bioihbjkbjnl/mcl2 huggingface dataset:
DIabetes REsearCh on Patient sTratification (DIRECT): GLP-1R Agonists
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to collect a cohort of patients treated with GLP-1R Agonists and
      to assess phenotypic, genetic and genomic biomarkers of glycaemic response to these agents.
    

Detailed description: 
      To develop a cohort of patients treated with GLP-1 R Agonists who are phenotyped at baseline
      and at 6 month follow up to determine clinical, imaging and other biomarker predictors of
      glycaemic response to GLP-1R Agonists. The hypothesis is that one, or a combination, of these
      biomarkers is associated with glycaemic response to GLP-1R Agonists. The primary outcome is
      therefore HbA1c reduction after 6 months of GLP-1R A treatment.

      This is a cohort study of 800 patients being treated with either exenatide or liraglutide for
      6 months, and carried out in 4 UK centres.
    

Intervention name(s): Exenatide, Liraglutide
Intervention type(s): Drug
Intervention description(s): Dosage, frequency and duration not specified by protocol
Other intervention name(s): Byetta; Victoza
Intervention MeSH terms: Liraglutide; Exenatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: GLP-1R agonist; biomarker
The Role of Antibiotics After Surgical Treatment of Simple Hand Infections: A Prospective Study
Condition: Hand Infections
MeSH terms: Infections
Study type: Observational

Summary: 
      Three patient groups with simple hand infections are tested regarding the necessity of
      antibiotics after surgical treatment.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Other intervention name(s): Since our study was observational after the beginning of treatment with or without antibiotics no intervention was influenced by the study.
Intervention MeSH terms: Anti-Bacterial Agents
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients with simple hand infections (no infection of the bone, tendon or joint)
Prevention of Nosocomial Bacteremia Among Zambian Neonates
Condition: Neonatal Sepsis; Neonatal Mortality
MeSH terms: Bacteremia; Neonatal Sepsis
Study type: Interventional

Summary: 
      The purpose of this study is to estimate the burden of disease, identify risk factors
      associated with nosocomial bacteremia among neonates and assess the efficacy of low-cost
      measures targeted to known and suspected nosocomial BSI (bloodstream) risk factors, the
      investigators propose to study the impact of a novel package of infection control
      interventions on nosocomial bacteremia and mortality among neonates at a tertiary care center
      in sub-Saharan Africa.
    

Detailed description: 
      The study is an18 month prospective quasi-experimental evaluation of nosocomial bacteremia
      and mortality among hospitalized neonates and will consist of a 6-month baseline period to
      capture the incidence and all-cause mortality of nosocomial BSIs, a 1-month implementation
      period of low-cost infection control strategies (including alcohol-based hand rub [AHR], 2%
      chlorhexidine gluconate [CHG], hospital staff education and text message-based reminders of
      infection control recommendation) and an 11-month intervention period.

      All neonates admitted to the neonatal intensive care unit (NICU) of the University Teaching
      Hospital (UTH) in Lusaka, Zambia during the study period will be eligible for study
      enrollment. This study will determine the capacity of an innovative bundle of low cost,
      simple and locally available interventions that leverage new technologies and expand
      application of highly effective interventions in order to reduce the incidence of nosocomial
      bacteremia among NICU patients in a developing country setting.
    

Intervention name(s): Chlorhexidine gluconate (CHG); Hand hygiene (HH); Infection control training; Infection control reminders via SMS text
Intervention type(s): Drug; Behavioral; Behavioral; Other
Intervention description(s): All enrolled neonates admitted to the NICU during the implementation and intervention periods will undergo CHG bathing (sparing head and face) at the time of admission at and thereafter once weekly.; Alcohol hand rub will be produced in the hospital pharmacy and will be readily available in the NICU (via wall-mounted dispensers) throughout the intervention period. Hand hygiene among NICU physicians and nurses will actively be promoted through the intervention period.; All NICU healthcare workers will receive infection prevention training which will involve structure training on HH, universal precautions, neonatal skin antisepsis and peripheral IV placement and line care.; Infection control practice reminders will be sent to NICU healthcare workers on a daily basis via SMS messages.
Other intervention name(s): 2% chlohexidine gluconate body wash
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
BE@Work: Brief Exercise at Work
Condition: High-intensity Interval Training
Study type: Interventional

Summary: 
      BE@Work (Brief Exercise at Work) is a pilot controlled before and after trial of a workplace
      physical activity programme.
    

Detailed description: 
      The aim of this study is to investigate the effect of an 8 week workplace physical activity
      programme on various markers of physical fitness, cardiometabolic health and wellbeing of
      employees. The primary outcome measures are the following: aerobic fitness, grip strength,
      leg extensor power, blood pressure, fasting blood glucose levels, lipid profiles, body mass
      index, waist and hip circumference and self-report measures of psychological wellbeing. The
      secondary outcome measure is total physical activity. The primary and secondary outcomes
      measures will be assessed in the control and intervention groups at baseline and at the end
      of the intervention (8 weeks).
    

Intervention name(s): High-intensity interval training
Intervention type(s): Behavioral
Intervention description(s): • Exercises will be conducted in an interval training format (60 second exercise bursts, followed by 75 seconds rest). The exercise bursts are designed to elicit ≥85% of participants age predicted maximum heart rate and will be tailored to each individuals fitness level and ability. Exercise sessions will be conducted 3 times per week for 8 weeks and will last between 15-25 minutes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Hypersensitivity Reactions During Anesthesia
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Observational

Summary: 
      Researchers are trying to study the natural history of allergic reactions during anesthesia
      and its causes and risk factors.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults undergoing surgery at Mayo Clinic Florida
Acceptance Of A Partially-Hydrolyzed Infant Formula
Condition: Stool
Study type: Interventional

Summary: 
      This clinical trial will evaluate stool consistency in infants receiving one of two study
      formulas through a 14-day feeding period.
    


Intervention name(s): Control; Investigational
Intervention type(s): Other; Other
Intervention description(s): Routine cow's milk-based infant formula; Partially-hydrolyzed cow's milk protein infant formula
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH)
Condition: Vascular Disease
MeSH terms: Pulmonary Arterial Hypertension; Hypertension; Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This open label, single-arm, non-controlled, multicentre study will determine the effect of
      ambrisentan on exercise capacity (6MWT) in Chinese subjects with PAH. The study consists of a
      screening period of 4 weeks, a 12-week primary evaluation period (PEP) and a 12-week
      dose-adjustment period (DAP). Ambrisentan 5 mg will be administered to eligible subjects for
      12 weeks (PEP).
    

Detailed description: 
      Pulmonary arterial hypertension (PAH) consists of a group of progressive and incurable
      diseases of the pulmonary vasculature. These are characterised by profound vasoconstriction
      and abnormal proliferation of smooth muscle cells in the walls of the pulmonary arteries,
      which leads to a progressive increase in pulmonary vascular resistance (PVR) and sustained
      elevations in pulmonary artery pressure (PAP). A variety of drug classes have been used to
      treat PAH but no single compound has yet been shown to be effective in treating all patients
      with the disease. Three widely used treatment options are calcium channel blockers (CCBs),
      diuretics and anticoagulants but all have varying responses.There is a lack of clinical data
      on ambrisentan among the Chinese population,Ambrisentan is conditionally approved for the
      treatment of PAH in China.A clinical trial with a minimum of 100 patients in the ambrisentan
      arm was requested by SFDA.Several PAH medications have been approved in China, so a
      placebo-controlled study is not ethically appropriate while an active control non-inferiority
      design is unfeasible due to sample size requirements and inconsistency in indications.
    

Intervention name(s): ambrisentan
Intervention type(s): Drug
Intervention description(s): Ambrisentan 5 mg will be administered to eligible subjects for 12 weeks
Intervention MeSH terms: Ambrisentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Oral Bisphosphonate for Osteopenic Women Treated With Adjuvant Aromatase Inhibitors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      A single--blind, randomized, placebo--controlled phase II study to evaluate the impact of
      oral bisphosphonate treatment on bone mineral density in osteopenic women receiving aromatase
      inhibitors as adjuvant treatment.
    

Detailed description: 
      Aromatase inhibitors (AIs) are the adjuvant treatment of choice in postmenopausal women with
      early, hormone receptor-positive breast cancer (BC), because they produce improved survival
      rates compared with tamoxifen. Progressive bone loss and subsequent fractures are associated
      with adjuvant AIs, administered either alone or sequentially after tamoxifen in
      postmenopausal women with early BC. Recent findings of National Surgical Adjuvant Breast and
      Bowel Project (NSABP) B-34 also suggest that bisphosphonates might have anticancer benefits
      for older postmenopausal women. "BONADIUV" trial is a single-blind, randomized,
      placebo-controlled study designed to evaluate the impact of bisphosphonate treatment on bone
      mineral density (BMD) in women taking AIs.

      Patients undergo a baseline BMD and if they result osteopenic (lumbar spine and/or trochanter
      -1< T-score <2.5), they are randomized in a 1:1 ratio to receive either placebo or oral
      ibandronate. All patients receive oral supplementation of calcium and Vitamin D3, once daily
      for two years. Study duration is 2 year, with planned six-months evaluation.

      A total of 72 patients per arm of treatment are needed to obtain a 85% statistical power in
      order to detect a 2% BMD mean difference between the two arms. Considering a 15% dropout,
      around 82 patients per arm are planned to be enrolled.
    

Intervention name(s): Ibandronic acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg per month oral ibandronate; 1 oral capsule of placebo per month
Other intervention name(s): Ibandronate; Placebo capsule
Intervention MeSH terms: Ibandronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: aromatase inhibitors; breast cancer; bone mineral density
Efficacy and Safety of Fermented Velvet Antler Extract on Fatigue Recovery After Exercise
Condition: Chronic Fatigue Syndrome
MeSH terms: Fatigue Syndrome, Chronic; Fatigue
Study type: Interventional

Summary: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Fermented Velvet Antler extract on fatigue
      recovery after exercise. The investigators measured fatigue recovery parameters , including
      lactate, ammonia, inorganic phosphorus, creatine kinase and LDH, and monitored their blood
      pressure.
    


Intervention name(s): Fermented Velvet Antler extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fermented Velvet Antler extract (1g/day); Placebo (1g/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study of Hierarchy of Afferents in Postural Control of Children With Dyslexia
Condition: Dyslexia
MeSH terms: Dyslexia
Study type: Interventional

Summary: 
      The purpose is to determine the hierarchy of sensory afferents according to different forms
      of dyslexia in children.

      The secondary purpose is to determine sensitive and sufficiently specific posturographic
      indexes for standard diagnosis of different types of dyslexia.
    

Detailed description: 
      This study evaluates the postural control and the importance of proprioception, evaluated by
      static and dynamic posturography, in dyslexic children compared to age-matched control group.
      Posturographic data and a questionnaire for motion sickness disorder are used as
      proprioceptive disorder index. This study aims to better characterize the dyslexic population
      with techniques targeting central integration of sensory proprioceptive afferents. The
      purpose of this study is not to search for a postural deficiency syndrome, but to study
      proprioception with posturography, with quantitative and normalized data of analyzed
      population. Moreover, these data could allow an objective evaluation of reeducation with
      quantifiable and reproducible parameters in order to judge its effectiveness. The
      demonstration of the existence of a relationship between proprioceptive disorders and
      dyslexia will imply a specific reeducation care of patients. A study using validated and
      standard indexes is necessary. The presence of postural disorders and a major susceptibility
      to motion sickness could contribute to distinguish different forms of dyslexia and thus be
      complementary to actual medical, orthophonic and neuropsychological criteria. In this
      evaluation, it is important to distinguish between visuo-attentional dyslexia from
      phonological dyslexia involving distinct anatomo-functional neuronal circuits.
    

Intervention name(s): Posturographic tests; Questionnaire of motion sickness susceptibility
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study of Ustekinumab Treatment in Children With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effectiveness of ustekinumab in achieving
      clinical remission in pediatric participants (greater than or equal to [>=] 2 to less than
      [<] 18 years and weight >= 40 kilograms [kg] at baseline).
    


Intervention name(s): Ustekinumab
Intervention type(s): Drug
Intervention description(s): No interventions will be administered as a part of this study. Participants will receive ustekinumab as per their routine clinical practice.
Intervention MeSH terms: Ustekinumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes pediatric participants (age greater than or equal to [>=] 2
        to less than [<] 18 years with body weight >=40 kilograms [kg]) and young adults (age >= 18
        to < 26 years) with moderately to severely active Crohn's disease. The primary study
        population will be pediatric participants who have moderate to severe disease activity
        defined as short pediatric Crohn's disease activity index (sPCDAI) >= 30, are treated with
        ustekinumab, and are followed at an ImproveCareNow (ICN) center.
Study Of The Efficacy And Safety Of Pregabalin Compared To Placebo For Treatment Of Post-Surgical Pain From Hysterectomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy of pregabalin compared to placebo on pain following hysterectomy ,
      measured using subject reported assessments of pain.
    


Intervention name(s): pregabalin (Lyrica); pregabalin (Lyrica); matched placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 150 mg/day double blind (divided doses); 300 mg/day double blind (divided doses); matched placebo
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pain after hysterectomy; amount of opioids used
Study Of Two Dosing Regimens Of PF-04937319 Compared To An Approved Agent (Sitagliptin) In Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Study B1621019 will assess efficacy and safety of two different dosing regimens of an
      investigational agent (PF-04937319) compared to an approved drug (sitagliptin) in patients
      with type 2 diabetes
    


Intervention name(s): PF-04937319 once-daily; PF-04937319 split-dose; Sitagliptin once-daily
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, 300 mg once-daily with breakfast, 14-days; tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days; tablets, 100 mg once-daily with breakfast, 14-days
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1b; type 2 diabetes; metformin background; PF-04937319
Potential Benefits of Black Seed Oil Supplementation on Asthma Inflammation and Outcomes
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      Traditionally, Black Seed (Nigella sativa) is a well-known food supplement and herbal product
      that has a wide range of medical claims (including asthma) that originate from different
      historical backgrounds. Today in the era of Evidence-based medicine, it is hard to accept
      those traditional medical claims of medicinal plants without valid scientific experiments.
      Thus, randomized clinical trials is important to rational the uses of herbal products.

      Asthma is a common chronic disorder of the airways, characterized by variable reversible and
      recurring symptoms related to airflow obstruction, bronchial hyper-responsiveness, and
      underlying inflammation. In Saudi Arabia, Asthma is considered one of the leading chronic
      diseases affecting more than 2 million Saudi citizens. The global Asthma Report 2014
      considered Asthma as an epidemic disease probably affecting about 334 million people
      worldwide and becoming a global health priority.

      This project investigates the use of herbal products to enhance asthma control in Saudi
      Arabia. In this context, Black Seed is one of the common herbal products used traditionally
      for asthma in the Saudi region. Black seed is a common unconventional therapy used among 10%
      of Asthmatic patients in King Abdulaziz Medical city, Riyadh. In fact, there are some
      pre-clinical evidence and preliminary clinical studies support the usefulness of Black seed
      in Asthma and its underlying causes
    


Intervention name(s): Black seed oil; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): vegetable oil
Other intervention name(s): Nigella sativa oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: asthma; black seed; Nigella sativa; supplementation
Comparison of Vascular Effects After Therapy With Irbesartan and Atorvastatin.
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      Vascular responses to angiotensin II and histamine are compared before and after 30 days of
      systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.
    

Detailed description: 
      Vascular responses to angiotensin II and histamine are compared before and after 30 days of
      systemic treatment with either irbesartan 150 mg or atorvastatin 20 mg.
    

Intervention name(s): atorvastatin; irbesartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Irbesartan; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: venoconstriction; venodilation; pleiotropic effects
Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia; Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Evaluation of the efficacy of postpartum 24 hour oxytocin infusion to reduce blood loss in
      patients with pre-eclampsia (PE)
    

Detailed description: 
      The overall goal of this study is to evaluate the efficacy of postpartum 24 hour oxytocin
      infusion as a prevention-oriented strategy to reduce blood loss in patients with
      pre-eclampsia (PE) in a blinded, placebo controlled, randomized controlled trial.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Our intervention simply replaces the standardly given normal saline with treatment (normal saline + oxytocin); This intervention utilizes a Placebo Camparator
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment