Topiramate or placebo, starting with a dose of 25 mg, then gradually increased over 12 weeks
      up to 400 mg daily (two 100-mg tablets taken by mouth twice a day) and continued on this dose
      for 12 weeks in the maintenance phase; up to 600 milligrams of topiramate in the open-label
      phase.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: tremor; essential tremor
Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments
Condition: Pregnancy; Miscarriage Less Than 12 Gestational Weeks; Extrauterine Pregnancy; Preeclampsia; Intrauterine Fetal Growth Restriction
MeSH terms: Pre-Eclampsia; Abortion, Spontaneous; Fetal Growth Retardation; Pregnancy, Ectopic
Study type: Interventional

Summary: 
      In this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian
      responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects
      undergoing IVF/ICSI when the treatment is started concomitantly with controlled ovarian
      hyperstimulation.
    

Detailed description: 
      Low-dose acetylsalicylic acid irreversibly inhibits the cyclo-oxygenase enzyme in platelets,
      thus preventing the synthesis of thromboxane, which causes vasoconstriction and platelet
      aggregation. By this mechanism low-dose aspirin may enhance ovarian and uterine blood flow
      and tissue perfusion and thus improve ovarian responsiveness for gonadotrophins and
      endometrial receptivity for implantation. Randomized controlled studies and meta-analyses on
      the low-dose aspirin therapy to improve IVF/ICSI outcome or uterine hemodynamics have
      revealed conflicting results.
    

Intervention name(s): Acetylsalicylic acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Acetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection; Acetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection
Other intervention name(s): Low-dose aspirin
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Assisted reproduction; Ovarian response; Uteroplacental hemodynamics; Doppler ultrasonography; Implantation rate; Pregnancy rate; Live birth rate
Intra-articular Hyaluronan After Arthroscopic Meniscal Surgery
Condition: Arthroscopic Meniscal Surgery
Study type: Interventional

Summary: 
      The primary objective of this clinical investigation is to determine whether
      post-arthroscopic treatment with 10 ml of 0.5% sodium hyaluronate (VISCOSEAL® SYRINGE) can
      relief pain, improve mobility and promote joint recovery, compared to the standard
      arthroscopy procedure alone, in patients undergoing arthroscopic procedure.
    


Intervention name(s): Hyaluronan (0.5%, 5 mg/10 ml); Standard arthroscopic meniscal surgery
Intervention type(s): Device; Procedure
Intervention description(s): Standard arthroscopic meniscal surgery and add-on treatment with VISCOSEAL® SYRINGE. Single injection of Hyaluronan directly after arthroscopic procedure.; Standard arthroscopic meniscal surgery without add-on treatment.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hyaluronan; hyaluronic acid
Diagnosis of Tuberculosis Infection in HIV Co-infected Children
Condition: Latent Tuberculosis Infection; Tuberculosis; HIV Infections
MeSH terms: Infections; Communicable Diseases; Tuberculosis; Latent Tuberculosis
Study type: Observational

Summary: 
      Background: The TB and HIV epidemics are closely linked in developing countries, where
      450,000 children die from HIV annually. TB is a major cause of death in HIV-infected children
      and is reversing gains made in child survival.

      The traditional tuberculin skin test (TST) has limited diagnostic accuracy for detecting TB
      infection. Adult studies suggest that new blood-based diagnostic TB testing offers a quicker,
      more accurate way to diagnose TB infection. Such diagnostic testing may directly guide
      clinical management and preventive strategies in immune-suppressed HIV-infected children, who
      are at high risk of becoming TB diseased following infection. Data regarding the usefulness
      of these tests in children is currently limited.

      Objective(s) and Hypothesis(es): The investigators hypothesize that blood-based TB diagnostic
      testing can accurately identify children with TB infection. In a community with high rates of
      TB and HIV infection, the following specific aims will be investigated in HIV-infected and
      uninfected children:

        1. assess the agreement between the TST and blood-based diagnostic testing,

        2. compare the performance of the TST and blood-based diagnostic testing to a standardized
           history of TB exposure,

        3. measure the impact of age, nutritional and immune status on children's response to
           blood-based testing,

        4. describe factors that might modify children's response to testing over time, and 5)
           examine the effect of environmental exposures and previous vaccination on the TST,
           blood-based testing and other measures of immune responses to TB.

      Potential Impact: The benefits of an accurate, rapid diagnostic test of TB infection in
      children include 1) timely institution of treatment for TB infection to prevent severe
      disease and mortality, and 2) preclusion of over diagnosis and treatment. Treatment of
      childhood TB infection also prevents future contagious adult disease, thus decreasing
      community transmission. Blood-based diagnostic testing may also be able to identify children
      that are more likely to become ill following TB infection. Therefore, blood-based diagnostic
      testing has great potential to improve TB control and the health of HIV-infected and
      uninfected children, their households and communities.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV seropositive and seronegative South African children (6months to 15years) with and
        without M.tb exposure
      
Keywords: Tuberculosis; HIV; Diagnostics; Pediatrics
Phase 1, Randomized, Double-Blind, Placebo-Controlled Exploratory Study That Will Assess the Safety, Tolerability, Pharmacokinetics and Hemodynamic Response to a Single 30 Minute Intravenous Infusion of Vasomera™ (PB1046) in Adult Subjects With Stage 1 or 2 Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an exploratory Phase 1 randomized, double-blind (Investigator and study subject
      and 2-D echo endpoint assessor), placebo-controlled single IV infusion dose escalation study
      that will enroll up to approximately 32 subjects with stage 1 or 2 essential hypertension.
    

Detailed description: 
      The study will be conducted in two parts.

      Part 1: For the initial evaluation of safety, pharmacokinetic exposure and pharmacodynamic
      response, subjects will be tapered off antihypertensive background therapy.The initial
      starting dose will be a sub-therapeutic dose. Dose escalation will continue with a maximum of
      a doubling of the previous dose until either 1) a maximum tolerated dose (MTD) is identified
      or 2) modeling of the pharmacokinetic (PK) data indicate that maximum exposure (Cmax) at the
      next planned dose level would exceed a maximum drug concentration (Cmax) which was the
      maximum observed drug concentration following a single subcutaneous administration in Study
      PB1046-PT-CL-0001.

      Part 2: The dose group which is capable of providing a Cmax exposure which is capable of
      eliciting a clinically relevant hemodynamic response, will be expanded to enroll an
      additional 12 subjects (6 active and 6 placebo).
    

Intervention name(s): Placebo Single IV (Intravenous) Infusion; Experimental: Single IV Infusion Vasomera (PB1046)
Intervention type(s): Drug; Drug
Intervention description(s): 0.9% Sodium Chloride - 30 minute IV infusion
Intervention MeSH terms: VIP-ELP fusion molecule PB1046
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: PB1046, VIP, Essential Hypertension, Vasomera
A Study of LY3537021 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of LY3537021 when
      administered in combination with glucagon-like peptide (GLP-1) receptor agonist called
      liraglutide in treatment-naïve healthy participants. The study will include 2 parts. The
      study will last up to 16 and 22 weeks for part A and B, respectively which includes a
      screening period of 6 weeks.
    


Intervention name(s): LY3537021; Liraglutide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC.; Administered SC.; Administered SC.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study has two parts. Part A is parallel model and part B is crossover.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral
      dose of [14C]EDP-305 in healthy male subjects.
    


Intervention name(s): EDP-305
Intervention type(s): Drug
Intervention description(s): [14C]EDP-305
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AME Study