bioihbjkbjnl/mcl2 huggingface dataset:
Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes
Condition: Gestational Diabetes Mellitus
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of the Safety and Efficacy of Humalog® Mix50/50TM administered as 3 injections
      daily to Humalog® plus Humulin N® insulin administered as 6 separate injections daily in
      terms of glucose control for women with Gestational Diabetes.
    

Detailed description: 
      Controlling hyperglycemia during pregnancy decreases the risk of adverse neonatal and
      maternal outcomes. Not only must fasting glucose be normalized, but clinical evidence also
      indicates that controlling postprandial hyperglycemia will significantly reduce the risk of
      adverse neonatal and maternal outcomes.

      Standard therapy to achieve near-normal glycemia in gestational diabetes involves combining
      intermediate-acting basal (NPH) insulin with rapid-acting insulin (insulin lispro), thereby
      requiring 6 daily injections. Premixed Humalog® Mix50/50TM has the potential advantage over
      combination rapid-acting plus NPH insulin because it involves fewer injections, and those
      injections are associated with mealtime. The potential downside to the premixed formulation
      is nocturnal hypoglycemia associated with the time lag between the dinner and breakfast dose.
      This study will evaluate the efficacy and safety of Humalog® Mix50/50TM compared to that of
      Humalog® plus Humulin N® insulin for the treatment of insulin-requiring patients with
      gestational diabetes mellitus, while monitoring glucose control, intrauterine growth and
      assessing pregnancy outcomes.
    

Intervention name(s): Insulin LISPRO; Insulin, Long-Acting and Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Humalog® Mix50/50™ [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)], three times daily at mealtime. Dose determined by blood glucose history.; Usual insulin regimen: Long-acting insulin three times daily on rising, mid-afternoon, and before bed, and insulin lispro three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal.
Other intervention name(s): Humalog® Mix50/50™; Humalin N(r); Humalog (r)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro; Isophane insulin, insulin lispro drug combination 50:50; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gestational diabetes mellitus; insulin analogues in pregnancy
Circumferential Spread of Anesthetic and Success in Sciatic Nerve Blockade
Condition: Sciatic Nerve Blockade for Foot/Ankle Surgery
Study type: Interventional

Summary: 
      Current practices when performing any peripheral nerve block may or may not involve ensuring
      circumferential spread of local anesthetic around the nerve. Ensuring circumferential spread
      can involve several redirections of the needle above and below the nerve, and potentially
      could result in either more discomfort for the patient or an increased chance of inadvertent
      direct trauma to the nerve. Not ensuring spread around the nerve may result in a slower and
      less complete blockade. The investigators suspect that by ensuring complete spread around the
      nerve, the speed of block onset would be quicker because it avoids the loss due to diffusion
      time.
    


Intervention name(s): Circumferential spread of local anesthetic; Non-circumferential spread of local anesthetic
Intervention type(s): Procedure; Procedure
Intervention description(s): The anesthetist will ensure, under ultrasound guidance, that local anesthetic (1 mL of 1% lidocaine) surrounds the sciatic nerve.; The anesthetist will perform a "single shot" injection of local anesthetic (1 mL of 1% lidocaine) near the sciatic nerve under ultrasound guidance, without ensuring circumferential spread around the nerve.
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sciatic nerve block; local anesthetic; lidocaine; ankle surgery; foot surgery; ultrasound-guided regional anesthesia; circumferential spread; anesthetic infiltration
Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV
Condition: Choroidal Neovascularization; Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 3

Summary: 
      This pilot study is designed to evaluate the safety and efficacy of intravitreal ranibizumab
      used in combination with verteporfin photodynamic therapy (Visudyne®) compared to ranibizumab
      monotherapy for the treatment of subfoveal CNV secondary to AMD
    

Detailed description: 
      Intravitreal ranibizumab has shown to increase average vision in patients with subfoveal CNV
      secondary to AMD. However, the treatment does not provide benefit to all patients and the
      treatment regimen requires monthly intravitreal injections. Ranibizumab is an anti-VEGF-A
      monoclonal antibody fragment. Verteporfin photodynamic therapy acts through occluding newly
      formed vessels. The combination of these therapies acting through different modes of action
      bears the potential to provide a more convenient and less frequent therapy while
      maintaining/improving the increase in vision improvement observed with ranibizumab
      monotherapy. The strategic goal is to evaluate whether intravitreal ranibizumab in
      combination with verteporfin photodynamic therapy is an effective, safe and convenient
      treatment for patients with subfoveal CNV secondary to AMD and explore potential advantages
      of such treatment compared to ranibizumab monotherapy
    

Intervention name(s): intravitreal ranibizumab; intravitreal ranibizumab & photodynamic therapy
Intervention type(s): Drug; Drug
Intervention description(s): intraocular injection; intraocular injection photodynamic treatment (LASER) after intravenous injection
Other intervention name(s): Lucentis; Visudyne
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: subfoveal choroidal neovascularization (CNV); age-related macular degeneration; ranibizumab monotherapy; combined verteporfin-therapy; Lucentis® (ranibizumab); Visudyne®; photodynamic therapy
Music and Adherence Home Programs Post Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to explore whether adherence to upper extremity home programs
      changes when persons post stroke practice with preferred music.
    


Intervention name(s): Preferred music playlist
Intervention type(s): Behavioral
Intervention description(s): Client will be instructed in a home program based on repetitive task practice principles and will complete this program with and without the use of a preferred music playlist during practice.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
EMA of Substance Use in Homeless Youth
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The proposed study will provide critical information on Ecological Momentary Assessment (EMA)
      design characteristics that promote retention in a vulnerable and under-represented
      population in research-youth experiencing homelessness. The study will use an EMA app to
      collect substance use, mood, craving, social surroundings, and trauma measures over a 14-day
      period in youth age 18-24 (n=40) recruited from Star House, a homeless youth drop-in center.
      Youth will be randomized in 2x2 factorial design (fixed incentive model vs. prize-based
      model; random assessment 3x vs. 6x per day).
    


Intervention name(s): Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day; Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day; Incentive Structure - fixed; Incentive Structure - prize based
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants receive 3 EMA survey prompts daily for the duration of the study.; Participants receive 6 EMA survey prompts daily for the duration of the study.; Those assigned to the "fixed" incentive condition will earn a fixed bonus based on EMA completion (50-74%=$3; 75-89%=$5; ≥90%=$10) each week.; Those assigned to the "prize-based" incentive will be rewarded for high survey completion with increasing numbers of "draws" depending on their level of response to EMA prompts each week (50-74%=1 draw, 75-89%=2 draws, ≥90%=3 draws). For each draw, individuals will use the EMA app to "spin the wheel" to see which prize amount they earn. Out of a total of 500 total draws, 50% will be $1, 43.6% will be $3, 6% will be medium prizes ($5), and 0.4% will be a "jumbo" prize ($90).
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day)
Masking: None (Open Label)
Primary purpose: Other
Low Molecular Weight Heparin to Improve Pregnancy Outcome in Patients With Recurrent Implantation Failure
Condition: Sterility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to determine the effect of Bemiparin, a low molecular weight
      heparin, on implantation rate in women with unexplained recurrent implantation failure
      undergoing IVF/ICSI treatment.
    

Detailed description: 
      Recurrent implantation failure (RIF), defined as failure of conception following three or
      more consecutive In Vitro Fertilization (IVF) cycles despite the transfer of good quality
      embryos, is a major cause of distress amongst infertile couples. While factors underlying
      implantation failure are many, most cases remain unexplained. In order to improve pregnancy
      outcomes and delivery rates in women with unexplained RIF, various investigational treatments
      have been proposed.

      The investigators propose a prospective controlled randomized comparative study to evaluate
      the effect of Bemiparin on implantation rates in women with unexplained RIF. A total of 200
      patients will be recruited and randomized between two groups. The study group will receive
      Bemiparin plus standard care; while the control group will receive only standard care.
      Treatment will start on the day following embryo transfer and will be continued until 12
      weeks gestation in the event of pregnancy.

      The primary objective is to determine the effect of Bemiparin on implantation rate in women
      with unexplained recurrent implantation failure.
    

Intervention name(s): Bemiparin sodium
Intervention type(s): Drug
Intervention description(s): Bemiparin sodium 3,500 IU will be started on the evening of the same day of embryo transfer and until the day of pregnancy test. If the test is positive, Bemiparin will be discontinued by the end of the 12th week of gestation.
Other intervention name(s): Hibor
Intervention MeSH terms: Bemiparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Recurrent Implantation Failure; Implantation; low molecular weight heparin; In vitro Fertilization; Assisted Reproductive Technology; Pregnancy
NATURE 3.2_New Approach for the Reduction of REnal Uremic Toxins
Condition: Hemodialysis
Study type: Interventional

Summary: 
      The objective of the pilot study is to validate a combined approach based on the use of an
      innovative symbiotic and an innovative dialysis cartridge in patients on hemodialysis (HD).

      The symbiotic consists of a mixture of probiotics (Lactobacilli and Bifidobacteria),
      prebiotics (fructoligosaccharides and inulin) and natural antioxidants (a mix of quercetin,
      resveratrol and proanthocyanidins).

      The cartridge is composed of a divinylbenzene (DVB) adsorbing resine, expected to have high
      affinity to protein-bound uremic toxins pCS and IS, on the basis of its chemical structure.

      This combined approach will be aimed at achieving two main objectives:

        1. reduction of blood levels of microbial-derived uremic toxins, involved in cardiovascular
           complications

        2. reduction of inflammation markers and oxidative stress and reduction of intestinal
           permeability
    


Intervention name(s): Symbiotic; Placebo; DVB cartridge
Intervention type(s): Dietary Supplement; Dietary Supplement; Device
Intervention description(s): HD patients follow a 8-weeks oral administration of the symbiotic supplement (2 bags/day); HD patients follow a 8-weeks oral administration of the placebo (2 bags/day); On the last week of the symbiotic/placebo period, patients undergo 3 dialytic sessions with the DVB cartridge
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: uremic toxins; gut microbiota dysbiosis; symbiotic; divinylbenzene cartridge
Targeting Inflammation in Acute Coronary Syndrome Using Colchicine
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome; Inflammation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of colchicine on high sensitivity
      C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute
      coronary syndromes.
    


Intervention name(s): Colchicine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1mg once daily; 1 capsule daily
Intervention MeSH terms: Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Hydration Status When Consuming Alkaline Water Compared to Reverse Osmosis Purified Water.
Condition: Hydration
Study type: Interventional

Summary: 
      To conduct a randomized, double-blinded, placebo-controlled, cross-over trial in a population
      of chronically, moderately dehydrated people comparing two waters on hydration status.
    

Detailed description: 
      A randomized, double-blinded, placebo-controlled cross-over study design will be used to
      evaluate the effects of consumption of alkaline water against reverse osmosis water. The
      study is of 5 weeks' duration, with evaluation at baseline, 2 weeks (beginning of wash-out
      period), 3 weeks (end of wash-out period), and 5 weeks.
    

Intervention name(s): Alkaline water; Reverse osmosis water
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1.5 liters per day; 1.5 liters per day
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, double-blinded, placebo-controlled, cross-over trial
Masking: Single (Investigator)
Primary purpose: Basic Science
Clinical Study to Establish the Feasibility and Usability of the EndoRings™
Condition: Colon Cancer; Bowel Cancer; Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Colonic Neoplasms
Study type: Interventional

Summary: 
      The purpose of this prospective clinical study is to establish the feasibility and usability
      of the ENDORINGS™ when used during standard colonoscopy procedure.
    

Detailed description: 
      The EndoAid Ltd. EndoRings is used during endoscopy procedures. The EndoRings is a short
      silicon rubber tube with flexible circular wings that attaches to the distal end of the
      endoscope to facilitate endoscopic therapy.

      The EndoRings is designed to fit specific endoscopes (as designated on the packaging), and is
      supplied sterile following ETO sterilization and is single use only.

      Indications for Use:

      To be attached to the distal end of the endoscope to facilitate endoscopic therapy, to be
      used for the following:

        -  Keeping the suitable depth of endoscope's view field

        -  Helping the endoscope with being inserted into the gastrointestinal tract

      Patient Population: The study population is comprised of patients indicated for colonoscopy.

      Study Design: Single-center study. A single treatment group of 60 patients. No. of Patients:
      Up to sixty (60) treated patients will be enrolled in the study.

      Primary Endpoints:The primary endpoint is reaching the cecum of the colon with the
      ENDORINGS™.

      Secondary Endpoints / Other Outcomes:

        1. Incidence of complications (number of complications)

        2. Ability to complete s therapeutic interventions as biopsies, polypectomies, APC etc.

        3. Procedure time.

        4. Ease of scope insertion, advancement and withdrawal.

        5. Ability to center the scope inside the gastrointestinal tract.

        6. Subjective evaluation of the additional area screened by the physician (recorded in the
           source documents by a questionnaire).

        7. Patient satisfactory (by a follow up phone-call in which questionnaire with VAS scale
           will be filled out).
    

Intervention name(s): EndoRings
Intervention type(s): Device
Intervention description(s): Colonoscopy procedure, standard endo-therapy interventions will be performed in accordance with physician's evaluation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: EndoRings
Trigger- vs. Substrate-Ablation for Paroxysmal Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare two strategies of catheter-based treatment of
      paroxysmal atrial fibrillation: Pulmonary vein isolation either alone or combined with
      electrogram-guided substrate-ablation.
    

Detailed description: 
      Catheter ablation has evolved an accepted alternative in the curative treatment of atrial
      fibrillation (AF). However, discussion about the best ablation strategy is still ongoing.

      In patients with paroxysmal AF, it has been reproducibly demonstrated that curing rates of
      approximately 65-70% can be achieved with the electric isolation of pulmonary veins (PV)
      eliminating the initiating triggers of AF episodes. Recently, a new catheter ablation
      approach targeting in both atria fractionated, complex electrograms during ongoing AF and
      modifying thus the substrate maintaining AF has been described. The first describer of this
      technique reports curing rates of 92%. We want to compare in a randomized prospective study
      the treatment by PV isolation alone with a combined approach of PV isolation together with
      ablation of fractionated complex electrograms in patients with paroxysmal AF. Study endpoint
      is the achievement of stable sinus rhythm as assessed by 7 days holter ECG in the absence of
      antiarrhythmic drug treatment.
    

Intervention name(s): trigger-guided catheter-ablation; trigger+substrate-guided catheter ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): trigger-guided ablation of paroxysmal atrial fibrillation; trigger-+substrate guided ablation of paroxysmal atrial fibrillation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Nasal Carbon Dioxide (CO2) in the Symptomatic Treatment of Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of four times a day treatment with nasal
      carbon dioxide in patients with Seasonal Allergic Rhinitis symptoms.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled, multi-center, parallel group, pilot study
      will evaluate the efficacy and safety of a four times a day treatment with nasal, non-inhaled
      administration of CO2 (nasal CO2) in patients with SAR. Approximately 50 patients who meet
      the eligibility criteria will be enrolled into this study at up to 4 sites to ensure that
      approximately 30 patients complete the study.

      Patients will be randomized to one of two treatment groups and be provided with either an
      active or placebo dispenser.

      All patients will administer study drug for 10 seconds to each nostril once on Day 0 in the
      clinic then four times a day during waking hours (approximately 4 hours apart) for 14 days.
      Patients will assess their nasal and non-nasal symptoms in a patient diary. Each patients
      participation in the study may last up to 72 days.

      There will be a total of 5 scheduled clinic visits:

        -  Visit 1 Screening

        -  Visit 2 Enrollment (within 42 days of Visit 1)

        -  Visit 3 Randomization (after the completion of a 3-7 day run-in period)

        -  Visit 4 Mid-Treatment (Day 7 ± 1 day)

        -  Visit 5 End of Treatment (within 1-3 days of last study drug administration) Sites will
           follow-up with randomized patients via telephone 7 ± 1 days after the last study drug
           administration.
    

Intervention name(s): Nasal CO2; Inactive Placebo Gas
Intervention type(s): Drug; Drug
Intervention description(s): Four times a day for 14 days; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized; Double-Blind; Multi-Center; Placebo-Controlled; Phase II; Nasal Carbon Dioxide; Carbon Dioxide; Efficacy; Safety; Total Nasal Symptom Score
Antiangiogenic Peptide Vaccine Therapy With Gemcitabine in Treating Patient With Pancreatic Cancer (Phase1/2)
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, and tolerability of HLA-A*2402
      restricted epitope peptide VEGFR1 and VEGFR2 emulsified with Montanide ISA 51 in combination
      with gemcitabine
    

Detailed description: 
      Vascular endothelial growth factor receptor 1 and 2 (VEGFR1 andVEGFR2) are essential targets
      to tumor angiogenesis, and we identified that peptides derived from these receptors
      significantly induce the effective tumor specific CTL response in vitro and in vivo.
      According to these findings, in this trial, we evaluate the safety, tolerability and immune
      response of these peptide emulsified with Montanide ISA 51 in combination with gemcitabine
    

Intervention name(s): VEGFR1-1084, VEGFR2-169; Gemcitabine
Intervention type(s): Biological; Drug
Intervention description(s): One mg of each peptide will be administered by subcutaneous injection on days 1, 8, 15, and 22 in group A, on days 3, 10, 17, 24 in group B, or 5, 12, 19, 26 in group C; Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 3, 10 and 17
Intervention MeSH terms: Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epitope peptide; CTL; Pancreatic cancer; Vaccination VEGFR1; VEGFR2