bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series at 2, 3,4 Months of Age and Followed by a Booster Dose Given at 16 to 17 Months of Age in Vietnamese Infants Who Previously Received a Dose of Hepatitis B Vaccine at Birth or Within 1 Week After Birth
Condition: Diphtheria; Tetanus; Pertussis; Poliomyelitis; Hepatitis B; Haemophilus Influenzae Type b
MeSH terms: Hepatitis A; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's
      DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2,
      3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a
      dose of Hep B vaccine at birth or within 1 week after birth.

      Primary Objective:

        -  To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep
           B-PRP-T combined vaccine in Vietnamese infants and toddlers.

      Secondary Objective:

        -  To demonstrate the non-inferiority of the immune response to all antigens induced by the
           study vaccine in Vietnamese infants one month after the third dose in a 3-dose primary
           series with the immune response to all antigens induced by the same study vaccine
           outside Vietnam.

        -  To evaluate the immunogenicity of the study vaccine one month after the 3-dose primary
           series.

        -  To describe the persistence of all antibodies before receipt of the booster vaccination.

        -  To evaluate the immunogenicity of the study vaccine one month after the booster.
    

Detailed description: 
      Participants will receive a total of 5 doses of Hep B: One dose of Hep B monovalent vaccine
      given at birth or within 1 week after birth followed by 3 doses of the Sanofi Pasteur's
      hexavalent vaccine given as primary series at 2, 3, and 4 months of age and then a booster
      dose at 16 to 17 months of age, to comply with Vietnamese vaccination recommendations.
    

Intervention name(s): Hexaxim®
Intervention type(s): Biological
Intervention description(s): DTaP-IPV-Hep B-PRP-T combined vaccine, 0.5 mL, Intramuscular
Other intervention name(s): Hexyon®; Hexacima®
Intervention model: Single Group Assignment
Intervention model description: Participants in this trial were randomized in a 1:1 ratio in 2 cohorts. All participants in both cohorts received Sanofi Pasteur's DTaP-IPV-HB-PRP~T combined vaccine in a 3-dose Infant Series. Participants from Cohort 1 provided blood samples for immunogenicity assessment and were evaluated for safety and immunogenicity. Participants in Cohort 2 did not provide any blood samples for immunogenicity analysis and were evaluated for safety only.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Poliomyelitis; Hepatitis B; Haemophilus Influenzae Type b; DTaP-IPV-Hep B-PRP-T Combined Vaccine (Hexaxim®)
A Phase I Trial to Evaluate Ad5-EBOV in Healthy Adult Africans in China.
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open, dose-escalation phase 1 clinical trial. This study will
      determine the safety and side-effect profile, and immunogenicity of an investigational
      Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China.
    

Detailed description: 
      This is a single center, open, dose-escalation clinical trial. According to the Chinese
      guidelines for vaccine clinical trial, the sample size of a phase 1 clinical trial should be
      at least 20. In this study, a total of 60 participants will be included.30 participants will
      be firstly recruited and assigned to receive the low dose Ad5-EBOV. After the safety of the
      low dose vaccination is confirmed, another 30 participants will be recruited and assigned to
      receive the high dose Ad5-EBOV.

      The whole follow-up period for each participant will be 28 days.
    

Intervention name(s): Ad5-EBOV
Intervention type(s): Biological
Intervention description(s): intramuscular injection
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccines; Ebola Virus Disease
Clinical Performance of Toric Hydrogel Contact Lenses Following One Week of Daily Wear
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The aim of this prospective study is to evaluate the clinical performance of filcon IV1 toric
      and ocufilcon D toric contact lenses after 1 week of wear in each pair.
    

Detailed description: 
      This is a 30-subject, prospective, randomized, double masked, bilateral, 1 week cross-over
      study comparing the fitting characteristics of filcon IV1 toric lenses against ocufilcon D
      hydrogel toric lenses.
    

Intervention name(s): filcon IV1 toric lens; ocufilcon D toric lens
Intervention type(s): Device; Device
Intervention description(s): toric contact lens; toric contact lens
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Novel Dietary Interventions for Treating Insulin Resistance
Condition: Insulin Resistance; Obesity; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance
Study type: Interventional

Summary: 
      Clinical and rodent studies have demonstrated the impact of specific dietary factors in
      modulating inflammation-related diseases including insulin resistance, type 2 diabetes, and
      cardiovascular disease. Such dietary factors include polyunsaturated fats, polyphenols, and
      glycemic index. The investigators know from previous studies in the literature that reducing
      the glycemic index and increasing the omega-3 fat and polyphenol content of the diet results
      in improved metabolic indices and reduced inflammation. These improvements can be observed
      even within the context of persistent obesity. The investigators will implement a
      reduced-calorie, multi-pronged dietary approach for improving insulin sensitivity and
      reducing inflammation in obese subjects with the metabolic syndrome. The active diet will
      include reduced glycemic index foods together with omega-3 fats and polyphenol supplements.
      The primary hypothesis is that the dietary combination of reduced glycemic index foods,
      omega-3 fats and polyphenols will work to reduce insulin resistance and inflammation more
      efficiently than a placebo-controlled, calorie- and macronutrient-matched diet in obese
      subjects with the metabolic syndrome.
    


Intervention name(s): Fish Oil; Polyphenol Capsules; Corn Oil Capsules; Corn starch capsules; Reduced glycemic index bread products; Market variety bread products
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Other; Other
Intervention description(s): fish oil capsules; delphinidin polyphenol capsules; Corn Oil Capsules; Maltodextrin capsules; Made by Zone Labs; placebo bread products
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Inflammation; Monocytes
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
Condition: Respiratory Tract Infection; Respiratory Syncytial Virus
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
      incidence of anti-drug antibodies (ADAs) of single ascending doses of clesrovimab in healthy
      pre-term (born at 29 to 35 weeks gestational age) and full-term (born at >35 weeks
      gestational age) infants. Participants will be randomized into 1 of 4 dose escalation panels
      (Panels A to D); an additional panel (Panel E) of full-term infants will receive the same
      dose as Panel D. Key safety and tolerability variables will be reviewed after each dose panel
      prior to administering the next-highest dose.
    

Detailed description: 
      Participants in Dose Panels A, B, C, D1, and E1 will be followed for up to 365 days. After
      protocol Amendment 4 (AM4), participants in Dose Panels D2 and E2 will be followed for up to
      545 days.
    

Intervention name(s): Clesrovimab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending doses of clesrovimab will be administered via IM injection.; Placebo (0.9% sodium chloride [NaCl]) will be administered via IM injection.
Other intervention name(s): MK-1654
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single ascending dose
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Assisted Nerve Blocks
Condition: Surgery
Study type: Observational

Summary: 
      The study investigates assisted nerve blocks using an ultrasound machine.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient undergoing surgery which necessitates a peripheral nerve block to relieve
        postoperative pain.
      
Keywords: Nerve Blocks
Dose Escalation of Bevacizumab With Ambulatory Blood Pressure Monitoring in Patients With Advanced Non-squamous NSCLC
Condition: Advanced Non-squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional

Summary: 
      The purpose of this study is to see if higher dose of bevacizumab can be taken safely by some
      patients and if changes in the dose of bevacizumab have any effect on blood pressure.
    

Detailed description: 
      Carboplatin and pemetrexed are FDA approved chemotherapy agents for patients with advanced
      non squamous non small cell lung cancer. Bevacizumab is also FDA approved in lung cancer ,
      and the combination of all three drugs is promising. The doctors directing this research want
      to learn how to better personalize drug dosing of bevacizumab by identifying people who could
      safely take a higher dose of the drug.
    

Intervention name(s): Pemetrexed; Carboplatin; Bevacizumab 7.5 mg/kg; Bevacizumab 15 mg/kg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pemetrexed 500 mg/m^2 intravenously over 10 minutes; Carboplatin at a dose calculated to produce an area under the concentration-time curve of 6 mg/ml•min intravenously over 30 minutes; Bevacizumab at 7.5 mg/kg intravenously over 90 minutes; Bevacizumab at 15 mg/kg intravenously over 90 minutes
Intervention MeSH terms: Bevacizumab; Carboplatin; Pemetrexed
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-squamous Non-Small Cell Lung Cancer; Bevacizumab; Ambulatory Blood Pressure Monitoring
Blood Pressure in Adolescents With PReclampsia and Eclampsia.
Condition: Adolescent Pregnancy; Preeclampsia and Eclampsia
MeSH terms: Pre-Eclampsia; Eclampsia
Study type: Observational [Patient Registry]

Summary: 
      Levels of blood pressure in adolescents with preeclampsia and eclampsia:

      Multicenter case-control study (Latin America). Maternities in Latin America: Two hospitals
      in Panama, one hospital in Mexico, one hospital in El Salvador, one hospital in Guatemala,
      two hospitals in Honduras, one hospital in Colombia, two hospitals in Peru and two hospitals
      in Bolivia.

      The objective is to evaluate the basal levels of blood pressure during pregnancy and
      determine if there is any increase that is associated with the development of preeclampsia
      and eclampsia without reaching the known values of 140/90 mm Hg.

      The sample is 1050: (350 Cases and 700 Controls).
    

Detailed description: 
      Levels of blood pressure in adolescents with preeclampsia and eclampsia: cases and controls
      study.

      It is unknown whether the blood pressure levels used for the diagnosis of preeclampsia have
      the same impact in adolescents as in older women, however for the diagnosis of preeclampsia
      and severe hypertension the same criteria of hypertension are used regardless of age
      maternal.

      It is necessary to do research to determine the values of blood pressure with which
      adolescents convulse and also to validate if slight increases in baseline blood pressure in
      adolescents are associated with prediction of preeclampsia and eclampsia.

      Unfortunately, 85% of teenage pregnancies occur in non-industrialized countries such as those
      in Latin America, and it is estimated that 25% of maternal deaths occur in adolescents

      Cases: patients with pregnancy that starts before the age of 19 that develops preeclampsia
      (mild), severe preeclampsia, gestational hypertension and eclampsia, that is 24 and more
      weeks pregnant with prenatal control started before 20 weeks of pregnancy. Controls are
      patients with the same criteria but WITHOUT hypertension during this pregnancy.

      The statistical analyzes are based on comparing blood pressure levels between the two groups,
      in addition blood pressure levels like 30/15 on the systolic and diastolic basal levels will
      be created and compared between the two groups, especially when it is not possible to have
      140 / 90 mm Hg.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Pregnant patients who are 19 years of age or younger and more than 23 weeks pregnant, where
        the cases are those that develop preeclampsia (mild), severe preclampsia, gestational
        hypertension and eclampsia; and the controls patients of the same age and with more than 23
        weeks of pregnancy without hypertension.
Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle Vaccine With/Without Matrix-M Adjuvant
Condition: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial.
      Part 1 (Phase 1) of the study is designed to evaluate the safety and immunogenicity of
      SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in 131 healthy
      participants ≥ 18 to 59 (inclusive) years of age at 2 sites in Australia. An interim analysis
      of Part 1 safety and immunogenicity will be performed prior to optional expansion to Part 2.
      Part 2 (Phase 2) of the study is designed to evaluate the immunogenicity, safety, and
      preliminary efficacy of a single construct of SARS-CoV-2 rS nanoparticle vaccine with
      Matrix-M adjuvant in up to 1,500 healthy participants ≥ 18 to 84 (inclusive) years of age at
      up to 40 sites across Australia and/or the United States.
    


Intervention name(s): SARS-CoV-2 rS - Phase 1; SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1; Normal saline solution (NSS), Placebo - Phase 1; Normal saline solution (NSS), Placebo - Phase 2; SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1; Normal saline solution (NSS), Placebo, Day 21 - Phase 1; SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2
Intervention type(s): Biological; Biological; Other; Other; Biological; Other; Biological
Intervention description(s): Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS (0.6 mL) on Days 0 and 21.; Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Days 0 and 21.; Alternating intramuscular (deltoid) injections of placebo (0.6 mL) on Days 0 and 21.; Intramuscular (deltoid) injections of placebo (0.5 mL).; Intramuscular (deltoid) injection of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Day 0.; Intramuscular injection of placebo (0.6 mL) in alternate deltoid on Day 21.; Intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL).
Other intervention name(s): NVX-CoV2373; Sodium chloride solution for injection, 0.9%; Sodium chloride solution for injection, 0.9%; NVX-CoV2373; Sodium chloride solution for injection, 0.9%; NVX-CoV2373
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Punctal Plugs on Tear Volume and Osmolality
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the role of tear volume in discomfort and dryness
      sensations during contact lens wear, and the possible influence on osmolality and ocular
      surface sensitivity.
    

Detailed description: 
      50% of contact lens wearers have dryness/discomfort during contact lens wear. Significant
      decreases in lipid layer and tear film break up time during contact lens wear have been
      reported, leading to excessive evaporation, reduced tear volume and an increase in
      osmolality.

      Similar tear film changes occur with Dry Eye Disease. A commonly used therapy in treating dry
      eye is the insertion of punctal plugs to increase tear volume and ease dry eye symptoms.
      Punctal plugs block the tear drainage system, and often increase tear stability, and improve
      ocular surface health.

      This study will evaluate the role of tear volume in discomfort and dryness sensations during
      contact lens wear, and the possible influence on osmolality and ocular surface sensitivity.
      Collagen punctal plugs will be used for this study, as these allow a temporary (3-14 days)
      occlusion of the ocular drainage system, are easily removed if necessary and are inserted
      with minimal risk.
    

Intervention name(s): Temporary Collagen Inserts
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: contact lenses; intolerance; punctal plugs; tear volume; Intolerance to contact lens wear due to dryness symptoms
ROM Outcomes in Patients Undergoing a Primary TKA
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The goal of this prospective, randomized study is to compare the outcomes of patients
      undergoing primary TKA after photographing final knee range of motion immediately
      post-operatively and sharing these photographs with patients at their first follow-up
      appointment versus a group that does not see a photograph.
    

Detailed description: 
      The goal of this prospective, randomized study is to compare the outcomes of patients
      undergoing primary total knee arthroplasty (TKA) after photographing final knee range of
      motion immediately postoperatively and sharing these photographs with patients at their first
      follow-up appointment versus a group that does not see a photograph. The knee will be
      photographed in maximum flexion and extension. The primary objectives will be to compare the
      range of motion of the operative knee at 2 weeks and 6 weeks postoperatively. In the
      investigator's institution, patients who have failed to achieve 90 degrees of flexion at a
      postoperative period of 6 weeks undergo manipulation of the knee under anesthesia (MUA). The
      investigators will also measure how many patients require MUA in the photograph group and
      non-photograph group. MUA will be performed if patients fail to achieve 90 degrees of flexion
      at 6 weeks post-op.
    

Intervention name(s): Patient will be shown a photograph of their knee at 2 weeks postop; Patient will not be shown a photograph of their knee at 2 weeks postop
Intervention type(s): Other; Other
Intervention description(s): Patients who undergo primary TKA surgery will then be shown a photograph of their knee at 2 weeks postoperative.; Patients who undergo primary TKA surgery will not be shown a photograph of their knee at 2 weeks postoperative.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Intravenous Ketamine Plus Neurocognitive Training for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study has two aims: 1) to characterize the effects of intravenous ketamine on
      neurocognitive markers in depressed patients; 2) to test the efficacy of a synergistic
      intervention for depression combining intravenous ketamine with neurocognitive training.
      Three of the primary outcomes listed (fMRI functional connectivity; Implicit Association
      Test; cognitive flexibility testing) pertain to Aim 1. For Aim 2, one primary clinical
      outcome (MADRS, a clinician-administered measure of depression severity) pertains to the
      acute (30-day) phase, while the QIDS (a self-report measure of depression severity) becomes
      the primary clinical outcome during the 12-month naturalistic follow-up.
    


Intervention name(s): Intravenous ketamine; Computer-based Cognitive Training
Intervention type(s): Drug; Behavioral
Intervention description(s): Intravenous ketamine is given at a subanesthetic dose, which previous research suggests is safe and efficacious for rapid relief from depression.; Computer-based Cognitive Training will be delivered following intravenous ketamine to test whether learning during a post-ketamine "window of opportunity" might extend relief from depression.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: depression; ketamine; neurocognitive; fMRI; cognitive training