bioihbjkbjnl/mcl2 huggingface dataset:
A New Neuraxial Position Technique " The Anatolian Sitting Position- Sitting Fetal Cross-legged"
Condition: Anesthesia, Conduction
Study type: Interventional

Summary: 
      A prosperous neuraxial anesthesia positioning ensures a raised chance of successful needle
      placement. The primary aim is to compare "The Anatolian sitting position-ASP" with "The
      Sitting Fetal Position-SFP" sonographically. Secondary aim is to compare their comfort.
    

Detailed description: 
      Fifty participants were included to this prospective, randomized, consecutive controlled
      clinical study. Six parameters were evaluated in each position; subcutaneous tissue (ST),
      skin to spinous process (S-SP), transverse diameters of bilateral paraspinal muscles (left
      paraspinal muscle [LPM] and right paraspinal muscle [RPM]), interspinous gap opening (ISGO),
      mean of bilateral paraspinal muscles (MPM). The change of every measurement recorded via
      ultrasonography (USG) according to the positioning techniques (the Anatolian Sitting Position
      [ASP] could also be named as "sitting fetal cross-legged position" and the Sitting Fetal
      Position [SFP] which is a traditional sitting position) were also calculated. The
      calculations are explained briefly in primary outcomes (including the change of ASP-SFP in
      ST, S-SP, LPM, RPM, MPM, ISGO). Stretcher comfort (SC), position comfort (PC), lumbar comfort
      (LC), and abdominal comfort (AC) were evaluated by the participants with the 5-point
      Numerical Rating Scale (NRS).
    

Intervention name(s): The SFP technique; The ASP technique
Intervention type(s): Procedure; Procedure
Intervention description(s): The USG, and the 5-point NRS evaluation in the SFP; The USG, and the 5-point NRS evaluation in the ASP
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Systematic randomization was made from 150 volunteers, and 50 participants were chosen.
All 50 participants were planned to sit on the stretcher in both of the two positioning techniques sequentially (one after another). The two positioning techniques are 1) sitting fetal position-" the SFP" ( a traditional position ) and 2) sitting fetal cross-legged-" the ASP" ( a new position, named as " Anatolian sitting position"). The investigator was planned to record all of the participants' anatomical measurements in both of those positioning techniques evaluated via ultrasonography. After each position participants were planned to evaluate each positioning technique's comfort by 5-point numerical rating scale from minimum 1 meaning "poor" to maximum 5 meaning "excellent."
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: neuraxial anesthesia positioning technique; Anatolian sitting position; sitting cross-legged position; sitting fetal position; ultrasonography; numerical rating scale
CM-101 in NASH Patients - The SPLASH Study
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2a study is a multi-center, double-blind randomized, placebo-controlled study. The
      study is designed to determine the safety and tolerability of the anti-human CCL24 monoclonal
      antibody CM-101 in adult patients with non-cirrhotic nonalcoholic steatohepatitis (NASH)
      patients with stage 1c, 2 or 3 fibrosis. The patients will be randomized to 1 of 2 treatment
      groups: 5 mg/kg CM-101 or placebo.
    

Detailed description: 
      This study will consist of screening period, treatment period and follow-up period. Adults
      with NASH will be included. Each subject will undergo screening procedures within up to 42
      days prior to Randomization, to assess eligibility to participate in the study. After
      randomization patients will receive a dose of investigational product once every 2 weeks for
      a total of 8 administrations. This will result in a total coverage of 16 weeks. Study
      participation will last for up to approximately 26 weeks (up to 6 weeks for screening
      followed by 14 weeks treatment and 6 weeks follow-up).
    

Intervention name(s): 5 mg/kg CM-101; Placebo
Intervention type(s): Biological; Other
Intervention description(s): CM-101, Monoclonal Ab blocking CCL24; Placebo
Intervention MeSH terms: Streptococcal polysaccharide type III group B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anti-fibrotic
Childhood Origins of Asthma (COAST)
Condition: Asthma; Allergy
MeSH terms: Asthma
Study type: Observational

Summary: 
      Although asthma is likely to be a heterogeneous disease or syndrome, three factors and/or
      events repetitively emerge for their ability to significantly influence asthma inception in
      the first decade of life: immune response aberrations, which appear to be defined best by the
      concept of cytokine dysregulation; lower respiratory tract infections (in particular RSV);
      and some form of gene by environment interaction that needs to occur at a critical time
      period in the development of the immune system or the lung. It remains to be firmly
      established, however, how any one or all of these factors, either independently or
      interactively, influence the development of childhood asthma. Thus, our efforts to determine
      and define the importance of these three factors to asthma pathogenesis are the focus and
      goal of this current grant application.
    

Detailed description: 
      No more description necessary.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        High risk birth cohort of children (one or both parents have allergies and/or asthma).
      
Biospecimen description: 
      nasal mucus samples, cord blood, peripheral blood samples, nasal cell brushing samples, cell
      lines
A Comparison of Pain Severity on Injection of MCT/LCT Propofol Between Lidocaine 20 mg, 40 mg, and Without Lidocaine.
Condition: Adult Disease
MeSH terms: Pain
Study type: Interventional

Summary: 
      To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20 mg, 40 mg,
      and without lidocaine.
    

Detailed description: 
      Background: Intravenous injection of propofol produces pain. Many factors are involved and
      various techniques have been tried to minimize the propofol-induce pain with variable
      results.

      Objective: To compare the severity of pain on injection of MCT/LCT propofol with lidocaine 20
      mg, 40 mg, and without lidocaine.

      Design: Randomize controlled trial. Method: Two hundred and ten ASA class I - III patients
      undergoing elective surgery were blinded and equally allocated into 3 groups. Patients in
      group N, L1, and L2 received MCT/LCT propofol 10 ml mixed with 0.9% NaCl 2 ml, 1% lidocaine 2
      ml, and 2% lidocaine 2 ml respectively. Pain at time of propofol injection was assessed by
      blinded anesthesiologist on a four point scale ; 0 = no pain, 1 = mild pain, 2 = moderate
      pain, and 3 = severe pain. Results: Patient's demographic data of each group were similar.
      There were significant differences in the incidence of propofol injection without pain among
      groups (p<0.001). The numbers of patients who had moderate and severe pain in groups L1 and
      L2 were significantly less than those in group N (p<0.001). The mean blood pressure and heart
      rate were not significant differences in among groups. Conclusion : The amount of 20 mg, and
      40 mg lidocaine to MCT/LCT propofol in our study is equally effective in decreasing pain and
      more effective than MCT/LCT propofol alone group significantly. They were no significant
      differences in hemodynamics change in among groups.
    

Intervention name(s): Lidocaine
Intervention type(s): Drug
Intervention description(s): dosage 20 mg and 40 mg
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Citrate Dialysate on Clot Formation and Anemia in Hemodialysis Patients
Condition: Hemodialysis; Citrate; Heparin
MeSH terms: Anemia
Study type: Interventional

Summary: 
      Acetate-free citrate containing dialysate is expected to be clinically effective in
      maintaining hemodynamic stability during hemodialysis (HD). It has been demonstrated that
      citrate dialysate help produce a local anticoagulant effect by chelating ionized calcium.
      Moreover, citrate can improve phosphate and beta2 macroglobulin and better control of
      arterial hypertension and hemoglobinemia. We therefore would like to study the effect of
      citrate dialysate on clot formation and anemia while reducing heparin in chronic hemodialysis
      patients.
    

Detailed description: 
      This is the prospective comparison study. This study enrolled chronic hemodialysis patients
      age more than 18 who undergo hemodialysis 3 times per week for at least 3 months. All the
      patients should have serum ferritin 200-1000 ng/L and TSAT of 15-50%. The investigators
      exclude patients with age more than 70 years, comorbidities influencing citrate metabolism
      (hepatic failure,liver transplantation,cancer with bone metastasis), patients using heparin
      free protocol, hyperkalemia worsened by hypocalcemia, contraindication to heparin, treatment
      with cinacalcet or oral anticoagulant, patients using central venous catheter with blood flow
      less than 300 ml/min, and patients using low molecular weight heparin.

      The study will be conducted in three phases over a period of 4 months. After run-in period
      for 2 weeks using acetate dialysate, the heparin dose will be titrated to lowest effective
      dose. During the first phase, citrate was replaced for acetate and heparin will be reduced to
      50%. The second and third phase will be performed by reducing heparin doses to 25 % and
      heparin free consecutively. Each phase lasts for 4 weeks. Washout period for 2 weeks will be
      alternated after each phase.

      Data collection: The investigators measure blood chemistries such as CBC, BUN creatinine
      electrolytes calcium phosphorus and KT/V at the beginning and at the end of each session.
      Ionized calcium will be monitored pre and post dialysis in each session. In addition, the
      investigators record clot score and erythropoietin dosage in each session and each phase.
    

Intervention name(s): Citrate dialysate
Intervention type(s): Device
Intervention description(s): Change form acetate to citrate dialysate
Intervention MeSH terms: Dialysis Solutions
Intervention model: Single Group Assignment
Intervention model description: prospective comparison study
Masking: None (Open Label)
Primary purpose: Treatment
Desaturation Validation of INVSENSOR00039
Condition: Healthy
Study type: Interventional

Summary: 
      This study is designed to compare the accuracy of a noninvasive measurement of oxygen
      saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial
      blood samples will be collected from healthy adult subjects while undergoing a desaturation
      procedure wherein the concentration of oxygen inhaled is slowly reduced. The subject will
      then be returned to breathing room air.
    


Intervention name(s): INVSENSOR00039
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Circuit Training and Aerobic Exercise Among Sedentary Elderly Population
Condition: Sedentary Behavior; Old Age; Debility
MeSH terms: Frailty
Study type: Interventional

Summary: 
      To compare the effects of Circuit training and aerobic exercise on cardiopulmonary fitness
      among Sedentary elderly population
    


Intervention name(s): Circuit Training program; Continuous aerobic exercise Group
Intervention type(s): Other; Other
Intervention description(s): The 4 weeks Circuit Training program, it will be of 3 times per week. Each CT workout includes 6 stations per circuit Training. Before the training period, all participants underwent an exercise familiarization session to ensure proper execution of technique.
The 6 stations will be included as 40 lb. carry for 100 ft., 3-min stair climb, 45 s plank pose, 20 lb. carry with a fast walk for 100 ft., right and left single leg stands for as long as balance was maintained, and a 15 lb. carry up and down 30 stairs; Continuous aerobic exercise Frequency 3 time per week Intensity 50% of Heart rate reserve Type continuous aerobic exercise Time 40 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Aerobic Exercise; Circuit Training
A Trial to Compare Three Methods of Performing Hysterosalpingography
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is:

        -  to determine whether the choice of the device for performing hysterosalpingography on
           the basis of the cervix characteristics can reduce the procedure failure rate;

        -  to determine whether patient medical history is correlated with the degree of pain
           experienced during the HSG procedure.
    

Detailed description: 
      A group of women will be randomized to undergo HSG, using 1) a balloon catheter in a first
      group of patients; 2) a cervical vacuum cup in a second group; 3) one of the two devices
      decided by the operator depending on the cervix characteristics in a third group (that will
      be named "operator's choice").

      The operator will ask the woman to evaluate the degree of pain experienced during the
      application of the device and the injection of the contrast, after 2, 6 and 24 hours. The
      degree of pain will be evaluated using the VAS system, an analogue scale rating from 1 to 10.

      A nurse will notice the patient's reaction and will evaluate the pain, depending on the
      movements of the hands and the body and the woman's moaning. Moreover, the assistant will
      note down the personal data and the history of the patient. The operator will record the
      objective and subjective difficulty of the performance, using a rating scale from 0 to 9. The
      length of the procedure, the volume of contrast used, the amount of radiations and the time
      of exposure of the patient will also be considered.

      At the end of HSG both the gynaecologist and the radiologist will express their satisfaction
      upon the examination with a score from 0 to 10.
    

Intervention name(s): Balloon catheter; Cervical vacuum cup
Intervention type(s): Procedure; Procedure
Intervention description(s): Hysterosalpingography is performed using intrauterine balloon catheter; Hysterosalpingography is performed using cervical vacuum cup
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Balloon catheter; Cervical vacuum cup; Hysterosalpingography; Infertility; Pain; Fallopian Tube Patency Tests; Female Infertility
Oxytocin in Spectrum Autism Disorders
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Observe effects of oxytocin on individuals with autism spectrum disorder
    

Detailed description: 
      To observe the effects of oxytocin on individuals with autism spectrum disorder according to
      gender, in facial recognition and eye tracking tests. The investigators will apply the nepsy
      and eye tracking tests before and 45 minutes after the puff with oxytocin or placebo at the
      dose of 0.4 IU / kg / dose maximum of 24 IU. The next week the volunteer will return and will
      do the same procedure because whoever took the placebo would take oxytocin and vice versa. Is
      a randomized, double-blind, placebo-controlled clinical trial.
    

Intervention name(s): Oxytocin; placebo
Intervention type(s): Drug; Other
Intervention description(s): Single dose oxytocin 45 minutes before the test; saline solution 0,9% spray nasal
Other intervention name(s): syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Effects of Two Supervised Training Programs for the Rehabilitation of Ankle Sprains
Condition: Ankle Sprains
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effects of supervised balance and
      proprioceptive neuromuscular facilitation (PNF) training for the rehabilitation of ankle
      sprains
    

Detailed description: 
      Supervised proprioceptive training has been recommended by recently published guidelines for
      the rehabilitation of ankle sprains. However, research evidence on the efficacy of this type
      of training is still weak, mainly owing to the methodological limitations of relevant
      studies. In addition, there is paucity of evidence concerning the effects of such training
      for the outcomes of functional performance, pain, ankle range of motion, and contradictory
      results have been reported for postural control.

      This study aimed to substantiate the benefits of supervised training for the rehabilitation
      of ankle sprains, and elucidate the effects of two different proprioceptive protocols on the
      above-mentioned outcomes.
    

Intervention name(s): PNF training; Balance training
Intervention type(s): Other; Other
Intervention description(s): Ten individual PNF sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period; Ten individual balance sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Novel Alpha-Glucan Metabolism
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      These are the characteristics of the project:

      Monocentric:

      Double blind randomized and crossover: you will test all the 3 products in random order.
    

Detailed description: 
      This study will be randomized, double blind, placebo-controlled, single-center, and 3x3
      crossover in design. Eligible participants will be randomized to receive the below products
      in single dose and in different random sequence, as determined by the randomization system

        1. 50 g novel alpha glucan

        2. 50 g (rapidly digestible control)

        3. 15 g (dietary fiber)
    

Intervention name(s): Drinkable solution
Intervention type(s): Dietary Supplement
Intervention description(s): the volunteer will consume the volume 300 ml of water with
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3X3
Masking: Double (Participant, Investigator)
Primary purpose: Other
An Expanded Access Program of Pegfilgrastim (Neulastim) in Participants With Non-Hodgkin's Lymphoma (NHL)
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the prophylactic effect of pegfilgrastim (Neulastim) on febrile and/or
      Grade IV neutropenia in participants receiving chemotherapy (CT) or immunochemotherapy (ICT)
      as first or second line treatment for NHL. Pegfilgrastim will be administered at a fixed dose
      of 6 milligrams (mg) subcutaneously 24 hours after the last dose of CT or ICT in each
      treatment cycle.
    


Intervention name(s): Chemotherapy; Immunochemotherapy; Pegfilgrastim
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The choice of CT will be as per standard of care and protocol does not specify any particular CT drug.; The choice of ICT will be as per standard of care and protocol does not specify any particular ICT drug.; Pegfilgrastim will be administered at a fixed dose of 6 mg subcutaneously 24 hours after the last dose of CT or ICT is received for 6 cycles.
Other intervention name(s): Neulastim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Thoracotomy Closure Technique and Postoperative Pain Study: A Randomized Controlled Trial
Condition: Hernia; Lung Cancer
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this study is to examine pain associated with thoracotomy (incision made
      during surgery to obtain access to your thoracic cavity) and how the closure technique may
      influence postoperative pain. Two types of routinely selected thoracotomy closure techniques
      will be examined; pericostal and intracostal sutures. The investigators hypothesize that
      intracostal sutures will result in less postoperative and chronic pain as a result of less
      compression of the intercostal nerve.
    


Intervention name(s): Pericostal suture technique; Intracostal suture technique
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thoracotomy; Pain; Intracostal Suture; Pericostal Suture
A Bioequivalence Study Between Fluticasone Salmeterol Xinafoate vs. ADVAIR DISKUS® in Healthy Volunteers
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioequivalence study between two inhaler products of fixed dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder
    

Detailed description: 
      A bioequivalence study of a single dose of the fixed-dose combination of fluticasone
      propionate and salmeterol xinafoate inhalation powder administered from Fluticasone
      propionate 500 mcg and Salmeterol xinafoate 50 mcg inhalation powder/Respirent
      Pharmaceuticals (test-Τ) as 2 inhalations and ADVAIR DISKUS® 500/50 mcg inhalation powder/GSK
      (reference-R) in healthy volunteers under fasting conditions. The study will be one-center
      crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded.
    

Intervention name(s): Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg; ADVAIR DISKUS
Intervention type(s): Drug; Drug
Intervention description(s): 2 inhalations of Test and Reference product in each study period; 2 inhalations of Test and Reference product in each study period
Other intervention name(s): Fluticasone propionate 500mcg and salmeterol xinafoate 50mcg/Respirent Pharmaceuticals; Fluticasone propionate 500mcg and salmeterol xinafoate 50mcg
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: One-center crossover, randomized, 2-period, 2-sequence (RT and TR), single dose, laboratory-blinded study
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: inhaler; fluticasone proprionate; salmeterol xinafoate; ADVAIR DISKUS