bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers.
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study will evaluate the concomitant administration of a Quadrivalent Inactivated
      Influenza Vaccine with the highest dose level of OVX836 (480µg) tested in the clinic to date,
      for which the likelihood for interference with Quadrivalent Inactivated Influenza Vaccine is
      considered the highest.
    

Detailed description: 
      This trial is a Phase 2a, randomized, double-blind, controlled study in 180 adult subjects to
      compare the immunogenicity and the safety of the concomitant administration (given
      intramuscularly, in healthy subjects, as 2 separate injections in the same arm) of:

        -  OVX836 influenza vaccine and a Quadrivalent Inactivated Influenza Vaccine

        -  Quadrivalent Inactivated Influenza Vaccine and placebo

        -  OVX836 influenza vaccine and placebo
    

Intervention name(s): OVX836 480µg; Quadrivalent Inactivated Influenza Vaccine (Fluarix® Tetra); Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One single administration intramuscularly at Day 1; One single administration intramuscularly at Day 1; One single administration intramuscularly at Day 1
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized assignment (1:1:1) into 3 groups of 60 subjects to receive:
First group: OVX836 480µg and Quadrivalent Inactivated Influenza Vaccine at commercial dose administered
Second group: Quadrivalent Inactivated Influenza Vaccine at commercial dose, concomitantly administered with placebo
Third group: OVX836 480µg, concomitantly administered with placebo
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study of Resistance Strengthening Versus Ambulation Post-Liver Transplant
Condition: Liver Transplantation; Resistance Training; Activities of Daily Living
Study type: Interventional

Summary: 
      Resistance strengthening exercise will increase strength and functional activity greater than
      ambulation in subjects post-liver transplantation.
    

Detailed description: 
      Individuals post liver transplantation are significantly muscle wasted due to chronic liver
      disease. Current Usual care only involves progressive ambulation. Resistance exercise
      targeted at the lower extremities are anticipated to increase muscle strength in the muscles
      that extend the hip, extend the knee, and plantar flex the ankle more than seen with the
      usual care ambulation. The anticipated increases in strength should improve functional
      performance of activities such as standing from a chair, walking, and climbing stairs. The
      improvement in strength and functional performance should improve an individuals quality of
      life.
    

Intervention name(s): Resistance Strengthening Exercise Program
Intervention type(s): Other
Intervention description(s): Home exercise Program. 3-4 days a week. 30 minutes a session. 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Muscle Wasting; Strengthening; Liver Disease; Transplant
Effects of 10 mg Monacolins on Vascular Health: a Clinical Trial
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      This will be a double-blind randomized clinical trial carried out on subjects with suboptimal
      control of LDL-cholesterolemia, following a Mediterranean diet, and treated with a red yeast
      rice extract (containing 10 mg monacolin K per daily dose) or placebo, in order to evaluate
      the middle-term effects on vascular health evaluated by non invasive methods (Vicorder(R)
      apparatus)
    


Intervention name(s): Red yeast rice; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 capsule to be taken before to sleep, each day, for 6 months
Intervention MeSH terms: Red yeast rice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Early Pregnancy Antioxidant Supplementation in the Prevention of Preeclampsia
Condition: Preeclampsia; Pregnancy Loss
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      Use of Juice Plus+ food supplements, when initiated in the first trimester and used
      continuously thereafter, will result in a lower incidence of preeclampsia and pregnancy
      complications. This is a prospective randomized and blinded placebo controlled study
      sponsored by NSA, LLC of Memphis, TN.
    

Detailed description: 
      Not desired
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients cared for in the University of Mississippi Medical Center
      
Biospecimen description: 
      Blood to be analyzed for various markers, then discarded, none to be retained.
    
Keywords: Preeclampsia; Prevention; Food Supplement
Clinical Efficacy and Tolerability of Two FSH Preparations (Human FSH Versus rFSH - Follitropin Alpha) in Women Undergoing IVF
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the clinical efficacy and general tolerability of two
      different subcutaneous FSH preparations (Fostimon®, IBSA vs Gonal-F®, Serono Inc.) when
      administered to patients undergoing controlled ovarian stimulation for IVF.
    

Detailed description: 
      This is a prospective, multicenter, investigator blinded, randomized, concurrent control,
      phase III clinical trial. Patients meeting the eligibility requirements of the study will be
      randomly assigned to receive either the test drug (Fostimon®, IBSA) or the reference drug
      (Gonal-F®, Serono Inc.). Investigators will be blinded by not allowing them to have any
      contact with the study medications (supplied in boxes labeled in a manner that does not
      reveal the content of the boxes), and requesting that patients do not make any statements to
      the investigator that might indicate the treatment to which they were assigned. Equivalence
      testing with regard to the primary outcome variable will establish whether the two treatments
      are indeed similarly effective.
    

Intervention name(s): FSH-IBSA; GONAL-F
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Infertility, FSH, IVF, Ovarian stimulation
Study Evaluating Combination of Levonorgestrel (LNG) and Ethinyl Estradiol (EE) in Premenstrual Dysphoric Disorder
Condition: Menstruation Disturbances; Premenstrual Syndrome
MeSH terms: Premenstrual Syndrome; Premenstrual Dysphoric Disorder; Menstruation Disturbances
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether levonorgestrel (LNG)/ethinyl estradiol (EE)
      is effective in treating the symptoms of severe premenstrual syndrome (PMS).
    


Intervention name(s): levonorgestrel/ethinyl estradiol
Intervention type(s): Drug
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Premenstrual Syndrome (PMS); Hormone Therapy
The Health Effect of Diet Rich in Nordic Berries
Condition: Metabolic Syndrome; Impaired Glucose Tolerance; Low-grade Inflammation; Dyslipidemia
MeSH terms: Metabolic Syndrome; Dyslipidemias; Glucose Intolerance; Inflammation
Study type: Interventional

Summary: 
      Dietary polyphenols might have beneficial effects on glucose and lipid metabolism based on
      the studies made in animals or cell cultures. The findings regarding the possible decrease of
      low-grade inflammation are existing also in humans. Low-grade inflammation has been suggested
      to be a mechanistic link between obesity and its consequences on cardiometabolic health. The
      aim of the present study is to examine the effect of diet rich in berries on glucose and
      lipid metabolism and inflammatory markers.
    

Detailed description: 
      Berries are traditionally an important part of the Nordic diet. About 50 different berries
      are grown in the northern region, and about half of them are edible. Phenolic compounds are
      one of the most diverse group of secondary metabolites present in edible plants, and berries
      are especially rich in them. Flavonoids, phenolic acids, lignans and complex phenolic
      polymers (polymeric tannins) are typical for berries. Phenolic compounds are reported to have
      a variety of beneficial biological properties. They are potent antioxidants, and exhibit
      various other physiological activities including anti-inflammatory, antimicrobial,
      antiallergic, anticarcinogenic and antihypertensive activities. Epidemiological studies
      indicate that diet rich in phenolic compound correlates with lower risk of cancer and
      cardiovascular disease.

      The aim of the present study is to examine the effect of diet rich in berries on glucose and
      lipid metabolism and inflammatory markers and gene expression profile in peripheral blood
      mononuclear cells (PBMCs) in subjects with features of metabolic syndrome.

      Randomized, controlled clinical intervention including 4 wk run-in period, 8 wk dietary
      intervention and 4 wk recovery period was conducted.
    

Intervention name(s): 300 g of strawberry, raspberry and cloudberry; 400 g of bilberry; Control diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 100 g of strawberry puree, 100 g of frozen raspberries and 100 g frozen cloudberries were concumed daily for 8 weeks. Bilberry consumption was restricted.; Equivalent amount to 400 g of fresh bilberries were consumed as 40 g of dried bilberries and as 200 g of frozen bilberries. Restriction of use of strawberries, raspberries and cloudberries were set.; Control diet, ie. habitual diet with restriction of berry consumption was consumed for eight weeks
Other intervention name(s): Diet with restricted consumption of berries.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bilberry; Vaccinium myrtillus; Metabolic syndrome; Glucose metabolism; Lipid metabolism; Inflammation; Gene expression
A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) Patients
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      A safety extension study to evaluate the long-term safety of QGE031 240 mg s.c. given every 4
      weeks for 52 weeks in Chronic Spontaneous Urticaria (CSU) patients who completed study
      CQGE031C2201
    

Detailed description: 
      A safety extension study to evaluate the long-term safety of QGE031 in Chronic Spontaneous
      Urticaria patients
    

Intervention name(s): Ligelizumab
Intervention type(s): Biological
Intervention description(s): QGE031 240 mg s.c. q4w
Other intervention name(s): QGE031
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: QGE031; chronic; spontaneous; Urticaria; CSU; adults; Safety; ligelizumab
Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus
      formation. The purpose of this study is to assess the effects of preoperative continuation of
      aspirin on platelet activation after off pump coronary artery bypass surgery.
    

Detailed description: 
      Patients undergoing OPCAB surgery will be randomized to continue preoperative aspirin or
      discontinue aspirin before surgery.

      Platelet activation can be evaluated by measuring platelet p-selectin using flowcytometry. In
      this study, we will compare platelet-activated markers and conventional coagulation tests.
    

Intervention name(s): aspirin continuation; aspirin discontinuation
Intervention type(s): Drug; Drug
Intervention description(s): Patients are randomized to continue aspirin before OPCAB surgery.; Patients are randomized to discontinue aspirin more than 4 days before OPCAB surgery.
Other intervention name(s): Low-dose aspirin (< 100mg/day)
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Keywords: preoperative aspirin use; platelet activation; off pump coronary artery bypass
A Prospective, Randomized Clinical Study on the Effects of Casein Phosphopeptide-amorphous Calcium Phosphate (CPP-ACP) Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 1
Condition: Early Caries Lesions
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      Influence of CPP-ACP paste on the evolution and appearance of white spot lesions in
      orthodontic patients after removal of the fixed appliances.
    


Intervention name(s): CPP-ACP (GC Tooth Mousse); CPP-ACP (GC MI Paste Plus)
Intervention type(s): Device; Device
Intervention description(s): Calcium and phosphate; Calcium, phosphate and fluoride
Intervention MeSH terms: 6-chloro-2-(1-piperazinyl)pyrazine; Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Shroom Tech Sport Supplementation and Concurrent Training
Condition: Body Composition; Performance Measures; Hormone Profiles; Blood Lipid Profiles
Study type: Interventional

Summary: 
      This study will examine how the supplement Shroom Tech Sport (STS) affects body composition
      and different performance and health measures over the course of 12 weeks. The supplement
      will be combined with a concurrent training regime consisting of resistance and high
      intensity interval training. Subjects will be tested for percent body fat to determine body
      composition. Further, they will also be tested for maximal strength (squat and bench),
      maximal power output and fatigue, lactate threshold and maximal oxygen volume consumption
      (VO2max). And finally, subjects will be tested for health and hormone markers in the blood.
      All of these measures will be compared against a placebo group participating in the same
      exercise intervention.
    


Intervention name(s): Shroom Tech Sport; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): STS will be given every day in accordance to company guidelines for 12 weeks.; Placebo will be given in the same fashion as the STS pills guidelines for 12 weeks.
Other intervention name(s): STS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A 12-week training model with testing weeks at baseline, mid point (week 7) and post-training.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Multi-ingredient performance supplement, High Intensity Interval Training, Concurrent training
The Impact of Reformulated Foods on Cardiovascular Risk Factors
Condition: Type 2 Diabetes Mellitus; Cardiovascular Disease; Obesity
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Specific policies on obesity reduction often include a recommendation to reduce sugar
      consumption as a means of lowering overall caloric intake. Reformulating processed foods
      (e.g. sugary products) is considered one of the key options for improving population diet.
      The implications of regular consumption of reformulated products are not fully understood.
      Previous studies have demonstrated that dietary compensation is common, although the extent
      is not fully elucidated. In addition to the perceived impact of sugar consumption on weight
      control, high sugar intake, specifically sucrose and fructose, has been implicated in the
      increase of plasma lipids and markers of insulin resistance. However to date no randomised
      controlled study has investigated whether the consumption of reformulated low sugar products
      as components of a habitual diet have a significant impact on plasma lipid, insulin or
      glucose concentrations within a free-living, non-diseased population. It is hypothesised that
      exchange of reformulated, low sugar food products for habitually consumed foods will result
      in dietary compensation and minimal weight change compared with unmodified products and will
      have little impact on plasma glucose, insulin and lipid levels.
    


Intervention name(s): Reformulated products; Conventional products
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks. Subjects were provided with reformulated beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.; Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks. Subjects were provided with conventional beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
Other intervention name(s): REF; CON
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Evaluation of the Ulthera System for Treating Axillary Hyperhidrosis
Condition: Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional

Summary: 
      To evaluate the Ulthera System and the 7-3.0mm transducer for treating axillary
      hyperhidrosis.
    


Intervention name(s): Microfocused ultrasound with visualization
Intervention type(s): Device
Intervention description(s): Subjects will receive 2 treatments (day 1 and day 30), each at a 3.0mm depth and 0.30 Joule of energy. Treatment will be delivered in a 3*4 grid, 12 treatment squares, delivering 60 lines of treatment per square, i.e., 720 lines per axilla in each treatment (1440 lines total per treatment.)
Other intervention name(s): Ultherapy; Ulthera treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)
Condition: Otitis Media
MeSH terms: Otitis Media
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate Pulmozyme® (dornase) as compared to a standard ear
      drop Floxin® (ofloxicin) to dissolve clogged tubes. This study will monitor the use of the
      new drug for any problems related to the medication. Patients are being asked to be in this
      study because they had tubes placed for the treatment of chronic ear infection and the
      tube(s) are now clogged. Clogged tubes are a common problem found in children with tubes.
      This problem occasionally is improved with ear drops like Floxin®. However, it is frequently
      not improved even after this standard ear drop treatment.
    

Detailed description: 
      The success in treating blocked tubes may relate to the ability to dissolve the material
      clogging the tube as well as dealing with the thick fluid in the middle-ear. The reasoning
      behind this study is that the use of Pulmozyme® may be able to treat both of these problems.
      Pulmozyme® was approved by the FDA in 1994 for the treatment of cystic fibrosis patients.
      Infections present in airway (lung) secretions of cystic fibrosis patients and the material
      that plugs ear tubes are in some ways the same. "Off-label" use of a drug is the practice by
      physicians to use a FDA-approved drug in treating conditions other than what the original
      approval was intended for. Pulmozyme® has been used to treat other lung diseases not related
      to cystic fibrosis. There has been no published report on the use of Pulmozyme® to treat ear
      infections. This study is a clinical trial that compares two treatments and will last for 3
      months.
    

Intervention name(s): dornase alfa (Pulmozyme®)
Intervention type(s): Drug
Intervention description(s): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: clogged ear tubes
Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      - To demonstrate the superiority of glimepiride and metformin free combination in comparison
      to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment
      period in patients with type 2 diabetes mellitus.

      Secondary Objectives:

      - To assess the effects of the free combination of glimepiride and metformin in comparison to
      glimepiride or metformin alone on:

        -  Percentage of patients reaching HbA1c < 7%

        -  Percentage of patients reaching HbA1c < 6.5%

        -  Fasting Plasma Glucose (FPG)

        -  Safety and tolerability
    

Detailed description: 
      The study duration for each patient is approximately 27 weeks with 3 periods: 2-week
      screening period followed by 24-week treatment period where patient is assigned to one of the
      three arms according to randomization, and 3 days follow-up period with a last call phone
      visit.
    

Intervention name(s): GLIMEPIRIDE; METFORMIN
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: oral
Route of administration: oral; Pharmaceutical form: oral
Route of administration: oral
Other intervention name(s): HOE490
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment