bioihbjkbjnl/mcl2 huggingface dataset:
The Influences of Caffeine on Heart Rate Variability of Preterm Infants
Condition: Autonomic Nervous System
Study type: Observational

Summary: 
      Caffeine has a stimulatory effect on the ANS. This has not yet been investigated in preterm
      infant who get caffeine before stopping ventilation. The investigators hypothesis is that
      this stimulatory effect may be characterized by HRV analysis methods.
    


Intervention name(s): Caffeine
Intervention type(s): Drug
Intervention description(s): Caffeine will be given according to departmental protocol
Intervention MeSH terms: Caffeine
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        25 preterm infants
      
Keywords: Autonomic nervous system
The Role of Agricultural Biodiversity in The Diet: a Vietnamese Study
Condition: Food Intake; Biodiversity
Study type: Interventional

Summary: 
      What is the role of Agricultural biodiversity in improving diet diversity, quality and
      nutrition?
    

Detailed description: 
      Agricultural biodiversity can have an important role in improving diet diversity, quality and
      nutrition and can be seen as the foundation of the food and nutrition value chain.

      Increasing the availability and access to local agricultural and/or wild biodiversity genetic
      resources has the potential to increase production, making more food available for
      consumption as long as entitlements to access it exist. However, as the history of food
      security interventions has shown, increasing the production and supply of staple crops alone
      is not enough to improve food security or nutritional status. However, while agricultural
      diversification is an important component, it is not alone sufficient to improve diet
      diversity. Other system elements including women's education and knowledge, intra-household
      dynamics and women's status and cultural beliefs and practices that improves children's
      health and nutrition are important to ensure biodiversity has a successful role in improving
      dietary diversity and quality.
    

Intervention name(s): Promotion of a biodiverse diet
Intervention type(s): Behavioral
Intervention description(s): Nutrition education combined with Agriculture Capacity building focused on a key set of nutritious crops. Component (C) 1 - Participatory Identification of Intervention Approach (PIIA); C2 - Local stakeholder consultation; C3 - Sensitisation of community; C4 - Formation of Diversity club. Club will receive capacity building from a Village health worker. The following topics will be covered species selected for promotion: 1. Where to locally source inputs and expected price, 2. How/when to prepare plots using organic inputs, 3. Planting and best-practice management practices, 4. Seed saving and storage and 4. Active Cooking demonstrations and Nutrition Education and counselling including Diversified cooking practices
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diet Diversity; Biodiversity; Agrobiodiversity; Nutrition; Vietnam
Growth Hormone Treatment of Children Diagnosed of Intrauterine Growth Retardation
Condition: Foetal Growth Problem; Small for Gestational Age
MeSH terms: Fetal Growth Retardation
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Europe. The aim of this trial is to assess and compare the
      efficacy and safety of two dose levels of somatropin over a long period (till final height is
      reached). This trial is an extension to trials GHRETARD/BDP/14/NL (a 2-year initial trial)
      and GHRETARD/BPD/20/NL (a 2-year extension trial).
    


Intervention name(s): somatropin; somatropin
Intervention type(s): Drug; Drug
Intervention description(s): 3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily; 3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Population Pharmacokinetics of Benznidazole in Children With Chagas Disease
Condition: Chagas Disease
MeSH terms: Chagas Disease
Study type: Interventional

Summary: 
      Background: Chagas disease is a parasitic infection caused by the Trypanosome cruzi. The
      initial phase of the infection happens mainly in children. Up to 10% of infected children
      die. Survivors often develop chronic infection leading to heart disease and other
      complications in 30% of patients. These complications often result in death or severe
      handicaps in early adulthood, depriving societies of individuals in their most productive
      years.

      There are 20 million people infected in Latin America. Complications lead to 20,000 deaths
      every year.

      Treatment during the acute phase with benznidazole leads to a high cure rate. However, there
      are very few studies of this drug and virtually none in children, even though benznidazole
      was developed over 30 years ago.

      Hypotheses and Specific Aims: We hypothesize that the pharmacokinetics of benznidazole in
      children is different from adults, and that obtaining information on how it is absorbed,
      distributed and eliminated in children will allow optimization of treatment of Chagas disease
      in this population. This will in turn improve the outlook for children by reducing mortality
      and long term complications. We aim to study the pharmacokinetics of benznidazole in children
      receiving the drug for treatment of Chagas disease, and to correlate it with treatment
      effectiveness and incidence of adverse effects.

      Potential Impact: This novel knowledge will allow better and more rational approaches to the
      treatment of Chagas disease. It will also set the foundation for further studies that will be
      able to test improved therapies that may increase treatment response in vulnerable children.
    


Intervention name(s): Benznidazole
Intervention type(s): Drug
Intervention description(s): benznidazole (RADANIL®, Roche) 5-8 mg/kg/d bid PO for 60 days
Other intervention name(s): Children with Chagas Disease Treated with Benznidazole; Niños con Chagas en Tratamiento con Benznidazol
Intervention MeSH terms: Benzonidazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Chagas disease; Pediatrics; benznidazole; population pharmacokinetics; neglected diseases; parasitology; pediatric clinical pharmacology
Spire Medical Health Tag Actigraphy and Sleep Validation in Adults
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      The purpose of this study is to collect data to validate the step- (actigraphy) and
      sleep-tracking performance of the Medical Health Tag device developed by Spire Health.
    

Detailed description: 
      The purpose of this study is to collect data to validate the step- (actigraphy) and
      sleep-tracking performance of the Medical Health Tag device developed by Spire Health. The
      step data will be evaluated in a controlled environment over a range of approximately 1.0-2.5
      miles per hour (i.e., slow to moderate walking) via Reference manual counting and pedometer.
      The sleep data will be evaluated in a natural environment (i.e., the participant's daily life
      and home) over one afternoon and night with Reference sleep/wake data.
    

Intervention name(s): Health Tag
Intervention type(s): Device
Intervention description(s): Health Monitoring Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subject selection will be a mix of males and females with diverse physiques. Healthy
        individuals 18 years or older, from the general population will be recruited for
        participation. The subjects must understand the study and consent to participate by signing
        the Informed Consent Form. The subjects must be healthy showing no evidence of medical
        problems as indicated by satisfactorily completing the health assessment form. Eligible
        subjects need to meet all of the inclusion criteria and none of the exclusion criteria for
        participation.
A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of New Plasmodium Falciparum Malaria Vaccine Candidates ChAd63 RH5 Alone and With MVA RH5
Condition: Malaria; Plasmodium Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess two new malaria vaccines, ChAd63 RH5 and MVA RH5, at
      different doses and alone or in combination. The study will enable us to assess the safety of
      the vaccines and the extent of the immune response in healthy volunteers. We will do this by
      giving volunteers one or two vaccinations, doing blood tests and collecting information about
      any symptoms that occur after vaccination. This is the first trial to use these vaccines in
      humans.
    


Intervention name(s): ChAd63 RH5 low dose; ChAd63 RH5 full dose; MVA RH5 low dose; MVA RH5 full dose
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): ChAd63 RH5 at 5 x 10^9 vp; ChAd63 RH5 at 5 x 10^10 vp; MVA RH5 at 1 x 10^8 pfu; MVA RH5 at 2 x 10^8 pfu
Other intervention name(s): ChAd63 RH5; ChAd63 RH5; MVA RH5; MVA RH5
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; Plasmodium falciparum; RH5
Non-immersive Virtual Reality for Pediatric Pain Management
Condition: Procedural Pain
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      This is a multicenter, randomized, clinical trial comparing treatment as usual to distraction
      with video projection or virtual reality in the management of pediatric (3-6 years) pain
      associated with venipuncture, intramuscular injection, and vaccination.
    

Detailed description: 
      Background: Recent studies have shown that the use of virtual reality (VR) may be useful to
      provide distraction that attenuates pain in minimally invasive procedures in preschool
      children.

      Aim: To assess the effectiveness of non-immersive virtual reality as a pain-distraction
      measure in children between the ages of 3 to 5 years undergoing painful injection procedures
      in an outpatient setting.

      Method: This clinical trial will recruit patients under 6 years of age treated at
      participating medical centers in whom a painful procedure like vaccination, venipuncture or
      administration of intramuscular medication will be performed. The experimental group will
      consist of two subgroups which, in addition to treatment as usual, will be distracted using
      virtual reality content delivered through goggles. The control group will receive treatment
      as usual. The LLANTO pain scale will be used to measure different characteristics of pain.
      This scale has been validated in Colombia, and will be filled by two health professionals
      (one of which will perform the painful procedure.) and the parents.

      Expected results: To show that virtual reality or projector distraction are effective
      distraction tools in pain management for children subjected to painful procedures of
      venipuncture, intramuscular medication administration, and vaccination.
    

Intervention name(s): Distraction with virtual reality; Treatment as Usual
Intervention type(s): Device; Other
Intervention description(s): Distraction content delivered through virtual reality goggles; Treatment as Usual
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child, Preschool; Virtual Reality; Procedural Pain; Phlebotomy; Vaccination
Effectiveness of a Massage Instrument Compared to Placebo for Upper Trapezius Muscle Pain
Condition: Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia
Study type: Interventional

Summary: 
      The purpose of this study was to determine if using a specialized massage tool was more
      effective than a placebo treatment in relieving pain in the upper trapezius muscle along the
      top of the shoulder.
    

Detailed description: 
      The purpose of the study was to determine if a statistically significant and clinically
      meaningful difference exits between the FascialEdge tool and placebo in the treatment of
      latent upper trapezius trigger points.
    

Intervention name(s): FascialEdge instrument; Placebo electric point stimulation
Intervention type(s): Device; Other
Intervention description(s): Stroking massage to patient tolerance over the muscle; Detuned electric point stimulation over the involved muscle
Other intervention name(s): FascialEdge tool; Pointer Plus stimulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myofascial pain syndrome; Trigger points, Myofascial; Chiropractic; Massage; Musculoskeletal manipulation
Comparison of Two Needle Aspiration Techniques for Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) in Solid Pancreatic Lesions
Condition: Pancreatic Solid Lesions; Pancreatic Mass
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare Endoscopic Ultrasound and Fine Needle Aspirate with a
      standard 22-gauge needle using either "standard-suction" or "capillary suction" methods for
      solid pancreatic lesions. Investigators hope to discover the best technique for obtaining
      diagnostic material when patients with a pancreatic mass undergo endoscopic ultrasound and
      fine needle aspirate procedure.

      There are currently several techniques for obtaining tissue during endoscopic ultrasound and
      fine needle aspirate. The procedure will be performed by either the capillary suction
      technique or no suction technique.
    


Intervention name(s): Standard technique EUS-FNA; Capillary suction technique for EUS FNA
Intervention type(s): Device; Device
Intervention description(s): Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.; Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Pancreatic solid lesions; Pancreatic mass; Pancreatic cancer; Endoscopic Ultrasound; EUS; Fine needle aspiration; FNA; EUS-FNA
Silver Diamine Fluoride Pilot Study (SDF)
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This pilot trial is randomized, double-blind, and placebo-controlled trial with two parallel
      arms: an intervention group using silver diamine fluoride (SDF) and a placebo group
      (control). 60 eligible healthy adults will be enrolled in the study and randomly assigned to
      one of the two treatment groups. Both groups will receive the traditional preventive measures
      including cleanings, Fluoride varnish, diet analysis and counseling. Study participants will
      be followed for one year and caries progression will be radiographically monitored.
    

Detailed description: 
      This pilot study will compare 1) Silver diamine fluoride (SDF) and fluoride varnish to 2)
      Placebo and fluoride varnish (conventional prevention) in the management of early approximal
      carious lesions. Early approximal carious lesions refers to decay between teeth, diagnosed
      with radiographs, not extending more than 1/3 of the way into dentin. Management of early
      approximal carious lesions refers to halting lesion progression, or encouraging lesion
      reversal after an early carious lesion is detected.

      SDF provides a novel, low-cost intervention option for managing early carious lesions that
      could potentially bridge the 'gap' between non-operative and operative options; thus,
      postponing the first placement of a restoration. SDF has been used in arresting carious
      lesions for more than 100 years. However, SDF has never been tested in the arrest of
      approximal caries lesions in permanent teeth.

      SDF acts to both prevent and arrest tooth decay in multiple ways: 1) it acts on the body of
      carious lesions by precipitating silver ion into the lesion, thus blocking diffusion pathways
      for cariogenic acids; 2) it interacts with dental enamel leading to the formation of
      fluoroapatite crystals making the tooth surface more acid resistant; and 3) the precipitated
      silver from SDF acts as a bactericidal agent disturbing the formation of cariogenic biofilm.
    

Intervention name(s): Silver Diamine Fluoride 38%; Group 2 (Placebo)
Intervention type(s): Device; Device
Intervention description(s): Group 1 (SDF group) subjects will receive the application of silver diamine fluoride (38% SDF solution) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.; Group 2 (Placebo) subjects will receive application of sterile water (placebo) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
Other intervention name(s): 38% SDF; Sterile Water
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Oxytocin, Couple Interaction and Wound Healing
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      effects of intranasal oxytocin and couple interaction on wound healing.

        -  Trial with medicinal product
    


Intervention name(s): Syntocinon (Oxytocin) nasal spray; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): two-times daily self-administration of nasal spray containing active substance (oxytocin) during five days after wounding.; two-times daily self-administration of nasal spray containing placebo during five days after wounding.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
CTx-1301 Comparative Bioavailability Study
Condition: ADHD
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of this study is to compare the bioavailability of CTx-1301
      (dexmethylphenidate) to the registered listed drug, Focalin XR and to evaluate dose
      proportionality of CTx-1301. In addition, this study seeks to characterize the
      pharmacokinetics of dexmethylphenidate and evaluate the safety and tolerability of CTx-1301.
    

Detailed description: 
      The study will comprise of a randomized, single-dose, four-sequence, four-period, in-clinic
      crossover study in approximately 36 adult ADHD subjects. All subjects considered eligible at
      Screening will proceed to tolerability test day, dosing 40 mg Focalin XR to evaluate safety
      and tolerability of the higher dose of d-MPH. If subject is able to safely tolerate the test
      dose, and meets all inclusion/exclusion criteria, they will be considered eligible for
      randomization into the study. All subjects will be randomized to receive four treatments
      throughout the course of the study; one CTx-1301 trimodal d-MPH tablet containing 6.25 mg
      d-MPH, one Focalin 5 mg XR capsule, one CTx-1301 50 mg tablet, and one 40 mg Focalin XR
      capsule. Administration of study drug will occur only on Assessment Days; no study drug will
      be administered during screening or unscheduled days (USVs).

      The lowest and highest doses of CTx-1301 (dexmethylphenidate, 6.25 and 50 mg) were selected
      to bridge to the lowest and highest doses of Focalin XR (dexmethylphenidate, 5 and 40 mg) in
      this comparative BA study.
    

Intervention name(s): Dexmethylphenidate 5 Mg Oral Capsule, Extended Release; Dexmethylphenidate 6.25 mg Tablet; Dexmethylphenidate 40 Mg Oral Capsule, Extended Release; Dexmethylphenidate 50 mg Tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Reference listed drug (RLD) for comparative BA evaluation; Experimental drug for comparative BA evaluation; Reference listed drug (RLD) for comparative BA evaluation; Experimental drug for comparative BA evaluation
Other intervention name(s): Focalin XR (dexmethylphenidate) 5 mg Capsule; CTx-1301 (dexmethylphenidate) 6.25 mg Tablet; Focalin XR (dexmethylphenidate) 40 mg capsule; CTx-1301 (dexmethylphenidate) 50 mg tablet
Intervention MeSH terms: Dexmethylphenidate Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; bioavailability; dexmethylphenidate; BA study; dMPH; d-MPH
Anti-psoriatic Effect of TL01 Light Therapy
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      This is a pilot study to investigate the effect of TL01 narrow band UVB therapy on the
      resident dermal dendritic cells characterized by expression of CD1c and CD141. These cells
      were reported to have a role in induction of tolerogenic regulatory T cells and production of
      IL-10. The investigators proposed to investigate the effect of NB-UVB on these subsets of
      cells after two weeks of treatment to provide better understanding of the mechanism of action
      of light treatment.
    

Detailed description: 
      Six patients with plaque psoriasis were recruited from the phototherapy unit. These patients
      were referred by their dermatologist to receive narrow-band UVB (TL01) light treatment. Two 6
      mm lesional skin punch biopsies were taken at baseline and 2 weeks after commencing the light
      treatment to study the effect of light on innate immune cells involved in psoriasis
      pathogenesis.
    

Intervention name(s): TL01 light treatment
Intervention type(s): Device
Intervention description(s): Patients received treatment in TL01 cabinet three sessions weekly according to a standard escalating protocol based on minimal erythema dose. Standard dose ranges between 0.55 and 3.13J/cm2.
Other intervention name(s): Waldmnn Gmbh cabinet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: psoriasis patients referred to receive TL01 NB-UVB therapy