bioihbjkbjnl/mcl2 huggingface dataset:
Ultrasound Guided Erector Spinae Plane Block vs Intrathecal Morphine
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Total abdominal hysterectomy (TAH) is a major surgical procedure after which significant
      post-operative pain and discomfort are anticipated. Abdominal field blocks have been followed
      for many years and extensively used for pain management following abdominal surgeries such as
      laparotomies and appendicectomies. Erector Spinae Plane Block (ESPB)-first recently described
      for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia
      technique that has since been reported as an effective technique for prevention of
      postoperative pain in various surgeries. Intrathecal opioid administration is an attractive
      analgesic technique since the opioid is injected directly into the cerebrospinal fluid, close
      to the structures of the central nervous system where the opioid acts.
    


Intervention name(s): Ultrasound Guided Erector Spinae Plane Block; Intra thecal morphine.; General anesthesia using intravenous fentanyl (1µgm/kg)
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive bilateral ultrasound-guided ESPB by the an experienced anesthetist in US regional blocks, with each block 20 mL of bupivacaine 0.25%; General anesthesia using intravenous fentanyl (1µgm/kg) and patients will receive intra thecal morphine with spinal needle 25G, 3 ml containing 300 ug preservative free morphine; Patients will receive general anesthesia using intravenous fentanyl (1µgm/kg)
Intervention MeSH terms: Fentanyl; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
To Predict Weight Loss Response to Liraglutide (Saxenda®), From fMRI-based Determination of Food Cue Reactivity
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The study is a single center, randomized, double blind, placebo controlled; parallel-group
      repeated measures design. Subjects will be randomly assigned to either Saxenda® or placebo
      group after baseline assessments. The study will consist of a 4-week partial dose period
      (Liraglutide 0.6mg, 1.2mg, 1.8mg, 2.4 mg) and a 12-week full-dose (Liraglutide 3.0 mg)
      period. The placebo group will administer equivalent volumes of the pre-filled solutions from
      pen-injector at the same time, using the same method during this period. The study proposes
      to identify factors contributing to early weight loss response in a Saxenda® treatment
      program. Specifically, the proposed experiments will help determine if Saxenda® changes brain
      functional Magnetic Resonance Imaging Food Cue Reactivity (fMRI-FCR) and whether the
      magnitude of that change is associated with changes in behavioral and physiological variables
      (hunger, satiety, cravings and weight loss).
    


Intervention name(s): Saxenda®; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Receiving escalating dose of Saxenda® for the first 4 weeks (0.6mg, 1.2mg, 1.8mg, 2.4 mg) and receiving full-dose (3.0 mg) for 12 weeks.; Receiving equivalent volumes of the pre-filled solutions from pen-injector as Liraglutide 3.0 group .
Other intervention name(s): Liraglutide 3.0
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuroimaging; Hormones
Behavioral Intervention Program and Vaginal Cones on SUI
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is a single blind randomized clinical trial to compare the efficacy of a
      behavioral intervention program versus vaginal cones on Stress Urinary Incontinence (SUI).
    

Detailed description: 
      Detailed Description: In this single-blind randomized clinical trial, 60 women aged 25-65 yrs
      with stress urinary incontinence were randomly divided in two groups by blocked randomization
      method; behavioral intervention program (n=30) and insertion vaginal device,vaginal cones
      (n=30). Women in behavioral intervention group were instructed for pelvic floor exercise and
      bladder control strategies. Other group was allocated to use vaginal cones. They were treated
      for 12 weeks and followed up every 2 weeks. The subjective changes in severity of SUI were
      measured using a Detection SUI Severity Questionnaire and leakage index and 3-day urinary
      dairy. The objective changes were measured by pad test. These two groups were then compared
      according to the scores of special questionnaires for quality of life, strength of pelvic
      floor muscles, capability to participate in social activities, severity of urinary
      incontinence, and the number of involuntary urine passage, taken before, and after 1 and 3
      months after finishing interventions. Data analysis will be done through descriptive and
      perceptive statistical methods by using SPSS.
    

Intervention name(s): behavioural program; Iranian version of vaginal cones
Intervention type(s): Behavioral; Device
Intervention description(s): interventional behavioural program; intravaginal device(vaginal cone) for promote the pelvic floor exercises
Other intervention name(s): bladder training program, exercise therapy; intravaginal cones with different weights,Physical Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Behavioral Intervention Program; Vaginal Cones; Stress Urinary Incontinence; treatment; Women
Nutrition Status of Adults Treated With Pegvaliase
Condition: Phenylketonurias
MeSH terms: Phenylketonurias
Study type: Observational

Summary: 
      Conduct a cross-sectional analysis of the nutritional status of individuals with PKU treated
      with pegvaliase for one or more years or who have followed an unrestricted diet for 6 or more
      months while on pegvaliase treatment. We will evaluate laboratory markers of nutritional
      status, including markers of protein and micronutrient nutriture. In addition, a three-day
      food record and food frequency questionnaire will be obtained to assess protein intake and
      overall diet quality.
    


Intervention name(s): Pegvaliase
Intervention type(s): Drug
Intervention description(s): Treated with pegvaliase for one or more years or followed an unrestricted diet for 6 or more months while being treated with pegvaliase.
Other intervention name(s): Palynziq
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        This cross-sectional study will recruit adults with PKU who have been treated with
        pegvaliase for one or more years or who have followed an unrestricted diet for 6 or more
        months while on pegvaliase treatment. This may include individuals who participated in the
        phase III clinical trials for pegvaliase.
Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis
Condition: Bronchiectasis; Lung Disease; Respiratory Diseases
MeSH terms: Lung Diseases; Bronchiectasis; Respiratory Tract Diseases; Respiration Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of AZD5069 in patients with
      bronchiectasis.
    


Intervention name(s): AZD5069; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral dose bid; Oral dose bid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bronchiectasis; Neutrophil; Respiratory disease; Sputum
Feasibility and Safety of Neoadjuvant Chemotherapy (FLOT ) for Gastric Cancer Patients in China
Condition: Chemotherapy Effect
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies,
      however, there was not any large scale randomized controlled trial (RCT) to support it until
      German oncologist introduced a novel regimen(FLOT regimen) in 2017. Investigator assessed the
      FLOT regimen for safety and feasibility in Chinese gastric cancer patients.
    

Detailed description: 
      Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies,
      however, there was not any large scale RCT to support it until German oncologist introduced a
      novel regimen(FLOT regimen) in 2017. FLOT regimen was prescribed for German patients and
      various questions are raised by experts from Eastern countries. As the FLOT regimen was
      officially included in NCCN 2018 guidelines, the investigator used standard protocol of FLOT
      regimen on Chinese gastric cancer patients. Safety and feasibility were assessed carefully to
      provide basic data for further large scale studies in China.
    

Intervention name(s): Chemotherapy
Intervention type(s): Drug
Intervention description(s): Patients will receive four cycles of the standard dose of FLOT chemotherapy prior to curative gastrectomy. And four cycles of the FLOT chemotherapy is recommended after surgery. Preventive antiemetic and dexamethasone are allowed before chemotherapy, growth factor, or other supportive medicines are allowed for treatment only. Surgical intervention is allowed for acute bleeding or other surgical emergencies.
Other intervention name(s): FLOT
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cohort of operable gastric cancer patients.
      
Keywords: gastric cancer; neoadjuvant chemotherapy; FLOT regimen
Relation Between Atherogenic Index of COVID-19 and Upcoming Cardiac Morbidity and Mortality in Non-Cardiac Patients
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Plasma lipids levels were estimated and the Atherogenic Index of Plasma (AIP) was computed in
      302 COVID confirmed patients. Patients were evaluated using the COVID-GRAM (CG) critical
      illness score and during a hospital stay the rates of admission to intensive care unit (ICU),
      development of cardiac insults, and need for admission to cardiac ICU (CCU) and its outcome
      were determined.
    

Detailed description: 
      All patients were admitted to the quarantine department at Tanta University hospital and
      quarantine hospitals at Al-Gharbia governorate with a diagnosis of SERS-CoV-19 infection that
      was confirmed by having positive nasopharyngeal swab for SARS-CoV-2 using reverse
      transcriptase-polymerase chain reaction (RT-PCR). The study protocol was approved by the
      Local Ethical Committee according to instructions of the Ministry of Health and written
      informed consents were signed by all enrolled patients or their nearest relative.

      Using the strict personal protective equipment, patients were clinically examined for
      collection of the demographic data age, sex, weight and height, history taking especially
      past and/or present history of diabetes mellitus (DM), hypertension, cardiac diseases,
      hypercoagulability events, chest, liver or kidney diseases or endocrinopathy. BMI was
      calculated in kg/m2 as weight (kg)/height (m2) (14) and was graded according to the
      guidelines of WHO (15). The chest was examined clinically and CT imaging was performed to
      assess the disease severity.

      Clinical parameters

        1. COVID-19 disease severity grading

        2. COVID-GRAM Critical Illness Risk Score

        3. Atherogenic index of plasma (AIP)

      Laboratory investigations A- Routine lab investigations included estimation of random blood
      glucose, complete blood count and serum levels of urea, creatinine, liver enzymes, and total
      and direct bilirubin B- Investigations for evaluation of SARS-CoV-2 infection severity
      including estimation of serum C-reactive protein, interleukin-6, lactate dehydrogenase,
      D-dimer levels.

      C- Estimation of a plasma lipid profile
    

Intervention name(s): Atherogenic Index of Plasma
Intervention type(s): Diagnostic Test
Intervention description(s): - The atherogenic index of plasma (AIP) is defined as the base 10 logarithms of the ratio of plasma triglyceride (TG) to high-density lipoprotein cholesterol (HDL-c) (17). AIP was employed as a predictor of cardiac risk (CR) with values of -0.3 to 0.1 are associated with low, values of 0.1-0.24 are associated with the medium, and values above 0.24 with high CR
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COVID confirmed patients free of Cardiac Diseases evaluated Clinically by laboratory
        investigations
Safety, Tolerability and Pharmacokinetics of BEA 2180 BR in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of safety, tolerability and pharmacokinetics of single rising intravenous doses of
      BEA 2180 BR; additional exploration of metabolism following inhalation
    


Intervention name(s): BEA 2180 BR solution for infusion; Placebo; BEA 2180 BR solution for inhalation; Respimat®
Intervention type(s): Drug; Drug; Drug; Device
Intervention description(s): Intravenous infusion
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
The Effect on Depressive Symptoms in ECF Residents With COPD
Condition: Chronic Obstructive Pulmonary Disease; Depression
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effect of treatment with Advair Diskus on
      depression using the Cornell depression scale in COPD patients in the nursing home.
    

Detailed description: 
      We are studying 35 residents in the ECF with a diagnosis of COPD. We are evaluating them for
      depressive symptoms using the Cornell Depression Scale and the MDS 3.0 section D. We are
      selecting patients who are not currently on treatment with Advair and starting them on Advair
      Diskus50/250 1 inhalation bid for a period of 16 weeks and reassessing the Cornell Depression
      SCale and MDS3.0 section D looking for any changes. We are also going to measure FEV1 and FVC
      using spirometry before treatment and at the end of 16 weeks. This is a pilot study. The
      numbers are not necessarily adequate to achieve statistical difference-we are looking for
      trends.
    

Intervention name(s): Advair diskus
Intervention type(s): Drug
Intervention description(s): Advair diskus 50/250 1 inhalation bid for 16 weeks
Intervention MeSH terms: Fluticasone-Salmeterol Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD; Depression; Nursing Home
Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of two doses of safinamide
      (50 and 100 mg/day, p.o.), compared to placebo, as add-on therapy in patients with idiopathic
      Parkinson's disease with motor fluctuations who are currently receiving a stable dose of
      levodopa.
    


Intervention name(s): Safinamide; Safinamide; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease; PD; Levodopa; Patients with idiopathic Parkinson's disease with motor fluctuations
Prulifloxacin in Chronic Bacterial Prostatitis (CBP)
Condition: Chronic Bacterial Prostatitis
MeSH terms: Prostatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to assess the efficacy and safety of prulifloxacin in comparison to
      levofloxacin in the treatment of patients affected by CBP.
    

Detailed description: 
      This is a randomized, double-blind, levofloxacin controlled, parallel group, multicentre,
      international, prospective study. The patients will be enrolled in the study and will be
      randomized to prulifloxacin or levofloxacin. Patient enrolment will be competitive.

      The present study is planned to verify the microbiological and the clinical efficacy of a
      28-day treatment period with prulifloxacin 600 mg in comparison with 28-day treatment period
      with levofloxacin 500 mg, both administered once daily, in patients with CBP. Safety and
      tolerability of a 28-day treatment period with prulifloxacin 600 mg will be also evaluated in
      comparison to levofloxacin 500 mg.

      Levofloxacin 500 mg tablets has been selected as treatment comparator because it represents
      the drug of choice authorised for the treatment of CBP. Consequently, the dosage regimen to
      be administered to the patients is consistent with that reported in the relevant SPC.
    

Intervention name(s): Prulifloxacin 600 mg; Levofloxacin 500mg
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration of one tablet once daily for 28 days of prulifloxacin 600 mg. The investigational drug will be taken with a glass of water, preferably in the evening and at about the same time each day, 2 hours before or at least 4 hours after the eventual administration of cimetidine, antacids containing aluminum and magnesium or preparations containing iron and calcium.; Oral administration of one tablet once daily for 28 days of levofloxacin 500 mg. The investigational drug will be taken with a glass of water, preferably in the evening and at about the same time each day, 2 hours before or at least 4 hours after the eventual administration of cimetidine, antacids containing aluminum and magnesium or preparations containing iron and calcium.
Other intervention name(s): Unidrox®; Levoxacin®
Intervention MeSH terms: Levofloxacin; Prulifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, levofloxacin controlled, multicentre, international, prospective study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bacterial prostatitis; CBP; Levofloxacin; Prulifloxacin
The Absorption of Vitamin B12 Among Healthy Pregnant Women
Condition: Pregnancy
Study type: Interventional

Summary: 
      During pregnancy the woman uses more vitamin B12, but we do not know, whether it is through
      increased absorption or it eats into the womans vitamin B12 deposit . Sufficient B-vitamin is
      crucial for the normal development af foetus during pregnancy.

      In Denmark the National Board of Health recommend an intake of Folic Acid, from the day the
      woman wishes to be pregnant and to the 12. week of gestation, but there is no recommendation
      for vitamin B12. We will measure the vitamin B12 absorption with a new non-radioactive test,
      CobaSorb.

      .
    


Intervention name(s): B12 vitamin (Cyanocobalamin)
Intervention type(s): Dietary Supplement
Intervention description(s): Arm A: B12 vitamin (Cyanocobalamin)
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Vitamin B12 absorption; Pregnancy
Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of ME3183 administered orally
      for moderate to severe plaque psoriasis in adults.
    


Intervention name(s): ME3183; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ME3183 capsule; Placebo capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nasal Intubation Using King Vision Video Laryngoscopy
Condition: Nasal Intubation
Study type: Interventional

Summary: 
      This study was designed to determine the comparison between the King Vision video
      laryngoscope 、 McGrath MAC video laryngoscope and Macintosh laryngoscope for nasotracheal
      intubation.Patients were divided into 3 groups of 30 patients each.Patients of King Vision
      group [n=30]、 McGrath MAC group [n=30] and Macintosh group[n=30]were intubated using
      respective devices.This study is the first to search the use of King Vision video
      laryngoscope for nasotracheal intubation.
    


Intervention name(s): King Vision video laryngoscope; McGrath MAC video laryngoscope; Macintosh laryngoscope
Intervention type(s): Device; Device; Device
Intervention description(s): nasal intubation using King Vision video laryngoscope Device after general anesthesia induction; nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction; nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: King Vision
A Study to Evaluate the Efficacy and Safety of Quinapril or Quinapril Plus Hydrochlorothiazide in Patients With Mild to Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the response rate for the therapeutic goal
      (diastolic blood pressure (BP) less than 90 mmHg and systolic BP less than 140 mmHg) at Week
      6 for quinapril 20 mg and at Week 12 for quinapril 20 mg, quinapril 40 mg, and quinapril 20
      mg plus hydrochlorothiazide 12.5 mg; and to determine the mean decrease in diastolic and
      systolic BP measurements and the change in heart rate at Week 6 and Week 12 compared with
      baseline.
    


Intervention name(s): quinapril 20 mg; quinapril 20 mg plus hydrochlorothiazide 12.5 mg; quinapril 40 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Quinapril 20 mg oral tablet daily for the first 6 weeks, and if a responder, continued on quinapril 20 mg for an additional 6 weeks; Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 20 mg plus hydrochlorothiazde 12.5 mg daily (Accuzide tablets) for 6 weeks; Quinapril 20 mg oral tablet daily for the first 6 weeks; if nonresponder, could be randomized to quinapril 40 mg oral tablet daily for 6 weeks
Intervention MeSH terms: Hydrochlorothiazide; Quinapril
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment