bioihbjkbjnl/mcl2 huggingface dataset:
Carbetocin Versus Syntometrine for the Third Stage of Labour
Condition: Postpartum Haemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Intramuscular carbetocin is as effective as intramuscular syntometrine for the prevention of
      postpartum haemorrhage
    

Detailed description: 
      Postpartum haemorrhage(PPH)or excessive bleeding at or after childbirth is a potentially life
      threatening complication and is one of the major contributors to maternal mortality and
      morbidity worldwide (Lewis 2001).Among the various agents that have been studied in addition
      to the routine oxytocin and syntometrine (which has adverse effects),oxytocin agonist
      (carbetocin) appears to be the most promising for this indication(Chong 2004).

      Carbetocin is a licensed medication for the use of prevention of postpartum haemorrhage in
      Singapore and many other countries. It is a long-acting synthetic octapeptide analogue of
      oxytocin with agonist properties.The clinical and pharmacological properties of carbetocin
      are similar to those of naturally occurring oxytocin. Like oxytocin, carbetocin binds to
      oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic
      contractions of the uterus, increased frequency of existing contractions, and increased
      uterine tone. In pharmacokinetic studies, intravenous injections of carbetocin produced
      tetanic uterine contractions within two minutes, lasting six minutes, followed by rhythmic
      contractions for a further hour.Intramuscular injection produced tetanic contractions in less
      than two minutes, lasting about 11 minutes, and followed by rhythmic contractions for an
      additional two hours. The prolonged duration of activity after intramuscular compared with
      the intravenous carbetocin was significant(Hunter 1992). In comparison to oxytocin,
      carbetocin induces a prolonged uterine response when administered postpartum, in terms of
      both amplitude and frequency of contractions.

      The potential advantage of intramuscular carbetocin over intramuscular oxytocin is its longer
      duration of action. Its relative lack of gastrointestinal and cardiovascular side-effects
      should also prove advantageous compared to syntometrine and other ergot alkaloids.
    

Intervention name(s): Syntommetrine and Carbetocin; Syntommetrine and Carbetocin
Intervention type(s): Drug; Drug
Intervention description(s): Syntommetrine 1ml and Carbetocin 100microgram; Syntommetrine 1ml and Carbetocin 100micgrams
Intervention MeSH terms: Carbetocin; Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Diets With a Spectrum of Fat Intake for Preventing Obesity: A Randomized Controlled-feeding Trial
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the current study is to evaluate the effects of diets with three levels of dietary
      fat on weight change and related cardiometabolic risk factors in a 6-month randomized
      controlled-feeding trial.
    


Intervention name(s): low-fat diet; moderate-fat diet; high-fat diet
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Energy from total fat, protein and carbohydrates are 20%, 14% and 66%, respectively; Energy from total fat, protein and carbohydrates are 30%, 14% and 56%, respectively; Energy from total fat, protein and carbohydrates are 40%, 14% and 46%, respectively
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: weight change; diet; dietary fat; feeding design
Immune Non-Inferiority, Safety and Lot-to-Lot Consistency of Oral Cholera Vaccine-Simplified Compared to Shanchol™
Condition: Cholera
MeSH terms: Cholera
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to evaluate immune non-inferiority, safety and lot-to-lot consistency of OCV-S
      compared to Shanchol™ in 1 to 40 years old healthy Nepalese participants. The investigators
      hypothesize that the simplified formulation is able to induce non-inferior immunogenicity
      compared to licensed OCV, Shanchol™.
    


Intervention name(s): Oral Cholera Vaccine Simplified (OCV-S); Shanchol™
Intervention type(s): Biological; Biological
Intervention description(s): Manufacturer: EuBiologics Co., Ltd.
Oral administration; Manufacturer: Shantha Biotechnics
Oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of Lasmiditan on the Heart in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to determine how two doses of lasmiditan affected the heart in
      healthy participants. The study also evaluated how much lasmiditan got into the blood stream
      and how long it took the body to get rid of it. Information about side effects was collected.
      The study lasted a maximum of 46 days for each participant, not including screening.
    


Intervention name(s): Lasmiditan; Lasmiditan; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mg administered orally (PO); 400 mg administered PO; Placebo administered for lasmiditan or moxifloxacin; 400 mg moxifloxacin administered PO
Other intervention name(s): LY573144; LY573144
Intervention MeSH terms: Moxifloxacin; Lasmiditan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Comparison of Beta-cryptoxanthin Bioavailability From Biofortified Maize in Humans
Condition: β-cryptoxanthin Bioavailability From Biofortified Maize in Humans
Study type: Interventional

Summary: 
      The purpose of this study is to determine how well the body absorbs the carotenoid
      beta-cryptoxanthin (BCX) from a type of corn that has been naturally bred (not genetically
      engineered) to contain higher amounts of BCX than traditional breeds of corn. Because this
      new type of corn contains higher amounts of BCX, it appears more orange in color than
      traditional types of corn. Understanding how well the body can absorb the BCX from the corn
      may help companies develop food products that may have improved nutritional quality.
    

