bioihbjkbjnl/mcl2 huggingface dataset:
Yoga to Prevent Mobility Limitations in Older Adults
Condition: Aging; Mobility Limitation; Sedentary Lifestyle
MeSH terms: Mobility Limitation
Study type: Interventional

Summary: 
      The loss of mobility during aging impacts independence and leads to further disability,
      morbidity, and reduced life expectancy. The study objective was to examine the feasibility
      and safety of conducting a randomized controlled trial of yoga for older adults at risk for
      mobility limitations. The investigators hypothesized that sedentary older adults could be
      recruited for the study, would attend either yoga or a health education control, would
      complete assessments, and that the interventions could be safely delivered.
    


Intervention name(s): Yoga Intervention; Healthy Aging Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The 60-minute yoga sessions began with a brief breathing practice led by the instructor. The yoga instructor then led students through yoga poses at a gentle pace using chairs as props as needed. The pace of the class increased slowly over time as students became more familiar and more capable with the poses. Meditation and breathing was followed by chair poses (15-20 minutes), standing poses (10-15 minutes), floor poses (15 minutes), and lastly a supine resting pose (Savasana; 10 minutes). In the Silver Age Yoga method at that time, there were 73 available postures overall including: 35 Chair Postures, 18 Standing Postures, 20 Floor Postures, with a typical class covering 20-25 poses.; The health education comparison intervention consisted of once weekly, 90-minute health information workshops conducted in group format. The 90-minute sessions generally consisted of a 60-minute lecture followed by 30 minutes of questions and discussion. The lecture titles for Weeks 1-10 were as follows: Introduction/ Exploring Communication, The Science of Successful Aging, Acupuncture 101: How it Works & What it is Good for, Quality of Life/Quality of Well Being, Fighting Cancer With Your Fork, Forgiveness via Shakespeare's: A Winter's Tale, Better Eyesight in Minutes a Day, Brain Fitness, The Importance of Organic Foods/ Organic Gardening, How Dementia Can Be Modified. Lectures were provided by a mix of credentialed experts (physicians/psychologists, etc) and other clinicians. Instructors were asked not to talk about yoga or medication in their lectures. Content was not otherwise closely monitored.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans
Condition: Cardiovascular Risk
Study type: Interventional

Summary: 
      The aim of this study is to examine the safety and the effects of EDs at high doses, either
      alone or in combination with other risk factors such as alcohol intake, physical exercise and
      sleep deprivation, on cardiovascular markers and subjective health.
    


Intervention name(s): Energy Drink, Taurine, Caffeine
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Extremity Manipulation Impact on Postural Sway Characteristics
Condition: Healthy
Study type: Interventional

Summary: 
      This study will evaluate the multi-segmental postural sway after upper versus lower extremity
      manipulation.
    

Detailed description: 
      The focus of this study is to explore the effect of upper and lower extremity chiropractic
      adjustments (manipulation) as well as surface condition (hard surface vs rocker board) on
      multisegmental postural control as represented by postural sway. Using a rocker (tilt) board,
      the participant cannot stand still, but has to adjust posture continuously to maintain
      balance. Body sways are considered to be self-induced because the design of the rocker board
      creates a natural instability without any external perturbation. This task provides a
      self-driven sensorimotor condition in addition to amplifying the sway dynamics. Because the
      rocker board has only one degree of freedom of motion, anteroposterior and lateral sways were
      considered separately on the device.

      The investigators had the following hypotheses.

      Hypothesis 1: Lower extremity adjustments will lead to reduced postural sway magnitude
      compared to upper extremity adjustments.

      Hypothesis 2: Lower extremity adjustments will reduce sway variability of the rocker board,
      trunk and head compared to upper extremity adjustments.

      Hypothesis 3: Lower extremity adjustments will facilitate the organization of sway behavior
      as assessed by the chaotic structure of sway.
    

Intervention name(s): Lower Extremity First (LEF); Upper Extremity First (UEF)
Intervention type(s): Procedure; Procedure
Intervention description(s): The intervention for the LEF group was a non-specific long-axis distraction to the ankle, knee, and hip or shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience).; The intervention for the UEF group was a non-specific long-axis distraction to the shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study used a randomized, crossover experimental design over three days of testing.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chiropractic; postural sway; manipulation
Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
Condition: Overactive Bladder; Neurogenic Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of
      fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive
      bladder.
    


Intervention name(s): Fesoterodine
Intervention type(s): Drug
Intervention description(s): 4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8
Intervention MeSH terms: Fesoterodine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Study of fesoterodine in pediatric overactive bladder patients
WEE1 Inhibitor With Cisplatin and Radiotherapy: A Trial in Head and Neck Cancer
Condition: Hypopharynx Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma; Larynx Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Laryngeal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is to determine what dose of a drug called AZD1775 can safely be given in
      combination with cisplatin before surgery and with chemo-radiotherapy after surgery in
      patients with Head and Neck Cancer. The Investigators will also get some preliminary
      information regarding the effectiveness of this combined treatment.
    

Detailed description: 
      Patients with head and neck cancer with high-risk features are at increased risk of relapse
      after surgery. Surgery, often followed by cisplatin chemotherapy and radiotherapy is
      currently the standard treatment offered. Whilst chemo-radiotherapy improves cure rates,
      outcomes remain poor, and treatment has a significant impact on quality of life. Chemotherapy
      has yet to find a definitive role prior to surgery. There is therefore an urgent need to
      develop more effective treatments which improve cure rates for this patient population.

      The purpose of this trial is to see whether incorporating a drug called AZD1775 into the
      management of head and neck cancer offers the possibility of addressing these clinical
      issues. AZD1775 is a drug that has been shown to increase the effect of cisplatin and of
      radiotherapy when tested in the laboratory. The blood samples and tumour biopsies taken
      during the trial will be important in learning as much as possible about the effects of
      AZD1775 on the body and to investigate how the tumour might develop resistance to the drug.

      The WISTERIA trial is for patients aged between 18 and 70 years with cancer of the oral
      cavity, larynx and hypopharynx who are to undergo surgery. Patients recruited to Group A must
      have accessible tumours for re-biopsy, whilst patients recruited to Group B will be at high
      risk of relapse after surgery.

      The primary objective of this trial is to see what dose of AZD1775 can safely be given in
      combination with cisplatin before surgery (Group A) and with chemo-radiotherapy after surgery
      (Group B). The Investigators will also get some preliminary information regarding the
      effectiveness of this combined treatment. To find the safe and effective dose of AZD1775,
      different doses will be tested for each Group.
    

Intervention name(s): AZD1775; Cisplatin; Radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): AZD1775 is a potent, selective small molecule inhibitor of WEE1; Chemotherapy drug; Intensity Modulated Radiotherapy
Other intervention name(s): IMRT
Intervention MeSH terms: Adavosertib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Anti-Inflammatory Agents on Biological Responses to Endotoxin Inhalation in Healthy Subjects
Condition: Innate Immunity
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The main objective of this study is to characterize the biological responses elicited by
      endotoxin inhalation applied to healthy subjects, and to assess the effect of standard
      anti-inflammatory agents (i.e. adalimumab and methylprednisolone) on these biological
      responses.
    

Detailed description: 
      This open-label, single-center, parallel-group clinical trial is designed to evaluate Humira®
      or methylprednisolone versus no treatment in healthy subjects applied inhaled endotoxin
      challenges.

      A total of 30 healthy adult subjects who meet all inclusion and exclusion criteria will be
      randomised in a 1:1:1 ratio to one of the following cohorts:

        -  Cohort 1 subjects receive no study drug during the study.

        -  Cohort 2 subjects receive an oral 7-day course of the corticosteroid
           (methylprednisolone) during the study, starting on study Day 1. The daily dose is 20 mg.

        -  Cohort 3 subjects receive a single subcutaneous injection of the anti-tumor necrosis
           factor (TNF) (adalimumab) on study Day 1, administered as a 40 mg dose.

      The study will include a Screening period of up to 21 days, during which subject eligibility
      will be assessed and Screening responses to endotoxin exposure challenge will be collected.
      Eligible subjects will initially undergo an 8-day treatment period, during which they will
      receive treatment based on their assigned cohort (or will receive no treatment if assigned to
      Cohort 1) and will be applied with the endotoxin challenges. After the treatment period,
      subjects will be followed up until study Day 42.

      Efficacy evaluations will include specific responses to endotoxin challenge, and effects of
      methylprednisolone and adalimumab on these responses. Safety will be monitored throughout the
      study.
    

Intervention name(s): adalimumab; methylprednisolone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Adalimumab; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: inflammation endotoxin anti-TNF corticosteroids
A Trial Comparing the Effect of Exercise on Blood Glucose in Subjects With Type 1 Diabetes, Who Are Treated With Either Insulin Degludec or Insulin Glargine
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to compare the effect of exercise
      on blood glucose in subjects with type 1 diabetes, who are treated with either insulin
      degludec (IDeg) or insulin glargine (IGlar).
    


Intervention name(s): insulin degludec; insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.; Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diabeloop for Kids
Condition: Closed Loop; Diabetes Mellitus, Type 1; Young Children (6 to 12 Years Old )
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      An open-label, three-center, randomized, two-session, 4 days inpatient and 6-week follow-up
      home study phase, crossover study comparing Diabeloop closed-loop (CL) system and
      sensor-augmented pump (SAP) therapy.

      The follow-up home study phase will be done only in French centers for a sub study. During
      this session, patient wearing the closed-loop system will benefit of a 24h/24, 7 d/7, remote
      monitoring follow-up by specialized nurses, under supervision of a diabetologist. A
      visualization of glucose CGM curves, insulin delivery, meal and physical activity
      announcements will be available online through secured website, and the system will send
      automated message in case of predetermined situations as persistent too high or too low Blood
      Glucose (BG). Custom settings will be possible by the nurses during the follow-up period.
    


Intervention name(s): Continuous Glucose Monitoring; External Insulin Pump; Diabeloop Software (Model predictive control); Remote monitoring (Telemedicine)
Intervention type(s): Device; Device; Device; Other
Intervention description(s): collection of glucose data; Insulin delivery; Diabeloop software embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.; Remote follow up by care health providers team
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Closed loop vs. Open loop
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: artificial pancreas
Invaplex 50 Vaccine Dose-Ranging
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 1

Summary: 
      The vaccine is given as a nose spray. Volunteers will receive a 3-dose vaccination with doses
      spaced two weeks apart. Volunteers will be assigned to a vaccination group based on their
      order of enrollment with consideration of their availability to complete the necessary
      vaccinations and follow-up visits.
    

Detailed description: 
      This is an open-labeled dose escalating trial in which a total of 32 subjects (minimum of 24
      allowable) will receive one of four intranasal Invaplex 50 vaccine doses according to the
      following chart:

      Test articles/dose

      Group / N* / Invaplex 50

      A / 8 / 10 micrograms

      B / 8 / 50 micrograms

      C / 8 / 240 micrograms

      D / 8 / 480 micrograms

      *minimum of 6 volunteers/group

      An interval no less than 7 days following the third (and final) dose (total of 35 days
      between initial dose at the lower dose level and the next initial dose at the next higher
      dose level) will separate volunteer groups receiving different doses. All volunteers will
      receive three immunizations. The first dosing time point is Day 0, the second is Day 14 (+-
      one day), and the third is Day 28 (+- 2 days). Blood and stool specimens will be collected at
      intervals to examine systemic and mucosal vaccine antigen-specific immune responses. Vaccine
      safety will be actively monitored during vaccination and for 28 days following the third
      vaccination dose.
    

Intervention name(s): Shigella flexneri 2a Invaplex 50
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Shigella; diarrhea
Effects of Robotic-Assisted Gait Training in Patients With Stroke (EoRAGTiPwS)
Condition: Stroke, Robotic Rehabilitation
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study was conducted to examine effects of gait training with exoskeleton ExoAthlet and
      Lokomat Free-D on functional independence, functional capacity and quality of life in stroke
      patients.
    

Detailed description: 
      The study included 32 patients who had stroke. Participants were randomized into two groups.
      Functional independence of patients was evaluated with Functional Independence Measure (FIM),
      physical function with 30-second chair stand test (30-CST), functional capacity with 6-Minute
      Walk Test (6MWT), and their quality of life with Short Form 36 (SF36). Conventional
      physiotherapy program was applied to groups for eight weeks, three days a week, each session
      60 minutes. Then, one group received walking exercise training with exoskeleton ExoAthlet
      (ExoAtlet 1 model/2019, Russia), other group with Lokomat Free-D (Hocoma, Lokomat Pro Free-D
      model/2015, Switzerland). Participants were assessed at baseline and post-intervention.
    

Intervention name(s): Exoskeleton ExoAthlet group; Lokomat Free-D group
Intervention type(s): Other; Other
Intervention description(s): This group included 16 patients who had stroke. The patients was evaluated with Functional Independence Measure (FIM), physical function with 30-second chair stand test (30-CST), functional capacity with 6-Minute Walk Test (6MWT), and their quality of life with Short Form 36 (SF36). Conventional physiotherapy program was applied to groups for eight weeks, three days a week, each session 60 minutes. Then, one group received walking exercise training with exoskeleton ExoAthlet (ExoAtlet 1 model/2019, Russia). Participants were assessed at baseline and post-intervention.; This group included 16 patients who had stroke. The patients was evaluated with Functional Independence Measure (FIM), physical function with 30-second chair stand test (30-CST), functional capacity with 6-Minute Walk Test (6MWT), and their quality of life with Short Form 36 (SF36). Conventional physiotherapy program was applied to groups for eight weeks, three days a week, each session 60 minutes. Then, one group received walking exercise training with Lokomat Free-D (Hocoma, Lokomat Pro Free-D model/2015, Switzerland). Participants were assessed at baseline and post-intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Stroke; Robotic Rehabilitation; Functional Independence; Functional Capacity; Quality of Life
A Neuropsychological Characterization of Social Feedback Processing in Social Anxiety
Condition: Social Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to characterize neuropsychological mechanisms (positive affect,
      negative affect and self-evaluation) mediating processing of social feedback in people with
      different levels of social anxiety, by implementing functional and structural MRI.
    

Detailed description: 
      Social anxiety (SA) disorder is a relatively widespread emotional disorder which is
      associated with considerable impairment in social, educational, and occupational functioning
      (Kessler et al., 2005). This condition is characterized by a debilitating preoccupation with
      the evaluation of the self by others, ultimately leading to excessive fear and avoidance of
      interpersonal encounters. As opposed to healthy individuals who typically process social
      feedback in a positively biased manner, Individuals with high levels of SA tend to evaluate
      the feedback conveyed by others negatively. Such biases have a profound contribution to the
      maintenance of social-related concerns (Clark & Wells, 1995).

      Thus, the overreaching goal of this research is to provide a neuropsychological account of
      biased processing of social feedback evident in SA. To meet this goal, participants varying
      in their level of SA are asked to deliver a speech and evaluate it before and after receiving
      social feedback during an fMRI scan. Additional structural and resting-state fMRI scans, as
      well as physiological and psychological measures, are obtained throughout the experiment in
      order to explain individual differences in processing of feedback. fMRI tasks probing basic
      neuropsychological processes include a self-referential paradigm, wherein participants judge
      if different traits varying in valence and social domain (power vs. affiliation) are
      descriptive of them; a reward vs. punishment task, in which participants can win or lose
      money; and an emotional reactivity task, in which participants view faces with different
      emotional expressions.

      The long-term goal of this study is to better delineate both neurobiological and
      psychological models of SA, as well as to help in directing future neuromodulation-based
      treatments of mood and anxiety disorders.
    

Intervention name(s): Social feedback; Self-referential paradigm; Reward vs. punishment task; Emotional reactivity task
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Social feedback regarding performance of a public speech is delivered to participants; Exposure to traits varying in valence (positive vs. negative) and social domain (power vs. affiliation); Reception of monetary gains vs. losses; Exposure to emotional faces vs. shapes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science