bioihbjkbjnl/mcl2 huggingface dataset:
In Vivo Optical Spectroscopy Monitoring in a New Model of Muscular Compartment Syndrome
Condition: Human Volunteers
MeSH terms: Compartment Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      Muscular compartment syndrome (MCS) is consecutive to an increase in intramuscular
      compartment pressures, and is a rare but serious postoperative complication.

      The INVOS (In Vivo Optical Spectroscopy) monitors tissular oxygenation continuously and
      non-invasively.

      The objective is to develop a model mimicking the physiopathology of MCS to assess the
      interest of the INVOS in this case.
    

Detailed description: 
      After inflation of a tourniquet (pressure equal to the mean arterial pressure, we will obtain
      a model of slight venous congestion and arterial hypoperfusion. A comparison will be made
      between INVOS monitoring, sensory deficits, pain, electromyography and invasive pressure.
    

Intervention name(s): Tourniquet; INVOS assessment; EMG assessment
Intervention type(s): Device; Device; Device
Intervention description(s): Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion; Near Infraread spectroscopy, non invasive; Electromyography, non invasive
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Human volunteers
To Compare The Efficacy Of N -Acetylcysteine and Standard Therapy Versus Standard Therapy In The Prevention Of Ischemic Hepatitis And Survival Post Upper GI Bleed
Condition: Ischemic Hepatitis
MeSH terms: Hepatitis A; Hepatitis; Ischemia
Study type: Interventional

Summary: 
      Patient presenting with upper GI bleed in ILBS (Institute of Liver and Biliary Sciences)
      emergency admitted to ICU (Intensive Care Unit) or shifted from ward to ICU (Intensive Care
      Unit) in view of upper GI bleed randomized to two groups

      GROUP A : 110 Patients will receive standard care + NAC infusion for 72 hours

      GROUP B : 110 Patients will receive standard care only

      NAC will be given at following rate :

      Initial loading of 150 mg/kg/hr over 1 hour Followed by 12.5mg/kg/hr for 4 hrs Then
      continuous infusion of 6.25 mg/kg for the remaining 67 hrs
    


Intervention name(s): Standard Care + NAC (N -ACETYLCYSTEINE); Standard Care (in control arm)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Utility of Caduet in Achieving Blood Pressure and Lipid Endpoints in a Specific Patient Population
Condition: Hypertension; Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose is to demonstrate the utility of Caduet (amlodipine/atorvastatin) in the African
      American population
    


Intervention name(s): Amlodipine/Atorvastatin
Intervention type(s): Drug
Intervention MeSH terms: Amlodipine; Amlodipine, atorvastatin drug combination; Atorvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Efficacy and Safety of Somatostatin Used as Inflow Modulator in Liver Transplantation.
Condition: Liver Transplant With Clinically Significant Portal Hypertension
MeSH terms: Hypertension, Portal; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a 5 day, single-center, randomized, double blind, placebo-controlled study to
      evaluate the efficacy and safety of Somatostatin used as inflow modulator in liver
      transplantation. Patient systemic and hepatic dynamics will be collected and recorded at
      predefined time-points. To evaluate the ischemia-reperfusion injury, it is planned to perform
      liver biopsies at two different time-points to compare the liver structure and proteomic
      variations.
    


Intervention name(s): Administration of Somatostatin; Administration of placebo
Intervention type(s): Drug; Drug
Intervention description(s): 6 mg will be diluted in saline in a 60 cc syringe to be infused over 24 h (250 mcg/h). The treatment will be started during the hepatectomy phase, after 1st measurement of native arterial and portal flow and pressure and given a clinically significant portal hypertension (CSPH) with a hepatic venous pressure gradient (HVPG) >= 10 mmHg.
5 cc will be injected in 2 minutes as a single bolus of 500 mcg. Somatostatin will be given a second time at the beginning of the warm ischemia time as a continuous infusion of 250 mcg/h(infusion rate 2,5 cc/h). This will allow the time needed for reaching a stable plasma concentration at reperfusion and minimizing risks of secondary effects. After portal revascularization of the liver graft, a new measurement of portal flow and pressure will be performed. Provided a portal vein flow (PVF) >= 90 ml/min * 100 g LW, the remaining 55 cc will be infused for the following 22 h. 6 mg per day of continuous infusion will be continued for 5 days.; The placebo treatment will be started during the hepatectomy phase, after the 1st measurement of native arterial and portal flow and pressure and given a clinically significant portal hypertension (CSPH) with a hepatic venous pressure gradient (HVPG) >= 10 mmHg.
5 cc of the 60 cc solution will be injected in 2 minutes as a single bolus of 500 mcg. The placebo will be given a 2nd time at the beginning of the warm ischemia time as a continuous infusion of 250 mcg/h (infusion rate 2,5 cc/h). This will allow the time needed for reaching a stable plasma concentration at reperfusion and minimizing risks of secondary effects. After portal revascularization of the liver graft, a new measurement of portal flow and pressure will be performed. Provided a portal vein flow (PVF) >= 90 ml/min * 100 gram LW, the remaining 55 cc will be infused for the following 22 h. 6 mg per day of continuous infusion will be continued everyday to complete 5 days of therapy.
Intervention MeSH terms: Somatostatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Liver transplant; portal hypertension
To Assess the Effectiveness of Multiple Dose, Multiple Concentrations of Qwo, for the Treatment of Mild to Moderate Cellulite.
Condition: Cellulite
MeSH terms: Cellulite
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single center, off-label, multiple dose, multiple injection areas, Phase 4 study to
      assess the safety and efficacy of multi-dilution CCH in adult women with mild or moderate
      edematous fibrosclerotic panniculopathy (EFP). 5 subjects will be screened and dosed in the
      buttock and thigh areas using a multi-dilution injection technique.

      Qualified subjects (determined by investigator assessment) will receive a single vial of 0.84
      mg of CCH to treatment areas (buttocks and thighs) for a total dose of 1.68 mg in both
      buttocks and both thighs per treatment session × 3 treatment sessions (Day 1, Day 22, and Day
      43). Subjects will have follow-up visits at approximately 90 after Day 1.
    


Intervention name(s): Qwo
Intervention type(s): Drug
Intervention description(s): Collagenase clostridium histolyticum-aaes is a combination of bacterial collagenases AUX-I and AUX-II, in an approximate 1:1 mass ratio, which are isolated and purified from the fermentation of Clostridium histolyticum bacteria. Collagenase AUX-I is a single polypeptide chain consisting of approximately 1000 amino acids. Collagenase AUX-II is a single polypeptide chain consisting of approximately 1000 amino acids.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect-site Concentration of Propofol for I-gel Insertion During Anesthesia Induction With a Single-dose Dexmedetomidine
Condition: Igel
Study type: Interventional

Summary: 
      Before anethetic induction, infuse dexmedetomidine 0.5 mcg/kg for 2 minutes and after
      injection of lidocaine 30 mg, propofol infusion by using target controlled infusion (TCI)
      pump. Effect site concentraion of propofol start from 5 and changes the concentration as
      previous response to i-gel insertion as up and down methods
    

Detailed description: 
      Before anethetic induction, infuse dexmedetomidine 0.5 mcg/kg for 2 minutes and after
      injection of lidocaine 30 mg, propofol infusion by using target controlled infusion (TCI)
      pump. Effect site concentraion of propofol start from 5 and changes the concentration as
      previous response to i-gel insertion as up and down methods. Failure of previous subjects are
      defined as difficulty to mouth open, severe nausea and couph and laryngeal spasm, and not
      loss of consciousness.
    

Intervention name(s): propofol concentration
Intervention type(s): Drug
Intervention description(s): First subjects start from effect site concentraion of 5ug/ml propofol, after insertion of i-gel, determine the next subjects' effect site concentraion would be increae or decrease 0.5 ug/ml as up and down method
Other intervention name(s): up and down method
Intervention MeSH terms: Propofol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Biomarker Study of Blood Samples From Patients With Non-Small Cell Lung Cancer Treated With Carboplatin and Paclitaxel With or Without Bevacizumab
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood in the laboratory from patients undergoing treatment for
      non-small cell lung cancer may help doctors predict how patients will respond to treatment.

      PURPOSE: This laboratory study is looking at proteomic patterns in stored blood samples from
      patients undergoing treatment for non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To develop a serum proteomic classifier using matrix-assisted
           laser-desorption/ionization time-of-flight mass spectrometry analysis of blood samples
           from patients with non-squamous cell non-small cell lung cancer to predict benefit, in
           terms of survival and time to progression, from treatment with bevacizumab in
           combination with carboplatin and paclitaxel.

      Secondary

        -  To better quantitate candidate biomarkers by using more advanced mass spectrometric
           technologies, including multiple-reaction monitoring and heavy-labeled peptides.

      OUTLINE: Previously collected pre-treatment samples of serum or plasma are randomly selected
      from patients enrolled on protocol ECOG-4599 (i.e., 60 from the bevacizumab arm and 30 from
      the control arm). Samples are analyzed by matrix-assisted laser-desorption/ionization
      time-of-flight mass spectrometry to identify patterns from protein spectra that correlate
      with patient survival.
    

Intervention name(s): bevacizumab; carboplatin; paclitaxel; proteomic profiling; laboratory biomarker analysis; matrix-assisted laser desorption/ionization time of flight mass spectrometry
Intervention type(s): Biological; Drug; Drug; Genetic; Other; Other
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples submitted for research from patients participating in E4599
      
Keywords: stage IIIB non-small cell lung cancer; recurrent non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer
Efficacy and Safety of Single, Low-dose Dexamethasone in Patients After Total Knee Arthroplasty
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to determine the efficacy of an additional preemptive, single,
      low-dose dexamethasone in terms of incidence and severity of postoperative nausea/vomiting
      (PONV), pain level, and the safety in terms of wound complications in patients managed with
      our antiemetic protocol based on Ramosetron following TKA.
    

Detailed description: 
      Postoperative pain and emesis can cause postoperative systemic complications and delay
      recovery and rehabilitation in patients following total knee arthroplasty (TKA). Furthermore,
      patients who suffered from severe postoperative pain and emesis tend to be dissatisfied with
      their surgical treatments. Although contemporary protocols to control perioperative pain and
      emesis after TKA have been reported to substantially reduce postoperative pain and emesis
      compared with traditional measures, pain and emesis after TKA remain to be a challenging
      issue for patients and health care providers. In our previous study, the use of Ramosetron
      was found to reduce postoperative emetic events, but the antiemetic effects by Ramosetron
      were incomplete. In search of a further antiemetic measure, we identified the use of
      dexamethasone as the additional measure fortifying our antiemetic protocol using Ramosetron.
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): Dexamethasone 10 mg intravenous administration
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: postoperative nausea and vomiting; postoperative pain
Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer
Condition: Gastric Cancer; Chemoradiation
MeSH terms: Stomach Neoplasms
Study type: Observational

Summary: 
      Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor
      prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are performed
      in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor
      control compared with NAC. This feasibility trial explored the feasibility and safety of
      neoadjuvant chemoradiotherapy (NACRT) in this type of gastric cancer.
    

Detailed description: 
      Since S-1 (combined drug of tegafur, 5-chloro-2,4-dihydroxypyridine and potassium oxonate)
      was approved in Japan in 1999 after a large-scale clinical trial, adjuvant chemotherapy with
      S-1 has been the standard treatment for stage II/III gastric cancer. However, for
      far-advanced gastric cancer, various adjuvant chemotherapies, including S-1, have not
      achieved satisfactory results. Therefore, Japan Clinical Oncology Group (JCOG) is currently
      performing phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) for locally
      far-advanced gastric cancer. However, previous studies of NAC have reported a pathological
      response rate of 15-50% for the main lesion, indicating no significant effect on local tumor
      control.

      On the other hand, other studies have reported that anticancer drugs, including S-1, have a
      radiosensitizing effect, and that neoadjuvant chemoradiotherapy (NACRT) achieves superior
      local tumor control compared with NAC. Therefore, we conducted a feasibility trial of NACRT
      with S-1 for locally far-advanced gastric cancer combined with adjacent tissue invasion.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  Histologically proven gastric adenocarcinoma

          -  Tumor invasion of adjacent structures (T4) and/or tumors with bulky nodal metastases
      
Biospecimen description: 
      tissue
    
Keywords: Gastric cancer; Chemoradiotherapy; Adjacent tissue invasion; Feasibility trial
Work-To-Rest Ratios
Condition: Hyperthermia
MeSH terms: Hyperthermia
Study type: Interventional

Summary: 
      The purpose of the study is to compare physiological responses to two hours of work adhering
      to two variations of a work-to-rest ratio in a hot environment.
    


Intervention name(s): Work to rest cycles of 40:20 minutes; Work to rest cycles of 20:10 minutes
Intervention type(s): Other; Other
Intervention description(s): Walking in a hot environment for 2 hours with repeated 40 minutes of work and 20 minutes of rest; Walking in a hot environment for 2 hours with repeated 20 minutes of work and 10 minutes of rest
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized counterbalanced study
Masking: None (Open Label)
Primary purpose: Prevention
Comparison of Efficacy of Little Lovely Dentist, Dental Song and Tell-show-do Techniques in Alleviating Dental Anxiety in Paediatric Patients
Condition: Anxiety; Paediatric; Dental Anxiety; Behaviour
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      To evaluate the efficacy of different techniques for the reduction of dental anxiety in
      pediatric patients. Generally, anxiety amongst paediatric patients is higher as compared to
      adult patients. So different modalities are used by the dentists in order to reduce the
      anxiety of such patient to help to make treatment procedures easier and optimal.
    

Detailed description: 
      Children who suffer from dental anxiety avoid any sort of dental treatment provided to them,
      which leads to poor oral hygiene, and if unaddressed, problems like missing teeth and decayed
      teeth further in life develop, and ultimately leading to problems making treatment planning
      intricate. Children normally follow the footsteps of their parents so it is of importance to
      consider how to avoid creating dental anxiety among them. If dental anxiety is left
      untreated, it might persist during adulthood, which eventually will deteriorate the oral
      health of such patients. Due to the substantial effect of dental anxiety in paediatric
      patients, many methods have been devised to alleviate or eliminate such anxieties of the
      patients. This study aimed to employ different strategies and measure heart rate and Facial
      Image Scale scores to determine their efficacy in reducing paediatric patient's dental
      anxiety by using these techniques before and after the procedure to compare the effectiveness
      of each of these techniques.
    

Intervention name(s): Anxiety
Intervention type(s): Behavioral
Intervention description(s): Techniques used to reduce anxiety in paediatric patients.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Anxiety; Dental Application; Dental Song; Tell-Show-Do; Behaviour
Fertility Decision-Making in Youth and Young Adults
Condition: Transgender Adolescents & Young Adults
Study type: Interventional

Summary: 
      The aim of this study is to test if using a web-based medical decision-making tool on the
      topics of fertility and fertility-preservation increases knowledge among transgender youth
      and young adults.
    

Detailed description: 
      The pilot trial of Aid for Fertility-Related Medical Decisions (AFFRMED) is a single-arm,
      pre-/post- feasibility, acceptability, and preliminary efficacy trial. 10 transgender
      adolescents and young adults (AYA) and 10 parents of transgender AYA participated in a 90-120
      min, virtual research visit via Zoom. During this visit they completed pre-test measures of
      fertility knowledge and decisional self-efficacy, followed by up to 1 hour to freely navigate
      AFFRMED decision aid. After using AFFRMED, participants completed post-test measures of
      fertility knowledge and decisional self-efficacy, as well as implementation outcomes measures
      (Acceptability of Intervention, Intervention Appropriateness Measure, and Feasibility of
      Intervention Measure).
    

Intervention name(s): Decision-aid
Intervention type(s): Behavioral
Intervention description(s): The decision aid consists of domains related to human reproduction, fertility, and fertility preservation. The domains address priority learning objectives in each domain to increase knowledge on the impact of gender-affirming medical interventions on fertility and fertility preservation options.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: fertility; decision-making
Patient Controlled Oral Analgesia for Postoperative Pain Management After Total Knee Replacement
Condition: Self-Administered Versus Nurse Administered Pain Medication.
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Patient Centered Care (PCC) is "an approach that consciously adopts the patient's
      perspective...about what matters" (Gerteis, Edgeman, Levitan, Walker, Stokes, Cleary,
      Delbanco, 1993). Experiencing pain is the most common concern of patients before surgery -
      even ahead of whether the surgery would improve their condition (Apfelbaum, 2003). Current
      standard of practice for post-operative pain management in most acute care hospitals today is
      intravenous patient controlled analgesia (IV PCA). However, despite the fact that patients
      prefer IV PCA because it affords them greater control and provides them with better pain
      relief (Ballantyne, Carr, deFerranti, Suarez, Lau, Chalmers, Angelillo, Mosteller, 1998 ;
      Rawal, 2001), hospitals routinely take control of pain medications away from patients once
      they are switched to pain tablets. Patients must then wait, in pain, for their nurse to bring
      them pain tablets.

      Patient controlled oral analgesia (PCOA) has been utilitzed in several centers in the US and
      Germany. Preliminary evidence from the literature seems to indicate that the benefits of PCOA
      are similar to IV PCA including increased patient satisfaction and better pain control
      (Striebel, Romer, Kopf, Schwagmeier ,1996; Striebel, Scheitza, Philippi, Behrens, Toussaint,
      1998). At the Toronto Western Hospital, University Health Network, we have successfully
      implemented a PCOA program on two surgical units (Orthopedics/Rheumatology and Spinal). The
      purpose of this study is to compare usual nurse administered oral analgesia to PCOA with
      respect to pain, patient satisfaction, and passive range of knee motion in postoperative
      total knee replacement patients.
    


Intervention name(s): Self-administration or nurse administered medication
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus
Condition: Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA); (Susceptible or Methicillin Resistant)
MeSH terms: Infections; Communicable Diseases; Staphylococcal Infections; Skin Diseases, Bacterial
Study type: Interventional
Phase: Phase 2

Summary: 
      The study investigates the safety and efficacy of PMX-30063 in patients treated for acute
      bacterial skin and skin-structure infection (ABSSSI).
    


Intervention name(s): Daptomycin; PMX-30063-investigational drug
Intervention type(s): Drug; Drug
Intervention description(s): Active Comparator: Daptomycin.; Experimental: PMX-30063
Intervention MeSH terms: Daptomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MRSA; ABSSSI; Staphylococcus aureus