bioihbjkbjnl/mcl2 huggingface dataset:
Ultrasound Imaging of Neck Blood Vessels in Pregnant and Non-Pregnant Women
Condition: Pregnancy
Study type: Observational

Summary: 
      There is no data regarding success rates and incidence of carotid punctures during central
      venous cannulation (CVC) in the pregnant patients. We hypothesize that because of the
      anatomical and physiological changes associated with pregnancy, these patients are at higher
      risk of procedure failure and carotid puncture than the general population. The purpose of
      our study is to determine the success rate and incidence of carotid punctures using an
      ultrasound-simulated procedure in pregnant and non-pregnant patients.
    

Detailed description: 
      There is no data regarding success rates and incidence of carotid punctures during central
      venous cannulation (CVC) in pregnant patients. We hypothesize that because of the anatomical
      and physiological changes associated with pregnancy, these patients are at higher risk of
      procedure failure and carotid puncture than the general population. The purpose of our study
      is to determine the success rate and incidence of carotid punctures using an
      ultrasound-simulated procedure in pregnant and non-pregnant patients.

      Pregnant patients and adult female volunteers (controls) were recruited. Subjects were placed
      supine with wedge under the right hip, and head turned 35 degrees to the left. Two different
      approaches for CVC, the central landmark and the palpatory approach were used. The ease of
      identification of the landmarks was noted. CVC was simulated using an ultrasound probe, on
      pre-marked points. Ultrasound images were obtained, within the same parasagittal plane,
      directed 30 degrees caudad, in a manner simulating how a syringe and needle would be placed
      for central venous cannulation. The investigator placing the probe was blinded to the image
      being generated. The vertical cursor of the ultrasound, which serves to delineate the path of
      a needle, was placed in the image. If the cursor intersects the vein, the attempt is
      considered successful. If the first attempt is not successful, the investigator placing the
      probe was asked to redirect the probe to the second and if necessary to the third marked
      point. This was done for each approach. If the cursor intersects the carotid artery, the
      attempt is considered an accident and no further attempts were made. In addition to
      determining the success rate and the incidence of carotid punctures, the relative position of
      vein and artery was studied in each patient. For each approach, the best image was recorded,
      and three experienced anesthesiologist scored the images for vein and artery degree of
      overlapping.
    

Intervention name(s): Internal jugular vein cannulation; ultrasound
Intervention type(s): Procedure; Device
Time perspective: Prospective
Keywords: Central venous cannulation; Internal jugular vein; Ultrasound; Obstetrics
Soluble VE-cadherin in Prediction and Diagnosis of Early Postoperative Hypoxemia After Cardiopulmonary Bypass
Condition: Hypoxemia; ARDS; Lung Injury, Acute; Cardiopulmonary Bypass
MeSH terms: Lung Injury; Acute Lung Injury; Hypoxia
Study type: Interventional

Summary: 
      More than 2 million patients worldwide receive heart surgery every year, majority of these
      surgical patients will undergo cardiopulmonary bypass. However, the incidence of
      postoperative acute lung injury due to cardiopulmonary bypass is still as high as 20% to 35%.
      According to clinical experience, the earlier lung damage is detected, the more successful
      the treatment will be. On the basis of traditional detection, the investigators found a new
      indicator, serum soluble vascular endothelial-cadherin, which are easy to obtain and have
      certain specificity. Importantly, they can predict postoperative acute lung injury within 1
      hour after cardiac surgery. It is meaningful that this indicator can provide clinicians with
      early decision-making advice and immediate treatment for patients who may be at risk.
    


Intervention name(s): blood cell analysis, blood gas surveillance, chest radiograph and echocardiography
Intervention type(s): Diagnostic Test
Intervention description(s): Laboratory parameters of all postoperative patients including blood cell analysis, blood gas surveillance, liver, and kidney function alone with chest radiograph and echocardiography were dynamically monitored.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Hypoxemia; acute lung injury; Cardiopulmonary Bypass; FiO2/PaO2
Study of Erenumab (AMG 334) in Women With Hot Flashes
Condition: Vasomotor Symptoms; Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to evaluate the frequency of moderate to severe daily
      hot flashes 4 weeks after a single dose of erenumab (AMG 334) in women with hot flashes
      associated with menopause.
    

Detailed description: 
      This study will test the hypothesis that the vasodilation associated with capsaicin-induced
      dermal blood flow (DBF) provides a good model for the vasodilation associated with hot
      flashes; therefore erenumab doses that cause DBF inhibition will be safe and well tolerated,
      and will be effective in the reduction of the frequency and/or severity of HFs.
    

Intervention name(s): Erenumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered via subcutaneous injection.; Administered via subcutaneous injection
Other intervention name(s): AMG 334; Aimovig™
Intervention MeSH terms: Erenumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vasomotor symptoms; Hot Flashes; Menopause
Effects Of Blood Flow Restriction Exercise Applications On Physical Fitness Parameters
Condition: Physical Performance
Study type: Interventional

Summary: 
      Aim: The aim of the study; during the non-race season, blood flow-restricted exercises
      applied in addition to routine training programs to determine the effects on physical fitness
      parameters and sportive motivation of male canoe athletes aged 18 and over and to compare the
      results between the groups.

      Method: Male athletes aged 18 and over who are licensed and actively engaged in canoeing in
      Turkey will be included in the study. Subjects will be divided into two groups , training and
      control. The training group will be given blood flow restricted exercise for 8 weeks and
      resistance training equivalent to 30% of 1 maximum repetition. In the control group, 30% of 1
      MT of resistance training will be applied for 8 weeks without blood flow restriction. Before
      and after, athletes will be evaluated with sport-specific performance tests, muscle thickness
      measurement with ultrasound, isokinetic measurement of hamstring and quadriceps muscles at a
      speed of 60°/sec and 300°/sec. In addition, the muscles of the athletes will be evaluated
      with dynamic muscular measurements.
    

Detailed description: 
      The first evaluation will be made before the 8-week training, and the second evaluation will
      be made at the end of the 8-week training. Both groups will be re-evaluated for follow-up at
      6 and 12 months from the start of the study. In the 4th week, it is aimed to improve the
      exercise protocols by increasing the number of sets and repetitions in both groups.

      The training will start with a 10-minute warm-up exercise on the static bike, and then
      stretching exercises will be applied. The athlete is dressed in the KAK apparatus and the
      pressure is given continuously so that it is on the device. In the 30-minute CAC exercise
      training, the athlete will complete the resistance exercises on the Leg Press, Leg Curl, Leg
      Calf Raise, Quadriceps Extension machines while attached to the device.

      In the exercise prescription, which is planned as 3 sets of 10 repetitions, a rest period of
      60 seconds will be given between sets. A 10-minute cool-down period will be added at the end
      of the training.
    

Intervention name(s): blood flow restriction exercise
Intervention type(s): Other
Intervention description(s): blood flow restricted exercise, resistance training will be applied, corresponding to 30% of 1 maximum repetition for 8 weeks, 2 days in a week
Other intervention name(s): resistance exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: blood flow restriction; physical parameters; sporting motivation; canoe
Study of Metronomic Capecitabine and Oxaliplatin Versus XELOX in Egyptian Metastatic Colorectal Cancer Patients
Condition: Clinical Response; Toxicity; Survival
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Colorectal cancer (CRC) in Egypt is advanced tumors at diagnosis. Although, the dramatic
      increase in efficacy, reduction of mortality, and improvements in survival by the use of
      standard doses of chemotherapy, some CRC patients suffer from severe toxicities besides
      disease progression. Use of chemotherapy less than the maximum tolerated dose, with no
      prolonged drug free breaks incapacitates the cells to engage in progression mechanisms,
      suggesting that it could be a better alternative to standard dose therapy with better
      toxicity profile
    

Detailed description: 
      This is a randomized phase II prospective study that included 70 (35 in each arm) metastatic
      Egyptian CRC cancer patients diagnosed at the National Cancer Institute, Cairo University
      between January 2016 and June 2018). Patients were randomly treated with either classic XELOX
      (arm A) or with capecitabine (2000 mg daily x 8 weeks) and oxaliplatin (30 mg/m2 weekly X 8
      weeks) then 2 weeks rest (arm B). Toxicities and the survival analysis after two years for
      both regimens were recorded. Blood samples are taken from both groups to assess
      pharmacokinetics of capecitabine and its relation to dosing.
    

Intervention name(s): metronomic XELOX; Classic XELOX; Blood samples for pharmacological studies
Intervention type(s): Drug; Drug; Other
Other intervention name(s): Capecitabine; Oxaliplatin; Capecitabine; Oxaliplatin; No other names
Intervention MeSH terms: Capecitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: colorectal cancer; metronomic capecitabine
Motivational Interviewing Compared to Psychoeducation for Smoking Precontemplators With SMI
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The investigators primary hypothesis was that recipients of the Motivational Interviewing
      intervention would be significantly more likely than those assigned to the Psychoeducation
      intervention to demonstrate increased readiness to quit smoking at the end of the
      intervention and to seek smoking cessation treatment in the one month period following the
      intervention. We also predicted that the Psychoeducation intervention would result in greater
      improvements in smoking knowledge.
    


Intervention name(s): Motivational Interviewing; Psychoeducation
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Transtheoretical Model; Stages of Change; Nicotine Dependence; Severe Mental Illness
Ketamine for Depression and Suicide Risk
Condition: Depression; Suicide
MeSH terms: Depression; Depressive Disorder; Suicide
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study was to find out if the medication known as ketamine could
      help the symptoms of depression. This drug is approved by the U.S. Food and Drug
      Administration (FDA) as an anesthetic agent; however, it is not approved for use in
      depression treatment. The FDA allowed the use of this drug in this research study.
    

Detailed description: 
      This was a single-arm, open-label trial conducted in two phases. During the acute-phase, i.v.
      ketamine was administered thrice-weekly for up to 2 weeks.Those who achieved depressive
      symptom remission (Montgomery Åsberg Depression Rating Scale (MÅDRS)) total score less than
      or equal to 9 measured 24h after any acute-phase infusion) received continuation-phase
      treatment that consisted of once-weekly i.v. ketamine infusions for 4 additional weeks.
      Remission could occur after any of the 6 acute-phase infusions, at which point the next
      infusion was the first (of four) continuation-phase infusions. Individuals who remitted
      during acute-phase and completed continuation-phase treatment had 4 additional weekly
      post-continuation follow-up visits.Those who responded to i.v. ketamine (less than or equal
      to 50% reduction from baseline in MÅDRS total score) but did not remit during acute-phase
      were not eligible for continuation-phase treatment. Suicidal ideation was assessed clinically
      throughout the trial, supplemented by scores on the MÅDRS suicide item.
    

Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): 0.3 mg/kg/hr of ketamine infused for 100 minutes
Other intervention name(s): Ketalar
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Unipolar; Bipolar; Suicidal
OPTIMISE-CKD Drug Utilization
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      This is a multi-national, observational study program using secondary data sources to address
      research questions related to 1) real-world dapagliflozin utilisation in CKD and potential
      for further utilisation, 2), the current CKD treatment landscape and 3) real-world
      effectiveness of dapagliflozin in CKD (pending feasibility assessment).
    

Detailed description: 
      OPTIMISE-CKD is an observational study program using secondary data sources to address
      research questions related to 1) real-world dapagliflozin utilisation in CKD and potential
      for further utilisation, 2), the current CKD treatment landscape and 3) real-world
      effectiveness of dapagliflozin in CKD (pending feasibility assessment).

      Primary objective: to characterize dapagliflozin 10mg utilisation in clinical practice, by
      describing treatment naïve patients who (1) are treated with dapagliflozin 10 mg and (2) who
      are eligible for CKD treatment with dapagliflozin but untreated.

      Secondary objectives: to describe the current clinical landscape among incident CKD patients,
      by:

        1. Describing baseline demographic and clinical characteristics, drug utilization, and CKD
           treatment (RAASi and dapagliflozin 10 mg) patterns; and

        2. Describing selected outcomes among overall, treated and untreated incident CKD patients.

      Exploratory objectives: to assess the real-world effectiveness of dapagliflozin in CKD
      patients, pending feasibility.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The overall study population will consist of adult (aged > 18 years) patients with CKD
Drug Interaction Study of Avanafil and Enalapril or Amlodipine
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the change in the blood pressure and pulse rate,
      pharmacokinetics and the safety when avanafil is taken with either enalapril or amlodipine.
    


Intervention name(s): avanafil and enalapril; avanafil and amlodipine
Intervention type(s): Drug; Drug
Intervention description(s): enalapril twice a day for 11 days avanafil/placebo once a day for 2 days; amlodipine 5mg once a day for 16 days avanafil/placebo once a day for 3 days
Intervention MeSH terms: Amlodipine; Enalapril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ED; Erectile Dysfunction
Incidence of Pain After Craniotomy in Children
Condition: Disruption or Dehiscence of Closure of Skull or Craniotomy
Study type: Observational

Summary: 
      The primary objective is to assess the incidence and severity of pain after major craniotomy
      in paediatric patients (from 1 month to 10 years of age).

      The secondary objective is to determine factors associated with significant pain following
      paediatric neurosurgery .
    

Detailed description: 
      Research in the adult population has evaluated incidence and severity of post-neurosurgical
      pain, and effectiveness of different post-neurosurgical analgesic regimens. Several small
      studies report the prevalence of some period of moderate to severe pain in the first 24
      postoperative hours to be from 41 to 84 % of patients. In a prospective single academic
      medical institution study, adult patients treated with only acetaminophen and modest amounts
      of opioids on an as needed basis reported moderate to severe pain for the first 2 days after
      surgery. These findings have supported a growing consensus that perioperative pain associated
      with intracranial surgery may be more significant than initially appreciated. Factors that
      have been associated with increased pain after intracranial surgery include sex, younger age,
      surgical site, and surgical approach to the site. Pain may also be a significant factor in
      the quality of recovery from intracranial surgery. In contrast there are few studies
      describing the incidence or management of pain after neurosurgery in children.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        330 paediatric patients undergoing major craniotomy from the following Italian Hospitals:
        Policlinico Universitario Catania Ospedale Gaslini, Genova Ospedale Regina Margherita,
        Torino Ospedale Gemelli, Roma Ospedale Meyer, Firenze Ospedale Civile di Padova Ospedale
        Riuniti di Bergamo Ospedale San Gerardo di Monza
      
Keywords: Craniotomy; Pain; Children
EFFICIENCY OF HEMOVIGILANCE MODULE TRAININGS GIVEN TO NURSES
Condition: Nurse's Role; Training Group, Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      The aim of the present study is to determine the effectiveness of hemovigilance module
      training given to nurses.
    

Detailed description: 
      125 nurses from the clinic and intensive care units, who received the most intensive blood
      transfusion from two different hospitals, were included in the study as the intervention and
      control groups. The control group was not trained. Only the pretest was administered one week
      after the posttest. After the pre-test was applied to the nurses in the intervention group,
      five modules of training, which lasted four hours, were given using interactive methods. Five
      modules of training were prepared by the researcher. These five modules are the 1st module of
      training; definition of hemovigilance, its aims, the development of hemovigilance in the
      world and in Turkey, and legal legislation, Module 2; Donor selection, Blood donation
      Process, Phlebotomy and Donor reactions, Module 3; blood, blood transfusion, its purpose,
      properties of blood and blood components, Blood transfusion process, Module 4; acute and
      delayed transfusion reactions and management, Module 5; It consists of the national
      hemovigilance system, the organization of the hemovigilance system at the hospital level,
      Traceability, Trace-back from the Patient to the Donor, and Look-back from the Donor to the
      Patient. the training was over, the final test was administered. One month later, this test
      was repeated.
    

Intervention name(s): Training
Intervention type(s): Other
Intervention description(s): Hemovigilance module training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, parallel-group, placebo-controlled study
Masking: None (Open Label)
Primary purpose: Other
First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects
Condition: SARS-CoV-2 (COVID-19)
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety of 2 dose vaccination schedule of orally administered CoV2-OGEN1 In
      healthy subjects
    

Detailed description: 
      The study will be conducted at 1 site in NZ. Patients who sign an Informed Consent and meet
      all eligibility criteria will be administered oral doses of 50mcg, 100mcg and 200mcg
      CoV2-OGEN1 on Day 1 and Day 15 during Cohort 1-3 respectively . Follow up visit in all the 3
      cohorts will be performed at 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 3 months, 6 months,
      and 12 months. One sentinel subject will be dosed at the start of each cohort and will be
      monitored for 24 hours post administration before the remainder of the cohort can be
      recruited. Each cohort will include one sentinel subject.

      Dose escalation will be done after assessing all adverse events and their relatedness in
      atleast 9 participants out of 15 receiving Cov2-OGEN1 who have completed their week 6 FU
      visit.

      In case three (3) or more participants receiving CoV2-OGEN1 withdraw before Visit 6 (Week 4)
      follow up visit, the dose escalation safety assessment will be made by assessing all Adverse
      Events and their relatedness status in all participants receiving CoV2-OGEN1 of the current
      Cohort.
    

Intervention name(s): Orally Suspension of CoV2-OGEN1
Intervention type(s): Drug
Intervention description(s): CoV2-OGEN1 will be supplied as a 10mL oral suspension in a plastic bottle containing 50-200 mcg of formulated drug
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of the Abuse Potential of Dronabinol in Recreational Cannabinoid Users
Condition: Drug Abuse, Medication
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the abuse potential of dronabinol oral
      solution in recreational cannabinoid users.
    

Detailed description: 
      Following a four-day period for screening and qualification, there are five treatment visits
      with a minimum 8-day washout between treatments. Each participant will receive all treatments
      in a 5-way crossover design.
    

Intervention name(s): Dronabinol 10 mg; Dronabinol 30 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dronabinol at a strength equivalent to 10 mg provided in capsules or as an oral solution in syringes.; Dronabinol at a strength equivalent to 30 mg provided in capsules or as an oral solution in syringes.; Matching placebo provided in capsules or as an oral solution in syringes.
Intervention MeSH terms: Dronabinol
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)