bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation the Preoperative Anxiety Level of the Surgeons
Condition: Preoperative Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      Many studies are present about the preoperative anxiety among patients. But the preoperative
      anxiety of the surgeons is not studied yet. The aim of this study is to evaluate the
      preoperative anxiety of the surgeons.100 surgeons consisted of performing operations in
      general surgery, obstetric and gynecology , orthopedic surgery ,ophthalmology,
      otorhinolaryngology, plastic and reconstructive surgery, urology, gynecologic oncology,
      surgical oncology, cardiovascular surgery, pediatric surgery and neurosurgery will be
      participated in the study. Surgeons will be chosen from the specialist doctor, assistant
      doctor, doctor lecturer, associate professor and professors.15 minutes prior to the first
      elective operation of the day, salivary cortisol samples will be taken from the surgeons and
      they will be asked to fill the evaluation form and State-Trait Anxiety Inventory Form (STAI).
    

Detailed description: 
      100 surgeons between the ages of 25-55 years will be participated in the study. Surgeons will
      be consisted of performing operations in general surgery, obstetric and gynecology,
      orthopedic surgery, ophthalmology, otorhinolaryngology, plastic and reconstructive surgery,
      urology, gynecologic oncology, surgical oncology, cardiovascular surgery, pediatric surgery
      and neurosurgery.They will be chosen from the specialist doctor, assistant doctor, doctor
      lecturer, associate professor and professors. Oral and written informed consent will be
      obtained from the surgeons.15 minutes prior to the first elective operation of the day
      salivary cortisol samples will be taken from the surgeons and they will be asked to fill the
      evaluation form and State-Trait Anxiety Inventory Form (STAI). The evaluation form will
      include the age, gender of the surgeon, surgical department, academic superscription, years
      of clinical experience in medical sciences and professions and the name of the surgery which
      is going to be done.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Surgeons will be consisted of performing operations in general surgery, obstetric and
        gynecology, orthopedic surgery, ophtalmology, otorhinolaryngology, plastic and
        reconstructive surgery, urology, gynecologic oncology, surgical oncology, cardiovascular
        surgery, pediatric surgery and neurosurgery.They will be chosen from the specialist doctor,
        assistant doctor, doctor lecturer, associate professor and professors.
      
Biospecimen description: 
      salivary cortisol
    
Keywords: surgeon; cortisol; anxiety
Development of Attention and Its Relationship With Emotions in Children and Adolescents
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Our aim was to describe the development and usability of a mobile device-based game therapy
      software for ADHD.
    

Detailed description: 
      A total of 51 ADHD children and 52 healthy children were included in the study. At baseline,
      subjects underwent tests such as ADHD symptom-related scale assessments, computer-assisted
      information processing tests, and physiological-psychological tests, after which participants
      completed a 4-week game intervention training at home. After complete completion of the
      intervention, subjects repeated all tests from the baseline period and answered treatment
      satisfaction questions.
    

Intervention name(s): a serious mobile device-based game prototype (Save the Muse Home)
Intervention type(s): Device
Intervention description(s): The cognitive impairment corresponding to the symptoms, which we are interested in, focuses on executive inhibition, motor inhibition, sustained attention, selective attention, working memory, and planning ability. The training content will be presented in different scenarios as effective training components. The story line of the warrior breakthrough runs through the whole game, each level is adapted according to the functional damage areas of different patients, and each level involves reward and punishment mechanisms to keep the interest of the players, the difficulty gradient of each level is kept moderate, and the game includes design elements such as space, time, object attributes, actions, rules, skills, and probabilities, etc., which ultimately completes Save the Muse Home, a serious game for the treatment of ADHD.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Dietary Intervention of Stress-Induced Neurovegetative Disorders With a Specific Amino Acid Composition (asn01)
Condition: Nervous System Disorder; Imbalance of Constituents of Food Intake
MeSH terms: Nervous System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Psychosocial stress leads to altered neuroendocrine functions, such as serotonergic
      dysfunction, as well as alterations of the autonomic nervous system and the
      hypothalamic-pituitary-adrenal (HPA) axis activity resulting in an imbalance between
      inhibitory and excitatory neurotransmitters. Clinical consequences include, inter alia,
      neurovegetative disorders, higher resting heart rate, hypertension, depressive symptoms,
      sleep disturbances, irregular body-weight changes, and insulin resistance. Poor dietary
      intake of the essential amino acid L-tryptophane as a precursor to 5-hydroxytryptamine (HT,
      serotonin) increases sensitivity to stress.

      It is therefore the investigators hypothesis that daily oral administration of an amino acid
      mixture (dosage 3.8 g/day) with micronutrients specifically designed to decrease
      neurovegetative disorders will target these neuroendocrine and metabolic alterations in
      adults with psychosocial stress. The principal endpoints will be a decrease in points in the
      psychological-neurological questionnaire (PNF).
    


Intervention name(s): amino acid composition (asn01); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Amino acid composition with micronutrients, once a day (in the evening, 2 hours after dinner) content of a sachet mixed with 200 ml water.
Duration: 12 weeks; Placebo; once a day (in the evening, 2 hours after dinner) content of a sachet mixed with 200 ml water.
Placebo contains no amino acids and micronutrients and is identical in appearance and solution properties.
Duration: 12 weeks
Other intervention name(s): Brand name: aminoplus neurostress
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: stress; lability and irritative disturbances; dietary supplement; amino acid composition; psychological neurological questionnaire (PNF)
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years
Condition: Chemotherapy Induced Nausea and Vomiting
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17
      years.
    


Intervention name(s): granisetron transdermal system; Granisetron IV
Intervention type(s): Drug; Drug
Intervention description(s): patch; IV
Other intervention name(s): Sancuso
Intervention MeSH terms: Granisetron
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CINV
Effects of Allium Hookeri on Blood Glucose
Condition: PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The researchers investigated the anti-diabetic effects of Allium hookeri root extract for
      Korean prediabetic participants.
    

Detailed description: 
      Allium hookeri root is widely consumed as a vegetable and herbal medicine in Asia. Although
      the antidiabetic activities of Allium hookeri have been documented in animal studies, the
      improved effects of Allium hookeri on human are not clear. Therefore, in this study, the
      researchers investigated whether Allium hookeri root extract could be effective in reducing
      the risk of type 2 diabetes in individuals with prediabetes.
    

Intervention name(s): Allium hookeri extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): take two capsules per day (486 mg/day) for 8 weeks; take two capsules per day
Other intervention name(s): AH
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia
Condition: Postpartum Anemia
MeSH terms: Anemia
Study type: Interventional

Summary: 
      The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron
      preparation will be equally effective in correction of postpartum iron deficiency anemia.
    

Detailed description: 
      Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can
      be given in intravenous infusion forms, in a relatively short period of time, in a single
      setting, after calculation of the required dose. This preparation has been used for treatment
      of anemia in patients with chronic renal disease, gastrointestinal disorders, anemia of
      malignancy and in gynecological disorders. It does not require a test dose to be given before
      total dose, nor does it require any premedication. It can be given in a dose of 20mg/kg. The
      drug has been licensed for use in Europe in 2009. It has been used for treatment of anemia in
      patients with chronic renal disease, inflammatory bowel disease and in anemia due to
      malignancies
    

Intervention name(s): Iron isomaltoside 1000; Ferrous sulphate
Intervention type(s): Drug; Drug
Intervention description(s): Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. It can be given in a dose of 20mg/kg body weight.; 200mg twice daily
Other intervention name(s): Monofer
Intervention MeSH terms: Iron isomaltoside 1000
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: iron; monofer; Pakistan
MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant
      Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in
      women undergoing controlled ovarian stimulation (COS) following GnRH treatment.
    


Intervention name(s): menotropin; recombinant FSH
Intervention type(s): Drug; Drug
Other intervention name(s): Menopur®; Gonal-f®
Intervention MeSH terms: Menotropins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Post-marketing, Observational, Retrospective Study to Assess the Safety of RefortrixTM (Tdap) When Administered During Pregnancy in a Maternal Immunization Program in Brazil.
Condition: Diphtheria
MeSH terms: Diphtheria
Study type: Observational

Summary: 
      The purpose of this study is to assess the safety of RefortrixTM (Tdap) when administered
      during pregnancy in a maternal immunization program in Brazil.
    

Detailed description: 
      In this retrospective cohort study the safety of RefortrixTM (Tdap) administered during
      pregnancy as part of the National immunization program in Brazil will be assessed by
      comparing the risk of pre-defined adverse events before and after introduction of the
      RefortrixTM (Tdap) maternal immunization program.
    

Intervention name(s): Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]
Intervention type(s): Biological
Intervention description(s): Subjects were included in the Exposed cohort if they received Refortrix as part of the maternal immunization program in Brazil.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The subjects who delivered in the study centre from May 2015 onwards will be considered as
        potentially exposed and those who delivered before September 2014 will be considered as
        potentially unexposed
      
Keywords: exposed and unexposed cohorts; post-marketing, maternal immunization; neonate related Adverse Events; Congenital anomaly; RefortrixTM; Pregnancy related Adverse Events
The Recuperation of Patients After Elective Shoulder Surgery Observational Cohort Study
Condition: Aucte Pain After Surgery; Persistent Pain After Surgery; Opioid Use After Surgery; Mode of Anaesthesia
Study type: Observational

Summary: 
      Around 6400 shoulder surgeries are performed yearly in Finland. The procedure is mainly
      day-case surgery and the patients go home in the afternoon. Shoulder surgery is one of the
      most common procedures performed in private surgical practices. Because of the complex nature
      of the joint, the recovery may be complicated by severe opstoperative pain, which is relieved
      with strong opioids. Recently this has been addressed in the literature, as prescribed
      opioids too often lead to substance abuse. Pain in the acute phase after surgery is one of
      the common risk factors for persistent postoperative pain, which is a major burden for both
      the individual patient and the society.

      In this prospective, observational cohort study we aim to describe current standards of
      practice in planning and taking care of anaeshtesia and prescribing opioids and adjuvants for
      postoperative pain relief at home.
    

Detailed description: 
      Around 6400 shoulder surgeries are performed yearly in Finland. The procedure is mainly
      day-case surgery and the patients go home in the afternoon. Shoulder surgery is one of the
      most common procedures performed in private surgical practices. Because of the complex nature
      of the joint, the recovery may be complicated by severe opstoperative pain, which is relieved
      with strong opioids. Recently this has been addressed in the literature, as prescribed
      opioids too often lead to substance abuse. Pain in the acute phase after surgery is one of
      the common risk factors for persistent postoperative pain, which is a major burden for both
      the individual patient and the society.

      In this prospective, observational cohort study we aim to describe current standards of
      practice in planning and taking care of anaeshtesia and prescribing opioids and adjuvants for
      postoperative pain relief at home.

      The data is collected prospectively from the care provider and the patient in a webrobol
      questionnaire at three time points: the day of surgery (care provider), one week after
      surgery (patient) and three months after surgery (patient).
    

Intervention name(s): Non- interventional
Intervention type(s): Other
Intervention description(s): Non- interventional
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prospective cohort of patients undergoing elective shoulder surgery and capable of
        answering an internet-based webropol questionnaire in Finnish.
Safety and Effectiveness of Zemplar Injection in Decreasing iPTH Levels in Pediatric ESRD Subjects on Hemodialysis
Condition: Secondary Hyperparathyroidism; End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if Zemplar, a vitamin D medication, safely and
      effectively decreases parathyroid hormone in children ages 2-20 with End Stage Renal Disease.
    


Intervention name(s): paricalcitol injection
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Condition: Uterine Fibroids; Heavy Menstrual Bleeding
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an extension study for women who have already received six months of treatment in the
      phase III clinical trial M12-815 (NCT02654054) or M12-817 (NCT02691494), and will evaluate
      the long-term efficacy and safety of elagolix administered alone and in combination with
      estradiol/norethindrone acetate for an additional six months in the treatment of heavy
      menstrual bleeding associated with uterine fibroids.
    


Intervention name(s): Estradiol/Norethindrone Acetate; Elagolix
Intervention type(s): Drug; Drug
Intervention description(s): capsules; film-coated tablets
Other intervention name(s): ABT-620; elagolix sodium
Intervention MeSH terms: Norethindrone; Norethindrone Acetate; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uterine Fibroids; Elagolix; Heavy Menstrual Bleeding; Elagolix Sodium; Elagolix plus Norethindrone Acetate
Performance Anxiety Changes With Exercise
Condition: Performance Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study investigates the effect of high-intense aerobe exercise training (HIIT) and aerobe
      exercise of low intensity on clinical and physiological parameters (anxiety, activity,
      cortisol, alpha amylase, heart rate, heart rate variability, spiroergometry) in patients with
      Music Performance Anxiety (MPA). Half of the patients will receive HIIT, while the other half
      will receive aerobe exercise of low intensity.
    

Detailed description: 
      In this study, 20 patients with MPA will receive a high-intensive aerobe training (HIIT, 6
      HIIT-sessions of 20 minutes within a period of 12 days). Additionally, 20 MPA-patients will
      undergo a less intense aerobe training matched regarding frequency and duration of sessions.
      Prior to the first training session, after completing the training (day 12) and 10 days after
      the Training (day 22), symptoms of anxiety and will be assessed by using questionnaires.
      Moreover, heart rate and heart rate variability will be obtained and activity level is
      measured using accelerometers. Before and after the training there will be an assessment of
      saliva samples for measuring cortisol and alpha amylase.

      Furthermore, a standardized performance situation is established before and after the
      Training. Before, during and after the performance anxiety ratings, cortisol, alpha amylase,
      heart rate and heart rate variability are assessed.

      The investigators hypothesize, that patients with MPA which undergo HIIT, will show a
      stronger and more sustained improvement of both, clinical symptoms and physiological
      measures. Specifically, a decreased heart rate, higher heart rate variability and decreased
      endocrinological parameters.
    

Intervention name(s): high-intensive aerobe exercise; low-intensive aerobe exercise
Intervention type(s): Other; Other
Intervention description(s): Aerobe bicycle ergometer training within 77-95% of maximum oxygen consumption; duration of each training session: 20 minutes; frequency of training: 6 sessions within 12 days; Aerobe training below 70% of maximum oxygen consumption (including light stretching and simple exercises adapted from yoga figures); duration of training session: 20 minutes; frequency of training: 6 sessions within 12 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: MPA; Music Performance Anxiety; HIIT; Exercise; Cortisol; HRV; Heart Rate
Compression And Functional Ability After Endovenous Varicose Vein Treatment
Condition: Varicose Veins of Lower Limb; Varicose Veins
MeSH terms: Varicose Veins
Study type: Interventional

Summary: 
      Study's aim is to study possible differences in post-operative rehabilitation, functional
      ability and visual disturbances after endovascular varicose intervention (RF-catheter and
      foam sclerotherapy) in two study groups, where patients will be randomised to either no
      compression group (Group I) or compression group (Group II)
    


Intervention name(s): Class II compression stockings
Intervention type(s): Other
Intervention description(s): Patients in this group will use class II compression stocking continuously until next evening and then next 4 days during daytime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Varicose veins; Compression stockings; Sclerotherapy; Radiofrequency ablation
Monotherapy Brexpiprazole (OPC-34712) Trial in the Treatment of Adults With Schizophrenia With Impulsivity
Condition: Schizophrenia With Impulsivity
MeSH terms: Schizophrenia; Impulsive Behavior
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of brexpiprazole, via functional magnetic
      resonance imaging (fMRI), on the right ventrolateral prefrontal cortex (VLPFC) activated by
      impulsive behavior.
    


Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks
Other intervention name(s): OPC-34712
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Mental Disorders, Antipsychotic,; Psychotic disorder, Impulsivity