bioihbjkbjnl/mcl2 huggingface dataset:
Bovine Lactoferrin and Antibiotic-associated Diarrhoea.
Condition: Antibiotic Associated Diarrhoea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This prospective, randomized, parallel-group, double blind, single-center study is to be
      conducted in the Medical University of Warsaw Public Paediatric Teaching Hospital in
      following departments: Department of Paediatric Gastroenterology and Nutrition, Department of
      Paediatrics and Nephrology, Department of Pediatric Pneumonology and Allergy, Department of
      Pediatrics with Medical Assessment Unit, Admissions Department. It is planned to include a
      total of 156 children aged between 12 months to 18 years old receiving antibiotic therapy
      because of acute respiratory tract infection/or urinary tract infection. The children will be
      randomly assigned to receive 100 mg of bovine lactoferrin or placebo twice a day orally for
      the whole period of antibiotic therapy. The primary efficacy parameter is occurrence of
      diarrhea during the antibiotic therapy and two weeks after, defined as > 3 stools a day, a
      watery or loose stool with/or occurrence of blood in the stool.
    


Intervention name(s): Bovine lactoferrin; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The children will be randomly assigned to receive 100 mg of bovine lactoferrin twice a day orally for the whole period of antibiotic therapy.; The children will be randomly assigned to receive 100 mg of placebo - maltodextrin twice a day orally for the whole period of antibiotic therapy.
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: lactoferrin; clostridium difficile; antibiotic associated diarrhoea; children; antibiotic therapy; diarrhoea
Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the next-day residual effects of a nighttime dose of gabapentin 250
      mg, diphenhydramine citrate 76 mg and triazolam 0.5 mg compared to placebo and each other on
      simulated driving performance in normal volunteer subjects. It will also examine other
      measures of next-day performance and next-day sleepiness.
    


Intervention name(s): Gabapentin; Diphenhydramine citrate; Triazolam; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 250 mg, oral, prior to bedtime on the night before performance testing; 76 mg, oral, prior to bedtime on the night before performance testing; 0.5 mg, oral, prior to bedtime on the night before performance testing; Oral, prior to bedtime on the night before performance testing
Intervention MeSH terms: Diphenhydramine; Promethazine; Triazolam; Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sleeplessness
PERG and mfPERG in Band Atrophy
Condition: Band Atrophy
MeSH terms: Atrophy
Study type: Observational

Summary: 
      The study is designed to evaluate the ability of pattern electroretinogram (PERG) and
      multifocal pattern electroretinogram (mfPERG) to measure and identify the pattern of band
      atrophy of the optic nerve in patients with long standing chiasmal lesions. The hypothesis is
      that these electrophysiological tests were able to identify this such pattern. The idea is to
      investigate the ability of the these electrophysiological technics in detecting the neural
      loss from chiasmal compression and to evaluate the ability of PERG and mfPERG parameters to
      differentiate between eyes with band atrophy of the optic nerve and healthy eyes.
    


Intervention name(s): Pattern electroretinogram
Intervention type(s): Device
Intervention description(s): Full field and hemifield (nasal and temporal) stimulation transient pattern electroretinogram (PERG) were recorded both in patients and controls.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with band atrophy from chismal compression and controls
      
Keywords: Band atrophy; Pattern electroretinogram; Chiasmal compression; Neural loss; Electrophysiological tests
A Study of Glyceryl Tri-(4-phenylbutyrate) (GT4P)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and tolerability of single oral doses of HPN-100 as a formulation
      (GT4P-F) and GT4P as the active pharmaceutical ingredient (GT4P-API) administered to healthy
      male subjects.
    

Detailed description: 
      A randomized, open-label, four-treatment, four-period crossover study in which healthy male
      subjects received a single dose of each of the following four treatments on four separate
      dosing days, 7 days apart:

        -  Oral sodium phenylbutyrate (Buphenyl®) equivalent to 3 g/m2 of 4-phenylbutyric acid
           (PBA) per dose

        -  Oral GT4P-F mole equivalents to 3 g/m2 of PBA per dose

        -  Oral GT4P-API mole equivalents to 3 g/m2 of PBA per dose

        -  Intravenous 10% sodium phenylacetate plus 10% sodium benzoate (Ammonul®) 2.75 g/m2
    

Intervention name(s): HPN-100; Ammonul; Buphenyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HPN-100 is a triglyceride that has a similar mechanism of action as Buphenyl. It is a liquid with minimal taste and odor. HPN-100 is broken down to phenylbutyric acid (PBA). PBA is converted to phenyl acetic acid (PAA) that is the active metabolite. Three teaspoons of HPN-100 (~17.4mL) delivers equivalent amount of PBA that 40 tablets of NaPBA do.
Intervention MeSH terms: 4-phenylbutyric acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ammonul; Sodium phenylacetate; sodium benzoate; Buphenyl; sodium phenylbutyrate; HPN-100; GT4P; Glyceryl tri-(4-phenylbutyrate); Healthy Volunteers
Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (IHCIS)
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Observational

Summary: 
      Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom
      burden is limited in commercially insured patients (age >= 18 years and < 65 years).
      Additionally, limited information exists on economic burden of adverse events associated with
      treatments for advanced/metastatic renal cell carcinoma. An objective of the current study is
      to estimate the incidence, prevalence, and symptom burden associated with advanced/metastatic
      RCC in a US "real-world" setting. Another objective is to quantify the economic burden of
      severe adverse events with agents used in management of first line advanced/metastatic RCC
      (sunitinib, sorafenib, bevacizumab, and pazopanib). This study will employ a retrospective
      cohort design. Analyses of health insurance claims data from a large commercially insured
      population will be employed in the current study. Study subjects will consist of all persons,
      aged ≥18 years, with evidence of advanced RCC between January 1, 2000 and December 31, 2009;
      these persons will be identified based in part on case-ascertainment algorithms. Analyses
      will be directed at estimating annual rates of incidence and prevalence of
      advanced/metastatic RCC, as well as symptom burden and costs of common severe adverse events
      associated with treatments used in management of advanced/metastatic RCC (sunitinib,
      sorafenib, bevacizumab, and pazopanib).
    


Intervention name(s): Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)
Intervention type(s): Drug
Intervention description(s): Metastatic RCC patients on either sunitinib or sorafenib or bevacizumab or pazopanib (identified based on claims) will be evaluated for presence or absence of common severe adverse events. These common severe adverse events will be identified from agent's product labels.
Intervention MeSH terms: Bevacizumab; Sunitinib; Sorafenib
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Study subjects will be selected from a source population consisting of all persons in the
        IHCIS database with one or more days of eligibility for comprehensive health benefits
        between January 1, 2000 and December 31, 2009.
      
Keywords: retrospective database analysis; economic burden
Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy
Condition: Sexual Function
Study type: Interventional

Summary: 
      This is a single center, double-blind, randomized controlled trial evaluating the change in
      sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants
      will be sexually active women who agree to randomization to having perineorrhaphy added to or
      excluded from their surgical repair. We hypothesize that sexual function will improve more
      significantly in women undergoing vaginal repair with perineorrhaphy.
    


Intervention name(s): Perineorrhaphy
Intervention type(s): Procedure
Intervention description(s): Procedure to build up the vaginal opening
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaginal prolapse; sexual function; sexual dysfunction; prolapse surgery
Neural Effects of Green Tea Extract on Dorsolateral Prefrontal Cortex
Condition: Exploratory Behavior
Study type: Interventional

Summary: 
      Green tea is being recognized as a beverage with potential benefits for human health and on
      cognitive function. In vitro and in vivo studies provide preliminary evidence that green tea
      intake may play a positive role in improving effects on cognitive functions. The
      investigators aim to examine the neural effects of green tea extract on brain activation in
      humans.
    

Detailed description: 
      As functional neuroimaging provides a means of examining how green tea extract acts on the
      brain, we used functional magnetic resonance imaging (fMRI) to study healthy volunteers while
      they performed a working memory task following intra-gastric administration of either 250 ml
      or 500 ml Rivella green® (RG), a milk whey based green tea extract containing soft drink, or
      Rivella blue® (RB), a milk whey based soft drink without green tea extract as sham condition
      in a double-blind, controlled design. Based on the literature on pharmacological and
      behavioural effects of green tea, we hypothesized - a priori - that green tea extract would
      subtly modulate the engagement of the dorsolateral prefrontal cortex (DLPFC), a brain region
      critically involved in many cognitive functions such as working memory processing.

      A double-blind, controlled, within-subject study with counterbalanced order of substance
      administration using an established protocol (6-8) was conducted over 4 sessions (250 ml or
      500 ml Rivella green® (including green tea extract; RG), 250 or 500 ml Rivella blue® (RB).
      Each participant was scanned four times with a one-week interval between scans. The order of
      substance administration across sessions was counterbalanced across subjects, such that equal
      numbers followed each substance sequence.
    

Intervention name(s): Single intragastric instillation of 250 ml green tea extract; Single intragastric instillation of 500 ml green tea extract; Single intragastric instillation of 250 ml control solution; Single intragastric instillation of 500 ml control solution
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Intragastric instillation by feeding tube; Intragastric instillation by feeding tube; Intragastric instillation by feeding tube; Intragastric instillation by feeding tube
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study to Assess Efficacy of New Malaria Vaccine Candidates AdCh63 AMA1, MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP & MVA ME-TRAP
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study aims to test the safety and efficacy of six new malaria vaccines - AdCh63 AMA1,
      MVA AMA1, AdCh63 MSP1, MVA MSP1, AdCh63 ME-TRAP & MVA ME-TRAP. These vaccines consist of
      inactivated viruses which have been modified - so they cannot reproduce (replicate) in
      humans, and also to include genetic material (genes) for malaria proteins which are expressed
      by the malaria parasite during both liver and blood stage infection. The vaccines are
      designed to stimulate an immune response to these malaria proteins (immunogenicity describes
      the nature and magnitude of this immune response) and thus provide protection against malaria
      infection. The protective efficacy of vaccines will be evaluated by challenging a small
      number of volunteers who have received the vaccines with malaria infection from the bites of
      infected mosquitos(sporozoite challenge).
    


Intervention name(s): AdCh63 MSP1, MVA MSP1, challenge; AdCh63 AMA1, MVA AMA1, challenge; AdCh63 AMA1, AdCh63 MSP1, MVA AMA1, MVA MSP1, challenge; AdCh63 MSP1, AdCh63 ME-TRAP, MVA MSP1, MVA ME-TRAP, challenge; Sporozoite challenge
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 1 dose of AdCh63 MSP1 5 x 1010 vp intramuscularly and 1 dose MVA MSP1 2.5 x 108 pfu intramuscularly 8 weeks later (range 6-12 weeks) followed by sporozoite challenge 12-28 days later; 1 dose of AdCh63 AMA1 5 x 1010 vp intramuscularly and 1 dose MVA AMA1 2.5 x 108 pfu intramuscularly 8 weeks later (range 6-12 weeks) followed by sporozoite challenge 12-28 days later; 1 dose of AdCh63 AMA1 5 x 1010 vp intramuscularly and 1 dose AdCh63 MSP1 5 x 1010 vp intramuscularly co-administered into separate arms followed 8 weeks later (range 6-12 weeks) by 1 dose of MVA AMA1 2.5 x 108 pfu intramuscularly and 1 dose MVA MSP1 2.5 x 108 pfu intramuscularly co-administered into separate arms (but the same arm as the corresponding AdCh63 vaccine) followed by sporozoite challenge 12-28 days later.; 1 dose of AdCh63 MSP1 5 x 1010 vp intramuscularly and 1 dose AdCh63 ME-TRAP 5 x 1010 vp intramuscularly co-administered into separate arms followed 8 weeks later (range 6-12 weeks) by 1 dose of MVA MSP1 2.5 x 108 pfu intramuscularly and 1 dose MVA ME-TRAP 2 x 108 pfu intramuscularly co-administered into separate arms (but the same arm as the corresponding AdCh63 vaccine) followed by sporozoite challenge 12-28 days later.; Non-vaccinated controls for sporozoite challenge
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccine; Safety; Immunogenicity; Protection; Sporozoite challenge
Effectiveness of Auricular Point Acupressure in Improving Quality of Life in Patients With Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      This study will investigate the effectiveness of auricular point acupressure in improving
      fatigue,sleep quality,physical activity and quality of life in patients with pancreatic
      cancer under chemotherapy in taiwan.

      Hypothesis:

        1. The fatigue in auricular point acupressure group is significant improving than
           usual-care group at 1st, 2nd, 3rd and 4th week.

        2. The sleep quality in auricular point acupressure group is significant improving than
           usual-care group at 1st, 2nd, 3rd and 4th week.

        3. The physical activity in auricular point acupressure group is significant improving than
           usual-care group at 1st, 2nd, 3rd and 4th week.

        4. The quality of life in auricular point acupressure group is significant improving than
           usual-care group at 1st, 2nd, 3rd and 4th week.
    

Detailed description: 
      This study will investigate the effectiveness of auricular point acupressure in improving
      fatigue,sleep quality,physical activity and quality of life in patients with pancreatic
      cancer under chemotherapy in taiwan.
    

Intervention name(s): Auricular Point Acupressure group
Intervention type(s): Behavioral
Intervention description(s): A 1-month regimen of auricular point acupressure, comprising usual-care of approximately 15-20 point pressing each time,3 times a day, seven times peer week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Chemotherapy; Fatigue; Sleep Quality; Physical Activity; Quality of Life
Effects of Chromium Picolinate on Food Intake
Condition: Obesity; Atypical Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of chromium picolinate on food intake, food
      cravings, eating attitudes, and appetite. If chromium picolinate is found to have a
      beneficial impact on satiety and food intake, then this supplement may be an alternative or
      adjunctive treatment for overweight people desiring to modify their food intake. The primary
      hypothesis of this study is that among individuals who report being carbohydrate cravers,
      chromium picolinate supplementation will reduce food intake during a test lunch meal and
      produce greater satiety in comparison to a placebo.
    


Intervention name(s): Chromium Picolinate
Intervention type(s): Drug
Intervention description(s): Test whether Chromium Picolinate supplementation affects food intake at both a test lunch meal and at a test dinner meal presented 4.5 hours later among healthy, overweight and/or obese, adult women who are determined to be carbohydrate creavers.
Intervention MeSH terms: Chromium; Picolinic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Combination of Serratus Anterior and Pectoral Nerve Blocks (PECS II) as Main Anesthetic Method in Breast Cancer Surgery
Condition: Anesthesia
Study type: Observational [Patient Registry]

Summary: 
      Aim of this study is to determine the success of combined serratus anterior and PECS-2 block
      as the main anesthetic method in breast cancer surgery and also to investigate the patient
      acceptability of this combination and its relationship with surgeon satisfaction.
    

Detailed description: 
      Breast conserving surgery or mastectomy is applied in the surgical treatment of breast
      cancer. Axillary interventions range from sentinal lymph node biopsy to lymph node
      dissection. Clinically significant acute pain develops following breast surgery in 35% of
      patients.

      Today, regional anesthesia is widely used as an opioid-sparing strategy in the treatment of
      acute postoperative pain. New fascial plane blocks have been developed as alternative or
      complementary techniques for chest wall analgesia, including pectoral nerve blocks (PECS1-2)
      and serratus plane block.

      In order to reduce the risk of perioperative morbidity and mortality and to meet the patient
      demand, the demand for awake surgery is increasing in institutions.

      Therefore, a prospective observational case series was conducted to explain the efficacy,
      patient acceptability, and surgeon satisfaction of combined serratus anterior and PECS-2
      block as the main anesthetic method for breast cancer surgery.
    

Intervention name(s): serratus anterior block and PECs II block combination
Intervention type(s): Other
Intervention description(s): The pre-surgery block will be applied. Sensorial block will be evaluated at the surgical incision site with the pinpirick test at 30 minutes after the block, and if the block is successful, surgery will begin.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Female patients aged 18-80 years with breast cancer
      
Keywords: regional anesthesia; interfascial plane block; Main anesthetic method
Study of the Effect of Velaglucerase Alfa (VPRIV®) on Bone-related Pathology in Treatment-naïve Participants With Type 1 Gaucher Disease
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary purpose of this study is to evaluate the effect of VPRIV therapy (60 units per
      kilogram [U/kg] every other week [EOW]) in treatment-naive participants with type 1 Gaucher
      disease on change from baseline in lumbar spine (LS) bone mineral density (BMD) Z-score as
      measured by dual energy x-ray absorptiometry (DXA) after 24 months of treatment.
    


Intervention name(s): Velaglucerase alfa; Vitamin D
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Participants will receive 60-minute intravenous infusion of 60 U/kg velaglucerase alfa EOW.; Participants will receive 800 IU vitamin D orally daily.
Intervention MeSH terms: Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact Study of Minnesota SNAP-Ed Health and Nutrition Education Programs
Condition: Obesity; Child
Study type: Interventional

Summary: 
      Supplemental Nutrition Assistance Program - Education (SNAP-Ed) is a national initiative with
      the goal of improving the health and wellbeing of low income families. University of
      Minnesota Extension every year offers nearly 4000 educational events, serving approximately
      70,000 Minnesotans through the program. Extension is conducting an impact study to determine
      program effectiveness and assess sustained changes of participants and their families that
      can be directly attributed to programming on a larger and methodically sound scale.
    


Intervention name(s): Go Wild with Fruits and Veggies!; Go Wild with Fruits and Veggies! delayed
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Fruits and Vegetables; Go Wild with Fruits and Veggies! delayed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Fruit; Vegetables; Motor Activity