bioihbjkbjnl/mcl2 huggingface dataset:
SC vs IC Approach for US-guided SC Vein Catheterization
Condition: Central Venous Catheter
Study type: Interventional

Summary: 
      Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane
      infraclavicular subclavian vein (IP-ISV) and in-plane supraclavicular subclavian vein
      (IP-SSV) catheterization.

      For IP-ISV cannulation, a linear transducer is placed in the infraclavicular fossa. After
      obtaining a long-axis view of the axillary vein and distal subclavian vein ,the needle is
      inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under
      real-time US guidance until visualizing the tip of the needle inside the vein while noticing
      the lung pleura underneath the vessels.

      For IP-SSV cannulation, a short-axis view of the IJV is obtained first. The probe is slid
      caudally following the IJV until getting the best long-axis view of the SCV. Using an
      in-plane approach, the needle is inserted at the base of the transducer at a 30° angle and
      advanced under the long axis under real-time US guidance targeting the SCV.
    

Detailed description: 
      Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane
      infraclavicular subclavian vein (IP-ISV) and in-plane supraclavicular subclavian vein
      (IP-SSV) catheterization.

      For IP -ISV, the Linear transducer is placed perpendicularly and inferior to clavicle.
      Transverse (short axis) view of subclavian vein (SCV), subclavian artery (SCA) and pleura is
      first obtained. With SCV centrally positioned, the transducer is rotated 90° clockwise until
      longitudinal view of subclavian vein is obtained. Pulse-wave Doppler view of the SCV confirms
      non-pulsatile flow and identifies the vessel. The needle is than inserted in the midpoint of
      the small footprint transducer using the in-plane approach. The needle is advanced slowly,
      under real-time US guidance targeting the SCV, taking note of the lung pleura underneath the
      vessels.

      For IP-SSV cannulation, a short-axis view of the IJV is first obtained . The probe is slid
      caudally following the IJV until the junction of the subclavian vein (SCV) and IJV is reached
      in the supraclavicular fossa. The probe is then turned slightly and tilted anteriorly to get
      the best long-axis view of the SCV and the brachiocephalic vein .

      Using an in-plane approach, the needle attached to a syringe is inserted at the base of the
      transducer at a 30° angle and advanced strictly under the long axis of the US probe from
      lateral to medial. The needle point is then guided.

      In both groups, catheterization was done through Seldinger technique.
    

Intervention name(s): Catheterization approach
Intervention type(s): Device
Intervention description(s): In plane infraclavicular subclavian vein VS in plane supraclavicular subclavian vein catetherization
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Behavioral and Cognitive Effects of the N-methyl-D-aspartate Receptor (NMDAR) Co-agonist D-serine in Healthy Humans
Condition: Healthy
Study type: Interventional

Summary: 
      The efficacy of compounds having agonistic activity at the glycine site associated with the
      N-methyl-D-aspartate receptor (NMDAR) is presently assessed in psychiatric disorders. In
      contrast to NMDAR antagonists, the neuropsychiatric effects of NMDAR agonists in the healthy
      human organism are not known. The investigators studied neuropsychiatric and neurochemical
      effects of the NMDAR-glycine site obligatory co-agonist D-serine (DSR) in healthy subjects
      using a randomized, controlled crossover challenge design including a baseline assessment day
      and two treatment administration days (DSR and placebo in randomized order). Thirty-five
      subjects aged 23-29 years participated in the study and received a 2.1g orally administered
      DSR dose. The main outcome measures were the changes in scores of mood-related Visual
      Analogue Scale (VAS), Continuous Performance Test - Identical Pairs (CPT-IP), and Rey
      Auditory Verbal Learning Test (RAVLT).
    

Detailed description: 
      The study employed a randomized, double-blind, placebo controlled crossover design according
      to which, following a baseline assessment session, subjects were tested under two acute
      treatment conditions on two separate days. Following the baseline assessment day, 16 subjects
      were randomized, using a computer-generated random number sequence, to receive during test
      day 1 DSR and 19 to receive placebo. During test day 2, these two groups of subjects were
      crossed over to receive the alternative experimental treatment. The time intervals between
      the baseline assessment day, test day 1 and test day 2 were two to three weeks and 1 month
      respectively, in order to avoid the possibility of any carry-over effects.
    

Intervention name(s): D-serine; Placebo
Intervention type(s): Other; Other
Intervention description(s): single P.O. administration of D-serine (2.1g); single P.O. administration of Placebo
Other intervention name(s): DSR; corn starch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: neuropsychiatric effects
Closing the Loop in Youth With Type 1 Diabetes in the Home Setting
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring
      life-long insulin therapy. Children and adolescents with T1D need regular insulin injections
      or the continuous insulin delivery using an insulin pump in order to keep blood glucose
      levels normal. The investigators know that keeping blood sugars in the normal range will help
      prevent long-term diabetes-related complications involving the eyes, kidneys and heart.
      However, achieving treatment goals can be very difficult as the tighter the investigators try
      to control blood glucose levels, the greater the risk to develop symptoms and signs of low
      glucose levels (hypoglycaemia). This is a particular problem at night and one solution is to
      develop a system whereby the amount of insulin injected is controlled by a computer and is
      very closely matched to the blood sugar levels on a continuous basis. This can be achieved by
      what is known as a "closed-loop system" where a small glucose sensor placed under the skin
      communicates with a computer containing an algorithm that drives an insulin pump. The
      investigators have been testing such a system in Cambridge over the last three years in
      children and have found that this system is effective at preventing nocturnal hypoglycaemia.
      The next stage of this research is to test the system for a longer period of time at home. In
      the present study the investigators are planning to study 16 adolescents aged 12-18 years on
      insulin pump therapy. During 21 nights glucose will be controlled by the computer and during
      the other 21 nights the subjects will make their own adjustments to the insulin therapy. The
      investigators will then analyze the data to determine the effect of the computer algorithm in
      keeping glucose levels between 3.9 and 8 mmol/L (normal levels) and reducing the time they
      spent with glucose below 3.9 mmol/L (hypoglycaemia). Subjects' response to the use of the
      system in terms of life-style change, daily diabetes management and fear of hypoglycaemia
      will be assessed. The investigators will also test for longer term glucose control by
      measuring glycated haemoglobin and other blood parameters.
    


Intervention name(s): Overnight closed-loop
Intervention type(s): Device
Intervention description(s): The closed-loop system is purpose-built and comprises a hand-held computer containing the algorithm and communicating with the CGM device and the insulin pump.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Exercise and Back Counselling for Nurses
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Low back pain (LBP) is most common occupational health problem among nurses. Therefore, how
      to prevent and reduce low back pain have been the important issue for nurses. A
      Quasi-Experimental design is used in this study to compare the effectiveness of 12-week
      exercise and counselling program to reduce low back pain in nursing personnel compared with
      counselling alone.
    

Detailed description: 
      A Quasi-Experimental design is used in this study. Purposive sampling is used to recruit
      participants from medical center in Central Taiwan. Participants will be randomly assigned to
      two groups: (1) exercise and back counselling, and (2) back counselling only. The results of
      this study will provide a guideline for nurses to prevent and to improve low back pain.
    

Intervention name(s): Exercise; Back counselling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Twelves-week exercise training sessions include a variety of strength, flexibility, and coordination exercises. Each exercise session lasts for one hour. Participants are expected to attend exercise session once a week and are encouraged to continue exercising at home.; Procedure of back counselling includes one session back counselling, lasting one hour. The topics of back counselling session are as follows: (1) Anatomy of lumbar; (2) Factors causing low back pain; (3) Problems of physical inactivity for the lumbar; (4) Risk of poor postures for developing persistent/chronic low back pain; (5) Maintaining right posture of the lumbar; (6) Avoiding harmful loading of the back during work and leisure time.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Quasi-Experimental design is used in this study. Participants are randomly assigned to exercise and back counselling group or back counselling only group.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary study objective: To confirm the efficacy of HBM9161 subcutaneous injection for the
      treatment of gMG in Chinese patients
    

Detailed description: 
      This is the phase 3 part of a multi-center, randomized, double-blind, placebo-controlled,
      group sequential designed, seamless phase 2/3 study to confirm the efficacy and safety of
      HBM9161 (HL161) subcutaneous injection for the treatment of gMG in patients with generalized
      myasthenia gravis.

      Study drug will be administrated by cycle. Each cycle consists of 5-week treatment period,
      followed by a 4-week observation period (9 weeks in total). During the 5-week treatment
      period, subjects will receive 6 doses of study drug (HBM9161 680 mg or matching placebo) by
      subcutaneous injection, once a week (QW). After the 5-week treatment period, subjects will be
      followed up weekly to assess efficacy and safety. After the completion of first treatment
      cycle, subjects may start the second cycle of treatment if re-treatment criteria are met.
      Otherwise, subjects will be followed up weekly until they are eligible for the second cycle
      or the end of the study, whichever is earlier.
    

Intervention name(s): HBM9161 Injection (680mg); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HBM9161 Injection; Placebo Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: To confirm the efficacy of HBM9161 subcutaneous injection for the treatment of gMG in Chinese patientsTreatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MG
Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge
Condition: Cytomegalovirus Infection
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Objectives of this trial are to:

      Evaluate the kinetics and magnitude of the CMV-specific immune response post-Towne challenge
      (3000 pfu) in healthy CMV-seronegative volunteers who receive VCL CT02 administered (1 mg
      weekly x 3) 3 months previously compared to randomized controls who do not receive VCL CT02
      as measured by:

        1. antibody titers for gB;

        2. T-cell IFN-g ELISPOT;

        3. T-cell proliferation assays for IE1, pp65, and/or gB; and

        4. cytokine and phenotypic flow cytometry responses to pp65, IE1, and/or gB.

      Evaluate the safety safety of Towne challenge in healthy CMV-seronegative adult subjects who
      have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02) administered
      intramuscularly.

      Our hypothesis is that the immune response to Towne vaccine 3000 pfu challenge after VLC-CT02
      priming will be greater than that after Towne vaccination alone.
    

Detailed description: 
      This is a Phase 1, single-center, randomized, open-label trial of the live, attenuated Towne
      CMV vaccine administered as a "challenge" to healthy, CMV-seronegative, adult subjects who
      previously receive the CMV immunotherapeutic trivalent pDNA-based vaccine, VCL-CT02, given by
      intramuscular route at Days 1, 7 and 14 or who receive no VCL-CT02.

      Up to 12 healthy, CMV-seronegative subjects will be enrolled. If a subject consents and meets
      all eligibility criteria, the subject will be randomized to the VCL CT02 (N=6)or control
      (N=6) groups. VCL CT02-assigned subjects will receive VCL CT02 (1 mg weekly x 3) and then on
      Day 77 will received Towne vacine (3000 pfu subcutaneously). Control-assigned subjects will
      receive Towne alone. Safety will be monitored and both antibody to CMV gB and T-cell
      responses to CMV antigens will be measured at specified intervals for 252 days post Towne
      challenge.
    

Intervention name(s): VCL CT02 pDNA vaccine; Towne CMV vaccine
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cytomegalovirus; vaccine; T cell; antibodies
Neural Correlates of Lower Extremity Motor Recovery in Stroke Patients: Longitudinal Diffusion Spectrum Imaging Studies
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      To investigate the relationship between the integrity of the white matter, including the
      corticospinal tracts and the corpus callosum, with the recovery of lower extremity function
      in patients with cerebral stroke at the subacute and chronic stages.
    

Detailed description: 
      Recent studies have provided strong evidence that motor recovery after adult ischemic stroke
      is a function of neural plasticity. Up to date, it remains largely unknown as to the
      relationship between the integrity of the subcortical white matter with the lower extremity
      function recovery. Given the fact that the white matter is more resistant to ischemia after
      acute stroke than the gray matter (Falcao et al., 2004) and that the intensity of white
      matter in stroke has been found to be much greater in many brain areas in stroke than in
      healthy controls (Wen et al., 2004), it is of interest to study how the integrity of the
      subcortical white matter, primarily the corticospinal tracts and the corpus callosum,
      contributes to the recovery of lower extremity function in subacute and chronic stroke with
      lesions involving different areas of the brain.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        stroke patients
      
Keywords: Stroke; Diffusion spectrum tractography; Functional MRI (fMRI); Lower extremity
"Evaluation of Postural Control in Children With Increased Femoral Anteversion"
Condition: Femoral Anteversion; Gait Disorders in Children; Postural Control; Postural Stability; Balance
Study type: Observational [Patient Registry]

Summary: 
      The relationship between increased femoral anteversion and postural control in healthy
      children has not been studied in the current literature. To our knowledge there is no study
      to evaluate postural control in children with increased femoral anteversion by computerized
      posturography. We aimed to evaluate postural control in children with increased femoral
      anteversion using computerized dynamic posturography (Biodex Balance System).
    

Detailed description: 
      Femoral anteversion is defined as the angle formed by the femoral condyles plane (bicondylar
      plane) and a plane passing through the center of the neck and femoral head. Toe-in-gait
      pattern may be due to foot deformity (metatarsus adductus) and / or abnormal transverse
      alignment of long bones (tibial torsion and / or increased femoral anteversion). Transverse
      plane deviations are frequently seen in infants and usually improve with typical
      physiological growth mechanisms. Persistent transverse plan disorder may lead to gait
      dysfunction. The most important function of the posture is to maintain the balance during the
      initiation and continuation of the movement. Postural control regulates maintaining the
      balance and keeping the center of gravity within the body's stability limits. It includes
      resistance to gravity forces and mechanical support during movement. Postural control is an
      integral part of achieving targeted action. To our knowledge the relationship between
      increased femoral anteversion and postural control in healthy children has not been studied
      in the current literature. Postural control in children with increased femoral anteversion
      was evaluated by computerized posturography. In this study, we aimed to evaluate postural
      control in children with increased femoral anteversion using computerized dynamic
      posturography (Biodex Balance System).
    

Intervention name(s): Biodex Balance System; Balance Error Scoring System (BESS)
Intervention type(s): Other; Other
Intervention description(s): For the computerized evaluation of postural control, Biodex Balance System will be used.; For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        16 children with bilateral increased femoral anteversion aged 6-15 years followed by
        Bezmialem Vakıf University Department of Orthopedics and Traumatology.

        16 healthy volunteers aged 6-15 years will be included in the control group.
Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids) Fitness Ancillary
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      The purpose of this ancillary study is to examine cardiorespiratory fitness, cognitive
      factors related to appetite, and objectively-measured food intake in a subsample of children
      and adolescents with overweight to severe obesity enrolled in the TIGER Kids prospective
      cohort. The primary study also collects data on habitual physical and sedentary activity,
      body weight and body composition, and cardiometabolic health markers.
    

Detailed description: 
      The investigators will enroll 30 boys and girls (50% female) between the ages of 10-16 years
      and above the 85th BMI percentile (i.e., overweight to severe obesity) in this pilot
      ancillary study. The objective is to examine interactions between the following
      energy-balance related factors:

        1. Ad libitum post-exercise food intake

        2. Cognitive factors, including inhibitory control, food wanting, and motivation for food

        3. Exercise-related factors, including cardiorespiratory fitness, substrate utilization
           (carbohydrate versus fat), and perceived exertion

        4. Habitual physical and sedentary activity

        5. Body composition and cardiometabolic health

      The prospective, longitudinal nature of the study will allow the investigators to examine
      these variables cross-sectionally and quantify change over two years. Of particular interest
      is whether cognitive factors related to energy balance, including perceived exertion,
      inhibitory control, food wanting, and food motivation, vary across time or are relatively
      stable. Finally, the investigators will assess the ability of these factors to predict
      changes in body composition and cardiometabolic health over two years.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will identify and recruit 30 participants from the TIGER Kids primary study
        sample of 340 participants. Ancillary participants will be between the ages of 10-16 years
        and above the 85th age- and sex-specific BMI percentile (i.e., overweight to severe
        obesity). We will have an even distribution of boys (n=15) and girls (n=15) and aim to have
        a representative distribution of race.
      
Biospecimen description: 
      Per the TIGER Kids primary study protocol, an aliquot of sample will be stored in case
      further tests are needed and if further consent is obtained from the subject. However, no
      additional samples are retained for the ancillary study.
    
Keywords: Cardiorespiratory fitness; Inhibitory control; Motivation; Food intake; Body composition
Effect of Pneumoperitoneum Anterior Abdominal Wall Tissue Oxygenation
Condition: Laparoscopy; Abdominal Wall
MeSH terms: Pneumoperitoneum
Study type: Interventional

Summary: 
      During laparoscopic surgery, the abdomen is inflated with carbon dioxide for abdominal
      imaging and increased intraabdominal pressure affects intraabdominal structures and abdominal
      wall.
    

Detailed description: 
      The investigators aimed to investigate the effects of pneumoperitoneum administered during
      laparoscopic cholecystectomy on abdominal wall oxygenation and postoperative pain scores.
    

Intervention name(s): rso2
Intervention type(s): Device
Intervention description(s): The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.
Other intervention name(s): abdominal wall tissue oxygenation
Intervention model: Single Group Assignment
Intervention model description: prospective, cohort,double blind
Masking: None (Open Label)
Primary purpose: Diagnostic