bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men
Condition: Type 2 Diabetes; Stroke; Myocardial Infarction
MeSH terms: Myocardial Infarction; Diabetes Mellitus, Type 2; Infarction
Study type: Interventional

Summary: 
      Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence
      world wide with an increased risk of myocardial infarction and stroke. GLP-1 has convincing
      effects on the high glucose levels in type 2 diabetic patients and is well tolerated. New
      animal studies indicate a protective effect of GLP-1 in the brain and the heart. The
      mechanism behind this is yet not known.

      The study hypothesis is that GLP-1 will stimulate glucose-uptake in the brain and heart
      independent of insulin and thereby exert its protective effects.
    

Detailed description: 
      Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence
      world wide. T2D is associated with a three-fold increase in cardiovascular complications
      (myocardial infarction and stroke) leading to significantly higher morbidity and mortality in
      this group of patients. The prospective British Diabetes Study (UKPDS) showed that neither
      diet alone nor the pharmaceutical treatment utilized (Sulphonylurea, Metformin, Insulin) were
      able to reduce these macrovascular complications. GLP-1 (glucagon-like-peptide-1)is an
      incretin with convincing effects on glycaemia in type 2 diabetic patients with little or no
      risk of hypoglycaemia. New research in animal models has shown a potential protective effect
      in the brain and heart in association with ischaemic damage. The mechanism behind this
      protective effect is not known.

      The effect of native GLP-1 on glucose uptake in the brain and heart will by visualized by
      fluoro-deoxy-glucose FDG-PET-scan during normoglycaemia in healthy young men. At the same
      time a pancreatic/pituitary clamp will be performed. The hypothesis is that GLP-1 directly
      will stimulate glucose uptake independent of the pancreatic hormones and through this
      mechanism exert its neuro- and cardioprotective actions.

      Comparisons: FDG-uptake in the brain and heart with GLP-1 infusion compared to placebo.
    

Intervention name(s): glucagon-like-peptide-1
Intervention type(s): Drug
Intervention description(s): Dose: 1.2pmol/kg/min for 6 hours
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: type 2 diabetes; GLP-1; PET; brain; heart
Reduced Intensity Double Umbilical Cord Blood Transplantation
Condition: Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Multiple Myeloma; Chronic Lymphocytic Leukemia; Acute Myelogenous Leukemia
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will use two cord blood units for transplantation using a reduced intensity
      regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood
      units (double cord blood) are being used, as the numbers of blood cells in one unit are too
      few to allow successful growth of these cells.

      Because the risk of infection, particularly virus infection, is high after double cord blood
      transplant, this study seeks to reduce the rise of virus infection by using a reduced
      intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior
      cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and
      fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The
      number of patients with virus infections in this study will be compared to our prior
      experience using the ATG.
    

Detailed description: 
      Subjects will receive their transplants as in-patients.

        -  IV-Catheter

             -  one or two IV catheters will be placed on the day of hospital admission

        -  Conditioning

             -  Fludarabine IV six days before transplant (days -7, -6, -5. -4, -3, -2)

             -  Melphalan IV (day -1)

             -  Total body radiation on day 0 (same day as transplant)

        -  Immunosuppressive Therapy

             -  Tacrolimus and sirolimus beginning day -3, daily for 6-9 months post-transplant.
                Given IV as in-patient, orally as out-patient

        -  Infusion of Cord Blood units

             -  2 cord blood units IV on Day 0 Routine post-transplant supportive care will be
                provided
    

Intervention name(s): Fludarabine; Melphalan; Total Body Radiation; Cord Blood
Intervention type(s): Drug; Drug; Radiation; Biological
Intervention description(s): 30 mg/m2/day IV x 6 days; 100 mg/m2/day IV x 1 day; 200 cGy on Day 0; 2 cord blood units IV
Other intervention name(s): Fludara
Intervention MeSH terms: Fludarabine; Melphalan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NHL; lymphoma; leukemia; myelodysplastic disorder; aplastic anemia
A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy of maternal immunization with the RSV
      F vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia
      through the first 90 days of life in infants.
    

Detailed description: 
      This is a randomized, observer-blind, placebo-controlled trial enrolling third-trimester
      pregnant women in the Northern and Southern hemispheres, for up to four consecutive RSV
      seasons in each hemisphere. The trial will enroll 4636 third-trimester pregnant subjects.
      Women in the third trimester of a singleton uncomplicated pregnancy and 18 to 40 years of age
      (inclusive) will be enrolled and randomized in a 1:1 ratio into one of two treatment groups,
      active or placebo, over approximately the three months prior to peak RSV season. After the
      first global season of enrollment, the randomization scheme will be changed to a 2:1
      (active/placebo) ratio to enable more efficient accrual of the safety database.

      All maternal subjects will receive a single intramuscular (IM) injection on Day 0 with the
      assigned test article, the RSV F vaccine or placebo. Study participation for maternal
      subjects will span approximately nine (9) months from the first dose, ending six (6) months
      post-delivery. Study follow-up for infant subjects who are consented will span approximately
      one (1) year post-delivery.
    

Intervention name(s): RSV F vaccine with adjuvant; Formulation buffer
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: RSV
ASP8825 - A Study to Investigate the Food Effect on the Pharmacokinetics of ASP8825
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the effect of food on the pharmacokinetics and
      safety after administration of ASP8825 in healthy non-elderly adult male subjects.
    


Intervention name(s): ASP8825
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): gabapentin enacarbil
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food effect; Pharmacokinetics; ASP8825; XP13512
Online HIV Prevention Vignette Evaluation
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      This is an evaluation of the effect that an online live action, dramatic vignette about four
      gay men, two HIV positive and two HIV negative, struggling with the responsibility for safer
      sex has on the sexual behavior and HIV testing intentions of the gay/bisexual men who watch
      the vignette and participate in the evaluation study. The primary hypothesis is that men will
      be more likely to: 1)express the intent to have an HIV test and 2) to express the intent to
      inform their sex partners of their HIV status after watching the vignette. The secondary
      hypothesis is that men will be more likely to follow through on these intentions in the three
      months following the intervention than they were in the three months before viewing the
      vignette. This is a one group pre-posttest intervention in which each man serves as his own
      control.
    

Detailed description: 
      -  Men over 18 years of age will be recruited for the study through a banner posted on the
           exit page of manhunt.net an internet gay hook-up site. Those clicking on the banner will
           go to the evaluation website (www.hivbigdeal.org)

        -  asked to read the consent and click agreement.

        -  asked to complete a relatively brief questionnaire about their sexual behavior, HIV
           testing and HIV disclosure in the preceding three months

        -  watch the 8 minute dramatic vignette

        -  complete a brief questionnaire that elicits their response to the video and their HIV
           testing and disclosure intentions.

        -  if they agree to provide the study with their e-mail address, participants will be
           re-contacted in three months and asked to complete a second behavioral survey online
           that asks about sexual behavior, HIV testing and HIV disclosure in the three months
           since watching the vignette.Behavior before and after watching the vignette will be
           compared.

        -  The entire study will be conducted online.
    

Intervention name(s): education
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
Keywords: HIV testing; HIV disclosure; HIV Seronegativity
Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section
Condition: Dysbiosis; Prophylaxis
MeSH terms: Dysbiosis
Study type: Interventional

Summary: 
      The aim of this study is to assess influence of probiotic Lactobacillus reuteri DSM 17938 on
      formation of gut microbiota in infant born by Caesarean section. It is anticipated that daily
      using of probiotic Lactobacillus reuteri DSM 17938 can prevent development of early dysbiosis
      of gut microbiota induced by Caesarean section.
    

Detailed description: 
      This is a single-center prospective randomized double-blind placebo-controlled clinical
      study. The planned duration of the study for each included infant will be 16 weeks, 4 weeks
      of study drug intake and 12 weeks of follow-up. 140 healthy infants born by Caesarean section
      will be included in the general group of the study, and 60 healthy infants born by natural
      vaginal delivery will be included in the control group. For infants included in the control
      group, all the same protocol requirements and procedures will be applied as for infants in
      the general group, except for randomization and the study product / placebo intake. Infants
      included in the general study group will be randomly assigned into the study product /
      placebo subgroups in 1: 1 ratio. During the study the gut microbiota will be analyzed. Feces
      samples should be collected no later than 72 hours after birth, and also on 14th day of life
      ± 3 days, 30th day of life ± 3 days and 112th day of life ± 3 days. Short-chain fatty acids
      (SCFA) will be analyzed in feces samples.
    

Intervention name(s): BioGaia Protectis drops; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): food supplement containing the patented lactic acid bacterium Lactobacillus reuteri Protectis®/™ (L. reuteri DSM 17938).; Contains same excipients as study drug, without the active ingredient L. Reuteri.
Other intervention name(s): BioGaia® Probiotic. Drops for baby
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gut Microbiota; Cesarean Section; Dysbiosis
Effects of Postoperative Analgesic Modalities on Plasma Creatine Phosphokinase(CPK) Levels After Knee Artroplasty
Condition: Myotoxicity
MeSH terms: Myotoxicity
Study type: Observational

Summary: 
      Regional anesthesia and analgesia technics are widely and securely used during orthopedic
      surgery. Interfascial plane blocks are the latest used ones for analgesia. There are studies
      in literature indicating that bupivacaine cause myotoxicity. We aimed to examine plasma
      CPK(creatine phosphokinase) levels to see whether myotoxicity occurs or not after
      suprainguinal fascial plane block is applied to patients undergoing knee artroplasty surgery.
    

Detailed description: 
      During 2 months period all elligible patients undergoing knee artoplasty surgery will be
      included in the study. Different postoperative analgesic modalities will be used according to
      the anesthesists experience. During routine blood sample tests plasma CPK levels will be
      tested 3 times of all patients.(preoperative, postoperative 6th hour, postoperative 24th
      hour) this data will be recorded for 2 months. After this period of time data will be
      analysed and patients will be grouped according to the analgesic modalities used.
    

Intervention name(s): suprainguinal fascia iliaca block
Intervention type(s): Other
Intervention description(s): Suprainguinal fascia iliaca block will be performed after the end of surgery for postoperative analgesia.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing knee artroplasty surgery of ASA status 1-3. aged between 18-75years.
      
Keywords: bupivacaine, myotoxicity, creatine phosphokinase,SFIPB
Effect of Genistein in Women With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether the phytoestrogen genistein is effective in
      improving bone condition in pre-menopausal and post-menopausal women suffering for
      osteopenia. Since, during the study the investigators realized that at least 70% of
      post-menopausal recruited women suffered for metabolic syndrome (MS), we have added only in
      these women, as secondary outcome measures, the evaluation of markers of cardiovascular risk.
    

Detailed description: 
      MS prevalence increases after the onset of menopause, because of estrogen deficiency. It is
      still not clear if menopause itself increases the risk of cardiovascular diseases in al women
      or only in those that develop MS. Many MS patients that show slight modification in
      cardiovascular and metabolic parameters are not generally pharmacologically treated since
      diabetes or alteration in the lipid profile are not evidenced. In this respect it is of
      importance to develop new therapeutic strategies to prevent and treat MS. Genistein
      (4,5,7-trihydroxyisoflavone), shown a potentially preventive role on the cardiovascular
      apparatus in post-menopausal women, may be termed as selective ER modulator (SERM), since it
      reveals both ER-alpha full agonist and ER-beta partial agonist activity.

      The investigators studied whether genistein may represent an efficacious and safe alternative
      for reducing vascular risk in postmenopausal women with metabolic syndrome. The clinical
      study was a randomized, double-blind, placebo-controlled study involving 150 patients with
      metabolic syndrome. After a 4-week stabilization on a standard fat-reduced diet, participants
      were randomly assigned to receive either phytoestrogen genistein (54 mg/day) or placebo for 6
      months. At baseline and following treatment fasting plasma glucose, insulin, insulin
      resistance (HOMA-IR), lipid concentrations, plasma total homocysteine, leptin, adiponectin
      and visfatin were measured. Bioimpedentiometric and nutritional analysis, as well as a safety
      assessment of the endometrium and vagina were also performed.
    

Intervention name(s): genistein; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): pills of 27 mg, twice per day for 12 months; sugar pills twice per day for 12 months
Intervention MeSH terms: Genistein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: menopause; genistein; pre-diabetes
Digital vs Analog Impression in Cases of All-on-4 - Prosthesis
Condition: Edentulous Mouth
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      Fifty six patients were randomly enrolled in the study. Participants were randomly stratified
      into two control groups and two test groups, from which conventional pick up and digital
      impressions were made respectively. Patients of group 1 (CIG Axial) and 3 (DIG Axial)
      received 4 axial implants whereas, group 2 patients (CIG Tilted), and group 4 (DIG Tilted)
      received two anterior axial implants and two distal tilted implants.

      All participants received hybrid dentures. Bone loss, implant loss, maintenance of prosthesis
      were evaluated at 6m,12m, and 24 months follow up period.
    


Intervention name(s): DIG Axial; DIG Tilted; CIG Axial; CIG Tilted
Intervention type(s): Other; Other; Other; Other
Intervention description(s): patients received 4 axial implants and digital impression; received two anterior axial implants and two distal tilted implants, and digital impression; patients received 4 axial implants and conventional impression; received two anterior axial implants and two distal tilted implants, and conventional impression
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: impressions; analogue; digital; All-on-Four
Albiglutide Thorough ECG Study in Healthy Volunteers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the effect of treatment with albiglutide on the cardiac
      repolarization (corrected QT interval) in healthy male and female subjects. Moxifloxacin, a
      positive control, or moxifloxacin placebo will be given in order to validate the ability of
      the study to detect a change in the corrected QT interval.
    

Detailed description: 
      This is a Phase I, randomized, double-blind study designed to investigate the effect of
      treatment with albiglutide given weekly over 6 weeks on the cardiac repolarization (corrected
      QT interval) in healthy male and female subjects. Moxifloxacin, a positive control, or
      moxifloxacin placebo will be given in order to validate the ability of the study to detect a
      change in the corrected QT interval.
    

Intervention name(s): Albiglutide; Moxifloxacin
Intervention type(s): Biological; Drug
Intervention description(s): once weekly subcutaneous injection; oral tablet
Intervention MeSH terms: Moxifloxacin; rGLP-1 protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: albiglutide; QT interval; cardiac repolarization; ECG study
Safety Evaluation of Bowel Cleansing Regimen for PillCam® COLON 2 Capsule Endoscopy
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2
      Capsule Endoscopy.
    

Detailed description: 
      The preparation regimen used for the PillCam® Colon 2 procedure consists of several colon
      cleansing materials.

      Different combinations of the above regimen were tested and evaluated for safety by
      monitoring of adverse events in multiple clinical studies, with more than 1000 subjects
      enrolled to date. No Serious Adverse Events related to the preparation were noted.

      In this study, each subject will be required to undergo serum chemistry tests (blood tests)
      at several time points to evaluate the safety of the regimen.

      No capsule ingestion is involved.
    

Intervention name(s): The preparation regimen
Intervention type(s): Other
Intervention description(s): Regimen includes administration of 4 Senna tablets 2 days before the procedure, 2-liters of PEG on the evening before the procedure, 2-liters of PEG on the morning of the procedure, 10mg Metoclopramide, two boosts (6-oz and 3-oz) of SUPREP oral sulfate solution and a 10mg Bisacodyl suppository
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy volunteers
Flash-free Brackets and Dental Plaque
Condition: Orthodontic Treatment
Study type: Interventional

Summary: 
      This study aimed to compare flash-free bracket system with conventional adhesive-coated
      bracket system in patients with maxillary crowding.
    

Detailed description: 
      Aim: The aim of this split-mouth study was to compare conventional and adhesive
      flash-free-bracket systems in terms of plaque retention, white spot lesion formation,
      biomarker levels and select microbes in gingival crevicular fluid (GCF).

      Materials & Methods: Thirty-seven systemically healthy patients (18 males, 19 females) with
      the age range of 13-18 years were involved in this split-mouth study. Clinical evaluations,
      quantitative light-induced fluorescence (QLF) imaging, GCF and plaque samplings were
      performed at baseline and at 1-, 2-, 3-months. QLF was repeated following debonding, GCF
      samples were analyzed by immunoassay and real-time PCR for the biomarker and bacteria
      content. Data were analyzed by Wilcoxon on dependent samples.
    

Intervention name(s): orthodontic treatment
Intervention type(s): Procedure
Intervention description(s): orthodontic treatment in maxillary crowding
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Study of CP-751,871 in Combination With Carboplatin and Paclitaxel in Advanced Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate safety, tolerability and pharmacokinetics of CP-751,871 when given in combination
      with carboplatin and paclitaxel in patients with advanced non-small cell lung cancer
    


Intervention name(s): CP-751,871 + carboplatin + paclitaxel
Intervention type(s): Drug
Intervention description(s): Chemotherapy (carboplatin and paclitaxel) and CP-751,871 (6, 10 or 20mg/kg) will be administered by intravenous infusion every three weeks.
Intervention MeSH terms: Paclitaxel; Carboplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CP-751,871, Non-small cell lung cancer, Phase 1