bioihbjkbjnl/mcl2 huggingface dataset:
An Study Investigating Nic's Keto Diet on Cardiovascular Health in Healthy Adults With Mildly Elevated LDL Levels
Condition: Ketogenic Dieting; Healthy
Study type: Interventional

Summary: 
      The present study will investigate the effects of Nic's Ketogenic diet, comprised of 70% fat,
      5% carbohydrate, and 25% protein on middle-aged males and females with mid-range elevated
      LDL. With the mixed evidence on the causative effect of LDL cholesterol on increased
      cardiovascular health risk, further studies are warranted to examine the relation of elevated
      LDL and other biomarkers of cardiovascular health in response to a lifestyle intervention.
      Furthermore, this study will investigate weight loss and body composition changes with
      adherence to this dietary intervention over a 140-day period. In this study the efficacy of
      Nic's Ketogenic diet on weight loss and biomarkers of cardiovascular health will be examined.
    


Intervention name(s): Nic's Keto Diet
Intervention type(s): Other
Intervention description(s): Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
Intervention model: Single Group Assignment
Intervention model description: Open-Label
Masking: None (Open Label)
Primary purpose: Other
Keywords: Ketogenic Diet; Nic's keto diet; Cardiovascular health; Elevated LDL levels
A Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to characterize the immune response in vivo using approved
      vaccines and antigen challenges, as well as a skin wounding challenge to stimulate the immune
      system.
    


Intervention name(s): Imvanex; Shingrix; LPS; Candin; Skin Biopsy; Saline Control
Intervention type(s): Biological; Biological; Biological; Biological; Other; Other
Intervention description(s): Imvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection.; Shingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection.; LPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection.; Candin 0.1 mL solution for injection will be administered as one intradermal injection.; 3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1.; Saline control solution for injection will be administered as one intradermal injection.
Other intervention name(s): Imvamune; Endotoxin; Candida albicans
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study to Evaluate the Pharmacokinetic Properties of SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend)
Condition: Systemic Mycotic Infection
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic properties and safety of
      SYP-1018 (Voriconazole-loaded PNP) and Voriconazole (Vfend).
    


Intervention name(s): SYP-1018 200mg; Voriconazole 200mg
Intervention type(s): Drug; Drug
Intervention description(s): SYP-1018 200mg, Intravenous administration; Voriconazole 200mg, Intravenous administration
Intervention MeSH terms: Voriconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial on HB-Vac Activated-DCs Combined With Peg-IFN or NAs in CHB
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate whether HB-Vac Activated-DCs Combined With
      Peg-IFN or NAs has more efficacy than Peg-IFN or NAs alone in the treatment of chronic
      hepatitis B patients
    

Detailed description: 
      The 450 patients meeting the entry criteria are divided into 6 groups, the clinical trial
      procedure is divided into 3 parts, according to the following steps:

      Part1 (0-12W):

        1. The research objects will be grouped according to the principle of a multicenter,
           randomized, open, parallel controlled clinical trial, 300 cases of cell therapy groups
           (100 cases with PEG-IFN treatment, LdT treatment for 100 cases, ETV treatment for 100
           cases), 150 cases of control groups (PEG-IFN therapy in 50 cases, LdT therapy for 50
           cases, ETV treatment for 50 cases).

           Part2 (12-36W):

        2. Cell therapy groups: enter the HBsAg sensitized dendritic cells activated T cells (HBsAg
           Pulse DCs-T, HPDCs-T) immune therapy combined with interferon (IFN) or nucleoside
           analogues treatment (NAs), infusion of HPDC-T every 2 weeks for 1 time, total 12 times.

        3. Control groups: antiviral therapy used only (IFN or NAs).

           Part3 (36-72W):

        4. The observation stage: discontinuation of interferon in the treatment of 48 weeks; NAs
           cases will continue on treatment with NAs.

      HPDCs-T produced procedure:

      The first step: 1-7 days Monocytes will be isolated from peripheral blood of patients. The
      monocytes obtained will be then incubated in fresh serum-free AIM-V medium (Gibco) containing
      800U/ml of GM-CSF and 400U/ml of IL-4 (Peprotech) for 5 days. After 5 days of culture in
      vitro, The DCs induced will be cultured with a commercially available hepatitis B vaccine
      containing 10 ug of HBsAg (GSK) for 2 days.

      The second step: 8-14 days The hepatitis B vaccine sensitized DCs (HPDCs) (from the first
      step) will be sub-cultured with patient's own PBMCs for 7 days: HBsAg can be efficiently
      presented to PBMCs by DCs, with producing HBV specific CTLs and HTLs (HPDCs-T).

      The third step: 15 days The PBMCs (the second step) containing enough HPDCs-T will be
      transfused back into the patient.
    

Intervention name(s): HPDCs-T immune therapy
Intervention type(s): Biological
Intervention description(s): HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, IV (in the vein), about 2*105-1*106 cells per time,total 12 times;
Other intervention name(s): The HBsAg sensitized dendritic cells activated T cells; HBsAg Pulse DCs-T
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CHB; Antiviral; Dentritic cells; Immune Therapy
Study to Assess the Effect Of Alosetron On Mucosal Blood Flow
Condition: Irritable Colon
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will look at colonic mucosal blood flow in subjects who have taken alosetron vs
      placebo and healthy volunteers vs diarrhea-predominant Irritable Bowel Syndrome (d-IBS)
      patients.
    


Intervention name(s): alosetron
Intervention type(s): Drug
Intervention MeSH terms: Alosetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: mucosal blood flow d-IBS
OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension
Condition: Eosinophilic Esophagitis (EoE)
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a clinical trial to test an experimental drug for the treatment of Eosinophilic
      Esophagitis (EoE)
    

Detailed description: 
      Eosinophilic Esophagitis (EoE) is an inflammatory disorder of the esophagus and is a
      recognized clinical entity. Symptoms include feeding problems, heartburn, regurgitation,
      vomiting, abdominal pain and food impaction. The symptoms of EoE may be similar to
      gastroesophageal reflux disease (GERD) but do not resolve with gastric acid suppression. EoE
      is defined histologically as the presence of > 15 intraepithelial eosinophils per high power
      fields on one or more esophageal biopsy specimens.

      This Phase II study is comparing oral budesonide (OBS) to placebo to demonstrate that OBS
      induces a histologic response and a symptom response using a Dysphagia Symptom Questionnaire
      over a 16 week course of therapy.
    

Intervention name(s): Oral Budesonide Suspension (MB-9); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): OBS suspension to be taken bid over a 16 week course of double blind therapy and OBS suspension to be taken qd to bid during a 24 week optional open label extension period
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: EoE
Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia
Condition: Glucosephosphate Dehydrogenase Deficiency; Hyperbilirubinemia; Hemolytic Disease of Newborn
MeSH terms: Erythroblastosis, Fetal; Glucosephosphate Dehydrogenase Deficiency; Hemolysis; Hyperbilirubinemia
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES: I. Compare the efficacy of preventive vs. therapeutic tin mesoporphyrin in direct
      Coombs' test-positive ABO hemolytic disease of the newborn and glucose-6-phosphate
      dehydrogenase deficiency in infants living in Greece.

      II. Assess the safety of tin mesoporphyrin in high-risk newborns.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients are stratified by gestational age and sex, and randomly assigned
      in pairs per stratum.

      One group receives a preventive dose of tin mesoporphyrin. Another group receives a
      therapeutic dose of tin mesoporphyrin according to the plasma bilirubin concentration.

      Patients in either group may be treated concurrently with phototherapy or exchange
      transfusion if clinically indicated.
    

Intervention name(s): tin mesoporphyrin
Intervention type(s): Drug
Intervention MeSH terms: Tin mesoporphyrin
Primary purpose: Treatment
Keywords: glucose-6-phosphate dehydrogenase deficiency; hematologic disorders; hemolytic disease; hyperbilirubinemia; neonatal disorders; rare disease
A Study to Investigate the Pharmacology of a Dual Pharmacophore in Healthy Volunteers
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Study will investigate the pharmacodynamics of a dual pharmacophore in which a combination of
      GSK961081 and Propanolol is used to give a total effect of bronchodilation.
    


Intervention name(s): GSK961081; GSK961081 matching placebo; Propranolol; Propranolol matching placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GSK961081 multidose dry powder inhaler (Diskus inhaler) will be available with dosing strengths of 400 micrograms and 1200 micrograms administered once daily in the morning.; GSK961081 matching placebo multidose dry powder inhaler (Diskus inhaler) will be available to be administered once daily in the morning.; Propranolol over encapsulated tablet will be available with dosing strengths of 40 milligrams administered orally with 240 milliliters of water.; Propranolol matching placebo over encapsulated tablet will be available to be administered orally with 240 milliliters of water.
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: propranolol; B2-agonist,; B-antagonist,
Effect of Drinking Fermented Milk on Immune Response
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional

Summary: 
      This blinded randomized controlled trial aims to investigate the effect of drinking fermented
      milk containing Lactobacillus paracasei (IMULUS) on immune response against influenza.
    

Detailed description: 
      This study is conducted in healthy volunteer using product approved by Thai FDA. This blinded
      randomized controlled trial compare immune response against influenza H1N1, H3N2 and Phu-B
      between study group and control group. The study group receives influenza vaccine and
      drinking fermented milk containing Lactobacillus paracasei (IMULUS), while the control group
      receives influenza vaccine and placebo acidified milk. The trial lasts for 8 weeks and
      include four time points of data collection (0, 2, 6, 8 weeks). Subjects, outcome assessor
      and investigators are blinded throughout the study.
    

Intervention name(s): Drinking fermented milk; placebo; Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)
Intervention type(s): Dietary Supplement; Dietary Supplement; Biological
Intervention description(s): Drinking fermented milk containing Lactobacillus paracasei (IMULUS); Acidified placebo milk with similar physical characteristics to the yoghurt drink; Intramuscular injection of a single shot of influenza vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza; vaccine; probiotic; immune response
Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
Condition: Epilepsies, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults
      with partial onset seizures
    

Detailed description: 
      Multicenter, double-blind, randomized, placebo-controlled, three-arm. parallel-group study of
      the efficacy and safety of extended-release oxcarbazepine in the treatment of adults with
      refractory partial onset epilepsy.
    

Intervention name(s): Placebo; 2400mg SPN-804; 1200mg SPN-804
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Non-active tablet identical to study drug tablets; tablets containing 600mg OXC XR, identical to non-active tablets; two active tablets and two non-active tablets, all identical
Other intervention name(s): sham treatment; Oxcarbazepine extended-release; Oxtellar XR; Oxtellar; Oxcarbazepine extended-release; Oxtellar XR; Oxtellar
Intervention MeSH terms: Oxcarbazepine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Partial onset epilepsy; Partial onset seizures
Study to Reveal if Fibrinogen Treatment Effects Blood Clotting Better Than a Platelet Transfusion
Condition: Blood Platelet Transfusion; Blood Clotting
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with need of platelet transfusion for any reason will participate in this study.
      Directly before the start of infusion and one hour after the end of platelet transfusion
      blood samples will be drawn and treated with different concentrations of Fibrinogen (a blood
      clotting factor) in-vitro. Blood samples with and without Fibrinogen/platelet transfusion
      will be compared. The study hypothesis is that treatment with Fibrinogen results in a better
      stabilisation of blood coagulation.
    

Detailed description: 
      In total 300 patients with the need of platelet transfusion for whatever reason will be
      included when meeting the inclusion- and exclusion criteria.

      For all patients three visits are planned, where blood samples will be taken. The first blood
      samples will be taken directly before the start of platelet transfusion, the second 1 hour
      after the end of the platelet transfusion and the third after 24 hours.

      Untreated citrate and EDTA blood samples from Visit 1 will be serving as baseline for the
      coagulation testing. Further citrate blood samples from the first visit will be spiked with
      different concentrations of fibrinogen in vitro. Untreated citrate and EDTA blood samples
      will be taken 1 hour and 24 hours after platelet transfusion for comparison. Further citrate
      blood samples will be spiked with different concentrations of fibrinogen in vitro again 1
      hour after platelet transfusion. In addition, randomly chosen samples will be analyzed using
      confocal microscopy. Routine coagulation analysis include activated partial thromboplastin
      time (aPTT), prothrombin time(PT), fibrinogen, blood coagulation factor thirteen (FXIII),
      thromboelastometry (ExTEM & FibTEM) before and after platelet transfusion.
    

Intervention name(s): Administration of platelet concentrate and taking blood samples
Intervention type(s): Drug
Intervention description(s): Patient with the need of a platelet transfusion, will have 4 intervention points. 1. directly before the start of the transfusion a blood sample will be drawn. 2. Patient receives the platelet transfusion. 3. One hour after the end of transfusion a second blood sample will be drawn. 4. 24 h after the end of the platelet transfusion a further bloos sample will be collected. The first two samples will be (beside blood cell counts) spiked in-vitro with different amounts of Human fibrinogen and blood clotting tests will be performed. The same with the 3. blood sample, but without spiking steps.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: platelet transfusion; Fibrinogen; blood coagulation; Thrombocytopenia; in-vitro experiments; FGTW; Fit2012; factor I; Fibrin
Ca:Mg Ratio and Cognitive Function
Condition: Cognitive Function
Study type: Interventional

Summary: 
      Between 2000 and 2015, mortality due to Alzheimer's disease (AD) increased by 123%. No drugs
      have yet been approved to stop or slow the progression of AD. A delay of five years in the
      expression of AD would reduce the incidence rate by half. Thus, it is critical to develop
      novel prevention strategies to delay the onset of this common disease.

      As an ancillary study conducted within a precision-based randomized trial (R01CA149633; PI,
      Dai & Yu]"), the investigators reduced Ca:Mg ratios to 2.3 through 3-month personalized Mg
      supplementation among those who consumed high Ca:Mg ratio diet, but otherwise in good general
      health. The investigators test the hypothesis that actively reducing the Ca:Mg ratio among
      those aged >65 years who consume high Ca:Mg ratio diets improves cognitive function compared
      to the placebo arm. The investigators further conduct molecular epidemiologic studies to
      understand the molecular mechanisms.
    


Intervention name(s): Magnesium glycinate; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral administration of magnesium glycinate daily for 12 weeks; Oral administration of identical-appearing placebo daily for 12 weeks
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees
Condition: Healthy
Study type: Interventional

Summary: 
      Coffee contributes to a large extent to our daily intake of phenolic compounds which have
      been associated with potential health benefits. A study by Richelle et al. (2001), using an
      LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity
      which varied depending on the coffee bean source and the degree of roasting. Little is known
      about the bioavailability of phenolic compounds from coffee at various roasting degrees.
      Therefore, further human studies are required in order to demonstrate the absorption, and
      bioavailability of metabolites that may also be efficient in vivo.

      The main objective of this clinical trial is to investigate the possible difference in the
      bioavailability of chlorogenic and phenolic acids from coffee at various roasting levels.
    

Detailed description: 
      Coffee contributes to a large extent to our daily intake of phenolic compounds which have
      been associated with potential health benefits. A study by Richelle et al. (2001), using an
      LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity
      which varied depending on the coffee bean source and the degree of roasting. Little is known
      about the bioavailability of phenolic compounds from coffee at various roast levels.
      Therefore, further human studies are required in order to demonstrate the absorption, and
      bioavailability of metabolites that may also be efficient in vivo.

      The main objective of this clinical trial is to investigate the possible difference in the
      bioavailability of chlorogenic and phenolic acids from coffee at different roast levels.

      After medical examination and approval, subjects will be randomly assigned to one of the four
      coffee treatments. Each study period correspond to the ingestion of one the treatments and
      study periods are separated by a one week washout period. Blood will be taken as a time
      course for 24h while urine will be collected for 30h. Investigators are also blinded with
      respect to the dose and the treatment given to the subjects.
    

Intervention name(s): Coffee bioavailability trial
Intervention type(s): Other
Intervention description(s): Coffee bioavailability trial
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Pentraxin-3 in Chronic Renal Failure
Condition: Inflammation; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Inflammation
Study type: Observational

Summary: 
      The aim of the study is to measure Pentraxin-3 levels in patients on hemodialysis, peritoneal
      dialysis and those in the pre-dialysis period; and to compare these groups with the control
      group; so as to investigate the eligibility of it as a reliable marker of inflammation;
      relationship with other inflammatory markers and carotis intima media thickness.
    

Detailed description: 
      The investigators planned to involve four group of patients: Hemodialysis, peritoneal
      dialysis, pre-dialysis and the control group; with about 25 patients planned to be involved
      in each group. The laboratory parameters to be measured are Pentraxin-3, C-reactive protein
      (CRP), high sensitive CRP, fibrinogen and interleukin-6. Concomitantly, carotis intima media
      thickness will be measured in the radiology clinic. Statistical analysis will be carried on
      by Statistical Package for Social Sciences (SPSS) for Windows 13.0. The variables acting on
      the inflammatory parameters and the correlation between them and carotis intima media
      thickness will be studied.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients will be selected among those who are followed up in our clinic.
      
Biospecimen description: 
      Serum
    
Keywords: Hemodialysis; peritoneal dialysis; chronic kidney disease; inflammation; carotis intima media thickness