bioihbjkbjnl/mcl2 huggingface dataset:
The Efficacy of Serratus Anterior Plane Block (ESAPB) for Thoracotomy: a Prospective Study
Condition: Pain, Postoperative; Anesthesia; Thoracotomy
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Thoracotomy is considered the most painful surgical procedure. Ultrasound-guided serratus
      anterior plane block (SAPB) is a relatively new truncal block method treating thoracotomy
      pain. In this study, investigators aim to ascertain the efficacy of SAPB in thoracotomy.
    

Detailed description: 
      Thoracotomy is considered the most painful surgical procedure, even with thoracic epidural
      analgesia (TEA) as a golden standard for acute post-thoracotomy pain. Ultrasound-guided
      serratus anterior plane block (SAPB) is a relatively new truncal block method treating
      thoracotomy pain, yet more evidence is needed to ascertain its efficacy.

      This is a prospective study carried out in a tertiary hospital. Patients scheduled for
      thoracotomy are randomized into two groups: Group M (intravenous patient-controlled-analgesia
      morphine) and Group S (intravenous patient-controlled analgesia morphine and SAPB). Morphine
      consumption, VAS pain score and Prince-Henry pain score are recorded for 72 hours
      respectively at PACU, 2hr, 6hr, 12hr, 24hr, 48hr and 72hr, with heart rate, systolic
      pressure, diastolic pressure, mean arterial pressure and SpO2. Moreover, the profile of
      opioids-related side effects and length of hospital stay are documented. The primary
      objective of the study is to evaluate the efficacy of SAPB. The secondary objective is to
      compare the opioids-related side effects (including nausea, vomiting and pruritus),
      hemodynamic parameters and the length of hospital stay.
    

Intervention name(s): Serratus anterior plane block; Intravenous patient-controlled-analgesia morphine
Intervention type(s): Procedure; Drug
Intervention description(s): Serratus anterior plane block was applied in Group S. It was performed at the end of the operation following the skin closure, while the patient lay on his side with his arm above the head. After proper site cleaning, the first and second ribs were identified with a linear probe in the midclavicular line. The USG probe was advanced caudally in the sagittal plane, and the fourth and fifth ribs were visualized. The USG probe was then directed posteriorly and the serratus, latissimus dorsi and intercostal muscles were visualized. Bupivacaine 0.25% 30 mL was administered to the lower plane of the serratus muscle through an inserted catheter under the guidance of USG through the in-line technique. Afterwards, 0.12% bupivacaine hydrochloride was maintained at the rate of 0.1ml/kg/hr.; Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.
Other intervention name(s): Serratus plane block; PCIA
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Investigate the Safety and Tolerability of Single and Repeat Doses of PC786
Condition: Respiratory Syncytial Virus (RSV)
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates the safety, tolerability and pharmacokinetics of single and repeat
      doses of PC786.
    


Intervention name(s): PC786 - Single doses; Placebo - Single doses; PC786 - Repeat doses; Placebo - Repeat doses
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Safety and tolerability of single doses; Safety and tolerability of single doses; Safety and tolerability of repeat doses; Safety and tolerability of repeat doses
Intervention MeSH terms: PC-786
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetic, Safety, and Efficacy of B/F/TAF in HIV-1 Infected, Virologically Suppressed, Pregnant Women in Their Second and Third Trimesters
Condition: HIV-1-infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the steady state pharmacokinetics of
      bictegravir (BIC) and confirm the dose of BIC/emtricitabine/tenofovir alafenamide (B/F/TAF)
      50/200/25 mg fixed dose combination (FDC) in HIV-1 infected, virologically suppressed
      pregnant women in their second and third trimesters.
    


Intervention name(s): B/F/TAF
Intervention type(s): Drug
Intervention description(s): 50/200/25 mg FDC tablet administered orally once daily without regard to food
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Linezolid Pharmacokinetics In Patients With Impaired Renal Function (PPT6)
Condition: Renal Failure; Impaired Renal Function
MeSH terms: Renal Insufficiency
Study type: Interventional

Summary: 
      Renal failure patients were treated with linezolid (LZD) for proven or suspected infections
      by multiresistant Gram-positive cocci. The aim of this study is to determine if dose
      adjustment of LZD is needed as a function of renal impairment or not, especially that a
      significant component of LZD is eliminated unchanged in urine.
    


Intervention name(s): 600 mg linezolid
Intervention type(s): Drug
Intervention MeSH terms: Linezolid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Linezolid; Pharmacokinetics; Haemodialysis; Dosing adjustment; Eligible subjects were classified into three groups depending on their 24-h urinary creatinine clearance (CLcr) values or HD status.; Group 1, included 6 healthy subjects with normal renal function (CLcr ˃80 ml/min);; Group 2, included 6 patients with acute renal failure (RF) (30˂CLcr˂80 ml/mine);; Group 3, included 6 patients on long term haemodialysis (minimum period of dialysis was 40 month while maximum period were 130 month)
Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
Condition: Postoperative Residual Paralysis
MeSH terms: Paralysis
Study type: Interventional

Summary: 
      Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate
      residual postoperative paralysis but it represents the most simple, inexpensive and
      widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered
      the gold-standard to avoid PORC (post operative residual curarization).

      This clinical trial is conducted to verify the reliability of accelerometer-based
      neuromuscular monitoring in order to exclude postoperative residual paralysis which is not
      highlighted by this instrument at a TOF-ratio=100%.

      The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests
      after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100%
      allows to evaluate whether the recovery of muscle function is concrete, although the
      monitoring device shows a complete decurarization; patients treated with sugammadex should
      not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.
    

Detailed description: 
      From the beginning of the surgery to the time of extubation neuromuscular block is monitored
      with accelerographic monitor TOF-Watch SX. Patients are extubated when TOF-ratio is 100%.

      Patients will perform pulmonary function tests (PFTs):

        -  the day ahead of surgery (for elegibility and training)

        -  60 minutes before surgery

        -  10 minutes after extubation

        -  5 minutes after sugammadex or placebo administration

        -  20 minutes after sugammadex or placebo administration.

      The following parameters will be evaluated and compared between the 2 groups:

        -  Maximal Inspiratory Pressure (MIP)

        -  Maximal Expiratory Pressure (MEP)

        -  Forced Expiratory Volume in the first Second (FEV1)

        -  Forced Vital Capacity (FVC)

        -  Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital
           capacity (MEF50/MIF50)

        -  PaO2, PaCO2, pH

        -  heart rate, blood pressure and respiratory rate

      Changes of pulmonary tests performed before and after sugammadex or placebo will be compared
      between study groups.
    

Intervention name(s): sugammadex; Sodium chloride solution
Intervention type(s): Drug; Drug
Intervention description(s): sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg); Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.
Other intervention name(s): Bridion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Age and Refraction in Predicting Myopia Progression in COVID-19
Condition: Refraction Error; Myopia
MeSH terms: Myopia; Refractive Errors
Study type: Observational

Summary: 
      To determine the longitudinal changes of age and refraction in predicting myopia progression
      with risk under the coronavirus disease 2019 (COVID-19) pandemic in a 3-year follow-up of a
      Chinese cohort.
    

Detailed description: 
      This was part of the large-scale Tianjin Eye Study, a population-based cohort study that
      longitudinally investigates the relationship between the age, refraction, and development of
      childhood RE in Tianjin, China.
    

Intervention name(s): screening
Intervention type(s): Other
Intervention description(s): This study included 34,400 students, as part of the Tianjin Eye Study who performed a 3-year follow-up from 2019 to 2021. All participants underwent yearly noncycloplegic refraction and ocular examinations. Time-related changes in sphere, cylinder, and spherical equivalent (SE) measurements in both sexes were analyzed.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This study includes 34,400 schoolchildren, with a 36-month follow-up from 2019 to 2021. In
        addition to RE considerations, the inclusion criteria were: no concurrent eye disease; age
        6-15 years. The exclusion criteria were: significant systemic illnesses or ocular
        conditions that could affect the corneal curvature, including congenital corneal diseases,
        pterygium, keratoconus, other corneal degeneration or dystrophy conditions, media opacity,
        uveitis, glaucoma or a history of intraocular surgery, refractive surgery, neurologic or
        retinal diseases, current corneal refractive therapy (ortho-K), or low-dose atropine
        therapy for myopia control. The ethics board of the Tianjin Eye Hospital, Tianjin, China,
        approved this school-based cohort study (No: 2022018).
Effect of Probiotics on Primary Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Gut microbiota was found to play a causal role in the pathogenesis of hypertension.
      Probiotics were shown to have a potential anti-hypertensive effect in human/rodent studies.
      This study aims to explore the effect, safety, and underlying mechanisms of the combination
      of probiotics, containing 10 strains from Lactobacillus and Bifidobacterium, on hypertension,
      compared with placebo.
    

Detailed description: 
      Background: Primary hypertension is the leading risk factor of cardiovascular diseases and
      all-cause mortality, and contributes to severe global health burden. Emerging evidence has
      shown a close association between gut microbiota and hypertension. Fecal transplantation from
      hypertensive patients/animals to germ-free mice caused elevation of blood pressure,
      indicating a causal role of gut dysbiosis in hypertension. Probiotics were found to have a
      potential anti-hypertensive effect in both human and rodent studies. Based on the
      investigators' previous findings of metagenomics analysis of hypertensive, prehypertensive
      patients and healthy control, hypertensive and prehypertensive patients were lack of
      probiotics. Therefore, the investigators developed this study to explore the effect, safety,
      and underlying mechanisms of the combination of probiotics, containing 10 strains from
      Lactobacillus and Bifidobacterium, on hypertension, compared with placebo.

      Objective: To explore the effect, safety, and underlying mechanisms of the combination of
      probiotics on grade 1 primary hypertension and prehypertension.

      Study Design: A multicenter, randomized, double-blinded, placebo-controlled pilot study.

      Data quality control and statistical analysis: The investigators have invited professional
      statistic analysts to assist in analyzing data and a third party to supervise data quality.

      Ethics: The Ethics Committee of Fuwai Hospital approved this study. Informed consent before
      patient enrollment is required.
    

Intervention name(s): Probiotic powder; Placebo powder
Intervention type(s): Biological; Biological
Intervention description(s): Probiotic powder containing 10 strains from Lactobacillus and Bifidobacterium genus.; Placebo powder containing maltodextrin and no probiotics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypertension; Microbiome; Probiotics; Treatment
Erlotinib and Carboplatin in Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor
      cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop
      tumor cells from dividing so they stop growing or die. Combining erlotinib with carboplatin
      may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining erlotinib and carboplatin in
      treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate in patients with recurrent ovarian epithelial, fallopian
           tube, or primary peritoneal cancer treated with erlotinib and carboplatin.

        -  Determine the duration of stable disease, time to progression, and response duration in
           patients treated with this regimen.

        -  Determine the toxicity of this regimen in these patients.

        -  Correlate the level of epidermal growth factor receptor tumor expression with objective
           tumor response in patients treated with this regimen.

      OUTLINE: This is a multicenter study. Patients are stratified according to response to prior
      platinum-containing therapy (platinum-sensitive, defined as 6 months or more since prior
      therapy with platinum agent [closed to accrual as of 2/13/2004], vs platinum-resistant,
      defined as less than 6 months since prior therapy with platinum agent).

      Patients receive carboplatin IV over 30 minutes on day 1 and oral erlotinib once daily on
      days 1-21. Treatment repeats every 21 days for up to 6 courses. After the completion of 6
      courses of therapy, patients with responsive or stable disease may continue to receive
      erlotinib and carboplatin in the absence of disease progression or unacceptable toxicity.

      Patients are followed at 4 weeks and then every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 23-60 patients (8-30 for platinum-sensitive stratum [closed to
      accrual as of 2/13/2004] and 15-30 for platinum-resistant stratum) will be accrued for this
      study within 15-23 months.
    

Intervention name(s): carboplatin; erlotinib hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carboplatin; Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer; fallopian tube cancer; peritoneal cavity cancer
Endometrial Genomic Profile in Endometrial Priming
Condition: Genomic Human Endometrial Expression Profile
Study type: Interventional

Summary: 
      The aim of this study is to analyse genomics profile expression in endometrium under
      different endometrial priming for recipients.
    

Detailed description: 
      We analyze the genomic profile of egg donors in different endometrial priming protocols,
      compared with natural cycle, including the conventional single long acting GnRH agonist
      injection in the mid luteal phase of the previous cycle of the endometrial priming and the
      single daily antagonist injection (Cetrorelix 0.25 mg) administered in the early follicular
      phase followed by endometrial priming. Endometrial biopsy will be taken in luteinizing
      hormone

        -  7 or with P4 +5 in cases with endometrial priming with oestrogens therapy.
    

Intervention name(s): endometrial biopsy
Intervention type(s): Procedure
Intervention description(s): endometrial biopsy
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Endometrial priming, genomic expression. Natural cycle. Antagonist GnRH.
Role of Transcranial Direct Current Stimulation (tDCS) in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether transcranial direct current stimulation
      (tDCS) is effective in the treatment attention deficit hyperactivity disorder (ADHD).

      Randomized, double-blind Controlled Clinical Trial

      Subjects Adults (between 18 and 59 years of age) with ADHD who meet the inclusion criteria
      and who agree to participate in the study Will recruit from advertisements and clinical
      referrals to a PRODAH

      Active tDCS Anode - right DLPFC Cathode - left DLPFC Electric current is 2mA - Current is
      applied for 20 min

      Sham tDCS Same assembly is used Current is applied for 30 sec

      Both groups 5 stimulation sessions on consecutive days

      Following tools at Baseline, 1st week, 2 st week, 3st week and 4st week Adult ADHD
      Self-Report Scale (ASRS) SDS - Sheehan Disability Scale CGI - Clinical Global Impression
    

Detailed description: 
      Randomized, double-blind Controlled Clinical Trial

      Subjects Adults (between 18 and 59 years of age) with ADHD who meet the inclusion criteria
      and who agree to participate in the study Will recruit from advertisements and clinical
      referrals to a PRODAH

      Active tDCS Anode - right DLPFC Cathode - left DLPFC Electric current is 2mA - Current is
      applied for 20 min

      Sham tDCS Same assembly is used Current is applied for 30 sec

      Both groups 5 stimulation sessions on consecutive days

      Following tools at Baseline, 1st week, 2 st week, 3st week and 4st week Adult ADHD
      Self-Report Scale (ASRS) SDS - Sheehan Disability Scale CGI - Clinical Global Impression
    

Intervention name(s): tDCS active; tDCS sham
Intervention type(s): Device; Device
Intervention description(s): Stimulation will be performed with the anode placed over the right DLPFC, and the cathode placed on the left DLPFC. The applied electric current will be 2mA and is going to be applied for 20 minutes. The electrodes have a size of 35cm ² each and will be covered by sponges soaked with saline.; For the sham tDCS, the same setting will be used. However, the current is going to be applied for only 30 seconds, not being able to induce effects on neuronal excitability.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
cAMP (Cyclic Adenosine Monophosphate) Levels in the Nose
Condition: Olfactory Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine the normal distribution of nasal tissue
      cathelicidin antimicrobial peptides (cAMP) levels in subjects with normal smell and subjects
      with smell dysfunction. The investigators will also look at the effect of nasal saline
      irrigation on olfaction and cAMP levels and if nasal irrigation is capable of harvesting
      olfactory cilia. The investigators hypothesize that nasal saline will have no effect on
      olfaction and will be inadequate to harvest olfactory cilia.
    

Detailed description: 
      The investigators will recruit 40 subjects: 10 with olfactory dysfunction and 30 with normal
      olfaction. The normal olfaction group will be randomized (15-15)to either daily saline nasal
      irrigation for one week or no irrigation. Normal olfaction subjects will be seen for two
      visits, olfactory dysfunction for one. All subjects will complete an UPSIT (smell
      identification test)and a co-morbidity form. All subjects will have a brief nasal exam and
      then have nasal cells collected by means of a curette on one side and a cytobrush on the
      other. All subjects will receive Afrin and lidocaine, to improve visualization and for
      comfort during cell collection. Subjects will then complete a Comfort Scale related to the
      methods of cell collection. Normal olfaction subjects randomized to nasal irrigation will
      receive instructions on how to do it and the irrigation results will be collected for
      analysis along with the nasal cells. At their return visit, normal olfaction subjects will
      repeat the UPSIT and the comfort scale--all normal olfaction subjects will have a repeat cell
      collection. Subjects randomized to nasal irrigation will also complete a transition scale
      which asks if they feel the irrigation made a difference in their sense of smell. Subjects
      are compensated for time with a gift card.
    

Intervention name(s): saline nasal irrigation
Intervention type(s): Other
Intervention description(s): subjects irrigate with nasal saline daily for one week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: olfaction; smell dysfunction
Safety, Tolerability, and Efficacy of ISIS-PTP1BRx in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus; Obese
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and efficacy of
      ISIS-PTP1BRx + oral antidiabetic drug/s (metformin and/or sulfonylurea) versus placebo + oral
      antidiabetic drug/s.
    


Intervention name(s): ISIS-PTP1BRx; Placebo; daily OAD (metformin and/or sulfonylurea)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; T2DM