bioihbjkbjnl/mcl2 huggingface dataset:
Examining the Effect of Exogenous Ketone Supplementation on Glucose Control in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Ketone bodies are a fuel source and signaling molecule that are produced by the body during
      prolonged fasting or if an individuals consistently eats a low-carbohydrate "keto" diet.
      Blood ketones can be used as a source of energy by the body, but they may also act as signals
      that impact the functioning of different cells in the body. Recently, the availability of
      ketone supplements that can be taken orally allows for raising blood ketones without having
      to fast or eat a "keto" diet. The investigators' studies and those of other researchers have
      shown that ketone supplementation can lower blood sugar without having to make any other
      dietary changes. Oral ingestion of ketones may therefore be an effective strategy to improve
      blood sugar control and influence how cells function.

      The main objective of this study is to determine if consuming a ketone supplement 3 times per
      day (before meals) for 14 days lowers blood sugar and impacts how the body's cells function.
      The results of this study will be used to guide future recommendations on the utility of
      ketone supplements for improving health in individuals with, or at elevated risk of, type 2
      diabetes.
    


Intervention name(s): Exogenous Ketone Monoester; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will consume 15g of the oral ketone monoester supplement 15 minutes prior to each meal of the day for 14 days. All meals will be provided throughout the 14-day supplementation period.; Participants will consume an equivalent volume (30ml) of the active intervention supplement 15 minutes prior to each meal for 14 days. All meals will be provided throughout the 14-day placebo supplementation period.
Other intervention name(s): KetoneAid KE4 Ketone Ester, D-β-hydroxybutyrate-R 1,3-Butanediol; Flavor- and volume-matched placebo supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 3-Hydroxybutyric Acid; Glycemic Control; Hyperglycemia; Ketones; Glucose Control; Inflammation; Immune cell function; Cognition
Pharmacokinetics of Enoxaparin in Intensive Care Patients
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the pharmacokinetics of the thromboprophylactic agent enoxaparin in critically
      ill patients by comparing plasma anti-factor Xa activity when enoxaparin is administered
      either as a continuous intravenous infusion or subcutaneous bolus once daily.

      To investigate possible ongoing coagulation by coagulation markers during antithrombotic
      therapy with standard doses of enoxaparin
    


Intervention name(s): Enoxaparin
Intervention type(s): Drug
Intervention description(s): Drug class: Low-molecular weight heparin
Other intervention name(s): Klexane (sanofi-Aventis Oy, Finland)
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Concurrent Chemoradiotherapy With Famitinib for Patients With Locally Advanced Nasopharyngeal Carcinoma
Condition: Locally Advanced Nasopharyngeal Carcinoma
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3,
      Flt1 and Flt3. Phase I study of mono famitinib has shown that the drug's toxicity is
      manageable.

      PURPOSE: This phase I trial is studying the safety and tolerance of concurrent
      chemoradiotherapy with famitinib for patients with locally advanced nasopharyngeal carcinoma.
    


Intervention name(s): Famitinib; Cisplatin; radiation（IMRT）
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): Either at 12.5 mg, 16.5 mg、20 mg or 25 mg qd p.o., 2 weeks before concurrent chemoradiotherapy and D1-D49, exception D1, D22, and D43.; 100 mg/m2, D1, D22, and D43(q3w); IMRT (Intensity-Modulated Radiation Therapy). Radiation is delivered to GTV at 70 Gy in 32-33 fractions, CTV1 at 60 Gy in 32-33 fractions and CTV2 at 54 Gy in 32-33 fractions
Intervention MeSH terms: Cisplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Concurrent Chemoradiotherapy
The Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis Patients
Condition: Hemodialysis Patients
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to investigate the pharmacokinetics/ pharmacodynamics and
      safety/tolerability of Evogliptin in hemodialysis patients
    


Intervention name(s): Evogliptin 5mg; Evogliptin 5mg
Intervention type(s): Drug; Drug
Intervention description(s): Participants receive Single oral administration of Evogliptin 5mg on day1; Period 1(1d,After hemodialysis) → Wash-out period → Period 2(15d,Before hemodialysis)
Hemodialysis patients receive Single oral administration of Evogliptin 5mg on day1 and day15 With a 14-day washout period
Other intervention name(s): Suganon; Suganon
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Training in the 21st Century: Using Virtual Role-Plays to Improve Nurse Communication for Medication Adherence
Condition: High Blood Pressure; Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study will utilize a three-phase approach that is informed by a theory-driven
      implementation framework to: 1) conduct a needs analysis in order to identify individual-,
      health care team-, and practice-level barriers and facilitators to conducting adherence
      counseling in safety-net primary care practices; 2) develop a virtual communication
      simulation designed to improve the quality of adherence counseling by allowing nurses
      repeated opportunities to practice discussing medication adherence with virtual patients; and
      3) conduct a pilot study to evaluate the feasibility, acceptability and preliminary efficacy
      of the simulation on changes in: a) nurses' collaborative communication skills, b) medication
      adherence, and c) reduction in BP in a sample of 20 patients with uncontrolled hypertension
      (HTN) who are non-adherent to their medications.
    


Intervention name(s): Audiotaped Counseling Session
Intervention type(s): Behavioral
Intervention description(s): Patients and nurses will complete audio taped counseling session at least 3 months following the baseline visit. Patients will rate quality of nurse communication skills
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this pilot, exploratory study is to evaluate the safety, tolerance,
      pharmacokinetics and potential activity of an investigational agent, HE3286, when
      administered orally, daily for 28 days to patients with mild-to-moderate ulcerative colitis.
    

Detailed description: 
      HE3286 has a potentially new mechanism of action that may improve the current therapeutic
      options available to patients with ulcerative colitis. In preclinical experiments, HE3286 has
      shown activity in animal models of ulcerative colitis. Additionally, HE3286 has shown to have
      anti-inflammatory activity associated with corticosteroids but without the side effects
      associated with corticosteroid use, such as immune suppression and bone loss.
    

Intervention name(s): Placebo; HE3286
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; daily for 28 days
Other intervention name(s): Triolex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: phase I/II; ulcerative colitis; safety; tolerance; pharmacokinetics
Optimal Protein Dose Per Meal During Weight Loss in Perspective to Maintaining Muscle Mass
Condition: Protein Metabolism
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The primary aim of the trial is to determine the optimal dose of protein per meal in relation
      to enhancing muscle protein synthesis and thereby in perspective counteract muscle loss
      during weight loss. In addition, we aim to determine whether the response to protein intake
      is reduced in women on hypocaloric diet compared to in women on an energy-balanced diet.
    

Detailed description: 
      Aim of this project is to determine the optimal protein dose (high quality milk protein) per
      meal in relation to enhancing muscle protein synthesis and thereby counteract muscle loss
      during weight loss.

      The hypothesis is that the optimum dose of protein for women on a hypocaloric diet will be
      greater than when women eat an energy sufficient diet, and also higher than the optimal dose
      previously determined in weight stable men.

      Methods: Forty women (~ 50 years) will be randomized to four groups. Following a five day
      hypocaloric diet (three groups) or an energy balanced diet (one group). The women will report
      to the laboratory to ingest one of three different protein doses. The muscle protein response
      to the different doses of protein will be determined by the muscle protein fractional
      synthetic rates using tracer kinetics.
    

Intervention name(s): 15 g protein hypocaloric; 35 g protein hypocaloric; 60 g protein hypocaloric; 35 g protein energy balance
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Following a 5 day hypocaloric diet one group of 10 women will ingest 15 g of protein; Following a 5 day hypocaloric diet one group of 10 women will ingest 35 g of protein; Following a 5 day hypocaloric diet one group of 10 women will ingest 60 g of protein; Following a 5 day energy balanced diet one group of 10 women will ingest 35 g of protein
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: : Forty women (~ 50 years) will be randomized to four groups. Following a five day hypocaloric diet (three groups) or an energy balanced diet (one group). The women will report to the laboratory to ingest one of three different protein doses.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Hypocaloric diet; Dietary protein
Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
Condition: Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      A phase 3, randomized, double-blind, placebo- and active-controlled, parallel-arm trial to
      assess the efficacy, safety, and pharmacokinetics of dasiglucagon relative to placebo and
      GlucaGen® when administered as a rescue therapy for severe hypoglycemia in children with type
      1 diabetes mellitus (T1DM) treated with insulin
    

Detailed description: 
      At least 40 children ≥6 years and <18 years of age with T1DM were planned to be randomized
      into the trial (2:1:1 for dasiglucagon:placebo:GlucaGen) and stratified by age intervals: 6
      years to <12 years, and 12 years to <18 years; and by injection site (abdomen or thigh). A
      minimum of 16 patients were enrolled into each age group, including a minimum of 8 patients
      in each age group in the dasiglucagon treatment arm. In Germany only, a staggered approach
      was applied, whereby a positive safety assessment needed to be available for at least 10
      patients in the age group of 12 years to <18 years who had completed the dosing visit in the
      overall trial before younger patients (6 to 11 years of age) were allowed to be enrolled.
    

Intervention name(s): dasiglucagon; placebo; GlucaGen HypoKit
Intervention type(s): Drug; Drug; Drug
Intervention description(s): glucagon analog; placebo for dasiglucagon; native glucagon
Other intervention name(s): ZP4207; placebo for dasiglucagon
Intervention MeSH terms: Glucagon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucagon; Dasiglucagon
Study to Determine the Pharmacokinetic (PK) Bioequivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Japanese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the bioequivalence of ABP 501
      (subcutaneous [SC] injection) compared to adalimumab (SC injection) as assessed principally
      by the area under the serum concentration-time curve from time 0 extrapolated to infinity
      (AUCinf), and maximum observed serum concentration (Cmax) in Japanese participants.
    


Intervention name(s): ABP 501; Adalimumab
Intervention type(s): Drug; Drug
Intervention description(s): SC injection; SC injection
Other intervention name(s): Humira®
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: ABP 501; Adalimumab; Humira®
Safety Study of Recombinant Human Alpha-mannosidase for the Treatment of Patients With Alpha-mannosidosis
Condition: Alpha Mannosidosis
MeSH terms: Mannosidase Deficiency Diseases; alpha-Mannosidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, dose escalation study of patients with
      alpha-mannosidosis. 10 patients will be enrolled in this study receiving intravenous
      infusions of Lamazym. In order to avoid development of delayed hypersensitivity all patients
      will continue weekly treatment at the designated dose until the Safety Committee approves
      transfer to the rhLAMAN-03 protocol.

      It is the hypothesis that Lamazym is safe to use.
    


Intervention name(s): Lamazym
Intervention type(s): Drug
Intervention description(s): Lamazym, ERT, infusion weekly
Other intervention name(s): rhLAMAN
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pain Management in Osteoarthritis Using the Centrally Acting Analgesics Duloxetine and Pregabalin
Condition: Hand Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Osteoarthritis is the most common form of arthritis worldwide. Specifically, osteoarthritis
      of the hands affects millions of people and is a major cause of hand disability and pain.
      Despite this, there are currently no treatments that delay or halt the development of
      osteoarthritis. Pain is one of the major symptoms of osteoarthritis and pain management is an
      important factor to consider in the treatment of this condition. Treatments for pain in
      osteoarthritis consists of local injections, anti-inflammatory gels or painkillers such as
      paracetamol. However, most people with osteoarthritis still have pain despite these
      treatments.
    

Detailed description: 
      Recent scientific studies have suggested that people with hand osteoarthritis not only feel
      pain in their hand joints, they also appear to have increased signals in their brain pain
      processing pathways. At St George's, University of London, the investigators have been
      conducting studies to find out which brain regions are activated in subjects with hand
      osteoarthritis. The investigators have found that certain brain regions (thalamus, insula,
      cingulate and somatosensory cortex) are activated during painful tasks in patients with hand
      osteoarthritis but not in healthy people. In this study the investigators will establish
      whether drugs that inhibit pain processing pathways in the brain can help. Patients who are
      still having pain despite their usual painkillers will be randomly divided into 3 groups: one
      group will receive a placebo, the other 2 groups will receive one of two different drugs,
      duloxetine or pregabalin. Participants will be assessed using questionnaires and a brain scan
      (functional MRI) before and after 13 weeks of taking the tablets. This study will help us to
      understand the ways in which people feel pain in osteoarthritis. If our trial proves
      successful,drugs that dampen central pain pathways could be used in combination with local
      pain-relieving drugs to improve treatment and reduce disability in patients with hand
      osteoarthritis.
    

Intervention name(s): Pregabalin or Duloxetine or Placebo
Intervention type(s): Drug
Intervention description(s): This is a randomized, double blind placebo controlled trial with a head-to-head comparison of duloxetine vs pregabalin vs placebo over-encapsulated to prevent unblinding of treatment arm
Other intervention name(s): DUPRO Capsules
Intervention MeSH terms: Pregabalin; Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain
Identification of the Region of Vitamin D Responsiveness
Condition: Diabetes; Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Hypothesis: low vitamin D status is associated with increased insulin resistance and
      increased blood pressure.

      Approach: Multiple regression analysis of information extracted from a large database
      accumulated by a Canadian health foundation, specifically evaluating statistical associations
      between serum 25(OH)D levels and insulin responsiveness measures as well as blood pressure,
      after adjusting these variables for BMI, age, sex, and waist circumference.
    

Detailed description: 
      Data obtained from the entry records of 4,116 adult men and women in Calgary,Alberta
      previously enrolled in the Pure North S'Energy Foundation's health program. Individuals with
      a clinical diagnosis of diabetes mellitus or a HOMA-IR value above 16 were excluded. Standard
      statistical analyses carried out. An association between 25(OH)D and the endpoints of
      interest was first established. The residual values after adjusting HOMA-IR, serum insulin,
      QUICKI, and blood pressure for BMI, age, sex, and waist circumference were then regressed
      against serum 25(OH)D using 40-percentile data blocks, stepping upward from the lowest
      25(OH)D values by 5 percentile increments through the 7th decile. Regression coefficients are
      then computed for each data block and each outcome variable. The location (along the 25(OF)D
      continuum) of the largest and most statistically significant coefficients is noted, and
      regions of null response noted as well.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults living in or near Calgary and associated with the oil and gas industries
      
Keywords: vitamin D; Associational study
Dimenydrinate vs Ondansetron for PONV (DONV)
Condition: PONV in Laparoscopic Cholocystectomies
Study type: Interventional

Summary: 
      This study will investigate the impact of dimenydrinate (H1-receptor antagonist) versus
      ondansetron (HT3-receptor antagonist) in postoperative nausea and vomiting, in
      surgery-related preoperative stress and in the incidence of postoperative complications that
      could lengthen the LOS in PACU and/or the overall LOS.
    

Detailed description: 
      Dimenydrinate has been extensively used for motion sickness. However, as far as postoperative
      nausea and vomiting is concerned the results are still conflicting.

      This study will investigate the impact of dimenydrinate (H1-receptor antagonist) versus
      ondansetron (HT3-receptor antagonist) in postoperative nausea and vomiting, in
      surgery-related preoperative stress and in the incidence of postoperative complications that
      could lengthen the LOS in PACU and/or the overall LOS.
    

Intervention name(s): Dimenhydrinate Tablets; Ondansetron iv
Intervention type(s): Drug; Drug
Intervention description(s): 2 hours preoperative per os administration of 50 mg dimenhydrinate; Intraoperative intravenous administration of 4 mg ondansetron
Intervention MeSH terms: Ondansetron; Dimenhydrinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy of Tibolone Versus Transdermal E2/NETA on Sexual Function in Naturally Postmenopausal Women (P06089)
Condition: Sexual Dysfunction
Study type: Interventional
Phase: Phase 3

Summary: 
      Tibolone has been registered for treatment of menopausal symptoms. It is, however, not known
      what the effects are of tibolone in postmenopausal women diagnosed with sexual dysfunction.
      This is important because there is currently no approved treatment of libido problems in
      postmenopausal women. Therefore, the primary aim of this study was to compare the effects of
      tibolone with an estrogen/progestogen skin patch in postmenopausal women diagnosed sexual
      dysfunction.
    


Intervention name(s): tibolone; estradiol-norethisterone
Intervention type(s): Drug; Drug
Intervention description(s): tibolone (2.5 mg) over 24 weeks; transdermal continuous combined E2-NETA (estradiol-norethisterone 50/140 mcg) over 24 weeks
Other intervention name(s): Livial®; Combipatch®; Estalis®
Intervention MeSH terms: Tibolone; Norethindrone; Norethindrone Acetate; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Oxidative Stress in Standard Laparoscopic vs Single Port Cholecystectomy
Condition: Uncomplicated Cholelithiasis; Cholecystectomy; Laparoscopy; Standard Technique; Single Port Laparoscopy
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional
Phase: Phase 4

Summary: 
      Study of Oxidative Stress Markers in order to assess whether there are differences between
      standard laparoscopic cholecystectomy vs single port cholecystectomy for uncomplicated
      cholelithiasis
    


Intervention name(s): Laparoscopic cholecystectomy; Single incision laparoscopic cholecystectomy
Intervention type(s): Other; Other
Intervention description(s): Standard 4 port laparoscopic cholecystectomy; One port placed through the umbilicus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: SILS; Oxidative Stress; 8-epiPGF2a; SILS vs standard laparoscopic cholecystectomy