Detailed description: 
      Randomized, blinded, 3 x 3 crossover intervention. Each treatment will last 12 d, followed by
      a 7-d wash-out period. After the washout, subjects will go back to their regular diet for two
      weeks before beginning the next cycle. Subjects will report to the research kitchen in the
      Nutritional Sciences building for their breakfast. Maize will be incorporated into two
      muffins. Other food choices will be yogurt and other low-fiber foods. Blood samples will be
      taken at baseline and days 3, 6, 9, 12, 15, and 19. Natural abundance measurements of
      13-carbone to 12-carbon will be taken at baseline, day 12 and day 19. Retinol isotope
      dilution testing will be done at the end of the study to determine total body stores of
      vitamin A in the subjects. This will include the day 19 blood sample of intervention phase 3
      and a final blood sample 14 days after the isotope dose administration.
    

Intervention name(s): Whole grain high-BCX maize; Refined grain high-BCX maize; Whole grain white maize
Intervention type(s): Other; Other; Other
Intervention description(s): The whole grain orange maize will be milled and prepared into muffins to be consumed daily. Muffins will contain a target of 500 µg beta-cryptoxanthin per day.; The refined grain orange maize will be degermed, milled, and prepared into muffins to be consumed daily. Muffins will contain a target of 500 µg beta-cryptoxanthin per day.; The whole grain white maize will be milled and prepared into muffins to be consumed daily. Muffins will contain minimal beta-cryptoxanthin, matched for dry maize weight.
Other intervention name(s): Whole grain high-beta-cryptoxanthin maize; Whole grain orange maize; Refined grain high-beta-cryptoxanthin maize; Refined grain orange maize; Whole grain low-beta-cryptoxanthin maize
Intervention MeSH terms: Beta-Cryptoxanthin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Diet and Learning Abilities in Norwegian Youths
Condition: Cognitive Performance; Health Behavior; Nutrient Status
Study type: Interventional

Summary: 
      The aim of this study is to assess the effects of giving a schoolmeal with fatty fish, a
      schoolmeal without fish or omega-3 capsules on Noregian adolescents cognitive performance
      (concentration and learning abilities), mental health statua and markers of nutritional
      status. In addition, to disentangle the effect of fatty fish eaten as food and the effects of
      omega-3 fatty acids taken as a supplement.
    

Detailed description: 
      There has been an increased attention to the role of nutrition for learning abilities among
      schoolchildren. As the diet provides humans with energy and several essential nutrients, a
      balanced supply of all nutrients promotes not only physical growth and health, but also
      cognitive development, helping children to learn from infancy throughout adolescence and
      beyond. In a three-armed non-blinded intervention trial the investigators will test whether
      ingestion of a schoolmeal or omega-3 capsules will improve cognitive function among pupils in
      9th grade at eight lower secondary school. The pupils will be randomised into three groups,
      one group will be served lunch with fatty fish, one group will be served similar lunch with
      meat/cheese (without fish) and one group will recieve omega-3 capsules three times week over
      a period of 12 weeks. At the beginning and at the end of the study, pupils should conduct
      cognitive tests, and blood-, urine- and hair samples will be taken. The pupils should also
      answer a questionnaire on their diet, physical activity, sleep pattern and mental health.
    

Intervention name(s): Schoolmeal with fatty fish; Schoolmeal without fish; Supplement
Intervention type(s): Other; Other; Dietary Supplement
Intervention description(s): Schoolmeal with fatty fish three times a week for 12 weeks; Schoolmeal with meat/cheese three times a week for 12 weeks; Omega-3 capsules three times a week for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Diet; concentration; seafood; youths; Norway; Nutrient status in blood; Inflammatory markers
Cost- Effectiveness and Quality of Life Assessment in Mood Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder; Mood Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effectiveness of three systematic interventions for Bipolar Disorder (BD)
      mixed episodes using medications available in the Brazilian Public Healthcare System (SUS),
      and assessment of the quality of life of these patients.

      A randomized pragmatic trial was conducted. An algorithm was developed for the treatment of
      episodes of bipolar mixed episodes.
    

Detailed description: 
      The study design was that of a pragmatic randomized clinical trial to evaluate the
      effectiveness of treatments for mood disorders in a public healthcare context in the city of
      Porto Alegre, in southern Brazil. The algorithm was originally developed for the treatment of
      mixed episodes by a Delphi panel of experts from psychiatric associations in Brazil. All
      subjects provided an informed consent form, in writing, in order to participate in the study
      protocol, which was approved by the institutional ethics committee.

      Procedures and measurements of the study

      The subjects under evaluation were selected and they followed the stages defined by the
      treatment protocol:

        1. Sample selection by being referred from the primary healthcare clinics in the
           municipality;

        2. Informative talk about mood disorders and the research, with the informed consent forms
           being provided to the subjects;

        3. Screening for BD mixed episodes with the use of the Patient Health Questionnaire
           (PHQ-9), and Hypomanic Symptoms Checklist Brazilian Version (HCL -32-BV);

        4. Diagnostic evaluation through the Mini International Neuropsychiatric Interview (MINI)
           and clinical interview for individuals with positive results in the screening
           instruments;

        5. Baseline and demographic assessments using standardized semi-structured interviews in
           the first and second visits;

        6. In each clinic visit, the severity of the symptoms were evealuated using the Clinical
           Global Impression Scale (CGI), Hamilton Rating Scale for Depression (HRSD), and Young
           Manic Rating Scale (YMRS);

        7. Biweekly follow-up, changed to monthly after stabilization - with a maximum follow-up
           period of 52 weeks.
    

Intervention name(s): Lithium; Valproic Acid; Carbamazepine
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): carbolitium; depakene; tegretol
Intervention MeSH terms: Carbamazepine; Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cost effectiveness; Bipolar disorder; Mixed episodes; Quality of life
Evaluate Bioequivalence of Palonosetron (0.25mg/5mL)
Condition: Chemotherapy-induced Nausea and Vomiting, Prophylaxis
MeSH terms: Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two
      formulations of palonosetron after intravenous administration of palonosetron in healthy
      volunteers under fasting conditions.
    


Intervention name(s): Palonosetron
Intervention type(s): Drug
Intervention description(s): Pharmacokinetic study under fasting conditions
Other intervention name(s): Stothu®
Intervention MeSH terms: Palonosetron
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: An open-label, randomized, balanced, two-treatment, two-period, twosequence, single dose, two-way crossover study
Masking: None (Open Label)
Primary purpose: Other
Delinieation of GIP's Effects During a Meal in Humans Using GIP Receptor Antagonisation (GA-4)
Condition: Glucose Metabolism Disorders
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.
    

Detailed description: 
      Aim: To evaluate the role of GIPR signalling in postprandial physiology, including lipid,
      bone and glucose homeostasis, using a naturally occurring GIP fragment, which antagonises the
      GIPR.

      Twelve healthy men (age 18-70 years, BMI 19-27 kg/m2) with normal kidney and liver parameters
      and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in
      a randomised, double-blinded, placebo-controlled cross-over study. Study consists of four
      study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist
      Exendin[9-39], C) GIP-A + Exendin[9-39], or D) saline (placebo).
    

Intervention name(s): GIP-A; Placebo; GLP-1 receptor antagonist Exendin[9-39]; GIP-A + Exendin[9-39]
Intervention type(s): Other; Other; Other; Other
Intervention description(s): GIP-A; Placebo; Exendin[9-39]; GIP-A + Exendin[9-39]
Other intervention name(s): Ex(9-39)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: GIP; GIP receptor antagonist
Diffuse Large B Cell Lymphoma of the Adult: Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14-Rituximab
Condition: Lymphoma, Large-Cell, Diffuse
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional

Summary: 
      The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III
      or IV with 1 to 3 adverse prognostic factors according to the International prognostic index.
      Patients with eligibility criteria and who gave informed consent will be randomised between
      CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous
      stem cell support. The aim of the study is to compare the Event free survival between the two
      arms and to gain insight into the prognostic significance of several biological markers
      gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA
      profile and BCL é expression).
    

Detailed description: 
      Diffuse Large B Cell Lymphoma not previously treated
    

Intervention name(s): CHOP+RITUXIMAB; CEEP-RITUXIMAB
Intervention type(s): Drug; Drug
Intervention description(s): CHOP-14- Rituximab x 8 courses; High dose chemotherapy with rituximab including autologous stem cell support.
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diffuse Large B Cell Lymphoma; not previously treated
A Bioequivalence Study of Idiazole 20mg DR Tabs and PARIET® 20 mg DR Tabs After a Single Oral Dose Administration Under Fasting Conditions in Healthy Adults
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, randomized, single dose, two-sequence, two-period crossover study,
      separated by 7 days washout interval from the first study drug administration.

      In this study, the bioavailability of Rabeprazole from Idiazole 20 milligram (mg) delayed
      release (DR) tablets and PARIET 20 mg DR tablets after a single oral dose administration of
      each to healthy adults under fasting conditions, will be investigated by determining the 90%
      confidence limits for the log-transformed ratio (Test product / Reference product) for the
      bioequivalence parameters. The influence of sequence, product and period effect will be
      tested by analysis of variance (ANOVA).

      In this study a total of 60 subjects plus 1-4 additional subjects will be enrolled and split
      into two groups (Group A and B) of 30 each. For each subject, a total of 33 blood draws will
      be done and the volume of blood will not exceed 300 milliliters (mL) for the study.

      PARIET is a registered trademark of EISAI Co. Limited.
    


Intervention name(s): Idiazole 20mg DR tabs; PARIET 20 mg DR tabs
Intervention type(s): Drug; Drug
Intervention description(s): Delayed release tablets containing 20 mg of rabeprazole; Orally administered, delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Idiazole 20mg; PARIET 20 mg; Rabeprazole; bioequivalence
Determining the Optimal Dose of AD-209 in Patients With Essential Hypertension
Condition: Hypertension,Essential
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the optimal dose of AD-209 in patients with
      Essential Hypertension.
    

Detailed description: 
      Condition or disease : hypertension Intervention/treatment Drug : AD-209-H Drug : AD-209-M
      Drug : AD-209-L Drug : Placebo Drug : Amlodipine Drug : Telmisartan Phase : Phase 2
    

Intervention name(s): AD209; Amlodipine low; Amlodipine high; Telmisartan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PO, Once daily(QD), 8weeks; PO, Once daily(QD), 8weeks; PO, Once daily(QD), 8weeks; PO, Once daily(QD), 8weeks
Other intervention name(s): AD209 Placebo; Amlodipine low placebo; Amlodipine high placebo; Telmisartan placebo
Intervention MeSH terms: Amlodipine; Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lung Pharmacokinetics (PK) in Epithelial Lining Fluid (ELF)
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of the present study is to increase the general understanding of lung PK of selected
      compounds by sampling epithelial lining fluid ELF and lung tissue.
    

Detailed description: 
      This study will investigate drug levels of selected compounds at multiple sites in the lung
      and explore different innovative sampling methods to obtain information on lung PK. The aim
      of the study is not to generate safety or efficacy data of the selected licensed drugs. The
      choice of drugs is based on general considerations regarding therapy of airway diseases and
      the physical-chemical properties of the compounds. It is not driven by the compounds per se.
    

Intervention name(s): Inhalation; Systemic; Bronchoscopy
Intervention type(s): Drug; Drug; Other
Intervention description(s): Salbutamol(200µg), Salmeterol (50µg) and Fluticasone propionate (500µg) by inhalation; Salbutamol 8mg M/R Tablet, Propranolol 40 mg administered orally; Bronchoadsorption sample, bronchial brushing, mucosal biopsy, and BAL samples during bronchoscopy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Lymph Node Ratio and Kras Mutation in R Colon Cancer
Condition: Colon Cancer Stage III
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      clinical impact of LN ratio with Kras expression in colon cancer
    

Detailed description: 
      LNR and K ras were evaluated with correlated with different clinicopathological parameters of
      the patients, PFS and OS.
    

Intervention name(s): k ras; Panitumumab
Intervention type(s): Device; Drug
Intervention description(s): K ras; vectibex in stage iv
Other intervention name(s): vectibex
Intervention MeSH terms: Panitumumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Case Studies: Promoting Strategy Use in Functional Activities
Condition: Cognitive Impairment; Executive Dysfunction; Acquired Brain Injury
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      The purpose of the study is to provide evidence of feasibility, acceptability, patient
      satisfaction, and patient perceived benefit of the Multicontext (MC) approach. The project
      consists of eight case studies of persons with acquired brain injury undergoing acute
      inpatient rehabilitation who have difficulties in completing multiple step activities due to
      deficits in executive function and/or visual perception. The MC approach provides a
      structured occupational therapy framework that provides guidelines for enhancing strategy use
      and self monitoring skills for person's with acquired brain injury.
    


Intervention name(s): Multicontext (MC) approach
Intervention type(s): Other
Intervention description(s): The Multicontext approach is a metacognitive intervention designed to improve awareness, strategy use, and executive functioning.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment