bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effect of Musashino Diabetes Diet in Type II Diabetes Mellitus Disease
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Evaluation the change of patients' glycosylated hemoglobin (HbA1c) after 12 weeks diet
      control
    

Detailed description: 
      In this study, we provide the delivery service of Musashino T2DM diet for 12 weeks to
      patients with T2DM, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression
      and compliance during study period.
    

Intervention name(s): Musashino T2DM diet
Intervention type(s): Dietary Supplement
Intervention description(s): provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: T2DM, type II diabetes Mellitus, HbA1c
Can Addition of Doxycycline Perioperatively Reduce Propionibacterium Acnes in Shoulder Arthroplasty?
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to investigate antibiotic treatment to target bacteria about the
      shoulder. This bacteria, Propionibacterium acnes, is detected in many revision shoulder
      surgeries and is thought to contribute to periprosthetic joint infections, pain, and failure
      of total shoulder arthroplasty as well as other shoulder surgeries. This study is
      investigating adding an FDA approved antibiotic that is commonly used for treatment of this
      bacteria and many common infections. The investigators will take intraoperative cultures to
      look for the presence or absence of specific bacteria. The investigators are conducting this
      trial to see if adding another antibiotic to specifically target this common bacteria found
      around the shoulder will be effective.
    

Detailed description: 
      Patients undergoing total and reverse shoulder arthroplasty for primary glenohumeral
      arthritis will be invited to participate in this study if patients meet inclusion and
      exclusion criteria. Patients will be randomized to receive either standard perioperative
      antibiotics with cefazolin or to the treatment group to receive doxycycline in addition to
      cefazolin. Patients will then undergo routine surgical treatment. 3 cultures from the
      superficial tissue, dermis, and glenohumeral joint will be taken and cultured for 14 days to
      detect any bacterial growth.
    

Intervention name(s): Doxycycline; Cefazolin
Intervention type(s): Drug; Drug
Intervention description(s): The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty.
Intervention MeSH terms: Doxycycline; Cefazolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Dose Escalation Trial of Nitroglycerin, 5-flourouracil and Rad Therapy for Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether topical nitroglycerin in addition to
      5-flourouracil and radiation therapy are effective in the treatment of operable rectal
      cancer.
    

Detailed description: 
      This is an open label, non-randomized, multi-cohort, dose escalation trial to evaluate the
      safety, tolerability, feasibility and maximum tolerated dose (MTD) of topical nitroglycerin
      in addition to 5-flourouracil and radiation therapy for neo-adjuvant treatment of, T3-T4 or
      clinically node positive, operable rectal cancer.

      Patients that would otherwise be eligible for concurrent neo-adjuvant chemotherapy with
      continuous infusion 5-FU, for locally advanced operable rectal cancer, will be assigned to 4
      sequential cohorts of 3 different dose levels of nitro glycerin patches (0.2; 0.4; and 0.6
      mg/hr). Each cohort will consist of 3 patients. All patients will receive radiation therapy,
      45-50 Gy in 25-28 fractions to the pelvis along with continuous infusion 5-FU 225mg/M2 for
      the duration of the radiation therapy. The radiation therapy will be planned and delivered as
      per institutional standard of care for the Dallas VAMC radiation oncology department.
    

Intervention name(s): Nitroglycerin 0.2 MG/HR; Nitroglycerin 0.4 MG/HR; Nitroglycerin 0.6 MG/HR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.2mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr).; 0.4mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr) if this is well tolerated a higher dose patch (0.4mg/hr) will be used for the next 3 patients.; 0.6mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr) if this is well tolerated a higher dose patch (0.4mg/hr) will be used for the next 3 patients and if this is well tolerated an even higher dose patch (0.6mg/hr) will be used.
Intervention MeSH terms: Nitroglycerin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nitroglycerin; 5-flourouracil; radiation therapy; neo-adjuvant treatment
Amblyopia and Strabismus Detection Using a Pediatric Vision Scanner
Condition: Amblyopia; Strabismus
MeSH terms: Amblyopia; Strabismus
Study type: Observational

Summary: 
      The purpose of this project is to compare the performance of the Pediatric Vision Scanner
      (PVS) with the Gold Standard Examination to determine the effectiveness of the PVS at
      detecting amblyopia and strabismus. All tests and observations will be done at a single visit
      over the course of approximately 30 minutes.
    


Intervention name(s): Pediatric Vision Scanner eye scan
Intervention type(s): Device
Intervention description(s): Subject is scanned with a 2.5 second pediatric vision scanner device test.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children presenting for ophthalmic exam at eye clinic.
4-Year Open-Label Extension Phase of the Parallel-Group Study of E2007 in Patients With Refractory Partial Seizures
Condition: Epilepsy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety of perampanel given as adjunctive,
      long-term treatment in patients with refractory partial onset seizures.
    

Detailed description: 
      This is an Open-Label Extension (OLE) study for patients who completed the E2007-A001-206
      (NCT00144690) or the E2007-G000-208 (NCT00416195) double-blind, placebo-controlled,
      dose-escalation, parallel-group studies.

      This study consisted of 3 periods: OLE Titration (12 weeks), OLE Maintenance (424 weeks), and
      OLE Follow-up (4 weeks). During the OLE Titration Period, participants were titrated to their
      maximum tolerated dose (MTD) of perampanel, up to a maximum of 12 mg/day. The OLE Maintenance
      Period began at completion of the OLE Titration Period; participants remained on the dose
      achieved at the end of the OLE Titration Period unless dose adjustment for tolerability
      reasons was necessary. Participants who either withdrew from the study prematurely or
      completed the OLE Maintenance Period returned for a final visit at the end of the 4-week OLE
      Follow-up Period.
    

Intervention name(s): Perampanel
Intervention type(s): Drug
Intervention description(s): Perampanel 2 mg to 12 mg, once daily during the OLE study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Refractory; Partial; Seizures
Safety, Tolerability, and Immunogenicity of CRV-101 in Healthy Adult Subjects
Condition: Herpes Zoster; Varicella Zoster
MeSH terms: Herpes Zoster
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to evaluate the safety, tolerability, and
      immunogenicity of vaccine candidate CRV-101, investigational vaccine in healthy adult
      subjects in the United States.
    


Intervention name(s): CRV 101; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): (Different formulations); 2 doses administered IM in deltoid region of non-dominant arm
Other intervention name(s): Saline injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: VZV, Vaccine, Shingles
Music and Colposcopy in Women With Cervical Dysplasia.
Condition: Uterine Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia; Hyperplasia
Study type: Interventional

Summary: 
      To assess the effect of music during colposcopy on women´s anxiety.
    


Intervention name(s): Headphones; No Headphones
Intervention type(s): Device; Other
Intervention description(s): Music can be heard through headphones; No Headphones will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: cervical dysplasia; colposcopy; anxiety; music; mozart; randomized controlled trial
Dental and Periodontal Changes Following the Acceleration of Alignment of Crowded Lower Anterior Teeth Using a Surgical Technique
Condition: Crowding, Tooth
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      Patients at the Orthodontic Department of the University of Damascus Dental School will be
      examined and subjects who meet the inclusion criteria will be included. Then, initial
      diagnostic records (diagnostic gypsum models, internal and external oral photographs, and
      radiographic images) will be studied to ensure that the selection criteria are accurately
      matched.

      This study aims to compare two groups of patients with moderate crowding of the lower
      anterior teeth. Experimental group: the patients in this group will be treated with
      periodontally accelerated osteogenic orthodontics Control group: the patients in this group
      will be treated using fixed appliances without any acceleration method.
    

Detailed description: 
      Correction of irregular teeth can take a long time, and this depends on various factors such
      as the good compliance of the patient, the amount of dental crowding, and the need for
      extraction in the course of orthodontic treatment.

      Many methods have been used to accelerate tooth movement, and recently the PAOO technique has
      emerged as an effective therapeutic intervention.

      PAOO is a promising procedure but only a few cases were reported in the literature.
      Controlled clinical and histological studies are needed to understand the biology of tooth
      movement with this procedure, the effect on teeth and bone, post-retention stability,
      measuring the volume of mature bone formation, and determining the status of the periodontium
      and roots after treatment.
    

Intervention name(s): PAOO; Fixed appliance
Intervention type(s): Procedure; Other
Intervention description(s): Periodontally accelerated osteogenic orthodontics will be applied to treat patients with moderate crowding.; Fixed appliances will be applied to treat patients with moderate crowding without any acceleration methods.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PAOO; moderate crowding; gingival index; plaque index; papillary bleeding index
Polyacrylate Polyalcohol Copolymer for Vesicoureteral Reflux
Condition: Vesicoureteral Reflux (VUR); Urinary Tract Infection
MeSH terms: Urinary Tract Infections; Gastroesophageal Reflux; Vesico-Ureteral Reflux
Study type: Observational

Summary: 
      Endoscopic correction of VUR has gained its popularity due to its less invasiveness,
      associated low morbidity and short hospital stay. Although short term follow-up had justified
      their efficacy; however, long term recurrence and complications following endoscopic
      correction were also being reported in the literatures (6). Currently, there are insufficient
      evidences on the efficacy and safety of biocompatible tissue augmenting materials used for
      endoscopic correction of VUR; particularly on the new tissue bulking agents. (6) Polyacrylate
      polyalcohol copolymer (PPC)-Vantris ® (Promedon, Cordoba, Argentina) is the newest tissue
      augmenting biocompatible Acrylics used for endoscopic correction of VUR.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        children diagnosed with primary VUR grade 2-4 from 2006-2012 treated by a single urologist
        with different treatment modalities- conservative continuous antibiotic prophylaxis,
        endoscopic correction with PPC and open ureteral re-implantation with Cohen technique.
      
Keywords: Vesicoureteral Reflux (VUR); Complicated Urinary Tract Infection; Vantris; Polyacrylate Polyalcohol Copolymer
Impact of Nurse-led Intervention on Asthma Control in Children
Condition: Asthma in Children
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This randomized control trial design (RCT) study was conducted on children aged 6 -11 years
    

Detailed description: 
      This randomized control trial design study was conducted on children aged 6 -11 years,
      visiting the pediatric outpatient department and emergency at Dr. Ruth Pfau Civil Hospital
      Karachi.

      For the experimental group, a nursing educational intervention session was conducted with the
      patient and family/caregiver by the principal investigator, and a doctor provided the usual
      care/treatment. In contrast, the control group received only the usual care/treatment
      provided by the doctor.

      For the control group, educational material on asthma was provided in a booklet according to
      Global Initiative of Asthma (GINA) guidelines. Pre Childhood-Asthma Control Test (C-ACT)
      score of participants was measured before the intervention, and post-C-ACT score measurement
      was made after one month using the same questionnaires and C-ACT tool.
    

Intervention name(s): Nursing Educational Intervention
Intervention type(s): Other
Intervention description(s): Nursing Educational Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention and control group
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Immunogenicity and Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Volunteers Aged From 3 to 35 Months
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of Meningococcal
      ACYW135 Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 35
      years.
    


Intervention name(s): Meningococcal ACYW135 Polysaccharide Conjugate Vaccine; Meningococcal ACYW135 Polysaccharide Conjugate Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Group 1: 3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugate.; Group 2: 3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugate.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Goal-directed Therapy Guided by Stroke Volume Variation and Cardiac Index in Non-severe Surgical Patients
Condition: Fluid Therapy
MeSH terms: Stroke
Study type: Interventional

Summary: 
      To evaluate the application of fluid-infusion therapy with the combination of stroke volume
      variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients
      underwent resection of gastrointestinal tumor. Fifty patients (ASA Ⅰ-Ⅱ, 26-55 years old,
      cardiac functional gradingⅠ) scheduled for gastrointestinal tumor surgery were divided into
      two groups randomly: group C with CI as the primary judgment and group S with the combination
      of SVV and CI as the primary judgment.
    

Detailed description: 
      To evaluate the application of fluid-infusion therapy with the combination of stroke volume
      variation (SVV) and cardiac index (CI) as the primary judgment in non-severe patients
      underwent resection of gastrointestinal tumor.

      Methods: Fifty patients (ASA Ⅰ-Ⅱ, 18-55 years old, cardiac functional gradingⅠ) scheduled for
      gastrointestinal tumor surgery were divided into two groups randomly: group C with CI as the
      primary judgment and group S with the combination of SVV and CI as the primary judgment.
      Patients in group C received a therapy with the goal of CI was no less than 2.5L•min-1•m-2
      while SVV was less than 12% and CI was no less than 2.5L•min-1•m-2 in group S. Indexes
      including MAP、HR、CVP、CI、SVV were recorded at the moment after anaesthetized (T1), when skin
      was incised (T2), when the intestina was anastomosed (T3) and after the abdomen was closed
      (T4). SaO2、ScvO2 and plasma lactic were determined at T1 and T4 and DO2,VO2 and ERO2 during
      the surgery were calculated .The volume of fluid, vasoactive drugs use, the incidence of
      adverse cardiovascular events, the convalescence of intestinal peristalsis, hospital stay and
      postoperative complications were recorded.
    

Intervention name(s): cardiac index; Stroke Volume Variation
Intervention type(s): Device; Device
Intervention description(s): group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment.; group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke volume variation; cardiac index; non-severe patients; gastrointestinal surgery
Anti-Diabetic Effect of Gynostemma Pentaphyllum Tea as add-on Therapy With Sulfonylureas in Type 2 Diabetic Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The present study aimed at investigating effect of Gynostemma pentapyllum (GP) extract,
      administered as a "tea", as add-on therapy with Sulfonylurea (SU) in drug-naive patients with
      newly diagnosed type 2 diabetes. After screening, all patients received gliclazide MR 30mg
      and instruction regarding diet and physical exercise for 12 weeks. After 4 weeks treated with
      gliclazide MR 30mg, the patients was randomized to additional GP tea or placebo tea, 3 g
      twice daily during 8 weeks. Oral glucose tolerance tests were performed at baseline, after 4
      and 12 weeks. Blood tests were taken with the purpose to monitor lipids, kidney and liver
      function.
    

Detailed description: 
      In Vietnam, herbal extracts have been used as a long-standing tradition to treat diabetic
      patients, but effects of these extracts have not been studied adequately. Based on previous
      results in experimental animal, the investigators have selected the plant Gynostemma
      pentapyllum (GP), which grows in the mountain region of Northern Vietnam. GP extract had a
      hypoglycemic effect on mice and rat. In addition, GP has been shown to reduce both
      hyperglycemia and hyperlipidemia in diabetic Zucker fatty rats.The present study aimed at
      investigating effect of Gynostemma pentapyllum (GP) extract, administered as a "tea", as
      add-on therapy with Sulfonylurea (SU) in drug-naive patients with newly diagnosed type 2
      diabetes.In addition to monitoring effects plasma glucose regulation, the investigators also
      studied possible effects on plasma lipids, kidney and liver function as well as body weight
      and blood pressure.
    

Intervention name(s): GP group; Placebo group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Gliclazide MR 30mg once a day, orally Gynostemma pentaphyllum tea 3 grams twice daily, orally; Gliclazide MR 30mg once a day, orally Placebo tea 3 grams twice daily, orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Herbal medicine; Type 2 diabetes; Gynostemma pentaphyllum Tea; Insulin sensitivity; add-on
Dexmedetomidine for Immediate Perioperative Analgesia in Pediatric Patients Undergoing Tonsillectomy
Condition: Tonsillitis
MeSH terms: Tonsillitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is:

        1. To compare dexmedetomidine with fentanyl in terms of intra-operative hemodynamics and
           post-operative analgesia.

        2. To determine an analgesic dose response relationship for dexmedetomidine.

        3. Compare recovery characteristics of dexmedetomidine to fentanyl.
    


Intervention name(s): Fentanyl; Fentanyl; Dexmedetomidine; Dexmedetomidine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Fentanyl 1mcg/kg, Intravenous (IV); Fentanyl 2mcg/kg, Intravenous (IV); Dexmedetomidine, 2mcg/kg, Intravenous (IV); Dexmedetomidine, 4mcg/kg Intravenous (IV)
Other intervention name(s): Actiq; Actiq; Precedex; Precedex
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dexmedetomidine,; fentanyl,; tonsillectomy; and adenoidectomy,
A 6 Month Safety Extension Study of MBGS205
Condition: Hypogonadotropic Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase IIb, multicentre, double-blind, randomised, placebo-controlled parallel-group 36-week
      study evaluating safety and efficacy of BGS649 in male obese subjects with hypogonadotropic
      hypogonadism (HH)
    

Detailed description: 
      This is a 6 months, active treatment, extension study, open to subjects who have completed
      full 24 weeks in Study MBGS205 (A Phase IIb multicentre, double-blind, dose-ranging,
      randomised, placebo-controlled study evaluating safety and efficacy of BGS649 in male obese
      subjects with hypogonadotropic hypogonadism [HH]).The main purpose of Study MBGS206 is to
      evaluate long term safety and efficacy parameters in subjects after 12 months exposure with
      BGS649.
    

Intervention name(s): BGS649
Intervention type(s): Drug
Intervention description(s): Capsules will be taken weekly for a maximum of 24 weeks
Other intervention name(s): Leflutrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypogonadotropic; hypogonadism; testosterone