bioihbjkbjnl/mcl2 huggingface dataset:
Postprandial Lipids in IBS and Nutritional Treatment
Condition: IBS - Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      Irritable Bowel Syndrome (IBS) is a disease that affects a large number of people. Adequate
      treatment is difficult, partially due to the heterogeneity of the patients and the
      complicated pathology in which not all mechanisms are understood. Based on literature and in
      vitro screening within the public private IBSQUtrition consortium project, a turmeric
      supplement was selected for in vivo validation of its potential beneficial effects on
      fat-induced intestinal barrier disruption as measured with LPS translocation in IBS patients
      with a diarrhea-predominant subtype (IBS-D).

      The primary objective of this study is to determine the effect of turmeric supplementation on
      LPS translocation in IBS-D patients after a high-fat challenge. The secondary objective of
      this study is to determine the effect of turmeric supplementation on gastrointestinal
      complaints and LPS-related biomarkers in IBS-D patients after a high-fat challenge.

      In this double-blind, randomized, placebo-controlled cross-over trial 20 adult (18-70 yrs)
      IBS-D patients will be included.

      Study participants have to invest about 16 hours of their time in this study. They will visit
      the research facility three times. The risks for participation are very small if not
      negligible. Consumption of high amounts of saturated fat may cause some gastro-intestinal
      discomfort. Blood sampling will be performed via a cannula and the insertion can be a bit
      painful and may cause a bruise. The amount of blood that is drawn from participants is
      relatively small and within acceptable limits.
    


Intervention name(s): turmeric; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Turmeric supplement; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy and Safety of MEDI3506 in Adult Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a research study to determine the efficacy and safety of investigational drug
      MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.
    

Detailed description: 
      This is a research study to determine the efficacy and safety of investigational drug
      MEDI3506 for the treatment of adult subjects with Atopic Dermatitis.

      Each participant will be assigned randomly to a treatment arm, which could be different
      strengths of the active treatment or a placebo which does not contain active treatment. Both
      Participants and investigators will be masked to the treatment assignment.

      Approximately 152 participants will take part in this study. There is a 4 weeks screening
      period to determine eligibility. After eligibility is confirmed, participants will receive
      investigational drug or placebo during the 16 weeks treatment period. This is then followed
      by an 8-week follow-up period.
    

Intervention name(s): MEDI3506; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): multiple doses; multiple doses
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomised to receive MEDI3506 dose 1, MEDI3506 Dose 2 or MEDI3506 dose 3 or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MEDI3506; Safety; Efficacy; Atopic Dermatitis; Eczema
Human Empowerment Aging and Disability (HEAD): New Technologies for Neurorehabilitation
Condition: Rehabilitation; Technology; Telerehabilitation; Nervous System Diseases
MeSH terms: Nervous System Diseases
Study type: Interventional

Summary: 
      Congenital or acquired neurological disorders could lead to consistent motor and cognitive
      disabilities. The continuity and persistency of a tailored home rehabilitation protocol after
      recovery is crucial to prevent disease aggravation or relapses. The integration of a
      web-based new technology in home rehabilitation programme can constitute a functional low
      cost resource by offering patients off-line (and on-line) monitoring and by proposing new
      motivating ways of rehabilitation through high tech tools such as serious games.
    


Intervention name(s): Multimedial Rehabilitation; Usual care program
Intervention type(s): Other; Other
Intervention description(s): Usual care at home program according to healthcare professional's advice
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with
      dyslipidemia already on statin therapy.
    


Intervention name(s): anacetrapib; Comparator: atorvastatin; Comparator: placebo to MK0859; Comparator: placebo to atorvastatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): [Intervention Name: MK0859] MK0859 100 mg tablet once daily for 8 weeks.; Atorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2.; Placebo to MK0859 once daily for 4 weeks.; Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2.
Intervention MeSH terms: Atorvastatin; Anacetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Prevent Pain and Stress Related Sickleave.
Condition: Stress, Psychological; Pain
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      Problems with stress and pain are common reasons for long-term sick-leave, and need
      preventive interventions. This RCT builds on a successful previous project (see reference
      section), where a program involving the work place, the individual and occupational health
      care resulted in decreased sick-leave and healthcare visits and a higher quality of life as
      compared to TAU for individuals with musculoskeletal pain. This study will replicate and
      evaluate the mechanisms behind the involvement from the work place. According to the
      transdiagnostic model, problems with stress and pain are maintained by similar processes.
      Consequently, the study will be extended to include both problems, and it will be explored
      how a refined version of the program affects sick leave and work ability in the employees.
    

Detailed description: 
      Compared to the earlier study, this RCT will include:

        1. A focused program targeting supervisors and employees

        2. An active control group

        3. An evaluation of the effects on both supervisor and employee

        4. Knowledge on the mechanisms involved

        5. Replication and extension of earlier findings

      The project will produce knowledge about:

      A procedure for identifying individuals at risk for sick-leave. The effects of a program
      targeting both workplace and individual to prevent problems with stress and pain.

      The role of the supervisor in preventing sick-leave. Mechanisms linked to decreased levels of
      sick-leave.
    

Intervention name(s): communication and problem solving; psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): a program for supervisors and employees including skills training, validating communication, problem solving; lecture/course for supervisors and employees on risk factors and actions for people experiencing stress and/or pain
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
High Intensity Aerobic Training on Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Now a days Aerobic Exercise programs has been widely used as non-pharmacological means of
      treating pain disorders. This study intends to determine the effects of high intensity
      aerobic training on pain intensity, dysmenorrhea symptoms and quality of life of young girls
      having primary dysmenorrhea.
    

Detailed description: 
      This study is a Randomized Control Trial, which will be conducted in Shifa Tameer-e-Millat
      University (Department of Rehabilitation Sciences). the calculated Sample size is 24
      individuals using Epitool with 95% Confidence Interval (CI) and power 80%. Individual will be
      screened out according to inclusion criteria. Individuals will be allocated randomly into two
      groups, 12 in High Intensity Aerobic training group and 12 in Low Intensity Aerobic Training
      group by sealed envelope method. High Intensity Aerobic Training will be use in experimental
      group. Low Intensity Aerobic Training will be used in Control group. Assessment will be done
      on baseline day 1 prior to the intervention and after 8 weeks of training.
    

Intervention name(s): High Intensity Aerobic Training.; Low intensity Aerobic Training
Intervention type(s): Other; Other
Intervention description(s): Participants will perform 2-5 minutes of low to moderate intensity warm up exercises and then 20 minutes of high intensity aerobic training at 80-90% of heart rate maximum increased gradually on treadmill and elliptical trainer and then 2-5 minutes of low to moderate intensity cool down exercises.; Participants will perform 2-5 minutes of low to moderate intensity warm up exercises and then 20 minutes of low intensity aerobic training at 40-60% of heart rate maximum increased gradually on elliptical trainer and jogging and then 2-5 minutes of low to moderate intensity cool down exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Both experimental and control groups will be treated at the same time following their respective protocols.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: pain; Dysmenorrhae symptoms; Menstrual Symptom Questionnaire
Study of CS-3150 in Hypertensive Patients With Type 2 Diabetes and Albuminuria
Condition: Hypertension
MeSH terms: Albuminuria; Hypertension; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To examine antihypertensive effect and safety of administration of CS-3150 in combination
      with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.
    


Intervention name(s): CS-3150
Intervention type(s): Drug
Intervention description(s): CS-3150 1.25 to 2.5, 5mg, orally
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension with Type 2 Diabetes and Albuminuria; Diabetic nephropathy; Diabetic renal disease; Albuminuria; Mineralocorticoid receptor antagonist
Stroke in Young Fabry Patients (sifap1): Frequency of Fabry Disease in Young Stroke Patients
Condition: Cerebrovascular Accident
MeSH terms: Stroke; Fabry Disease
Study type: Observational

Summary: 
      More than one million people in Europe suffer from a stroke every day. Normally older people
      have a stroke, but also a significant number of younger people between 18 and 55 years.
      Usually, these cannot be explained by the classical risk factors such as diabetes, overweight
      and high blood pressure. New studies indicate that in about 1 - 2 % of the younger stroke
      patients the cause could have been an undiagnosed genetic disease, the so called Fabry
      disease. The purpose of this study is to determine in a large number of young stroke
      patients, how many strokes were caused by Fabry Disease.
    

Detailed description: 
      Aim:

      To determine the frequency of Fabry disease in an unselected group of young patients (18 - 55
      years of age) with acute cerebrovascular event (CVE)

      Fabry disease and stroke:

      Rolfs and co-workers have shown a high frequency of Fabry disease in a cohort of patients
      with cryptogenic stroke (4 % [28/721]) aged between 18 and 55 years. This corresponds to
      about 1.2 % in the general population of young stroke patients. Therefore the authors stated
      that Fabry disease must be considered in all cases of unexplained stroke in young patients,
      especially in cases with the combination of infarction in the vertebrobasilar artery system
      and proteinuria.

      Cryptogenic strokes are cerebrovascular lesions of unknown origin. Clinical and laboratory
      data show that Fabry disease is itself a risk factor for accelerated atherosclerosis and
      cardiac and renal disease, which can lead to emboli and hypertension. The pilot-phase started
      April 2007; the official study started January 2008.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): Observational study, only laboratory analysis and diagnostic interventions done; no drug tested
Other intervention name(s): only 1 observational group
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients (18 - 55 years of age) with an acute cerebrovascular event of any etiology
        defined as patients having an acute ischemic stroke or transient ischemic attack less than
        3 months before enrollment into the study
      
Biospecimen description: 
      Fabry diagnostic will be done centrally: blood samples will be retained for analysis of
      a-galactosidase in blood to diagnose an a-galactosidase deficit; in females direct analysis
      of the gene has to be done since due to the Lyonisation effect a-galactosidase activity might
      be normal in blood although the patient might suffer from Fabry disease.
    
Keywords: Cerebrovascular Accident; Cerebrovascular Accident, Acute; CVA (Cerebrovascular Accident); Cerebral Stroke; Stroke, Acute; Cerebrovascular Stroke; Fabry Disease; Anderson-Fabry Disease; Fabry's Disease
Physical Activity and Obesity
Condition: Obesity; Prediabetic State; Sedentary Lifestyle
MeSH terms: Obesity; Prediabetic State
Study type: Interventional

Summary: 
      The purpose of the study is to see if a twelve-week exercise intervention in overweight or
      obese subjects with pre-diabetes or early disease course type 2 diabetes can lead to improved
      skeletal muscle capillary blood flow by improving substances that dilate blood vessels and
      result in improved insulin sensitivity.
    


Intervention name(s): High Activity
Intervention type(s): Behavioral
Intervention description(s): The high activity group will undergo a 12 week ramped exercise protocol.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Prediabetic State; Sedentary Lifestyle; Insulin Resistance; Endothelium; Eicosanoids; Nitric Oxide; Regional Blood Flow
EPIMix Versus CT Brain Pediatric Study
Condition: Brain Diseases
MeSH terms: Brain Diseases
Study type: Observational

Summary: 
      This study aims to assess the diagnostic feasibility and diagnostic performance of a new fast
      MR sequence EPIMix for neuroradiological evaluation in comparison to computed tomography of
      brain in pediatric population.
    

Detailed description: 
      The study aims to assess the feasibility of fast MR sequence for neuroradiological evaluation
      in comparison to computed tomography of brain in pediatric population. Imaging quality is
      analysed with regards to artefacts and lesion conspicuity as well as its diagnostic potential
      in rendering a probable diagnosis. The primary study aim is to define feasibility and the AUC
      for diagnostic performance of minute MRI compared to computed tomography.

      Included patients are children age 4-18 with suspicion of cerebral pathology with referral to
      elective computed tomography of the brain.

      Study participants are in addition to computed tomography investigated during same day at 3T
      MR.
    

Intervention name(s): MRI
Intervention type(s): Diagnostic Test
Intervention description(s): Brain MRI without intravenous contrast
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Child with indication for elective brain CT.
      
Keywords: MRI (magnetic resonance imaging); Neuroradiology; EPIMix (Echo planar imaging mix); Multicontrast EPI (echo planar imaging); Clinical validation
Glycemic Response to Two Enteral Formulas in Persons With Type 2 Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This will be a randomized, cross-over design. Subjects will be randomized to one of two
      interventions on two separate study days, 1 week apart.
    


Intervention name(s): Enteral Nutrition Formula
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
A Study to Assess the Systemic Exposure of FLIXOTIDE™ (Fluticasone Propionate) and SERETIDE™ (Fluticasone Propionate and Salmeterol) Given With VENTOLIN™ Mini-Spacer Compared to the Aerochamber Plus Spacer
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The VENTOLIN Mini-Spacer is being developed in order to support patients in the Emerging
      Markets and Asia Pacific regions who do not have access to affordable spacers. The aim of
      this exploratory study is to investigate whether the systemic exposure for fluticasone
      propionate (FP) and salmeterol observed with the VENTOLIN Mini-Spacer is comparable to the
      systemic exposure for FP and salmeterol observed with the Trudell Aerochamber Plus spacer for
      both FLIXOTIDE and SERETIDE Metered Dose Inhaler (MDI) products. There will be four study
      periods in the study and all participants will receive four study treatments during the
      study. The total duration of study including screening, treatment period, washout period, and
      follow-up period will be 58 days. Study is planned to enroll 20 healthy subjects.

      VENTOLIN is a registered trademark of GlaxoSmithKline. FLIXOTIDE is a registered trademark of
      GlaxoSmithKline. SERETIDE is a registered trademark of GlaxoSmithKline.
    


Intervention name(s): VENTOLIN Mini-Spacer; Aerochamber Plus spacer
Intervention type(s): Device; Device
Intervention description(s): VENTOLIN mini-spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler; Aerochamber Plus spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects; SERETIDE; Pharmocokinetics; FLIXOTIDE; VENTOLIN Mini-Spacer
Open Multicenter Study for Assessment of Efficacy and Safety of Molnupiravir in Adult Patients With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This is open-labe randomized multicenter comparative Phase III study conducted in 12 medical
      facilities. The objective of the study is to evaluate efficacy and safety of the drug
      JCBC00101, capsules in the setting of pathogenetic and symptomatic therapy as compared to
      standard therapy in outpatients with COVID-19.
    

Detailed description: 
      Upon signing the informed consent form and screening, 240 eligible outpatients with mild or
      moderate COVID-19 were randomized at a 1:1 ratio to receive either molnupiravir capsules, 800
      mg, 2 times a day with 12 ±2 hours interval for 5 days, or SOC
    

Intervention name(s): Molnupiravir (Esperavir); Standard of care
Intervention type(s): Drug; Drug
Intervention description(s): Capsules 800 mg, 2 times a day with 12 ±2 hours interval for 5 days; The administration of 'Standard of care' drugs was done according to the regimen recommended in the 'COVID-19 TreatmentGuidelines'(Version 14 of 27.12.2021), or inforce at the time of the study
Other intervention name(s): JCBC00101
Intervention MeSH terms: Molnupiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SARS-CoV-2; Molnupiravir; Esperavir
6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA
Condition: Sexual Dysfunctions, Psychological
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is designed to assess the safety and efficacy of flibanserin in the treatment of
      premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) that meet standard
      diagnostic criteria. Efficacy for flibanserin will be assessed vs. a parallel placebo group.
    


Intervention name(s): flibanserin; flibanserin; flibanserin; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Experimental: flibanserin 25 mg b.i.d; Experimental: flibanserin 50mg qhs; Experimental: flibanserin 50mg b.i.d.; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy Study of p38 Kinase Inhibitor to Treat Patients With Atherosclerosis
Condition: Vascular Diseases
MeSH terms: Vascular Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether a p38 kinase inhibitor reduces inflammation
      in atherosclerotic plaque
    


Intervention name(s): Placebo; BMS-582949; Atorvastatin; Statin
Intervention type(s): Other; Drug; Drug; Drug
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment