bioihbjkbjnl/mcl2 huggingface dataset:
Formative Research - Developing a Family-based Obesity Prevention Intervention in the Canadian Context
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This formative research shows that parents of preschool-aged children are enthusiastic about
      learning general parenting skills, such as discipline strategies, but that they are less
      interested in information on child nutrition and physical activity needs. To capitalize on
      this enthusiasm, Dr. Haines developed Parents and Tots Together (PTT), an intervention that
      embeds strategies to improve children's nutrition and activity behaviours within an existing
      general skills parenting program. Results from the investigators feasibility trial with 16
      Boston-area parents show that PTT is feasible for implementation and is extremely
      well-received by parents. Results are also encouraging with respect to changing parent
      feeding behaviours and children's nutrition and activity behaviours. What is not known is
      whether this program is feasible and contextually appropriate for Canadian families. Thus,
      the next step in this research program, and the overall goal of this study, is to assess
      Parents and Tots Together (PTT), a family-based intervention to prevent obesity among
      children 3 to 5 years of age, within the Canadian context.

      To achieve this goal, the investigators will conduct a pilot trial of the PTT program with 60
      families recruited through Ontario Early Years Centres (OEYC). The investigators will
      randomize 30 families to the 3-month PTT intervention and 30 to a control condition.

      The investigators primary objective is to implement and test the feasibility and
      acceptability of PTT among families with preschool children so appropriate revisions can be
      made to adapt it to a Canadian context. The investigators secondary objective is to compare
      the following outcomes among intervention versus control participants:

        1. Parent weight-related behaviours (i.e., parent physical activity, intake of
           sugar-sweetened beverages, and television/video viewing, as well as responsiveness to
           child satiety cues).

        2. General parenting behaviours (i.e., use of positive discipline strategies).

        3. Child weight-related behaviours (i.e., sleep duration, physical activity, intake of
           sugar-sweetened beverages, television/video viewing).

        4. Nutritional risk score based on a screening tool for preschoolers.

        5. Child change in body mass index (BMI), standardized to age and gender.
    


Intervention name(s): Parents and Tots Together Program; Supervision for Safety
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Group-based parenting program, 9 weeks delivered in a community setting; group-based safety intervention for parents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Does Treating Anxiety Symptoms With ACT Improve Vascular Inflammation and Function?
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the effectiveness of a brief, intensive 1-day
      psychotherapy group intervention (Acceptance and Commitment Therapy, ACT), compared to a 12
      week time control group on anxiety symptoms, vascular function, inflammation, muscle
      sympathetic nerve activity (mSNA), and oxidant stress. Similar measures will be performed at
      baseline in individuals with low or no anxiety for comparison. Individuals who are interested
      in the study will be identified by an online screening survey and will be contacted by the
      research team; advertisements, flyers and mass emails will direct individuals to the online
      screening survey. Those deemed eligible to participate will be randomized to the ACT
      intervention or a control group. Assessments of anxiety symptoms (via various surveys) and
      vascular function (via non-invasive, well-established techniques) will be performed at
      baseline and 12 weeks post-ACT group intervention session. In addition, reassessment of
      anxiety symptoms via aforementioned surveys will take place 6 weeks post-ACT group session.
      After 12 weeks, anxiety and vascular assessments will be repeated to re-evaluate severity of
      anxiety symptoms, vascular function, inflammation, and oxidant stress.
    

Detailed description: 
      The investigators hypothesize that reducing the burden of anxiety symptoms using Acceptance
      and Commitment Therapy (ACT) will improve vascular function, inflammation, mSNA, and oxidant
      stress.

      The investigation also explore other secondary endpoints related to oxidant stress and
      inflammation in vascular endothelial cells. If anxiety increases inflammation, then we
      predict that ACT will reduce circulating pro-inflammatory cytokines, and produce a phenotype
      of endothelial cell proteins reflecting decreased inflammation compared to pre-treatment. And
      if anxiety increases oxidative stress, then ACT should produce a phenotype of endothelial
      cell proteins reflecting decreased oxidant stress and increased nitric oxide synthase
      activity.
    

Intervention name(s): Acceptance and Commitment Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effects of a Multiple Component Training Program on Muscles in Adults With Myotonic Dystrophy Type 1
Condition: Myotonic Dystrophy 1
MeSH terms: Myotonic Dystrophy
Study type: Interventional

Summary: 
      A strength and endurance training program was conducted in adults with myotonic dystrophy
      type 1 (DM1). Participants underwent a 12-week/18-session supervised training program
      consisted of 6 exercises: elbow flexion/extension, shoulder horizontal adduction, leg press,
      and knee flexion/extension. To offer a complete training program aimed at improving function
      it was divided: the first 6 weeks were dedicated to strength-training, whereas the following
      weeks focused on endurance-training. To evaluate the effects of the training program,
      participants completed maximal strength, endurance and functional evaluations. Volunteers
      could also add a muscle biopsy at the beginning and the end of the program to evaluate
      physiological parameters.
    


Intervention name(s): Training program
Intervention type(s): Other
Intervention description(s): 12-week, 18-session training program. To offer a complete training program aimed at improving function it was divided : the first 6 weeks were dedicated to strength-training (2 sets of 6 repetitions at 80% of 1-RM), whereas the following weeks focused on endurance-training (1 set of 25 repetitions at 40% of 1-RM).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Serum TWEAK Levels in Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the serum level of TWEAK in patients with AV and their relations before and after
      treatment with isotretinoin.
    

Detailed description: 
      Acne vulgaris is a chronic inflammatory disease of the pilosebaceous follicles, characterized
      by comedones, papules, pustules, cysts, nodules, and occasionally scars. Its pathogenesis
      includes follicular hyperkeratinization, sebaceous hypersecretion due to androgen
      stimulation, follicular colonization by Propionibacterium acnes, immune and inflammatory
      responses. It affects the face, anterior chest, and upper back . Inflammation is regarded as
      a key component in the pathogenesis of acne . An increase in the activity of the pro
      inflammatory cytokine, interleukin (IL) 1, is observed before the beginning of
      hyperproliferation around the uninvolved follicles and is thought to trigger the activation
      of keratinocyte proliferation. Nuclear factor kappa beta (NF κβ) regulated mRNA gene levels
      of the cytokines tumour necrosis factor (TNF) α, IL 1 β, IL 8 and IL 10 levels also affected.

      Isotretinoin (13-cis retinoic acid) is a synthetic analog of vitamin A. Its oral form is
      prescribed for severe cases which are resistant to other treatments.

      Tumor necrosis factor (TNF)-like weak inducer of apoptosis (TWEAK) belongs to the TNF
      superfamily. It has an important role in the regulation of cell growth, apoptosis,
      angiogenesis, and immune reactions.
    

Intervention name(s): Isotretinoin; ELISA Assays of Serum TWEAK.
Intervention type(s): Drug; Diagnostic Test
Intervention description(s): systemic isotretinoin was given to all 90 patients , dose was prescribed according to weight for 3 months; : From each subject, 5mL of blood was collected into vacutainers before and after treatment with isotretinoin. The blood samples were centrifuged at 3000g for 10 min at a temperature of 4°C, then . Quantitative determinations for serum TWEAK were achieved using the corresponding commercially available ELISA kit supplied by the AssayMax
Intervention MeSH terms: Isotretinoin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Study of Concurrent Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The phase I study is to determine the maximum tolerated dose and dose limiting toxicity of
      docetaxel and nedaplatin prescribed twice weekly in combination with concurrent chest
      radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.
    


Intervention name(s): Docetaxel; Nedaplatin; chest radiation
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): 5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation; 5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation; continuous chest radiation at 64 Gy/32f
Intervention MeSH terms: Docetaxel; Nedaplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal squamous cell carcinoma; Chemoradiotherapy; Docetaxel; Nedaplatin; Twice weekly
Injection of Corticoids for the Treatment of Acute Sprains of the Proximal Interphalangeal Joints of the Fingers.
Condition: Sprain
MeSH terms: Sprains and Strains
Study type: Interventional
Phase: Phase 2

Summary: 
      There is currently no real consensus on the optimal management of acute sprains of the
      proximal interphalangeal joint of the long fingers.

      The aim of this study is to assess the beneficial effect of an injection of corticosteroids
      for the treatment of this type of sprain (one single sub-cutaneous injection, in the acute
      phase). This treatment, if effective, might become the treatment of choice for these types of
      injuries, instead of a prolonged immobilization or a careful early mobilization.
    


Intervention name(s): Diprophos
Intervention type(s): Drug
Intervention description(s): Single subcutaneous injection of Diprophos, in the acute phase.
Intervention MeSH terms: Betamethasone dipropionate, betamethasone sodium phosphate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sprains of the proximal interphalangeal joints of the long fingers; Diprophos
A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy
      adult volunteers.
    

Detailed description: 
      This is a single-center, two-part, randomized, double-blinded, placebo-controlled, ascending
      dose study of BBP-711 in healthy male and female adult volunteers. The purpose of this study
      is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers. Each
      volunteer will participate in the study for about 20 days.
    

Intervention name(s): BBP-711; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BBP-711, oral suspension; Placebo matching BBP-711
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Condition: Acute Gouty Arthritis
MeSH terms: Arthritis; Arthritis, Gouty
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety
      and tolerability in patients who have frequent flares of acute gouty arthritis.
    


Intervention name(s): Canakinumab 150mg in prefilled syringe
Intervention type(s): Drug
Intervention description(s): Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares
Intervention model: Single Group Assignment
Intervention model description: Uncontrolled
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gout; arthritis; gout flare; acute gout; gouty; rheumatic disease; uric acid; podagra
The Effect of Whole Body Cryotherapy on Recovery and Performance: a Randomized Controlled Trial
Condition: Cold
Study type: Interventional

Summary: 
      This study investigates the effects of whole-body cryotherapy vs. cold-water immersion after
      a muscle damage protocol.
    

Detailed description: 
      In this study the effects of a single- or multiple whole body cryotherapy (-135°C for max. 2
      minutes) vs. cold water immersion (10°C for 15 min) and a passive control group (20 min
      supine position) are compared. These effects are examined after a muscle damage protocol of
      the frontal thighs (3 x 30 jumps). The objective recovery parameters are vertical jump,
      maximum voluntary contraction of the anterior thigh muscle, heart rate, blood pressure,
      skin-core body temperature and the oxygen saturation of the thigh muscles. Subjective
      recovery parameters are the local muscle soreness details and the general exhaustion details.
      The parameters are directly and 24, 48 and measured 72 hours after exposure. The aim is to
      elicit the effects of whole body cooling to make recommendations to. The current scientific
      knowledge situation calls for further studies to whole body cooling.
    

Intervention name(s): Kryosauna Space Cabin; cold water tub
Intervention type(s): Device; Other
Intervention description(s): The whole body cryotherapy device is able to generatue temperatures up to -195°C for 3 minutes. In this study, we generate temperatures of -135°C for 2 minutes as proposed in the manual. The participant will enter the cabin in cold-resistant shoes and will remain in standing position during the whole procedure. The cold temperature is generated by vaporization of liquid nitrogen.; The tub will be filled with cold water up to the sternal level of the participants. Adding ice will ensure a constant temperature. The participant will sit inside the tub during the whole procedure.
Other intervention name(s): Cryomed s.r.o.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cold; recovery
Laser Acupuncture in Rheumatoid Arthritis Geriatric Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      Studying the effect of laser acupuncture on geriatric patients with rheumatoid arthritis
    


Intervention name(s): Laser, exercise, and methotrexate; Exercise, and methotrexate
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Laser therapy at acupuncture points, aerobic exercise, and methotrexate; Aerobic exercise, and methotrexate
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Clinical Study to Evaluate the Pharmacokinetics and Bioequivalence of HMPL-523 Tablets Produced by Two Different Manufacturers
Condition: Healthy Subject
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate
      clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of
      HMPL-523 Tablets produced by two different manufacturers in healthy subjects.
    

Detailed description: 
      This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate
      clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of
      HMPL-523 Tablets produced by two different manufacturers in healthy subjects. This study
      plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three
      sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single
      dose in each cycle with a washout period of at least 7 days, where T is the test product
      [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the
      reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).

      The study includes three periods expected to last for 2 months: screening period, treatment
      period (for three cycles), and follow-up period
    

Intervention name(s): HMPL-523
Intervention type(s): Drug
Intervention description(s): This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a monocentric, randomized, open-label, single-dose, three-cycle, partial replicate clinical study designed to evaluate the pharmacokinetic profile and bioequivalence of HMPL-523 Tablets produced by two different manufacturers in healthy subjects. This study plans to enroll 39 healthy Chinese subjects who will be randomized (1:1:1) into one of three sequence groups (Test [T]/Reference[R]/R group, RTR group and RRT group) to receive a single dose in each cycle with a washout period of at least 7 days, where T is the test product [i.e., HMPL-523 Tablets manufactured by Hutchison MediPharma (Suzhou) Limited.], and R is the reference product (i.e., HMPL-523 Tablets manufactured by WuXi STA).
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe
Condition: Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in
      clinical practice in Europe
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        tertiary referral
      
Keywords: Vizamyl; flutemetamol; Alzheimer's disease; cognitive impairment; dementia
Health Promotion and Wellness Program for Adults With Disabling Conditions
Condition: Stroke; Multiple Sclerosis; Rheumatoid Arthritis
MeSH terms: Multiple Sclerosis
Study type: Interventional

Summary: 
      The objective of this study is to conduct a randomized controlled pilot study to examine the
      efficacy, feasibility and safety of the SystemCHANGE™(SC) health promotion and wellness
      program in adults with disabling conditions. Particularly, the study will focus on developing
      a program of research on adapting and testing SC weight management interventions in
      overweight and obese stroke survivors and persons with chronic inflammatory
      autoimmune/immune-mediated diseases, specifically those with multiple sclerosis (MS) and
      rheumatoid arthritis (RA).
    

Detailed description: 
      Individuals with disabling conditions, such as stroke, multiple sclerosis, or rheumatoid
      arthritis, face many barriers to engaging in physical activity, healthy nutritional habits,
      and good sleep hygiene. This leads to weight gain, de-conditioning, and declines in upper-
      and lower- extremity function, which makes it even more difficult to engage in healthy
      behaviors, thereby perpetuating a cycle of functional decline. Developing an effective weight
      management intervention may be a strategy for disrupting this disabling cycle and reducing
      the impact of the disease. Fostering a positive social environment may help adults with
      disabling conditions overcome barriers to engaging in healthy behaviors. SystemCHANGE (SC) is
      a new behavior change program that uses approaches consistent with social ecological theories
      and process improvement techniques (i.e. changing the dynamics of a system or group) to
      increase social support in lifestyle behaviors that promote energy balance. SC focuses on
      redesigning the social environment using a series of trial-and-error "experiments", which is
      in contrast to cognitive-behavioral interventions that focus on changing a person's viewpoint
      of a situation and increasing motivation. In a SC intervention, individuals are taught a set
      of skills to assist them in incorporating habitual lifestyle behaviors into their daily
      systems so they succeed despite wavering motivation. The rationale for developing a weight
      management intervention for these patients is to slow disability progression and prevent
      secondary conditions.
    

Intervention name(s): SystemCHANGE Group Lifestyle counseling; Phone Lifestyle Counseling
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Self Care; Exercise; Weight management