bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I/IIa Study of the Safety, Immunogenicity and Efficacy of FMP2.1/AS01B, an Asexual Blood-Stage Vaccine for Plasmodium Falciparum Malaria
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate an experimental malaria vaccine for its ability to
      prevent malaria infection or disease in a blood-stage challenge model (when volunteers are
      infected with malaria parasites using malaria-infected red blood cells). The vaccine being
      testing is a protein called FMP2.1, which is given with an adjuvant (a substance to improve
      the body's response to a vaccination) called AS01B.

      The aim is to use this protein and adjuvant to help the body make an immune response against
      parts of the malaria parasite. This study will enable assessment of:

        1. The ability of the vaccine to prevent malaria infection.

        2. The safety of the vaccine in healthy participants.

        3. The response of the human immune system to the vaccine.

      This will be done by giving participants three vaccinations and then exposing them to malaria
      infection by transfusing a small number of red blood cells infected with malaria under
      carefully regulated conditions. Participants will be followed closely to observe if and when
      they develop malaria. If the vaccine provides some protection against malaria, participants
      will take longer to develop malaria than usual or will not develop malaria at all.

      The study will enrol 15 participants to be vaccinated and then challenged with malaria in
      addition to recruit 15 individuals to be control subjects.
    


Intervention name(s): FMP2.1/AS01B
Intervention type(s): Biological
Intervention description(s): 50 µg FMP2.1 in 0.5 mL of the adjuvant AS01B (containing 50 mcg MPL + 50 mcg QS21) is administered via intramuscular (IM) injection in the deltoid region of the non-dominant arm
Other intervention name(s): FMP2.1; AS01B
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Plasmodium Falciparum; Malaria; Vaccine; Plasmodium; Falciparum
A Survey To Elicit The Relationship Between Literacy And Glycemic Control In Pediatric Diabetes
Condition: Diabetes; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this study is to see if a patient's ability (and/ or parent) to read, write,
      and do basic math problems affects blood sugar control in children with type 1 diabetes
      mellitus.
    

Detailed description: 
      "Literacy" is defined as an individual's ability to read, write, and speak English, and
      compute and solve problems at levels of proficiency necessary to function on the job and in
      society, to achieve one's goals, and develop one's knowledge and potential, according to the
      National Literacy Act of 1991. The National Work Group on Health and Literacy reported that
      between 40 and 44 million persons in the United States have rudimentary literacy skills, and
      are unable to understand written materials that require only basic reading proficiency.
      Illiteracy has become an increasingly important problem, especially as it relates to
      healthcare. Literacy skills are paramount to effective self-management of type 1 and type 2
      diabetes mellitus. And, "Diabetes Self-Management Education" is the cornerstone of care for
      all individuals with diabetes who want to achieve successful health-related outcomes. Self
      care of diabetes plays a major role in achieving DCCT recommended level of hemoglobin A1C.
      Deficient self-management will lead to uncontrolled diabetes, resulting in multisystem
      complications, increasing exponentially the burden on our healthcare system. Structured
      education of individuals tailored to combat poor literacy skills is imperative in helping
      these individuals achieve good glycemic control. Hence we would like to evaluate literacy in
      our clinic so appropriate educational material can be developed to help patient with T1DM who
      have low literacy.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children with diabetes attending clinic followup at Texas Children's Hospital
      
Keywords: Diabetes; Type 1 diabetes mellitus; Type 2 diabetes mellitus; Literacy; Glycemic control
Aquatic Therapy and Autism Spectrum Disorders
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional

Summary: 
      To compare the efficacy of one-on-one versus group-based aquatic therapy on the social
      interactions, behaviors and physical activities of children with autism spectrum disorders
      (ASDs).
    


Intervention name(s): Aquatic Physical Therapy
Intervention type(s): Other
Intervention description(s): Swim Whisperer's Aquatic Therapy Sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aquatic therapy, hydrotherapy
Non-prescription Versus Prescription Topical Treatments Versus no Treatment in the Control of Sweating
Condition: Hyperhidrosis; Excess Sweating
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effectiveness of the prescription treatment
      compared to the non-prescription treatment. It is hypothesized that the prescription
      treatment will have a significantly greater effect than the non-prescription treatment on
      decreasing excess sweating.
    

Detailed description: 
      The objective of this study is to assess the effectiveness of the prescription treatment
      compared to the non-prescription treatment. It is hypothesized that the prescription
      treatment will have a significantly greater effect than the non-prescription treatment on
      decreasing excess sweating.
    

Intervention name(s): Drysol; Drioff
Intervention type(s): Drug; Drug
Intervention description(s): 20% aluminum chloride hexahydrate; 1% aluminum acetate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Action Modules on Resilience and Psychological Health
Condition: Stroke Patients
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study aimed to determine whether interventions that use the Specific Thematic Nursing
      Care Action Modules (STNC-AM) platform improve patients' psychological health over a
      two-month period.
    

Detailed description: 
      The STNC-AM platform that investigator present here is an educational program that integrates
      education and coaching. STNC-AM has six key aspects: stroke prevention, management of
      emotions, management of fatigue, physical activity, caregiver training, and integrative
      resources. Each scope contains detailed care guidance. The nurse coaching component was based
      on the six key aspects detailed above. This online platform can guide nurses' health
      education for the comprehensive care of stroke patients.
    

Intervention name(s): Specific Thematic Nursing Care Action Modules (STNC-AM)
Intervention type(s): Other
Intervention description(s): The STNC-AM platform that investigators present here is an educational program that integrates education and coaching.
The nurse coaching component was based on the STNC-AM platform. This online platform can guide nurses' health education for the comprehensive care of stroke patients. Nurses can use an iPad and enter the STNC-AM platform website, where they can directly access the Care Action Module.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The Specific Thematic Nursing Care Action Modules (STNC-AM) platform that we present here is an educational program that integrates education and coaching. STNC-AM has six key aspects: stroke prevention, management of emotions, management of fatigue, physical activity, caregiver training, and integrative resources. Each scope contains detailed care guidance.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: anxiety; depression; resilience; illness representation
Effect of OC000459 on Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether OC000459 is in reducing disease severity
      and preventing flares in people with moderate to severe atopic dermatitis (AD).
    

Detailed description: 
      The study will include patients with a Th2 high eosinophilic phenotype who typically have
      more severe disease and are prone to flare.
    

Intervention name(s): OC000459
Intervention type(s): Drug
Intervention description(s): Oral CRTH2 antagonist
Other intervention name(s): timapiprant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Long Term Nebulised Gentamicin in Patients With Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The hypothesis of this randomized placebo controlled trial is that targeted nebulized
      gentamicin to the airways will reduce bacterial burden and limit neutrophil airways
      inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise
      capacity and health related quality of life with a reduction in exacerbation frequency and
      health care utilization.
    


Intervention name(s): Gentamicin; Saline
Intervention type(s): Drug; Drug
Intervention description(s): Nebulised 80mg twice daily; Nebulised 4mls 0.9% Saline twice daily
Intervention MeSH terms: Gentamicins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nebulised antibiotics; Non cystic fibrosis bronchiectasis; Bacterial Load; Inflammation; Quality of Life; Side Effects
Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease
Condition: Gluten Sensitivity
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Celiac disease (CD) is the most common genetically based food intolerance in the world, with
      a prevalence among approximately 1% of the general population (Guandalini & Assiri, 2014). CD
      is a frequent disorder among Egyptian children, both in the general population and in at-risk
      groups(Abu-Zekry et al., 2008). It is estimated that the incidence of CD is 3 to13 cases
      per1000, with a higher prevalence among first-degree relatives of patients with CD.Lifelong
      adherence to a strict gluten free diet (GFD) remains the only available treatment for
      patients with CD and typically results in a complete return to health. Nevertheless, gluten
      is not found only in diet, Gluten is commonly used as a binder in products like medication,
      cosmetics, oral and skin care, and even children's toys. Gluten is found also in toothpastes
      and other oral health products and it can be swallowed by mistake and initiate immune
      response(Anon, n.d.). Unfortunately, there is no gluten free toothpaste available in the
      Egyptian market and it is very expensive if we bought it from Europe or USA. The tube will
      cost nearly 10 dolars .As a result, the production and availability of gluten free toothpaste
      in Egypt has become mandatory.
    

Detailed description: 
      production of an experimental gluten free toothpaste and providing it for children with
      celiac disease
    

Intervention name(s): experimental gluten free toothpaste
Intervention type(s): Drug
Intervention description(s): we prepared gluten free toothpaste in the faculty of pharmacy -Cairo university because there is no gluten free toothpaste available in the Egyptian market .
Other intervention name(s): natural toothpaste
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gluten-free toothpaste,celiac disease, GFD, children
Use of NIRS in Preterm Population Born at Altitude
Condition: Prematurity; Extreme
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Near-infrared spectroscopy (NIRS), is a technology that can provide continuous, non-invasive
      monitoring of oxygenation in tissue. The objective of this study is to obtain the cerebral
      regional oxygen saturation (cRSO2) in a preterm population that is born at altitude to
      determine if the range of "normal" values is different than those obtained at sea level.
    


Intervention name(s): Near-infrared spectroscopy (NIRS) utilization
Intervention type(s): Device
Intervention description(s): The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.
Intervention model: Single Group Assignment
Intervention model description: The study will be a prospective observational study, in which any infant consented to participate in the study will have the NIRS applied for the first 96 hours of life.
Masking: None (Open Label)
Primary purpose: Supportive Care
To Demonstrate the Relative Bioavailability of Bupropion HCI 300 mg Extended-Release Tablets Under Fasting Conditions
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the relative bioequivalence of Bupropion HCI 300
      mg ER Tablets under fasting conditions.
    


Intervention name(s): Bupropion HCI 300 mg Extended-Release Tablets EON; WELLBUTRIN XL 300 mg Extended-Release Tablets GlaxoSmithKline
Intervention type(s): Drug; Drug
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics & Safety of Cambia® in Migraine With or Without Aura in 12-17 Year Olds
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Study Objectives:

        1. The primary objective is to characterize the pharmacokinetics of a single oral
           administration of 50 mg Cambia in pediatric subjects, ages 12-17 years with a diagnosis
           of episodic migraine with or without aura.

        2. The secondary objectives are to determine:

             1. The safety and tolerability of Cambia from a single dose

             2. Three-month safety evaluation of Cambia in outpatient usage in this population
    


Intervention name(s): Diclofenac Potassium for Oral Solution
Intervention type(s): Drug
Intervention description(s): NSAID
Other intervention name(s): Cambia
Intervention MeSH terms: Diclofenac
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migraine with and without aura
Study To Assess Safety, Tolerability And PK Of ATB-346 In Healthy Subjects
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, placebo-controlled, phase I study to assess safety, tolerability and
      pharmacokinetics of single/multiple ascending doses of atb-346 orally administered in healthy
      male and female subjects.
    

Detailed description: 
      Single ascending doses of ATB-346 given to multiple cohorts followed by multiple ascending
      doses of ATB-346 given to multiple cohorts in order to assess its safety, tolerability, and
      pharmacokinetics. A single dose cohort was also conducted to assess the effect of food on the
      drug's characteristics.
    

Intervention name(s): ATB-346; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Comparison of Mcgrath Mac, C-MAC, and Macintosh Laryngoscope in Novice Users: a Manikin Study
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate whether the McGrath MAC videolaryngoscope is
      superior when compared to the C-MAC videolaryngoscope and the Macintosh laryngoscope for
      novice users in manikin.
    


Intervention name(s): Mcgrath Mac videolaryngoscope; C-MAC videolaryngoscope; macintosh laryngoscope
Intervention type(s): Other; Other; Other
Intervention description(s): Participants perform three intubation attempts using Mcgrath Mac videolaryngoscope in the manikin with the normal airway and difficult airway settings.; Participants perform three intubation attempts using C-MAC videolaryngoscope in the manikin with the normal airway and difficult airway settings.; Participants perform three intubation attempts using macintosh laryngoscope in the manikin with the normal airway and difficult airway settings.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Simulated manikin
Comparison of Raloxifene and Lasofoxifene - A Randomized, Blinded Study of These Drugs and Placebo on Bone Loss
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the effects of 2 years of lasofoxifene treatment with 2 years of raloxifene 60
      mg/day use and 2 years of placebo use on bone mineral density (BMD) of the lumbar spine.
    


Intervention name(s): lasofoxifene; raloxifene; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): lasofoxifene 0.25mg; raloxifene 60 mg/day; 0 mg/day
Intervention MeSH terms: Raloxifene Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses
      of MEDI-528 in to healthy adult volunteers.
    

Detailed description: 
      The primary objective of this Phase I study is to evaluate the safety and tolerability of
      escalating single SC doses of MEDI-528 administered to healthy adult volunteers in four dose
      groups.
    

Intervention name(s): MEDI-528 0.3 mg/kg; MEDI-528 1 mg/kg; MEDI-528 3 mg/kg; MEDI-528 9 mg/kg
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose; MEDI-528 (1 mg/kg) administered as a single, SC dose; MEDI-528 (3 mg/kg) administered as a single, SC dose; MEDI-528 (9 mg/kg) administered as a single, SC dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fractionated Versus Target-controlled Propofol Administration in Bronchoscopy
Condition: Lung Cancer; Sarcoidosis; Interstitial Pneumonia
MeSH terms: Lung Diseases, Interstitial; Sarcoidosis
Study type: Interventional
Phase: Phase 4

Summary: 
      After randomization, the subjects undergo flexible bronchoscopy either with fractionated
      propofol administration or with propofol-TCI. Measurement of blood pressure, heart rate,
      oxygen saturation, and oxygen requirement are measured continuously during the procedure and
      thereafter. Cumulative propofol dose, and induction, procedure, and recovery time are noted
      continuously during and after the procedure.
    

Detailed description: 
      In daily clinical praxis, propofol sedation is given manually in repeated doses
      (fractionated) by a specially-trained nurse in attendance of the bronchoscopist. But,
      fractionated propofol administration (FPA) may lead to oversedation and enhanced side effects
      (oxygen desaturation and arterial hypotension), as a stable plasma concentration of propofol
      is not maintainable. In contrast to FPA, continuous infusions of propofol are commonly used
      to induce and maintain long-term sedation in intensive care units and general anesthesia.
      Recently, continuous propofol infusion for sedation in bronchoscopy has been shown comparable
      to FPA in terms of safety and efficacy. Generally, infusion devices can be manually
      controlled (MCI) or target-controlled (TCI). In the latter, the physician sets a target blood
      concentration and the computerized infusion device makes the necessary changes to the
      infusion rate.

      The objective of this study is to compare propofol TCI with FPA in flexible bronchoscopy
      concerning patient safety and sedation quality.
    

Intervention name(s): Flexible bronchoscopy in moderate sedation; Oxygen saturation; Blood pressure; Propofol dosage; Recovery time after bronchoscopy
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;; Continuous measurement of oxygen saturation;; Measurement of non-invasive blood pressure every 3 minutes; Report of dose adjustments und cumulative propofol dosage;; Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Bronchial Thermoplasty in Severe Persistent Asthma
Condition: Severe Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston Scientific
      to generate data to assess the durability of the BT treatment effect as well as safety data
      in the intended use population in the United States.
    

Detailed description: 
      This is a multicenter, open-label, single arm study designed to demonstrate durability of the
      treatment effect and to evaluate the short-term and longer-term safety profile of the Alair
      System in the United States in the intended use population (patients 18 years and older with
      severe persistent asthma).
    

Intervention name(s): Alair System
Intervention type(s): Device
Intervention description(s): Treatment of airways with the Alair System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Procedural Advantages of a Novel Drug-Eluting Coronary Stent
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      This study sought to compare procedural performance of a new coronary stent generation, that
      is already available in Germany, with hitherto established current drug-eluting stents.
    


Intervention name(s): Synergy Stent; Currently common drug-eluting stent (DES)
Intervention type(s): Device; Device
Intervention description(s): Patients with narrowed coronary artery disease qualifying for PCI were treated with Synergy stent implantation.; Patients with narrowed coronary artery disease qualifying for PCI were treated with DES implantation (Xience Prime, Resolute Integrity, Promus Element Plus)
Other intervention name(s): Synergy Coronary Stent; DES including Xience Prime, Resolute Integrity, Promus Element Plus.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment