bioihbjkbjnl/mcl2 huggingface dataset:
Plasma Concentrations of Bupivacaine After Peri-articular Injection in Total Knee Arthroplasty
Condition: Serum Bupivacaine Level; Periarticular Block; Total Knee Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with knee arthroplasty usually performed under spinal anesthesia with a single-shot
      femoral nerve block and periarticular block, so we would like to know the plasma
      concentration of bupivacaine in these patients.
    


Intervention name(s): Bupivacaine
Intervention type(s): Drug
Intervention description(s): 20 ml of 0.5% bupivacaine for single-shot femoral nerve block will be done at the beginning then another 20 ml of 0.5% bupivacaine for periarticular block will be performed at the end of operation.
Blood sample will be drawn at 60 min after femoral nerve block and before periarticular block, 15, 30, 45, 60 min after periarticular block.
Intervention MeSH terms: Bupivacaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bupivacaine level; periarticular block; total knee arthroplasty
Evaluation of the Efficacy and Safety of Advantage® Strips in Women Stress Urinary Incontinence (SUI )
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Observational

Summary: 
      This is a single-center retrospective study that evaluates the effectiveness and long-term
      safety of the TVT tape ( advantage Boston Scientific) in the treatment of stress urinary
      incontinence in women on a population of 500 patients with a mean follow-up of 6 years.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        patient of CHU Nîmes
A Phase 1 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is SAD(Single Ascending Dose)/MAD(Multiple Ascending Dose) study to Explore the
      Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of GC1102 (Recombinant Hepatitis B
      Human Immunoglobulin) in Chronic Hepatitis B Patients.
    

Detailed description: 
      GC1102 is a new recombinant hepatitis B human immunoglobulin. This study is composed with 2
      Parts, Part A for SAD and Part B for MAD and total 4 dosing program which is escalated after
      confirming safety. Maximum 48 subjects will be participated in the study.
    

Intervention name(s): GC1102
Intervention type(s): Biological
Intervention description(s): GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety and Efficacy Evaluation of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study is to evaluate multiple doses of BLI801 Laxative for safety and
      efficacy versus placebo in adults experiencing non-idiopathic constipation.
    


Intervention name(s): BLI801 Laxative; BLI801 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BLI801 oral laxative; BLI801 oral laxative placebo
Intervention MeSH terms: Laxatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Chemoradiotherapy on Nutritional Status in Advanced NPC Patients
Condition: Nasopharyngeal Carcinoma; Malnutrition
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Malnutrition
Study type: Observational

Summary: 
      This is an prospective，open-label, none-interventional, observational， multicenter phase II
      clinical trial. The purpose of this study is to observe the effect of neoadjuvant
      chemotherapy followed by concurrent chemoradiation therapy(CCRT) on nutritional status in
      locoregionally advanced nasopharyngeal carcinoma(NPC) patients, analyse the changes of
      patients' nutrition status during the treatment and the connection between nutrition changes
      and curative effects, evaluate nutritional risks under the neoadjuvant chemotherapy and CCRT
      and provide data and basis for further study。
    


Intervention name(s): cisplatin and docetaxel
Intervention type(s): Drug
Intervention description(s): NC：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two courses.
CCRT: intensity modulation radiation therapy(IMRT) and cisplatin (100mg/m2 on day 1) every three weeks for three\three cycles during radiation therapy(RT).
Dietary supplement: enteral nutrition and parenteral nutrition
Other intervention name(s): radiation; enteral nutrition and parenteral nutrition
Intervention MeSH terms: Docetaxel
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        III-IVb(Union for International Cancer Control,UICC 7th) NPC patients with histologic
        diagnosis of World Health Organization(WHO) II
      
Keywords: Nutritional Status; Locoregionally Advanced Nasopharyngeal Carcinoma
A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the relative bioavailability of the intended Commercial Formulation (iCF)
      (Test, T) compared with Trial Formulation 2 (TFII) (Reference, R) and to assess potential
      food effects following oral administration of BI 1358894.
    


Intervention name(s): BI 1358894, intended Commercial Formulation (iCF) (T); BI 1358894, Trial Formulation 2 (TFII) (R)
Intervention type(s): Drug; Drug
Intervention description(s): Test Treatment (T); Reference Treatment (R)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized Study to Assess the Safety of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer Disease; Mild to Moderate Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is evaluating the safety, tolerability, and feasibility of GRF6019, a
      plasma-derived product, administered as an intravenous (IV) infusion, to subjects with mild
      to moderate Alzheimer's disease.
    

Detailed description: 
      This is a randomized, double-blind, dose-comparison concurrent control study to assess the
      safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered by
      intravenous (IV) infusion to subjects with mild to moderate Alzheimer's disease.

      Subjects will be randomized 1:1 to a low dose or a high dose of active treatment in a
      double-blind manner. All subjects will receive one infusion per day at the randomized dose
      for 5 consecutive days during Week 1 and, again, during Week 13 (for a total of 10 doses per
      subject). All IV infusions will take place at an inpatient research unit while the follow-up
      visits after each treatment period will be on an outpatient basis. Subjects will participate
      for a total of 6 months in this study.
    

Intervention name(s): GRF6019
Intervention type(s): Drug
Intervention description(s): GRF6019 for IV infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Paratracheal Esophagus Pressure on the Insertion of Laryngeal Mask Airway
Condition: General Anesthesia; Pulmonary Aspiration
Study type: Interventional

Summary: 
      Laryngeal mask airway is inserted into the oral cavity and seals the upper esophagus and the
      surrounding tissue, effectively securing airway. Laryngeal mask airway has been widely
      adopted in the clinical practice.

      On the other hand, cricoid pressure has been used to reduce the risk of pulmonary aspiration
      of gastric contents during induction of general anesthesia. However, cricoid pressure might
      impede placement of the laryngeal mask airway, thereby preventing effective ventilation.

      Recently, left paratracheal pressure was introduced as an alternative to cricoid pressure and
      reported to be more effective than cricoid pressure in the prevention of gastric air
      insufflation during positive-pressure ventilation by facemask. Since this method compresses
      low left paratracheal level, it may affect the successful insertion of laryngeal mask airway.

      In this study, the investigators aimed to evaluate the effect of paratracheal esophagus
      pressure on the insertion of laryngeal mask airway compare to conventional cricoid pressure.
    


Intervention name(s): Paratracheal pressure; Cricoid pressure
Intervention type(s): Procedure; Procedure
Intervention description(s): To apply paratracheal pressure, the thumb was placed over the left side of the trachea cephalad to the clavicle and medial to the sternocleidomastoid muscle.; To apply cricoid pressure, the cricoid cartilage is compressed by 30N force with a single-handed three finger maneuvre towards the vertebral bodies.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double blinded clinical trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Laryngeal mask airway; Paratracheal esophageal pressure; Cricoid pressure
A Study of XW001 in Healthy Adult Subjects
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first-in-human, single-center, randomized, double-blinded, placebocontrolled,
      single-dose and multiple-dose escalation Phase Ia study
    

Detailed description: 
      Single ascending dose (SAD), healthy participants will be randomized to receive a single
      inhalational dose of either XW001 or placebo in each of the planned SAD cohorts. Multiple
      ascending dose (MAD), healthy participants will be randomized to receive inhalational doses
      of XW001 or placebo in each of the planned MAD cohorts.
    

Intervention name(s): XW001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled XW001; Matched inhaled placebo
Other intervention name(s): XW001 Inhalational solution; Matched placebo Inhalational solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treatment With Atomoxetine Hydrochloride in Children and Adolescents With ADHD
Condition: Attention-Deficit/Hyperactivity Disorder; Comorbid Dyslexia
MeSH terms: Hyperkinesis; Dyslexia; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy and safety of atomoxetine administered
      once daily in the treatment of children and adolescents with ADHD and comorbid dyslexia.
    


Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Does Adolescent Idıopathic Scoliosis Cause Pelvic Floor Dysfunction?
Condition: Scoliosis Idiopathic; Pelvic Floor Disorders
MeSH terms: Scoliosis; Pelvic Floor Disorders
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study was to investigate relationship between the type and severity of
      scoliosis and pelvic floor dysfunctions in individuals with adolescent idiopathic scoliosis.
    

Detailed description: 
      While a healthy spine has a flat appearance in the axial line in the frontal plane,
      individuals with scoliosis have lateral flexion to one side and rotation deformity in the
      horizantal plane. In other words, it is a 3-dimensional problem that causes severe postural
      disorder in advanced stages, accompanied by lateral flexion of the spine of 10 degrees or
      more in the frontal plane, axial rotation in the transverse plane and kyphosis-lordosis
      deformity in the sagittal plane. Especially the "core" region, which is formed by 4 main
      muscle groups, stabilizes the pelvic organs by balancing intra-abdominal pressure increases
      and provides spinal stabilization. Studies showing that pelvic floor functions may be
      affected in normal spinal physiologic curvature changes are available in the literature.
      However, the relationship between the angle and severity of scoliosis and pelvic floor
      dysfunctions due to idiopathic scoliosis has not been clearly clarified.

      In this context, the study aims to evaluate and compare scoliosis-related parameters (type of
      scoliosis, cobb angle, axial rotation angle), pelvic floor dynamics and dysfunctions in
      individuals with idiopathic scoliosis and healthy individuals with the same age group and
      characteristics.
    

Intervention name(s): Examination
Intervention type(s): Other
Intervention description(s): Posture Evaluation, Scoliosis Examination, Pelvic Floor Assesments
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Individuals aged between 11-18 years and followed up in physiotherapy centers that met the
        inclusion criteria were selected.
A Study to Assess the Food Effect on Bioavailability of Metformin/Gliclazide in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the food effect on bioavailability of Metformin/Gliclazide fixed dose
      combination tablet in fed and fasted state.
    


Intervention name(s): Metformin/Gliclazide Fixed Combination
Intervention type(s): Drug
Intervention description(s): Participants will receive single oral dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasting or fed state.
Intervention MeSH terms: Metformin; Gliclazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Metformin; Bioavailability; Food effect; Pharmacokinetics
Effect of Methyldopa on MHC Class II Antigen Presentation in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Type 1 Diabetes is an autoimmune condition in which segments of the immune system cause the
      destruction of insulin producing cells in the pancreas, leaving individuals with an impaired
      ability to control blood glucose levels. Currently there is no cure for Type 1 Diabetes and
      the treatments involve lifelong insulin administration and careful monitoring of blood
      glucose levels. Long-term complications like cardiovascular disease, nerve damage, and retina
      damage, may result. Previous studies have shown that improvement in the control of blood
      glucose can reduce the risks from these long-term complications. Residual insulin production,
      typically within the first few years following diagnosis, helps to reduce an individual's
      need to supplement insulin by injection or pump. This effect helps in maintaining the body's
      ability to regulate blood glucose levels and reducing the needs of external insulin.

      Methyldopa, or Aldomet, has been approved by the Food and Drug Administration and is commonly
      used to treat high blood pressure. This drug has been approved for several decades and has
      been shown to be safe and effective. This drug has been identified by the researcher to be
      able to block the communication between two important types of immune cells; which play a
      critical role in the autoimmune processes of Type 1 Diabetes. The investigators hypothesize
      that Methyldopa, over a 6 week treatment period, will block this communication and possibly
      slow down the destruction of insulin producing cells. The investigators hope to assess the
      appropriate and safe dose to achieve this effect, along with the drug's ability to maintain
      insulin production and blood glucose control.
    


Intervention name(s): Methyldopa
Intervention type(s): Drug
Intervention description(s): 6 weeks of Methyldopa administration; where the dose will be increased according to safety of efficacy.
Other intervention name(s): Aldomet
Intervention MeSH terms: Methyldopa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Diabetes Mellitus; Type 1 Diabetes
Nutritional Safety and Metabolic Benefits of Oncometabolic Surgery for Obese Gastric Cancer Patients
Condition: Oncology; Metabolic Disease; Gastric Cancer
MeSH terms: Stomach Neoplasms; Metabolic Diseases
Study type: Interventional

Summary: 
      The metabolic effect of oncometabolic surgery (long limb Roux-en Y reconstruction) for early
      gastric cancer patients has been revealed in a few pilot studies. However, the nutritional
      safety has not been dealt with in previous literatures. This is a prospective pilot study for
      evaluating the nutritional safety and metabolic benefits of oncometabolic surgery for obese
      early gastric cancer patients.
    

Detailed description: 
      We performed long limb uncut Roux-en Y gastrojejunostomy (uRYGJ) in 20 patients with clinical
      T1N0 stage and preoperative body mass index (BMI) ≥ 32.5 kg/m2 or ≥ 27.5 kg/m2 with
      co-morbidities between September 2015 and July 2016.

      The primary endpoint was the incidence of micronutrients' deficiency (iron, folate, vitamin
      B12) at postoperative 1 year and secondary endpoints were anemia incidence, BMI change and
      remission rates of co-morbidities.
    

Intervention name(s): Oncometabolic reconstruction
Intervention type(s): Other
Intervention description(s): The length of biliopancreatic limb is 50cm and the length of Roux limb is 100cm. (long limb uncut Roux-en-Y gastrojejunostomy) These limbs are longer than the conventional uncut Roux-en-Y reconstruction for gastric cancer patients.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oncometabolic surgery; Long limb uncut Roux-en-Y gastrojejunostomy; Obesity; Diabetes; Early gastric cancer
Preoperative Inflammatory Biomarkers and Postoperative Day 1 Drain Amylase Value Predict Pancreatic Fistula After Pancreaticoduodenectomy
Condition: Pancreatic Fistula; Pancreas Cancer; Inflammatory Response
MeSH terms: Pancreatic Neoplasms; Pancreatic Fistula; Fistula
Study type: Observational

Summary: 
      Particularly, pancreatic fistula is the most common and serious complication after
      pancreaticoduodenectomy (PD) and is reported in up to 40% of cases. The aim of this
      retrospective single-center study was to investigate the utility of the combination of
      preoperative inflammation biomarkers (PIBs) with postoperative day 1 drains amylase
      (POD1-d.a.) levels in predicting grade C Pancreatic Fistula (PF).
    

Detailed description: 
      Data from a prospective collected database of 317 consecutive PDs performed at the University
      Campus Bio-Medico di Roma during the years 2005-2019, have been retrospectively analyzed.
      Local Ethical Committee approved the study.

      Patients undergoing PD for periampullary neoplasms were included in the study. All patients
      underwent to PD with pancreaticojejunostomy reconstruction. Two surgical drains were always
      placed at the end of the surgery.

      Data regarding PIBs, as full blood count including white blood cell (WBC) count, lymphocytes,
      neutrophils and platelets counts, neutrophil-to-lymphocyte ratio (NLR), derived
      neutrophil-to-lymphocyte ratio (d-NLR), platelet-to-lymphocyte ratio (PLR) and POD1-d.a.
      levels were collected and Positive Predictive Values (PPV) and Negative Predictive Values
      (NPV) were computed to investigate the probability to develop PF combining PIBs and drains
      amylase values.
    

Intervention name(s): Surgical Drain Management
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        According to the inclusion criteria, 227 patients were eligible for the study. The median
        age of all the series was 69 years (IQR= 60.25-74). Male patients were 131 (57.7%), the
        median BMI was 24.06 Kg/m2 (IQR= 22.15-27.59). Biochemical leak, grade B and grade C PF
        have been detected in 67/227 (29.5%), 21/227 (9.25%) and 22/227 (9.7%) of the cases,
        respectively.
      
Keywords: Pancreatic Fistula; Pancreatic anastomoses; Surgical Drain Management; Inflammatory Biomarkers
Bioequivalence Study of Bosentan 125 mg Tablets Immediate Release (IR) Versus Tracleer® 125 mg Tablets IR In Healthy Subjects
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence Study of 2 formulation of bosentan (Bosentan GEROPHARM vers. Tracleer®
      Actelion)
    

Detailed description: 
      Study to evaluate the bioequivalence of orally administered bosentan preparations, immediate
      release tablets, 125 mg in normal healthy subjects under fasting conditions
    

Intervention name(s): Bosentan 125 mg; Tracleer 125Mg Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Single administered dose of Bosentan (125 mg tablet immediate release) in a fasting condition; Single administered dose of Tracleer® (125 mg tablet immediate release) in a fasting condition
Other intervention name(s): bosentan; bosentan
Intervention MeSH terms: Bosentan
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment two-way crossover
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: AUC; Cmax; Pharmacokinetics; bosentan; fasting