bioihbjkbjnl/mcl2 huggingface dataset:
Retroclavicular Versus Costoclavicular Approach for Infraclavicular Brachial Plexus Block
Condition: Disorder of Upper Extremity
Study type: Interventional

Summary: 
      The primary aim of this study is to compare needle shaft visibility between the
      retroclavicular approach and costoclavicular approach for infraclavicular brachial plexus
      block in patients undergoing elective upper limb surgery. Secondary aim is to investigate the
      differences between the two groups in sensorial block success rate, block performance time,
      block performance related pain, motor block success rate, surgical success rate,
      complications, patient satisfaction, use of supplemental local anesthetic, use of analgesic.
    

Detailed description: 
      Infraclavicular blocks are performed with different approaches. This study evaluated the
      effectiveness, safety and feasibility of a retroclavicular brachial plexus block as compared
      with costoclavicular approach for infraclavicular brachial plexus block. 60 patients
      scheduled for elective upper limb surgery were recruited and randomized into two groups:
      Retroclavicular approach for infraclavicular block (Group I), costoclavicular approach for
      infraclavicular block (Group R). Sensory block, adverse effects and complications were
      evaluated and recorded every 5 minutes until 30 min after local anesthetic injection. Success
      rate of each nerve sensory block, complications, rate of satisfaction, rate of failure and
      incidence rate of adverse effects, the needle shaft visibility, procedure time,duration of
      the block's effect, use of supplemental local anesthetic, use of analgesic are compared with
      both groups.
    

Intervention name(s): retroclavicular approach; costoclavicular approach
Intervention type(s): Other; Other
Intervention description(s): Retroclavicular approach for ultrasound guided infraclavicular brachial plexus block; costoclavicular approach for ultrasound guided infraclavicular brachial plexus block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: infraclavicular brachial plexus block; retroclavicular approach; costoclavicular approach; upper limb surgery; needle shaft visibility
Evaluation and Modeling of the G-CSF Effect on the Evolution of Neutrophils During Chemotherapy Based on Eribulin
Condition: Breast Cancer
Study type: Interventional

Summary: 
      The anti-cancer cytotoxic chemotherapy is often the cause of neutropenia of grade IV or
      febrile neutropenia. Those neutropenia, in addition to being a comorbidity factor, result in
      dose reductions and/or temporary or permanent stop of chemotherapy, thus impacting clinical
      response. To avoid those episodes, or to shorten the duration and reduce the associated risk,
      administration of Granulocyte Colony Stimulating Factor (G-CSF) is recommended. Recombinant
      G-CSF reproduces the physiological effects of endogenous G-CSF by increasing the
      proliferation of granulocytes progenitors. Different forms of G-CSF are available: daily
      administration (such as filgrastim, lenograstim) and a single administration (pegfilgrastim).

      Various international learned societies offer recommendations for primary care, secondary or
      curative neutropenia induced by chemotherapy based on G-CSF. However, guidance on the ideal
      time for the administration of growth factors and duration of administration are not very
      clear. If it seems clear that the treatment should not be initiated within the first 24 hours
      following administration of chemotherapy, summaries of the characteristics of different
      products do not provide evidence to optimize the administration day depending on the kinetics
      evolution of neutrophils. In addition, no information is given as to the choice of a
      formulation with respect to the other.

      The pilot study the investigator propose aims to model the effect of exogenous G-CSF on the
      evolution of neutrophil function of time and explain the pharmacodynamic variability during
      the administration of chemotherapy based on eribulin. The description of the evolution of
      neutrophils when growth factors are administered give the opportunity to streamline
      administration regimens of these factors and to provide guidance on the circumstances in
      which they should or should not be given while weekly chemotherapy.

      Expected benefits and foreseeable risks With the exception of surplus withdrawals during the
      first 2 cycles of treatment, this study will have no impact on the care of patients.
    


Intervention name(s): ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor)
Intervention type(s): Procedure
Intervention description(s): 8 additional blood samples
Intervention MeSH terms: Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Long-term Varenicline Treatment for Smoking Cessation
Condition: Smoking
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a clinical study of the efficacy and safety of up to 52 weeks of varenicline therapy
      in conjunction with individual counseling for smoking cessation. Adult volunteers in
      generally good health, smoking 5 or more cigarettes per day, will receive 13 weeks of
      open-label varenicline therapy. At 12 weeks after their target quit date, they will be
      assigned in a random, double-blind manner to either 40 additional weeks of varenicline or
      placebo. It is hypothesized that biochemically-confirmed abstinence rates will be higher for
      the varenicline group at 52 weeks. Participants will be followed for an additional 26 weeks
      post-treatment.
    


Intervention name(s): varenicline; varenicline; Individual smoking cessation counseling
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Extension of 1 mg twice daily treatment to 52 weeks; Double-blind switch to placebo after 12 weeks of open-label therapy; Brief (<10 minutes) smoking cessation counseling delivered at clinic visits
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking; relapse; withdrawal
Primary Vitrectomy for the Treatment of Retinal Detachment in Highly Myopic
Condition: Intraocular Pressure,; Postoperative Complications
MeSH terms: Retinal Detachment; Postoperative Complications
Study type: Observational

Summary: 
      Purpose:

      To assess the functional and anatomical outcome of primary vitrectomy without scleral
      buckling for rhegmatogenous retinal detachment (RRD) in highly myopic eyes with axial length
      over 30 mm.

      Methods Design: Retrospective single center series. Setting: University Hospital. Patients:
      High myopic patients treated with primary vitrectomy without scleral buckling for a
      rhegmatogenous retinal detachment.

      Outcome measures: Anatomical success rate with complete reattachment of the retina without
      silicone oil tamponade and postoperative best-corrected visual acuity (BCVA).
    


Intervention name(s): Pars plana vitrectomy with gas tamponade
Intervention type(s): Procedure
Intervention description(s): A standard three-port 20 Gauge vitrectomy under a wide-angle-viewing contact lens was performed. Peripheral vitreous shaving was completed under slit-lamp illumination without contact lens by gentle scleral indentation. Posterior hyaloid detachment was checked and completed if necessary without dye. The epiretinal membrane removal or internal limiting membrane (ILM) peeling was performed if necessary. In general this latter procedure was not conducted for RD secondary to peripheral retinal tears without any sign of PVR or ERM but was done in almost all cases related to posterior break.
Subretinal fluid was aspirated through the retinal tear, the MH, the PVT or through a retinotomy to obtain a complete peroperative retinal reattachment.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        On the basis of axial length greater than 30 mm, 67 eyes of 67 patients with at least
        six-month follow-up in our department were selected.
      
Keywords: Retinal detachment; high myopia; macular hole; axial length; Scleral buckling; Vitrectomy; Visual acuity; fundus examination results
Resisted Sprint and Plyometric Training on Lower Limb Functional Performance in Young Adult Male Football Players.
Condition: Football Players
Study type: Interventional

Summary: 
      This study aims to evaluate the short-term effects of resisted sprint training on sprint
      performance together with lower limb physiological and functional performance in young
      professional football players.
    

Detailed description: 
      Ninety collegiate football players were recruited, with a mean age of 20.48 at the university
      campus. All of which were randomly divided into two experimental groups RST(n=30), PLT (n=30)
      participated in training for six weeks on alternate days (i.e., three sessions per week) and
      one control group (n=30) did not train. The control group was instructed to maintain regular
      activities and avoid any strenuous physical activity during the study. No significant
      between-group baseline or pre-to-post-training differences in anthropometrics were observed.

      Under the Declaration of Helsinki, participants were informed about the study's possible
      risks and benefits, and all participants have signed informed consent before participation in
      the study. Ethical sub-committee of College of applied medical science, Majmaah, Saudi Arabia
      approved this study (Ethics Number: MUREC-Dec.15/COM-2020 / 13-2).
    

Intervention name(s): Resisted Sprint Traininig
Intervention type(s): Other
Intervention description(s): The Participants in this group had received plyometrics exercises; double leg jumping, drop jumping, hopping, bounding and hurdling.
Other intervention name(s): Plyometric Training
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Strength; Plyometric training; Function performance; Resisted sprint training
Study in Taiwanese Subjects Identified as CYP2C19 Poor and Extensive Metabolizers Receiving Rosuvastatin
Condition: CYP2C19 Poor; Extensive Metabolizers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to examine Taiwanese subjects identified as CYP2C19 poor
      and extensive metabolizers while taking single and multiple dosing a rosuvastatin calcium.
    


Intervention name(s): Rosuvastatin Calcium
Intervention type(s): Drug
Intervention description(s): single oral dose on days 1, 4, 5, 6, 10-16, 17
Intervention MeSH terms: Rosuvastatin Calcium; Calcium
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Taiwanese Subjects; CYP2C19; Poor Metabolizers; Extensive Metabolizers; Taiwanese Subjects identified as CYP2C19 Poor or Extensive Metabolizers
Efficacy of Golimumab in Early Axial Spondyloarthritis in Relation to Gut Inflammation
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      The hypothesis of the study is that the presence of (subclinical) gut inflammation at
      baseline in patients with early active axial spondyloarthritis predisposes to a more severe
      disease defined as more need to use anti-tumor necrosis factor α therapy and a shorter time
      to relapse after stopping anti-tumor necrosis factor α therapy after obtaining sustained
      clinical remission. Overall, the investigators hypothesize that subclinical gut inflammation
      is an important predictor in therapy response and outcome. These data could provide better
      insights into the complex interactions between gut and joint inflammation and guide the
      physicians in the therapeutic approach.
    


Intervention name(s): Golimumab
Intervention type(s): Drug
Intervention description(s): Axial spondyloarthritis patients who don't have a good treatment response on 2 NSAIDs, will be treated with golimumab. After remission, the therapy will be stopped.
All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission.
Other intervention name(s): ileocoloscopy
Intervention MeSH terms: Golimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of High Intensity Interval Training (HIIT) vs. Inspiratory Muscle Training on the Recovery After a Maximal Apnea.
Condition: Exercise Training; Respiratory Muscle Training; High-Intensity Interval Training; Apnea
MeSH terms: Apnea
Study type: Interventional

Summary: 
      The aim of this randomized cross-over controlled study was to assess the effects of an 4-week
      exercise program on the recovery capacity after a voluntary maximal apnea. Participants will
      be randomly allocated to receive either a high intensity interval training (HIIT), or an
      inspiratory muscle training (IMT) using an inspiratory resistance device.
    

Detailed description: 
      It is a multi-center study. 3 different Spanish Freedivers Centres are included in the study
      (Madrid, Zaragoza, and Barcelona).

      For each participant, exercise program started with one or the other program. Hence, both
      interventions were applied once with the participant randomly allocated to receive the same
      intervention. The trial included four study visits. Each exercise training program will be
      applied sessions per week during 4 weeks. Participants received baseline assessments at the
      beginning of nay intervention, and post-intervention assessments at the end of the fourth
      week. The wash-out period will be two weeks. After these two weeks participants switched
      intervention.
    

Intervention name(s): High intensity interval training; Inspiratory muscle training
Intervention type(s): Other; Other
Intervention description(s): Participants will perform 3 HIIT sessions per week, involving 10 min of intense exercise within a time commitment of 30 min per session, including warm-up, recovery between intervals and cool down.; Participants will perform 3 inspiratory resistance training sessions per week, involving 30 min per session, including warm-up, recovery between intervals
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Driving Performance of People With Parkinson's Using Autonomous In-Vehicle Technologies
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      For drivers with Parkinson's Disease (PD), autonomous in-vehicle technologies may help
      mitigate functional deficits, improve driving performance, decrease driving errors and
      enhance their ability to stay on the road. Using a pretest/posttest design the investigators
      will quantify the use of In-vehicle Information Systems (IVIS) and Advanced Driver Assistance
      Systems (ADAS) during driving to illustrate how IVIS and ADAS may affect driving, and provide
      recommendations to drivers with PD, the clinical community and industry.
    


Intervention name(s): PD Drivers Using AV Technologies On-road
Intervention type(s): Other
Intervention description(s): All drives will include events to assess the impact of in-vehicle information systems (IVIS) and advanced driver assistance systems (ADAS) on the driving performance (driving errors) of drivers with PD. For IVIS the investigators will include options to assess errors with lane maintenance (with and without the lane departure warning system) and signaling (with and without blind spot detection). For ADAS the investigators will include conditions to assess errors in speeding (with and without adaptive cruise control) and lane exceedances (with and without lane keeping assist).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Parkinson Disease; In-vehicle information system; Advanced driver assistance system
CD19-CART Treatment for ALL
Condition: Acute Leukemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of
      refractory or recurrent ALL.
    

Detailed description: 
      Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring
      an artificial antigen binding receptor and also intercellular co-stimulating molecules into T
      cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor
      cells and initiate the killing process in a HLA-independent way. CD19 is the specific
      cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in
      treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is
      equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a
      humanized scFv. This study aims to evaluate the safety and efficacy of both murine and
      humanized CD19-CART in treating refractory or recurrent ALL.
    

Intervention name(s): CD19 CART
Intervention type(s): Biological
Intervention description(s): Patients will get one course of CART treatment with the dose of 0.5-5*10~6/KgBW.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Enrolled patients will receive CD19-CART cell immunotherapy.
Masking: None (Open Label)
Primary purpose: Treatment
Olanzapine Treatment of Patients With Bipolar I Disorder
Condition: Depression, Bipolar
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess whether olanzapine is superior to placebo in patients
      with bipolar depression.
    

Detailed description: 
      1. Dose range and administration mode: Oral Olanzapine 5mg - 20mg/day

        2. Duration:

             1. Screening phase is 2-28 days.

             2. Double-blind treatment phase is 6 weeks

             3. Open-label extension phase is 18 weeks
    

Intervention name(s): Olanzapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 5-20 mg, oral, once daily, for 24 weeks (participants randomized to olanzapine in double-blind treatment period) or 18 weeks (participants randomized to placebo in double-blind treatment period).; placebo tablets, oral, once daily at bedtime, 6 weeks
Other intervention name(s): LY170053; Zyprexa
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Combined Interventions on Pressure Pain Threshold
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The effect of mobilizations on decrease of peripheral and central sensitivity has been proven
      in KOA. Furthermore, the effect of conservative therapy has also been proven in the increase
      of pain threshold in KOA. However, no study has investigated the effect of these
      interventions combined till date in KOA.

      The aim of the present study is to investigate the short-term and long-term effect of
      end-range mobilization in addition to conservative therapy on decrease of pressure pain
      threshold in KOA.
    

Detailed description: 
      The positive effect of different manual mobilizations have been proven in the management of
      knee osteoarthritis (KOA). Pressure pain threshold, as a measure of somatosensory function,
      is a well-applied measurement technique for the pain perception in KOA. The effect of
      mobilizations on decrease of peripheral and central sensitivity has been proven in KOA.
      Furthermore, few studies has revealed the effect of conservative therapy as an effective
      intervention in the increase of pain threshold. However, no study has investigated the effect
      of these interventions combined till date in KOA, which could give a long-lasting effect in
      the decrease of sensitization in KOA.

      Therefore, the aim of the present study is to investigate the short-term and long-term effect
      of end-range mobilization in addition to conservative therapy on decrease of pressure pain
      threshold in KOA.
    

Intervention name(s): end-range mobilization; Non end-range mobilization; Control
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): accessory technique applied on the tibiofemoral joint with the aim of increasing extensibility of the periarticular tissues; accessory technique applied on the tibiofemoral joint with the aim of alleviating pain; hands-on cutaneous technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Musculoskeletal Manipulations; Osteoarthritis, Knee; Pain Threshold; Conservative Treatment
Taxotere Combinations as First Line Therapy for Locally Advanced Unresectable or Metastatic Non-small Cell Lung Cancer.
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the antitumour activity (response rate) in patients with locally advanced or
      metastatic non-small cell lung cancer (NSCLC) of two different combinations of docetaxel and
      gemcitabine and of a sequential treatment of cisplatin /gemcitabine followed by docetaxel as
      first line chemotherapy · To evaluate the quantitative and qualitative toxicity of each
      treatment arms.· To determine time to progression, duration of response, time to treatment
      failure, and overall survival in each group.· To evaluate changes from baseline in the Lung
      Cancer Symptom Scale of patients in each treatment arm.
    


Intervention name(s): Docetaxel and Gemcitabine; Docetaxel and Gemcitabine; Gemcitabine cisplatin followed by docetaxel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Docetaxel: 40 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 8 immediately followed by Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8; Docetaxel: 50 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 15 immediately followed by Gemcitabine: 1600 mg/m2, administered IV over 30 minutes on day 1 and 15.; Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8 followed by Cisplatin 75 mg/m2, administered IV over 30-60 minutes on day 2
Intervention MeSH terms: Gemcitabine; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment