bioihbjkbjnl/mcl2 huggingface dataset:
Personalized Virtual Reality Naturalistic Scenarios in Cognitive Impairment
Condition: Cognitive Impairment; Cognitive Decline; Cognitive Deterioration; Anxiety State
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The goal of this feasibility study is to investigate the feasibility of a personalized
      naturalistic Virtual Reality scenario by assessing motion-sickness effects, engagement,
      pleasantness, and emotions felt considering a sample of individuals with cognitive impairment
      resident at the Azienda Pubblica di Servizi alla Persona (APSP) "Margherita Grazioli", a
      long-term care home in Trento (Italy) in collaboration with the Department of General
      Psychology - University of Padova (Italy) and the Centre for Health and Wellbeing-Fondazione
      Bruno Kessler (Italy). The current proof-of-concept and feasibility study is a one-session
      single-centre trial based on a mixed-methods approach inspired by the Obesity-Related
      Behavioral Intervention Trials (ORBIT) framework for the design (Phase Ib) of digital
      interventions and their preliminary testing (Phase IIa).
    

Detailed description: 
      The impact of customizing VR scenarios is growing, showing different kinds of positive
      effects, such as an increased sense of presence and engagement in the virtual environment. A
      relaxing and customizable VR environment could allow the management of any interfering
      environmental factors that might also be present in the natural context. Additional
      investigations are still needed to obtain more consistent data on its feasibility and
      effectiveness.

      Considering this evidence, the current proof-of-concept study is based on the following
      goals:

        -  evaluate the impact of VR on self-reported and observational levels of motion-sickness,
           engagement, and pleasantness in older adults living with cognitive impairment and
           residing in long-term care.

        -  investigate if personalized, relaxing virtual environments can positively impact
           feelings and state anxiety.

        -  investigate the VR apparatus's usability from the health staff's perspective.
    

Intervention name(s): Exposure to a Virtual Reality scenarios
Intervention type(s): Other
Intervention description(s): Exposure to a personalized, relaxing Virtual Reality scenario deployed by a Head-mounted tool (Oculus Quest 2). The administration was deployed in one session.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: virtual reality; personalized virtual scenario; user centered approach; mixed-methods study; user-experience; feasibility study; relaxation; anxiety
A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a First-in-Human, Phase I, randomized, double-blind, placebo-controlled study
      evaluating single and multiple ascending oral doses of GLPG2451 and combined multiple doses
      of GLPG2451 and GLPG2222 in healthy female subjects. The purpose of the study is to evaluate
      safety and tolerability after single ascending oral doses and of multiple doses of GLPG2451
      given to healthy female subjects compared to placebo as well as of multiple doses of the
      combination of GLPG2451/GLPG2222 compared to GLPG2451/placebo.
    


Intervention name(s): GLPG2451 single dose; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GLPG2451 oral suspension, single ascending doses, daily; Placebo, oral suspension, daily
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Biodistribution, Pharmacokinetics, and Safety of F-18 THK-5351 PET in Alzheimer's Disease Patients and Healthy Subjects.(Positron Emission Tomograph )
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Biodistribution, pharmacokinetics, and safety of F-18 THK-5351 PET in Alzheimer's disease
      patients and healthy subjects.
    

Detailed description: 
      Totally 24 subjects age 20-90 including 12 healthy cognitively intact subjects and 12
      probably Alzheimer's dementia patients with NINCDS-ADRDA criteria. For disease subjects,
      caregiver should be able to report activities of daily living and their mental status.
      Patient should be able to give informed consent or have a caregiver give consent with subject
      assent.
    

Intervention name(s): F-18 THK-5351
Intervention type(s): Drug
Intervention description(s): Totally 24 subjects age 20-90 including 12 healthy cognitively intact subjects and 12 probably AD patients with NINCDS-ADRDA criteria. For disease subjects, caregiver should be able to report activities of daily living and their mental status. Patient should be able to give informed consent or have a caregiver give consent with subject assent.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: F-18 THK-5351 PET
Right For Me: Birth Control Decisions Made Easier
Condition: Contraception
Study type: Interventional

Summary: 
      Right For Me is a study that aims to improve the conversations patients and health care
      providers have about birth control. Right For Me will test two different strategies for
      improving these conversations. The first strategy is to give patients a video to watch that
      encourages them to ask three specific questions in their health care visit, as well as a
      prompt card that reminds them of the three questions. The second strategy is to give health
      care providers a set of decision aids that describe available birth control methods, as well
      as training in how to use them with patients during the health care visit. Right For Me will
      test whether introducing one or both of these strategies leads to better conversations than
      providing health care as usual.
    


Intervention name(s): Video + Prompt Card; Decision Aids + Training
Intervention type(s): Other; Other
Intervention description(s): A brief video (available in English and Spanish) intended to be viewed by patients immediately before the health care visit. The video aims to enhance patients' motivation, skills, and self-efficacy to ask their health care providers three specific questions: (1) What are my options? (2) What are the pros and cons of those options? and (3) How likely are those pros and cons to happen to me?
A prompt card (available in English and Spanish) intended to be provided to patients when they view the video and kept. The card aims to remind patients of the three questions presented in the video.; Seven one-page decision aids on contraceptive methods (available in English and Spanish) intended to be used by health care providers with patients during the health care visit.
A five-minute training video and accompanying written guidance (available in English) intended to be reviewed by health care providers before implementing the decision aids (and as frequently as desired thereafter). The training aims to enhance providers' motivation, skills, and self-efficacy to use the decision aids to facilitate shared decision-making in the health care visit.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Shared Decision-Making; Patient-Provider Communication
A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain
Condition: Plantar Fascitis; Myofacial Pain Syndromes; Trigger Point Pain, Myofascial
MeSH terms: Fasciitis; Fasciitis, Plantar; Myofascial Pain Syndromes; Facial Neuralgia; Facial Pain
Study type: Interventional

Summary: 
      This is a clinical trial that will be done in the state of Kuwait, at the physical
      rehabilitation medicine hospital. the participants will be recruited from all over Kuwait,
      there is a clinical registry upon the ethical committee in Kuwait assigned by the ministry of
      health.
    

Detailed description: 
      Physical therapy approaches continue evolving. During the last years, minimally invasive
      techniques such as percutaneous needle electrolysis (PNE) was being developed, obtaining
      promising results for tendon pathology. PNE technique is a minimally invasive treatment that
      consists of an application of a galvanic electrolytic current that causes a controlled local
      inflammatory process in the target tissue. This allows for phagocytosis and the subsequent
      regeneration of the affected tissue. Nowadays, PNE is being used in clinical practice to
      manage MTrP, but there are no studies supporting that they have an additional beneficial
      effect over DN.

      From a biological point of view, it seems reasonable to ascertain that a patient will obtain
      benefits thanks to the mechanical effects provided by the needle and that patients may
      benefit more if the electrolysis effect is added to the mechanical stimuli provided by the
      needle. Therefore, the aim of this randomized controlled study is to compare the
      effectiveness of DN versus PNE for the level of pain in patients suffering from PHP.
    

Intervention name(s): dry needling
Intervention type(s): Other
Intervention description(s): The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
Other intervention name(s): Percutaneous needle electrolysis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a prospective, two parallel-groups (participant) randomized controlled trial with blinded outcome assessment at baseline, and at 4, 8, 12, 26 and 52 weeks. The study flow chart shown in Figure 1 conforms to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines for nonpharmacological studies
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Phase 3/Safety & Efficacy of Esomeprazole in Infants
Condition: Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to look at the improvement of a once a day dose of esomeprazole
      for reducing the signs and symptoms of infants with gastroesophageal reflux disease (GERD).
      This research study consists of a screening, open-label, and double-blind treatment
      withdrawal phase. The screening phase ensures the patient eligibility. No study medication is
      dispensed during the screening phase. During the open-label phase, patients are administered
      esomeprazole 2.5mg, 5.0mg or 10.0mg based on his/her weight. During the double-blind phase,
      the patients are administered either his/her open-label dose or placebo. Double-blind means
      neither the physician, parent, or patient will know if patient is taking esomeprazole or
      placebo. The patient will have an equal chance of receiving esomeprazole or placebo.
    


Intervention name(s): Open Label Run In Esomeprazole; Double Blind Esomeprazole; Double Blind Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg); Esomeprazole magnesium in capsules dosing weight-dependent (2.5 mg - 10 mg); Double Blind Placebo
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pediatrics; neonates
Effectiveness of Telerehabilitation in Improving Walking and Balance Among Stroke Survivors?
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      A good rehabilitation program may not be accessible for all individuals living with stroke
      due to cost, transportation and compliance. Telerehabilitation is an alternative health care
      program that may help in overcoming this issue. In this study we aim to find if the use of
      telerehabilitation in Saudi Arabia would improve balance and walking in stroke survivors
      during this pandemic.
    

Detailed description: 
      Background: Rehabilitation program is commonly provided after stroke to improve functional
      outcomes. A good rehabilitation program may not be accessible for all individuals living with
      stroke due to cost, transportation and compliance. Telerehabilitation is an alternative
      health care program that has been used to provide therapy for stroke survivors living in
      rural areas. With COVID-19 pandemic, many stroke survivors have lost their access to
      rehabilitation. Therefore, telerehabilitation may help in overcoming this issue. In this
      study we aim to find if the use of telerehabilitation in Saudi Arabia would improve balance
      and walking in stroke survivors during this pandemic.

      Methods: 2 stroke survivors ( male and female/ >6 months post stroke) are included in this
      case study. Participants will receive a task-specific activity training (3days/week moderate
      exercises for 4 weeks) Both participants will provide feedback through questionnaires pre and
      post the 4 weeks intervention. We will use the Activities- specific balance confidence (ABC)
      scale, Lower limb functional scale (LEFS) and Stroke severity quality of life scale (
      SS-Qol).

      • Intervention: The participants will follow a home-based exercise through videos with follow
      up from the therapists for 4 weeks.
    

Intervention name(s): Home-based exercise program
Intervention type(s): Other
Intervention description(s): The exercise program will include task specific training to improve balance and the training will progress every two weeks. A Physical therapist will be following up and monitoring the participants adherence to the training by audio or video call.
The exercise program for Week 1: Sit to Stand 5 times, Steps forward, backward and to the sides 5 times, 10 meters walk. 45 minutes session /3 times per week. Week 2: Sit to stand 10 times, Steps forward, backward and to the sides 5 times , Sit and reach 5 min for each hand and walk for 15 meters. 45 minutes session, 3 times per week. Week3 Sit to stand 10 times, Step on bench 5 times, Stand and reach 5 and walk for 15 meters. 45 minutes session, 3 times per week. Week 4 Stand and reach 5 times, Step on bench 10 times, climbing stairs (5 steps flight stairs up and down) and walk for 20 meters. 50 minutes session, 3 times per week.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers
Condition: Common Cold; Gastroenteritis
MeSH terms: Respiratory Tract Infections; Common Cold; Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      We hypothesize the herbal preparation will enhance the preschoolers' immune response and when
      taken prophylactically for 12 weeks will decrease episodes of upper respiratory infections
      and gastroenteritis in the active versus the control group.
    

Detailed description: 
      This combination of herbs has been studied only once before in preschoolers. In a study of
      430 preschoolers reported in Archives of Pediatric and Adolescent Medicine in March of 2004,
      a similar preparation with a slightly lower dose of Vitamin C decreased upper respiratory
      infections by 55% (308 to 138). We are repeating this study to see if our results confirm or
      contradict those of the previous study.
    

Intervention name(s): dietary supplement--echinacea, propolis, and vitamin c
Intervention type(s): Drug
Intervention MeSH terms: Propolis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: vitamin c; echinacea; propolis; upper respiratory tract infection; common cold; gastroenteritis; dietary supplement; herbal remedy
the Effective Bolus Dose of Remifentanil for Laryngeal Mask Airway (LMA) Insertion in Children
Condition: Respiratory Complication
Study type: Interventional

Summary: 
      This research attempts to find the optimum dose of remifentanil that can prevent the
      unnecessary responses such as coughing, gagging, and movement when LMA is inserted during
      sevoflurane induction in pediatric patients.
    

Detailed description: 
      Anaesthesia is induced by inhalation with 3% sevoflurane. A predetermined bolus dose of
      remifentanil is injected over 30 seconds. The LMA is attempted 60 seconds after bolus
      administration. The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg.
      If LMA insertion is successful or failed in previous patient, an decrement or increment of
      0.05μg/kg remifentanil is injected to next patient, respectively.
    

Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention description(s): The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.
Other intervention name(s): remifentanil (ultiva)
Intervention MeSH terms: Remifentanil
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Study of BOTOX and JUVEDERM for Treatment of Moderate to Severe Facial Wrinkles and Folds
Condition: Wrinkles
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see how well Juvederm Ultra XC or Juvederm Ultra Plus XC, and
      BOTOX Cosmetic, work compared to each other and when used together for the cosmetic treatment
      of age-associated wrinkles and folds of the face.
    

Detailed description: 
      1. Compounds:

             1. BOTOX Cosmetic (onabotulinumtoxinA) for Injection

             2. JUVEDERM Ultra XC and JUVEDERM Ultra Plus XC Injectable Gel

        2. The objectives of this study are:

             1. To assess physician assessment of efficacy and incremental benefit following BOTOX
                Cosmetic and Juvederm for the treatment of moderate to severe facial wrinkles and
                folds;

             2. To assess patient perceptions of treatment outcomes and incremental benefit
                following BOTOX Cosmetic and Juvederm for the treatment of moderate to severe
                facial wrinkles and folds.

        3. Investigator and study sites:

             1. multicenter study

             2. 5 Sites: 2 in US, 2 in Canada, 1 in EU
    

Intervention name(s): onabotulinumtoxinA; JUVÉDERM
Intervention type(s): Drug; Drug
Intervention description(s): Group 1 will initially receive BOTOX® Cosmetic or VISTABEL® injections to the affected facial regions;
Group 2 will initially receive JUVÉDERM® Ultra XC or JUVÉDERM® Ultra 2 (for moderate facial lines or folds) or JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions.
At 4 weeks,Group 1 patients who initially received BOTOX® Cosmetic or VISTABEL® treatment will be crossed over and receive JUVÉDERM® treatment, and Group 2 patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment.; Group 1 will initially receive BOTOX® Cosmetic or VISTABEL® injections to the affected facial regions;
• Group 2 will initially receive JUVÉDERM® Ultra XC or JUVÉDERM® Ultra 2 (for moderate facial lines or folds) or JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions.
At 4 weeks,Group 1 patients who initially received BOTOX® Cosmetic or VISTABEL® treatment will be crossed over and receive JUVÉDERM® treatment, and Group 2 patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment.
Other intervention name(s): Europe Investigative Sites:; VISTABEL® (Botulinum toxin type A) for Injection; EU Investigative Sites:; JUVÉDERM® Ultra 2 and JUVÉDERM® Ultra 3 Injectable Gel
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BOTOX; JUVEDERM; Prospective; Open Label; Randomized; Crossover Study
A Randomised, Cross-Over, Nicotine Pharmacokinetic and Pharmacodynamic Study of Heated Tobacco Products Compared to Combustible Cigarettes
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This is a randomised, cross-over, open-label, confinement study conducted in 24 adult male or
      female smokers of combustible cigarettes. The study investigates combustible and heated
      tobacco (HT) products in a cross-over design, including pharmacokinetic evaluation,
      subjective questionnaire assessments, as well as safety evaluation.

      Subjects will perform a screening visit and a 5-day confinement period.
    


Intervention name(s): Heated tobacco device Intense (Product A); Heated tobacco device Regular (Product B); Heated tobacco device Menthol (Product C); Combustible cigarette (Product D)
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Heated Tobacco device Intense, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration); Heated Tobacco device Regular, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration); Heated Tobacco device Menthol, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration); Subject's own brand combustible cigarette, used under controlled conditions (i.e., completely use a single unit of the product, with puffs taken at 30-second intervals and puffs 3 seconds in duration)
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other