bioihbjkbjnl/mcl2 huggingface dataset:
Isocaloric Dietary Interventions for Insulin Resistance and the Metabolic Syndrome
Condition: Obesity
MeSH terms: Metabolic Syndrome; Insulin Resistance
Study type: Interventional

Summary: 
      In recent decades, the prevalence of obesity has increased dramatically in the United States.
      Obesity has been associated with an increased risk of the metabolic syndrome, which is
      characterized by a cluster of metabolic derangements, including insulin resistance, high
      blood sugar, high triglycerides, low high density lipoprotein (HDL) cholesterol levels, high
      blood pressure, and inflammation. Lifestyle interventions, including dietary modification,
      physical activity, and weight loss, form the basis of treatment for individuals with the
      metabolic syndrome. However, the optimal composition of the diet is not known at this time.
      Furthermore, due to hormonal and metabolic changes that accompany weight loss, most people
      find it very difficult to maintain significant weight reductions over time. As a result,
      weight regain is exceedingly common.
    

Detailed description: 
      Several dietary patterns, including the Dietary Approaches to Stop Hypertension study diet
      (the DASH diet) and the low glycemic index diet (low GI diet), may be useful in the treatment
      of individuals with the metabolic syndrome, even if body weight stays the same. Novel
      findings from our own pilot study suggest that these dietary patterns may improve insulin
      resistance and some other features of the metabolic syndrome, even after just two weeks and
      in the absence of weight loss. In this important follow-up study, the metabolic effects of
      the DASH diet and the low GI diet will be compared to those of an Western-style control diet.
      At least 39 overweight, insulin-resistant volunteers with the metabolic syndrome will be
      studied during a 32-day inpatient admission. All food will be provided, and body weight will
      be kept stable throughout the study. Subjects will first undergo testing after consuming a
      Western-style diet for two weeks. They will then be randomized to one of three study diets:
      the DASH diet, the low GI diet, or the Western-style diet. Testing will again be conducted
      after 2 weeks of weight stability on the study diet. Testing will include the assessment of
      insulin sensitivity and other metabolic parameters, such as blood sugar and cholesterol
      levels, blood pressure, and inflammation. This study will provide important information about
      the effects of these promising dietary patterns on features of the metabolic syndrome, in the
      absence of weight loss.
    

Intervention name(s): Dietary intervention
Intervention type(s): Other
Intervention description(s): Subjects will be randomly assigned to receive 1 of 3 diets for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Jafron Haemoadsorption During Cardiopulmonary Bypass
Condition: Cytokine Release Syndrome
MeSH terms: Cytokine Release Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      Cardiopulmonary bypass (CPB) is often associated with degrees of complex inflammatory
      response mediated by various cytokines. This response can, in severe cases, lead to systemic
      hypotension and organ dysfunction. Cytokine removal might therefore improve outcomes of
      patients undergoing cardiac surgery. Jafron is a device designed to remove cytokine from the
      blood using haemoadsorption (HA). This preliminary report aims to evaluate the potential of
      Jafron to decrease peri-operative cytokine levels in cardiac surgery.
    

Detailed description: 
      In this context the investigators introduce the study design for multi-centre pilot
      randomized report in 40 patients undergoing elective CPB procedures with an expected time
      >120 minutes for each extracorporeal procedure. Patients will be randomly allocated to either
      standard of care (n = 20) or Jafron HA(n = 20) during cardiopulmonary bypass (CPB). The
      primary outcome will be the difference between the two groups in cytokines levels (IL-2,
      IL-6,TNF-α, IFN gamma) and secondary parameters (Fibrinogen, Albumin, Platelets, Hemoglobin,
      Hematocrit, White Blood Cells, Neutrophils,Lymphocytes, Monocytes, Eosinophils, Basophils)
      will measured at anaesthesia induction, at the endof CPB , Primary outcomes: hemodynamics
      with or without vasoconstrictors use, the mechanical ventilation (MV) (hours) time and length
      of stay in intensive care unit (ICU) (hours). This prospectivemulti-centre randomized
      controlled report will take place in two Centres: Anthea Hospital, GVMCare & Research, Bari,
      Italy; Virgen de la Arrixaca University Hospital, Murcia, Spain; between May 2022 and
      September 2022. The target population per centre will include (n=20) patients; will
      beallocate for each center to either standard of care (n = 10) or Jafron HA (n = 10) planned
      for elective cardiac surgery with increased risk of cytokine release.
    

Intervention name(s): Jafron use during CPB
Intervention type(s): Drug
Intervention description(s): Use of filter Jafron during CPB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Streptococcus Mutans Cariogenicity by Real-time PCR in High Caries Risk Patients
Condition: Streptococcus Mutans; High Caries Risk Patients
Study type: Interventional

Summary: 
      In patients with high caries risk, will the use of cinnamon extract or chlorohexidine based
      mouthwashes have an effect on the percentage of recovery and cariogenicity of Streptococcus
      mutans (SM) detected by real-time Polymerase Chain Reaction (PCR) over one month follow up
    

Detailed description: 
      This clinical study will be held in the clinic of conservative dentistry department, Faculty
      of Dentistry, Cairo University. The operator in charge will be Mostafa Mahmoud El-Ghazali.
      Patients will be examined and selected according to inclusion and exclusion criteria, the
      purpose and method of the study will be explaned to the selected patients, written informed
      consent will be obtained from the patients for participation in the study. In the first
      visit, ADA caries risk assessment model will be done. Participants will be divided into two
      groups according to the tested mouthwashes.

      All patients will be instructed not to have breakfast and to refrain any oral hygiene
      measures on the day of sample collection to avoid the inﬂuence of food consumption and
      contamination on the composition of saliva. The patient will sit in an erect position on the
      dental chair and will be given paraffin block to chew. The stimulated saliva will be
      collected after 2 minutes of paraffin chewing in sterile containers held near the mouth. The
      containers will be properly labeled. The study will be carried over a period of one month,
      the saliva samples for each patient will be collected on the ﬁrst dental visit. These samples
      will be then sent to the laboratory for microbiological assessment. Patients will be provided
      with mouthwashes according to the tested groups and they will be instructed to use it 2 times
      per day for 1 minute each time and no eating or drinking permitted for a minimum of 30
      minutes post rinsing. Each patient will be given the same instructions with respect to oral
      hygiene measures. They will be advised to continue on same diet and will be instructed not to
      change their dietary habits. Patients will come after 2 weeks for salivary samples collection
      and samples will be sent to the laboratory for microbiological assessment. After treatment
      continuity for another 2 weeks, patients will come for the last visit to collect the salivary
      samples which will be sent to the laboratory for microbiological assessment.
    

Intervention name(s): cinnamon extract mouthwash; chlorohexidine based mouthwash
Intervention type(s): Drug; Drug
Intervention description(s): cinnamon extract mouthwash; chlorohexidine based mouthwash
Other intervention name(s): Natural Product Mouthwash; Synthetic Mouthwash
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Speech Locator In-car Performance Evaluation
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Listeners will conduct sound quality ratings of recordings talkers in a moving car processed
      using three different microphone processing strategies: an investigational adaptive
      directional microphone, an omnidirectional microphone and a fixed directional microphone.
      Participants will listen to the recordings streamed via commercially-available and
      individually-prescribed hearing aids, and conduct ratings onsite in the lab. The procedure
      will involve a training session and within-subject repeated measures. Stimuli will be
      randomized.
    


Intervention name(s): Investigational adaptive directional microphone strategy; Comparator omnidirectional microphone strategy; Comparator fixed directional microphone strategy
Intervention type(s): Device; Device; Device
Intervention description(s): A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.; A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator omnidirectional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.; A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Trial Comparing Adjuvant Oral UFT/LV to 5-FU/l-LV in Stage III Colorectal Cancer (JCOG-0205-MF)
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the clinical effectiveness of oral UFT/LV comparing 5-FU/l-LV as adjuvant therapy
      for stage III colorectal cancer.
    

Detailed description: 
      Oral fluoropyrimidines are widely used in practice for postoperative adjuvant chemotherapy
      for curatively resected colorectal cancer in Japan. In order to evaluate a clinical benefit
      of oral anticancer drugs in adjuvant chemotherapy, we conducted randomized controlled trial
      comparing the oral combination chemotherapy, UFT+LV, to the standard intravenous combination
      chemotherapy, 5-FU+l-LV, in stage III colorectal cancer.

      UFT+LV: UFT 300mg/m2/day and LV 75mg/day, orally for 28days with 7days rest, repeated five
      times every 5 weeks.

      5-FU+l-LV: 5-FU 500mg/m2, l-LV 250mg/m2, weekly administration for 6 times, repeated three
      times every 8 weeks.

      Primary endpoints are disease-free survival and secondary endpoints are overall survival and
      adverse event rate.
    

Intervention name(s): 5FU+l-leucovorin; UFT+Leucovorin
Intervention type(s): Drug; Drug
Intervention description(s): 5FU+l-leucovorin; UFT+Leucovorin
Intervention MeSH terms: Leucovorin; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adjuvant chemotherapy; Stage III colorectal cancer; 5-FU+l-LV; UFT+LV; randomized controlled trial
Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
Condition: Complicated Urinary Tract Infection
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of intravenous CXA 101 and
      comparator in complicated urinary tract infection
    

Detailed description: 
      This is a Phase 2, multicenter, prospective, randomized, double-blind, comparative efficacy
      and safety study of IV CXA 101 versus IV ceftazidime for 7 to 10 days.

      Subjects are followed up 6 to 9 days after the last dose of study drug to assess clinical
      signs and symptoms of infection. A Late Follow Up evaluation (21 to 28 days after the last
      dose of study drug) occurs for those subjects who respond to therapy. The primary assessment
      of effectiveness is the microbiological response (the eradication at post-therapy of the
      infectious organism identified at the start of study). An additional assessment of efficacy
      includes the overall clinical response, which is described as cured, improved, or failed.
      Safety assessments include the incidence of adverse events throughout the study, clinical
      laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at
      the start of the study and post-therapy.
    

Intervention name(s): CXA-101; Ceftazidime
Intervention type(s): Drug; Drug
Intervention description(s): intravenous; intravenous
Intervention MeSH terms: Ceftazidime; Ceftolozane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Complicated Urinary Tract Infection; Pyelonephritis; Antimicrobial; Cephalosporin; Intravenous
Effect of Arabinoxylan Oligosaccharides Consumption on Insulin Resistance in Patients With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      During this project the investigators will evaluate whether the effects of arabinoxylan
      oligosaccharides (AXOS) consumption on insulin resistance in participants with metabolic
      syndrome can be explained by the production of short-chain fatty acids (SCFA). Secondly, the
      investigators will evaluate whether changes in gut hormone production might explain the
      effect on insulin resistance.
    


Intervention name(s): Arabinoxylan oligosaccharides; Short chain fatty acids
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Arabinoxylan oligosaccharides administered; Short chain fatty acids administered
Other intervention name(s): AXOS; SCFA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
New E-Service for a Dietary Approach to the Elderly
Condition: Aged; Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Ageing of the population is a major event in the world. Gerontological/geriatric literature
      unanimously indicate that physical exercise and diet are at present the two available
      fundamental approaches to contrast/prevent most of the age associated alterations. In the
      elderly the inflammageing, the oxidative stress and the alteration of the intestinal
      microbiota can be influenced by nutritional status and possibly corrected by an appropriate
      dietetic intervention:

      Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve
      the quality of individual diet for specific needs
    

Detailed description: 
      Ageing of the population is a major event in the world. Gerontological/geriatric literature
      unanimously indicate that physical exercise and diet are at present the two available
      fundamental approaches to contrast/prevent most of the age associated alterations. In the
      elderly the inflammageing, the oxidative stress and the alteration of the intestinal
      microbiota can be influenced by nutritional status and possibly corrected by an appropriate
      dietetic intervention:

      Nowadays the nutraceutical food supplements become an opportunity for the consumer to improve
      the quality of individual diet for specific needs
    

Intervention name(s): Optimal Diet; VSL#3®; AISA-5203-L; Argan oil
Intervention type(s): Behavioral; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): a dietician will train each subject (or the caregiver) to use the personalized diet on web platform; probiotic blend Product should be administrated orally, 2 capsules b.i.d. on an empty stomach (at least 30 min. before lunch and dinner) with a glass of water; fruit extracted terpene Product should be administrated orally, the dosage depending from the body weight of the subject enrolled in the study as already stated : 1-2 pills three times a day with a meal and a large glass of water; Product should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad …) and a large glass of water
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healthy Elderly People
Pain Control in Pediatric Oncology: Utility of EMLA Cream vs Lidocaine Injection in Lumbar Punctures
Condition: Leukemia-Lymphoma
Study type: Interventional
Phase: Phase 4

Summary: 
      A common procedure in children with cancer is the spinal tap, or lumbar puncture (LP), in
      which a needle is inserted into the spinal canal. In this population, LPs are most commonly
      performed to collect cerebrospinal fluid (CSF, the liquid surrounding the brain and spinal
      cord) for diagnostic testing, and to inject medications including chemotherapy. Local
      analgesic (pain control medicine) during pediatric LP procedures is underutilized and not
      standardized. The first local analgesic routinely used for LP procedures was lidocaine
      injection. The discovery of the topical EMLA (lidocaine 2.5%/prilocaine 2.5%) cream, approved
      by the FDA for local skin use in pediatric patients, has provided an additional option for
      local LP analgesia. A comparison between topical EMLA vs lidocaine injection for LP pain
      control in the pediatric population has not been performed. Pediatric oncology patients often
      require serial LPs for diagnostics purposes and/or chemotherapy delivery. Due to a lack of
      standardization of LP analgesia in this population, the investigators have designed a
      prospective, single-blind, randomized control crossover trial to examine EMLA vs. lidocaine
      injection in reducing pain associated with LP in children being treated for leukemia or
      lymphoma.
    


Intervention name(s): EMLA; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): EMLA cream (lidocaine 2.5% and prilocaine 2.5%); lidocaine 1%
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Newly Formulated, Extruded Fortified-blended Foods for Food Aid: the MFFAPP Tanzania Efficacy Study
Condition: Anemia, Iron-Deficiency; Deficiency, Vitamin A
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies; Avitaminosis; Vitamin A Deficiency
Study type: Interventional

Summary: 
      Corn-soy vitamin and mineral fortified blended foods (FBFs) are primarily used for food aid,
      although sorghum and cowpea may be suitable alternative FBF commodities. The objective of the
      Micronutrient Fortified Food Aid Pilot Project (MFFAPP) Tanzania Efficacy Study is to
      determine whether newly formulated, extruded sorghum- and cowpea-based FBFs have equal, or
      better, nutritive value and acceptance compared to a traditional corn-soy blend. The
      effectiveness of each blend will be determined in an efficacy study of Tanzanian children
      under the age of 5 that are deficient, or at risk for deficiency, in iron and vitamin A.
    


Intervention name(s): Corn Soy Blend Plus (CSB+); Corn Soy Blend 14 (CSB14); White Sorghum Cowpea Blend Variety 1; White Sorghum Cowpea Blend Variety 2; Red Sorghum Cowpea Blend; White Sorghum Soy Blend
Intervention type(s): Other; Other; Other; Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fortified-blended foods; Extrusion; Sorghum; Cowpea; Vitamin A; Iron; Protein; Food Aid; Anemia, Iron-Deficiency; Deficiency, Vitamin A; Growth Velocity; Stunting; Wasting; Protein-Energy Malnutrition; Complementary Feeding; Corn; Soy; Fortified Foods; Food assistance
Glycemic Control, Safety and Tolerability of TC-6987 Monotherapy in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      TC-6987 is a selective nicotinic α-7 receptor ligand (open channel stabilizer) that has
      demonstrated potent anti-inflammatory/antioxidant properties in animal models. Following the
      oral administration of a 1mg/kg dose of TC-6987 to diabetic mice (db/db mouse) for 7 weeks,
      numerous metabolic improvements were observed. Specifically, plasma glucose and triglyceride
      concentrations declined by approximately 30%; Hb1Ac was reduced by nearly 50%; and TNF-α
      declined more than 60% relative to control db/db mice Therefore, it appears that TC-6987
      could prove beneficial in reducing elevated glucose concentrations in diabetic patients as
      well as in ameliorating organ damage associated with inflammation, oxidative stress and
      hyperglycemia.
    

Detailed description: 
      This is a Phase II, multicenter, randomized, double-blind, parallel group, placebo-controlled
      study to assess the efficacy, safety, tolerability, and pharmacokinetic parameters of TC-6987
      in subjects with type 2 diabetes mellitus (T2DM). The study is organized into three phases:
      (a) Screening phase consisting of a 1-week Screening (Week -5)and a 4-week Washout (Week -4
      to Day 1); (b) 4-week, Double-Blind Treatment (Day 1 to Week 4) during which subjects are
      randomized to either TC-6987 (20 mg on Day 1 and 10 mg from Day 2 to Week 4) or placebo; and
      (c) 2-week Follow-Up (Week 6). Unscheduled visits will be allowed between visits from Washout
      through Follow-up to evaluate a subject's glycemic status or other safety issues, as
      required. Subjects will fast overnight for a minimum of 10 hrs and refrain from drinking
      alcohol 24 hrs prior to each visit.
    

Intervention name(s): TC-6987; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TC-6987-23 (TC-6987 HCl) as experimental treatment: 20 mg loading dose (2 capsules) on Day 1 and 10 mg (1 capsule) on Days 2 to 28 (dose expressed as free base). Each dose will be given once daily.; Matching placebo: Mode of administration: p.o. (microcrystalline cellulose in capsule) given once daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Type 2 Diabetes Mellitus