bioihbjkbjnl/mcl2 huggingface dataset:
Freestyle Libre-based Education on MDI in T2DM (FreEdoM-2)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Multicenter, Open-label, Randomized Trial to Compare the Effectiveness of Structured
      Education and Safety of FreeStyle Libre or Self-Monitoring of Blood Glucose (SMBG) in
      patients with type 2 Diabetes Mellitus using Multiple Daily Injections or Insulin Pumps
    

Detailed description: 
      All subjects must participate in Blind Continuous Glucose Monitoring(CGM) for two weeks prior
      to Visit 2 visit (random assignment).

      Subjects who meet the selection/exclusion criteria in Visit 2 visits are randomly assigned to
      the test group (personal in-depth education and FreeStyle Libre) or control 1 (standard
      education and FreeStyle Libre) or control 2 (standard education and SMBG) at a 1:1:1 ratio.

      In the test group, personal in-depth education is conducted at baseline (Visit 2), 4 weeks
      (Visit 3), 8 weeks (Visit 4), 12 weeks (Visit 5), and 18 weeks (Visit 6), and the time
      required for education and preparation time required for patient education are checked.

      Control groups 1 and 2 conduct routine insulin basic injection training as standard education
      at baseline (Visit 2) and 12 weeks (Visit 5).

      After randomization, FreeStyle Libre is applied to the test group and control group 1 for 24
      weeks, and SMBG is performed for 22 weeks and Blind CGM is applied for 2 weeks at 22 weeks
      (Visit 7).

      Blood glucose measurements collected from FreeStyle Libre are collected through the reader
      program, and are checked in real time by researchers and used for education, research, and
      analysis. Prior to the implementation of FreeStyle Libre for the collection of real-time
      blood sugar collected through FreeStyle Libre, the subject is given consent to disclose blood
      sugar information.

      All subjects visit baseline (Visit 2), 12 weeks (Visit 5), and 24 weeks (Visit 8) to conduct
      surveys on physical examinations, blood tests and urine tests (Central Lab), and treatment
      satisfaction questionnaire (DTSQ).
    

Intervention name(s): FreeStyle Libre; SMBG
Intervention type(s): Device; Other
Intervention description(s): FreeStyle Libre flash sensor-based glucose monitoring system (FSGM; Abbott Diabetes Care, Witney, Oxon, UK); Self-Monitoring of Blood Glucose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Cortical Neuromodulation in Post Stroke Dysphagia
Condition: Dysphagia
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      The investigators aim is to try to rehabilitate post stroke dysphagia using electrical
      stimulation of the mylohyoid muscles.
    

Detailed description: 
      Aspiration could have fatal complication especially in post stroke dysphagia. The aim of this
      study is to improve post stroke dysphagia using electrical stimulation of mylohyoid muscles.

      The investigators measure swallowing time before and after electrical stimulation, performed
      one hour per day, 5 consecutive days during paste consistency swallowing
    

Intervention name(s): electrical stimulation
Intervention type(s): Procedure
Intervention description(s): sub motor threshold stimulation of mylohyoid muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: swallowing; stroke; aspiration; human; electrical stimulation; post stroke dysphagia
IOP and Ocular Biometrics Changes After Phacoemulsification in Glaucoma Patients and Controls
Condition: Glaucoma; Cataract
MeSH terms: Glaucoma; Cataract
Study type: Interventional

Summary: 
      Effect of phacoemulsification on intraocular pressure has been studied with variable
      results.Furthermore, effect of phacoemulsification on ocular biometrics including anterior
      chamber depth and angle opening distance has also been studied. In our study we aim at
      establishing a quantitative relationship between preoperative ocular biometrics and
      postoperative intraocular pressure change and comparing this relationship in glaucomatous and
      non-glaucomatous eyes.
    

Detailed description: 
      All patients will have the anterior chamber angle assessed by indentation gonioscopy
      preoperatively. Anterior Chamber Depth & lens thickness will be measured by Optical Biometry
      (lenstar 900) as well as measurement of the angle & lens vault using the Ultrasound
      Biomicrosopy (UBM) before and 1 month after cataract surgery. IOP will be measured pre- &
      postoperatively on day 7 and 30. Possible Risk (s): Risks of surgery(hemorrhage,
      endophthalmitis), Risks for investigations: minimal risk of infection To minimize the risk of
      infection: adherence to pre-& intraoperative infection-control measures, postoperative UBM is
      to be done at 1 month.
    

Intervention name(s): phacoemulsification and Intraocular lens implantation; Ultrasound Biomicrosopy (UBM)
Intervention type(s): Procedure; Diagnostic Test
Intervention description(s): Standartd surgical procedure with small incision to remove catarct using ultrasound waves. it can be done by topica, local or general anaesthesia acoording to patients general fitness and preference.; A diagnostic test using ultrasound waves to evaluate the anterior chamber depth, angle and lens vault.
Intervention model: Single Group Assignment
Intervention model description: All participants are assigned to the same interventions. All will undergo pre- & postoperative assessment, cataract surgery.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ocular bio-metrics; Anterior chamber depth; UBM
Safety of Prasaprohyai 95%Ethanolic Extract Capsules in Healthy Volunteer
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the safety of Prasaprohyai 95% ethanolic extract at doses of 100 mg and 200 mg
      for for 6 weeks. (Clinical Trial phase I)
    

Detailed description: 
      Sample size Group 1 (100mg/meal) = 6 female, 6 male Group 2 (200mg/meal) = 6 female, 6 male

      Volunteers will be divided into 2 groups. One will take Prasaprohyai 95% ethanolic extract
      capsules at a dose of 100 mg three times a day before meals and the other take Prasaprohyai
      95% ethanolic extract capsule at a dose of 200 mg 3 times a day before meals for six weeks.
      After that, they will cease using the drug for 2 weeks (wash out period). All volunteers will
      be followed up in the third week, sixth week and eighth week to evaluate the safety of the
      medicines. The researcher will record data such as age, career, BMI, vital signs, signs and
      symptoms. Safety will be monitored by hematology tests such as liver function test, renal
      function test, lipid profile and blood sugar.

      The first step in this research will be to study group 1 (100 mg). If it proves safe, the
      group 2 (200 mg) will be studied.

      The data gathered will be evaluated using statistical software. The results are in the form
      of mean ± standard deviation. The study will be planned as repeated measured ANOVA or
      Friedman's test in order to evaluate differences between groups, accompanied by using paired
      t-test or Wilcoxon's test in order to evaluate differences within groups. A significance
      level of p < 0.05 will be considered statistically significant.
    

Intervention name(s): Prasaprohyai
Intervention type(s): Drug
Intervention description(s): Prasaprohyai 95% ethanolic extract capsules will take three times a day before meals
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Volunteers will be divided into 2 groups. One will take Prasaprohyai 95% ethanolic extract capsules at a dose of 100 mg three times a day before meals and the other take Prasaprohyai 95% ethanolic extract capsule at a dose of 200 mg 3 times a day before meals for six weeks. After that, they will cease using the drug for 2 weeks (wash out period). All volunteers will be followed up in the third week, sixth week and eighth week to evaluate the safety of the medicines. The researcher will record data such as age, career, BMI, vital signs, signs and symptoms. Safety will be monitored by hematology tests such as liver function test, renal function test, lipid profile and blood sugar.
The first step in this research will be to study group 1 (100 mg). If it proves safe, the group 2 (200 mg) will be studied.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prasaprohyai extract, Healthy volunteers
Loss of Resistance, w/wo Stimulation, For Epidural Placement
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this randomized, observer-blinded, investigative trial is to determine if the
      use of electrical stimulation, compared to the traditional loss of resistance technique
      alone, improves the success rate of epidural catheter placement at an academic teaching
      institution.
    

Detailed description: 
      All subjects will receive a thoracic epidural catheter placement at the level appropriate for
      their surgery and will be randomized to either have the epidural placed with a loss of
      resistance technique alone or loss of resistance technique with confirmation by nerve
      stimulation. In the traditional loss of resistance technique group, the epidural catheter
      will be placed after achieving loss of resistance to air. In the electrical stimulation
      group, following the location of the epidural space with a loss of resistance technique
      (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the
      abdominal or thoracic wall. Nerve stimulation will be started at a pulse width of 0.3 ms and
      a frequency of 1 Hz and a current of 0.2mA.
    

Intervention name(s): Thoracic epidural block; Electrical Nerve stimulation; Solution For Thoracic epidural block
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Thoracic epidural block with epidural placed with a loss of resistance technique alone.; In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall.stimulating peripheral nerve catheters(19 Ga. x 90 cm StimuCath® Continuous Nerve Block Catheter with SnapLock™ Adapter (Arrow by Teleflex Medical, Morrisville, NC), and stimulation will be achieved using a B Braun Stimuplex HNS12 Nerve Stimulator product id 4892098.; Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine
Other intervention name(s): Lidocaine; Epinephrine
Intervention MeSH terms: Lidocaine; Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: epidural catheter placement
Study Of Men With Mild To Moderate Erectile Dysfunction To Evaluate The Efficacy Of Viagra 8 Hours Post-Dose
Condition: Impotence
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      Safety/Efficacy of 100mg Viagra at 8 hours post dose in men with mild to moderate erectile
      dysfunction
    


Intervention name(s): Viagra (Sildenafil Citrate) 100 mg
Intervention type(s): Drug
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity
Condition: Obesity & Overweight
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will compare two different ways of giving cagrilintide and semaglutide for
      treating overweight and obesity. The medicines will either be given together in 1 injection
      or as 2 separate injections.

      The aim of the study is to find out how the different ways of injection affect the level of
      the medicines in the blood.

      For the first 14 weeks of the study, participants will get cagrilintide and semaglutide as 2
      separate injections. Then participants will either switch to getting the medicines as a
      combined injection or continue to get the separate injections for 8 weeks. Which treatment
      participants get after the first 14 weeks is decided by chance.

      Participants will get the study medicines once a week for 22 weeks. A study nurse at the
      clinic will inject the medicines with a thin needle in participants stomach area.

      The study will last for about 8 months.Participants will have 28 clinic visits with the study
      staff. For 4 of these visits, participants will stay in the clinic for 5 nights.

      Participants will have blood drawn at 21 visits. Participants will have clinical assessments
      and participants will be asked about their health, medical history and habits including
      mental health questionnaires.

      For women: Participants must not be able to become pregnant if they wish to participate in
      this study.
    


Intervention name(s): Cagrilintide; semaglutide; Cagrilintide and semaglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Once weekly doses of cagrilintide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. for 2 weeks; Once weekly doses of semaglutide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. over 2 weeks; Cagrilintide and semaglutide combined and administered using the DV3384 manual syringe
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The trial consists of a Part A with multiple weekly dosings at site and a Part B with a single dose (SD) part of the first dose step in Part A.
Masking: None (Open Label)
Primary purpose: Treatment
Laparoscopic Recurrent Inguinal Hernia Repair
Condition: Congenital Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Laparoscopic management of recurrent inguinal hernia in children has been recently introduced
      in surgical practice. One of the most important advantages of using the laparoscopic approach
      in cases with recurrent inguinal hernia (RIH) is that it avoids the previous operation site
      thus avoiding injuries to the vas and vessels [19]. Some authors designed a study to compare
      laparoscopic hernia repairs with classical open repairs for pediatric RIH following the ﬁrst
      open repair. They stated that avoiding the scarred tissue the former operation area with the
      laparoscopic approach facilitates the procedure and decreases both the operative time and
      complication rate. [5]. Further, it is as simple as a fresh hernia repair because the time
      taken for the repair of recurrent hernia laparoscopically was the same as the fresh
      laparoscopic repair with no added complication [5,20]. In laparoscopic surgery, approaching
      the hernia defect from within the abdomen, makes the area of interest bloodless, and the
      magnification renders anatomy very clear, making surgery precise [6,7].
    

Detailed description: 
      Abstract: Background: Open repair of recurrent inguinal hernias [RIH] in infancy and
      childhood is difficult and there is definite risk of damaging the vas deferens and testicular
      vessels. Laparoscopic repair of RIH has the benefit of avoiding the previous operative site.
      The aim of this study is to present the investigator's experience with laparoscopic repair of
      RIH either after open or laparoscopic hernia repair with stress on technical refinements to
      prevent recurrence. Patients and methods: This is a retrospective study of laparoscopic
      repair of recurrent inguinal hernia. Records of patients that have been subjected to
      laparoscopic inguinal hernia repair for RIH were reviewed and evaluated. All patients were
      subjected to laparoscopic repair of 42 recurrent hernial defects. The primary outcome
      measurements of this study include; operative time. The secondary outcomes include; hydrocele
      formation, iatrogenic ascent of the testis and testicular atrophy.
    

Intervention name(s): hernia repair
Intervention type(s): Other
Intervention description(s): Two 3-mm needle holders were used for stitching the wide IIR. Then the suture was continued along the upper margin of IIR, but in a deeper plane to include the peritoneum and the deeper fascia transversalis.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopy; Recurrent inguinal hernia; Children
Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma
Condition: Childhood Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      Non-Hodgkin's lymphoma is an aggressive malignance disease in children and adolescents. This
      study was designed to evaluate the efficacy and toxicity of the modified NHL-BFM-90 protocol
      in Chinese children and adolescents with Non-Hodgkin's lymphoma.
    

Detailed description: 
      Non-Hodgkin's Lymphoma (NHL) in children and adolescents include Burkitt's lymphoma (BL),
      diffuse large B cell lymphoma (DLBL), anaplastic large cell lymphoma (ALCL) and lymphoblastic
      lymphoma (LBL). These subtypes of NHL are an aggressive group of diseases. At present, in
      developed countries, 80 to 90% of children with NHL are cured by intensive, risk-adapted
      chemotherapy.The best protocols include BFM-90, LMB-89 and FAB/LMB/96. However, in developing
      countries, such as those with low and moderate incomes, the limited availability of resources
      is an obstacle for using these complicated and intensive protocols.As such, very simple
      protocols, such as the CHOP protocol, were often used to treat children and adolescents with
      NHL, thus resulting in poor survival rates. To improve the survival rate of Chinese children
      and adolescents with NHL, This study was designed to evaluate the efficacy and toxicity of
      this modified NHL-BFM -90 protocol in Chinese children and adolescents with NHL.
    

Intervention name(s): Modified BFM-90 protocol
Intervention type(s): Other
Intervention description(s): Using Modified BFM-90 protocol to treat Chinese children and Adolescents with NHL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Hodgkin's lymphoma;; Childhood and adolescence;; Survival Rate
Development, Implementation, and Evaluation of School-based Smoking Prevention Education Program Among Non-smoking Adolescents
Condition: Smoking Behaviors
Study type: Interventional

Summary: 
      Preventing smoking among adolescents is critical to end the epidemic of smoking in Malaysia.
      Despite the implementation of several smoking prevention programs, the prevalence of
      adolescent smoking and experimenting with tobacco in Malaysia is still increasing. Therefore,
      the purpose of this quasi-experimental study was to evaluate the effectiveness of Smoking
      Prevention Education Programs (SPEP) in preventing the smoking initiation among non-smoker
      adolescents based on their smoking status on follow-up and smoking intention, which includes;
      attitude, subjective norms, and perceived behavioural control as described by the Theory of
      Planned Behaviour. A total of 140 Primary five students (non- smokers) were involved in this
      study. Four schools in Kuantan district were randomly assigned to intervention and control
      groups. The intervention schools received a lecture on the hazards of smoking and SPEP
      intervention whereas the control schools received just a lecture on the hazards of smoking.
      The questionnaires and exhale carbon monoxide levels were first assessed at baseline and then
      again after three months.
    


Intervention name(s): Smoking Prevention Education Program
Intervention type(s): Other
Intervention description(s): The SPEP consisted of three lessons and each lesson took one to two hours to be implemented. SPEP was conducted through direct and indirect method. Direct method was conducted through lectures, question and answer, role play and educational videos. The tools used were video projectors and Power Point presentations. On the other hand, the indirect method was done through distributing of badge buttons and fridge magnets "Be Free from Smoking". This method brought a simple message to increase awareness among adolescents to prevent smoking uptake. All instruments and protocols in this intervention were pilot tested to confirm feasibility and cultural appropriateness.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention