bioihbjkbjnl/mcl2 huggingface dataset:
A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of MabThera/Rituxan plus methotrexate in
      patients with active rheumatoid arthritis who have had an inadequate response to at least 1
      DMARD treatment. All patients will receive MabThera (1000mg iv infusion) on days 1 and 15,
      and methotrexate (10-25mg po) weekly. The anticipated time on study treatment is 3-12 months.
    


Intervention name(s): rituximab [MabThera/Rituxan]; methotrexate; methylprednisolone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1000 mg iv Days 1 and 15; 10 - 25 mg/week; iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Rituximab; Methotrexate; Prednisolone hemisuccinate; Prednisolone phosphate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of CP-778,875 on HDL-C in Subjects With Abnormal Lipid Levels and Type 2 Diabetes.
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the effect of CP-778,875 on HDL-C cholesterol in adult subjects with dyslipidemia
      and type 2 diabetes
    


Intervention name(s): CP-778,875
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Prediction of Intraoperative Blood Loss and Postoperative Recovery by Liver Stiffness Measurement (Fibroscan®) in Right Hepatectomy
Condition: Liver Malignancy
MeSH terms: Neoplasms; Hemorrhage
Study type: Interventional

Summary: 
      Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France) is a newly
      introduced noninvasive tool that generates an elastic wave using a vibrator applied to the
      thoracic wall at the level of the right lobe of the liver and measures the prolongation
      velocity of the wave, which is directly associated with liver stiffness (LS). Although recent
      advances in surgical techniques and perioperative management have made with established
      perioperative management have now made it possible to perform hepatectomies as a safe
      procedure with minimum mortality, the possibility of massive blood loss and resultant
      transfusion during hepatectomy still exist. The objective of this research was to identify
      the role of liver stiffness measurement for the prediction of intraoperative blood loss and
      postoperative recovery after elective right hepatectomy.
    


Intervention name(s): preoperative liver stiffness measurement
Intervention type(s): Other
Intervention description(s): Liver stiffness measurement (LSM) using Fibroscan is a newly introduced noninvasive tool that generates an elastic wave using a vibrator applied to the thoracic wall at the level of the right lobe of the liver and measures the prolongation velocity of the wave, which is directly associated with liver stiffness (LS).
Other intervention name(s): Liver stiffness measurement (LSM) using Fibroscan®(EchoSens, Paris, France)
Intervention MeSH terms: Liver Extracts
Intervention model: Single Group Assignment
Masking: None (Open Label)
Nefopam for Post Video-Assisted Thoracoscopic Lobectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Video-assisted thoracoscopic (VATs) lobectomy is mild to moderately pain procedure. For
      conventional thoracotomy, there are many invasive pain control such as epidural analgesia,
      paravertebral block. However, for VATs, the invasive pain control somehow are too invasive.
      Nefopam is non-opioid painkilling medication, Serotonin, norepinephrine, dopamine reuptake
      inhibitor. Many study were demonstrated positive outcome of nefopam usage in many operation
      such as abdominal surgery, laparocopic surgery, orthopedic surgery. Nevertheless, nefopam for
      VATs is not well studied yet.
    


Intervention name(s): Nefopam 20 MG/ML; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Nefopam group nefopam 20 mg during surgery and follow by 80 mg in 24 hours postoperative; Placebo
Intervention MeSH terms: Nefopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Soliton Planar Acoustic Wave Device System for Dermal Tattoo Clearing Human Trial Protocol
Condition: Tattooing
Study type: Interventional

Summary: 
      To further evaluate accelerated fading resulting from additional treatment sessions of
      Soliton AWD as accessory to laser in tattoo reduction treatment.
    

Detailed description: 
      To further evaluate accelerated fading resulting from additional treatment sessions of
      multi-pass Q-Switched laser with the Soliton Planar Acoustic Wave Device System (AWD) as an
      accessory to Q-Switched laser in tattoo reduction treatment.
    

Intervention name(s): Soliton Acoustic Wave Device
Intervention type(s): Device
Intervention description(s): Treatment of tattoos with Soliton Acoustic Wave Device as an accessory to laser
Other intervention name(s): AWD
Intervention model: Single Group Assignment
Intervention model description: Single Group
Masking: None (Open Label)
Primary purpose: Treatment
Dietary Nitrate and Physiological Aging
Condition: Aging
Study type: Interventional

Summary: 
      The main purpose/s of this study is to examine the effects of 4 weeks of dietary nitrate
      supplementation on peripheral chemoreceptor sensitivity, spontaneous baroreflex sensitivity,
      and blood pressure responsiveness to a variety of physiological stressors in older healthy
      adults. We will also examine the effect of dietary nitrate supplementation on measures of
      central artery stiffness and aortic blood pressure in older adults. Lastly, we will also
      recruit a group of young subjects in order to help characterize the age-related changes
      associated with the physiological outcome measures of the present study.
    

Detailed description: 
      1 in 3 adults in the U.S. have hypertension which is known to increase the risk of heart
      disease and stroke. Blood pressure regulation is mediated by many factors including but not
      limited to metabolic factors, pressure/stretch sensing receptors located in the aorta and
      carotid arteries, endothelial cell function, and kidney function (via water and sodium
      absorption/excretion). It has been shown that many of these regulatory mechanisms are altered
      and/or become dysfunctional with aging. Specifically older adults commonly demonstrate a
      decreased sensitivity in pressure receptors and/or endothelial dysfunction. Additionally with
      aging, there is an increase in sympathetic nervous system activity and arterial stiffness
      which can contribute to higher blood pressure. The important vasodilator, nitric oxide (NO),
      has been implicated as a key signaling molecule involved in several of the mechanisms in
      blood pressure regulation outlined above. A decreased NO production or bioavailability is
      thought to contribute to several of the physiologic changes that come with aging. Therefore,
      the overall aim of this study is to use a randomized, double-blind crossover, placebo
      controlled study to examine the effects of acute dietary nitrate supplementation (to boost
      bioavailable NO) on various parameters of blood pressure regulation and responsiveness in
      normal healthy older adults. Our main hypothesis is that 4 weeks of dietary nitrate
      supplementation will decrease the blood pressure responses in older adults in response to a
      variety of physiological stressors.
    

Intervention name(s): Super Beets; Super Beets Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Nitrate rich beetroot powder (10g/day) for 4 weeks; Nitrate deficient beetroot powder (10g/day) for 4 weeks
Other intervention name(s): Beetroot crystals; Beetroot crystals no nitrate
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: nitrate; blood flow; blood pressure; vascular function; hypoxia
Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy
Condition: CIDP; Chronic Inflammatory Demyelinating Polyneuropathy
MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to examine if alpha lipoic acid is an effective treatment for
      chronic inflammatory demyelinating polyneuropathy (CIDP).
    

Detailed description: 
      Chronic inflammatory demyelinating polyneuropathy (CIDP) is a progressive disease leading to
      paralysis. CIDP is an immune-mediated disorder resulting from a synergistic interaction of T
      cell-mediated and B cell-mediated immune responses directed against peripheral nerve
      antigens. These immune mediated responses in turn increase the production of reactive oxygen
      intermediate and cause oxidative damage of the peripheral nerve system. Although
      corticosteroids, plasma exchange, and intravenous immunoglobulin (IVIg) reduce impairment
      caused by CIDP at least temporarily and can be used as a first-line treatments, they are not
      ideal for long-term treatment because of serious side effects and cost. Alpha lipoic acid
      (LA) is an antioxidant that also possesses anti-immune activity. It is effective in treating
      diabetic neuropathy. It is also promising in treating patients with multiple sclerosis.
    

Intervention name(s): lipoic acid
Intervention type(s): Drug
Intervention description(s): Subjects will be started on a single daily dose of 600 mg of alpha lipoic acid or placebo for the first 4 weeks and then increased to 1200 mg for the remainder of the study.
Other intervention name(s): LA
Intervention MeSH terms: Thioctic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: neuropathy, lipoic acid
Endovenous Lidocaine and Serum Cytokines Concentration
Condition: Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional
Phase: Phase 4

Summary: 
      Ineffective treatment of postoperative pain may cause organic damage and chronic pain.
      Nevertheless, opioids, the leading drugs used for this purpose, present side effects that
      sometimes restrict their usability. In a multimodal context, new postoperative analgesia
      techniques have been developed focusing in the reduction of opioid use and their adverse
      effects, as well as postoperative chronic pain prevention. In this background, continuous
      intravenous infusion of lidocaine during perioperative period has shown to be promising. This
      trial aimed to compare postoperative analgesia, opioid consumption, duration of ileus and
      length of hospital stay and IL-1, IL-6, IL-10, α TNF and γ IFN levels in patients undergoing
      to laparoscopic cholecystectomies who received intravenous lidocaine in comparison to a
      control group. Intravenous lidocaine in the perioperative period of laparoscopic
      cholecystectomies was not able to reduce postoperative pain, opioid consumption, and duration
      of ileus or length of hospital stay. However, its anti-inflammatory effect was evidenced by
      the significant changes in the studied cytokines.
    

Detailed description: 
      Forty-four patients undergoing laparoscopic cholecystectomy, under general anesthesia, were
      randomly allocated in two groups. The first group received intravenous lidocaine infusion
      during the procedure until one hour postoperatively; meanwhile the second group received
      intravenous saline for the same period of time. The intervention was double-blind. In the
      postoperative period, both groups received dipyrone and morphine PCA. Pain was assessed by
      Visual Numeric Scale (VNS) at rest and when coughing at 1st, 2nd, 4th, 12th e 24th hour after
      the end of the surgery. Blood samples for cytokines measurement were taken at the end of
      procedure and 24 hours later. The total morphine PCA demand, the time for the first flatus
      and the length of hospital stay were also recorded and compared.
    

Intervention name(s): Lidocaine; Saline solution
Intervention type(s): Drug; Drug
Intervention description(s): Lidocaine was administered in bolus of 1.5 mg.kg-1 at the start of the procedure and maintained at a dose of 3 mg.kg-1.h-1 until one hour after the end of the procedure. Solution of 0,3% lidocaine was used, so that the infusion rate was equal to the weight of the patient.; Saline solution was administered in bolus of 1.5 mg.kg-1 at the start of the procedure and maintained at a dose of 3 mg.kg-1.h-1 until one hour after the end of the procedure.
Other intervention name(s): Xilocayne; Lidocaine hydrochloride
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cholelithiasis; Cytokines; under general anesthesia
Saraiki Translation, Validity & Reliability of the Activities Specific Balance Confidence (ABC) Scale Questionnaire
Condition: Old Age; Debility
MeSH terms: Frailty
Study type: Observational

Summary: 
      There is a need for a culturally adapted screening tool to aid health care professionals or
      clinicians screen for the presence of fall and balance issues associated with injuries in
      saraiki population. Furthermore, while culturally adapting the scale is necessary, it is
      important that changes do not alter the original intent, which requires it to be broad,
      comprehensible and applicable to the entire population. As saraiki language is the most-used
      language in the South Punjab, translating and adapting the ABC scale to the saraiki
      population while accounting for its sociocultural characteristics is an important task. So, I
      decided to conduct a tool translation and validation study. This study will help the
      clinicians to assess their patient's confidence and balance easily through the saraiki
      version of ABC scale in saraiki population and hence will help in timely management of the
      balance.
    

Detailed description: 
      The ABC scale is a 16-item questionnaire with 11-point subscales that assess the level of
      confidence in performing a specific task without losing balance or becoming unsteady. Each
      item score ranges from 0% (no confidence) to 100% (total confidence).

      As cross-border and cross-cultural studies continue to increase, there is a greater need for
      linguistic validation of tools across a variety of societies. Until now, no translation or
      adaptation of the ABC scale has been made for the population with different languages in
      Pakistan. In order to use questionnaires in areas with different languages and cultures,
      translation into new languages of ABC scale, for identifying fall and balance issues is
      required.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Older Adults
      
Keywords: balance; older adults
Ametop - Friend and Foe A Prospective Study of the Incidence of Adverse Reactions With Ametop
Condition: Adverse Drug Event
MeSH terms: Drug-Related Side Effects and Adverse Reactions
Study type: Observational

Summary: 
      Ametop was introduced into the formulary as it was deemed more efficacious for intravenous
      cannulation compared to EMLA. However, the incidences of adverse reactions seemed to be
      higher compared to other studies. This lead to a prospective observational study to look at
      the incidence and severity of skin reactions following routine clinical application of
      Ametop.
    

Detailed description: 
      Ametop was introduced into the formulary as it was deemed more efficacious for intravenous
      cannulation compared to EMLA. After several critical incidences of adverse reactions that
      occurred with its application, a departmental audit was carried out to look at the incidence
      and severity reactions with its application as well as its outcome on intravenous
      cannulation. The findings of the departmental audit showed that the incidence of adverse
      reactions seemed to occur more commonly compared to other studies.

      A prospective observational study was carried out to look at the incidence and severity of
      skin reactions following routine clinical application of Ametop.

      This study aims to achieve the following:

        1. Investigate the incidence and severity of adverse skin reactions following topical
           application of Ametop prior to intravenous cannulation

        2. Assess the success rate of intravenous cannulation

        3. Identify the possible risk factors associated with adverse skin reaction.
    

Intervention name(s): Tetracaine
Intervention type(s): Drug
Intervention description(s): Application of Ametop prior to intravenous cannulation
Other intervention name(s): Ametop
Intervention MeSH terms: Tetracaine
Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        Paediatric patients presenting for surgery in KK Women's and Children's Hospital
      
Keywords: Tetracaine
Acceptance-based Behavioral Treatment for Obesity: Maintenance and Mechanisms
Condition: Acceptance-based Treatment; Standard Behavioral Treatment
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The primary goal of this project is to determine if an innovative behavioral weight loss
      program that incorporates new developments from the field of behavior therapy produces
      superior weight control than standard behavioral treatment. A sample of 200 adults from the
      community are participating in this study.
    


Intervention name(s): Acceptance-based treatment; Standard behavioral treatment
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Impact of Probiotic Bacteria on the Efficacy of Anti-retroviral Therapy and Recurrence of Bacterial Vaginosis
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Purpose of the proposed research is to determine the impact of probiotic yogurt supplemented
      with Lactobacillus rhamnosus (Fiti) compared to regular yogurt on the well-being of women
      living with HIV.
    


Intervention name(s): Yogurt supplemented with L. rhamnosus fiti; Yogurt not supplemented with a probiotic strain.
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 200 ml of L. rhamnosus fiti at 10*9 cfu/ml daily for 30 days.; 200 ml yoghurt without L. rhamnosus fiti daily for 30 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
DHA and Vitamin D in Children With Biopsy-proven NAFLD
Condition: NAFLD; Non Alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Non-alcoholic fatty liver disease (NAFLD) has reached epidemic proportions and is rapidly
      becoming the one of most common causes of chronic liver disease in children. The pathogenesis
      of NAFLD is generally considered the result of a series of liver injuries, commonly referred
      as "multi-hit" hypothesis. Several studies suggest that inflammatory pathways and oxidative
      stress could be responsible of disease progression.

      The purpose of this interventional study is to evaluate the efficacy and tolerability of
      docosahexaenoic acid (DHA) and Vitamin D in children and adolescents with biopsy-proven
      nonalcoholic fatty liver disease (NAFLD).
    

Detailed description: 
      Sixty-six children or adolescents (4-16 years) with liver biopsy proven NAFLD will be
      enrolled. They will be randomized to treatment with DHA and Vitamin D (n=33) or an identical
      placebo (n=33) given orally for a period of 6 months. All patients will be included in a
      lifestyle intervention program consisting of a diet tailored on the individual requirements
      and physical exercise.

      Patients will undergo a medical evaluation at 3-6 and 12 months during the 12-months study
      period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric
      measurements and laboratory tests, including liver enzymes, gluco-insulinemic profile and
      lipids will be performed at baseline and repeated at 6-12 months
    

Intervention name(s): DHA plus Vitamin D; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DHA 500 mg plus Vitamin D 800 IU; Placebo pearls mimicking pearls with DHA and Vitamin D
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NAFLD; NASH; DHA; VITAMIN D; OBESITY; CHILDREN
Effect of Transportation Method on Preoperative Anxiety in Children
Condition: Anxiety; Child Behavior
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      To evaluate the effect of wagon for transporting vehicle instead of standard stretcher car
      for reducing preoperative children's anxiety.
    


Intervention name(s): Wagon; Standard stretcher car
Intervention type(s): Device; Device
Other intervention name(s): wagonTM, Step 2 company; Stryker, Stryker medical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment