bioihbjkbjnl/mcl2 huggingface dataset:
Randomised Placebo-controlled Duloxetine-referenced Study of Efficacy and Safety of 15 and 20 mg of Vortioxetine (Lu AA21004) in Acute Treatment of Major Depressive Disorder in Adults
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the efficacy, tolerability and the safety of two
      fixed doses of vortioxetine in the treatment of major depressive disorder.
    


Intervention name(s): Placebo; Vortioxetine (Lu AA21004); Duloxetine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): capsules, daily, orally; encapsulated tablets, daily, orally; encapsulated capsules, daily, orally
Other intervention name(s): Brintellix; Cymbalta®
Intervention MeSH terms: Duloxetine Hydrochloride; Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major depressive disorder; Placebo-controlled; Active reference; Multicenter study; Randomised study; Acute treatment
Comparison of Early Versus Very Early Postnatal Discharge on Hospital Readmissions in Newborns
Condition: Hospital Readmission; Newborn Morbidity; Newborn Complication; Newborn
Study type: Interventional

Summary: 
      This study compared hospital readmission and complications between very early discharge and
      early discharge in healthy newborn patients.
    

Detailed description: 
      Introduction. Very early postnatal discharge is defined as a hospital stay of the
      mother-child dyad of less than 24 hours. It is usually performed in public institutions of
      low-income countries due to high birth rates; it has not been associated to a higher
      proportion of neonatal admissions, however, very early discharge might increase this risk.
      The objective of this study was to compare the rate hospital readmission in patients with
      very early vs early postnatal discharge.

      Methods A prospective, randomized clinical study was performed with healthy term infants born
      in a hospital in Mexico from July 2016 to June 2018. Sample was randomized into two groups, a
      very early discharge group (<24 hours) and an early discharge group (24-48 hours). Hospital
      readmission rate was analyzed in both groups.
    

Intervention name(s): Time to discharge less than 24 hours; Discharge time between 24 and 48 hours
Intervention type(s): Other; Other
Intervention description(s): Allow the joint medical discharge of the newborn together with its mother in less than 24 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications.; Allow the joint medical discharge of the newborn together with its mother between 24-48 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: They were selected based on a random computer program in a 1: 1 model, assigning each subject randomly to one of the two study groups
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Newborn Infant; Hospital readmission; Early discharge; Very early discharge
Ketamine's Effect Changes the Cortical Electrophysiological Activity Related to Semantic Affective Dimension of Pain
Condition: Acute Pain; Chronic Pain, Widespread; Schizophrenia
MeSH terms: Chronic Pain; Acute Pain; Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a clinical trial that intend to determine the effects of S-ketamine on event-related
      potentials associated with semantic affective pain-processing
    

Detailed description: 
      Ketamine is a unique anesthetic with neural effects that are distinct from more commonly-used
      γ-aminobutyric acid agonists. Evidence suggest that analgesic effect of ketamine is primarily
      related to the affective than the sensorial aspects of pain interpretation. The investigators
      investigated whether ketamine, a noncompetitive NMDA antagonist, would modify the perceived
      emotional valence of pain-related words when compared to non-pain-related ones in healthy
      volunteers. Using a single session double-blind parallel placebo-controlled design, 24
      healthy volunteers were randomized to receive intravenous S-ketamine (n=12) or placebo
      (n=12). During infusion (plasmatic target of 60 ng/ml), the effects of ketamine were recorded
      using EEG and oddball behavioral data was monitored. Evoked potentials (N200 and P300
      components) were recorded during performance of a semantic written word oddball task
      containing pain-related (targets) and non-pain-related words (standards). Expected results:
      The findings of this study can help in the understanding of neurophysiologic mechanisms
      involved in ketamine's effects both in psychiatric diseases as in the treatment of
      postoperative acute and chronic pain.
    

Intervention name(s): Ketamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): S-ketamine will be administered in precalculated infusion rates to obtain a plasmatic level of 60 ng/ml; Administered in an identical way than ketamine.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ketamine; ERP; Oddball
The Turkish Validity and Reliability of "Toe Walking Scale" in Children With Idiopathic Toe Walking
Condition: Exercise; Rehabilitation; Reliability; Validity
Study type: Observational [Patient Registry]

Summary: 
      In clinics, many scales have been developed to examine daily living activities and function
      in children with idiopatic toe walking. "The Idiopatic Toe Walking (ITW)" was developed in
      2010 by Cylie M.Williams, contains 21 items which measure medical, birth & developmental
      history and assessment. The aim of the investigator's study was to investigate translating
      the ITW scale and using it in clinics reliably and valiably with a Turkish version of ITW in
      children with idiopatic toe walking.
    

Detailed description: 
      Demographic information was recorded which are included gender, age, using orthosis,
      botox/surgical history, use and duration of walkers/child-runner (WCR). The scale was
      translated into Turkish with the following translation steps. Thirty four children with
      idiopatic toe walking were included in the study. Internal structure consistency and
      test-retest reliability were measured for reliability analyses. For each item on the scale,
      Cronbach's alpha coefficient and item-total score correlations were calculated. The scale was
      administered for test-retest reliability at baseline and one week later by one rater.
      Test-retest reliability was assessed by Pearson's correlation test with observational gait
      analysis and 'co-validity' was investigated, statistically.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        diagnosed with toe walking by the pediatric neurologist and conducted to us.
      
Keywords: exercise; toe walking; scale; reliability; validity
A Study to Evaluate the Efficacy of Anti-emetic Drug Upon the Combination Chemotherapy for Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the
      combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC).
    

Detailed description: 
      The purpose of this study is to evaluate the efficacy of anti-emetic drug Aprepitant upon the
      combination chemotherapy of nedaplatin and docetaxel for non-small cell lung cancer (NSCLC).
      The incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in
      patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of
      nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed
      retrospectively in patients who had received the combination chemotherapy with anti-emetic
      agents except Aprepitant.
    

Intervention name(s): Aprepitant
Intervention type(s): Drug
Intervention description(s): The incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents but Aprepitant.
Other intervention name(s): Emend
Intervention MeSH terms: Aprepitant
Observational model: Case-Control
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Non-small cell lung cancer patients who receive the combination chemotherapy of nedaplatin
        and docetaxel
Quality of Perioperative Invasive Ventilation in PICU
Condition: Invasive Ventilation; Elective Surgery
Study type: Observational

Summary: 
      This is purely observational study in which quality of invasive ventilation is observed with
      electrical impedance tomography (EIT) during perioperative intensive care. EIT parameters
      will be used to assess if protective ventilation strategies are successfully followed during
      routine care.
    

Detailed description: 
      20 neonates and infants undergoing elective surgery and requiring postoperative treatment and
      follow up in PICU or in pediatric anestesiology clinic, will be included in this prospective
      observational study. Swisstom BB2-monitor and NeoSensorBelts will be used to monitor their
      ventilatory care from arrival to the operation room (prior intubation) to postoperative
      intensive care (until 2 hours after extubation). EIT parameters assessing lung aeration and
      ventilation distribution will be used to assess the quality of invasive ventilation.
    

Intervention name(s): Swisstom BB2 EIT device
Intervention type(s): Device
Intervention description(s): Swisstom BB2 EIT device and NeoSensor Belts will be used to assess lung aeration, ventilation distribution and strech during invasive ventilation in perioperative care.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates and infants undergoing elective/semi-elective surgery
      
Keywords: electrical impedance tomography
Hydroxyzine for the Prevention of Pruritus From Spinal Morphine in Transabdominal Hysterectomy Patients
Condition: Pruritus; Nausea; Vomiting
MeSH terms: Pruritus; Nausea; Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      Hydroxyzine is one of antihistamines that antagonizes H1 receptor, and it's effects are
      reducing pruritus, nausea/vomiting, and the mild effect of sedation.With these effects
      Hydroxyzine should be used in the prevention of these symptoms.
    

Detailed description: 
      80 patients scheduled for elective transabdominal hysterectomy under combined spinal-general
      anesthesia. they were randomized to receive either hydroxyzine 75 mg and midazolam 7.5 mg
      (ATR group) or placebo and midazolam 7.5 mg (control group) as premedication at least half an
      hour before operation. Clinical data (vital signs, pruritic score, nauseous score, sedation
      score, etc) was recorded at preoperative, intraoperative and 48-hour postoperative periods.
      All patients had spinal block with 0.5% heavy bupivacaine 2 ml with 0.3 mg preservative free
      morphine and general anesthesia with thiopental sodium 250-300 mg as induction, intubated
      with atracurium 0.6 mg/kg and maintenance with nitrous oxide, oxygen and isoflurane.
      Conventional reversal technique was done in all patients. Fentanyl intravenous was used for
      pain as needed, chlopheniramine syrup 2 tsp (4mg/10 ml) every 4 hours was used for pruritus
      and ondansetron intravenous (8 mg) was used for nausea/vomiting in postoperative period. The
      results were reported in number of patients or percent of patients who were suffered from
      pruritus, nausea, vomiting or sedation.
    

Intervention name(s): hydroxyzine
Intervention type(s): Drug
Intervention description(s): 75 mg of hydroxyzine orally as premedication drugs at least half an hour before operation.
Other intervention name(s): atarax
Intervention MeSH terms: Hydroxyzine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: sedation
A Study of Carbon-14-Labeled LY2835219 ([^14C]-LY2835219) in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This type of study is called a radiolabeled study. For this study, LY2835219 (study drug) has
      been specially prepared to contain radiolabeled carbon [^14C]. [^14C] is a naturally
      occurring radioactive form of the element carbon. This study will help understand how the
      drug appears in the blood, urine, and stool after it is administered.

      In addition, this study will also evaluate the safety and tolerability of a single dose of
      LY2835219 when given to healthy participants. Information about any side effects that may
      occur will also be collected.

      This study will last about 3 weeks for each participant, not including screening.
    


Intervention name(s): [^14C]-LY2835219
Intervention type(s): Drug
Intervention description(s): Administered as oral solution
Other intervention name(s): abemaciclib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Telemedecine on Post -Trauma Pain Medication Adherence .
Condition: Post-traumatic Pain
Study type: Interventional

Summary: 
      The impact of telemonitoring on patients' adherence to post trauma pain treatment , their
      satisfaction and pain relief after discharge from the ED.
    

Detailed description: 
      This is a prospective, multicenter, randomized trial . Participants are recruited from the
      emergency departement of Fattouma Bourguiba Monastir.

      This study is a seven day three-arm parallel group trial . Participants inculded are aged
      more than 16 years old who presented to the ED for minor trauma and discharged with analgesic
      treatment. They are randomized to one of two trial TM intervention groups (SMS and TM) or
      usual care group (control) in a 1 :1 :1 allocation ratio.

      For all inculded patients, demographic characteristics were collected as well as clinical
      examination findings. The interventional care provided at the ED was mentioned. At ED
      discharge the pain Visual Analogue Scale (VAS) was evaluated and the analgesic treatment
      prescribed was noted.
    

Intervention name(s): SMS reminding; telemonitoring
Intervention type(s): Other; Other
Intervention description(s): patients received SMS at day 2 , day 4 and day 7 after emergency departement discharge to remind them to take their treatment .; Patients received a phone call on day 2 and day 4 to evaluate the adherence , to detect any problem that can affect the adherence to the treatment and modify the analgesic protocol treatment if needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Included patients were randomized to one of the 3 groups:
Usual care (control) group Patients enrolled in this group were discharged and they didn't undergo any intervention within the treatment period.
SMS group Or short message service (SMS) group: patients received SMS at day 2 every day to remind them to take their treatment .
Telemonitoring group:
Patients received a phone call on day 2 and day 4 to evaluate the adherence , to detect any problem that can affect the adherence to the treatment and modify the analgesic protocol treatment if needed according to an algorithm:
At each call (day 2 and day 4), the VAS was assessed. If VAS ≥ 3 we looked for a medication discontinuation, inadequate dose or change of the prescribed treatment and the patient was instructed to take action accordingly . If the problem is related to side effects, the analgesic treatment was changed or associated to another analgesic
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telemedecine; Adherence; post- traumatic pain
Sun Protection Factor Assay (SPF Assay 200/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987516
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z46-096)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Computer-Assisted Tobacco Interventions in Dental Offices
Condition: Smoking
Study type: Interventional

Summary: 
      Electronic dental records (EDR) are a potentially powerful tool to incorporate current
      scientific evidence into clinical practice by providing key information at the point of
      patient care. The investigators know that disseminating evidence-based guidelines is not
      sufficient to change clinical practice so innovative approaches need to be tested in
      dentistry. The composite expertise of the investigators and consultants on this project and a
      large group practice with multiple clinics utilizing one EDR are essential to address the
      aims of this study. This project will examine whether dentists and hygienists will assess
      interest in quitting and deliver a tobacco intervention more frequently when provided with
      computer assisted guidance compared to a control group. Specifically the investigators will
      measure the delivery of questions assessing willingness to change and appropriate
      interventions based on willingness to change by measuring the recording of these activities
      in the EDR and patient receipt of these recommendations through a phone survey. In addition,
      the study will do a qualitative assessment of the patient perceived value of the
      provider-patient encounter to further inform us about patient perception of this interaction.
      The investigators want to know if dental providers will utilize these tools during the dental
      encounter. If they are used, the investigators would propose further studies examining
      smoking cessation rates. The investigators were not able to measure cessation rates due to
      the short two year timeline of this funding mechanism. This tool has potential application
      for other clinical topics, which makes this approach very innovative when considering the
      translation of evidence into the unique clinical practice of dentistry.
    


Intervention name(s): CATI Tool
Intervention type(s): Behavioral
Intervention description(s): Using Screening for drug use, Brief Intervention, Referral to Treatment (SBIRT) as a model, a CATI tool was designed for the Electronic Dental Record which required assessment of 4 variables for patients reporting cigarettes use: 1) number of cigarettes daily, 2) how soon upon waking the first cigarette was smoked, 3) interest in quitting, and 4) previous quit attempts. Level of dependency was calculated and displayed in the health history using the Heavy Smoking Index. Pop-up provider scripts were generated using rule-based algorithms. Links to printable patient education materials on the quit line and on medications to help quit smoking were embedded in the scripts window. The tool automatically recorded tobacco-cessation details.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Clinical decision support (CDS); Tobacco; Behavioral; Dental hygienist; Dentist; Smoking; Electronic health record
Sodium-Endothelial Function-CKD Study
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Heart disease and stroke, known as cardiovascular disease, are major causes of death in
      people with chronic kidney disease. Abnormalities of a metabolic pathway called the
      "L-arginine-nitric oxide" pathway are thought to be particularly important in these people,
      and previous research in animals has suggested that sodium (salt) affects part of this
      metabolic pathway. The purpose of our research is to study the effects of sodium intake on
      the "L-arginine-nitric oxide" pathway, and on blood vessel function, in patients with kidney
      disease.
    

Detailed description: 
      Chronic kidney disease (CKD) is associated with abnormalities of endothelial function (EF)
      and nitric oxide (NO) synthesis, and it is proposed that the endogenous NO synthase inhibitor
      asymmetrical dimethylarginine (ADMA) plays a central role. In man ADMA is largely metabolized
      by dimethylarginine dimethylaminohydrolase (DDAH), with some renal excretion occurring.
      Sodium inhibits DDAH expression in experimental animals and, given that CKD is frequently
      characterized by sodium retention, it would be interesting to study the effects of sodium
      loading on DDAH activity/expression, ADMA levels and EF in CKD patients.

      To answer these questions, we have designed a double-blind cross-over study employing Slow
      Sodium (150 mmol/day) and placebo for seven days in individuals with mild-to-moderate CKD.
      Changes in the ratio of urinary ADMA to dimethylamine (DMA, an ADMA metabolite) will be used
      as an marker of DDAH activity/expression. ADMA will be measured by ELISA, DMA by high
      performance liquid chromatography, and EF by venous occlusion plethysmography.

      We propose to test the following hypothesis; that in subjects with mild-to-moderate CKD under
      conditions of high sodium intake, as compared to low-normal sodium intake:

      (i) The ratio [ADMA]urine:[DMA]urine is increased (ii) [ADMA]plasma is increased (iii)
      Endothelium-dependent vasodilatation is reduced
    

Intervention name(s): Slow sodium
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Endothelial dysfunction; ADMA; DDAH; Sodium