bioihbjkbjnl/mcl2 huggingface dataset:
Technology Intervention for Diabetes Engagement & Self-Care (TIDES)
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this 3 site, 24-week, Comparative Effectiveness Randomized Clinical Trial in
      Primary Care is to compare usual care to an online, multi-media, digital intervention for
      Persons with Type 2 Diabetes to Improve Engagement, Knowledge, and Self-Care.
    

Detailed description: 
      Objective: Technology shows promise to enhance standard care of diabetes with cost-effective,
      online lifestyle interventions. Compared to Primary Care (PC) Diabetes System of Care
      (control), the investigators hypothesized Technology Intervention for Diabetes Engagement &
      Self-Care (TIDES) would significantly improve diabetes knowledge and self-care.

      Methods: Following Institutional Review Board (IRB) approval, physician letters were sent to
      patients with type 2 diabetes, age >18 years with HgA1c >8% identified via Electronic Health
      Record (EHR) of an integrated US health system to invite participation in a 3-site, 24-week
      diabetes study. Of the 270 with >1 week email/web use invited to the shared medical visit
      (SMV) orientation, 166 subjects provided written informed consent. Diabetes knowledge and
      self-care assessments, vital signs, HgA1c, fasting glucose and lipids were collected at
      baseline, 3 and 6 months. Following randomization to TIDES (N=117) or usual care (N=49),
      TIDES group was oriented to the multimedia online intervention including a dosed sequence of
      learning via email, video, slide shows, food solutions, expert questions and answers,and
      quizzes.
    

Intervention name(s): Educational Intervention; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): Following randomization to TIDES (N=117) or usual care (N=49), TIDES group was oriented to the multimedia online intervention including a dosed sequence of learning via email, video, slideshows, food solutions, expert questions and answers, and quizzes.; Following randomization to TIDES (N=117) or usual care (N=49), TIDES group was oriented to the multimedia online intervention including a dosed sequence of learning via email, video, slideshows, food solutions, expert questions and answers, and quizzes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes Internet Education; Diabetes Education; Diabetes Self-Care; Diabetes Self-Management; Diabetes Behavior Intervention
N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19)
Condition: Coronavirus; Covid19
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study examines the efficacy of N-acetylglucosamine (NAG) in treating patients with novel
      coronavirus (COVID-19) infection.
    

Detailed description: 
      This is a single center, prospective, observational cohort study. A total of 150 cases who
      test positive for the novel coronavirus (COVID-19) will be recruited. Presenting to the
      emergency room of the study site, these cases will be treated with N-acetylglucosamine (NAG)
      in 700 mg doses every 12 hours as first-line treatment for 30 days. Standard of care (e.g.,
      remdesivir approved for emergency use in severe cases, ventilator for patients with
      respiratory failure, etc.) will be provided based on the patient's clinical needs, which will
      be at the discretion of the treating physician. Upon admission, the research team will record
      patient demographics, comorbidities, symptoms, disease severity (as assessed by the World
      Health Organization Ordinal Scale for Clinical Improvement), need for supplemental oxygen,
      and time from symptom onset until hospital arrival. The research team will also collect
      bloodwork for the following at admission: white blood cell count (WBC), hematocrit (HCT),
      hemoglobin (HBG), C-reactive protein (CRP), procalcitonin (PCT), interleukin-6 (IL-6), and
      erythrocyte sedimentation rate (ESR). During the study period, discretionary treatments and
      interventions will be recorded daily until study exit. The primary outcomes of interest are
      rate of intubation, hospital length of stay, and mortality. Secondary outcomes of interest
      include intensive care unit (ICU) admission, ICU length of stay (LOS), supplemental oxygen
      duration, rate of hospice initiation, and poor clinical outcome (defined as combined
      death/hospice initiation).
    

Intervention name(s): N-acetyl glucosamine (NAG); Control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.; Patients do not receive treatment with N-Acetylglucosamine. They may receive other treatments at the discretion of the treating physician, as with the treatment group.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: N-acetyl glucosamine
An Efficacy and Safety Study of Fentanyl Transdermal Patch in Filipino Participants With Osteoarthritis and Chronic Low Back Pain
Condition: Osteoarthritis; Low Back Pain
MeSH terms: Osteoarthritis; Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of fentanyl among Filipino
      participants with osteoarthritis (disorder which is seen mostly in older persons in which the
      joints become painful and stiff) and chronic (lasting a long time) low back pain.
    

Detailed description: 
      This is an open-label (a medical research study in which participants and researchers are
      told which treatments the participants are receiving, "unblinded") single-arm and prospective
      study (study following participants forward in time) of fentanyl in participants with
      osteoarthritis and Chronic low back pain with moderate (medium level of seriousness) and
      severe (very serious, life threatening) pain levels. Participants will be treated with
      fentanyl transdermal patch (patch containing a drug that is put on the skin so the drug will
      enter the body through the skin) starting with 12.5 microgram (mcg) dose of fentanyl. The
      dose will be increased on Day 3, if needed, by 12.5 mcg. Dose adjustments will be done every
      3 days. Maximum of 50 mcg dose of fentanyl will be allowed. Participants will be evaluated
      for pain levels and quality of life using Brief pain inventory (BPI) score and Clinical
      global impression-severity (CGI-S) score. Tramadol 50 milligram tablet at a maximum of 6
      tablets per day will be used as supplemental doses of analgesic (drug used to control pain).
      Participants' safety will be monitored through out the study.
    

Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention description(s): Fentanyl transdermal patches releasing 12.5 microgram of fentanyl will be applied for 3 days. The patches will be replaced every 3 days (Day 3, 7 and 10).
Other intervention name(s): DUROGESIC-D-TRANS
Intervention MeSH terms: Fentanyl
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Osteoarthritis; Low back pain; Fentanyl transdermal patch; Durogesic-D-Trans
Efficacy and Safety of Cortex Eucommiae (CE: Eucommia Ulmoides Oliver Extract) in Subjects With Mild Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to evaluate the efficacy and safety of Cortex Eucommiae
      (CE: Eucommia ulmoides Oliver extract) in subjects with mild osteoarthritis (OA).
    

Detailed description: 
      This is a 12-week, multi-center, randomized, double-blind, placebo-controlled trial to
      evaluate the efficacy and safety of Cortex Eucommiae (CE: Eucommia ulmoides Oliver extract)
      in subjects with mild OA. One hundred subjects with mild OA will be recruited and randomly
      divided into 2 groups, each group will receive Cortex Eucommiae (CE: Eucommia ulmoides Oliver
      extract) or placebo and will take CE or placebo for 12 weeks. Outcomes will be evaluated by
      self-administered questionnaires and lab test results. The hypothesis is that Cortex
      Eucommiae (CE: Eucommia ulmoides Oliver extract) which as a dietary supplementation may slow
      down or reverse OA.
    

Intervention name(s): CE; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 550mg capsule (Eucommia ulmoides Oliver extract); 550mg capsule (Placebo)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cortex Eucommiae; mild OA
Radiotherapy-Associated Atrial Fibrillation
Condition: Atrial Fibrillation New Onset
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Radiotherapy associated Atrial Fibrillation (RADAF) is an observational study to evaluate
      onset time and frequency of atrial fibrillation in patients with thoracic malignancies and
      breast cancer.

      Each patient will have 12 lead ECG prior, and daily during radiotherapy.
    

Detailed description: 
      Collected data will be truly anonymised and individuals will no longer identifiable, and than
      evaluated for occurrence of atrial fibrillation.

      Inclusing Criteria:

        1. Patients with radiotherapy for thoracic malignancy or breast cancer

        2. Between 18-99 years-old

      Exclusion Criteria:

        1. Patients with history of radiotherapy

        2. Patients with history of atrial fibrillation

        3. Patients with pacemaker implantation
    

Intervention name(s): ECG
Intervention type(s): Diagnostic Test
Intervention description(s): 12 lead ecg for each participant
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with breast and thoracic cancers will be evaluated for incidence and onset time of
        AFib.
      
Keywords: Atrial fibrillation; breast cancer; lung cancer; thoracic malignancies; cardiotoxicity
Effect of Neutralization of Endogenous Acid Production on BMD and Bone Microarchitectural
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypothesis: Neutralization of acid production induced by the Western diet with oral
      administration of potassium citrate increases bone mineral density and bone mass as well as
      skeletal muscle mass and strength in elderly people (> 65y).
    

Detailed description: 
      We will perform a prospective, randomized, placebo-controlled trial evaluating the effect of
      K citrate on bone mineral density, microarchitectural composition of bone,nutritional
      parameters, lean body mass, parameters of skeletal muscle mass and strength, 24h and exercise
      induced blood pressure changes in otherwise healthy, elderly ambulatory subjects of both
      genders.

      Potassium citrate (60 mEq) is supplied as tablets with a wax matrix (10 mEq of citrate per
      tablet) and ingested in three doses/day. All subjects will receive daily oral 500 mg of
      calcium and 400 IU of vitamin D to ensure adequate calcium and vitamin D supply.
    

Intervention name(s): potassium citrate
Intervention type(s): Drug
Intervention description(s): 6 times 10 mEq per day, oral for 24 months
Intervention MeSH terms: Potassium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endogenous acid production; metabolic acidosis; potassium citrate; osteoporosis; sarcopenia; hypertension; Effect of potassium citrate on bone mineral density and bone mass
Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatrics
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System
      when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to 17
      years-old with diabetes mellitus.
    

Detailed description: 
      Performance of the system will be primarily evaluated by comparing the blood glucose
      measurements from the reference device, a blood glucose meter, to the CGM System values
      collected during the study. Specifically, performance will be primarily evaluated in terms of
      the proportion of G4 System values that are within ±20% of glucose meter reference value for
      glucose levels >80 mg/dL and ±20 mg/dL of glucose meter reference values <80 mg/dL. These
      G4-meter matched pairs will be analyzed across the 7 days of wear.

      Safety data of the CGM System will also be collected and safety will be characterized by the
      incidence of anticipated device-related adverse events (ADEs) of subjects who participate in
      the study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents with diabetes mellitus (Type 1 or Type 2)
      
Keywords: diabetes mellitus; pediatric; continuous glucose monitoring system; CGM
Cervical Priming With Misoprostol Prior to Operative Hysteroscopy
Condition: Cervical Ripening
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary outcome measure in this study was the preoperative cervical width after
      misoprostol administration. The secondary outcomes were duration of cervical dilatation, up
      to Hegar number 10, complications during cervical dilation and the hysteroscopy, and
      misoprostol associated side effects. The cervical width was assessed by performing cervical
      dilatation, starting with a number 10 Hegar dilator and subsequently inserting smaller Hegar
      dilatators until the dilator could pass through the internal os without resistance. The
      largest one that could be passed was recorded as the initial cervical width.

      The mean cervical diameter, after oral and vaginal misoprostol of 400 μg, has been reported
      to be 6.0 ± 1.5 mm and 7.3 ± 1.6 mm, respectively 4. The investigators hypothesized that
      equivalence was of clinical significance if the difference in the initial cervical width was
      less than 1 mm among groups with the standard deviation of the initial cervical width of 1.6
      mm. The estimated sample size was 47 patients in each group; this would be able to detect an
      equivalent effect in the groups with a power of 80% and a type 1 error (a) of 0.017. Data are
      expressed as the mean ± SD (standard deviation) or median with range or as the number (%) of
      cases.
    


Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Masking: Single (Care Provider)
Keywords: endometrial pathology of uterus; operative hysteroscopy; efficacy of misoprostol per different routes
Lidocaine Infusions for Chronic Pain in Children
Condition: Pain, Chronic
MeSH terms: Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate the efficacy and safety of lidocaine in the management of chronic
      pain in children. All participants will receive lidocaine infusion and severity of pain and
      degree of chronic-pain related disability will be assessed before and up to 4 weeks after
      infusion. Adverse events will be recorded.
    

Detailed description: 
      Reports have shown that intravenous lidocaine infusions have been effective in relieving
      chronic pain that has been resistant to other therapies, with minimal side effects. The
      investigators would like to determine whether severity of pain and degree of chronic-pain
      related disability could be reduced with lidocaine infusion in children and to understand
      whether the dose of lidocaine correlates with blood levels in the same manner as it does in
      adults. The investigators will recruit 24 patients aged 8-18 with chronic pain that has not
      been relieved by standard therapies. Each patient will receive a lidocaine infusion over 2
      hours. Blood will be drawn for lidocaine concentration before the beginning of the infusion,
      immediately after and 0.5, 2 and 4 hours after. Severity of pain and degree of disability
      will be recorded using a questionnaire measuring pain scores, sleep disruption, social
      disruption, physical abilities and school attendance before the infusion, weekly for 2 weeks
      and then 4 weeks after. This study will help the investigators better understand the
      effectiveness and safety of intravenous lidocaine for chronic pain in children.
    

Intervention name(s): Lidocaine Infusion
Intervention type(s): Drug
Intervention description(s): Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg.
Other intervention name(s): Preservative Free Lidocaine Hydrochloride
Intervention MeSH terms: Lidocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anesthetics, Local; Lidocaine; Pediatrics; Children; Adolescents
Efficacy and Economic Evaluation of Nonbiological Artificial Liver Therapy in Acute-on-chronic Hepatitis B Liver Failure.
Condition: Chronic-on-acute Liver Failure
MeSH terms: Hepatitis B; Liver Failure; Hepatic Insufficiency; Liver Failure, Acute
Study type: Interventional

Summary: 
      This was a non-blinded, prospective clinical study. From June 2020 to October 2021, 254
      patients with HBV-ACLF were treated at the Department of Infectious Diseases, Xiangya
      Hospital, Central South University (Changsha, China). 186 patients who met the enrollment
      criteria were included in this study. Inclusion criteria were as follows: (1) aged 18-65
      years old; (2) patients with ACLF caused by HBV infection; (3) meeting the diagnostic
      criteria for ACLF by the Asian Pacific Association for the Study of Liver (APASL).The
      exclusion criteria were as follows: (1) pregnancy or lactation; (2) previous liver
      transplantation; (3) hepatocellular carcinoma or other malignancy; (4) human immunodeficiency
      virus(HIV) infection or other immunocompromised states; (5) complicated with underlying
      diseases such as severe heart, respiratory, and blood system diseases. Based on the inclusion
      and exclusion criteria, the investigators randomly matched patients at a 1:1:1 ratio to three
      groups whose age, sex ratio, complication, and liver function were comparable: comprehensive
      medical treatment (Control group), PE group, and DPMAS plus half-dose sequential PE (DPMAS +
      PE group). As a result, 62 subjects per group were recruited into the study. This study was
      approved by the Clinical Research Ethics Committee of Xiangya Hospital, Central South
      University with informed content obtained from all participants (No. 202201022). The study
      protocol followed the principles of the Helsinki Declaration strictly.

      All the 186 patients enrolled received comprehensive medical treatment after admission to the
      hospital, including anti-viral treatment, general supportive treatment, supplementation of
      blood products, such as albumin and plasma, and symptomatic treatment.
    


Intervention name(s): KM-8800 plasma exchange device (Kuraray, Tokyo, Japan)
Intervention type(s): Other
Intervention description(s): Artificial liver scavenges inflammatory factors.
Other intervention name(s): EC-40W plasma separator (Asahi Kasei Medical, Tokyo, Japan); BS330 bilirubin adsorption column (Jianfan Biotechnology, Zhuhai, China); The neutral microporous adsorption resin HA330-Ⅱ (Jianfan Biotechnology)
Intervention MeSH terms: Bilirubin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to
      RLD2104 in Healthy Volunteers
    

Detailed description: 
      A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety,
      Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy Volunteers
    

Intervention name(s): HIP2105; RLD2104
Intervention type(s): Drug; Drug
Intervention description(s): Test drug; Reference drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study,
      designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5%
      topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel,
      Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne
      vulgaris.
    


Intervention name(s): Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel; BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment