bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Benefits of Physiologic Insulin Delivery
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      In normal physiology insulin is secreted by beta cells into the portal vein. There have been
      a number of purported benefits among long-term intraperitoneal insulin users. In the present
      study we will inject ultra-rapid acting insulin into the upper and lower peritoneum under
      ultrasound guidance and compare it to subcutaneous injection. We will measure glucose,
      insulin and glucagon following these injections, to assess for benefits in counter-regulatory
      hormone production and insulin pharmacokinetics.
    

Detailed description: 
      The eventual goal of this line of work is an implanted insulin pump that delivers insulin
      automatically into the peritoneum based on continuous glucose data. All prior intraperitoneal
      pharmacokinetic studies used only concentrated regular insulin, which may be too slow to
      provide full closed-loop insulin delivery without meal announcement. A description of
      intraperitoneal ultra-rapid insulin kinetics, as well as counter-regulatory hormonal factors
      that may counter hypoglycemia is needed. Upper versus lower peritoneal delivery may also
      affect insulin kinetics. A possible benefit of intraperitoneal insulin is restoration of
      glucagon response in longstanding diabetes and clearance of insulin by the liver, both of
      which could provide hypoglycemic rescue in automated insulin delivery systems.
    

Intervention name(s): Ultra-rapid insulin
Intervention type(s): Other
Intervention description(s): Following 0.5-3 hours of insulin suspension from insulin pump, participants will receive insulin injection in respective locations (separated by at least 1 week) and then have serial lab measurements (YSI glucose, insulin and glucagon) taken during induced hypoglycemia.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will each come in for 3 visits separated by at least 1 week. During the first two visits they will be randomized to either upper or lower peritoneal injection followed by the other site. During the third visit a subcutaneous injection will be performed to provide comparative data to the standard of care.
Masking: None (Open Label)
Primary purpose: Other
A Study of Plant-based Diet on Postprandial Sleepiness
Condition: Drowsiness
MeSH terms: Sleepiness
Study type: Interventional

Summary: 
      This research aims to develop a better understanding and clinical knowledge of the effects of
      a plant-based diet on postprandial sleepiness.
    


Intervention name(s): Plant-based diet
Intervention type(s): Behavioral
Intervention description(s): 21 day diet that excludes any form of meat and other animal products, including dairy products.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Postprandial Sleepiness
Clotting With Different Dialyzer Membranes
Condition: Kidney Failure
MeSH terms: Renal Insufficiency
Study type: Observational

Summary: 
      Primary Objective:

      The purpose of this study is to measure the amount of convection achieved with two different
      haemodiafilters designed for haemodiafiltration and clotting during haemodiafiltration
      treatment.
    

Detailed description: 
      This is a prospective observational cohort pilot study of patients under the care of the
      Royal Free Hospital with chronic kidney disease who have been established on regular thrice
      weekly haemodiafiltration treatments in a dialysis centre. Information on the study will be
      disseminated to the Royal Free consultant nephrologists at the dialysis centre with primary
      responsibility for the individual patient.
    

Intervention name(s): FX100 dialyzer; SOLACEA 21H
Intervention type(s): Device; Device
Intervention description(s): comparison of dialyzers; comparison of dialyzers
Other intervention name(s): Fresenius FX 100
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        attending RFH kidney care centre for routine outpatient HDF treatments for chronic kidney
        disease
      
Keywords: coagulation; haemodialysis
The Use of a Community-based Organization to Change Lifestyle Characteristics Related to Non Communicable Diseases
Condition: Diabetes; Hypertension; Stroke; Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Noncommunicable Diseases
Study type: Interventional

Summary: 
      This study attempts to implement a lifestyle intervention programme aimed at changing the
      dietary habits, physical activity and alcohol and tobacco consumption in the 25-60year old
      adults in the MOH area, Ragama and measure the effectiveness of the programme.
    

Detailed description: 
      Sri Lanka as a developing nation needs to identify feasible and cost effective measures to
      face the epidemic of NonCommunicable Diseases(NCDs) in the future. Experiences gained over
      many years in the developed countries can be of great value in planning and implementing NCD
      prevention and control activities in the developing countries Results from many studies have
      emphasized the fact that merely providing risk reduction measures for clinically high-risk
      people in health service settings would have only a limited impact in the whole country. On
      the other hand, if the population as a whole were to be targeted, even a modest risk factor
      and healthy lifestyle change would potentially have a huge public impact.This study attempts
      to implement a lifestyle intervention programme aimed at changing the dietary habits,
      physical activity and alcohol and tobacco consumption in the 25-60year old adults in the MOH
      area, Ragama and measure the effectiveness of the programme. Outcome measures are process
      indicators, as measured by change in the dietary patterns, alcohol and tobacco consumption
      and physical activity. Short term outcome indicators would be blood pressure and
      anthropometric measurements. The long term outcome indicators such as morbidity and mortality
      due to NCD will not be measured as this will be a short term study.
    

Intervention name(s): lifestyle modification
Intervention type(s): Behavioral
Intervention description(s): Lifestyle modification for six months
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Non communicable disease; Lifestyle Modification; Community Based organization; community based study
Home Ovulation Test One Cycle at Home Study
Condition: Pregnancy; Fertility
Study type: Observational

Summary: 
      This study will assess the usability of a Home Ovulation Test when used at home by lay-users
      seeking to conceive.
    

Detailed description: 
      This study will assess the ease of use of a Home Ovulation Test when used by lay-users for
      one cycle in their home environment. The home ovulation test to be used in the study is a
      visual home ovulation test used to detect luteinising hormone (LH) in urine to identify when
      ovulation is imminent.

      A sample size of 120 volunteers (minimum) will provide adequate information for assessing the
      usability of the home ovulation test. Usability of the test will be assessed through a
      questionnaire completed at the end of the study.

      This observational study will be conducted remotely and volunteers representative of the
      intended user (lay-users) will be recruited.
    

Intervention name(s): Home Ovulation Test
Intervention type(s): Device
Intervention description(s): Visual read home ovulation test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women seeking to conceive
      
Keywords: Trying to Conceive; Home Ovulation Test; Usability
Study of an Investigational Nasal Aerosol or Placebo in Children (Ages 4 to 11) With Perennial Allergic Rhinitis (PAR)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of Beclomethasone
      dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).
    


Intervention name(s): BDP Nasal Aerosol; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Beclomethasone dipropionate; QNASL®
Intervention MeSH terms: Beclomethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergic rhinitis; pediatric subjects; BDP nasal aerosol
The Efficacy & Safety of the UAS Immunotherapy Protocol
Condition: Perennial Allergic Rhinitis With Seasonal Variation
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Observational

Summary: 
      Hypothesis: The UAS Immunotherapy protocol is efficacious and at least as efficacious as
      protocols described in the Allergy literature.
    

Detailed description: 
      Patients will be assessed for efficacy of the immunotherapy protocol by completing
      Consented-IRB approved clinical, medication, quality of life survey questions comparing
      current status while on therapy in contrast to 12 months before the inception of therapy.
    

Intervention name(s): allergen immunotherapy
Intervention type(s): Other
Intervention description(s): allergy shots
Other intervention name(s): allergy shots
Intervention MeSH terms: Immunomodulating Agents
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with allergic rhinitis pre and post immunotherapy (1 to 2 years).
      
Keywords: Allergic Rhinitis; Allergen Immunotherapy
Comparing the Impact of Cancer on Quality of Life Between Survivors of Childhood Solid Tumors and Leukemia
Condition: Childhood Solid Tumor
Study type: Observational

Summary: 
      The aim of the study is to examine the impact of cancer and treatment-related effects on the
      physical and psychosocial well-being and quality of life among Hong Kong Chinese survivors of
      childhood solid tumors.
    

Detailed description: 
      In general, cancer can be divided into two main categories: blood cancer and solid tumors.
      Leukemia refer to the cancers in blood while solid tumors refer to the cancers which involve
      the formation of an abnormal mass without any liquid or cysts. Patients suffer from leukemia
      are usually have better prognosis which result in better psychological well-being when
      compared with those suffer from solid tumors (Rodin et al., 2010). The development of solid
      tumors in children is different from that in adult. Some of the solid tumors such as
      osteosarcoma, neuroblastoma, rhabdomyosarcoma, Wilms' tumor and retinoblastoma are
      exclusively found in children. Other types of solid tumors such as brain tumor can also be
      found in children.

      Yet, most of recent studies in Hong Kong have focused in general childhood cancer survivors
      or their family members but no study has been conducted to focus on the physical and
      psychological well-being of survivors of childhood solid tumors (Li, Lopez, Chung, Ho, &
      Chiu, 2013; Wills, 2009). Therefore, the quality of life and psychological well-being of
      solid tumors survivors are always be overestimated. The actual psychological needs of solid
      tumors survivors may be overlooked. There is thus an imperative need to investigate the
      impact of cancer and treatment-related effects on the physical and psychosocial well-being
      and quality of life among Hong Kong Chinese survivors of childhood solid tumors.
    

Intervention name(s): questionnaires
Intervention type(s): Other
Intervention description(s): Participants were asked to respond to the questionnaires including the Chinese version of the Paediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0), the Chinese version of the Center for Epidemiological Studies Depression Scale for Children (CES-DC), the Chinese version of Rosenberg self-esteem scale, the Chinese version of the Herth Hope Index (HHI) and the Chinese version of Resilience Scale for Children (RS10).
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Hong Kong Chinese under the age of 19 years who completed the entire course of treatment at
        least 6 months and were diagnosed with childhood solid tumors or leukemia under the age of
        19 years.
A Multicenter Pilot Study of Pallidal Deep Brain Stimulation for Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional

Summary: 
      The purposes of this study are:

        -  to determine if bilateral pallidal deep brain stimulation results in improvement in neck
           postures/movements;

        -  to determine if bilateral pallidal deep brain stimulation results in improvement in
           quality of life; and

        -  to document the adverse effects of surgery in patients with cervical dystonia.
    

Detailed description: 
      Deep brain stimulation (DBS) of the globus pallidus has been proposed as a treatment for
      cervical dystonia. At present there are only anecdotal reports of benefit. The objective of
      this project is to prospectively assess the outcomes of DBS on cervical dystonia in a blinded
      manner. Our hypothesis is that in patients refractory to medical management, bilateral
      pallidal DBS will reduce the severity of cervical dystonia at 1 year follow up.

      The research plan is that of a feasibility study, examining outcomes of 10 patients who would
      be referred for surgical management due to the severity of their disease. The Toronto Western
      Spasmodic Torticollis Rating Scale (TWSTR) will be preformed by a blinded neurologist at the
      completion of the trial.
    

Intervention name(s): Deep brain stimulation
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Cervical dystonia; Deep brain stimulation
Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy
Condition: Sufentanil
Study type: Interventional

Summary: 
      To study the effect of different doses of sufentanil on anesthesia induction and analgesia
      after tonsillectomy in children. According to the different doses of sufentanil used in
      anesthesia induction, the children were divided into 3groups. The vital signs during
      anesthesia, the recovery period of anesthesia and the complications after anesthesia were
      compared among the groups. The anesthetic effects and safety of sufentanil at different doses
      were discussed, which provided theoretical basis for clinical selection of the best drug
      dosage.
    

Detailed description: 
      Fifteen minutes before operation, midazolam 0.1 mg/kg was slowly intravenously injected. Five
      minutes later, the child entered the operating room. Pi, Narcotrend, blood pressure, ECG,
      SpO2 and body temperature were monitored. Penehyclidine hydrochloride 0.01 mg/kg,
      dexamethasone 0.1 mg/kg, propofol 3 mg/kg, sufentanil (0.3μg/kg, 0.4 μg/kg, 0.5 μg/kg) were
      given during anesthesia induction. cis-atracurium 0.15 mg/kg, using the required type of tube
      for tracheal intubation. Sevoflurane 1.0 MAC + remifentanil 0.15 ug/kg/min 50% oxygen was
      given during anesthesia maintenance. Effective analgesia was achieved by adjusting the dosage
      of remifentanil during operation.

      The changes of vital signs including perfusion index, Narcotrend, Bp, HR, oxygen saturation
      were observed before anesthesia induction, immediately after tracheal intubation, during
      tonsillectomy and adenoidectomy during operation, after extubation and in the recovery room.
      Then record the recovery time, restlessness and pain score during recovery period,
      postoperative pain, nausea and vomiting and other complications.
    

Intervention name(s): Sufentanil Injection
Intervention type(s): Drug
Intervention description(s): three doses of sufentanil was intravenously given during anesthesia induction
Other intervention name(s): adenotonsillectomy
Intervention MeSH terms: Sufentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Sufentanil; perfusion index
The Effects of Electroacupuncture on Postoperative Pain
Condition: Periodontal Diseases; Periodontitis; Acupuncture; Electroacupuncture
MeSH terms: Periodontitis; Periodontal Diseases; Pain, Postoperative
Study type: Interventional

Summary: 
      In this study,the investigators aimed to examine the effect of electroacupuncture application
      on the amount of pain felt by patients after periodontal surgery.

      The main question it aims to answer is there any efficiacy of electroacupuncture application
      on postoperative pain reduction.

      Participants will get periodontal flap surgery treatment with/without electroacupuncture

      Researchers will compare EA and control groups to see if there is any relationship between
      acupuncture application and postoperative pain
    

Detailed description: 
      Postoperative pain is an acute pain that begins with surgical trauma and decreases over time
      with tissue healing. The level of pain and discomfort felt varies from person to person. The
      patient's sex and age, physiological and psychological structure, operation area, duration of
      surgery, premedication, type of anesthetic used, postoperative complications and several
      other environmental factors can affect this level. After the operation, especially within 48
      hours, the pain increases and gradually decreases. Postoperative pain may cause an increase
      in anxiety and general fear and concern. The stress level caused by surgical trauma in the
      patient delays recovery and increases mortality and morbidity.

      Electroacupuncture (EA) applies electrical stimulation current to needles placed on
      acupuncture points. It is mainly used to relieve pain and provide operative analgesia.

      No study has been found in the literature on the pain-reducing functionality of acupuncture
      applications in periodontal surgical treatments. In this study, the investigators aimed to
      examine the effect of electroacupuncture application on the amount of pain felt by patients
      after periodontal surgery.
    

Intervention name(s): Electroacupuncture; periodontal flap surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Electroacupuncture was applied bilaterally to the LI4, ST5 and ST6 acupuncture points before and after periodontal flap surgery; periodontal flap surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Periodontitis; Acupuncture; Electroacupuncture
A Randomized Controlled Study of Postoperative Adjuvant Therapy of Uracil-tegafur (UFT) Compared With Cyclophosphamide/Methotrexate/5-fluorouracil (CMF) in Breast Cancer (NSAS-BC)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized controlled study designed to evaluate the relapse-free survival of the
      UFT group compared with the CMF group. Patients will be randomly assigned to receive either
      CMF or UFT within 12 weeks after curative resection. To evaluate treatment efficacy, data on
      recurrence, and survival will be collected for up to 10 years after enrollment of the final
      patient. To assess safety, data on adverse events will be collected for 2 years after the
      start of treatment. Patients'quality of life will be assessed by means of a questionnaire.
    


Intervention name(s): UFT (uracil, tegafur); cyclophosphamide, methotrexate, and fluorouracil
Intervention type(s): Drug; Drug
Intervention description(s): uracil, tegafur was orally administered by 300 mg per square meter per day for 2 years; cyclophosphamide:100 mg, po, day 1-14 methotrexate:40 mg/m2, day 1, 8 q28 days x 6 cycles fluorouracil:500 mg/m2, day 1, 8
Intervention MeSH terms: Cyclophosphamide; Fluorouracil; Methotrexate; Tegafur
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer
Ketone Supplementation, Glucose Control, and Cardiovascular Function
Condition: Hyperglycemia, Postprandial; Overweight and Obesity; Diabetes Mellitus Risk
MeSH terms: Overweight; Hyperglycemia
Study type: Interventional

Summary: 
      Post-prandial hyperglycemic excursions induce a cascade of deleterious effects on the body,
      including increased inflammation, production of reactive oxygen species, and impaired
      cardiovascular function. Ingestion of an exogenous oral ketone supplement blunts
      hyperglycemia in response to an oral glucose tolerance test. Accordingly, it is hypothesized
      that exogenous ketone supplement ingestion prior to a meal could be an effective strategy for
      blunting postprandial hyperglycemia. Therefore, the purpose of this study is to investigate
      the effect of short-term (14-days) pre-meal exogenous ketone supplementation on glucose
      control, cardiovascular function, inflammation, and oxidative stress in individuals at an
      elevated risk of type 2 diabetes.
    


Intervention name(s): Exogenous ketone monoester
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will consume 20g of the oral ketone monoester supplement 15 minutes prior to each meal of the day for 14 days. All meals will be provided throughout the 14-day supplementation period.
Other intervention name(s): HVMN ketone monoester supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Flow mediated dilation; Glucose control; Inflammation; Immune cell function; Cognition; Oxidative stress; Cardiovascular function
Immunogenicity of the Booster Dose of Two MenC Vaccines
Condition: Meningococcal Infection
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the immune response of toddlers, to a booster dose in
      the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to
      assess the interchangeability of the two different vaccines.
    

Detailed description: 
      Children 14 to 18 months of life, previously vaccinated with 2 doses of tetanus toxoid
      conjugated polysaccharide men C vaccine or three doses of the CRM197 conjugated
      polysaccharide men C vaccine before 7 months of age, are randomized to receive any of the two
      vaccines. Serum antibody activity against meningococcus C will be measured inmediately before
      and 4 weeks after the booster dose. Children will also be vaccinated with a combined vaccine
      containing DTaP+IPV+Hib.
    

Intervention name(s): conjugated polysaccharide menC vaccine
Intervention type(s): Biological
Intervention description(s): Booster vaccine dose at 14 to 18 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal vaccine; Immunization, secondary; vaccines conjugated; Meningococcal disease