bioihbjkbjnl/mcl2 huggingface dataset:
Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA BN® RSV Vaccine
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A total of 63 subjects will be recruited into three groups (18 subjects per group will
      receive MVA BN RSV vaccine and three subjects per group will receive placebo). Liquid frozen
      suspension of MVA BN RSV.

      Each subject will receive two vaccinations with either MVA-BN RSV vaccine 1 x 108 TCID50 per
      0.5 ml, 1 x 107 TCID50 per 0.5 ml or with placebo.
    


Intervention name(s): MVA BN RSV; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Liquid frozen suspension of MVA-mBN294B; Tris Buffered Saline, sterile
Other intervention name(s): MVA-mBN294B; TBS
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: RSV Vaccines; Respiratory Syncytial Virus Vaccines
A Study of the Safety, Tolerability & Immunogenicity of CSL Limited's Influenza Virus Vaccine In a Paediatric Population
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the Safety, Tolerability & Immunogenicity of CSL
      Limited's Influenza Virus Vaccine in a two dose primary vaccination series, with a 12-month
      booster vaccination, in a paediatric population equal to or greater than 6 months to less
      than 9 years old.
    


Intervention name(s): Influenza Virus Vaccine; Influenza Virus Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 2 dose vaccine regimen: 2 X 0.25mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose; 2 dose vaccine regimen: 2 X 0.50mL vaccinations 30 days apart and a booster vaccination was administered 12 months after the first dose
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Healthy Infants
Condition: Diarrhea; Fever; Nausea; Vomit; Irritability
MeSH terms: Nausea; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced
      by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in
      Vietnam. In addition, we evaluate different dosages and schedules to determine the best
      regimen to test in a clinical trial.
    

Detailed description: 
      Rotavirus (RV) is the most important cause of acute gastroenteritis in children worldwide. In
      Vietnam rotavirus causes an estimated 122,000-140,000 hospitalizations and 2900-5400 deaths
      per year among children under 5 years of age (1). Over the past 13 years, sentinel hospital
      surveillance identified rotavirus in 44%-62% of children admitted for the treatment of acute
      diarrhea in Vietnam (2-4). Such a high burden of disease justified accelerated development of
      a new and locally manufactured vaccine against rotavirus in Vietnam. It is estimated that if
      a vaccine was introduced in the current childhood immunization schedule, it could reduce
      severe rotavirus disease by about 60% or more given current vaccine efficacies and coverage
      (5).

      The Government of Vietnam has pursued a policy to encourage local vaccine production so the
      country could be self-reliant with affordable vaccines for its population (6). Over the past
      decades, several locally produced vaccines for poliomyelitis, cholera, Japanese encephalitis,
      and Diphtheria-Pertussis-Tetanus have contributed to the reduction in the prevalence of these
      diseases and to the eradication of polio over the past decade. While two commercial rotavirus
      vaccines, RotarixTM (GSK, Belgium) and RotaTeq® (Merck), have both been tested in Vietnam,
      neither is currently available at an affordable cost for the national program. Therefore, the
      candidate vaccine, Rotavin-M1, was developed in order to fill this need for a more affordable
      vaccine for Vietnamese children (6). This vaccine is similar to RotarixTM, and was developed
      by selecting a common G1P[8] strain and attenuating it through serial passages and plaque
      purification in qualified Vero cells under GLP conditions.
    

Intervention name(s): Rotarix
Intervention type(s): Biological
Intervention description(s): 2 doses of Rotarix vaccine, 106.5CID/dose, 1-month interval between doses
Other intervention name(s): RotarixTM, GSK biologicals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: diarrhea; fever; nausea; vomit; irritability
Scaling Mental Healthcare in COVID-19 With Voice Biomarkers
Condition: Major Depressive Disorder; Generalized Anxiety
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      This study aims to advance research on group sessions for mental health. The
      first-of-its-kind study measuring various features in a group setting, combining rich
      metadata in creating state-of-the-art machine learning models, and developing workflows for
      mental health that are both scalable and personalized.
    

Detailed description: 
      The anticipated impact of this study is defining voice biomarker features and reward
      functions for a deep reinforcement learning based system from group interactions that improve
      depression and anxiety outcomes. The investigators' ability to quantify the real-time impact
      of human-intervention in scaled group video sessions can be very meaningful for creating best
      practices in the area where measurement is infrequent.

      The investigators' priority is to scale the optimal mix of individuals for group therapy
      sessions based on reward functions that maximize improvements in depression and anxiety
      scores. Current group therapy appointments may track little save few who use various group
      feedback questionnaires (e.g. OQ, GCQ, or GQ). Voice biomarkers can play a key role in the
      real-time measurement of mental health.

      The proposed work is to conduct a feasibility study on creating reward functions that most
      effectively enable engagement for group sessions as measured by voice biomarkers before,
      during, and after group video meetings.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes men and women over the age of 18 years
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of KUC 7483 CL Tablets in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate safety, tolerability and pharmacokinetics of KUC 7483 CL
    


Intervention name(s): KUC 7483 CL - single rising dose; Placebo; standardized high fat meal
Intervention type(s): Drug; Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Ab Interno Gelatin Microstent With MMC vs. Trabeculectomy With MMC: 3 Year Retrospective Cohort Analysis
Condition: Filtering Surgery; Trabeculectomy
Study type: Observational

Summary: 
      To compare 3-year post-operative efficacy and safety of standalone ab interno gelatin
      microstent (Xen45®) versus trabeculectomy.
    

Detailed description: 
      This is a single-center retrospective cohort study. Patients included were consecutive
      patients from June 2012 - July 2017 who received standalone Xen45® or standalone
      trabeculectomy. The primary outcome was time to failure, defined as intraocular pressure
      (IOP) outside of 6mmHg - 17mmHg on no medications on two consecutive visits despite in-clinic
      maneuvers (including needling). Secondary outcomes included IOP cutoffs of 14mmHg and 21mmHg
      with and without medications, as well as interventions, complications, and reoperations.
    

Intervention name(s): Ab interno gelatin microstent; Trabeculectomy
Intervention type(s): Device; Procedure
Intervention description(s): Ab interno gelatin microstent; Trabeculectomy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Glaucoma patients who received received a gelatin stent 45 with MMC (mitomycin C) or a
        trabeculectomy with MMC
      
Keywords: Xen; Ab Interno Gelatin Microstent
Anticonvulsant Mood Stabilizers, Antipsychotic Drugs and the Insulin Resistance Syndrome
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
MeSH terms: Insulin Resistance; Metabolic Syndrome; Schizophrenia; Bipolar Disorder; Psychotic Disorders
Study type: Interventional

Summary: 
      The objective of this study is to determine the effect of various mood stabilizers (MS) on
      the insulin resistance syndrome (IRS; also called the metabolic syndrome) alone and in
      patients treated with antipsychotic drugs (APDs). Patients will be switched from their
      current antipsychotic medication to aripiprazole (Abilify) or ziprasidone (Geodon) (unless
      clinically contraindicated) for comparison with metabolic levels during treatment with the
      former medication.

      The metabolic syndrome is an empirical concept based on extensive evidence that a
      constellation of 5 metabolic abnormalities, e.g. increased cholesterol, hypertension, low
      HDL, taken together, predict marked increases in the risk of CVD, stroke and some types of
      cancer.
    


Intervention name(s): ziprasidone vs. aripiprazole; aripiprazole vs. ziprasidone
Intervention type(s): Drug; Drug
Intervention description(s): ziprasidone vs. aripiprazole dosed according to package insert; aripiprazole vs. ziprasidone dosed according to package insert
Intervention MeSH terms: Aripiprazole; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; schizoaffective disorder; bipolar disorder; metabolic syndrome
The Effects of Contact Lenses With Experimental Dye on Visual Function
Condition: Ametropia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and
      subject-masked study to measure potential benefits of the new UV blocker.
    


Intervention name(s): senofilcon A with new UV blocker; senofilcon A
Intervention type(s): Device; Device
Intervention description(s): Test Lens; Control Lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Tolerability and Efficacy of CD+A Compared to AQ+SP for the Treatment of P.Falciparum Malaria in Rwandan Children
Condition: Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional

Summary: 
      In 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of
      the combination chlorproguanil-dapsone+artesunate (CD+A): 800 children aged 12-59 months with
      uncomplicated P. falciparum malaria randomly allocated to AQ+SP or CD+A were followed up
      until day 28 after treatment. Adverse events, clinical and parasitological outcomes were
      recorded.
    

Detailed description: 
      Between 2001 and 2006, as an interim strategy, Rwanda chose amodiaquine+
      sulfadoxine-pyrimethamine (AQ+SP) as the first line anti-malaria treatment. Although the
      clinical response to this combination was relatively good in 2001, since then its efficacy
      has steadily declined: in 2002 the proportion of successful treatment (recorded at 28 days
      and PCR-unadjusted) was 83 % (Rwagacondo et al., 2003) and in 2003 it was 74% (Karema et al.,
      2006). Different artemisinin-based combination treatments (ACTs) such as
      amodiaquine+artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPPQ) and
      artemether-lumefantrine (ALN) have been tested in the past few years as possible alternatives
      to AQ+SP (Fanello et al., 2006; Karema et al., 2006).

      Chlorproguanil-dapsone (also known asLapDap) is an antifolate combination similar to
      sulfadoxine/pyrimethamine (SP) but for two important features: (1) it is rapidly eliminated
      and therefore exerts less selective pressure for resistance-conferring parasite mutations
      than does SP (Winstanley et al., 1997; Nzila et al., 2000b) and (2) it is active against the
      SP-resistant forms of the parasite that are found in Africa (Mutabingwa et al., 2001a,b;
      Kublin et al., 2002). Moreover, a pediatric course of treatment of LapDap is estimated to
      cost $0.15 (Mutabingwa et al., 2001b), making it orders of magnitude less expensive than any
      marketed antimalarial drug other than chloroquine and SP.

      In 2005-2006, a clinical trial was carried out to test safety, tolerability and efficacy of
      the combination chlorproguanil-dapsone+artesunate (CD+A): 800 children aged 12-59 months with
      uncomplicated P. falciparum malaria randomly allocated to AQ+SP or CD+A were followed up
      until day 28 after treatment. Adverse events, clinical and parasitological outcomes were
      recorded.

      Based on the results of all trials carried out by the NMCP, The Rwandan Ministry of Health
      has now changed the first line to artemether-lumefantrine (ALN), Coartem®. The drug arrived
      in the country in October 2006.
    

Intervention name(s): Chlorproguanil-dapsone + artesunate
Intervention type(s): Drug
Intervention MeSH terms: Artesunate; Dapsone; Chlorproguanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: P.falciparum; malaria; lapdap+artesunate; safety; efficay
Study To Assess Adverse Events and Drug to Drug Interaction of Oral Tablet Atogepant and Ubrogepant in Adult Participants With a History of Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Migraine is a common neurological disorder typically characterized by attacks of throbbing,
      moderate to severe headache, often associated with nausea, vomiting, and sensitivity to light
      and sound. This study will assess the drug to drug interaction between atogepant and
      ubrogepant and assess the safety of atogepant and ubrogepant, when given alone or in
      combination, in adult participants with migraine.

      Atogepant is an investigational (unapproved) drug for the preventative treatment of migraine.
      Ubrogepant is a drug approved for the acute treatment of migraine. Adult participants with a
      history of migraine will be enrolled. Approximately, 30 participants will be enrolled in the
      study in multiple sites in the United States.

      Participants will receive oral tablets of ubrogepant, followed be oral tablets of atogepant,
      followed by administration of oral tablets of atogepant and ubrogepant in combination. The
      study duration will be 30 days with a 7 day follow period.

      There may be higher treatment burden for participants in this trial compared to their
      standard of care. Participants will attend regular visits during the course of the study at a
      hospital or clinic. The effect of the treatment will be checked by medical assessments,
      telephone assessments, blood tests, checking for side effects, and clinician-rated
      assessments.
    


Intervention name(s): Atogepant; Ubrogepant
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Tablet; Oral; Tablet
Other intervention name(s): UBRELVY
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine; Atogepant; Ubrogepant; UBRELVY
Comparison of Intraocular Pressure Measurements Between Reichert Tono-Vera Tonometer and Goldmann Tonometry
Condition: Intraocular Pressure; Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Determine if the Tono-Vera Tonometer accurately measures intraocular pressure (IOP). The
      hypothesis of this test is to confirm the Tono-Vera Tonometer is equivalent to the Goldmann
      Applanation Tonometer (within +/- 5.0 mmHg).
    

Detailed description: 
      The Tono-Vera Tonometer (Reichert, Inc.) is a portable rebound tonometer intended to measure
      IOP. Subjects will undergo a standard ophthalmologic examination. Subjects will then be
      measured with four tonometers: Goldmann Applanation Tonometer (C.S.O. SRL), Ocular Response
      Analyzer G3 (Reichert, Inc.), iCare ic100 tonometer (iCare Finland Oy), and Tono-Vera
      Tonometer.
    

Intervention name(s): IOP with Goldmann Applanation Tonometer; IOP with comparator ORA G3 and ic100 tonometers; IOP with Tono-Vera Tonometer
Intervention type(s): Device; Device; Device
Intervention description(s): Measurement of intraocular pressure (IOP) with Goldmann Applanation Tonometer. Measurement will be used to categorize each subject as having Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (>23 mmHg).; Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers.; Measurement of IOP with Tono-Vera Tonometer
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: All study-related tests will be conducted in a single stage, with one clinical visit, to a single clinical center.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Tonometry, Ocular
A Study of the Effect of Fluvoxamine on the Pharmacokinetics of RO4917523 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open-label, cross-over study will evaluate the effect of fluvoxamine on
      the pharmacokinetics of RO4917523 in healthy volunteers. Healthy volunteers will receive a
      single dose of RO4917523 alone and in combination with multiple doses of fluvoxamine in a
      cross-over design. The anticipated time on study treatment is 40 days.
    


Intervention name(s): Fluvoxamine; RO4917523
Intervention type(s): Drug; Drug
Intervention description(s): Multiple doses of fluvoxamine; Single dose of RO4917523
Intervention MeSH terms: Fluvoxamine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Pediatric Hypothalamic Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is being conducted in pediatric patients with Hypothalamic Obesity. This generally
      occurs in people who have had an injury to or tumor in their hypothalamus (gland or organ
      that secretes hormones). The purpose of this trial is to see how an investigational treatment
      controls the hormone insulin by lowering the level of insulin in the body resulting in a
      weight loss in children who are at least 6 years of age but less than 18 years of age. Some
      children in this trial will receive placebo.

      To qualify for this study, you and your child's doctor must feel that your child's weight is
      inadequately controlled within a year from the time of injury to the hypothalamus or tumor of
      the hypothalamus. This study will help to determine if an investigational treatment is of
      benefit in controlling a child's weight.
    


Intervention name(s): Sandostatin LAR
Intervention type(s): Drug
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Figure of 8 Walk Test in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational [Patient Registry]

Summary: 
      Balance disorder is common in people with MS. As the disease worsens, it is associated with
      impaired balance, difficulty walking, decreased mobility, and an increased risk of falling.
      Given the prevalence and clinical significance of balance dysfunction in individuals with MS,
      the assessment of balance has become an important focus in MS clinical practice and research.
      The figure of 8 Walk Test is a standard clinical measure used to evaluate the forward walking
      performance required in daily life. Beyond walking straight, turning ability is required in
      many situations in daily life such as walking around a table, avoiding obstacles and
      navigating the street. The gait characteristics of walking on a straight and curved road are
      different. During curved walking, the center of mass of the body shifts to the inner leg as
      the stance time of the inner leg increases, as opposed to walking on a straight track.
      Compared to other standardized tests, scoring is not dependent on the subjectivity of the
      examiner, can be administered by a person with minimal training, and requires minimal time,
      space, and equipment. The test assesses the ability to quickly change direction of movement
      and is a timed test involving the use of assistive devices.
    

Detailed description: 
      Multiple sclerosis (MS) is a progressive disease of the central nervous system characterized
      by demyelination and destruction of motor and sensory axons. As the disease worsens, it is
      associated with impaired balance, difficulty walking, decreased mobility, and an increased
      risk of falling. The prevalence of balance dysfunction in individuals with MS and Given its
      clinical relevance, the assessment of balance has become an important focus in MS clinical
      practice and research. The figure of 8 Walk Test is a standard clinical measure used to
      evaluate the forward walking performance required in daily life.In the figure of 8 walk test,
      two cones are placed 1.5 meters apart. The individual stands in the middle of this distance.
      At the start of the test, he goes around the first cone as fast as he can walk around the
      first cone, then when he comes to the other starting point, this time around the other cone.
      The elapsed time is recorded.

      The aim of the study is to examine the validity and reliability of the 8-shape walking test
      in MS patients.
    

Intervention name(s): Assesment
Intervention type(s): Other
Intervention description(s): The figure of walk test, Berg Balance scale, Timed 25-Foot Walk, Timed up and go test, Foursquare walk test
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Multiple Sclerosis Patients
      
Keywords: multiple scleorsis; balance; Walking