bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Study Evaluating Steroid Hormone Levels, Safety And Tolerability Of GW870086X In Healthy Volunteers
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      GW870086X is a novel inhaled steroid that has an improved safety profile over other steroids
      but is also less potent. This study will look at higher doses to confirm the improved safety
      profile.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled, dose ascending, 3-cohort parallel group study
      to measure the systemic cortisol profile and evaluate the safety, tolerability and
      pharmacokinetics of GW870086X, administered as single doses (12mg and 15mg),and repeat doses
      over 3 days (6mg, 12mg and 15mg) in healthy male subjects.
    

Intervention name(s): GW870086X
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GW870086X, inhaled, asthma, cortisol, pharmacokinetics, osteocalcin
Stabilizing Training in Degenerative Disc Disease
Condition: Degenerative Disc Disease; Protrusion; Extrusion of Migrated Disc; Hernia
MeSH terms: Spinal Diseases; Intervertebral Disc Degeneration
Study type: Interventional

Summary: 
      This study evaluates efficacy of stabilizing training of deep core muscles in the lumbar
      spine in degenerative disc disease subjects, considering the progression level of
      degenerative disc disease: protrusion or extrusion.
    

Detailed description: 
      Degenerative disc disease (DDD) is one of the causes of low back pain, and contributes to
      increasing the socio-economic problem. Depending on the reason for the dysfunction, various
      classifications describing the level of advancement are used. Literature on the subject
      commonly uses the division into protrusion and extrusion of the intervertebral disc, as
      approved by the American Society of Neuroradiology.

      Stabilizing training is one of the forms of conservative treatment of lumbar pain, alongside
      manual treatment or techniques from the field of chiropractics or physiotherapy. It is
      thought that the proper stabilization of this region of the body is crucial for coping with
      pain.

      Therefore, the aim of the study was to assess the effectiveness of stabilizing training of
      deep core muscles in the lumbar spine in subjects in the age of 20-35 years, considering the
      progression level of degenerative disc disease: protrusion or extrusion, on the basis of the
      clinical condition.
    

Intervention name(s): Stabilizing training
Intervention type(s): Behavioral
Intervention description(s): The training will include the activation of the lumbar multifidus muscle (m. multifudus) and the transverse abdominal muscle (m. transversus abdominis). The performance of the individual stages of the training will be based on Richardson's methodology. One session will comprise 4 sets in which the patient will be asked to do pelvic tilts (draw-in) with simultaneous full exhalation, thus activating the aforementioned muscle groups in different positions: a) prone b) supine with lower extremities flexed c) quadruped d) standing back to the wall. The subjects will perform 3 series consisting of 10 repeats, each of which will last ca. 10 seconds.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: degenerative disc disease; stabilizing training; protrusion; extrusion
Biosimilar Study Comparing PK, PD, Safety and Immunogencity of BP11 With US Licensed Xolair and EU Approved Xolair
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose, double blind comparative trial to assess the pharmacokinetics,
      pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and
      EU-Xolair) containing 150mg of Omalizumab as subcutaneous injection in healthy male
      volunteers.
    

Detailed description: 
      The study will be conducted at 2 sites in New Zealand and 1 site in Australia.

      A total of 165 healthy male subjects (55 subjects per arm) who meet the required entry
      criteria will be randomly assigned to one of 3 treatment groups in a 1:1:1 ratio to receive a
      single SC injection of either BP11, EU-Xolair, or US-Xolair.
    

Intervention name(s): Omalizumab Prefilled Syringe
Intervention type(s): Drug
Intervention description(s): 150mg/ml of Omalizumab prefilled syringe
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Using Reinforcement Schedules to Increase Fruit&Vegetable Intake, Reduce Waste, and Increase School Lunch Participation
Condition: Behavioral Changes; Psychology, Social; Nutrition
Study type: Interventional

Summary: 
      Using small monetary rewards to reinforce healthy behaviors, such as the consumption of
      fruits and vegetables (F&V), the investigators tested fixed and variable reinforcement
      schedules in three middle schools.

      The investigators measured carotenoid levels, as a biomarker of F&V intake, and F&V waste
      over the intervention time frame. The investigators also tracked the school lunch
      participation rates over time.
    


Intervention name(s): Variable (random) interval; Variable (non-random) interval; Variable (random) interval with table tents; Control
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Using Variable (Random) Interval Reinforcement Schedules to Increase Fruit and Vegetable Intake, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation; Using Variable (Non-random) Interval Reinforcement Schedules to Increase Fruit and Vegetable Intake, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation; Using Variable (Random) Interval Reinforcement Schedules and Table Tents with Health-related Messages to Increase Fruit and Vegetable Intake, Reduce Fruit and Vegetable Waste, and Increase School Lunch Participation; No intervention
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Number of participants below is best estimate of students exposed to the intervention based on school lunch participation rates.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: fruit, vegetable, food waste
The Role of Short Chain Fatty Acids in Microbiota-gut-brain Axis
Condition: Emotions; Stress; Fear
Study type: Interventional

Summary: 
      The role of short chain fatty acids (SCFA) in the microbiota-gut-brain axis is examined in a
      sample of healthy volunteers. SCFA are the major products of bacterial fermentation of
      dietary fiber in the colon, and are hypothesised to mediate the bidrectional communication
      between the gut and the residing microbiota on the one hand, and the central nervous system
      on the other hand. We perform a 1-week intervention with SCFA and measure their effects on a
      range of affective outcomes in healthy male volunteers.
    

Detailed description: 
      The study is an interventional double-blind, placebo-controlled, parallel group design with 3
      arms (placebo, high-dose of SCFA, and low-dose of SCFA). The high and low doses of SCFA are
      equivalent to 20 and 10 grams of fiber respectively. Healthy male participants follow a
      low-fiber diet for the study duration (11 days). On day 4, baseline measurements are taken in
      the lab, including biological samples and psychophysiological measurements. Participants then
      consume placebo or SCFA for one week and revisit the lab on day 11 for a second measurement
      of the outcomes of interest. Specifically, we investigate the effect of SCFA supplementation
      on affective processing, including stress sensitivity, fear-related processes (e.g.
      extinction learning), and attentional bias to emotional stimuli. Volunteers also respond to
      questionnaires in relation to mood, and provide biological samples (blood and faecal samples)
      for analysis of circulating short chain fatty acids and microbiota composition, respectively.
    

Intervention name(s): SCFA mixture
Intervention type(s): Dietary Supplement
Intervention description(s): Intracolonic administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Marwo-D Research -Need for Vitamin D in Different Population Groups
Condition: Serum 25-hydroxyvitamin D Concentrations (25OHD)
Study type: Interventional

Summary: 
      Insufficient intake of vitamin D is a public health problem, affecting about 40% of the
      Finnish population in the winter. Vitamin D has a wide range of health effects: in addition
      to its effect on bone, it is known to affect inflammatory response among other things. The
      sources of vitamin D are the synthesis in the skin as well as diet and dietary supplements.
      In Finland and in Northern Europe vitamin D is formed in the skin only from March to October.
      This alone is not sufficient to cover the need for year-round, because vitamin D storage is
      used in a few months. During the winter months the only sources of vitamin D are diet and
      vitamin preparations. Current vitamin D recommendations are usually based on studies in white
      population. However, there can be a difference in the need of vitamin D and in vitamin D
      metabolism between different population groups. More research evidence is needed from the
      northern countries. The aim of this study is to evaluate the vitamin D need in Somali
      immigrant population and in original Finnish population. The hypothesis is that the Somalis
      need more vitamin D to exceed the serum 25(OH)D concentration of 50 nmol/L than the original
      Finnish population.
    


Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin D; Serum 25-hydroxyvitamin D (25OHD); Dietary supplement; Ethnicity; Immigrant
Competency-based Approaches to Community Health
Condition: Obesity, Childhood
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      This study is a family-centered, community-based intervention to prevent and treat childhood
      obesity among 3-5 year old children from undeserved communities. Half of participants will
      receive a healthy lifestyle intervention and half of participants will receive a
      school-readiness intervention.
    

Detailed description: 
      The complex multi-level determinants of childhood obesity necessitate a personalized
      approach. One of the main challenges to effective behavior change interventions is the
      complexity of the systems in which these behaviors are situated. Namely, health behaviors are
      the result of the confluence of macro-level influences (e.g., the built environment, family,
      etc.) and micro-level influences (e.g., stress). Furthermore, it is imperative that attempts
      to support healthy childhood growth consider the foundational contribution of a person's
      culture to their health behaviors, especially as children from traditionally underserved
      minorities are often hardest hit by obesity.

      This program will test a 15 week behavioral intervention followed by 3 months of coaching
      calls that uses principles from the learning sciences and health behavior change to help
      shape healthy behaviors in the context of family. The follow-up of the study will last 1
      year. The content of the intervention will focus on health behavior change, including
      teaching goal-setting and self monitoring skills, as well as parenting strategies.

      The primary outcome of interest will be early childhood BMI trajectory over 1 year.
      Additional measures will include survey data to measure parent and child health behaviors
      (e.g., diet, physical activity, sleep, media use) that are associated with obesity.
    

Intervention name(s): COACH: Healthy Bodies; COACH: Strong Minds
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.; School Readiness Intervention focusing on literacy and parent skills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Women Helping Women - Lung Cancer Screening
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      The Women Helping Women Lung Cancer Screening (WHW-L) Study will be conducted to develop a
      scalable, easy to apply community-based intervention to increase rates of lung cancer
      screening and follow-up in high-need/low-resource populations, based on a Transtheoretical
      Stages of Change theoretical model. The investigators will test the feasibility of using
      Community Health Workers to recruit (Aim 1) and partner with 60 community members (Aim 2)
      within 6 months, to take the steps to consult with a doctor, schedule screening, and/or
      attend screening (Aim 3) [84 people may be screened for the study assuming some don't
      continue}.CHWs will use the HealthStreet 12,000+ cohort to identify current or former female
      smokers (adults 50 to 77 years old) with a smoking history of 25 pack-years who could benefit
      from LDCT screening for lung cancer and will facilitate steps in their screening receipt. All
      participants will benefit from the Standard Intervention; additionally, a random sample of 30
      will receive the Enhanced CHW Intervention (E-CHW-I). The investigators hypothesize that
      women who may be at higher risk of lung cancer due to lack of knowledge, access, and
      resources will take steps to receipt of LDCT in both interventions, with those receiving the
      Enhanced Intervention more likely to take these steps. Ultimately, such an intervention could
      lead to a lower lung cancer burden in the target population
    


Intervention name(s): Enhanced CHW Intervention
Intervention type(s): Behavioral
Intervention description(s): community-based intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
Condition: Major Depression; Bipolar Depression; Schizoaffective Disorder
MeSH terms: Depression; Depressive Disorder; Psychotic Disorders; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat
      problems with thinking and memory caused by electroconvulsive therapy (ECT).
    


Intervention name(s): Razadyne; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The starting dose of study medication is 4 mg twice a day; 4 mg, 2 times a day
Other intervention name(s): Galantamine
Intervention MeSH terms: Galantamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Mycoprotein and Muscle Protein Synthetic Response
Condition: Anabolic Response to Mycoprotein and Micronutrient Ingeston
Study type: Interventional

Summary: 
      Dietary protein is vital for the preservation of health and optimal adaptation to training.
      However, traditional animal proteins come with a number of economic, environmental, and
      ethical issues. Accordingly, there is a need to develop an understanding of the utility of
      more sustainable non-animal derived dietary proteins to support our nutrition. Mycoprotein,
      produced by Quorn Foods™, has recently been shown to stimulate a greater anabolic response
      within skeletal muscle compared with milk protein, suggesting its utility within sports
      nutrition. However, it is unclear what accounted for the greater anabolic response of
      mycoprotein. One explanation could be the non-protein nutrients contained within mycoprotein
      (e.g. fibre, carbohydrate, fat or micronutrients).

      Therefore, the present study will compare the muscle anabolic response between mycoprotein
      (MYC) as a whole food and the protein isolated from mycoprotein (PIM).
    


Intervention name(s): Mycoprotein ingestion
Intervention type(s): Dietary Supplement
Intervention description(s): The ingestion of mycoprotein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study in Healthy Adult Female Subjects
Condition: Mass Balance Recovery
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open Label Phase 1 Study in Healthy Adult Female Subjects to Determine the Mass Balance
      Recovery, Absorption, Metabolism, and Excretion of [14C] D-0502 Following Single Oral Dose
      Administration
    


Intervention name(s): [14C]-D-0502
Intervention type(s): Drug
Intervention description(s): Drug: [14C]-D-0502 and D-0502
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Metabolic Availability of Lysine From White Maize
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      Our objective is to determine the metabolic availability of Lysine in white maize using the
      indicator amino acid oxidation (IAAO) technique in adult men.
    

Detailed description: 
      Our objective is to determine the metabolic availability of Lysine in white maize. 7 young,
      healthy, male adults will receive graded levels (29, 37,46 and 54%) of lysine requirement of
      35 mg/kg/d as a crystalline AA mixture and a porridge of white cornmeal protein respectively.
    

Intervention name(s): Crystalline Lysine Amino Acid Mix; White corn meal porridge
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Crystalline Lysine from Amino Acid Mixture in amount of 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.; A cornmeal porridge including 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: lysine; bioavailability; amino acids; corn
Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty
Condition: Analgesia
Study type: Interventional

Summary: 
      Total knee replacement (total knee arthroplasty) is performed to resurface a knee damaged by
      arthritis and relieve pain in patients with severely damaged knee joints.

      Total knee arthroplasty (TKA) is associated with severe postoperative pain, and the
      management of postoperative pain continues to evolve with the advancement of surgical
      techniques and pharmacological treatments.

      Femoral, lateral femoral cutaneous nerve and obturator nerve block is provided with
      suprainguinal fascia iliaca plan block, which is used for postoperative analgesia, especially
      in hip surgeries. In this way, the investigators think it can be used as a part of multimodal
      analgesia in total knee arthroplasty surgery.
    


Intervention name(s): Group Suprainguinal fascia iliaca block; Group Periarticular Infiltration
Intervention type(s): Other; Other
Intervention description(s): After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic injection will be made between the fascia and the muscle.; A total volume of 80 ml local anesthetic will be applied to the medial and lateral capsule, the medial and lateral meniscus margins, the deep part of the medial ligament, the medial and lateral synovial space, and the patellar ligament and quadriceps tendon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: Defining the Optimal Cryoballoon Duration Therapy for Treatment of Atrial Fibrillation: The 1-2-3 Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      Cryoballoon based therapy is an established therapy for the treatment of (paroxysmal) atrial
      fibrillation. However, with the rapid evolution in cryoablation technique and its increased
      effectiveness, the risk of complications increases. Therefore it is of utmost importance to
      define the optimal duration of cryoballoon ablation time.The objective of the study is to
      assess the optimal ablation duration using the second generation cryoballoon for isolation of
      pulmonary veins in the treatment of atrial fibrillation.
    

Detailed description: 
      Rationale Cryoballoon based therapy is an established therapy for the treatment of
      (paroxysmal) atrial fibrillation. However, with the rapid evolution in cryoablation technique
      and its increased effectiveness, the risk of complications increases. Therefore it is of
      utmost importance to define the optimal duration of cryoballoon ablation time.

      Objective To assess the optimal ablation duration using the second generation cryoballoon for
      isolation of pulmonary veins in the treatment of atrial fibrillation.

      Study design The study is designed as a prospective multicentre randomized efficacy study.

      Study population Patients 18-70 years of age with paroxysmal atrial fibrillation eligible for
      pulmonary vein isolation according to current international guidelines.

      Intervention Patients will be randomized to 2 cycles of 1, 2 or 3 minutes of cryoballoon
      ablation after reaching the temperature "plateau phase".

      Main study parameters/endpoints Acute success of pulmonary vein isolation.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness:

      No additional risk is present as the procedure is common clinical practice, current
      cryoballoon application time is 3 minutes Shorter application times are not expected to add
      to the risk.
    

Intervention name(s): Cryoballoon ablation
Intervention type(s): Other
Intervention description(s): PVI using cryoballoon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pulmonary Vein Isolation; Atrial fibrillation; Cryoballoon therapy; Duration