bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Local Intraoperative Steroid Administration on Post-ACDF Dysphagia
Condition: Swallowing Function
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      Few methods were available to determine which muscle groups are associated with PD in details
      in previous investigations. Local steroid administration has shown some effects on PD in a
      large number meta-analysis. In this study, we aimed to conduct a prospective
      randomized-double blinded study to exam the efficacy and the safety of the local steroid
      administration on ACDF patients by using high resolution impedance manometry in patients
      receiving ACDF.
    

Detailed description: 
      Postoperative dysphagia (PD) is the most common complication after anterior cervical
      discectomy and fusion (ACDF). However, few methods were available to determine which muscle
      groups are associated with PD in details in previous investigations. Local steroid
      administration has shown some effects on PD in a large number meta-analysis. In this study,
      we aimed to conduct a prospective randomized-double blinded study to exam the efficacy and
      the safety of the local steroid administration on ACDF patients, and the also apply the high
      resolution impedance manometry (HRIM) on patients receiving ACDF for better delineation of
      the swallowing function. Pressure-flow analysis (PFA), derives pharyngeal pressure flow
      variables obtained from HRIM were used to analyze the mechanisms of PD.
    

Intervention name(s): steroid injection; placebo
Intervention type(s): Drug; Drug
Intervention description(s): steroid injection at surgical location; saline injection at surgical location
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Remineralization of Early Carious Lesion Using Natural Agents Versus Bioadhesive Polymers
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study will be conducted to evaluate:

        1. The remineralization potential of natural agents (egg shell powder and clove extract)
           versus bioadhesive polymers (carbopol and carboxymethyl cellulose) with or without PH
           cycling using microhardness test.

        2. The clinical efficacy of all agents in patients with early carious lesions.
    


Intervention name(s): Clove water extract; Carbopol; Carboxymethyle cellulose
Intervention type(s): Other; Other; Other
Intervention description(s): natural product; Bioadhesive polymer; Bioadhesive polymer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
The Evolution of Relationship Between Results of Peripheral Blood Test and Outcomes of in Vitro Fertilization
Condition: Infertility, Female; Immune Tolerance
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      The purpose of this study was to assess the relationship between infertility blood test
      results and outcomes of pregnancy and alive birth of women who underwent with or without
      intravenous immunoglobulin (IVIG) before in vitro fertilization.
    

Detailed description: 
      Study Design (Brief Description)

        1. Inclusion criteria Patients had underwent infertility blood test or treatment in Lee's
           women hospital

        2. Exclusion criteria No

        3. Endpoint

      1. Values of blood test (PTT, IDM, ANA, Lupus, protein-s) 2. Embryo quality 3. Results of
      intravenous immunoglobulin (IVIG) treatment (pregnancy or not) 4. Alive birth rate

      4. Withdraw criteria and rescue medication No 5. Sample Size and Study Duration Sample Size:
      total 500 women who underwent IVF treatments and tests from Jan. 2007 to Dec. 2010.

      Study Duration: from date of IRB agreement to Dec. 2012 6. Please specify objectives of study
      when collecting extra specimen from participants No more need to collect extra specimen from
      participants in this study 7. Expected Endpoints of Treatment No 8. Others No
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients had underwent infertility blood test and in vitro fertilization treatment in Lee's
        women hospital
Efficacy of Noninvasive Radiofrequency in Attenuating Diabetic Neuropathic Pain
Condition: Diabetic Neuropathy, Painful
MeSH terms: Neuralgia; Diabetic Neuropathies
Study type: Interventional

Summary: 
      Peripheral neuropathy increases the prevalence of diabetic foot ulcers following a decrease
      in foot sensation. Therefore, the treatment of this disorder is very important.
    

Detailed description: 
      The current study aimed to investigate the efficacy of TECAR therapy on lower limb perfusion
      index (PI) and to evaluate the efficacy of TECAR therapy in improving the peripheral
      vascularity, reducing foot pain, and improving the tactile sensation of the soles in diabetic
      peripheral neuropathy (DPN) patients. twenty three diabetic neuropathy patients were included
      in the study and underwent 12 sessions of Capacitive TECAR therapy over one month. Pain,
      tactile sensation of the sole and PI were evaluated at the start and after each session till
      the end of the study.
    

Intervention name(s): Capacitive-Resistive Noninvasive Radiofrequency
Intervention type(s): Device
Intervention description(s): The two passive plates were under the back of the patient. The active capacitive plates of the machine (CAPENGERY, C200, Spain) will be applied initially for 20 minutes over the sole of both feet, with the machine adjusted on the A-thermal mode (37 oC). During the remaining 20 minutes, active capacitive plates are relocated over femoral vessels at the femoral triangle with the machine adjusted on the frank thermal mode (41 oC).
Other intervention name(s): TECAR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Enhancing Cognitive Abilities With Comprehensive Training
Condition: Cognitive Abilities
Study type: Interventional

Summary: 
      The purpose of this study is to measure the efficacy of an online cognitive training program
      against an active control condition in a large, randomized trial.
    

Detailed description: 
      The present study aims to evaluate a targeted, progressively challenging, online cognitive
      training program comprised of 49 distinct exercises targeting a variety of cognitive
      capacities. The cognitive training program will be compared to a plausibly beneficial active
      control condition in which participants completed online crossword puzzles.

      The investigators hypothesize that the cognitive training will show greater transfer to a
      range of underlying cognitive abilities than the active control, as measured by a broad
      battery of neuropsychological assessments and participant-reported outcomes.
    

Intervention name(s): Lumosity Cognitive Training; Crossword Puzzles
Intervention type(s): Other; Other
Intervention description(s): adaptive online cognitive training; timed online crossword puzzles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: Cognitive Training; Lumosity; Crossword Puzzles
Fitostimoline® Hydrogel Versus Saline Gauze Dressing in Diabetic Foot Ulcers
Condition: Diabetic Foot
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      Diabetes Mellitus (DM) is one of the most widespread metabolic diseases and the alarming rise
      in its prevalence worldwide poses enormous challenges. The microvascular and macrovascular
      complications of DM heavy impact on longevity and quality of life, and in particular diabetic
      foot ulcers (DFUs) are among the ten top causes of worldwide disease burden and disability
      Essential components of the standard care, management, and treatment of DFUs are represented
      by health education, strict control of blood glucose and cardiovascular risk factors,
      offloading, local debridement, and adequate dressing. A wide variety of dressing is
      available, and these include basic contact dressings (low adherence dressings such as saline
      gauze, paraffin gauze or simple absorbent dressings) and advanced dressings (alginate,
      hydrogel, films, hydrocolloid, foam).

      It is important underline that due to lack of evidence from head-to-head randomized
      controlled trials (RCTs), the relative effects of any of these dressings in DFUs remain
      unclear. Consequently, so far clinical evidence supporting the choice for either hydrogel or
      saline gauze dressing, has been related mostly on clinician perception rather than high
      quality evidence. Here we evaluated the efficacy and safety of Fitostimoline® hydrogel
      dressing versus saline gauze dressing in patients with DFUs in a monocentric, two-arm,
      open-label, randomized, controlled trial.
    


Intervention name(s): Fitostimoline ® hydrogel group; Saline gauze group
Intervention type(s): Drug; Drug
Intervention description(s): Treatment of DFUs with Fitostimoline® hydrogel every day for 12 weeks.; Treatment of DFUs with saline gauze every day for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetic foot; dressing; medication
TL011 in Severe, Active Rheumatoid Arthritis Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and pharmacology of TL011 in patients
      with severe rheumatoid arthritis.
    


Intervention name(s): TL011, anti CD20, for the treatment of rheumatoid arthritis; MabThera infusions
Intervention type(s): Biological; Biological
Intervention description(s): TL011 administered by 2 infusions, 2 weeks apart; MabThera, administered by 2 infusions, 2 weeks apart
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Dimethyl Fumarate (DMF, Tecfidera®) Persistence in RR-MS Patients Included in the French Patient Support Program OroSEP
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The primary objective is to compare oral dimethyl fumarate (DMF) persistence at six months in
      relapsing-remitting multiple sclerosis (RR-MS) participants initiating DMF with and without
      OroSEP patient support program (PSP), respectively.

      The secondary objectives are: to compare oral DMF persistence at one month and three months
      in RR-MS participants initiating DMF with and without OroSEP PSP, respectively; To compare
      oral DMF adherence at six months in RR-MS participants initiating DMF with and without OroSEP
      PSP; To compare at three months and six months the reason of oral DMF discontinuation, in the
      two groups; To describe the percentage of participants with treatment-related adverse events
      globally and by class of adverse events, in the two groups of participants; To assess the
      evolution of participants' anxiety globally and to compare it at inclusion and at six months
      in participants with and without OroSEP PSP, respectively; To describe participants'
      satisfaction regarding oral DMF initiation and follow-up globally at six months and to
      compare it in patients with and without OroSEP PSP, respectively;

      For OroSEP PSP group: To assess participants' satisfaction regarding their participation in
      OroSEP PSP at six months; To assess neurologists' satisfaction regarding their participation
      in OroSEP PSP, after the last participant last visit of center.
    


Intervention name(s): Dimethyl Fumarate; PSP
Intervention type(s): Drug; Other
Intervention description(s): DMF as prescribed as standard of care.; PSPs is to support patient care.
Other intervention name(s): Tecfidera®
Intervention MeSH terms: Dimethyl Fumarate
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population included participants with RR-MS treated with DMF in clinical practice.
Safety and Tolerability of Liraglutide in Subjects With Impaired Kidney Function and in Subjects With Normal Kidney Function
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Oceania. The aim of this trial is to assess whether dose
      adjustment is required for patients with renal impairment by investigating the
      pharmacokinetics of liraglutide in subjects with various degrees of renal impairment.
    


Intervention name(s): liraglutide
Intervention type(s): Drug
Intervention description(s): Single dose of 0.75 mg, administered as a subcutaneous injection
Intervention MeSH terms: Liraglutide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lung and Diaphragm Ultrasound in the Early Postoperative Course Following Lung Transplantation
Condition: Lung Transplantation
Study type: Interventional

Summary: 
      This feasibility study tries to define the value of daily Lung and Diaphragm Ultrasound in
      the early postoperative course following Lung transplantation by comparing its diagnostic
      accuracy with that of standard of care diagnostic procedures
    

Detailed description: 
      Lung transplantation remains a high risk procedure. Common complications in the early
      postoperative course are, among others, primary graft dysfunction (PGD), hemorrhage,
      anastomosis insufficiency leading to pneumothorax, pneumonia, atelectasis and diaphragm
      dysfunction. Early diagnosis of complications is important to avoid further deterioration.
      Lung ultrasound (LUS) and diaphragm ultrasound (DUS) has a high diagnostic accuracy for
      identifying frequent conditions in the critically ill. Studies evaluating its value in
      patients following lung transplantation are missing. This study investigates the feasibility
      and clinical ability of LUS and DUS to identify common complications following lung
      transplantation and compares it to standard of care diagnostic procedures. The investigators
      start a prospective cohort study of lung transplant recipients who undergo lung
      transplantation at the university hospital Munich. Daily LUS and DUS in the early
      postoperative phase will be performed to detect and monitor complications. The US results
      will be compared to the results of diagnostic procedures of the clinical routine such as
      clinical examination, chest x ray, hemodynamic monitoring, expert opinion on PGD and
      laboratory parameters.

      The hypothesis is that daily LUS and DUS following lung transplantation helps to diagnose
      complications early and with higher accuracy compared to the results of diagnostic procedures
      of the clinical routine.
    

Intervention name(s): Ultrasound
Intervention type(s): Diagnostic Test
Intervention description(s): daily ultrasound of the lung and the diaphragm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Lung ultrasound; Lung transplantation; primary graft dysfunction; Lung Sliding
Evaluation of Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is evaluating the safety and feasibility of the novel deep TMS H-coil designs in
      the treatment of resistant major depression in an open study using two different H-coil
      designs.
    


Intervention name(s): H1 and H2 deep TMS coils
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: major depression; TMS
High PEEP Application Following Pulmonary Thromboendarterectomy; Does it Have Any Impact on Outcome?
Condition: Reperfusion Injury After Pulmonary Thromboendarterektomy
MeSH terms: Reperfusion Injury
Study type: Interventional

Summary: 
      Investigation of the effect of intraoperative lung protection high PEEP maneuver on ischemic
      reperfusion injury in patients undergoing pulmonary endarterectomy.
    

Detailed description: 
      Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare disease characterized by
      progression of thromboembolism obstructing pulmonary arteries as an organized tissue.
      Pulmonary thromboendarterectomy (PTE) is a treatment option for chronic thromboembolic
      pulmonary disease. However, PTE is associated with specific postoperative complications, such
      as pulmonary edema and right ventricular failure due to reperfusion injury, with a
      significant mortality rate of 7% to 24%. Some strategies have been proposed to reduce lung
      injury after PTE, such as rectification maneuvers and high PEEP. The aim of this study was to
      investigate the effect of intraoperative lung protection high PEEP maneuver in patients
      undergoing pulmonary endarterectomy for ischemic reperfusion injury.
    

Intervention name(s): PEEP; control group
Intervention type(s): Other; Other
Intervention description(s): performing 35 cm/H2O PEEP and 2-3 ml/kg tidal volume; performing 6 cm/H2O PEEP and 6-8 ml/kg tidal volume
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective, randomized
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Chronic thromboembolic pulmonary hypertension; PEEP; reperfusion injury
Trait Injustice, Social Exclusion, and Anger
Condition: General Population
Study type: Interventional

Summary: 
      Participants will be randomly allocated to one of two experimental conditions: social
      exclusion or social inclusion. Participants, but not experimenters will be blind to the
      assignment. Pre- and post-tests will be administered. Participants will be offered 7 euros in
      compensation for participating.
    


Intervention name(s): Cyberball experimental task
Intervention type(s): Other
Intervention description(s): Cyberball is an experimental task in which participants have to pass a ball to two virtual players during 60 passes in total
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The two conditions, based on the experimental task called Cyberball, will be: social inclusion and social exclusion.
Masking: Single (Participant)
Primary purpose: Basic Science
Τhe Effectiveness of Hydrotherapy Exercises on the Rehabilitation of Hemiplegic Patients
Condition: Hemiplegics
Study type: Interventional

Summary: 
      The purpose of this current prospective study is to assess and compare the effects of a
      hydrotherapy exercise programme against a conventional land-based exercise programme in
      individuals with hemiplegia. Both exercise interventions aim at improving posture, balance
      and weight-bearing capability. Patients were randomized to the hydrotherapy or conventional
      therapy groups according to balance function (Berg Balance Scale score) and age (age<59 and
      >60 years). The physical examination consisted of (1) a lower-limb motor function recovery of
      the paretic side score according to the 6-stage Brunnstrom scale, (2) the hemiplegic limb
      strength measured by the Motricity Index, (3) the strength of ankle dorsiflexors and
      plantarflexors by manual muscle testing, (4) the spasticity of the ankle score by Modified
      Ashworth Scale, (5) the trunk function through the Trunk Control Test, (6) the postural
      control assessed by Postural Assessment Scale for Stroke Patients and (7) the functional
      status measured with the Functional Independence Measure. Postural sway was evaluated with a
      pressure platform by using the variables of center of pressure (COP) displacements in the
      mediolateral (ML) and anteroposterior (AP) directions. The results will be collected and
      evaluated using statistical programme SPSS.
    


Intervention name(s): Hydrokinesiotherapy Intervention; Land-based exercise intervention
Intervention type(s): Procedure; Procedure
Intervention description(s): The hydrotherapy exercise intervention consisted of 5 minutes of warm-up, 10 minutes of lower-extremity stretching exercises, 10 minutes of lower-extremity strengthening exercises, 20 minutes balance and gait training (water walking, running, side stepping), 5 minutes of a light cool down (marching on the spot), and 10 minutes of gentle stretching in the water.; The conventional exercise intervention used no water-based exercises but land-based exercises. The exercise program consisted of 5 minutes of warm-up, 10 minutes of lower-extremity stretching exercises, 10 minutes of lower-extremity strengthening exercises, 20 minutes balance and gait training (walking, side stepping), 5 minutes of a light cool down, and 10 minutes of gentle stretching out of the water.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hemiplegic; balance; hydrotherapy
The Role of Nitric Oxide in Cognition in Schizophrenia
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This study evaluates the role of the Nitric Oxide system in cognition in patients with
      schizophrenia. Participants will be randomised to 2 equal groups and receive either the
      Nitric Oxide donor molecule glyceryl trinitrate, or a placebo. Performance on several
      cognitive tasks will be assessed.
    

Detailed description: 
      Nitric oxide [NO] is a gaseous neurotransmitter substance found in the brain. Nitric oxide is
      integrated with the glutamate system. Glutamate has received considerable attention as an
      important factor in the cognitive distortions and cognitive impairments that underlie
      schizophrenia. Deficits in glutamate in schizophrenia may impact upon cognition via the NO
      system, as glutamate receptors signal by way of NO.

      Here the investigators aim to extend knowledge of glutamate-NO systems by directly examining
      the role of NO in cognition in patients with psychosis. We aim to assess the role of the NO
      system in cognition, downstream of glutamate and before patients are started on any
      anti-psychotic medication which perturb brain neurochemistry.

      The primary outcome measure is change in a particular style of cognition referred to as
      'jumping to conclusions' following the administration of a potent Nitric Oxide donor molecule
      [glyceryl trinitrate (GTN)], under placebo-controlled, double-blind conditions. This will
      shed light on the direct role of NO in cognition in psychosis, beyond the glutamate system.
    

Intervention name(s): Glyceryl Trinitrate; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Nitric Oxide; Cognition