bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.
Condition: Hepatic Encephalopathy; Cirrhosis; Portosystemic Encephalopathy; PSE
MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Fibrosis
Study type: Interventional

Summary: 
      This study is being done to find out if the laxative polyethylene glycol (also known as
      GoLYTELY® or Miralax®) can treat your hepatic encephalopathy (confusion due to your liver
      disease and/or cirrhosis) better and/or more safely than lactulose (another laxative). In
      this study, the investigators will evaluate if polyethylene glycol (GoLYTELY®) is more
      effective than lactulose on neurocognition (memory and thinking skills) and determine if it
      decreases the hospital stay.
    


Intervention name(s): Polyethylene glycol 3350-electrolyte solution (GoLYTELY®); Lactulose
Intervention type(s): Drug; Drug
Intervention description(s): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon; If randomized to this arm, subjects will receive 10-30 grams per standard of care
Other intervention name(s): GoLYTELY® or Miralax®
Intervention MeSH terms: Lactulose; Polyethylene glycol 3350
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic Encephalopathy; HE; Cirrhosis; PSE; Portosystemic Encephalopathy; Hepatic coma; AMS; Altered mental status; Complications of cirrhosis; Chronic liver disease
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of 14C-AB1010 in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To assess the mass balance recovery after a single oral dose of 14C-AB1010
    

Detailed description: 
      The objective is to characterize the distribution, metabolism and elimination of AB1010 in
      humans through the sampling of blood, urine, and faeces. This is accomplished through the
      administration of 14C-AB1010 oral solution with a therapeutic relevant dose of AB1010 as a
      single oral dose. There was no control group and no blinding as the objective was to assess
      the mass balance of masitinib after a single oral intake. There was only one group of healthy
      male volunteers.
    

Intervention name(s): 14C-AB1010
Intervention type(s): Drug
Intervention description(s): Oral solution of 14C radiolabelled AB1010 (200 mg per subject)
Other intervention name(s): radiolabelled masitinib
Intervention model: Single Group Assignment
Intervention model description: An open label, non-randomized, single-dose, single-period study
Masking: None (Open Label)
Primary purpose: Treatment
Study of Ingaron's Effect on Efficacy and Resistance to Antibiotics in Community-acquired Pneumonia
Condition: Community-acquired Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      The primary purpose of this study is to effect of Ingaron®, a lyophilisate for the
      preparation of a solution for intramuscular and subcutaneous administration of 100,000 IU
      (LLC NPP Farmaklon, Russia) on the effectiveness of antibiotic therapy in patients with
      community-acquired pneumonia who fell ill during the epidemiological rise of ARVI.
    

Detailed description: 
      Pilot, open, single-centre, randomized controlled trial. Patients will be prescribed basic
      combination antibiotic therapy. In addition to antibiotic therapy, half of the patients will
      receive Ingaron®, a lyophilisate for the preparation of a solution for intramuscular and
      subcutaneous administration of 100,000 IU (LLC NPP Farmaklon, Russia). The study drug
      solution Ingaron® will be administered intramuscularly at 100,000 IU once daily for 5 days.
    

Intervention name(s): Interferon-Gamma
Intervention type(s): Drug
Intervention description(s): received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein
Other intervention name(s): Ingaron; Interferon gamma human recombinant
Intervention MeSH terms: Interferons; Interferon-gamma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interferon gamma; IFN-g; antibiotic resistance; Community-acquired Pneumonia
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The aim of study is to assess the possible impact of assisted hatching on delivery rate after
      transfer of vitrified-warmed human blastocysts.
    

Detailed description: 
      Zona pellucida (ZP) manipulation, termed "assisted hatching" (AH), has been introduced in
      order to favor embryo hatching and ultimately improve assisted reproductive technology
      success but with poor proofs of safety and biological plausibility.

      Vitrifying and warming of blastocysts may impair the successful hatching process of the
      embryo out of its ZP and its following implantation into the uterus. Theoretically, AH may
      facilitate the hatching process and subsequently increase implantation rates.

      In this prospective randomized controlled trial (RCT), the hypothesis is to test whether the
      application of a partial AH to vitrified/warmed blastocysts might affect patients' delivery
      rate.

      Patients with vitrified blastocysts will be randomized at the time of blastocyst warming to a
      study group (with AH) or a control group (without AH). AH will be performed at the expanded
      blastocyst stage using a laser technique and a laser opening will be initiated at the 1
      o'clock position. Consecutive laser shots will be applied to reach the 5 o'clock position of
      the blastocyst. The blastocysts will then be cultured at least 2 h and subsequently
      transferred into the patient's uterus.
    

Intervention name(s): Laser assisted hatching
Intervention type(s): Procedure
Intervention description(s): After warming, blastocysts are subjected to laser assisted hatching (LAH) following the standard procedure.The LAH procedure lasts one minute per blastocyst.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Assisted hatching; Zona pellucida; Implantation failure; Blastocyst; Cryopreservation
The Clinical Study on the Mangrove Sword Bean Food Bar Effect for Older People
Condition: Nutrition Disorders in Old Age; Disaster
MeSH terms: Nutrition Disorders
Study type: Interventional

Summary: 
      The goal of this clinical study is to assess the api-api mangrove sword bean food bar effect
      on the older people's weight affected by a landslide

      The main questions aimed to answer are:

        -  Can api-api mangrove sword bean food bar improve the weight of older people affected by
           landslide?

        -  Can balanced nutrition education increase the older peoples' knowledge?

      Participants divided in the two groups i.e.:

        -  Treatment group received 50 g mangrove sword bean food bar each day during 15 days.

        -  Control group received 50 g sword bean food bar each day during 15 days.

        -  Both groups obtained balanced nutrition of older people education once at the first week
           of study.
    

Detailed description: 
      Treatment group received 50 g mangrove sword bean food bar each day during 15 days.

      Control group received 50 g sword bean food bar each day during 15 days. Both groups obtained
      balanced nutrition of older people education once at the first week of study.

      Compliance monitoring to control the food compliance by the subjects at two groups through
      home visit, weight measurement, three days food recall, and food bar distribution checking by
      trained enumerators.
    

Intervention name(s): Clinical study on the mangrove sword bean food bar effect for older people
Intervention type(s): Dietary Supplement
Intervention description(s): The treatment group consumed 50 g mangrove sword bean food bar each day during 15 days.
Other intervention name(s): EFP
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Treatment group consumed mangrove sword bean food bar during 15 days. Control group consumed sword bean food bar during 15 days. Balanced nutrition education undertaken to all subjects at two groups once at the first week of study.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Older people; disaster; weight; mangrove-sword bean food bar
Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in
      the home or neighborhood compared with at home, individualized, parent training in preschool
      aged children with autism.

      II. Identify intake measures that predict differences in outcome between subjects in the
      experimental group.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized study. Children are randomized to receive either 35
      hours of intensive one-on-one behavioral treatment in the home and neighborhood for 2 years
      or individualized, in home parent training for 6 months.

      A common group of tests to evaluate autism are administered at intake, 12 and 24 months into
      treatment, and when patients reach age 6.
    

Intervention name(s): intensive one-on-one behavioral treatment; Individualized in home parent training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Up to 40 hours per week of one-to-one intervention based on applied behavior analysis; Offered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autism; neurologic and psychiatric disorders; rare disease
Study to Evaluate the Efficacy and Safety of MEDI9929 (AMG 157) in Adult Subjects With Inadequately Controlled, Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the effect of 3 dose levels of MEDI9929
      (AMG 157) on asthma exacerbations in adult subjects with inadequately controlled, severe
      asthma.
    


Intervention name(s): Placebo; MEDI9929 70 mg; MEDI9929 210 mg; MEDI9929 280 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.; Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.; Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.; Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma
Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2
Condition: Obesity; Obesity, Morbid; Obesity; Endocrine; Bariatric Surgery Candidate
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      Rapid metabolic improvements seen with sleeve gastrectomy are likely a result of changes in
      gastric origin. The gastric mucosa is an endocrine organ that regulates satiation pathways
      and is a complex regulator of food intake as well as lipid and glucose metabolism. This study
      aims to assess the efficacy and safety of endoscopic selective gastric mucosal devitalization
      (GMD) for the management of obesity and its related comorbidities.
    

Detailed description: 
      Endoscopic approaches to obesity may help fulfill the unmet need of over half the US adult
      population that would benefit from therapy for obesity but are not receiving it. Endoscopic
      approaches to obesity have the potential to be more efficacious than antiobesity medications
      and have a lower risk-cost profile compared with bariatric surgery.

      Endoscopic approaches to obesity need to be increasingly modeled on the proposed mechanisms
      contributing to the benefits of bariatric surgery.

      The investigators seek to decipher if the gastric mucosa is an independent regulator of food
      intake, body weight, lipid and glucose metabolism and serum gut hormones. The investigators
      also wish to ascertain if selective devitalization of the gastric mucosa, without alteration
      in gastric volume, will improve obesity related comorbidities.

      This study will be divided into 3 parts. The purpose of completing the 3 phases is to develop
      a minimally invasive weight loss technique that is effective, safe and ready for more
      rigorous assessment via a future randomized control trial.

      Objectives:

      Overall:

      To assess the efficacy and safety of gastric mucosal devitalization for the management of
      obesity and its related comorbidities.

      Part 2:

      Aims to confirm that the optimal color of the tissue identified by part 1 corresponds to
      selective mucosal devitalization in the in vivo setting by histopathologic examination. For
      this, patients will be enrolled in the study after being scheduled to undergo vertical sleeve
      gastrectomy (VSG). GMD will be performed three days prior to the VSG, and the excised tissue
      including devitalized gastric mucosa will be evaluated. The degree and correlation of
      devitalization with mucosal discoloration will be assessed.
    

Intervention name(s): Gastric mucosal devitalization
Intervention type(s): Procedure
Intervention description(s): Gastric mucosal devitalization is an endoscopic procedure which uses argon plasma coagulation to result in selective damage to the gastric mucosa and submucosa.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bariatric endoscopy; obesity; metabolic syndrome; gastric mucosal devitalization; Endoscopic bariatric therapies
Latinos CARES (Colorectal Cancer Awareness, Research, Education and Screening)
Condition: Colorectal Cancer; Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to conduct 4 focus groups and recruit for 12 participants per
      focus group to explore community members' views about colorectal cancer screening (CRCS)
      processes and perceived benefits and impediments, what information they believe should be
      communicated, communication preferences (style, tone) and perceptions of screenings.
    


Intervention name(s): Immunochemical Fecal Occult Blood Test (I-FOBT) Kit; LATINOS CARES Toolkit; Standard Intervention
Intervention type(s): Other; Behavioral; Behavioral
Intervention description(s): Both intervention groups will receive an I-FOBT kit (by study coordinator) with verbal and written instructions in Spanish on how to complete the stool sampling at home within 1 week, and mail the completed kit in the pre-addressed, postage paid mailer. Patients with abnormal results will receive a call explaining the meaning of an abnormal I-FOBT and encouraging them to take specific next steps.; DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population.; Standard intervention (CDC brochure) on colorectal cancer screening in community health clinics.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: After completion of baseline assessments, participants will be randomized so that the study personnel are unaware of the intervention assignment at the time of the baseline assessment.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: cancer screening; colon
Neuropsychological Consultation as Part of Pediatric Diabetes Care: Does it Improve Glycemic Control and Family Functioning?
Condition: Diabetes; Glycinemia
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      This is a randomized controlled open label study design (study team will not be blinded) to
      measure whether including targeted neuropsychological consultations as part of pediatric
      diabetes care informs treatment and educational planning, improves glycemic control, and
      improves quality of life. Patients will be randomized 1:1 ratio to Group 1-Control group and
      Group 2-Neuropsychological consultation group.
    


Intervention name(s): Usual standard of care; Neuropsychological Consultation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive treatment and diabetes management as usual standard of care from their diabetes care team. They will also complete as part of the study visit: a pediatric quality of life scale(PedsQL,GenericScale and Diabetes Module) and diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study.; Children and parents in Group 2 will also complete a pediatric quality of life scale (PedsQL,Generic Scale and Diabetes Module),diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study, as well as the self-report form of the BRIEF-2 if they are over age 11. Parents will also undergo a brief literacy and numeracy screening using the Wide Range Achievement Test, complete a parent report assessing their children's executive functioning skills at the start of the study (BRIEF-2) and they will fill out the Family Impact Module.
Other intervention name(s): Control Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Study to Investigate the Effect on QT/QTc Interval of Moxifloxacin After a Single Dose in Healthy Male Subjects
Condition: the Effect of Moxifloxacin on QT/QTc Interval
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate effect of moxifloxacin on QT/QTc interval in healthy
      male subjects. Moxifloxacin is a positive control drug used in QT study. In this study,
      moxifloxacin 400mg and 800mg will be used, to get information on effect of moxifloxacin on
      QT/QTc interval.
    

Detailed description: 
      The purpose of this study is to evaluate effect of moxifloxacin on QT/QTc interval in healthy
      male subjects. Moxifloxacin is a positive control drug used in QT study. In this study,
      moxifloxacin 400mg and 800mg will be used, (therapeutic and supratherapeutic doses) to get
      information on effect of moxifloxacin on QT/QTc interval in healthy Korean male subjects.
    

Intervention name(s): Moxifloxacin
Intervention type(s): Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: QT,; QTc,; electrocardiogram,; moxifloxacin
Effect of Preoperative Oral Carbohydrates on Quality of Recovery in Laparoscopic Colorectal Surgery Patients
Condition: Colorectal Disease
Study type: Interventional

Summary: 
      Preoperative midnight NPO is a traditional method for preventing aspiration during general
      anesthesia. However, recent studies reported that drinking carbohydrate beverage, three hours
      prior the surgery helps reducing patients starving, uncomfortment, and fatigue without other
      complication. QOR 40 is developed for evaluating patients' recovery condition regarding
      physical, psychological, and social aspects. Enhanced Recovery After Surgery(ERAS) is a
      concept for reducing patients' hospital stay and helping recovery. Studies showed that
      drinking carbohydrate beverage made better recovery of bowel function and shorter hospital
      stay in colorectal surgeries. However, the effect of carbohydrate drink for laparoscopic
      surgery is not yet proved. Therefore, the investigators will show the effect of carbohydrate
      drinking through this study.
    


Intervention name(s): carbohydrate beverage; NPO(None Per Oral)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Carbohydrate group drinks carbohydrate beverage 400ml(9PM~MN) the day before the surgery and 200ml three hours before the surgery.; NPO group does not drink any water from the MN before the surgery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: carbohydrate; quality of recovery(QOR) 40; enhanced recovery after surgery(ERAS)
Study to Compare the Safety and Pharmacokinetics of CKD-330 8/5mg With Coadministration of the Two Separate Drugs
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and pharmacokinetics of CKD-330
      (fixed-dose combination of Candesartan Cilexetil 8 mg and Amlodipine 5 mg) with
      coadministration of the two separate drugs in healthy male volunteers.
    


Intervention name(s): Candesartan 8mg; Amlodipine 5mg; CKD-330 8/5mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PO, 1day or 22day; PO, 1day or 22day; PO, 1day or 22day
Intervention MeSH terms: Amlodipine; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Healthy male volunteer; Candesartan, Amlodipine
Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions
Condition: Secondary Hyperparathyroidism; Hypocalcemia
MeSH terms: Hypocalcemia; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional

Summary: 
      The objective of this study was to assess the bioequivalence of Roxane Laboratories'
      Calcitriol capsules, 0.25 mcg, to ROCALTROL® capsules, 0.25 mcg (Roche) using a single-dose,
      2-treatment, 2-period, crossover design, under fasting conditions
    


Intervention name(s): Calcitriol
Intervention type(s): Drug
Intervention MeSH terms: Calcitriol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Experimental Word Learning in Children With and Without Language Impairment
Condition: Developmental Language Disorders
MeSH terms: Language Disorders; Language Development Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to compare the performances of normally developing children and
      children with Language Impairment (LI) in three different experimental settings designed to
      promote vocabulary acquisition. This comparison will also provide evidence to support
      different intervention approaches designed to increase vocabulary abilities, which has been
      proved to be one of the major deficits of young children with LI.
    


Intervention name(s): Word-learning; Word-learning
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exposure to five nonwords for three sessions of controlled interaction with the experimenter; Exposure to five nonwords for three sessions of controlled interaction with the experimenter
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child Language; Language Therapy; Vocabulary