bioihbjkbjnl/mcl2 huggingface dataset:
Psychometric Proprieties and Validation of Self-report Measures of Eating Behaviors
Condition: Obesity; Eating Disorders
MeSH terms: Obesity; Feeding and Eating Disorders
Study type: Observational [Patient Registry]

Summary: 
      Obesity is a global epidemic and a major contributor to some of the leading causes of death.

      Although research on overweight and obesity is constantly increasing, to date, in the Italian
      panorama, there is a lack of (A) rigorous psychological measurement tools of obesity-related
      constructs and (B) analysis of the relationships between constructs (and indicators) involved
      in the development and maintenance of overweight and obesity.

      The present study aims to examine the psychometric properties of the main questionnaires for
      the assessment of eating behaviors in 3 groups of subjects (1) the general population
      (control group); (2) subjects with obesity without a comorbid diagnosis of an eating
      disorder; (3) subjects with obesity and a comorbid diagnosis of an eating disorder.
    

Detailed description: 
      Participants were selected in the main rehabilitation centers for the treatment of obesity
      and eating disorders (sample of subjects with obesity) and through an online survey
      (community sample). The survey lasted about 30 minutes and - together with selected
      demographic and biomedical information - required the completion of the following self-report
      measures: the Binge Eating Scale (BES); the Modified Yale Food Addiction Scale version 2
      (mYFAS 2.0); the Repetitive eating questionnaire (Rep-EAT); the Measure of Eating
      Compulsivity (MEC); the Addiction-like Eating Behavioural Scale (AEBS); the Three Factor
      Eating Questionnaire 18 (TFEQ-18); the Eating Disorders Examination Questionnaire-Short Form
      (EDEQ-SF); the Palatable Eating Motive Scale (PEMS); the Weight Sigma Questionnaire (WSSQ);
      the Emotional Eating Scale (EES); the Somatic Symptom Scale 8 (SSS8).

      Before administration, all questionnaires were first translated from English (their original
      language) to Italian by two bilingual translators, independently - then back-translated into
      English by another independent translator whose mother tongue was English to ensure
      equivalence between the translations. Following, a purposive sample of respondents was asked
      to fill in the final version of each measure in order to assess its items' comprehensibility.

      In order to avoid halo effects, the questionnaires were presented to the subject in random
      order.

      The responders could withdraw the administration at any time, and contact a psychologist
      independent from the study in case of perceived emotional distress.
    

Intervention name(s): Questionnaire administration
Intervention type(s): Other
Intervention description(s): Questionnaire administration
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Subjects with obesity with/without an eating disorder AND the general population (non
        clinical)
STimulation to Improve Auditory haLLucinations
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Hallucinations; Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      Investigating the effects of non-invasive transcranial current stimulation as a treatment for
      auditory hallucinations in patients with schizophrenia.
    

Detailed description: 
      The investigator's primary objective is to conduct a pilot clinical trial to establish the
      feasibility and to collect first effectiveness data for the use of transcranial alternating
      current stimulation (tACS) to re-normalize pathological alpha oscillations in dorso-lateral
      prefrontal cortex (dl-PFC) of patients with schizophrenia or schizoaffective disorder by
      comparing Auditory Hallucination Rating Scale (AHRS) scores immediately before the first
      stimulation session and immediately after the last stimulation session. As a secondary
      objective the investigators will assess the differential clinical effects of sham, 10 Hz and
      2 mA transcranial direct current stimulation (tDCS) on electroencephalogram (EEG) measures of
      alpha oscillations.
    

Intervention name(s): tACS (alpha); tDCS
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tACS; tDCS; sham; auditory hallucinations; Schizophrenia; Schizoaffective Disorder
Individualized Preoperative Rehabilitation Pilot
Condition: Quality of Life; Complex Gastrointestinal Surgery
Study type: Interventional

Summary: 
      A pilot to test feasibility of improving patient/caretaker quality of life and resilience.
    

Detailed description: 
      Our overall goal is to investigate if pre-operative interventions can address patients' and
      patients' care givers quality of life/resilience deficits and thus improve outcomes. This
      initial pilot study will test the feasibility of offering patients and their care givers
      prehabilitation interventions prior to complex gastrointestinal surgery such as
      pancreatectomy, esophagectomy, proctectomy, or hepatectomy.
    

Intervention name(s): Interventions to improve preop QOL/resilience deficits
Intervention type(s): Behavioral
Intervention description(s): Identify patients' and patients' care givers quality of life/resilience deficits and supply information and resources prior to undergoing complex GI surgery.
Other intervention name(s): Candidate interventions include, but not limited to:; Participate in SMART (Stress Management And Resiliency Training) program; Caregiver participation in Caregivers study protocol (IRB 13-002943); Nutritional recommendations (deficiencies, immuno-nutrition); Low impact resistance training/tai chi; Referral to financial or counseling services; Establish information sources/plans for concerns not frequently covered in clinical practice such as sleeplessness, spiritual assistance.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Quality of life; Deficits; Complex gastrointestinal surgery
SMART Study (Sellick's Maneuver Assisted Real Time) to Deliver Target Cricoid Pressure in Simulated Environment
Condition: Pulmonary Aspiration of Gastric Contents
MeSH terms: Respiratory Aspiration of Gastric Contents
Study type: Interventional

Summary: 
      Cricoid force is applied during airway management to prevent pulmonary aspiration of
      regurgitated gastric contents. This force is usually applied by a nurse or anaesthesia
      assistant. Currently this is performed WITHOUT monitoring and the force applied is determined
      by the individual's "educated hand" that is derived from his/her experience from past
      training and practice. Studies have shown that the actual force applied by nurse and
      anaesthesia assistant is inconsistent and deviates from the optimal force. Under application
      of cricoid force results in ineffective cricoid pressure and the risk of pulmonary
      aspiration. Consequences of pulmonary aspiration include lung injury and infection, hypoxia,
      long Intensive Care Unit stay and even death. Over exertion of cricoid force results in
      distortion of the larynx (leading to difficult bag mask, difficult tracheal tube insertion
      and hypoxia). Preliminary results from previous study (IRB 2014/437/D), an observation
      crossover pilot was carried out comparing the amount of cricoid force applied by 16 nurses on
      manikin with and without direct feedback. Nurses were instructed to apply a range of force of
      30-44 Newtons on a marked site on the neck region of manikin. A flexiforce load sensor was
      used. Unblinded nurses performed significantly better with feedback using the load sensor
      then blinded nurses. With Funding from a National grant, a real-time measurement of cricoid
      force is developed to give feedback and guide the operator to exert and maintain the TARGET
      cricoid pressure during rapid sequence induction (RSI).

      In this study we aim to verify the sensor system with a manikin and compare the forces
      applied by nurses with the sensor system and without.
    

Detailed description: 
      A total of 22 nurses or anesthetists will be recruited Inclusion criteria include healthy
      subjects Exclusion criteria include (1) pregnant subjects (2) history of back pain or injury

      Cricoid pressure applied on manikin will be measured

        1. By electronic medical grade weighing scale

        2. By sensor system electronically
    

Intervention name(s): Cricoid force sensor monitor system; Sham Cricoid force sensor monitor system
Intervention type(s): Device; Device
Intervention description(s): Comprise of a sensor and a monitor system; Comprise of a sensor and a sham monitor system
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: cricoid pressure
A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study
      is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in
      healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1)
      vaccination.
    

Detailed description: 
      There will be two immunization arms. 1200 healthy subjects will be randomly assigned (1:1) to
      receive an experimental vaccine or a parallel comparator vaccine. All of them will be
      received five doses of rabies vaccine at day 0,3,7,14,28 according to the traditional Essen
      methods (1-1-1-1-1) vaccination.
    

Intervention name(s): Changchun Werersai; Jilin Maifeng
Intervention type(s): Biological; Biological
Intervention description(s): A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd.
1.0 ml experimental vaccine on day 0,3,7,14,28; A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd.
1.0 ml comparator vaccine on day 0,3,7,14,28
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Meal Glycaemic Index and Exercise After Gastric Bypass
Condition: Roux-en-Y Gastric Bypass; Obesity
Study type: Interventional

Summary: 
      The study will evaluate postprandial glucose excursions and gut hormone secretion after
      ingestion of meals with different glycaemic index (GI) values (high vs low) followed by an
      acute bout of exercise or rest in gastric bypass operated subjects and matched control
      subjects.
    


Intervention name(s): Low GI mealtest; Low GI mealtest and subsequent exercise; High GI mealtest; High GI mealtest and subsequent exercise
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Meal with low glycaemic index (GI) is consumed over 20 min; Meal with low glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min; Meal with high glycaemic index (GI) is consumed over 20 min; Meal with high glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gut hormones; Glucose excursions
The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy
Condition: Drainage; Laparoscopic Cholecystectomy; Acute Cholecystitis
MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
Study type: Interventional

Summary: 
      Investigators want to assess the safety and efficacy of using abdominal drainage with not
      using any drainage, by estimating different outcomes after laparoscopic cholecystectomy for
      different reasons. Patients are seen at the Accident and Emergency Department or in the
      surgical wards at Aleppo University Hospital (AUH) over 12 months period.
    

Detailed description: 
      The routine use of prophylactic drainage has become common in many hospitals around the world
      after cholecystectomy for different reasons. In elective surgeries, the evidence does not
      support the use of drainage. But in emergency laparoscopic cholecystectomy surgeries, using
      drainage remains controversial. Surgeons who support the use of drainage find it useful to
      identify the early complications of surgery and removing intra-abdominal collections, while
      opponents of drainage use believe that it increases the risk of wound infection. But, a
      systematic review and meta-analysis discussed the ineffectiveness of the routine use of the
      prophylactic drainage after laparoscopic cholecystectomy for acute cholecystitis and
      requested more randomized clinical trial studies on the subject. However, this study and
      others in the medical literature contain very few high-quality randomized controlled trials,
      hence our randomized controlled trial compares the use and non-use of drainage in patients
      undergoing laparoscopic cholecystectomy for different reasons.
    

Intervention name(s): Prophylactic Drain
Intervention type(s): Device
Intervention description(s): We want to put a prophylactic drain after cholecystectomy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prophylactic Drainage; Laparoscopic cholecystectomy; Acute cholecystitis.; Upper GI Surgery; Cholecystitis; Choledocholithiasis; Gallbladder Diseases
Histamine H1/H2 Receptors and Training Adaptations
Condition: Exercise Training; Physical Activity
Study type: Interventional

Summary: 
      Exercise training is beneficial for both health and performance. Histamine has been shown to
      be involved in the acute exercise response. The current study addresses the role of histamine
      H1/H2 receptor signaling in the chronic training-induced adaptations. Results from this study
      will yield more insights into the molecular mechanisms of adaptations to exercise training.
    


Intervention name(s): Lactose; Fexofenadine Hydrochloride; Famotidine; High-intensity interval training (HIIT)
Intervention type(s): Other; Drug; Drug; Other
Intervention description(s): Placebo: Lactose capsules; H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride; H2 receptor antagonist: 40 mg Famotidine; 6 weeks HIIT
Intervention MeSH terms: Fexofenadine; Famotidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo + exercise vs histamine blockade + exercise
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Exercise; Physiology
Immunogenicity and Safety of Human Papillomavirus (HPV)-16/18 Vaccine in Healthy Females
Condition: Human Papillomavirus
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate immunogenicity and safety of recombinant human papillomavirus bivalent ( types 16
      and 18 ) vaccine ( Yeast )in different age group. And evaluate persistence of immune response
      in 9-17years age group. To demonstrate that 9-17years age group was non-inferior to 18-26
      years age group and 27-45 years age group in terms of immunogenicity.
    

Detailed description: 
      This study is a multi-centre, randomized, blinded, placebo controlled study. The study
      vaccine is recombinant human papillomavirus bivalent (types 16 and 18) vaccine (Yeast), the
      placebo is aluminium phosphate diluent.

      After informed and received the consent of participants/guardians, 1200 healthy females aged
      9-45 will be enrolled into three age groups: 9-17, 8-26, 27-45. With the proportion of 1:1,
      vaccine group and placebo group will receive injection of 0.5ml of vaccine or placebo
      diluent.

      Participants will be injected of vaccine or placebo on a three-dose schedule (0, 2, 6
      months). After each inoculation, the immediate reaction will be observed for 30 minutes, and
      the local and systemic reaction will be systematically observed for 7 days. After the first
      inoculation, adverse event will be collected until one month after the final inoculation,
      while serious adverse event will be collected until 6 months after the final inoculation. For
      every participants, blood samples will be collected before the first inoculation (month 0),
      one month after the final inoculation (month 7), 6 months after the final inoculation (month
      12) to detect the neutralizing antibody of HPV type 16 and 18, and proceed safety and
      immunogenicity analysis. For participants in 9-14 age group who received the vaccine,
      neutralizing antibody will also be detected in month 24, 36 and 48 to examine the immune
      persistency. Meanwhile, some participants will be chosen to study the deviation of gene
      expression after the vaccination and the association of that with the neutralizing antibody
      level.
    

Intervention name(s): HPV vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule; Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Human papillomavirus; vaccine; cervical infection; cervical cancer
Effects of Intracoronary Prourokinase on the Coronary Flow During Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction
Condition: Myocardial Infarction; Percutaneous Coronary Intervention; Thrombolytic Therapy
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether intracoronary selective thrombolysis are
      more effective than tirofiban on the coronary flow during primary percutaneous coronary
      intervention for the acute myocardial infarction.
    


Intervention name(s): Prourokinase; Tirofiban; normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 20mg intracoronary bolus infusion using selective catheter during PCI; 10ug/kg intracoronary bolus infusion using selective catheter during PCI; intracoronary bolus infusion using selective catheter during PCI
Other intervention name(s): Reocmbinant Human Prourokinase for Injection; TIANJIN TASLY PHARMACEUTICAL CO.,LTD; Grand Pharmr (China) Co. Ltd
Intervention MeSH terms: Tirofiban; Saruplase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: No-Reflow Phenomenon
Functional and Metabolic Changes in the Course of Antidepressive Treatment
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Observational [Patient Registry]

Summary: 
      The study will investigate functional and metabolic changes in the course of antidepressive
      treatments.

      The investigators will apply different imaging methods to investigate the effects of
      antidepressive interventions on resting state neural activity, functional activation during
      cognitive and emotional stimulation, neurotransmitter concentrations as well as
      concentrations of brain- derived neurotrophic factor.
    

Detailed description: 
      The study will investigate functional and metabolic changes in the course of antidepressive
      treatments.

      The investigators will apply different imaging methods to investigate the effects of
      antidepressive interventions on resting state neural activity, functional activiation during
      cognitive and emotional stimulation, neurotransmitter concentrations as well as
      concentrations of brain- derived neurotrophic factor.

      The investigators hypothesize that antidepressive interventions modulate the excitatory
      glutamatergic system and thereby increase either the concentration of glutamate or the
      glutamate/ glutamine ratio. These metabolic changes are accompanied by altered functional
      activation in medial and lateral prefrontal areas during emotional and cognitive stimulation,
      respectively. After longterm treatment, excitatory glutamate and inhibitory
      gamma-aminobutyric acid concentrations adapt to a new homeostatic level which is reflected in
      antidepressive response or remission of symptoms. The investigators assume that the levels of
      glutamate and gamma-aminobutyric acid determine the amplitude of BOLD responses during
      emotional and cognitive stimulation. Furthermore, the investigators hypothesize that the
      plasma concentration of brain- derived neurotrophic factor might be a predictor for therapy
      response and changes in the course of treatment.

      With our protocol we adhere to the rules of good scientific practice and observe all relevant
      laws, regulations and guidelines that pertain to the project. The investigators' study is in
      compliance with the Declaration of Helsinki and approved by the local ethics committee.
      Storage of data is in accordance with german privacy laws.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        depressive patients from a primary care clinic
      
Biospecimen description: 
      whole blood
Mental Fatigue and Industrial Work Performance
Condition: Healthy; Mental Fatigue; Industrial Work; Robotics
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional

Summary: 
      To investigate the effect of mental fatigue on industrial work performance, biomechanical
      determinants, (electro-)(psycho-) physiological measures and physical ergonomics.
      Additionally, the current project wants to evaluate whether or not the Laevo exoskeleton
      influences the aforementioned parameters when mental fatigue is acutely induced.
    


Intervention name(s): Mental fatigue (Stroop task); Control (documentary)
Intervention type(s): Other; Other
Intervention description(s): A modified Stroop task of approximately 60 min will be used in order to induce mental fatigue (MF). This will be based on their performance during the max test that was conducted during the familiarization session. In this task, which will be partitioned in 4 blocks of 468 stimuli, four colored words ("rood", "blauw", "groen" and "geel") will be presented one at a time on a computer screen. The participants will be required to indicate the color of the word, ignoring the meaning of the word itself.; In the control task subjects will have to watch a documentary of 60 min on the same computer screen as the one used for the experimental trial. In order to avoid under- and over-arousal the subjects will have the opportunity to choose between several documentaries as proposed by the research team.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention