bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Extended Wear Technology
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of
      extended wear technology with the commercially available device as a comparator.
    

Detailed description: 
      A interventional study in which participants will be fit with the commercially available
      device in one ear and the experimental device in the opposite ear. After two weeks, the
      devices will be switched so that the participant has worn each device in each ear for a total
      of 2 weeks. Participants will be blinded as to which device they are wearing in each ear.
      Comfort and sound quality will be assessed for each device prior to removing from ears.
    

Intervention name(s): Lyric extended wear hearing aid device A; Lyric extended wear hearing aid with fitting modification device B
Intervention type(s): Device; Device
Intervention description(s): Current commercially available extended wear hearing aid; Extended wear hearing aid with fitting modifications
Intervention model: Single Group Assignment
Intervention model description: Participants will be fit with commercially available extended wear hearing aid device A in the right ear and extended wear hearing aid with fitting modifications device B in the left ear for two weeks (first intervention); then fit with extended wear hearing aid with fitting modifications device B in the right ear and commercially available extended wear hearing aid device A in left ear for two weeks (second intervention). There will be no washout period.
Masking: None (Open Label)
Primary purpose: Other
Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients
Condition: Morbidly Obese Patients
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain
      good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission
      blocking agents, such as rocuronium (Esmeron®) are used. It sometimes happens that there is
      still some neuromuscular blocking activity left in the patient on awakening from anesthesia.
      This is called residual curarization and is known to cause postoperative complications such
      as impairment of respiratory function.

      Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®). It
      allows for reversing of neuromuscular transmission blocking activity. Until now, all studies
      with sugammadex were performed in non-obese patients.

      Obese patient have a high risk to suffer from post-operative respiratory failure. Therefore
      it is vital to avoid residual curarization. Sugammadex might be an important factor.

      Obese patients have a large total body weight different from ideal body weight. Recent
      research demonstrated that the dose for the neuromuscular blocking agent rocuronium
      (Esmeron®) needs to be calculated on the patients' Ideal Body Weight rather than on Total
      Body Weight.

      At this moment no data is available on the dose-response relationship of sugammadex in
      morbidly obese patients.

      We hypothesize that in morbidly obese patients sugammadex should be dosed on ideal
      bodyweight, instead of total bodyweight.
    

Detailed description: 
      Flowchart :

      72 participants

      Stratification

      BMI<50 BMI >50

      Randomization Randomization

      TBW IBW TBW IBW

      2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9

      TBW : Total Body Weight IBW : Ideal Body Weight
    

Intervention name(s): Sugammadex 2 mg/kg; Sugammadex. 4 mg/kg; Neuromuscular monitoring.; Clinical evaluation of residual curarization .
Intervention type(s): Drug; Drug; Procedure; Procedure
Intervention description(s): Patients receive 2 mg/kg Sugammadex.; Patients receive 4 mg/kg Sugammadex.; Neuromuscular monitoring using a TOF watch SX (Organon).; Every 30 min, during the first 2 hours after the end of the surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness and Safety of CT-guided Needle Placement in the Liver With the Aid of the ActiSight Needle Guidance System
Condition: Accurate Navigation to the Lesion
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to confirm the safety and effectiveness of the ActiSight™ Needle
      Guidance System with CT-guided percutaneous (through the skin) liver biopsies and ablations .
      The device used in this study is designed to assist the physician in guiding the needle
      towards the suspected area. This device does not change the procedure of liver biopsy or
      ablation. The only difference is that a small adhesive pad is placed on the skin and a
      miniature video camera is attached to the end of the needle. This camera does not enter the
      body.
    


Intervention name(s): biopsy or ablation
Intervention type(s): Device
Intervention description(s): biopsy or ablation performed as in standard of care with assistance of ActiSight Needle Guidance system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation in Low-risk Patients
Condition: Colonic Neoplasms
MeSH terms: Colonic Neoplasms
Study type: Interventional

Summary: 
      Adequate quality of bowel preparation(BP) is essential for colonoscopy. In recently, Kang
      suggested that for low-risk patients, single dose of 2L PEG is an effective regimen for bowel
      preparation.However, due to the poor palatability, there still more than 30% patients with 2L
      regimen experienced nausea or vomiting in our center.

      Oral lactulose is a treatment for constipation. Several studies have compared the
      effectiveness between use PEG and lactulose for colonoscopy preparation in average-risk
      patients. However, the data in low-risk patients is vacant. The objective of current study
      was to compared the effectiveness of bowel preparation and patient tolerance using lactulose
      and 2L PEG regimen in low-risk patients.
    


Intervention name(s): Lactulose oral solution; PEG
Intervention type(s): Drug; Drug
Intervention description(s): In the LOS group, patients were instructed to drink 200ml lactulose (Duphalac, Olst, the Netherlands; 200ml/bottle) diluted with clear water into 1L 4-6h before colonoscopy at a rate of 250ml every 30min.; patient in the PEG group were instructed to drink 2L of PEG (each liter containing 59g PEG 4000, 1.46g sodium chloride, 5.68g sodium sulfate, 0.74g potassium chloride, 1.68g sodium bicarbonate; WanHe Pharmaceutical Co, Ltd., China) 4-6h before colonoscopy at a rate of 250ml every 15min
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: colonoscopy; bowel preparation
Intrapleural Minocycline Following Simple Aspiration for Primary Spontaneous Pneumothorax
Condition: Pneumothorax
MeSH terms: Pneumothorax
Study type: Observational

Summary: 
      The optimal initial management of primary spontaneous pneumothorax (PSP) remains
      controversial. This study was conducted to evaluate the safety and efficacy of additional
      minocycline pleurodesis after successful aspiration of the first episode of PSP.
    

Detailed description: 
      Primary spontaneous pneumothorax (PSP) most commonly occurs in young, tall, lean males. The
      estimated recurrence rate is 23-50% after the first episode. The high recurrence rate
      stimulated the development of many different therapeutic approaches, ranging from
      conservative treatment such as observation to more invasive therapies such as surgery, and
      optimal treatment of patients presenting with a first episode of PSP remains controversial.
      In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is
      recommended as the first line treatment for all PSP requiring intervention because this
      treatment provided the advantage of reduced hospital admission rate and reduced length of
      hospital stay when compared with chest tube drainage. However, the recurrence rate of this
      procedure was around 30%, making it inappropriate as a standard of care.

      Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way
      to reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical
      patients. Previously, chemical pleurodesis had usually been administrated through chest tube
      or thoracoscopy. Administration of sclerosing agents through intravenous needle catheter or
      pigtail catheter after simple aspiration had never been reported and the safety and efficacy
      remained unknown.

      Because the recurrence rate after simple aspiration remains high, we began to instill
      minocycline into the pleural cavity through the pigtail or intravenous needle catheter since
      December 2005 to determine if this adjuvant is effective in reducing the rate of recurrence.
      In the present study, we report our experience of minocycline pleurodesis in treating first
      episode of PSP after successful aspiration of pneumothorax. The effects of this adjuvant
      therapy were evaluated by comparing the outcomes of the patients who underwent simple
      aspiration alone with those who underwent additional minocycline pleurodesis.
    

Observational model: Defined Population
Time perspective: Retrospective
Keywords: minocycline; pleurodesis; aspiration; pneumothorax; Primary spontaneous pneumothorax; First attack; Successful aspiration
Effect of Daily Consumption of Vitamin B12 Fortified Yoghurt on Vitamin B12 Status in Older Adults
Condition: Vitamin B 12 Deficiency
MeSH terms: Vitamin B 12 Deficiency
Study type: Interventional

Summary: 
      Older adults are recommended to meet their daily vitamin B12 (B12) requirements by consuming
      foods with added B12 and/or taking B12 supplements (i.e. sources of free B12) because of an
      age-related decreased digestion and absorption capacity for food-bound B12. Currently, B12 is
      not added to foods in Canada, except for simulated dairy and meat products. Yoghurt with
      added B12 is a novel dairy product that could fill a gap that presently exists in the
      Canadian market and has the potential to provide Canadian older adults with an alternative
      dietary source of B12 that could help improve their B12 status. Thus, the objective of this
      study was to assess the efficacy of the daily consumption of one serving of yoghurt fortified
      with B12 versus unfortified yoghurt for 8 weeks on the B12 status of healthy older adults,
      assessed using serum total B12. The primary hypothesis of this study was that the daily
      consumption of B12-fortified yoghurt would increase serum total B12 concentration of older
      adults compared to the consumption of unfortified yoghurts.
    


Intervention name(s): Fortified yoghurt; Control yoghurt
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Food-grade vitamin B12 in the form of methylcobalamin (purity: 99%) was used for fortification. Yoghurts were Greek-style and locally produced by a yoghurt company in British Columbia, Canada. The pre-measured vitamin B12 was added into yoghurt vats in amounts that corresponded to the chosen dosage (50 µg of B12 per 150 g). The yoghurt was packaged into white cups, each containing 150 grams of yoghurt, labelled with the date of production and study code.; Yoghurts were locally produced by a yoghurt company in British Columbia, Canada. Yoghurts produced were Greek-style and packaged into white cups, each containing 150 grams of yoghurt, labelled with the date of production and study code.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Food fortification; Yogurt; Vitamin B12; Older adults; Fortified food; Yoghurt; Vitamin
The Effect of a Talocrural Thrust Manipulation on Lateral Ankle Ligament Integrity in a Subgroup of Healthy Individuals
Condition: Healthy
Study type: Interventional

Summary: 
      Measure the effect of a common used ankle manipulation on ligament length in the ankle.
    

Detailed description: 
      The purpose of this study is to determine what the effect of a common ankle manipulation on
      the supporting ligaments of the ankle.

      Design: The researchers will conduct a quasi-experimental study with a method of convenience
      sampling. The design of this study will allow to determine what the direct effect of a common
      a commonly used physical therapy ankle manipulation is on the length of the soft tissue
      connection between the smaller bone in the lower leg and the heel bone and the smaller bone
      in the leg and the ankle bone.
    

Intervention name(s): Distraction thrust manipulation
Intervention type(s): Procedure
Intervention description(s): Distraction thrust manipulation of the talocural joint in supine position
Intervention model: Single Group Assignment
Intervention model description: Pretest post test study design
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Manipulation; Thrust; Ankle; Ligaments
Effects of Dexmedetomidine During Radiofrequency Ablation of Abdominal Tumours
Condition: Cancer of Kidney and Renal Pelvis; Cancer of Liver
MeSH terms: Liver Neoplasms; Kidney Neoplasms; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of he study is to evaluate effects of dexmedetomidine on pain during
      radiofrequency ablation of liver and kidney tumours.
    

Detailed description: 
      Although radiofrequency ablation (RF) is accepted as the best therapeutic choice for patients
      with early stage hepatocellular carcinoma when liver transplantation or surgical resection
      are not suitable options, it is still performed only in a few hospitals and experience is so
      far limited (Goldberg & Ahmed, 2002; Shiina et al., 2005). In addition, RF ablation is
      emerging as a viable alternative to surgery for inoperable patients with limited hepatic
      metastatic disease, especially from colorectal cancer. Although radiofrequency ablation has
      been accepted as a safe and effective treatment for liver and kidney tumours, there are few
      studies addressing periprocedural pain.

      Thus, the optimal anaesthetic procedure is still to be determined. Currently at our
      institution RF is performed as monitored sedation procedure using remifentanil infusion
      supplemented with midazolam boluses, when considered necessary. However, when using
      remifentanil and midazolam combination it is quite difficult to avoid too deep respiratory
      depression.

      Dexmedetomidine is an α2-adrenoreceptor agonist with sedative, analgesic and anxiolytic
      effects, and it has more selective α2-adrenergic effect than clonidine. Dexmedetomidine has a
      great deal of potential in this arena given its analgesic and anxiolytic properties while
      preserving respiratory drive (Bergese SD et al., 2010).

      All patients will receive dexmedetomidine 0.4 µg/kg/hr infusion from the start of procedure.
      The infusion will be continued during the whole RF procedure.

      At the same time all patients will receive remifentanil infusion according to TCI (target
      controlled infusion) protocol. Plasma concentration target will be set from 0.5 ng/ml and, if
      necessary, will be increased to achieve a comfortable state of patient (Ramsey Sedation
      Scale: 2-3).
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Dexmedetomidine 0.4 µg/kg/hr infusion during RF procedure
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Metabolism With HDL Cholesterol
Condition: Heart Disease; Diabetes
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      High levels of good cholesterol (HDL) in our blood decreases our chance of having a heart
      attack. This relates in part to the role good cholesterol plays in reducing build up of fat
      in the arteries. However, good cholesterol has many other protective effects. We have
      recently identified three enzymes (proteins) activated by HDL in cells lining the blood
      vessels, which may be responsible for some of HDL's protective actions.
    


Intervention name(s): rHDL
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Reproducibility of Computed Tomography
Condition: Tuberculosis; Pleural Effusion
MeSH terms: Tuberculosis; Pleural Effusion
Study type: Observational

Summary: 
      Thus, the aim of this study was to evaluate the reproducibility of the Computed Tomograph
      scan three-dimensional reconstruction method for the measurement of the TB pleural effusion
      volume in clinically stable patients.
    

Detailed description: 
      Speed, accuracy, and precision in the quantification of pleural effusion are of critical
      importance as it determines whether or not thoracocentesis should be carried out and which
      technique should be employed for such a procedure. This study evaluates the precision of
      thoracic computed tomography with three-dimensional (3D) rebuilding in determining the volume
      of tuberculosis pleural effusion.Twenty patients with pleural effusion were screened and
      invited to take part in the study. Each patient underwent two computed tomography scans,
      before and after one month of treatment for tuberculosis, a total of 40 exams. These were
      evaluated by two expert radiologists. In conclusion, the quantification of the pleural
      effusion volume by using thoracic CT with volumetric three-dimensional reconstruction is a
      highly reproducible method.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients age 18 years or older with a confirmed diagnosis of pleural TB effusion
      
Keywords: Tuberculosis; Pleural Effusion; Computed Tomography
TEAS Reduces Remifentanil Consumption
Condition: Anesthesia; Pain
Study type: Interventional

Summary: 
      Transcutaneous electrical acupoint stimulation (TEAS) has been shown to decrease the need of
      opioids including remifentanil during anaesthesia. However, it is not clear whether
      combination of two or more acupoints could induce stronger analgesia. Moreover, evidence for
      the long-term effect of TEAS has been limited. The present study was to compare the
      short-term and long-term effect on pain of dual-acupoint and single-acupoint TEAS.
    


Intervention name(s): acupoint stimulation; single acupoint; dual acupoints
Intervention type(s): Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
An Additional Study of NPC-22 in Healthy Adult Males
Condition: Safety and Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the safety and pharmacokinetics of high dose NPC-22
      administration in healthy adult males.

      The effect of administration routes for pharmacokinetics will be examined in advance.
    


Intervention name(s): NPC-22; NPC-22; NPC-22 Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single administration of middle dose NPC-22; Single administration of high dose NPC-22; Single administration of NPC-22 Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Clinical Evaluation of PoreSkin
Condition: Treatment
Study type: Interventional
Phase: Phase 1

Summary: 
      PoreSkin, a human acellular dermal matrix (hADM) manufactured by Faculty of Medicine,
      Chulalongkorn University, is the first human dermal substitute developed in Thailand. It is a
      permanent dermal substitute aiming to reduce skin contracture. The objective of this study is
      to assess the safety and ability in achieving durable and cosmetic coverage of PoreSkin.
    


Intervention name(s): PoreSkin
Intervention type(s): Device
Intervention description(s): a human acellular dermal matrix
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human acellular dermal matrix, burns, wound healing
Behavioral Exercise Intervention for Smoking Cessation
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the effect of a moderate-intensity aerobic exercise
      intervention for smokers interested in quitting smoking. We expect that this project will
      contribute much needed knowledge about the role of aerobic exercise in smoking cessation. If
      the efficacy of moderate-intensity, aerobic exercise for smoking can be established, smokers
      may have a valuable adjunct to more traditional smoking cessation approaches.
    


Intervention name(s): aerobic exercise; Health Education Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12-week moderate intensity behavioral exercise intervention (MIBE) AND a 12-week standard smoking cessation program (including transdermal nicotine patch); 12-week health education control (HEC) AND a 12-week standard smoking cessation program (including transdermal nicotine patch).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: smoking cessation; exercise; physical activity; health education
Standard Treatment Compliance of Participants, Effectiveness and Prognosis in Acute Respiratory Distress Syndrome
Condition: Respiratory Failure; Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Respiratory Insufficiency; Acute Lung Injury; Syndrome
Study type: Observational

Summary: 
      The Acute Respiratory Distress Syndrome (ARDS) is one of common clinical critically diseases.
      In the United States, the incidence of ARDS reaches 31%, which is one of the main causes of
      death in patients. There is no unified treatment process for ARDS currently and the treatment
      measures are not yet standardized, so the standardization of ARDS treatment processes is
      needed to reduce mortality in patients. Following the evidence-based medicine principles and
      six-step treatment standards of ARDS, this study uses the method of multi-center randomized
      controlled clinical trials to evaluate the standardized treatment process of ARDS, which
      provides the basis for the standardized treatment of ARDS.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ARDS patients
      
Keywords: mechanical ventilation; ARDS; Ventilator strategy; outcome