bioihbjkbjnl/mcl2 huggingface dataset:
Elimination of Incretin Hormones in Patients With Severe Kidney Failure
Condition: Uremia
MeSH terms: Uremia
Study type: Observational

Summary: 
      The prevalence of type 2 diabetes (T2D) is increasing rapidly worldwide. T2D is characterized
      by a severely impaired incretin effect. The incretin effect refers to the insulinotropic
      action of the nutrient-released incretin hormones glucagon-like peptide-1 (GLP-1) and
      glucose-dependent insulinotropic peptide (GIP). The incretin effect is defined as the
      difference in insulin secretory responses between oral and isoglycaemic intravenous glucose
      challenges (OGTT and IIGI, respectively) and in healthy individuals it accounts for as much
      as 70% of the insulin response following oral glucose, whereas patients with T2D exhibit an
      incretin effect in the range of 0 to 30%. Patients with T2D and non-diabetic patients with
      severe kidney failure share several pathophysiological characteristics, including decreased
      insulin sensitivity, fasting hyperinsulinaemia and impaired beta-cell function. The reason
      for these findings remains to be fully elucidated. An ongoing study in our research group is
      investigating the incretin effect and the incretin hormone secretory responses following
      OGTT, IIGI and meal ingestion, respectively. In continuation of this study, essential
      knowledge of metabolism of incretin hormones in an uremic milieu will be obtained in the
      present study prior to evaluation of the use of incretin-based agents in patients with
      impaired kidney function. In this second study we evaluate the elimination and biodegradation
      of GLP-1 and GIP. The biological active incretin hormones are rapidly degraded by the
      ubiquitous enzyme dipeptidyl peptidase-4 (DPP-4), generating inactive metabolites. The active
      hormones are however also eliminated by renal clearance, although the importance of this
      remains questionable. It is likely that the degradation and elimination of the active
      hormones will be significantly affected in patients with severe kidney impairment.

      We hypothesize that elimination and biodegradation of the two incretin hormones, both in it´s
      active and inactive forms, will be affected in non-diabetic patients with severe kidney
      failure.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        1. Hemodialysis patients

          2. Healthy control subjects
      
Keywords: Incretin hormones; GLP-1; GIP; Uremia; Dialysis
Trial for Treatment of Adult Patients With Standard Risk Acute Lymphoblastic Leukemia With Chemotherapy and Rituximab
Condition: Adult Acute Lymphocytic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The study evaluates the efficacy and tolerability of an intensified induction and
      consolidation therapy in combination with rituximab in CD20 positive standard risk patients.
      Thereafter patients receive additional consolidation and reinduction cycles combined with
      rituximab. In parallel minimal residual disease is evaluated. After six months and one year
      the decision on intensification or discontinuation of therapy is made based on results of MRD
      evaluation
    


Intervention name(s): Cyclophosphamide; Dexamethasone / Prednisolone; Vincristine; Daunorubicin; Asparaginase; Methotrexate; Cytarabine; Mercaptopurine; G-CSF; Vindesine; VP16; Adriamycin; Thioguanine; VM26; Rituximab; CNS irradiation; Mediastinal irradiation (if residual TU); Stem cell transplantation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Procedure; Procedure; Procedure
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisolone; Cyclophosphamide; Rituximab; Methotrexate; Vincristine; Doxorubicin; Daunorubicin; Asparaginase; Mercaptopurine; Thioguanine; Vindesine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALL; Treatment; De novo; Minimal residual disease; Rituximab; Adult
Simplification and Implementation of Awake Fibreoptic Orotracheal Intubation
Condition: Anesthesia; Trachea; Intubation
MeSH terms: Tracheal Diseases
Study type: Observational [Patient Registry]

Summary: 
      Awake fibreoptic intubation (AFOI) is a classic and standard method for some special patients
      which is also difficult for anesthesiologists to learn and master. The procedure is sometimes
      hard and often takes about 20-30 min. Most of patients have a strong sense of discomfort.
      Investigators conducted the research to study the simplification and feasibility of AFOI.
    

Detailed description: 
      Many studies have studied the sedative drugs and regional anesthesia related to awake
      intubation. However, several problems of AFOI are existing including long operation time,
      patients' strong discomfort, coughing and resistance. And, to investigators' knowledge, there
      was a lack of a fixed procedure for the implementation of AFOI. Investigators conducted the
      research and aimed to study the simplification and feasibility of a new AFOI method based on
      years of clinical theory, practice and experience.
    

Intervention name(s): Awake fiberoptic intubation (AFOI)
Intervention type(s): Procedure
Intervention description(s): With forty patients (ASA I~II, aged 18~75, simulating cervical instability injury) recruited to be operated on under general anesthesia, two experienced anesthesiologists performed the whole procedures within the study. Pre anesthetic interview was taken to illustrate the procedures of tracheal intubation to the patients. The simplified method consisted of three parts: conscious sedation, regional anesthesia and intubation. The time of AFOI, rate of one-time intubation success, hemodynamic parameters, pulse oxygen saturation (SpO2), rate of amnesia of the intubation, patients' satisfaction, and relative complications were recorded accordingly.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The trial will be performed at Zhongshan Hospital, Fudan University in Shanghai, China.
      
Keywords: Awake fiberoptic intubation
Solar Lighting to Reduce Indoor Air Pollution in Rural Uganda
Condition: Pollution; Exposure; Hypertension; Pollution Related Respiratory Disorder
MeSH terms: Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional

Summary: 
      This study evaluates the impact of a solar lighting system on kerosene lamp use, levels of
      indoor air pollution, and health in women living in rural Uganda. Half of the participants
      will receive the lighting systems immediately, while the other half will receive them after
      an 18 month delay.
    

Detailed description: 
      One fifth of the global population relies on kerosene lamps for lighting, yet few studies
      have focused on kerosene lighting as a source of indoor air pollution. In our preliminary
      studies performed in Uganda, we show that homes using solar lighting have much lower levels
      of indoor air pollution compared to homes using kerosene lighting. The primary goal of this
      study is to determine the extent to which solar lighting will reduce kerosene use and indoor
      air pollution in rural Uganda, whether this intervention improves lung health, and to
      identify the role bacteria in our gut have on determining whether or not people will get sick
      from indoor air pollution.
    

Intervention name(s): Solar lighting system
Intervention type(s): Other
Intervention description(s): consisting of a solar panel, rechargeable lead acid battery, charge controller, wiring and switches to 4 lighting points fitted with LED bulbs. This system will include a two-year service warranty.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: household air pollution; fine particulate matter; kerosene
A Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders
Condition: Autistic Disorder; Asperger Syndrome; Child Development Disorders, Pervasive
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Asperger Syndrome; Developmental Disabilities
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC)
      will improve behavior problems often associated with autism spectrum disorders.
    

Detailed description: 
      Autism is increasingly being recognized as a common disorder with enormous public health
      significance. The core symptoms of autism include severe deficits in social relatedness and
      communication, and interfering repetitive behavior. No medications have been shown to
      consistently improve any of these symptoms.

      The central hypothesis of this study is that NAC will improve behavioral manifestations of
      autism which may include core or associated symptoms. We plan to test our hypothesis and
      complete the objectives of this project by pursuing the following specific aims:

        -  Evaluate the efficacy of oral NAC in a 12-week, double-blind, placebo-controlled study
           involving 32 children and adolescents with autism spectrum disorders.

        -  Evaluate the safety and tolerability of oral NAC in 32 children and adolescents with
           autism spectrum disorders.
    

Intervention name(s): N-acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day.; Subjects randomized to placebo arm will receive placebo pill for duration of study.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Autistic Disorder; Asperger's; PDD NOS; Pervasive Developmental Disorder; Autism; N-acetylcysteine; acetylcysteine; NAC; antioxidant; treatment; core symptoms; Autism Spectrum Disorders; Asperger's Disorder; Pervasive Developmental Disorder Not Otherwise Specified; Pervasive Developmental Disorders
Web-based Weight Loss Intervention
Condition: Overweight and Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Excess weight is a major risk factor underlying leading causes of death globally, including
      cardiovascular disease, type 2 diabetes, and some cancers. Among participants assigned to the
      same lifestyle intervention arms in prior weight loss randomized controlled trials, large
      inter-individual differences in weight loss success have been observed, ranging from >50lbs
      of weight loss to >10lbs of weight gain. Both genetic and non-genetic factors underlying
      differential adherence and weight loss success are poorly understood.
    

Detailed description: 
      23andMe aims to recruit 91,227 adults to participate in a web-based weight loss intervention.
      Primary aims include: a.) to confirm whether AG/GG individuals at MTIF3 rs1885988 lose more
      weight on lifestyle interventions; and b.) to test the performance of a randomized controlled
      trial vs. self-selection study design in terms of weight loss, drop-outs, and adherence.
      Secondary (exploratory) analyses will focus on discovery of genetic and non-genetic
      predictors of weight loss success overall, and examination of potential interactions by
      intervention type. Web-administered intervention content, videos, and forums will be surfaced
      to participants every two weeks, and self-reported surveys will be surfaced weekly for the
      active intervention duration.
    

Intervention name(s): Lower carbohydrate diet; Higher fiber diet; Physical activity focused
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity; Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity; Focused on aerobic and resistance exercise, while following dietary guidelines <https://www.choosemyplate.gov>
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are randomized to either a RCT or 'Participant choice' block, with 3 parallel interventions within each block
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: nutrition, diet, genetics, physical activity, weight loss
The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis
Condition: Chronic Rhinosinusitis With Nasal Polyps
MeSH terms: Sinusitis; Nasal Polyps
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To investigate the usage of budesonide as an agent in the injection of Type 2 chronic
      rhinosinusitis with nasal polyps
    

Detailed description: 
      this is a randomized controlled clinical trial where 3 groups with nasal polyps will be
      treated medically, Group A with oral corticosteroids, Group B with budesonide intrapolyp
      injection, Group C with placebo saline intrapolyp injection
    

Intervention name(s): Budesonide; Prednisone; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): after application of topical vasoconstrictor packs into both nasal cavities, using 1 cc 28 gauge needle sterile syringe, one pack of budesonide ampule 0.5 mg/2ml was injected into visible polyps on both cavities 1 ml in each cavity weekly for 5 consecutive weeks; patients given oral prednisone 1 mg/ kg with max. dose 70 mg/d divided into two doses for 3 days then tapered gradually for two weeks; saline intrapolyp injection
Intervention MeSH terms: Prednisone; Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CRSwNP; Intranasal steroid injection; Budesonide
Photosensitivity Proof of Concept Trial
Condition: Photosensitive Epilepsy
MeSH terms: Epilepsy; Epilepsy, Reflex
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether patients who usually have abnormal
      electrical EEG responses when shown flashing lights will show a reduction in abnormal
      electrical activity when they take a single dose of 2 marketed drugs (carbamazepine and
      levetiracetam). If so, a similar study in the future may be able to identify promising new
      drugs for epilepsy.

      Patients who successfully complete the screening visit, will return 4 additional times and
      will receive either placebo (2 times) or a single oral dose of both carbamazepine 400mg and
      levetiracetam 1000mg in random order.

      During each of the study days, several procedures and intermittent photosensitivity (IPS)
      assessments will be performed at 5 pre-determined times over the course of the day, one
      pre-dose and 4 post-dose.
    


Intervention name(s): carbamazepine 400mg; levetiracetam 1000mg
Intervention type(s): Drug; Drug
Other intervention name(s): Tegretol; Keppra
Intervention MeSH terms: Carbamazepine; Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Photosensitive epilepsy; Photosensitivity; Seizures; Epilepsy
Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an 8 week, outpatient research study testing the use of long-acting naltrexone
      (Vivitrol) as a treatment for marijuana dependence. Vivitrol is a medication that is
      effective in treating dependence on opiates and opioids, and in treating dependence on
      alcohol. It is FDA approved for these disorders. It is a long-acting medication that contains
      enough medicine in each injection to last for one month. One way it works is by blocking the
      effects of opiates, including opiates released by the body in response to drugs and alcohol.
      In this study, we are interested in testing the effects of Vivitrol in people with marijuana
      dependence.

      Individuals participating in this study will receive two Vivitrol injections, each given four
      weeks apart, (week 1 and week 5). The injection is given in the muscle of the buttock on one
      side. Participants will attend clinic visits two times a week during this 8-week study for
      medical management for drug use and for monitoring of physical and psychological health.
    

Detailed description: 
      This is an 8 week, outpatient, open-label clinical trial of long-acting injectable naltrexone
      as a treatment for cannabis dependence.

      The purpose of the study will be to evaluate marijuana use patterns and tolerability of
      long-acting naltrexone in 7 treatment-seeking, cannabis-dependent outpatients; also to assess
      feasibility of conducting a larger trial with this medication. Cannabis dependent patients
      will have twice weekly clinic visits where they will receive injections of Vivitrol four
      weeks apart, in Week 1 and in Week 5. The psychosocial intervention for this study will be
      Medical Management, designed to facilitate adherence to the study medication and monitoring
      procedures, as well as to support the participant in achieving his or her marijuana use
      goals.

      Participants will self-report cannabis use, will provide urine toxicology for quantitative
      assessment of THC (Tetrahydrocannabinol, the active ingredient in marijuana), and will
      provide serum samples for safety monitoring, and will answer questionnaires and will report
      on their physical and psychological health weekly.
    

Intervention name(s): Long-acting injectable naltrexone
Intervention type(s): Drug
Intervention description(s): Vivitrol is a long-acting opioid antagonist which blocks opioid agonists from binding at opioid receptors. It be administered as described above.
Other intervention name(s): Vivitrol
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cannabis; Cannabis Dependence; Cannabis Use Disorder; Marijuana; Naltrexone; Long Acting Injectable Naltrexone; Treatment
Administration of Tramadol and Ketorolac Separately and Simultaneously to Assess a Potential Pharmacokinetic Interaction
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Tramadol (Tradol) and ketorolac (Dolac) are marketed products to treat acute pain. This study
      was performed to determine if both medications can be given to a patient simultaneously
      without a change of the products' bioavailability.
    

Detailed description: 
      The primary objective of the study was to compare the bioavailability of tramadol 25 mg and
      ketorolac 10 mg after oral single-dose administration of the individual components, either
      separately or simultaneously, in healthy volunteers under fasting conditions, to demonstrate
      the absence of a pharmacokinetic interaction.

      The secondary objective of the study was to evaluate the safety of both drugs when
      administered separately and simultaneously based on adverse events reported after treatment.

      Participants were admitted to the study site for approximately 42 hours (12 hours before and
      30 hours after dosing) for each of the 3 treatment periods. A final examination was performed
      2 days after completion of the last treatment period.
    

Intervention name(s): Tramadol hydrochloride 25 mg capsule; Ketorolac Tromethamine 10 mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): Capsule with tramadol hydrochloride 25 mg; Product of Grünenthal de Mexico S.A. de C.V.; Tablet with ketorolac tromethamine 10 mg; Product of Siegfried Rhein, S.A. de C.V., Mexico
Other intervention name(s): Tradol (trade mark); Dolac (trade mark)
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Open-label, randomized, crossover design with three treatment periods and six sequences (A3-A1-A2, A1-A2-A3, A2-A3-A1, A3-A2-A1, A1-A3-A2, A2-A1-A3) with single administration of tramadol (A1), ketorolac (A2) or tramadol and ketorolac (A3). Treatment periods were separated by a washout period of at least 4 days.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tramadol; ketorolac; interaction
A Study of Abemaciclib in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine:

        -  The effect of single increasing doses of the study drug, abemaciclib, on healthy
           participants.

        -  The relationship between the amount of abemaciclib and the electrical tracing of the
           heart rhythm when abemaciclib is given.

        -  How much abemaciclib is found in the bloodstream and how long the body takes to get rid
           of it.

      Information about any side effects that occur will be collected. The study will enroll two
      groups (cohorts) of participants. Each group will complete 4 study periods. This study is
      expected to last about 3 months. Screening may occur up to 28 days prior to enrollment. All
      participants will undergo a follow-up assessment approximately 21 days after administration
      of their final dose of study drug.
    


Intervention name(s): Abemaciclib; Placebo; Loperamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Other intervention name(s): LY2835219
Intervention MeSH terms: Loperamide; Antidiarrheals
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) "After Multiple Oral Doses" in Healthy Volunteers
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the safety and tolerability of three doses of PBF-509 (80 mg, 160 mg and 240
      mg) after repeated (8 days) single daily oral dose administration in young male and female
      healthy subjects.
    


Intervention name(s): PBF-509; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adenosine A2a receptor antagonist; adenosine receptor modulator; Cancer