bioihbjkbjnl/mcl2 huggingface dataset:
Dose-Dependent Effects of Anthocyanins on Endothelial Function in Healthy Men
Condition: Healthy Men
Study type: Interventional

Summary: 
      Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes.
      Increasing evidence from human epidemiological and dietary intervention studies suggests that
      anthocyanins may have cardiovascular health benefits. The present study aimes to investigate
      whether pure anthocyanin consumption improves endothelial function in healthy individuals and
      if these effects are dose-dependent.
    

Detailed description: 
      Anthocyanins are a subclass of (poly)phenols very abundant in berries and red grapes.
      Increasing evidence from human epidemiological and dietary intervention studies suggests that
      anthocyanins may have cardiovascular health benefits. A double blind randomized controlled
      crossover, dose-response study will be conducted in 10 young healthy men. On 6 different
      days, subjects will consume capsules containing 0, 80, 160, 240, 320 and 480 mg of purified
      anthocyanins with a one-week wash-out period. Flow-mediated dilation (FMD) and blood pressure
      will be measured at baseline and at 2 and 6 h after consumption. Blood samples will also be
      taken and quantification of plasma anthocyanin metabolites using UPLC-Q-TOF-MS will be
      performed. The aim is to investigate whether purified anthocyanins are able to increase FMD
      at 2h and 6h post consumption and whether these effects correlate with anthocyanin- derived
      phenolic acids quantified in the plasma.
    

Intervention name(s): anthocyanins
Intervention type(s): Dietary Supplement
Intervention description(s): Acute intake of capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double blind randomized controlled crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.
Condition: Relapsing Multiple Scelrosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4
      weeks versus teriflunomide administered orally once daily in patients with relapsing multiple
      sclerosis
    

Detailed description: 
      This was a randomized, double-blind, double-dummy, active comparatorcontrolled,
      parallel-group, multi-center study with variable treatment duration in approximately 900
      patients with relapsing multiple sclorosis (RMS). The maximal treatment duration in the study
      for an individual patient was 2.5 years. Eligible patients were randomized to receive either
      experimental ofatumumab subcutaneous (s.c.) injections every 4 weeks or active comparator
      teriflunomide orally once daily. The dose regimen for ofatumumab for this study was a loading
      dose regimen of 20 mg at Day 1, Day 7 and Day 14, followed by a maintenance dose regimen of
      20 mg administered every 4 weeks starting at Week 4. In order to blind for the different
      formulations, double-dummy masking was used, i.e., all patients will take injections
      (containing either active ofatumumab or placebo) and oral capsules (containing either active
      teriflunomide or placebo).
    

Intervention name(s): Ofatumumab subcutaneous injection; Teriflunomide-matching placebo capsules; Teriflunomide capsule; Matching placebo of ofatumumab subcutaneous injections
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ofatumumab 20 mg prefilled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter; Placebo capsule, matching in appearance to teriflunomide, taken orally once daily; Teriflunomide 14 mg oral capsule taken once daily; Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter
Intervention MeSH terms: Teriflunomide; Ofatumumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Relapsing multiple sclerosis; Ofatumumab; adult; OMB157; multiple sclerosis; T1 lesions; T2 lesions; relapse; GD-enhancing MRI; McDonald criteria; RRMS; SPMS
Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease
Condition: Cardiac Disease
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      A committee will judge the safety and effectiveness of edoxaban and the regular treatment
      (standard of care).

      All children in the study will receive free treatment. They will have a 2 in 3 chance to
      receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood
      clots.

      The study will find out if edoxaban is safer and more effective than the standard of care.
    

Detailed description: 
      The primary objective is to compare the safety of edoxaban with the standard of care (SOC) in
      pediatric subjects with cardiac diseases at risk of thromboembolic complications who need
      primary or secondary anticoagulant prophylaxis with regard to the combination of major and
      clinically relevant non-major (CRNM) bleeding per International Society on Thrombosis and
      Haemostasis [ISTH] definition.

      The key secondary objective is to compare the efficacy of edoxaban against SOC with regard to
      the development of symptomatic thromboembolic events (TE) in the systemic arterial or venous
      pathways including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, intracardiac
      thrombus and myocardial infarction (MI), and asymptomatic intracardiac thrombus identified by
      cardiac imaging.
    

Intervention name(s): Edoxaban; Standard of Care (SOC)
Intervention type(s): Drug; Drug
Intervention description(s): Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration; Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen
Other intervention name(s): Lixiana; Savaysa; Warfarin/heparin; Enoxaparin
Intervention MeSH terms: Heparin; Enoxaparin; Warfarin; Edoxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; Pediatrics; Cardiac disease with potential for thromboembolic complications; Prophylactic treatment; Anticoagulant drugs
Neurosensory Deficit of Inferior Alveolar Nerve Following Mandibular Orthognathic Surgery.
Condition: Sensory Deficit
Study type: Interventional

Summary: 
      This clinical study investigates the sensation deficit in the lower lip and chin area after
      surgical correction of lower jaw deformity.

      The primary null hypothesis is: Lower jaw osteotomy cause no sensory deficit in the inferior
      alveolar nerve.

      The secondary null hypothesis is: Concurrent genioplasty with sagittal split does not
      increase the risk of sensory deficit in the inferior alveolar nerve.
    


Intervention name(s): Bilateral Sagittal Split Osteotomy
Intervention type(s): Procedure
Intervention description(s): Surgical correction of lower jaw deformity by performing bilateral intraoral sagittal osteotomy of the mandible under general anesthesia.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sensory deficit; Orthognathic surgery; Mandibular osteotomy; Inferior alveolar nerve
Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients
Condition: Organ Transplantation, Renal Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of everolimus in combination
      with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney
      transplant recipients.
    

Detailed description: 
      This is a combined analysis using 81 patients randomized and treated in CRAD001A2419
      (NCT00154284) with 33 randomized and treated in CRAD001A2423 (NCT00170807). This approach is
      reflected in the protocol amendments for each study, and the one clinical study report for
      both.
    

Intervention name(s): Everolimus (Certican); Cyclosporine (Neoral); Steroid; Basiliximab (Simulect)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
Other intervention name(s): Certican; Neoral; Prednisone; Simulect
Intervention MeSH terms: Cyclosporine; Prednisone; Everolimus; Cyclosporins; Basiliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal transplantation,; everolimus,; immunosuppressants,; basiliximab,; cyclosporine microemulsion discontinuation, cyclosporine microemulsion minimization
European Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss
Condition: Obesity; Weight Control
MeSH terms: Body Weight; Weight Loss
Study type: Observational

Summary: 
      The objective of this study is to evaluate the initial safety and preliminary effectiveness
      of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27
      - 35 kg/m^2
    


Intervention name(s): Obalon Gastric Balloon
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients were selected from investigators' patient population and included patients with a
        BMI in the range of 27 - 35 kg/m^2
      
Keywords: Obesity; Weight loss; Weight control; Intragastric balloon; gastric balloon
Epidural Catheter Thread Between Two Different Vendors
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      The aim of the study is to assess if there is a difference in ability to thread the epidural
      catheter from two different epidural pain management kits vendors
    

Detailed description: 
      The aim of the study is to assess if there is a difference in ability to thread the epidural
      catheter from two different pain management kits. In order to improve patient care, if there
      is a difference in the time to thread epidurals with one kit over the other, we would like to
      use the kit with decreased time to thread in the future.
    

Intervention name(s): Arrow Catheter Kit.; B.Braun Catheter Kit
Intervention type(s): Device; Device
Intervention description(s): The group will be randomized to receive this labor analgesia kit.; The group will be randomized to receive this labor analgesia kit.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Spirulina on Liver Iron Concentration in Beta Thalassemic Children With Hepatitis C
Condition: Beta Thalassemia Major
MeSH terms: Hepatitis C; Thalassemia; beta-Thalassemia
Study type: Interventional

Summary: 
      Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection.
      The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics.
      Excess liver iron is clearly recognized as a co factor for the development of advanced
      fibrosis in patients with hepatitis virus C infection. Magnetic resonance imaging represents
      the most available noninvasive technique to assess the level of iron in the liver.there is
      evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and
      liver failure in those with chronic liver disease.
    


Intervention name(s): spirulina
Intervention type(s): Dietary Supplement
Intervention description(s): Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effects of Proteins Fraction Derived From Milk on Osteoporosis Prevention
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Osteoporosis is defined as a systemic skeletal disease characterised by low bone mass and
      microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility
      and susceptibility to fracture. Osteoporosis is a serious public health problem that is
      responsible for approximately 3 million women with osteoporosis in France, with approximately
      150,000 cases per year occurring in vertebral fractures, of which only one third would be
      diagnosed and 50,000 hip fractures (causing death in 20% of cases). The frequency of the
      disease increases with age, particularly among women: 10% among women aged 60 years and 20%
      among women aged 65 and 40% among women aged 75. At menopause, oestrogen deficiency causes
      alterations of the immune system, decreased bone formation, microarchitectural deterioration
      and a decrease in bone mass. Various factors may contribute to this decrease in bone density
      such as diet, lifestyle, or the genetic background.

      According to prospective studies, an overexpression of 135% of hip fractures is expected at
      European level in 50 years. Therefore, it is interesting to develop new prevention approaches
      aimed at maintaining the healthy aging population. Nutritional researches can consider
      setting up a real prevention.

      Studies suggest that specific milk protein fraction contain factors able to promote bone
      formation, inhibit bone resorption in vitro. In animal model, they showed that the specific
      fraction prevents bone loss in aged ovariectomised rats by reducing bone resorption.
      Furthermore, in human volunteers, a supplementation with the specific milk protein fraction
      maintains balanced bone remodelling and increase bone mineral density. For example, in
      healthy postmenopausal women, it has been reported that a mean rate of gain of lumbar BMD in
      the MPF group (1.21%) was significantly higher than in placebo group (-0.66%; p<0.05).

      The objective of this study is to assess the efficacy of daily consumption of the milk
      proteins fraction on bone mineral density improvement in healthy postmenopausal women.
    


Intervention name(s): Milk proteins fraction
Intervention type(s): Dietary Supplement
Intervention description(s): capsules, one per day, 24 months
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Venticute in Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment (BY2001/M1-007)
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to demonstrate that administration of Venticute increases survival of patients with
      pneumonia or aspiration of gastric contents leading to intubation, mechanical ventilation,
      and severe oxygenation impairment.
    


Intervention name(s): Venticute
Intervention type(s): Drug
Intervention description(s): Patients With Pneumonia or Aspiration of Gastric Contents and Intubation/Ventilation/Oxygenation Impairment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Aspiration of gastric contents
The Effect of Amiloride and Spironolactone in Healthy Persons
Condition: High Blood Pressure
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate whether retaining potassium in the body will lead to changes in
      blood pressure and changes in blood and urine samples.
    

Detailed description: 
      The purpose is to measure the effect of amiloride and spironolactone on:

        1. Renal function (GFR, u-AQP2, u-ENaCβ, u-cAMP, u-PGE2, CH20, FENa, FEK),

        2. Pulsbewave velocity, augmentation index and central blood pressure,

        3. Vasoactive hormones (PRC, AngII, Aldo, AVP, ANP, BNP and Endot), and

        4. Ambulatory blood pressure
    

Intervention name(s): Amiloride; Spironolactone; Placebo; Placebo and spironolactone; Spironolactone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet twice a day; 1 tablet twice a day; Placebo; 5mg twice daily; 25mg twice daily
Intervention MeSH terms: Amiloride; Spironolactone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of a Stretching Protocol in Patients With Hip Osteoarthritis
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      Hip osteoarthritis (OA) is one of the most prevalent chronic disease in the world. Clinical
      guidelines recommend non-pharmacological conservative treatments for the management of OA.
      Hip flexors seems to play an important role in the development of hip OA but there is no
      published studies evaluating the results of a stretching protocol of hip flexors in hip OA
      patients.

      The objective of this trial is to evaluate if a stretching protocol of hip flexors is more
      effective in symptoms, functional capacity , range of motion, strength, muscular length, pain
      threshold and anxiety and depression compared to control.

      For this purpose the investigators conduct a single-group, pretest-posttest clinical
      trial.The investigators included patients diagnosed of hip osteoarthritis Grade I-III by
      Scale of Kellgren and Lawrence.

      The variables are measured at the beginning and at the end of treatment of the control phase,
      and at the end of the stretching protocol phase.
    


Intervention name(s): Hip flexors stretching protocol
Intervention type(s): Other
Intervention description(s): Stretching protocol of rectus femoris, vastus lateralis and iliopsoas according to Kaltenborn- Evjenth Orthopaedic Manual Therapy Concept (OMT)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hip Osteoarthritis; Manual therapy; physiotherapy
Esomeprazole for Treatment of GERD in Pediatric Patients
Condition: Gastroesophageal Reflux Disease (GERD); Erosive Esophagitis; Non-erosive Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis
Study type: Interventional
Phase: Phase 4

Summary: 
      To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in
      children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis")
      caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy.

      To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the
      lining of the food pipe.

      To collect information that will describe the psychological, social, and economic effects on
      the primary caregiver of raising children ages 1 to 5 years old with GERD.
    


Intervention name(s): Esomeprazole (Nexium)
Intervention type(s): Drug
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
LCS12 Adolescent Study
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will assess the safety of a sex hormone (levonorgestrel) releasing T-shaped
      intrauterine contraceptive system in female adolescents under 18 years of age. Approximately
      300 generally healthy, post-menarcheal female adolescents with regular menses at the
      beginning of the study requiring contraception will be enrolled into the study.

      Duration of study treatment is approximately 12 months with an option to continue the use of
      the contraceptive system up to three years if the woman is willing to continue the use after
      the first 12 months.

      The incidence of adverse events over 12 month treatment period will be the main outcome of
      this study. Also the efficacy (number of pregnancies), discontinuation rate and
      pharmacokinetics will be evaluated.
    


Intervention name(s): Skyla (Levonorgestrel, BAY86-5028)
Intervention type(s): Drug
Intervention description(s): Levonorgestrel intrauterine contraceptive system (LCS12) insertion into the uterus at insertion visit 2 with the study treatment of 12 months. An optional follow up phase up to 3 years will be offered for all subjects completing 12 month treatment time.
Intervention MeSH terms: Levonorgestrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intrauterine; contraception; adolescent
Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of
      efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in combination with
      methotrexate in patients with active rheumatoid arthritis.
    


Intervention name(s): BCD-055; Remicade®; Methotrexate; Folic acid
Intervention type(s): Biological; Biological; Drug; Drug
Intervention description(s): BCD-055 is infliximab biosimilar; All patients will receive methotrexate in a dose from 10 to 25 mg per week.; All patients will receive folic acid in a dose of 5 mg per week.
Other intervention name(s): infliximab; infliximab
Intervention MeSH terms: Folic Acid; Infliximab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment