bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Fatty Acid Composition on Energy Intake and Satiety
Condition: Obesity
Study type: Interventional

Summary: 
      The objective of the study is to investigate the effect of fatty acid composition of a fat
      supplement:

        1. acutely (after single intake) on subjective and objective measurements of hunger,
           satiety and wellness, on energy intake, and postprandial hormonal changes;

        2. in the long-term (after one week) on (regulators of) fat tissue metabolism.
    

Detailed description: 
      One of the physiological factors regulating the food intake pattern is satiety. Satiety is
      defined as the absence of ingestive motivation, which ends when the next meal is initiated
      (Blundell et al., 1996). Food intake affects a number of physiological objective parameters
      in blood known to be involved in signaling satiety, such as glucose (Melanson et al, 1999;
      Chapman et al, 1999; Campfield et al, 1996), insulin (Speechly et al, 2000) and
      cholecystokinin (CCK) (Gutzwiller et al., 2000; Beglinger et al., 2001; French et al., 2000;
      Degen et al., 2001; Burton-Freemanet al., 2002, 2004). More recently, the gastric hormone
      ghrelin was identified as a marker for hunger and meal initiation (De Graaf et al, 2004).
      Ghrelin concentrations in blood were highly correlated with subjective measures of appetite.
      PYY, a gut hormone produced postprandially, will be measured in this study because it has
      been mentioned that this hormone inhibits food intake (Batterham et al., 2003). The baseline
      level of PYY is lower in obese subjects than in lean subjects. The two groups different in
      body weight will therefore show different baseline levels, and perhaps different curves as
      well.

      Humans do not only eat in response to a metabolic or physiological need. Humans also respond
      to a significant extend to other internal subjective and emotional signals (cues). The exact
      relations between the physiological internal signals and subjective and emotional internal
      signals are not known. Besides also external and social factors modulate
      physiological-derived hunger and satiety signals.

      In the present clinical trial, the effect of fatty acid composition of a fat supplement will
      be studied on hunger and satiety. In the supplement a mixture of fatty acids known for their
      satiating effect will be tested and will be compared with a control supplement containing
      fatty acids normally consumed with breakfast.
    

Intervention name(s): Fatty acid composition of a margarine (spread)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Satiety, ad libitum food intake, fatty acids, hormones
Therapeutic Hypothermia for Severe Traumatic Brain Injury in Japan
Condition: Brain Injuries, Traumatic
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Hypothermia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to determine if mild hypothermia therapy, for severe head trauma
      patients, improves neurological outcome.
    

Detailed description: 
      Mild hypothermia therapy shows protective effects for damaged brains of animals and post
      cardiac arrest patients. However, Clifton et al. reported that mild hypothermia has no
      protective effect for severe head trauma but has a risk of complications. In this study, all
      the participants must be treated with continuous monitoring of cardiac output and jugular
      venous oxygen saturation to get optimal physiological conditions. Adequate anesthesia such as
      neuroleptanesthesia is essential to maintain organ function and tissue microcirculation.
      Participants are randomly assigned to two groups of mild hypothermia (32.0 - 34.0 degree
      Celsius) and anti-hyperthermia (35.5 - 37.0 C). The body temperature must be kept for at
      least 72 hours. Hypothermia must be induced within 6 hours after traumatic brain injury.
      Glasgow outcome score at 6 months after injury and the total medical expenses of the two
      groups will be evaluated.
    

Intervention name(s): Therapeutic mild hypothermia
Intervention type(s): Procedure
Intervention description(s): Keeping 32 - 34 degree celsius of core temperature at least for 72 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypothermia, induced; Traumatic Brain injuries; Anesthesia; Neuro-intensive care; neurochemistry
Problem Specific Templates for Electronic Hospital Documentation
Condition: Quality/Accuracy of Physician Documentation; Efficiency of Physician Documentation
Study type: Observational

Summary: 
      The emergence of electronic documentation has led to multiple new challenges for physicians.
      Despite positive expectations, many physicians have received electronic health systems with
      mixed results. Review of current literature has identified the following reasons for concern:
      increased time required for documentation, deteriorating quality of notes, mindless use of
      copy-and-paste functions, and fragmentation of clinical work from poorly designed computing
      workflows. The study of template use has not been done in a large scale or with clear outcome
      measurements. The purpose of this study is to examine the effects of Problem Specific
      Templates on quality, accuracy, and efficiency of physician documentation practices.
    

Detailed description: 
      This is a prospective cohort study, which will examine the effects of Problem Specific
      Templates on quality, accuracy, and efficiency of physician documentation practices. The
      Hospitalist physicians will be the subjects. All physicians of the Hospital Medicine Service
      will be invited to participate. For the intervention, participating Hospitalists will be
      trained on the use of templates for 20 common hospital problems. Once trained, the
      Hospitalists will be asked to use these templates for a one-month period. Pre-intervention
      and post-intervention medical records will be compared using chart reviews, validated
      document assessment instruments, physician surveys, and electronic medical record time
      auditing.
    

Intervention name(s): Hospitalists
Intervention type(s): Other
Intervention description(s): Introduction of Problem Specific Templates
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Physicians of the Hospital Medicine Service
      
Keywords: Problem Specific Template; Physician Documentation; Electronic Medical Record Documentation
Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouch 1.0 Compared to Velo® Ice Cool and Zyn® Cool Mint Mini Dry in Healthy Smokers
Condition: Smoking; Nicotine
Study type: Interventional

Summary: 
      This is a single-center, randomized, controlled, open-label, cross-over study in healthy
      smoking subjects to investigate the nicotine pharmacokinetic (PK) profiles of 4 variants of
      Nicotine pouch 1.0 compared to marketed Velo - Nicotine Pouch (NP) and Zyn-NP. In addition,
      pharmacodynamic (PD) effects will be evaluated to provide further insights on Nicotine pouch
      1.0 product acceptance and abuse liability. The study will be conducted with 3 periods and 6
      sequences in a Williams design (cross-over).
    

Detailed description: 
      The purpose of the study is to evaluate the nicotine PK profiles of 4 variants of NP 1.0
      versus Velo-NP and Zyn-NP following a 30-minute use period. In addition, PD, including
      subjective effects and related behavioral assessments will be evaluated, to provide further
      insights on NP 1.0 product acceptance and abuse liability. Safety will be assessed throughout
      the study.

      The aim is to evaluate if NP 1.0 can provide an acceptable alternative to smoking cigarettes
      in terms of both, nicotine delivery and sensorial satisfaction for smokers who would
      otherwise continue smoking cigarettes.
    

Intervention name(s): NP-1; NP-2; NP-3; NP-4; Velo-NP; Zyn-NP
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): NP-1; 8.4 mg nicotine; pH 8.0; moisture 30; NP-2; 8.4 mg nicotine; pH 9.0; moisture 30; NP-3; 3.6 mg nicotine; pH 8.0; moisture 15; NP-4; 3.6 mg nicotine; pH 8.0; moisture 30; Velo-NP; 10 mg nicotine;; Zyn-NP; 3 mg nicotine;
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Nicotine-containing products; Nicotine delivery
Immunogenicity and Safety of Enterovirus Type 71 Vaccine,Inactivated(Vero Cells) in Volunteers Aged From 6 to 71 Months
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus
      Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months.
    

Detailed description: 
      The goal of this clinical trial is to evaluate the immunogenicity and safety of Enterovirus
      Type 71 Vaccine,Inactivated(Vero Cells) in healthy volunteers aged from 6 to 71 months.

      Qualified subjects were screened and randomly divided into low-dose group, high-dose group,
      and control group according to the ratio of 2:2:1. The experimental group was vaccinated with
      the experimental vaccine (low-dose or high-dose enterovirus 71 inactivated vaccine from
      Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd.), and the control group was vaccinated with
      the control vaccine (enterovirus 71 inactivated vaccine produced by the Institute of Medical
      Biology of the Chinese Academy of Medical Sciences). All participants received two doses of
      the vaccine 28 days apart.
    

Intervention name(s): Enterovirus Type 71 Vaccine
Intervention type(s): Biological
Intervention description(s): Participants received two doses of the vaccine, 28 days apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Enterovirus Type 71 Vaccine
Periodontal Status in Fermented Food and Food Consumption
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      Lack of certain nutrients and foods may negatively affect oral health. Therefore, nutrition
      plays an important role in maintaining oral health. This study aimed to evaluate and compare
      the nutrient intakes, consumption of food groups and some fermented foods of individuals with
      periodontal disease and health.

      Ninety-three patients who applied to Periodontology Clinic were divided into three groups:
      periodontal health, gingivitis and periodontitis. In addition, plaque, gingival indices,
      bleeding on probing, periodontal pocket depth, and clinical attachment level were evaluated.
      To determine individuals' daily energy and nutrient intakes and the consumption amounts of
      food groups, food consumption records were kept by the nutritionist for three consecutive
      days, with one of them was weekend, using the 24-hour recall method. Data on individuals'
      frequency and amount of consumption of some fermented products were recorded, considering the
      foods available in our culture and the market.
    


Intervention name(s): food consumption in periodontal health and disease
Intervention type(s): Other
Intervention description(s): To determine individuals' daily energy and nutrient intakes and the consumption amounts of food groups, food consumption records were kept by the nutritionist for three consecutive days, with one of them was weekend, using the 24-hour recall method. Data on individuals' frequency and amount of consumption of some fermented products were recorded, considering the foods available in our culture and the market.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel controlled trial
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: fermented foods; periodontal health; periodontal disease
Bioequivalence of Cefprozil Granule in Healthy Chinese Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, randomized, single-dose, two-period, two-group, crossover study was conducted
      in 60 healthy Chinese volunteers under fasted or fed conditions (30 volunteers for each
      condition) to assess the bioequivalence between two formulations of cefprozil.
    

Detailed description: 
      Cefprozil, an oral second-generation semi-synthetic cephalosporin, possesses a broad spectrum
      of antimicrobial activity. A granule formulation has been developed to improve medication
      adherence of the patients. This study was conducted to assess the bioequivalence of the
      granule formulation to dry suspension in healthy Chinese volunteers and estimate the
      pharmacokinetics profiles of cefprozil. An open-label, randomized, single-dose, two-period,
      two-group, crossover study was conducted in 60 healthy Chinese volunteers under fasted or fed
      conditions (30 volunteers for each condition) to assess the bioequivalence between two
      formulations of cefprozil. Blood samples were collected at specified time intervals, and the
      plasma concentrations of cis- and trans-cefprozil were determined by a validated liquid
      chromatography- mass spectrum/ mass spectrum method. Pharmacokinetic and bioavailability
      parameters were estimated via non-compartmental methods. Adverse events were also recorded.
      If the 90% confidence intervals of the ratios of geometrical mean of test and reference
      formulations for Cmax, AUC0-t and AUC0-infer are all within the predefined bioequivalence
      criteria range of 80%-125% for cis-, trans-and total cefprozil, the two formulations can be
      considered bioequivalent.
    

Intervention name(s): Cefprozil 125mg/5ml Susp; Cefprozil granule (125mg)
Intervention type(s): Drug
Intervention description(s): Subjects were allocated to one of two groups randomly and equally with a 3-day washout interval between the two periods."Cefprozil for Suspension®" (125mg/5mL, 50mL/bottle, batch no. F701087, manufactured by Lupin Pharmaceuticals, Inc.) and cefprozil granule (125mg, batch no. 8G001F07, manufactured by Qilu Pharmaceutical Co., Ltd) were used in this study.
Intervention MeSH terms: Cefprozil
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: An open-label, randomized, single-dose, two-period, two-group, crossover study.
Masking: None (Open Label)
Primary purpose: Treatment
Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

Summary: 
      This pilot clinical study, which focuses on feasibility and proof-of-principle, will be
      conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device
      three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI
      episodes and OAB quality of life.
    


Intervention name(s): TENS
Intervention type(s): Device
Intervention description(s): Transcutaneous electrical nerve stimulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TENS
Sufentanil as Adjuvant of Balanced Anesthesia
Condition: Anesthesia
Study type: Interventional

Summary: 
      The aim of the study was to compare the efficacy and safety between sufentanil and
      remifentanil as an adjuvant of balanced general anesthesia.
    

Detailed description: 
      The investigators hypothesized that sufentanil would reduce postoperative pain than
      remifentanil without prolonging recovery times in minor laparoscopic surgery when
      administered equivalent antinociceptive doses during surgery. Intraoperative opioid
      administration for equivalent nociception-antinociception balance could be achieved via
      surgical pleth index (SPI)-guided analgesia. This study was designed to compare the efficacy
      and safety between sufentanil and remifentanil as an adjuvant of balanced anesthesia in
      patients undergoing laparoscopic cholecystectomy under SPI-guided opioid administration.
    

Intervention name(s): Sufentanil; Remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): The infusion rate of sufentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.; The infusion rate of remifentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.
Other intervention name(s): Group S; Group R
Intervention MeSH terms: Sufentanil; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Effects of HIV and Hepatitis C Virus on the Brain
Condition: HIV Infections; Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      This study will determine the effects that HIV and hepatitis C virus have on thinking
      abilities and whether the viruses affect brain chemistry.
    

Detailed description: 
      Hepatitis C is a liver disease that is caused by the hepatitis C virus (HCV). It can be
      successfully treated with 6 to 12 months of medication in both HIV infected and HIV
      uninfected people. Among HIV infected people, HCV infection is a common co-morbidity, and is
      more serious when it occurs in this population than others because it leads to liver damage
      more quickly. HIV is known to cause neurological deficits, and studies suggest that HCV may
      do so, as well. Knowledge about how to treat these deficits, however, is limited. More
      information about the nature of the neurological problems and their causes is needed to
      develop effective treatments. This study will determine the effects that HIV and HCV have on
      thinking abilities, such as memory, attention, and problem-solving, and whether the viruses
      affect brain chemistry.

      Participants in this 4-year, observational study will undergo a series of tests and
      interviews. Participants may choose to complete all procedures over 2 days or three
      appointments. Procedures will include a 20-minute medical interview, a 4-hour
      neuropsychological evaluation, a 5-minute functional ability questionnaire, blood and urine
      collection (approximately 15 minutes), and a 1-hour magnetic resonance imaging (MRI) test of
      the head. The neuropsychological evaluation will test participants' memory, concentration,
      reasoning, and speed of thinking. All procedures will be completed over approximately 6
      hours.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HIV / HCV Coinfected, HIV moninfected, & HCV monoinfected
      
Keywords: HIV; HCV; Treatment Naive; Treatment Experienced; HIV and HCV Coinfection
Safety and Efficacy of Bimatoprost Solution in Treating Eyelash Loss or Hypotrichosis in Children
Condition: Eyelash Hypotrichosis; Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata; Hypotrichosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the safety and efficacy of bimatoprost solution 0.03% once daily
      application to the upper eyelid margins compared with vehicle in treating eyelash loss or
      hypotrichosis (inadequate or not enough eyelashes) in children.
    


Intervention name(s): bimatoprost ophthalmic solution 0.03%; Vehicle Sterile Solution
Intervention type(s): Drug; Drug
Intervention description(s): One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.; One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
Other intervention name(s): LATISSE®
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Comprehensive Assessment in Children After Surgical Treatment of Patellar Recurrent Dislocation.
Condition: Recurrent Patellar Dislocation; Patellar Instability
MeSH terms: Joint Dislocations; Patellar Dislocation; Recurrence
Study type: Observational

Summary: 
      The aim of this prospective study is to assess extension apparatus function of the knee based
      on clinical, radiological, isokinetic and gait analysis data in patients after surgical
      treatment. There will be used physical examination, Lysholm-Tegner and Kujala scale for
      clinical assessment. Merchant and lateral X-ray pictures will be analysed for patellar
      position verification along with isokinetic and gait evaluation to produce conclusions
      referring to efficacy of the treatment. All subjects included in the study were treated with
      mpfl reconstruction. Follow-up longer than 2 years in all cases, about 45 patients included.
    

Detailed description: 
      Recurrent patellar dislocation occurs mostly in adolescents. Recently medial patellofemoral
      ligament reconstruction has become treatment of choice in most cases. There is still
      insufficient literature to assess the operative treatment results according to functional
      testing.

      The aim of this prospective study is to assess extension apparatus function of the knee based
      on clinical, radiological, isokinetic and gait analysis data in patients after surgical
      treatment. There will be used physical examination, Lysholm-Tegner and Kujala scale for
      clinical assessment. Merchant and lateral X-ray pictures will be analysed for patellar
      position verification along with isokinetic and gait evaluation to produce conclusions
      referring to efficacy of the treatment. All subjects included in the study were treated with
      mpfl reconstruction with gracilis tendon harvesting. Follow-up provided is longer than 2
      years in all 45 cases planned to enroll. All subject are to be mailed and invited to check-up
      visit including analysis of parameters mentioned above. Soon after data collection text of
      the publication will be made. The results will be discussed with recent literature and
      conclusions will be made.
    

Intervention name(s): mpfl reconstruction
Intervention type(s): Procedure
Intervention description(s): Harvested gracilis tendon is pulled through patella and femur in anatomic position and locked with interference screw.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        45 patients under 18 yo, 30 females, 15 males, average age of 15 yo
      
Keywords: Patellar instability; Recurrent patellar dislocation; Isokinetics; Children; MPFL reconstruction