bioihbjkbjnl/mcl2 huggingface dataset:
Comparision of Different Dose of Neostigmine at Advanced Decurarization
Condition: Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      Neuromuscular blockers (NMB) are currently used in anesthesia. Residual paralysis (RP) due to
      NMB is responsible for respiratory disorders after extubation. Neuromuscular blockade is
      monitored by train-of-four (TOF) stimulation at the adductor pollicis. To exclude a RP a
      mechanomyographic TOF ratio of 0.9 is mandatory. But mecanomyography is not available in
      clinical routine. Acceleromyography is the most currently monitoring available in daily
      practice but it has been proved that an acceloromyographic (AMG) TOF ratio of 1.0 is
      necessary to exclude a RP. The incidence of RP in recovery room is underestimated. So to
      perform a safe extubation, reversal of the neuromuscular blockade is necessary when an AMG
      TOF ratio has not reached 1.0. Reversal of neuromuscular blockade is achieved with
      neostigmine. The recommended dose is 0.04 mg/kg. The administration of neostigmine causes
      parasympathomimetic effects which has to be reversed with atropine. When neuromuscular
      blockade is light (AMG TOF ratio of 0.4 which corresponds to the absence of fade at the
      visual evaluation of the TOF), a low dose of neostigmine might be sufficient with less side
      effects expected. The goal of the study is to compare the delay between a light neuromuscular
      block and an AMG TOF ratio of 1.0 for three neostigmine regimens of neostigmine 0.04, 0.02,
      0.01 mg/kg with atropine respectively 0.02, 0.01, 0.005 mg/kg and a placebo.
    


Intervention name(s): neostigmine; neostigmine; neostigmine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.04 mg/kg IV bolus, injection when the of train of four is > or = to 40 %; 0.02 mg/kg IV bolus, injection when the of train of four is > or = to 40 %; 0.01 mg/kg IV bolus, injection when the of train of four is > or = to 40 %
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neostigmine; neuromuscular blocking agent; train of four; anesthesia
Effect of Biliopancreatic Diversion on Glucose Homeostasis
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Biliopancreatic diversion (BPD) surgery results in greater resolution of type 2 diabetes than
      all other bariatric surgical procedures, and it is hypothesized that this procedure has
      specific beneficial effects on glucose homeostasis beyond weight loss alone. The BPD
      procedure is performed in more than 150 patients/year by surgeons at the Division of Obesity
      and Metabolic Disorders, Catholic University of the Sacred Heart, School of Medicine, in
      Rome, Italy. The purpose of this study is to provide a better understanding of the effect of
      the BPD bariatric surgical procedure on insulin action and pancreatic beta cell function. It
      is hypothesized that weight loss achieved with BPD surgery will have greater effects on
      insulin sensitivity and beta cell function than weight loss induced by Roux-en-Y gastric
      bypass (RYGB).
    


Intervention name(s): Roux-en-Y Gastric Bypass Surgery; Biliopancreatic Diversion Surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): In Roux-en-Y Gastric Bypass Surgery a small gastric pouch is created and connected to a segment of jejunum. Bowel continuity is restored by reconnecting the "Roux" limb and the biliopancreatic limb approximately ~75-150 cm distal to the gastrojejunostomy. Therefore, ingested food bypasses most of the stomach, the entire duodenum, and a short segment of the jejunum.; In Biliopancreatic Diversion Surgery a horizontal gastrectomy is conducted leaving a portion of the stomach, which is connected to the small intestine, ~250 cm from the ileocecal valve and the biliopancreatic limb is connected to the ileum, ~50 cm from the ileocecal valve. Digestive secretions from the biliopancreatic limb mix in the common channel, where ingested food is also delivered by the alimentary limb.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bariatric Surgery; Roux-en-Y gastric bypass; Biliopancreatic Diversion
Study of PaQ™ (a Simple Patch on Insulin Delivery Device) in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the ability of a patient, who has type 2 diabetes
      (T2DM) who is currently treated with basal/bolus insulin therapy, to use PaQ™ (a simple patch
      on insulin delivery device) to control his/her blood glucose.
    

Detailed description: 
      This is a single center, open label, feasibility of use and performance evaluation of PaQ™
      (using insulin aspart) in patients with T2DM who are currently receiving basal/bolus insulin
      therapy with or without oral anti-diabetic drugs (OADs) for glycemic control. The patient's
      participation in the study is comprised of four phases: screening, baseline evaluation,
      transition to PaQ™ use, and PaQ™ treatment period. The use of these phases will allow an
      orderly transition to PaQ™ treatment as well as a reliable construct from which to interpret
      the final data.
    

Intervention name(s): PaQ™ insulin infusion device
Intervention type(s): Device
Intervention description(s): Basal/bolus insulin therapy administered by CSII for 4 weeks. First two weeks is transition period to identify correct basal rate for the patient, second 2 weeks is treatment period to evaluate efficacy of CSII device.
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vaginal Misoprostol With Intracervical Foley Catheter in Induction of Labor
Condition: Induction of Labor Affected Fetus / Newborn
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus
      the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor
      at term pregnancy.
    

Detailed description: 
      Cervical status is a good predictor of the likelihood of vaginal delivery when labor is
      induced. Any induction method is likely to be effective in a woman with a favorable cervix,
      whereas no method is highly successful when performed in a woman with a cervix that is
      unfavorable.

      The use of a balloon catheter as induction method was first described in 1862 by Trainer. The
      goal of the catheter was to ripen the cervix through direct mechanical dilatation of the
      cervical canal and indirectly by increasing endogenous prostaglandin secretion.

      Alternatively, Prostaglandins are one of the key players in cervical ripening by a number of
      different mechanisms.

      The aim of present study is to compare the safety and efficacy of vaginal misoprostol versus
      the combination of vaginal misoprostol and intracervical Foley catheter in induction of labor
      at term pregnancy.
    

Intervention name(s): Transcervical Foley catheter; Misoprostol
Intervention type(s): Device; Drug
Intervention description(s): combined methods of induction of labor Floey Catheter with misoprstol; Misoprstol inserted vaginally for induction of labor
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: misoprostol , intracervical Foley catheter , induction of labor , term pregnancy.
Effectiveness of Different Candies Against Bad Breath
Condition: Bad Breath
MeSH terms: Halitosis
Study type: Interventional

Summary: 
      This study is to analyze whether the candies can relieve or eliminate bad breath, both
      subjectively and objectively.
    

Detailed description: 
      This study is to systematically examine an existing candy, which is easily available and is
      intended to relieve or eliminate bad breath. The main aim of the study is to determine the
      effectiveness of the candies on the subjective perception of bad breath. The secondary
      outcome of the study is to investigate whether there is actually a decrease in volatile
      sulphur compounds (VSC) in the exhaled air and also a decrease in bad breath during
      organoleptic measurement.

      The purpose of the study is to investigate whether the different candies can relieve or
      eliminate bad breath, both subjectively and objectively.
    

Intervention name(s): Intake of 3 different candies against bad breath
Intervention type(s): Other
Intervention description(s): Intake of 3 different candies against bad breath on three different days (2-days interval each) after artificially creating a temporary bad breath (by eating of chips and cheese); analysis of breathing during intake of candy both subjectively and objectively
Intervention model: Single Group Assignment
Intervention model description: Three different variants of a candy are being tested by each participant. The candies are randomly assigned to the subjects, so that each subject has tested each of the three candies once. Randomization creates a different order for each participant. The study will be carried out on three different days.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: halitosis; volatile sulphur compounds
A Study of BufferGel in Women
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if it is safe to use BufferGel in the vaginas of women
      who do not have HIV and who have a low risk of getting HIV.

      Many new cases of HIV are the result of heterosexual activity. Condom use is currently the
      only effective way of preventing the spread of HIV and other sexually transmitted diseases
      (STDs). However, women, who have a greater risk of getting HIV, are often unable to convince
      their partner to use a condom. Therefore, it is important to develop methods that prevent the
      spread of HIV and that are controlled by the woman, such as medicines used in the vagina.
      BufferGel is known to kill the organisms that cause STDs, including HIV. BufferGel may do
      this without causing genital irritation and sores as other medicines do. More studies are
      needed to see if this is true.
    

Detailed description: 
      Heterosexual transmission of HIV presently accounts for the vast majority of new HIV
      infections worldwide. Currently the condom is the only method available that has been shown
      to be effective against HIV and other sexually transmitted diseases (STDs). However, women
      who are at the greatest risk for acquiring HIV are often unable to negotiate condom use.
      Therefore, it is important that effective female-controlled barrier methods, such as topical
      microbicides, be made available to women. BufferGel has sufficient buffer capacity to acidify
      twice its own volume in human semen, which inactivates STD pathogens, including HIV. Unlike
      most other topical microbicides, BufferGel is non-detergent so it should not cause genital
      irritation and lesions. The safety and acceptability of BufferGel still need to be studied
      more carefully.

      Participants are divided into two cohorts. Cohort IA consists of sexually abstinent women and
      cohort IB consists of sexually active women. Within each U.S. cohort, participants are
      assigned to apply BufferGel either once or twice daily. Within each international cohort, all
      participants apply BufferGel twice daily. Participants apply BufferGel for 14 days. Pelvic
      examinations are performed at Days 7 and 14.
    

Intervention name(s): BufferGel
Intervention type(s): Drug
Primary purpose: Prevention
Keywords: Administration, Topical; Mucous Membrane; Anti-Infective Agents; Cervix Uteri; Vagina; Vulva; Buffers
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
Condition: Surgery
Study type: Interventional

Summary: 
      The study will collect cerebral oximetry data from pediatric and neonatal subjects using the
      Masimo O3 regional oximetry device, for the purposes of device calibration and validation.
    


Intervention name(s): O3 regional oximeter sensor
Intervention type(s): Device
Intervention description(s): Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Blood-aqueous Barrier Changes After the Use of Timolol and Prostaglandin Analogues Fixed Combination in Pseudophakic Patients With POAG
Condition: Uveitis, Anterior; Cystoid Macular Edema
MeSH terms: Macular Edema; Uveitis; Uveitis, Anterior
Study type: Interventional
Phase: Phase 4

Summary: 
      Glaucoma, a progressive optic disc neuropathy causing visual field reduction, is the second
      leading cause of world blindness. The treatment of glaucoma is mainly based in reducing
      intraocular pressure (IOP) with topical medications. Many patients required two or more
      medications to achieve a target IOP. Combinations of B-blockers and prostaglandin analogs
      (PGA) are frequently used in clinical practice because their additive effect in lowering IOP
      levels. The aim of this study was to investigate the effects of fixed combinations of timolol
      maleate and PGA on the blood-aqueous barrier and evaluate the measurement of foveal thickness
      in pseudophakic patients with primary open-angle glaucoma (POAG).
    

Detailed description: 
      Most studies found a lower incidence of systemic and ocular adverse events with fixed
      combinations than with the unfixed combinations. Fixed combinations are better tolerated than
      their respective prostaglandin analogue. However, among the most serious side effects induced
      by PGA are the breaking down of the blood-aqueous barrier (BAB) and the development of
      cystoids macular edema (CME). Also, timolol maleate drops increase protein concentration in
      the human and benzalkonium chloride, eye drops preservative induces anterior chamber
      inflammation. This randomized, masked-observer, prospective clinical trial was approved by
      the Ethics Committee of the University of Campinas, and it adhered to the tenets of the
      Declaration Of Helsinki. Written informed consent was obtained from each patient.
    

Intervention name(s): travoprost and timolol maleate fixed combination; latanoprost and maleate timolol fixed combination; bimatoprost and timolol maleate fixed combination; dextran and hypromellose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): travoprost 0.004% and timolol maleate 0,5%, 1 eye drop at 8p.m. for 6 months; Latanoprost 0.005% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months; bimatoprost0.03% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months; Dextran 70 and hypromellose, lubricant eye drop at 8 a.m and 8 p.m for 6 months
Other intervention name(s): Duo-travatan; Xalacom; Ganfort; Lacribell
Intervention MeSH terms: Timolol; Bimatoprost; Travoprost; Dextrans; Latanoprost; Maleic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: primary open angle glaucoma; timolol; prostaglandin analogues
A Research Study About Weight Loss and Treatment Patterns With the Use of Saxenda® in Adults in Real-life Settings in Switzerland
Condition: Obesity or Overweight
MeSH terms: Overweight; Weight Loss
Study type: Observational

Summary: 
      The study is investigating weight loss and treatment patterns associated with the use of
      Saxenda® in adult patients.

      The aim of the study is to assess the weight loss associated with Saxenda® in patients with
      obesity or overweight. Saxenda® was prescribed to participants by study doctor independently
      of this study.

      The study will last for about 4 months, where the data will be collected from the available
      medical records.

      There will be no additional activities expected from participants in the scope of study
      because it is a chart-review study.
    


Intervention name(s): Saxenda®
Intervention type(s): Drug
Intervention description(s): Patients will be treated with commercially available Saxenda® according to local label and to routine clinical practice at the discretion of the treating physician.
The indication is for adults who need help managing their weight based on two different body mass index (BMI) groups.
Intervention MeSH terms: Liraglutide
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population will consist of male or female adults who have been prescribed
        Saxenda® for weight management in 2 cohorts reimbursed and non reimbursed
A Pilot Project to Assess the Impact of Diabetes Education During Ophthalmology Visits
Condition: Diabetes Complications; Diabetic Retinopathy
MeSH terms: Diabetic Retinopathy; Diabetes Mellitus; Diabetes Complications
Study type: Observational

Summary: 
      The overarching purpose of this project is to provide diabetes education to the diverse
      patient population at the Lions Eye Clinic, a resident-run ophthalmology practice at
      California Pacific Medical Center. Because of high clinic volume in a teaching environment,
      our patients often experience long wait times. The goal of this program is to utilize this
      wait time for diabetes education, a much-needed corollary to the eye care that patients
      receive at our clinic.

      This pilot project will investigate the impact of a program like this in our patient
      population. Specifically, the investigators are investigating whether diabetes education
      delivered in an ophthalmology setting enhances patient understanding of diabetes (via
      knowledge surveys) and/or leads to improved blood glucose control (via hemoglobin A1c). This
      is a 6-month study that runs through April 2015, and looks at the impact of an interactive
      diabetes education iPad app +/- in-person sessions with a diabetes educator. A subset of
      patients who meet with a diabetes educator will also be shown their own retinal images
      (compared to a normal retina).
    


Intervention name(s): iPad app; Educator sessions; Retinal photos
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Provided by the Patient Education Institute, the "X-plain" iPad app includes modules on healthy eating for diabetics, eye complications, foot care, and others.; A certified diabetes educator and/or registered dietitian will meet with patients for 30-60 minutes prior to their ophthalmology visits, when scheduling permits.; A resident ophthalmologist will spend approximately 5 minutes showing patient their own retinal photos, compared to a normal retina, and explaining the pathology present (if applicable).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The proposed subjects are diabetic patients already approved to be seen in the Lions Eye
        Clinic, specifically for dilated eye exam by a retinal specialist. This is a high-risk
        population with advanced disease and often with limited preexisting knowledge about
        diabetes, thus providing the motivation for these educational interventions.
Effect Of Talnetant Versus Risperidone Versus Placebo On Psychotic Symptoms In Schizophrenic Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test the safety and effectiveness of talnetant vs.
      risperidone vs. placebo in reducing positive and negative symptoms in acutely psychotic
      schizophrenia patients.
    


Intervention name(s): Talnetant
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: psychosis; cognition
Novel Executive Function Training for Obesity
Condition: Overweight and Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      Currently, the best behavioral treatments for obesity only work for 50% of adults, and of
      those who initially succeed, most do not maintain their weight loss. One reason for this
      failure may be due to neurocognitive deficits found among individuals with obesity,
      particularly related to executive function, which make it difficult for these adults to
      adhere to treatment recommendations. The proposed study aims to develop a Novel Executive
      Function Treatment (NEXT), which when administered prior to the behavioral treatment, could
      help improve outcomes by addressing the neurocognitive deficits in adults with overweight or
      obesity.
    

Detailed description: 
      First, to assist with treatment development, two groups of approximately 10 participants will
      be enrolled in a 12-week open-label treatment group of NEXT. These participants will then
      provide qualitative feedback to help with treatment development. After the two pilot groups,
      a randomized control trial will evaluate NEXT compared to standard BWL to assess feasibility,
      acceptability and preliminary efficacy. Treatment will be 6 months long and assessments will
      occur at baseline, mid-treatment, post-treatment and 6-months after treatment.
    

Intervention name(s): Behavioral Weight Loss - BWL; Novel Executive Function Training - NEXT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): All participants will be instructed on how to consume a balanced deficit diet of conventional foods; individual goals for energy intake will be based on initial body weight. Participants will be instructed in measuring portion sizes, counting calories (with a calorie counter provided or on their phone), and self-monitoring food intake. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations include stimulus control, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss.; Modifies programs like CogSMART and cognitive remediation training to help participants improve executive functioning to adhere to recommendations from BWL.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: weight loss; executive function