bioihbjkbjnl/mcl2 huggingface dataset:
Outpatient Discharge Therapy With Saxagliptin+MetforminXR vs GlipizideXL for Type 2 Diabetes With Severe Hyperglycemia
Condition: Diabetes Mellitus Type 2; Hyperglycemia
MeSH terms: Diabetes Mellitus; Hyperglycemia; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Saxagliptin + Metformin XR (S+M) will be effective in stabilizing blood glucose (BG) levels
      in patients with newly diagnosed type 2 diabetes (T2DM) with severe hyperglycemia (BG levels
      300 to 450 mg/dl) and glucose toxicity and with no criteria for inpatient admission or
      occurrence of severe hypoglycemia compared to glipizide XL.

      The study may provide preliminary evidence to support the role of S+M as a bridging,
      stabilizing and safe therapy in patients with severe hyperglycemia
    

Detailed description: 
      There is very little information regarding diabetes discharge regimens for patients with
      recently diagnosed diabetes (<1 year duration) who present with severe hyperglycemia (blood
      glucose 300-450 mg/dl) to the ED or other clinical settings and who do not need to be
      admitted.

      A combination of Saxagliptin+Metformin XR, could be a potential drug combination to be tested
      as an initial treatment in these circumstances compared to Glipizide XL which was shown to be
      effective in our previous study. We expect Saxagliptin to improve beta cell function and
      decrease glucagon levels as was shown for the DPP-IV class medications and in turn improve
      blood glucose levels, while Metformin XR may reduce insulin resistance and hepatic glucose
      output. Such discharge therapy may help to prevent deterioration into acute metabolic
      complications (DKA or hyperosmolar states) and avoid hospitalization. A high proportion of
      patients may achieve glycemic targets without significant hypoglycemia as measured by self
      glucose monitoring and objectively by continuous glucose monitoring system (CGMS). Such an
      easy regimen may safely bridge the time gap until patients will be seen by their providers.
    

Intervention name(s): Glipizide XL; Saxagliptin + Metformin XR; Metformin XR
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The control group will receive Glipizide XL (10mg orally) for a total duration of 12 weeks.; The intervention group will receive Saxagliptin 5 mg daily for a total duration of 12 weeks.; The intervention group will receive Metformin XR 1000 mg daily and will be automatically titrated weekly in 2 weeks to Metformin XR 2000 daily for a total duration of 12 weeks.
Other intervention name(s): Glucotrol XL; Onglyza; Glucophage XR
Intervention MeSH terms: Metformin; Saxagliptin; Glipizide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus Type2.; Hyperglycemia
Virtual World Training for Community Health Workers (CHW)
Condition: Diabetes Mellitus Risk
Study type: Interventional

Summary: 
      Standard, effective, and scalable training models are needed to help equip community health
      workers in their community-based diabetes prevention awareness efforts. This study will
      tailor/adapt, implement, and evaluate an innovative internet-based virtual world model to
      remotely deliver a diabetes prevention awareness training program to community health
      workers.
    

Detailed description: 
      Standard, effective, and scalable training models are needed to help equip community health
      workers in their community-based diabetes prevention awareness efforts. This study will
      tailor/adapt, implement, and evaluate an innovative internet-based virtual world model to
      remotely deliver a diabetes prevention awareness training program to community health
      workers. A sequential mixed-methods design is used to address these specific aims: 1. Use
      community-based participatory research methods to guide the overall study and inform
      tailoring and adaptation of our virtual world model to deliver the CHW training program; 2.
      Conduct a randomized pilot study to compare change in primary outcomes (0, 12 weeks) after
      the in-person versus virtual world delivery of the program; and 3. Conduct summative focus
      groups to gather information to refine the program and study methodology.
    

Intervention name(s): Virtual Training; In Person Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention involves a CHW training focused on raising awareness of diabetes prevention in the community. It is delivered remotely over 10 weeks using an internet based approach.; The intervention involves a CHW training focused on raising awareness of diabetes prevention in the community. It is delivered in person over 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized 2 group repeated measures design (Pre-Pandemic) [Pandemic modification: Only Virtual world group]
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Hormonal Status and Quality of Life in Female Postmenopausal Patients With Burning Mouth Syndrome
Condition: Burning Mouth Syndrome; Progesterone; Dehydroepiandrosterone; Quality of Life; Hormone Disturbance; 17β-Estradiol
MeSH terms: Burning Mouth Syndrome; Endocrine System Diseases; Syndrome; Burns
Study type: Observational

Summary: 
      The aim of this study was to determine the level of salivary estradiol, progesterone and
      dehydroepiandrosterone in female postmenopausal women with and without burning mouth
      syndrome. In all participants the quantity of unstimulated and stimulated saliva would be
      determined and they would fulfill self-perceived quality of life questionnaire Oral Health
      Impact Profile-14 (OHIP-14). Intensity of burning symptoms would be determined on
      visual-analogue scale grading 0-10. All data would be compared between study and control
      group.
    


Intervention name(s): unstimulated saliva sample for hormone analysis; quality of life questionnaire
Intervention type(s): Diagnostic Test; Other
Intervention description(s): hormone levels will be determined in frozen samples of unstimulated saliva; all participants will fill out self-perceived quality of life questionnaire
Intervention MeSH terms: Hormones
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        postmenopausal women are most frequently affected with burning mouth syndrome, and we
        wanted the groups to be as similar as possible so we included only postmenopausal women,
        with and without burning mouth syndrome
      
Keywords: burning mouth syndrome; hormonal status; quality of life
Buprenorphine Maintenance Dose Schedule and Treatment Setting - 2
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of treating opioid-dependent
      individuals with buprenorphine on a thrice-weekly schedule compared to daily dosing.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
Keywords: Opioid-Related Disorders
Efficacy of CPR Teaching in Mass Training
Condition: Teaching CPR
Study type: Interventional

Summary: 
      This prospective study evaluate teaching efficacy of CPR training using different methods in
      general population, medical students and non medical students with the 12 months evaluation
      of its recall
    

Detailed description: 
      In a prospective and observational study of 2000 individuals in three different groups
      including medical students, non-medical students and general populations four different
      protocols of CPR training were applied and their efficacy were compared between the groups.
      Meanwhile, 12 months after the study course, 460 participants from three groups were asked to
      take part in a theoretical and practical exam to evaluate the long term efficacy of the four
      protocols.
    

Intervention name(s): Workshop using Lecture and human model; Workshop using Educational Film; Workshop using Lecture, human model as well as Educational Film; Workshop using Lecture, human model, Educational Film as well as reference book
Intervention type(s): Other; Other; Other; Other
Intervention description(s): workshop to teach CPR with lecture and human models; workshops using film review about CPR; using educational films and human model and lecture for training; training volunteers with lecture, films, and human models and giving them reference book for referral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: Cardiac Arrest; Cardiopulmonary Resuscitation; Training
E-health Interventions to Promote Physical Activity Among Inactive Adults
Condition: Physical Activity Promotion Among Inactive Adults
Study type: Interventional

Summary: 
      The project addresses physical inactivity as a global health issue. Physical inactivity is
      the fourth leading risk factor for global mortality. Moreover, inactive adults have a higher
      risk to develop lifestyle diseases. To date, there is preliminary evidence of the efficacy in
      the use of certain strategies including fitness technologies and digital interventions for
      physical activity (PA) promotion. Intervention studies are needed to test the effectiveness
      of PA promotion strategies.

      A Hybrid Type I effectiveness-implementation randomised controlled trial (RCT) will
      investigate the effects of 1) fitness trackers, 2) home-based online training, and 3) peer
      support via social media among inactive adults. The design will allow testing the study
      outcomes while gathering information on implementation in a real-world situation. The study
      will produce evidence on whether these interventions increase the levels of PA among inactive
      adults and improve health outcomes. Increased PA will also result in better primary
      prevention of lifestyle diseases.
    


Intervention name(s): Fitness tracker; Online training; Peer support via social media
Intervention type(s): Device; Other; Other
Intervention description(s): Fitness tracker Mi Smart Band 5 with the computational algorithm PAI; Les Mills On Demand; Facebook group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously
Condition: Healthy Volunteers; Pharmacokinetics of Mirabegron
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates whether mirabegron (YM178) has an effect on the pharmacokinetics of
      solifenacin and whether solifenacin has an effect on the pharmacokinetics of mirabegron.
    


Intervention name(s): solifenacin succinate; mirabegron
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): Vesicare; YM905; YM178
Intervention MeSH terms: Mirabegron; Solifenacin Succinate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: YM178; Mirabegron; DDI; Phase I; Solifenacin; Pharmacokinetics; Pharmacokinetics of mirabegron
Selective Nerve Root Block With Ultrasound Guidance Improves Surgical Outcome of Selective Discectomy in Patients With Multilevel Cervical Disc Disease
Condition: Selective Nerve Root Block; Selective Discectomy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Disc degeneration is a natural part of growing older. Up to 60% of asymptomatic people have
      MRI findings that are positive. As a result, MRI only provides morphological information and
      may not be able to determine the clinical significance of the findings.
    

Detailed description: 
      Many authors believe that patients who suffer from cervical radiculopathy as a result of
      degenerative disease and have multilevel pathology on imaging studies still have moderate
      surgical outcomes. This occurs due to a misdiagnosis or the need to perform surgery on
      multiple levels despite a single painful lesion.

      Although the complication rate for 1- and 2-level ACDF is so low that it is considered one of
      the safest procedures in spine surgery. There is concern that increasing levels of fusion
      will lead to more complications, such as a higher incidence of persistent axial neck pain,
      dysphagia, and vertebral artery injury, as well as more postoperative pain and higher
      narcotic dosages.
    

Intervention name(s): selective anterior cervical discectomy and fusion (ACDF); SNRB+ selective anterior cervical discectomy and fusion (ACDF)
Intervention type(s): Procedure; Procedure
Intervention description(s): selective anterior cervical discectomy and fusion (ACDF); US-guided selective nerve root block (SNRB) + selective anterior cervical discectomy and fusion (ACDF)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Iron and the Breast-Fed Infant: Iron Status and Two Regimens of Iron Supplementation
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      Normal breastfed infants can develop iron deficiency by 6 months of age. This trial tested
      the hypothesis that regular provision of a source of iron beginning at 4 months of age
      improves iron status and could prevent iron deficiency. This was a prospective randomized
      trial involving breastfed infants. To be eligible, infants had to be predominantly breastfed
      (<200 ml/day of formula) at 4 months of age. At 4 months infants were randomly assigned to
      one of two interventions or to control. The interventions consisted in the daily
      administration of medicinal iron in a dose of 7.5 mg (Medicinal Iron Group) or in the daily
      feeding of one jar of an iron-fortified cereal providing 7 mg of iron each day (Cereal
      Group). The control group received complementary foods chosen by he parents but no source of
      iron provided by the investigators. The interventions took place from 4 to 9 months. All
      infants were subsequently followed to 2 years of age.
    


Intervention name(s): Fer-In-Sol (ferrous sulfate); Iron fortified cereal
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 7.5 mg/day in the form of 0.3 ml once each day; 1 jar each day of one of three wet pack cereals manufactured by the Gerber Company: Each jar provided 7 mg of ferrous sulfate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Iron, breastfed infant
Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping
Condition: Aneurysmal Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to demonstrate that clazosentan, administered as a continuous
      intravenous infusion at 5 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH),
      reduces the incidence of cerebral vasospasm -related morbidity and all-cause mortality within
      6 weeks post-aSAH treated by surgical clipping. The primary endpoint of the study is the
      occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6
      weeks post-aSAH, defined by at least one of the following:

        1. Death (all causes).

        2. New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant
           contributing cause, or not adjudicated to be entirely due to causes other than
           vasospasm.

        3. Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the
           primary or relevant contributing cause, or not adjudicated to be entirely due to causes
           other than vasospasm.

        4. Neurological signs or symptoms (depending on state of consciousness), in the presence of
           confirmed cerebral vasospasm on angiography (DSA or CTA), leading to the administration
           of a valid rescue therapy.

      An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet
      the primary endpoint and its individual morbidity components.
    


Intervention name(s): Clazosentan; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous clazosentan administered by continuous infusion at 5 mg/h; Placebo administered by continuous infusion matching clazosentan administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aneurysmal; Subarachnoid; Hemorrhage; vasospasm; clazosentan; PIVLAZ; surgical clipping
Study to Evaluate Treatment Effects Associated With the NeuroStar SoftStart Treatment Feature
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the comfort of the NeuroStar® Advanced Therapy
      System regular prescribed TMS protocol versus a New Feature.
    

Detailed description: 
      This is a 2 week study to evaluate the New Feature an exclusive feature available on the
      NeuroStar® Advanced Therapy System. This feature introduces a series of stepped pulses within
      each pulse train ramping up the pulse magnitude to the prescribed treatment level. Patients
      will be randomized after consent to receive either the standard Dash protocol or the modified
      Dash protocol with the New feature enabled. The subjects will be switched between treatment
      protocols and asked to complete comfort, and depression questionnaires.
    

Intervention name(s): repetitive Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): the administration of a series of magnetic stimuli to the brain for the purpose of altering brain function
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients will be switched between different treatment arms and asked to complete questionnaires.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: TMS; Major Depressive Disorder; NeuroStar TMS
Does Radiofrequency Ablation of the Articular Nerves of the Knee Prior to Total Knee Replacement Improve Pain Outcomes
Condition: Arthroplasty, Replacement, Knee
Study type: Interventional

Summary: 
      More than 300,000 total knee joint replacement surgeries are performed per year in the United
      States and safe, effective management of post-operative pain in these patients, often
      elderly, deconditioned, obese, or with co-morbid diseases like sleep apnea, can be
      challenging and often require a multidisciplinary, multimodal approach. Opiates have been a
      mainstay of treatment in the post-operative period with varying degrees of success and
      complications. Inadequately controlled postoperative pain is not uncommon. Poorly controlled
      pain inhibits early mobilization and hinders post-operative physical therapy.

      A new paradigm for treating post-operative pain following total knee replacement may be the
      use of cooled radiofrequency ablation (C-RFA) of the articular sensory nerve supply of the
      knee capsule prior to surgery, to desensitize the knee by blocking sensory afferents to the
      anterior capsule and thereby decrease post-operative pain. There are several publications
      that have demonstrated the use of RFA in patients with chronic knee pain from osteoarthritis
      however the use of RFA in the preoperative management of pain in patients undergoing total
      knee joint replacement has not been investigated.

      The aim of this study is to determine if patients undergoing unilateral total knee
      replacement obtain any post-operative pain relieving benefits from C-RFA of the articular
      sensory nerve supply when performed prior to surgery, as compared to sham controls who
      receive only local anesthetic injections of these same nerves without the benefit of ablation
      treatment.
    


Intervention name(s): Radiofrequency Ablation (RFA); Simulated Radiofrequency Ablation (RFA)
Intervention type(s): Procedure; Procedure
Intervention description(s): The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.; The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total Knee Replacement, Replacement of the knee joint,
Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors
Condition: Locally Advanced or Metastatic Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to determine the safety and tolerability of pamiparib,
      the maximum tolerated dose (MTD) or maximum administered dose (MAD) for pamiparib combined
      with TMZ, to select the recommended Phase 2 dose (RP2D) and schedule of pamiparib in
      combination with TMZ, and to determine the antitumor activity of pamiparib in combination
      with TMZ.
    


Intervention name(s): Pamiparib; Temozolomide
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg (20 mg capsules) administered orally twice a day; Doses of up to 120 mg (as 20 mg capsules) administered orally once daily (QD) as specified in the treatment arm
Other intervention name(s): BGB-290; TMZ; temodar
Intervention MeSH terms: Temozolomide; Pamiparib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian cancer; Triple negative breast cancer; Small cell lung cancer; Prostate cancer,; Gastric cancer; temozolomide; BGB-290; antineoplastic agents; alkylating, alkylating agents,; Poly (ADP-ribose) polymerase inhibitors; enzyme inhibitors; Head and neck cancer; Esophageal cancer; Soft tissue sarcoma; Non small cell lung cancer; pamiparib