bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
Condition: SARS-CoV Infection; Covid19
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and
      immunogenicity of a quadrivalent HA nanoparticle influenza and SARS-CoV-2 rS nanoparticle
      combination vaccine with Matrix-M1 adjuvant; this combination is referred to as ICC vaccine.
    

Detailed description: 
      This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and
      immunogenicity of a quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) and
      severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS)
      nanoparticle combination vaccine with Matrix-M1™ adjuvant; this combination vaccine is
      referred to as Influenza COVID-19 Combination (ICC) vaccine.

      The study will enroll approximately 640 healthy (based on history and physical examination)
      adult male and female participants 50 to 70 years of age, inclusive, targeting participants
      who are baseline seropositive (either previously infected with SARS-CoV-2 ≥ 8 weeks prior to
      enrollment, or have been previously immunized against SARS-CoV-2 with a completed regimen of
      an authorized vaccine at ≥ 8 weeks prior to enrollment). Randomization will be stratified on
      age ≥ 50 to ≤60 or

      ≥ 60 to ≤ 70 years to distribute the proportions of each age stratum evenly across vaccine
      groups.
    

Intervention name(s): ICC Vaccine; qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant; SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.; Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.; Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Coronavirus
Heparin and the Reduction of Thrombosis (HART) Trial
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional

Summary: 
      Heparin is frequently used in central venous catheters (CVCs) in post-operative cardiac
      patients. It remains unclear if a heparin infusion, compared to a normal saline infusion,
      prevents thrombosis of CVCs after surgery. This study will answer the question: does a
      low-dose heparin infusion (10 units/kg/h) prevent thrombosis, compared to a normal saline
      infusion, in patients less than one year of age after cardiac surgery?
    

Detailed description: 
      Patients are contacted pre-operatively and their parents consented. The following criteria
      apply:

      Inclusion criteria:

      All infants < 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital

      Exclusion Criteria:

      Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need
      for therapeutic heparinization ECMO

      Randomization and blinding are performed in the Pharmacy. The intervention is initiated at
      the intensive care unit physician's discretion, generally within the 1st 24 hours
      post-operatively. The study is terminated when all catheters have been discontinued or at POD
      #14, whichever occurs first.

      Thrombosis is demonstrated by echocardiogram or ultrasound performed at

      1 - 3 days, 5 - 7 days, and 10 - 14 days after initiation of the study drug.

      The following are calculations for statistical analysis:

      Sample size determination - Using 2 - sided alpha = 0.05 and Beta = 0.2, and assuming a
      baseline thrombosis incidence of 20%, 160 patients are required to detect an effect size of
      15%.
    

Intervention name(s): Heparin sulfate infusion at 10 units/kg/hour; Placebo infusion
Intervention type(s): Drug; Drug
Intervention description(s): Infusion of heparin to prevent central line thrombosis in infants after cardiac surgery; Infusion of normal saline
Other intervention name(s): heparin
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)
Condition: Infant, Very Low Birth Weight; Infant, Premature; Ductus Arteriosus, Patent
MeSH terms: Ductus Arteriosus, Patent; Birth Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999
      grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy
      or developmental problems at 18 to 22 months of age.
    

Detailed description: 
      Prophylactic indomethacin reduces patent ductus arteriosus (PDA) and intraventricular
      hemorrhage in very low birth weight infants. However, the effects of early indomethacin on
      long-term neurodevelopment remain uncertain. There is also insufficient evidence to rule out
      serious adverse effects, such as increases in the risk of necrotizing enterocolitis (NEC) and
      retinopathy of prematurity (ROP). The aim of this trial was to determine if prophylactic
      administration of indomethacin improves survival without neurosensory impairments in
      extremely-low-birth-weight infants. Infants (n=1202) with birthweights 500 to 999 grams were
      randomized between 2 and 6 hours after birth to receive either intravenous indomethacin (0.1
      mg/kg) or equal volumes of normal saline placebo, daily for 3 days. The primary outcomes at a
      corrected age of 18 months was a composite of death, cerebral palsy, cognitive delay,
      deafness, or blindness. Secondary long-term outcomes were hydrocephalus necessitating the
      placement of a shunt, seizure disorder, and microcephaly. Secondary short-term outcomes were
      patent ductus arteriosus, pulmonary hemorrhage, chronic lung disease, cranial
      ultrasonographic abnormalities, nectrotizing enterocolitis and retinopathy. Infants were
      evaluated in follow-up at 18-22 months corrected age.
    

Intervention name(s): indomethacin; Indomethacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Indocid P.D.A., Merck Frosst, Kirkland, Que., Canada, and Merck, West Point, Pa; 0.1 mg per kilogram of body weight; 0.1 mg per kilogram of body weight
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Chronic lung disease; Indocin; Indomethacin; Infants, very low birth weight; Intraventricular hemorrhage; Necrotizing enterocolitis; Patent ductus arteriosus; Pulmonary hemorrhage
A Clinical Trial Of Two Educational Strategies In Cardiovascular Health In Child Population
Condition: Obesity; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      AIM: To evaluate the effectiveness of two strategies in cardiovascular risk in children 2º
      grade in the community of Madrid.

      DESIGN: cluster-randomized trial with blinded evaluator SCOPE AND SUBJECTS OF STUDY: Children
      of both sexes enrolled in 2º grade in public schools in the community of Madrid. Rate
      exclusion criteria INTERVENTION: Schools were randomly assigned to two groups: an
      experimental group that the investigators organized a concert teaching focused on messages
      cardio, a second group or control group to which they will host a healthy breakfast as it has
      been offering the Community of Madrid .

      MEASUREMENTS: The primary end result is the increase of correct answers on a standardized
      test to be administered before and after the activity.

      Secondary outcomes will be, improving the same questionnaire at 6 months and reduced overall
      weight and center from before the intervention at 6 months of it.
    


Intervention name(s): Didactic Concerts
Intervention type(s): Other
Intervention description(s): The activity we are going to test consists in a communication and spreading strategy.
The activity will take place in the auditorium of the school, scheduling 1 hour for concert, within the school hours, and having maximum 50 children per turn.
Preparation of the auditorium for the activity 5 classic musical pieces and a story as a conducting thread. Children will be asked to clap and raise hands to participate in the mission of becoming a heart-savers: Ideal number of daily meals, Importance of daily breakfast for the activity, Time for breakfast, Basic components for a healthy breakfast, The role of cereals at breakfast, dairy products in breakfast, fruits at breakfast, Importance of exercise for cardiovascular health, The role of sedentary lifestyle.
Students will be invited to take the playbill as a bookmark format and a cup is inscribed: "I am a heart-saver", so that they take them home and serve as a reminder of the activity. A NAOS strategy pamphlet will also be delivered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Obesity; Cardiovascular Diseases Prevention; Paediatrics
A Study of the Effectiveness and Safety of SP2086 to Treat Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to explore the
      effective dose range of SP2086 in Patients with type 2 diabetes.
    


Intervention name(s): Placebo; 50 mg SP2086; 100 mg SP2086; 200 mg SP2086; 100 mg Sitagliptin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablets(n=4),once daily for 84 days; Tablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days; Tablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days; Tablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days; Tablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sp2086; Phase II; monotherapy
Improving Practice Patterns for the Treatment of Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      To improve the quality of hypertension care in our facility, while concurrently, examining
      the relative contribution of each aspect of a multi-factorial intervention designed to
      improve hypertension care.
    

Detailed description: 
      This project was a randomized trial designed to examine the relative contribution of three
      quality improvement interventions of increasing intensity on BP control in veterans.
      Providers in each stratum and their eligible patients were randomized to one of three study
      arms. The providers randomized to the first arm received education alone, and were considered
      the controls. Providers randomized to the second arm received both provider education and a
      hypertension alert. The third arm included provider education, a hypertension alert, and
      patient education. Patients were eligible for inclusion if they were aged 21- 90 years and
      filled their medications with the VA pharmacies. Between July and December 2003, we
      determined patient eligibility using a search strategy using data from the Mid South Quality
      Improvement Data warehouse, which is downloaded monthly from Veterans' Health Information
      System and Technology Architecture (VistA).
    

Intervention name(s): Provider Education; Hypertension Alert; Patient Education
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Behavior Change; patient Education
The Effect of Reflexology on Lactation and Postpartum Comfort for Cesarean-delivery Primiparous Mothers
Condition: Breastfeeding; Lactation Failure; Nursing Caries; Postpartum; Reflexology
Study type: Interventional

Summary: 
      Immediately after cesarean birth, many women suffer from breastfeeding problems due to pain,
      fatigue, activity intolerance, anesthesia, and delayed onset of lactation. Because of these
      avoidable problems, the baby cannot get enough breast milk, and mothers' postpartum comfort
      decreases.

      This study aimed to investigate the effect of reflexology on lactation and postpartum comfort
      in primiparas giving births through cesarean section.
    

Detailed description: 
      Methods: This randomized controlled trial was conducted with 100 women with first birth
      through cesarean section were investigated between May 2016 and May 2017. Expectant mothers
      were randomly included into an intervention and a control group. The intervention group
      consisted of mothers for whom reflexology was performed three times per day for 30 min every
      eight hours.

      With face-to-face interviews, all participants were informed about the design, content and
      methods to be used in the study, and the sociodemographic data obtained self-reportingly from
      the primiparas were recorded. The data were collected between May 2016 and May 2017. In
      collecting the data related to primiparas and infants, a questionnaire structured by the
      researchers in light of literature was used, as well as The breastfeeding charting system
      (LATCH), The visual analogue scale (VAS) for signs of onset of lactation and The postpartum
      comfort questionnaire (PPCQ).
    

Intervention name(s): Reflexology
Intervention type(s): Other
Intervention description(s): Reflexology: foot massage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Safety, Tolerability and Pharmacodynamics of BIIF 1149 BS in Healthy Young Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study is to obtain information about the safety and tolerability
      of BIIF 1149 BS, to determine the pharmacologically active dose (range) by performing a
      citric acid challenge test and to obtain preliminary pharmacokinetic data
    


Intervention name(s): BIIF 1149 BS - single rising doses; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Lateral Retinacular Release in Total Knee Arthroplasty With Patellar Replacement
Condition: Anterior Knee Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to assess the effect of systematic lateral retinacular release on
      anterior knee pain, as well as its impact on the functional and radiological outcomes after
      total knee arthroplasty with patellar resurfacing.
    

Detailed description: 
      Anterior knee pain is an important cause of persistent pain after total knee arthroplasty.
      Lateral retinacular release has been proposed as a procedure to prevent anterior knee pain
      syndrome, based on the reduction of lateral tension and improving patellar tracking.

      However, its effect on anterior knee pain after total knee arthroplasty is not clear when it
      is not strictly needed to correct maltracking.

      The purpose of this trial is to evaluate the effect of systematic lateral retinaculare
      release on anterior knee pain, peformed during a total knee arthroplasty with patellar
      resurfacing.
    

Intervention name(s): Lateral retinacular release
Intervention type(s): Procedure
Intervention description(s): During the implantation of a total knee arthroplasty a lateral retinacular release is performed in the intervention group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total knee arthroplasty; Patellar resurfacing; Lateral retinacular release; Anterior knee pain
ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients
Condition: Childhood Acute Lymphoblastic Leukemia in Remission
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      This randomized pilot phase II trial studies how well nutritional intervention and exercise
      intervention works in preventing metabolic syndrome in younger patients with acute
      lymphoblastic leukemia. Nutritional intervention may help weight loss and improve quality of
      life in patients with acute lymphoblastic leukemia. Exercise may help decrease feelings of
      being tired caused by cancer, may help improve strength, and may help build up lost muscle
      tissue. Nutritional intervention plus exercise intervention may be effective at preventing
      metabolic syndrome.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To evaluate feasibility, adherence, completion rates and participant satisfaction
      associated with a family based lifestyle intervention for overweight pediatric acute
      lymphoblastic leukemia (ALL) patients or those at high risk to become so (body mass index
      [BMI] >= 50th percentile).

      II. Assess changes in BMI z-score, waist circumference, body composition, blood pressure
      exercise tolerance and physical activity at baseline, immediately post intervention and three
      months later.

      III. Assess changes in serum glucose, insulin, leptin and adiponectin in patients over the
      intervention course and at 3 months post intervention.

      IV. Assess changes in self-reported quality of life, physical activity, caloric intake, and
      fatigue associated with the nutrition and exercise program in the participant and their
      primary caregiver.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive standard of care individualized diet and exercise plan and monthly
      booster follow-up sessions from the nutritionist and exercise physiologist and weekly phone
      counseling with a trained health coach to address barriers to improve plan adherence.

      ARM II: Patients receive standard of care individualized diet and exercise plan.

      After completion of study treatment, patients are followed up at 3 and 6 months.
    

Intervention name(s): nutritional intervention; exercise intervention; follow-up care; counseling intervention; quality-of-life assessment; laboratory biomarker analysis; questionnaire administration
Intervention type(s): Dietary Supplement; Behavioral; Other; Behavioral; Other; Other; Other
Intervention description(s): Receive nutritional intervention; Receive exercise intervention; Receive booster follow-up sessions from the nutritionist and exercise physiologist; Receive phone counseling with a trained health coach; Ancillary studies; Correlative studies; Ancillary studies
Other intervention name(s): counseling and communications studies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adiponectin, Glucose, Insulin, Leptin
Single Increasing Dose Tolerance Study in Healthy Male Volunteers of BIIR 561 CL
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to obtain information about safety, tolerability and
      pharmacokinetics of BIIR 561 CL after single intravenous administration of increasing doses
      in healthy male volunteers
    


Intervention name(s): BIIR 561 CL; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
The Hope Soap Study: a Hand-washing Intervention Among Children in South Africa
Condition: Hand-washing Behavior; Diarrhea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      The Hope Soap Study is a randomised-control pilot study of a hand-washing intervention in
      which children in treatment households received a bi-monthly delivery of HOPE SOAP©, a
      colourful, translucent bar of soap with a toy embedded in its centre.
    


Intervention name(s): Hope Soap; Control group soap
Intervention type(s): Combination Product; Combination Product
Intervention description(s): HOPE SOAP© is a colourful, translucent bar of soap with a toy embedded in its centre.; A colourful, translucent bar or soap with the toy alongside it
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Platelet Rich Plasm Versus Hyaluronic Acid Injection in Chronic Painful Shoulder
Condition: Chronic Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      Aim of This study is to compare between the effect of ultrasound-guided local injection of
      Platelet Rich Plasma (PRP)versus Hyaluronic (HA) for the treatment of chronic shoulder pain.
    

Detailed description: 
      This study was prospective randomized comparative trial on patients with chronic shoulder
      pain presented at outpatient Clinic of Physical Medicine, Rheumatology and Rehabilitation
      Department at Assiut University Hospitals from June 2019 to December 2020. Our study started
      by 70 patient with chronic shoulder pain 20 of them were missed in follow up period, the
      range of age from 36 - 56 years, history, clinical examination, Laboratory investigation, and
      imaging (X-ray or MRI) done for all patient to complete the diagnosis, patient divided
      randomly into two groups, Group (A) included 25 patients were treated by PRP injection and
      group (B) included 25 patients were treated by HA injection, both injections were performed
      under ultrasound (US) guidance. Randomization by sealed envelopes technique, the follow up
      was at the baseline, 4 weeks and 6 months post injection.
    

Intervention name(s): platelet rich plasm; Hyaluronic acid
Intervention type(s): Procedure; Procedure
Intervention description(s): local injection of shoulder joint by platelet rich plasm; local injection of shoulder joint by Hyaluronic acid
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a demonstration of safety and efficacy of the ablation for pulmonary vein isolation
      in the treatment of paroxysmal atrial fibrillation.
    


Intervention name(s): CardioFocus HeartLight Endoscopic Ablation System
Intervention type(s): Device
Intervention description(s): PVI ablation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation; PAF