bioihbjkbjnl/mcl2 huggingface dataset:
Imaging of Cannabinoid 1 Receptors Using [11C]OMAR and PET
Condition: Obesity; Alcohol Dependence; High Stress
MeSH terms: Alcoholism
Study type: Observational

Summary: 
      The aim of the present study is to conduct a human trial of [C-11]OMAR, a new PET imaging
      agent for the brain cannabinoid type 1 receptors (CB1), to determine its pharmacokinetics and
      binding characteristics.
    

Detailed description: 
      This is a pilot, 2-part study to assess the kinetics of radioactivity in medically healthy
      subjects, subjects with alcohol dependency (AD), and obese subjects following the intravenous
      administration of the imaging agent [C-11]OMAR.
    

Intervention name(s): [C-11]OMAR
Intervention type(s): Drug
Intervention description(s): PET radioligand
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        N = 30 Medically Healthy control subjects N = 30 Subjects with high stress exposure N = 30
        Subjects with Alcohol Dependence (AD) N = 30 Obese subjects
Effect of Sleep Restriction on Decision Making and Inflammation
Condition: Sleep Deprivation
MeSH terms: Sleep Deprivation; Inflammation
Study type: Interventional

Summary: 
      -  hypothesis: sleep restriction in healthy subject trigger alteration of decision making
           associated with immuno-inflammatory changes

        -  inclusion criterias: healthy subjects, men, under 35 years, BMI<26, no sleep troubles,
           intermediate chronotype

        -  design: 12 subjects, longitudinal study 2 days of baseline, 7 night of sleep restriction
           (4h sleep/night), recovery (1, 2, 3 and 9 normal sleep nights).

        -  parameters: decision making tests, reaction time, wakefulness test, biological
           parameters (cathecholamines, pro-inflammatory cytokines...), heart rate, blood pressure

        -  control of sleep restriction: continuous polysomnographic survey
    


Intervention name(s): Sleep restriction
Intervention type(s): Other
Intervention description(s): 4 hours sleep by night during one week
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: sleep restriction, decision making, wakefullness
Ear Drops for Children With Otitis Media
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a commercially available homeopathic ear drop
      preparation is effective in reducing symptoms in children 6 months - 11 years old with acute
      otitis media. A total of 120 study patients with otitis media will be randomized to receive
      homeopathic ear drops, or no ear drops, in addition to receiving standard care. It is
      postulated that children using the ear drops will have more rapid resolution of symptoms and
      need fewer antibiotics than those randomized to not receive the ear drops.
    


Intervention name(s): Hyland's earache drops
Intervention type(s): Drug
Intervention description(s): 3-4 drops in affected ear 3 times a day as needed for up to 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: otitis media; children
Granisetron Versus Ondansetron for Nausea and Vomiting in Pediatric Age Group
Condition: Nausea and Vomiting in Pediatric Age Group
MeSH terms: Nausea; Vomiting
Study type: Interventional

Summary: 
      The current clinical trial will include 160 children who will be presented with vomiting to
      the Outpatient Department of the Children's Hospital, Faculty of Medicine, Ain Shams
      University. Participants will be assigned randomly to receive either a dispersible film
      Ondansetron or oral Granisetron. After initial assessment, both groups will be followed up
      after 6 and 48 hours to check the frequency of vomiting, diarrhea, fever, headache as well as
      the return of appetite and the need for further treatment. The impact of nausea and vomiting
      on patients' daily lives will be assessed using a modified version of the Functional Living
      Index-Emesis (FLIE).
    


Intervention name(s): Ondansetron Oral Film; Granisetron Oral Liquid Product
Intervention type(s): Drug; Drug
Intervention description(s): 5-hydroxytryptamine (5-HT) receptor antagonist; 5-hydroxytryptamine (5-HT) receptor antagonist
Intervention MeSH terms: Ondansetron; Granisetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Levonorgestrel-intrauterine System (LNG-IUS) Versus Depot Medroxyprogesterone Acetate (DMPA) in Treatment of Pelvic Pain in Clinically Diagnosed Endometriotic Patients
Condition: Endometriosis
MeSH terms: Endometriosis; Pelvic Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      randomized controlled trial

      Eligiblility criteria Provisional diagnosis Clinical presentation Progressive dysmenorrhea
      Chronic pelvic pain Deep dyspareunia Evidences of endometriosis Endometriotic nodule
      Cul-de-sac nodularity Endometrioma detected by ultrasonography size < 4 cm

      Inclusion criteria Female age 18-45 yr Moderate to severe pelvic pain categorized by VAS >50
      Previous sexual intercourse

      Exclusion criteria Co-existing other genital tract disease associated pain Previous hormonal
      use within 3 months History of DMPA treatment failure WHO eligibility criteria 2009 for DMPA
      and LNG-IUS Category 3,4 Fertility desire in upcoming 1 year

      Primary objective To compare efficacy of pain control in endometriosis associated pelvic pain
      between LNG-IUS and DMPA

      Secondary objective To compare side effect, continuation rate, satisfaction and quality of
      life between LNG-IUS and DMPA in treatment of endometriosis associated pelvic pain

      Primary outcome Severity of pelvic pain Measured by VAS score 0 mean no pain 100 mean most
      pain

      Secondary outcomes Vaginal bleeding pattern Side effects of systemic progestogen Lipid
      profiles Weight gain Quality of life Measured by quesionaire SF36 Satisfaction Measrured by
      linket scale 0-4 0 mean very dissatisfied 1 dissatisfied 2 not satisfied and dissatiffied 3
      satisfied 4 very satisfied Continuation rate Endometrioma size reduction
    


Intervention name(s): LNG-IUS; DMPA
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Wheat Germ Supplementation Will Improve Markers of Gut Health, Inflammation, and Insulin Resistance in Overweight Adults
Condition: Overweight; Insulin Resistance; Inflammation
MeSH terms: Overweight; Insulin Resistance; Inflammation
Study type: Interventional

Summary: 
      The objective of this pilot study is to determine the effects of wheat germ (WG)
      supplementation on gut health and subsequent effects on markers of inflammation and insulin
      resistance in overweight individuals. WG is a by-product of wheat processing and an excellent
      source of omega-3 fatty acids, vitamin E, and fiber. A few studies have shown the health
      benefits of WG including gut modulatory potential, but the prebiotic functions of WG in
      humans remain in question and warrant further investigation.
    

Detailed description: 
      Healthy overweight (body mass index, BMI, between 25.0 - 30 kg/m2) between 18 to 45 years old
      regardless of gender will be recruited. They will be randomly assigned to receive two energy
      balls containing 30 grams of wheat germ or corn meal (control) in a 4-wk randomized
      controlled pilot trial. The energy balls will contain wheat germ or corn meal, peanut butter,
      honey and milk. Participants will be asked to consume two energy balls daily for 4 weeks.
      Anthropometric measures, questionnaires (medical, diet, physical activity and bowel habits),
      blood and fecal samples will be collected at baseline and at the end of the four week study.
      The investigator's primary outcome variables will be changes in fecal bacteria,
      immunoglobulin A, zonulin and short chain fatty acids while secondary outcome variables will
      be alterations in plasma markers of inflammation and insulin resistance.
    

Intervention name(s): Wheat germ energy ball; Control
Intervention type(s): Other; Other
Intervention description(s): wheat germ mixed other ingredients to make an energy ball; corresponding control without wheat germ
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: wheat germ; overweight; gut microbiome; inflammation; insulin resistance
Effectiveness of V-Go™ for Patients With Diabetes in a Real-world Setting
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The aim of the present study is to observe glycemic control, dose requirements, hypoglycemia
      risk, other possible adverse effects and weight changes, as well as to compare these
      parameters to prior treatment when patients with type 2 diabetes are initiated and treated
      using V-Go during circumstances as close to normal clinical practice as possible.
    


Intervention name(s): V-Go™
Intervention type(s): Device
Intervention description(s): Use of Insulin Delivery Device, V-Go, and the effect on A1C for T2DM patients in five categories of baseline oral antidiabetes drug (OAD) use with or without insulin.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Type 2 Diabetes Mellitus
      
Keywords: V Go™; Type 2 Diabetes; Insulin; Oral Anti Hypoglycemic Drugs
The Effect of Fecal Microbiota Transplantation in Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily
      for 50 days.
    

Detailed description: 
      7 patients with active Ulcerative Colitis are treated with 25 multi-donor FMT Capsules daily
      for 50 days All patients are followed with regular follow up after 2,4,8,12,16, 20 and 24
      weeks.
    

Intervention name(s): Fecal Microbiota Transplantation Capsules
Intervention type(s): Other
Intervention description(s): 25 daily multi-donor FMT Capsules for 50 days
Other intervention name(s): FMT Capsules
Intervention model: Single Group Assignment
Intervention model description: The trial is an open-label pilot study treating 7 patients with Ulcerative Colitis with 25 daily multi-donor FMT Capsules for 50 days with 6 months follow up including the treatment period
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fecal Microbiota Transplantation
Prebiotics and Mental Health: Behavioural
Condition: Emotion Regulation; Anxiety
Study type: Interventional

Summary: 
      A behavioural study of the microbiota-gut-brain axis in brain development and mental health
    

Detailed description: 
      Research suggests that modifying microbial ecology therapeutically via the intake of
      so-called 'psychobiotics' could help reduce stress responses and symptoms of anxiety and
      depression (Burnet & Cowen, 2013; Dinan, Stanton, & Cryan, 2013; Tang, Reddy, & Saier, 2014).
      The term psychobiotics refers to both, beneficial gut bacteria (probiotics), as well as
      prebiotics, which enhance the growth of beneficial gut bacteria (Sarkar et al., 2016). In a
      recent study, Schmidt and colleagues explored the effects of prebiotics on the secretion of
      the stress hormone cortisol and emotional processing in healthy volunteers (Schmidt et al.,
      2015). They found that cortical awakening response was significantly lower after
      BimunoÒ-galacto-oligosaccharides (Bimuno) intake over 4 weeks compared with placebo.
      Moreover, participants exhibited decreased attentional vigilance to negative information in a
      dot-probe task. Given that anxious people show increased biases towards negative information
      (Bar-Haim, Lamy, Pergamin, Bakermans-Kranenburg, & van, 2007), this suggests that prebiotic
      intake may be useful in modifying anxiety-related cognitive mechanisms.

      These findings will be extended to a sample of late adolescents in order to investigate how
      prebiotic intake for 4 weeks affects cognitive functioning, psychological well-being and gut
      microbiota a sample of 60 undergraduate students (aged 18-25 years).

      At time 1 (pre-assessment), participants in both groups will undergo comprehensive
      behavioural and psychological testing to establish baseline measures of cognitive functioning
      and psychological well-being (such as anxiety levels) and asked to collect a stool sample at
      home for 16s rRNA sequencing of the microbiome. Group 1 will then receive a daily dosage of a
      galactooligosaccharide (GOS) prebiotic over 4 weeks, whereas group 2 will receive a placebo
      over the same period. At time 2 (post-assessment), both groups will again undergo cognitive
      and psychological testing and stool sampling.

      Hypothesis: It is predicted that the treatment group (GOS) will show improvements in
      behavioural indices of emotion regulation (e.g. dot probe task) and in self reported
      psychological measures related to emotion regulation (e.g. anxiety) in comparison to the
      placebo group. Changes/differences in gut microbiome samples will be explored.
    

Intervention name(s): GOS; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Prebiotic; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Tumor: Breast Ratio Study
Condition: Breast Cancer; LCIS; DCIS
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This is an observational study of 3 arms: breast conservation therapy, mastectomy and
      reconstruction, and mastectomy only.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females ages 18 - 72 years of age scheduled to undergo breast conservation therapy (BCT),
        mastectomy or mastectomy with immediate reconstruction for ductal carcinoma in situ (DCIS),
        lobular carcinoma in situ (LCIS), and early stage breast cancer (Clinical Stages IA-IIB).
      
Keywords: Mastectomy; Breast Cancer; Reconstruction; Lumpectomy; Breast Conservation Therapy
Crossover Bioequivalence Study of Irbesartan HCTZ 300/25 mg Tablets Under Fasted Conditions
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Irbesartan and Hydrochlorothiazide 300 mg / 25 mg Tablets under fasted conditions.
    


Intervention name(s): Irbesartan and Hydrochlorothiazide; Avalide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide; Irbesartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Development and Evaluation of the DEA App
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional

Summary: 
      Background, current situation, and motivation

      According to current estimates, 100,000 people in Austria suffer from various types of
      dementia. According to forecasts, this number of people will rise to approximately 230,000 by
      2050 due to the demographic development and the increase of the prevalence rate. Data from
      the service statistics show that 85% of dementia patients still live in the community in
      their homes and informal caregivers, such as relatives, support them. In total, more than
      300,000 people care for their relatives in Austria in addition to professional support.
      However, not only the person affected from dementia suffers from the disease, but also, and
      often at a higher rate, the informal caregivers. Vice versa, the quality of life of those
      suffering from dementia is significantly influenced by the caregivers' competences and their
      strategies for resilience.

      Study aim and hypothesis

      The aim of this study is to evaluate the usability, acceptance, and effect of an app
      consisting of three modules that provide multidimensional support for informal caregivers of
      a person with dementia.
    


Intervention name(s): DEA-App; Standard Information group
Intervention type(s): Other; Other
Intervention description(s): The intervention (DEA) group will receive the newly developed app. DEA will consist of three simultaneous modules that provide multidimensional support for informal caregivers aiming to reduce the caregiver burden:
Information module
The information module consists of general information on the disease and the care of people suffering from dementia.
Activity module
The activity module suggests individualized activities and physical fitness exercises by a self-learning algorithm, which supports the caregiver to deliver more targeted and easier care.
Communication module
If two or more persons are caring for one person with dementia, the communication module provides a networking possibility.; The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: informal caregivers; person with dementia; e-health solution
The Use of Faster Acting Aspart in Type 1 Diabetes Patients
Condition: Type 1 Diabetes; Insulin; Time in Range
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Data on switching from traditional mealtime insulins to fast-acting insulin aspart (Fiasp) in
      routine clinical practice are sparse. The aim was to evaluate the efficacy and safety of
      switching from traditional mealtime insulin to Fiasp in a "real-world" clinical practice
      setting in people with type 1 diabetes in Belgium.
    

Detailed description: 
      The primary endpoint was the evolution of time in range (TIR, 70-180 mg/dl) at 6 and 12
      months. Secondary endpoints included change in HbA1c, BMI, insulin doses, time below range
      (T<70 and T<54 mg/dl) and time above range (T>180 and T>250 mg/dl).

      Retrospective analysis Two-center study
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Adult type 1 diabetes patients, with a duration of diabetes of > 2 years
      
Keywords: fast acting insulin; glucometrics
Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare the responsiveness of lower airways in adult patients
      with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment
      medication will be administered as follows: ciclesonide will be inhaled once daily at one
      dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study
      duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study
      will provide further data on safety and tolerability of ciclesonide.
    


Intervention name(s): Ciclesonide; Fluticasone
Intervention type(s): Drug; Drug
Intervention description(s): inhaled Ciclesonide 160 µg, once daily in the morning; inhaled Fluticasone 100 µg, twice daily
Intervention MeSH terms: Fluticasone; Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; AMP; Ciclesonide; Fluticasone propionate
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Homozygous Familial Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Homozygous Familial Hypercholesterolemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To evaluate the efficacy of alirocumab (75 or 150 milligrams [mg] depending on body weight
      [BW]), administered every 2 weeks (Q2W), on low-density lipoprotein cholesterol (LDL-C)
      levels at Week 12 of treatment in children and adolescents with homozygous familial
      hypercholesterolemia (hoFH) of 8 to 17 years of age on top of background treatments.

      Secondary Objectives:

        -  To evaluate the efficacy of alirocumab after 24 and 48 weeks of treatment on LDL-C
           levels.

        -  To evaluate the effects of alirocumab on other lipid parameters (eg, apolipoprotein B
           [Apo B], non-high density lipoprotein cholesterol [non-HDL-C], total cholesterol
           [Total-C], high density lipoprotein cholesterol [HDL-C], lipoprotein a [Lp (a)],
           triglycerides [TG], apolipoprotein A-1 [Apo A-1] levels) after 12, 24, and 48 weeks of
           treatment.

        -  To evaluate the safety and tolerability of alirocumab up to 48 weeks of treatment.
    

Detailed description: 
      The study duration was up to 62 weeks, which included (if needed) a run-in period of up to 4
      weeks, a screening period of up to 2 weeks, a treatment period of up to 48 weeks, and a
      follow-up of 8 weeks.
    

Intervention name(s): Alirocumab SAR236553 (REGN727); Atorvastatin; Simvastatin; Fluvastatin; Pravastatin; Lovastatin; Rosuvastatin; Ezetimibe; Cholestyramine; Nicotinic acid; Fenofibrate; Omega-3 fatty acids
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution for injection in pre-filled syringe,
Route of administration: subcutaneous (SC); Pharmaceutical form: tablet,
Route of administration: oral; Pharmaceutical form: tablet,
Route of administration: oral; Pharmaceutical form: capsule,
Route of administration: oral; Pharmaceutical form: tablet,
Route of administration: oral; Pharmaceutical form: tablet,
Route of administration: oral; Pharmaceutical form: tablet,
Route of administration: oral; Pharmaceutical form: tablet,
Route of administration: oral; Pharmaceutical form: oral suspension,
Route of administration: oral; Pharmaceutical form: tablet,
Route of administration: oral; Pharmaceutical form: tablet,
Route of administration: oral; Pharmaceutical form: capsule,
Route of administration: oral
Intervention MeSH terms: Nicotinic Acids; Niacin; Niacinamide; Atorvastatin; Rosuvastatin Calcium; Simvastatin; Ezetimibe; Pravastatin; Alirocumab; Lovastatin; Cholestyramine Resin; Fenofibrate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatrics, Homozygous Familial Hypercholesterolemia, Alirocumab, PCSK9 inhibitor, Low-density Lipoprotein Cholesterol (LDL-C)