bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Frailty on Postoperative Complications in Oncosurgery
Condition: Frailty; Postoperative Complications
MeSH terms: Frailty; Postoperative Complications
Study type: Observational

Summary: 
      Advanced ageing is accompanied by loss of reserve in multiple organ systems leading to
      increased risk of complications after surgery.Frailty is a functional syndrome involving
      reduced physiological reserve and 25-56% of all elderly surgical patients are reported to be
      frail .
    

Detailed description: 
      Patients above 65 years age undergoing major Oncosurgery under general anaesthesia with or
      without Epidural will included , written informed consent will be obtained from all patients.
      Age, Heigth , Weigth , polypharmacy , smoking status , history of Diabetes ,Hypertension will
      be noted. Basic investigation Hb% , Serum Albumin , Serum creatinine will be done. ASA
      Physical status and Surgical risk will be noted .Patients will be evaluated for Frieds 5
      point Frailty Assessment Scale (i) Unintended weigth loss of > 5kg in last one year.(ii) self
      reported exhaustion, (iii) muscle weakness (grip strength) (iv)slow walking speed,(v) Low
      physical activity and assigned to either No Frail Group (0 criteria) , Pre-Frail (1-2
      positive criteria ), Frail (3-5 positive criteria Group).The assessment will be done in the
      preoperative anaesthesia clinic and include paper based questionnaire, hand dynamometer to
      measure muscle strength and walking test .

      All patients will receive standard general anaesthesia along with Epidural for
      Abdomino-pelvic surgeries.Intraoperative monitoring 5 lead ECG, NIBP/IBP , SPO2, ETCO2,
      CVP(Optional),BIS will be done.After induction of anaesthesia Ultrasonography will be
      performed with curvilinear probe --- at the midpoint of femur anteriorly to measure Rectus
      Femoris muscle thickness of Right thigh , three consecutive readings will be measured and
      average of value noted for all patients.

      At the end of surgery patient's neuromuscular block will be reversed and trachea extubated ,
      if any patient requires ventilator support note will be made accordingly. Postoperative
      patients vitals and Input/Output charting will be done .Postoperative analgesia either
      epidural analgesia or intravenous opioids according to Institutional protocol will be given
      .Length of ICU Stay and any major cardiac , respiratory , Renal complications ,
      re-exploration will be noted.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients 65 years old and above undergoing elective major onco- surgeries .
Effects of Respiratory Physiotherapy on Pleural Effusion
Condition: Pleural Effusion
MeSH terms: Pleural Effusion
Study type: Interventional

Summary: 
      Pleural effusion and the complexity of diagnosis and treatment make planning and delivering
      care challenging. Respiratory physiotherapy is recommended, and should be applied during the
      first weeks of treatment.The aim of the present study is to demonstrate the effectiveness of
      a respiratory physiotherapy protocol in patients with Pleural Effusion who attended a
      University Hospital.
    

Detailed description: 
      Approximately 1.5 million patients are diagnosed with pleural effusion each year in the
      United States . Pleural effusion (PE) is an accumulation of fluid in the pleural space that
      is classified as transudate or exudate according to its composition and underlying
      pathophysiology. The goal in the management of pleural effusion is to provide symptomatic
      relief by removing fluid from the pleural space and to allow the treatment of the underlying
      disease. While some authors (REF) propose respiratory physiotherapy, in the majority of the
      cases only the medical treatment combined with the pleural fluid removal by thoracentesis are
      the most common practice. The objective of this study is verify the effectiveness of
      respiratory physiotherapy in pleural effusion
    

Intervention name(s): Respiratory physiotherapy; Conservative treatment
Intervention type(s): Other; Other
Intervention description(s): The respiratory physiotherapy intervention included:
Mobilisation techniques: limb exercises (passive, active assisted, or active resisted)
Chest physiotherapy: it included a Controlled breathing program, pursed lips breathing (PLB), active expiration and incentive spirometry.; Conservative medical treatment intervention for pleural effusion.
Other intervention name(s): Respiratory techniques added to conservative treatment; Medical treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pleural Effusion; Respiratory physiotherapy; Length of stay
Evaluation of the Effectiveness of Therapy for Patients With Covid-19 Using Food Supplements Viusid + Asbrip
Condition: Covid19; COVID-19 Pneumonia; COVID-19 Respiratory Infection; Viral Infection; Respiratory Tract Infections; Infection, Coronavirus; SARS-CoV2 Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Coronavirus Infections; Respiratory Tract Infections; Virus Diseases
Study type: Interventional

Summary: 
      This is a two-arm, randomized, open label, monocenter, controlled study to evaluate the
      safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of
      respiratory illness caused by Coronavirus 2019 infection.
    

Detailed description: 
      This is a two-arm, randomized, open label, monocenter, controlled study to evaluate the
      safety and efficacy of Viusid plus Asbrip in patients with mild and moderate symptoms of
      respiratory illness caused by Coronavirus 2019 infection.

      A total of 80 subjects will be randomized 2:1 in this study. 50 patients will be assigned to
      receive daily oral doses of 4,5 g of Viusid every 12 hours and 10 ml of Asbrip every 12 hours
      and standard care with antivirals or not. Other 30 patients will be assigned to receive only
      standard care.

      Treatment duration: 21 days

      Objective of the study: to increase the effectiveness of therapy for patients with Covid-19
      using food supplements Viusid and Asbrip.

      Research objectives:

        1. To assess the clinical symptoms of Covid-19 in patients on the background of combination
           therapy with the inclusion of food supplements Viusid + Asbrip.

        2. To investigate the dynamics of indicators of laboratory diagnostics against the
           background of complex therapy with the inclusion of food additives Viusid + Asbrip in
           the complex treatment of Covid -19.

        3. To study the dynamics of indicators of instrumental methods of treatment.

        4. To develop an algorithm for the management of patients with coronavirus infection in
           order to increase the effectiveness of therapy and rehabilitation of patients with this
           pathology.
    

Intervention name(s): Viusid and Asbrip; COVID-19 Standard Therapy
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Patients will be assigned to receive daily oral doses of 4.5gr of Viusid and 10 ml of Asbrip every 8 hours and standard care.; Patients will be assigned to receive the standard therapy for COVID-19 disease: Antibiotic, Antivirals, Analgaesic, Anti-inflammatory drugs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: covid-19; supportive care; Immuno-modulator; antiviral; symptoms relieve
PENTA15: Pharmacokinetic Study of Once Versus Twice Daily Abacavir in HIV-1 Infected Children Aged 3 to <36 Months
Condition: HIV Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the plasma pharmacokinetic (PK) parameters of q24h versus q12h dosing of abacavir
      in HIV-1-infected infants and children aged 3 months to 36 months

      The secondary objectives of PENTA15 were:

      To compare the plasma PK parameters of q24h versus q12h dosing of lamivudine in
      HIV-1-infected infants and children aged 3 months to 36 months who were receiving lamivudine
      in combination with abacavir

      To compare age-related differences in the PK parameters of q24h versus q12h dosing of
      abacavir and lamivudine infants and children in 3 age groups (≥3 to <12 months, ≥12 to <24
      months and ≥24 to <36 months)

      To describe child and family acceptability of and adherence to q24h compared to q12h dosage
      regimens of abacavir and lamivudine
    


Intervention name(s): Intervention 1: PK assessment while on Twice Daily Abacavir; Intervention 2: PK assessment while on Once Daily Abacavir
Intervention type(s): Other; Other
Intervention description(s): Week 0; Week 4
Other intervention name(s): Ziagen; ABC; Ziagen; ABC
Intervention MeSH terms: Abacavir; Dideoxynucleosides
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Abacavir; Lamivudine; Pharmacokinetics
Developing Nursing Students' Intercultural Sensitivity Levels
Condition: Nursing Caries; Education
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      This study; This is a randomized controlled experimental type study designed to improve the
      intercultural sensitivity levels of nursing students.
    

Detailed description: 
      Cultural sensitivity is extremely important for healthcare professionals. Understanding
      cultural differences can help build a trusting relationship between patients and healthcare
      professionals. This increases patient satisfaction and improves the quality of health
      services.

      This work; This is a randomized controlled experimental type study designed to improve the
      intercultural sensitivity levels of nursing students.

      Intercultural sensitivity training does not affect the intercultural sensitivity level of
      nursing students.
    

Intervention name(s): Structured education
Intervention type(s): Other
Intervention description(s): The educational content of the research was created by the researcher in line with the literature and expert opinions and covers the following topics.
Educational subjects
Culture and Concepts Related to Culture
Culture/Cultural Characteristics and Cultural Elements in Terms of Social Structure
Cultural Factors Affecting Health and Disease
Concepts and Practices Related to the Field of Study
The training is an online training and continued via video conference, and a session invitation was sent to the participants before each session. In addition, after the training, brochures containing the training topics of each week were prepared and delivered to the participants. The trainings were conducted by the researcher in a total of four sessions (each session 20 minutes) once a week during the training process. During the training, the questions of the participants were answered.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Following recruitment, students were divided into a study and a control group by randomization (1:1 randomization)
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Nursing; Student; Culture; Intercultural; Sensitivity; Education
Pharmacokinetics Study of XG005 Capsule
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase 1, single-center, randomized, placebo-controlled, 2-period, ascending
      single-dose study assessing the PK, safety, and tolerability of single ascending doses of
      XG005 (Period 1) and the naproxen and pregabalin combination (Period 2), in 5 dose groups
      each with 10 subjects.
    

Detailed description: 
      Period 1 was double-blind and randomized 8 subjects (1:1 allocation ratio by gender) to XG005
      and 2 subjects (1:1 allocation ratio by gender) to placebo. Subjects were enrolled
      sequentially into a total of 5 ascending dose levels pending safety review, and PK review
      where possible, of Period 1 of the prior dose level. Sentinel dose participants (1 for XG005
      and 1 for placebo) were included as the first dose administered at each dose level in Period
      1.

      In Period 2, all subjects in the last three XG005 dose groups received approximate molar
      equivalents of naproxen and pregabalin corresponding to XG005 doses after a 7-day washout
      period. Period 2 was open-label with 10 subjects per group.

      PK blood samples in each treatment period were collected at 0 (pre-dosing), 0.5, 1, 1.5, 2,
      3, 4, 6, 8, 12, 24, 48, and 72 hrs after drug administration.
    

Intervention name(s): XG005; Combination of Naproxen and Pregabalin; Placebos
Intervention type(s): Drug; Drug; Drug
Intervention description(s): XG005 Capsule; Naproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica; Placebo Capsule
Intervention MeSH terms: Naproxen; Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Period 1: ascending single-dose of XG005 vs Placebo; Period 2: combination of Naproxen and Pregabalin
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD
Condition: Alzheimer Disease; CVA (Cerebrovascular Accident)
MeSH terms: Alzheimer Disease; Stroke
Study type: Interventional
Phase: Phase 4

Summary: 
      Rivastigmine, an acetylcholinesterase inhibitor which has been approved by FDA & HSA, is
      authorized for use in the treatment of mild to moderate dementia of the Alzheimer's type.

      In this trial, the investigators will be studying the effectiveness of Rivastigmine in
      subjects with AD and cerebrovascular disease.
    


Intervention name(s): Rivastigmine
Intervention type(s): Drug
Other intervention name(s): Exelon
Intervention MeSH terms: Rivastigmine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Addressing Dementia Via Agitation-Centered Evaluation
Condition: Agitation in Patients With Dementia of the Alzheimer's Type; Alzheimer Disease; Agitation,Psychomotor
MeSH terms: Alzheimer Disease; Dementia; Psychomotor Agitation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled study, to assess the
      efficacy and safety of AXS-05 in the treatment of agitation in patients with Alzheimer's
      disease.
    


Intervention name(s): AXS-05; Bupropion; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AXS-05; Bupropion; Placebo
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pupil Dynamics and Color Vision for the Detection of Eye Diseases
Condition: Retinitis Pigmentosa; Leber's Hereditary Optic Neuropathy; Stargardt Disease
MeSH terms: Optic Nerve Diseases; Optic Atrophy, Hereditary, Leber; Retinitis; Retinitis Pigmentosa; Stargardt Disease
Study type: Interventional

Summary: 
      The development of new oculometry techniques allows fine and dynamic measurements of
      pupillary diameter and use in routine clinical practice.

      The preliminary results obtained with innovative devices on healthy sjuets make it possible
      to envisage a clinical study on a population of patients suffering from retinal pathologies.

      This is a "proof of concept" study, which, if the expected results are confirmed, will make
      it possible to consider a study on a larger population, as well as the industrial development
      of a commercial device.
    

Detailed description: 
      This is a single-head study that will take place at the National Ophthalmology Hospital
      Center (CHNO) and the Vision Institute (Streetlab) and the total duration of the study is 24
      months .

      It is planned to include 60 participants divided into different groups:

        -  15 healthy subjects, called controls.

        -  15 patients with retinitis pigmentosa.

        -  15 patients with Leber's hereditary optic neuropathy.

        -  15 patients with Stargardt's disease.

      Patients will be pre-selected on files at the CHNO clinical investigation center based on the
      visual assessment carried out on the day of their arrival, the doctor may suggest that they
      participate in the study if the inclusion criteria are respected.

      The control subjects will be recruited thanks to the database of the Vision Institute at
      Streetlab.
    

Intervention name(s): Dynamic pupillometry sessions
Intervention type(s): Behavioral
Intervention description(s): The evaluation protocol will include the following steps:
Installation of the subject, adaptation of the chin rest for the best comfort of the participant
Calibration of the oculometer consisting of ocular fixation of 9 fixation points distributed on the stimulation screen
Final validation of the eligibility of the subject in the study according to the success or not of the calibration.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Safety Study of PGA (Poly-gamma Glutamic Acid) for Cervical Intraepithelial Neoplasia
Condition: Cervical Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy and the safety of PGA(Poly-gamma
      Glutamic Acid) for the the fertile women with Cervical Intraepithelial Neoplasia (CIN1).
    

Detailed description: 
      This study is to compare the regression rate of Cervical Intraepithelial Neoplasia (CIN1)
      between the treatment group and the control group.

      The treatment group will be administered with PGA (Poly-gamma Glutamic Acid) for 4 weeks
      followed by 8 weeks observation.

      The control group will be observed for 12 weeks without any comparator.
    

Intervention name(s): Poly-gamma Glutamic Acid; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment of Cervical Intraepithelial Neoplasia(CIN1)
Atropine or Ephedrine Pretreatment for Preventing Bradycardia in Elderly Patients
Condition: Anesthesia, Spinal; Dexmedetomidine; Bradycardia
MeSH terms: Bradycardia
Study type: Interventional
Phase: Phase 4

Summary: 
      Spinal anesthesia is widely used for lower extremity surgery, and sedation is often required
      during surgery. For sedation, propofol, midazolam and dexmedetomidine are frequently used.
      Dexmedetomidine is a highly selective alpha 2 receptor agonist, and has sedating and
      analgesic effect. Compared with propofol and midazolam, it has little or no respiratory
      inhibition and hemodynamically stable. It also has the effect of reducing delirium in the
      elderly. Dexmedetomidine has also been reported to prolong the duration of sensory and motor
      blockade effects of spinal anesthesia. However, several studies have reported that
      administration of dexmedetomidine in spinal anesthesia increases the incidence of
      bradycardia.

      In a study of healthy young adults, concurrent administration of atropine with
      dexmedetomidine in spinal anesthesia significantly reduced the frequency of bradycardia
      requiring treatment. However, in elderly patients, it is often reported that there is little
      response to atropine in bradycardia, and ephedrine is more effective in treating bradycardia
      than atropine in the elderly.

      The investigators therefore compared ephedrine and atropine as pretreatment to reduce the
      incidence of bradycardia when using dexmedetomidine as a sedative in elderly patients
      undergoing spinal anesthesia.
    


Intervention name(s): normal saline; atropine 0.5mg; ephedrine 8mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): intravenous normal saline pretreatment at the onset of dexmedetomidine infusion; intravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion; intravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion
Intervention MeSH terms: Atropine; Ephedrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Phase II Study Evaluating the Efficacy and Safety of AbGn-168H in Patients With Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate efficacy, safety, tolerability, and immunogenicity of AbGn-168H administered
      intravenously in patients with active psoriatic arthritis.
    

Detailed description: 
      This is an open-label, multi-center, multi-dose phase II proof of principle trial to study
      the efficacy and safety of AbGn-168H in patients with moderate to severe active psoriatic
      arthritis. A minimum of 15 patients and a maximum of 20 will be recruited in 1 dosing group.
      For safety evaluation, the parameters to be assessed include physical examination, vital
      signs (blood pressure, heart rate, respiratory rate and body temperature), 12-lead ECG,
      safety laboratory tests, adverse events and tolerability. For efficacy evaluation, patients
      will be evaluated for proportion of subject reaching American College of Rheumatology 20 (ACR
      20) in week 12 and proportion of subjects reaching ACR 20, ACR 50 and ACR 70 at different
      time points; Disease Activity Score 28 (DAS28) at different time points, as well as Target
      Lesion Psoriasis Severity Score (TLPSS) and static Physician Global Assessment (sPGA) for
      subjects with active skin lesions at different time point.
    

Intervention name(s): AbGn-168H
Intervention type(s): Biological
Intervention description(s): monoclonal antibody
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diaphragmatic Echography in Critically Ill patientS
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency; Critical Illness
Study type: Observational

Summary: 
      Acute respiratory failure (ARF) is characterised by a discrepancy between load imposed on
      respiratory muscles and their capacity. Recently, diaphragmatic ultrasonography has been
      introduced in the clinical practice to evaluate diaphragmatic function. In particular, the
      investigators will focus on Diaphragmatic Displacement measured by M-mode ultrasonography.
      The aim of this study was to compare the diaphragmatic displacement with traditional weaning
      parameters in potentially ready to be extubated patients undergoing a spontaneous breathing
      trial (SBT).
    


Intervention name(s): Ultrasonography
Intervention type(s): Device
Intervention description(s): Ultrasonographic assessment of the diaphragm function
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Critically ill patients undergoing a spontaneous breathing trial
      
Keywords: Diaphragm; Ultrasound; Critically ill patients