bioihbjkbjnl/mcl2 huggingface dataset:
Evidence-informed Choice for Women Participating in Mammography Screening
Condition: Early Detection of Cancer
Study type: Interventional

Summary: 
      Study objectives: to evaluate the effects of information about benefits and risks of
      mammography screening on participants in terms of knowledge, attitude, rates of uptake, fear
      of cancer, anxiety, and conflict decision. Study hypothesis: information about benefit and
      risks of mammography screening increases the women´s knowledge of it; allows women to make an
      informed decision on whether to stop or continue the screening program, changing the actual
      participation rate; anxiety and fear are not increased. Design: randomized controlled
      clinical trial with non-pharmacological intervention. Subjects and setting of study: women
      referred to mammography screening in the District Bay of Cádiz-La Janda. Interventions:
      random assignment of women in two arms according to the information provided. Control arm is
      the standard information; it consists of receiving information normally provided to women
      attending the screening program for breast cancer. Intervention arm is the experimental
      information and consists of receiving accurate verbal and written information about the
      benefits and real risks of mammography screening programs by a physician investigator.
      Determinations: knowledge, attitude, rates of uptake, fear of cancer, anxiety, and conflict
      decision.
    


Intervention name(s): Information
Intervention type(s): Other
Intervention description(s): The experimental information consists of receiving verbal and written evidence-based information about the benefits and risks of mammography screening program. The standard information consists of receiving the information that public institutions provide to the women invited to the screening program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Cancer Screening Tests; Early Diagnosis of Cancer; Mammography; Informed Consent; Consent Forms
A First-in-Human, Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15136 in Healthy Subjects
Condition: Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, randomized, placebo controlled, single ascending dose (SAD) study to
      investigate the safety, tolerability, PK and PD of the SC administration of HM15136 in
      healthy subjects.

      The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8
      subjects per cohort. Subjects will be randomized to HM15136 or placebo in a ratio of 6:2 (6
      active, 2 placebo).
    


Intervention name(s): HM15136; Placebo of HM15136
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg/mL as protein in prefilled syringes; Placebo in prefilled syringes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Ankle Taping and Balance Exercises on Postural Stability
Condition: Disturbance; Balance, Labyrinth; Proprioceptive Disorders
MeSH terms: Somatosensory Disorders
Study type: Interventional

Summary: 
      Both taping and balance exercises have effects on dynamic balance, so this study compared
      ankle taping and balance exercise on postural stability indices in healthy women. we
      hypothesized that both balance exercise and taping would increase stability indices but the
      effects of balance exercise was more greater than taping.
    

Detailed description: 
      The ability to control the body in the space is a complex interaction between musculoskeletal
      and neural systems. This set is called postural control system. Postural control involves the
      control of body position in space for the dual purposes of postural stability and postural
      orientation. Balance process is divided into four-stage by Sullivan and Markos: mobility,
      stability, controlled mobility, and skill. Several types of exercise have been proposed to
      improve proprioception. Bout and Gahery stated that balance exercises improve neuromuscular
      relations and reduces the proprioception errors. They believe that those who have more
      proprioception difficulty may benefit more from exercise therapy.Taping is another technique
      to enhance proprioception. Improvement in proprioception leads to better function and
      reduction of disability. Kinesiotaping is being used to prevent injuries and to help curing
      the injury. It can also improve efficiency in sport, improve lymph and venous circulation,
      decrease edema, stimulate the mechanoreceptors and increase awareness of subject about the
      ankle position, reduces the pain and improves muscle performance
    

Intervention name(s): Balance exercise and ankle taping
Intervention type(s): Other
Intervention description(s): Balance Exercises: The first group performed balance exercise which last for six weeks, 3 times a week, and 40 minutes each session. Each session started by several minutes of slow walking and progressive stretching of ankle, knee and hip muscles which was gradually increased in time and repetition. After that, balance exercises were performed.
Ankle taping: In second group Ankle joint taping continued for 6 weeks and was renewed three times a week.
Other intervention name(s): Balance Exercises; Ankle taping
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Balance exercise; Ankle; Postural stability; Taping; Biodex
Canned Herring for Prevention of Childhood Malnutrition During the Early Rainy Season in Rural Guinea-Bissau
Condition: Malnutrition; Undernutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      This study will test the effectiveness of a weekly village distribution of canned herring for
      prevention of malnutrition in children aged 2-5 years old during a food-insecure time of the
      year in rural villages in Guinea-Bissau. The study will use community health workers to
      conduct the herring distribution, making this a test that will provide valuable information
      on what could become a practical food aid supplementation practice. The primary study
      hypothesis is that distribution of canned herring as a weekly food supplement to families
      with young children at the beginning of the rainy season will prevent a seasonal decrease in
      weight-for-age Z-score (primary variable) of children with mild to moderate malnutrition at
      baseline.
    


Intervention name(s): Canned Herring
Intervention type(s): Other
Intervention description(s): Families with children in this study arm will receive a weekly ration of herring throughout the 8-10 week study period (2 cans herring/day per study child).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: malnutrition; undernutrition; Z-score; Guinea-Bissau; food aid
Telephone Based Management of Hyperlipidemia
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to demonstrate that systematic self measurement of blood lipids
      reduces LDL cholesterol more effectively than standard care. The hypothesis is that
      cholesterol lowering medication adherence will be improved with self monitoring and reporting
      of frequent blood lipids and the percentage of patients achieving LDL goal will be greater
      than without home monitoring.
    

Detailed description: 
      The study utilizes a telephone reporting system to self report lipid values and provide
      educational counseling regarding lifestyle modification methods to reduce cardiovascular
      risk. Study patients will be randomized to receive a home monitoring device and will be
      instructed on its use. Generic simvastatin will be given to reduce LDL levels in all groups.
      It is the hypothesis that those study patients receiving a home device will reach target LDL
      (goal LDL) more frequently than those randomized to usual care( no device).
    

Intervention name(s): Self Monitoring Lipid Analyzer
Intervention type(s): Device
Intervention description(s): The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values.
Other intervention name(s): Cardiochek
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Internet based monitoring system
Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET
Condition: Smoking Cessation; Tobacco Use Cessation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of the present study is to use positron emission tomography brain imaging to
      investigate D3 occupancy of buspirone, an FDA-approved anxiolytic which acts as a serotonin
      partial agonist but has recently been identified as a D3 antagonist. It is hypothesized that
      clinically relevant doses of buspirone will occupy the D3 receptor.
    

Detailed description: 
      Buspirone is used for anxiety disorder treatment, a therapeutic effect that has been thought
      to be mediated through its partial agonist properties at the serotonin receptor. However,
      since one PET study in humans has shown low occupancy of the serotonin by buspirone in
      clinical doses and since the DRD3 has been recently implicated in anxiety, some therapeutic
      effects of buspirone may be mediated through the DRD3. In human clinical studies, promising
      effects of buspirone have been reported for treatment of substance dependence, including
      tobacco, marijuana, and opiates, and clinical studies in cocaine dependent subjects are
      underway. However, it is unclear if buspirone is producing those effects through the DRD3 and
      no human study has incorporated a PET imaging component to investigate this question; it
      remains unclear whether buspirone significantly occupies the DRD3 at therapeutic doses in
      humans.
    

Intervention name(s): Buspirone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The buspirone will be given once as a tablet and encapsulated for blinding.; Placebo will be lactose and encapsulated for blinding. A single capsule will be given.
Other intervention name(s): Buspar; lactose
Intervention MeSH terms: Buspirone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: buspirone; smoking cessation; dopamine; PET imaging; [11C]-(+)-PHNO
Blood Flow Analysis of the Human Mucosa After Vestibuloplasty Procedures
Condition: Mucogingival Defect
Study type: Observational

Summary: 
      Apply the LSCI for follow-up the postoperative microcirculation after surgical procedures to
      enlarge keratinized gingiva in order to characterize the kinetics of the blood flow changes
      during wound healing in human subjects.
    

Detailed description: 
      Vestibuloplasty is the common name of those procedures designed to widen the zone of attached
      gingiva. The apically repositioned split thickness flap with a xenogeneic collagen matrix or
      with a combination of strip gingival graft and a xenogeneic collagen matrix are frequently
      used surgical techniques, however no data are available, how these graft tissues affect the
      microcirculation of the healing gingiva.

      LSCI is a non-invasive, two dimensional method to evaluate microcirculation of different
      tissues. This new method let us monitor the entire surgical area real-time during the healing
      period.

      The aim of the present study is to define blood flow patterns, which might characterize the
      wound healing of such surgical procedures during the first 6 months of healing in order to
      facilitate treatment.
    

Intervention name(s): laser speckle contrast imaging of the oral mucosa; wound fluid measurement; quantitative determination of VEGF
Intervention type(s): Device; Device; Device
Intervention description(s): Non-invasive method to measure tissue blood perfusion applied for oral mucosa; Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument.; For the quantitative determination of VEGF in the fourth day wound fluid sample the Human VEGF Quantikine ELISA Kit will be used.
Other intervention name(s): LSCI Perimed PSI; Periotron 8010; Human VEGF Quantikine ELISA Kit
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Caucasians subjects presenting multiple Miller Class I. and II. gingival recessions
        (Multiple Adjacent Recession Type Defects, MARTD) were recruited in the Department of
        Periodontology in Semmelweis University.
      
Keywords: mandibular vestibuloplasty; wound healing; microcirculation; Laser Speckle Contrast Imager; Mucograft; strip gingival graft
Impact of Sprint Stair Climbing "Snacks" on Markers of Metabolism and Vascular Function
Condition: Physical Activity; Diet Modification
Study type: Interventional

Summary: 
      Prolonged sitting has been shown to impair metabolism and vascular function. The overall
      purpose of this study is to determine if breaking up prolonged (9 hours) of sitting with
      brief (~20 second) stair climbing exercise "snacks" can improve markers of metabolic control
      and vascular health in healthy young male participants and in males or females with
      overweight/obesity who are at risk of insulin resistance. An additional purpose is to
      determine if saliva insulin can be used as a valid indicator of blood insulin when measured
      throughout the day in sedentary and active conditions and when diets with different amounts
      of carbohydrates are consumed.
    


Intervention name(s): High-Carbohydrate Sedentary; High-Carbohydrate Active; Low-carbohydrate Sedentary
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Three high-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period.; Three high-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period except that once every hour they will ascend three flights of stairs vigorously (stair climbing sprint "snack") for a total of 8 active breaks.; Three low-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period. This condition will provide a condition where the blood glucose and insulin responses are relatively low and stable throughout the day.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants complete three conditions in a repeated crossover design.
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety of the Use of Venocur Triplex® in Patients With Chronic Venous Insufficiency
Condition: Venous Insufficiency
MeSH terms: Venous Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the therapeutic efficacy and safety of Venocur
      Triplex®, administered BID for 60 days in patients with Chronic Venous Insufficiency rated
      between CEAP 2 and 4, in comparison to a Placebo group.
    


Intervention name(s): Venocur Triplex®; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages.; Administered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages.
Other intervention name(s): ABT-401; venopyronum; Venocur Triplex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic Venous Insufficiency, Venocur Triplex®
Pilot Study: Intraoperative Clonidine and Postoperative Behaviour
Condition: Negative Behaviour Change
Study type: Interventional
Phase: Phase 3

Summary: 
      Children who are upset during induction of general anaesthesia are frequently distressed
      postoperatively and are more likely to demonstrate negative behaviour changes.

      This pilot study is a randomised controlled study of clonidine vs placebo during anaesthesia
      to identify whether postoperative behavioural disturbance may be minimised.
    


Intervention name(s): Clonidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Comparison between placebo and 2 different concentrations of clonidine
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Prophylactic Treatment: Lessdrops™ vs Standard Drops Regimen
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the use of a compounded eye drop containing an antibiotic, a non-steroidal and
      steroidal anti-inflammatory to standard of care that is the use of 3 different topical
      medications to prevent inflammation and infection after routine cataract surgery.
    

Detailed description: 
      Cataract surgery is one of the most commonly performed surgeries in the world today. To
      improve the overall procedure outcome, prophylactic topical antibiotics and
      anti-inflammatories (steroidal and non-steroidal, NSAID) are frequently used to decrease the
      risk of postoperative infection (e.g., endophthalmitis) and intraocular inflammation (e.g.,
      macular edema, CME).

      Even though, the large body of literature that supports the significance of prophylactic eye
      drops prior to surgery, patient compliance is a common problem. Different factors have been
      associated with patient's lack of compliance. It could be due to patient's inability to self-
      administer the drops, lack of understanding of the importance of using the prophylactic
      treatment as well as understanding the instructions of how to administer the drops and its
      storage, or just forgetfulness or the fact that they don't like to put the drops multiple
      times a day for 2-4 weeks, therefore they just avoid doing it. About 64% of patients adhere
      to the prescribed treatment.

      There is a new alternative that combines the most commonly used antibiotic and
      anti-inflammatories into a single drop. The use of a single drop compounded ophthalmic
      solution may offer advantages such as increased compliance, patient comfort and reduced
      ocular toxicity. T

      The purpose of this study is to compare the Pred-Gati-Brom formulation to the standard
      topical drops regimen that includes the topical use of Gatifloxacin, Bromfenac and
      Prednisolone acetate 1%.
    

Intervention name(s): Pred-Gati-Brom; Prednisolone acetate 1% ophthalmic suspension; Gatifloxacin Ophthalmic; Bromfenac 0.075% Oph Solution
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%; Steroidal anti-inflammatory; Antibiotic; Non-steroidal anti-inflammatory
Other intervention name(s): LessDrops
Intervention MeSH terms: Gatifloxacin; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Bromfenac; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants' eyes are assigned to one of two groups.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cataract surgery; Prophylaxis
A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to
      evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and
      Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.
    

Detailed description: 
      This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to
      evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF), and
      Glycopyrronium/Formoterol Fumarate (GFF), on specific image based airway volumes and
      resistance in subjects with moderate to severe Chronic Obstructive Pulmonary Disease. In this
      study, airway dimension parameters will be calculated for each of the active compounds.

      This imaging methodology will allow an assessment of the extent of airway changes using a
      triple combination of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and the dual
      combination Glycopyrronium/Formoterol Fumarate (GFF).
    

Intervention name(s): BGF; GFF
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Treatment with Budesonide/Glycopyrronium/FormoterolFumarate; Treatment with Glycopyrronium/Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: COPD
Study to Investigate the Pharmacokinetics, Safety and Tolerability of Odalasvir and AL-335 in Healthy Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the pharmacokinetics (PK), safety and
      tolerability following single oral administration of ascending doses of odalasvir (ODV) in
      healthy Japanese participants (Panel 1) and to investigate the PK, safety and tolerability
      following single oral administration of ascending doses of AL-335 in healthy Japanese
      participants (Panel 2; Sequential Design).
    


Intervention name(s): Odalasvir (ODV); AL-335; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.; AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.; Matching placebo will be administered.
Intervention MeSH terms: Odalasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment