bioihbjkbjnl/mcl2 huggingface dataset:
Roflumilast and Cognition
Condition: Dementia
MeSH terms: Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the current project is to validate PDE4 inhibitors as a target for cognition
      enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will
      demonstrate whether memory, but also attention, information processing or executive function
      improves with the PDE4 inhibitor roflumilast in healthy humans.
    


Intervention name(s): roflumilast (EU: Daxas, USA: Daliresp); Placebo; roflumilast
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Acute intervention: 1 time each dose on different days. Capsulated; Acute intervention: single administration, capsulated form.; Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.
Other intervention name(s): Daxas; Daliresp; PDE4-inhibitor
Intervention MeSH terms: Phosphodiesterase 4 Inhibitors
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Comparative Safety Study of Two Vaginal Applicators With Tenofovir
Condition: Microbicide Applicator
Study type: Interventional

Summary: 
      The primary objective of this study is to compare the effect of two vaginal applicators,
      delivering the candidate microbicide Tenofovir, on symptoms and signs of irritation of the
      external genitalia, cervix and vagina as seen on colposcopy after seven days of twice daily
      use.

      The secondary objectives are to:

        1. Evaluate and compare the dosing accuracy and precision of the user-filled applicator and
           pre-filled applicator with the candidate microbicide, Tenofovir.

        2. Compare the acceptability of the user-filled applicator with the pre-filled applicator.
    


Intervention name(s): Tenofovir
Intervention type(s): Drug
Intervention description(s): Delivered using prefilled and user-filled applicator
Other intervention name(s): TFV
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Microbicide, Applicator, Safety
Is Monitoring Activity Important for Short- and Long-term Weight Loss?
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study is comparing the effectiveness of two techniques for monitoring physical activity
      and energy balance on long-term weight management (two years). The focus is on weight loss,
      prevention of weight gain, and the maintenance of a healthy weight over time. It is expected
      that both techniques will benefit long-term weight management.
    

Detailed description: 
      The major objective of this study is to determine if two techniques for monitoring physical
      activity and energy balance promote the maintenance of weight loss in healthy overweight and
      obese individuals. The study compares two approaches designed to help individuals monitor
      physical activity and to adjust their calorie intake to maintain a reasonable energy balance
      (bodybugg® & Step Diet Book systems). Full subject participation in the study spans two
      years. Participants periodically report to a pre-arranged location to be measured by a
      qualified fitness professional for height, weight, circumferences, and estimated body fat
      using a bioelectric impedance scale (body fat scale).
    

Intervention name(s): Self monitoring of estimated energy balance
Intervention type(s): Behavioral
Intervention description(s): Participant estimation of energy intake and energy expenditure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: overweight; obesity; accelerometer; pedometer; energy balance; weight loss; weight maintenance
A Randomized, Open Label Study to Compare the Current Phase II and Planned Phase III Capsule Formulation of AZD6244
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in Healthy Males to Compare the White and Blue Formulations of AZD6244.
    

Detailed description: 
      A Phase I, Single-center, Randomized, Open-label, Crossover Study to Compare the White
      (Current Phase II) and Blue (Planned Phase III) Capsule Formulations of AZD6244 Hyd-Sulfate
      in Healthy Male Subjects.
    

Intervention name(s): AZD6244 Dosing Period 1; AZD6244 Dosing Period 2; AZD6244 Dosing Period 3; AZD6244 Dosing Period 4
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A, B, or C depending on randomization assignment; Treatment A, B, or C depending on randomization assignment; Treatment A, B, or C depending on randomization assignment; Treatment B
Other intervention name(s): AZD6244; AZD6244; AZD6244; AZD6244
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I; healthy volunteers; AZD6244; pharmacokinetics; AUC; Cmax; tmax; AUC(0-t)
HeartLight X3 Endoscopic Ablation System With Excalibur Balloon for Treatment of Symptomatic Persistent AF
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The objective of the study is to demonstrate the improved ablation and procedure times of the
      HeartLight X3 compared to the original HeartLight catheter in the treatment of persistent
      atrial fibrillation.
    


Intervention name(s): HeartLight X3
Intervention type(s): Device
Intervention description(s): Pulmonary vein isolation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical and Urodynamic Effects of Minimally Laser (IncontiLaseTM) Procedure for Female Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to get the effect of IncontiLaseTM procedure; and its impact on
      urinary symptoms and female sexual function.
    

Detailed description: 
      To get the objective urodynamic and sonographic effects of IncontiLaseTM procedure on women
      with stress urinary incontinence; and its impact on urinary symptoms and female sexual
      function.
    

Intervention name(s): the IncontiLaseTM procedure
Intervention type(s): Procedure
Intervention description(s): Utilizing laser (IncontiLaseTM) to treat the anterior vaginal wall area to intensify periurethral tissue and achieve urinary continence
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder
Condition: Diabetes Mellitus; Frozen Shoulder
MeSH terms: Bursitis; Diabetes Mellitus
Study type: Observational [Patient Registry]

Summary: 
      The purpose of the study is to investigate how high the prevalence of diabetes (known and
      unknown) is among patients with a frozen shoulder. Our hypothesis is that it is around 30-40
      %.

      Another purpose is to investigate whether patients with diabetes have a worse and more
      painful frozen shoulder than patients without diabetes, and whether the diabetes have an
      influence on the prognosis.
    

Detailed description: 
      Patients who are not diagnosed with diabetes would be ask to give a blood sample to
      investigate if they have an unknown diabetes.

      All patients with frozen shoulder will be asked to fill out a questionnaire (Oxford Shoulder
      Score) to clarify how bad their frozen shoulder is. All patients will receive the
      questionnaire 6 and 24 month following the date on inclusion.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All newly referred patients to one of the involved hospitals who is diagnosed with frozen
        shoulder.
      
Biospecimen description: 
      whole blood for patients not diagnosed with diabetes.
    
Keywords: Diabetes Mellitus; frozen shoulder; adhesive capsulitis
Clinical Investigation of the MiStent Drug Eluting Stent (DES) in Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The DESSOLVE II clinical trial is to assess the safety and performance of the
      sirolimus-eluting MiStent for the treatment for improving coronary luminal diameter in
      patients with symptomatic ischemic heart disease due to discrete de novo lesions in the
      native coronary arteries.
    

Detailed description: 
      The DESSOLVE II clinical trial is to assess the safety and performance of the
      sirolimus-eluting MiStent as compared to the Endeavor DES for the treatment for improving
      coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete
      de novo lesions in the native coronary arteries.
    

Intervention name(s): MiStent DES; Endeavor DES
Intervention type(s): Device; Device
Intervention description(s): The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).; The Endeavor is a device/drug combination comprised of two components; a stent and a drug product (everolimus within a durable polymer coating).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Coronary Artery Disease; Drug-eluting Stent; Sirolimus
Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age
Condition: Rubella; Measles; Mumps
MeSH terms: Measles; Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate consistency in terms of the immune response to three
      different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies,
      and compare its immunogenicity to Merck & Co., Inc.'s MMR vaccine, which is approved for use
      in the United States (US).
    

Detailed description: 
      This study will evaluate the consistency of the immune response to three different lots of
      GSK Biologicals' trivalent investigational MMR vaccine (referred to as INV_MMR vaccine,
      throughout this document) and compare its immunogenicity to the US standard of care
      comparator vaccine (M-M-R II, Merck and Co., Inc., referred to as COM_MMR throughout this
      document) in children during their second year of life. The INV_MMR vaccine will be given as
      one of three consistency lots manufactured to target potencies designated as INV_MMR_L1,
      INV_MMR_L2 and INV_MMR_L3. The COM_MMR vaccine will be given as one of two lots designated
      COM_MMR_L1 and COM_MMR_L2 and will be analysed as pooled lots within the study. The MMR
      vaccine will be co-administered with Varivax (VV), Havrix (HAV) and (in the US sub-cohort
      only) Prevnar 13 (PCV-13) which are routinely administered to children of this age in the US.
    

Intervention name(s): Priorix; M-M-R II; Varivax; Havrix; Prevnar 13
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.; Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.; Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.; Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.; US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.
Other intervention name(s): GSK Biologicals' live attenuated measles; mumps and rubella vaccine (GSK209762)
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Consistency study; Measles, mumps and rubella diseases; Healthy children; Immunogenicity
An Audit on Management of Chronic Diarrhea
Condition: Chronic Diarrhea
MeSH terms: Diarrhea
Study type: Observational

Summary: 
      The study is to assess whether the staff in gastroenterology unit are sticking to the agreed
      up on unit's protocol in management of chronic diarrhea over the period of one year(september
      2017-september 2018)
    

Detailed description: 
      chronic diarrhea is defined as having loose or watery stools more than three times
      aday.Awakening at night to pass stools us often sign of an organic cause of diarrhea.In some
      cases chronic diarrhea is the result of intestinal infection that persists longer than
      expected. In other cases chronic diarrhea is apart of a systemic illness.

      Etiology:

        1. post enteritis diarrhea syndrome in whic small intestinal mucosal damage persists after
           acute gastroenteritis.Also secondary disaccharidase deficiency and reinfection may be a
           cause.

        2. infectious causes:enteric infection is an important cause.Associated conditions may be
           T.B or impaired immunity as in malnutrition potentiating the likely-hood of prolonging
           or acquiring another infection.Viral infection like Rota virus,parasites as
           E.coli,Giardia lamblia as well as amebiasis have been implicated in chronic diarrhea.

        3. Cytomegalovirus on the other hand may act as an opportunistic agent in immuno
           compromised patients.

        4. Non infectious causes include cow's milk allergy,lactose intolerance and inflammatory
           bowel disease,all of which may cause chronic diarrhea that is often associated with
           abdominal pain with or without elevated levels of inflammatory markers.

        5. Malabsorption syndrome e.g Celiac disease,cystic fibrosis where the stools are usually
           fatty in nature and bulky in amount.

      Good management of chronic diarrhea must include investigations and treatment.A protocol must
      be followed accurately therefore.

      Methodology:

      measurment of the degree of sticking of staff in Gastro-enterology unit to the agreed upon
      unit's protocol in management of chronic diarrhea over the period of one year (September
      2017-September 2018).
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        an audit
Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo
Condition: Mild Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized prospective trial which addresses the question of whether use of an oral
      hypoglycemic agent as an adjunct to diet therapy in women with mild gestational diabetes will
      result in achieving euglycemia in a shorter period of time and, in turn, result in less
      frequent maternal and neonatal morbidities. This study is designed to test the hypothesis
      that in women with mild GDM, use of Glyburide in addition to diet and nutritional counseling
      lowers mean infant birth weight by 200 grams as compared with diet and nutritional counseling
      alone.
    


Intervention name(s): Glyburide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Starting dosage is 2.5 mg once daily. This dose will be titrated as necessary during the pregnancy to achieve glycemic control.; Sham dose adjustments of the placebo will be made.
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
MD1003-AMN MD1003 in Adrenomyeloneuropathy
Condition: Adrenomyeloneuropathy; Adrenoleukodystrophy; AMN
MeSH terms: Adrenoleukodystrophy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of the trial is to demonstrate the superiority of biotin at 300 mg/day
      over placebo in the clinical improvement (walking tests) of patients with
      adrenomyeloneuropathy
    

Detailed description: 
      AMN and progressive multiple sclerosis share some similarities including progressive spastic
      paraparesis and secondary energy failure leading to progressive axonal degeneration.
      Therefore, it was hypothesized that high doses of biotin might be efficient in patients with
      AMN.
    

Intervention name(s): MD1003 100 mg capsule; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): High Dose Biotin
Intervention MeSH terms: Biotin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AMN; MD1003; Adrenomyeloneuropathy; ALD; Adrenoleukodystrophy; Biotin; 2MWT; Two-minute walk test; TW25; Timed 25-Foot Walk
Urine Sample Collection From FOP Patients
Condition: Fibrodysplasia Ossificans Progressiva
MeSH terms: Myositis Ossificans
Study type: Observational

Summary: 
      The purpose of this study is to collect urine samples from patients with fibrodysplasia
      ossificans progressiva (FOP) for the assessment of biomarkers related to disease, disease
      progression and for prediction of flare-ups of the disease. Disease related biomarkers in
      these patients are currently unknown. This study aims to support the development of novel
      therapy/ies for this disease.
    


Sampling method: Probability Sample
Study population: 
        Patients with Fibrodysplasia Ossificans Progressiva.
      
Biospecimen description: 
      Urine samples
Lutein Bioavailability From Fresh and Dried Beverages
Condition: Macular Pigment
Study type: Interventional

Summary: 
      Macular pigment is composed primarily of the xanthophylls lutein and zeaxanthin, which are
      members of the carotenoid family. Epidemiological evidence indicates that a higher intake of
      lutein and zeaxanthin is associated with a lower risk to develop age-related macular
      degeneration (AMD). The lipid matrix of an egg yolk is an excellent vehicle for the efficient
      absorption of dietary lutein and it is possible to increase the natural lutein concentration
      in an egg yolk. A fresh lutein-enriched egg yolk beverage has been produced using these
      lutein-enriched egg-yolks. However, this beverage has a limited shelf life of maximum three
      weeks. Drying this fresh beverage extents the shelf live, however, this should be without
      loosing its functional properties concerning lutein bioavailability. At WUR-FBR two types of
      drying procedures have been evaluated resulting in two different dried product formulations,
      which need to be tested. The question is, whether the lutein bioavailability is not affected
      by different drying procedures.
    


Intervention name(s): Fresh lutein-enriched egg-yolk beverage; Dried-1 lutein-enriched egg-yolk beverage; Dried-2 lutein-enriched egg-yolk beverage; Placebo beverage
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Fresh lutein-enriched egg-yolk beverage; Dried-1 lutein-enriched egg-yolk beverage; Dried-2 lutein-enriched egg-yolk beverage; Placebo beverage
Other intervention name(s): NWT-02
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: focus of study
Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer
Condition: Esophageal Cancer; Malignant Neoplasm of Cardio-esophageal Junction of Stomach
MeSH terms: Esophageal Neoplasms; Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see whether giving azacitidine before each cycle of
      chemotherapy prior to surgery is safe.
    

Detailed description: 
      Currently patients with resectable (can be removed by surgery) esophageal cancer will receive
      chemotherapy before surgery to try to shrink the tumor before it is removed. This study will
      evaluate whether giving azacitidine before each cycle of chemotherapy to increase the
      shrinkage of the tumor prior to surgery is safe.

      Azacitidine is currently approved by the Food and Drug Administration (FDA) for treatment of
      myelodysplastic syndrome (MDS). Azacitidine is not approved by the FDA for use in this study
      and is therefore considered investigational. Because azacitidine has not been given before in
      combination with epirubicin, oxaliplatin and capecitabine, we will also evaluate the safety
      and tolerability of azacitidine and find out what dose of azacitidine is safe to give with
      this chemotherapy.
    

Intervention name(s): Azacitidine; Oxaliplatin; Epirubicin; Capecitabine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dose level -1: 50 mg/m2 subcutaneous injection on Day 1-3 of a 21 day cycle. Repeat for a total of 3 cycles. Dose level 1: 75 mg/m2 subcutaneous injection on Day 1-3 of a 21 day cycle. Repeat for a total of 3 cycles. Dose level 2: 75 mg/m2 subcutaneous injection on Day 1-5 of a 21 day cycle. Repeat for a total of 3 cycles.; 130 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.; 50 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.; 625 mg/m2 orally twice daily beginning on Day 3 or 5 and will be taken without interruption for each 21-day cycle.
Other intervention name(s): Vidaza®; 5-Azacitidine; Eloxatin; Ellence; Xeolda
Intervention MeSH terms: Capecitabine; Azacitidine; Oxaliplatin; Epirubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gastroesophageal junction; GEJ; esophageal; esophagus
Gastrointestinal Tolerance of D-allulose in Children
Condition: Healthy
Study type: Interventional

Summary: 
      D-allulose, a low-calorie sugar, provides an attractive alternative to sucrose and added
      sugars in products. This study aimed to verify the tolerance of d-allulose in children, in
      doses that are Generally Recognised As Safe (GRAS) and below maximum tolerable levels on g/kg
      basis.
    


Intervention name(s): D-allulose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fruit-flavoured drink with d-allulose at 2 dosages; Fruit-flavoured drink with high fructose corn syrup
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Acute, randomised, double-blind, placebo-controlled, cross-over
Masking: Double (Participant, Investigator)
Primary purpose: Prevention