bioihbjkbjnl/mcl2 huggingface dataset:
Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)
Condition: Determination of Beneficial Effect of Using Enamel Matrix Derivative During Implant Treatment
MeSH terms: Peri-Implantitis
Study type: Observational [Patient Registry]

Summary: 
      The existing records of a private practice limited to the practice of periodontology were
      reviewed to locate patients who had been diagnosed with peri-implantitis (failing dental
      implant) and had been surgically treated utilizing enamel matrix derivative (Commercially
      available FDA product Emdogain sold by Straumann USA). Various clinical factors were gathered
      from the existing records. Some of the factors recorded were: retention of the implant,
      presence of bleeding, presence of further damage, and presence of inflammation. All patients
      had signed an informed consent for treatment and the anonymous use of their data for research
      purposes. All HIPA requirements were followed.
    

Detailed description: 
      See brief summary.
    

Intervention name(s): peri-implantitis surgery with enamel matrix derivative
Intervention type(s): Procedure
Intervention description(s): surgical procedures around dental implants with peri-implantits to remove infectious material and apply enamel matrix derivative to the implant.
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Routine adult patients in a private periodontal practice.
      
Keywords: dental implant; peri-implantitis; enamel matrix derivative
A Study to Evaluate the Bioavailability, Safety and Tolerability of a Solid Dosage Formulation Relative to a Suspension of JNJ-54175446 in Healthy Male and Female Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to investigate the plasma pharmacokinetics and
      bioavailability (BA) of a single dose of a solid dose formulation with 2 different strengths
      of JNJ-54175446 (50 milligram [mg] and 100 mg capsules) relative to the suspension of
      JNJ-54175446 under fasting conditions.
    


Intervention name(s): JNJ-54175446 (capsule); JNJ-54175446 (suspension)
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-54175446 capsule at a dose of 50 mg or 100 mg, orally.; Participants will receive JNJ-54175446 suspension at a dose of 50 mg or 100 mg, orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Acoustic Structures Crying of Infants From 1 to 4 Months and Their Signification
Condition: Infants
Study type: Observational

Summary: 
      Crying is a survival mechanism for babies and their almost exclusive means of expression
      until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger,
      discomfort or separation following the departure of a parent around. Crying is a complex but
      essential means of communication and information between a baby and his parents that raises
      the question of their meaning.

      The cry phenomenon consists of complex acoustic signals produced by the vocal cords and
      filtered by the vocal tract. The vibrations frequency determines the fundamental frequency,
      itself responsible for the perception of the cry tone (pitch). The frequency spectrum of a
      cry is modified during the passage through the upper airways forming broad bands called
      "resonance frequency" or "formants".

      From the specificity of a crying sequence, it is possible to extract dynamic information and
      relate it to the perception that the adult has of it. Thus dynamic crying is often perceived
      by the adult as an imminent need of the baby.

      Some studies have shown that a child's crying may change according to his degree of
      discomfort, suggesting that crying was a "graduated signal" whose frequency and timbre could
      vary along a continuum. These changes would explain why adult listeners would be able to
      dissociate crying babies of different intensities.

      Conversely, an inappropriate response to crying could gradually generate disorders of the
      relationship between the baby and the parent.

      However, despite their potential neuro-ethological interest, knowledge of information
      transmitted by babies's cry remains superficial. This could be related to the relatively
      obsolete techniques of recording or due to the lack of objective physiological data on babies
      'cry. Finally, the perception and reactions of adults when they hear crying babies are not
      fully understood.
    

Detailed description: 
      The objective of this study is to evaluate acoustic structures crying of infants from 1 to 4
      months for to study individual acoustic signature.
    

Intervention name(s): Song Meter (SM)4
Intervention type(s): Device
Intervention description(s): Their cries will be longitudinally registered using an automatic record device: Song Meter (SM)4 during 3 consecutive days and nights. This record will take place at 15 days of life, 1 and half months, 2 and half months and 3 and half months.
Other intervention name(s): automatic record device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants at the birth
      
Keywords: Infants; Principal Component 1 (PC1); Principal Component 2 (PC2); Song Meter 4; Acoustic structures crying; PRAAT software
Platelet Function in Resuscitated Patients
Condition: Acute ST Segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Approx. 65% of resuscitated patients at the intensive care unit for internal medicine are due
      to myocardial infarction. Almost all patients are initially diagnosed and treated in the cath
      lab. Therapy usually consists of one or more stent implantations. After implantation of a
      coronary stent, dual platelet inhibition is necessary for 12 months. Insufficient platelet
      inhibition causes an pronounced increase in risk of stent thrombosis. Therefore, knowledge of
      the individual platelet function is valuable.

      Several factors potentially promote a delayed or reduced mode of action of platelet function
      inhibitors in resuscitated patients:

        1. oral administration is impossible and medication needs to be administered via a gastric
           line.

        2. gastric absorption is delayed after resuscitation

        3. according to current guidelines patients are treated with therapeutic hypothermia.
           Including the time of rewarming cooling period is ~48h
    

Detailed description: 
      Patients after successful resuscitation associated to a myocardial infarction will be
      included into the study the morning after the index event. Patients get dual platelet
      inhibition at the discretion of the interventionist. Patients are treated with therapeutic
      hypothermia according to the local Standard operating procedure for 24h and rewarming is
      performed within an additional 20h. Platelet function is measured every morning and Aspirin
      mediated as well as P2Y12 (purinergic G protein-coupled receptors-12)-inhibition mediated
      platelet function inhibition is recorded. All relevant clinical data including APACHE (Acute
      Physiology and Chronic Health Evaluation) and SOFA ( Sequential Organ Failure Assessment
      score) scores are collected.

      The degree of platelet inhibition over time (7 days) and differences between the three drugs
      tested will be evaluated by optical aggregometry and by using the commercial VerifyNow test
      system.
    

Intervention name(s): diagnostic analysis of platelet function
Intervention type(s): Other
Intervention description(s): analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients surviving the first night after resuscitation due to myocardial infarction
Effects of Androgen Administration on Inflammation in Normal Women
Condition: Hyperandrogenism
MeSH terms: Hyperandrogenism; Inflammation
Study type: Interventional

Summary: 
      The hypothesis of this study is that DHEA administration to increase male hormone in healthy
      normal-weight young women to levels present in women with Polycystic Ovary Syndrome will
      cause an inflammatory response in white blood cells in the fasting state, and in response to
      glucose ingestion.
    


Intervention name(s): Dehydroepiandrosterone (DHEA); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): DHEA 130 mg administered orally for 5 days.; Placebo contained in a capsule that is identical in appearance to the one used to package DHEA for 5 days.
Intervention MeSH terms: Dehydroepiandrosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Hyperandrogenism; Inflammation; Insulin sensitivity; Body composition
Comparison of Popular Weight Loss Diets
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the safety and effectiveness of three popular weight loss plans.
      These plans will be compared with the USDA Dietary Guidelines.
    

Detailed description: 
      Obesity is the single most significant, nutrition-related health issue of the new millennium.
      Several "medical experts" have designed and promoted weight loss diets that dramatically
      differ from one another and from the USDA Dietary Guidelines. These diets have gained
      surprisingly widespread and persistent popularity among Americans despite the lack of
      evidence supporting their claims. This clinical trial will provide preliminary feasibility
      data for a full-scale study that will examine health outcomes (e.g., benefits, risks,
      success) of three popular weight loss diets. The study will investigate behavioral and
      physiological factors that influence adherence and retention to these diet plans.

      Overweight women will be randomly assigned to one of four diets for 1 year: Atkins (extremely
      low carbohydrate), Zone (low carbohydrate, high protein), Ornish (very low fat), or USDA/Food
      Pyramid (high carbohydrate/moderate-low fat). Behavioral and physiological data will be
      collected. Participants attend study visits at baseline, 8 weeks, 6 months, and 1 year. At
      these visits, measurements will include that will include weight and blood pressure
      measurements and blood tests. Participants will be asked to complete ten questionnaires over
      the course of the study to assess behavior and appetite. Participants will also undergo a
      DEXA scan to assess body composition.
    

Intervention name(s): Atkins diet (extremely low carbohydrate); Zone diet (low carbohydrate, high protein); Ornish diet (very low fat)
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Weight Loss; Obesity; Overweight; Premenopausal women; Diet
The Effect of Fruit and Fruit Juice on Plasma Total Antioxidant Capacity
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the study is to compare the effect of consumption of a fruit beverage on plasma
      antioxidant capacity with that of the consumption of fruit.
    


Intervention name(s): Order 1; Order 2; Order 3; Order 4; Order 5; Order 6
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out.; Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out.; Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out.; Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out.; Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out.; Supplement is fruit, fruit salad and fruit drink in different order. Fruit (two apples) Fruit salad, 400g (consist of apple, banana, orange, mandarin, pear, strawberry, grape, kiwi and melon) in amount relative to the popularity of the fruits consumed in the Netherlands.
Fruit drink (fruit2day, strawberry/orange, 200ml) Each supplement is taken once, with one week wash out.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: fruit; antioxidant; Healthy subjects
Hypothermia for Cardiac Arrest in Paediatrics
Condition: Cardiac Arrest
MeSH terms: Heart Arrest; Hypothermia
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesized that, following cardiac arrest in pediatric patients,
      hypothermia therapy will improve the proportion of patients with a good functional outcome
      compared to a normothermic control group.
    

Detailed description: 
      Cardiac arrest is associated with a high morbidity and mortality in children and hypothermia
      therapy has the potential to be beneficial in children following cardiac arrest. We have a
      track record of both clinical and laboratory research of hypothermia therapy following
      cardiac arrest at the Hospital for Sick Children and have completed a 3-site randomized
      controlled pilot study of hypothermia therapy following cardiac arrest in children funded by
      The Hospital for Sick Children Research Institute and the Heart and Stroke Foundation of
      Ontario. This protocol was used to develop the protocol for the THAPCA trials (see 2
      manuscripts published Moler et al NEJM 2015 and 2017 and multiple other manuscripts).
      Hypothermia therapy, compared to active maintenance of normothermia, had no beneficial effect
      on functional outcome or mortality in children with out-of-hospital or in-hospital cardiac
      arrest.
    

Intervention name(s): Normothermia; Hypothermia
Intervention type(s): Other; Other
Intervention description(s): Patients randomized to the Normothermia arm (esophageal temp 36.5-37.5 ºC) were maintained at an esophageal temperature of 36.5-37.5ºC for 48 hours. Patients who were hypothermic (temperature < 35 ºC) when randomized to the normothermia group were rewarmed slowly using the servo-controlled mattress. Patients who were hyperthermic following randomization to the normothermia group were actively cooled to normothermia using the servo-controlled mattress. Neuromuscular blockers were administered as needed intravenously in both groups of patients to prevent shivering.; Patients randomized to the Hypothermia arm (esophageal temp 33º to 34 °C) were cooled rapidly using the cooling protocol developed for the Hypothermia Paediatric Head Injury Trial. A temperature probe was placed in the esophagus and its position confirmed using a chest radiograph. Patients were placed on a servo-controlled cooling blanket and covered in crushed ice (in sealed plastic bags covered by pillow cases) and a second cooling blanket. Once the esophageal temperature reached 34.0ºC, the ice and second cooling blanket was removed and esophageal temperature was maintained at 33º to 34 °C for 48 hours using the servo-controlled cooling mattress. Patients treated with ECMO were cooled using the extracorporeal circuit cooling-device. Rewarming was done at a rate of 0.5 ºC every 2 hours until an esophageal temperature of 36.5 ºC was reached. Thereafter temperature was recorded but not controlled by surface cooling.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Paediatrics
DaxibotulinumtoxinA for Injection for the Treatment of Plantar Fasciitis
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel group, multi-center trial of
      a single administration of DaxibotulinumtoxinA (DAXI) (high-dose; low-dose) for injection
      versus placebo for the management of Plantar Fasciitis.
    

Detailed description: 
      Approximately 150 subjects, recruited from approximately 20 study centers in the United
      States (US) will be randomized to DAXI (HIGH-dose; LOW-dose) or placebo group, respectively.
    

Intervention name(s): DAXI 80 U; DAXI 120 U; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) with 80 U (Low Dose Group); DaxibotulinumtoxinA for injection for the treatment of unilateral plantar fasciitis (PF) 120 U (High Dose Group); Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to 1 of 3 treatment groups: DAXI for injection LOW dose, DAXI for injection HIGH dose, Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: DAXI for injection,; Plantar Fasciitis,; Heel Pain,; BotulinumtoxinA
Determination of the UL of Leucine in Healthy Elderly Men
Condition: Elderly Men
Study type: Interventional

Summary: 
      Amino acid are the building blocks of the body's protein. Some amino acids, including
      leucine, cannot be made in the body and must be obtained from diet, these are called
      essential. With increase in age the body's muscle mass decrease and studies have suggested
      that dietary supplementation of leucine may have potential health benefits in elderly in
      regards to prevention of age related loss of lean muscle mass, and thus may help improve the
      quality of life in elderly.

      Currently, a safe upper dietary intake level of leucine has not been established for healthy
      elderly. Prior to exploring whether leucine supplementation will prevent or decrease loss of
      lean muscle mass in elderly we propose to identify the upper intake of leucine in healthy
      elderly.

      The purpose of this study is to determine the tolerable upper intake level (UL) of leucine in
      healthy elderly men (70 - 75 yrs)

      The investigators hypothesize that with a careful graded stepwise increase in leucine intake
      in elderly men, above the Estimated Average Requirement (EAR - 50 mg/kg/d), the body's
      ability to oxidize/dispose of excess amino acids will reach a maximum. With increased leucine
      intakes we hypothesize an increase in plasma ammonia concentrations and increases in plasma
      leucine and urinary leucine excretion.
    


Intervention name(s): Leucine intake
Intervention type(s): Dietary Supplement
Intervention description(s): Oral consumption of eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Leucine; Upper Intake Level (UL); Elderly; Amino acids; Protein
Association Between Mitochondrial DNA Content and Risk of Gastric Cancer
Condition: Stomach Neoplasms
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      Compelling epidemiological evidence indicates that alterations of mitochondrial DNA,
      including mutations and abnormal content of mitochondrial DNA (mtDNA), are associated with
      the initiation and development of gastric cancer.The aim of this study was to explore
      association between mtDNA content in peripheral blood cells could be used as a risk predictor
      for gastric cancer.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A total of 300 eligible gastric cancer patients were anticipated to include in this study.
        Moreover, 300 healthy controls without previous cancer history were also recruited from
        individuals who visited investigator's hospital for physical examination during the same
        time period.
      
Biospecimen description: 
      Mitochondria are responsible for multiple cellular functions including regulation of energy
      production, modulation of oxidation-reduction status, generation of reactive oxygen species
      and apoptosis. Each mitochondrion possesses multiple copies of a mitochondrial genome
      comprised of independently replicating double stranded DNA (mtDNA).
    
Keywords: Mitochondrial DNA copy number; Gastric cancer
King Vision Video Laryngoscope Ambu (aBlade) System for Use in Children
Condition: Pediatric Anesthesia; King Vision Video Laryngoscope Intubation
Study type: Interventional

Summary: 
      This is a single center trial to evaluate the performance of the King Vision video
      laryngoscope in pediatric patients between the ages of one month and 10 years of age. If the
      performance is satisfactory, this device may become a standard laryngoscope for tracheal
      intubation in elective and emergent tracheal intubations.
    


Intervention name(s): King Vision video Laryngoscope
Intervention type(s): Device
Intervention description(s): The King Vision video laryngoscope (Ambu) will be used for tracheal intubation.
Other intervention name(s): Ambu
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other