bioihbjkbjnl/mcl2 huggingface dataset:
Investigating the Acute Effects of Blueberry (Poly)Phenols on Vascular Function and Cognition in Healthy Individuals.
Condition: Healthy
Study type: Interventional

Summary: 
      This study aims to determine the effect of blueberry (poly)phenol vs placebo on vascular
      function and cognitive performance with an insight into cerebral blood flow velocity changes,
      across all ages of the general healthy population.
    

Detailed description: 
      Foods rich in certain (poly)phenols, particularly flavonoids, such as berries, have been
      shown to improve measures of vascular function as well as cognitive performance in human
      intervention studies. Blueberries are rich in anthocyanins, a subclass of flavonoids that
      have been widely linked to health benefits, particularly improvements in endothelial
      function. Research have previously shown that blueberries improve executive functioning and
      memory in both healthy adults and children. These improvements were seen within 2-5 hours
      post-consumption of blueberries, a time-course that positively correlates with improvements
      in vascular function (measured as flow-mediated dilation). This indicates that increases in
      blood flow may influence improvements in cognitive performance. To date no study has
      investigated whether blueberry consumption can induce an increase in cerebral blood flow,
      with subsequent improvements in vascular and cognitive function. In this study, investigators
      aim to directly link wild blueberry consumption with increased vascular and cerebral blood
      flow and positive cognitive outcomes in healthy individuals through the life course, between
      the ages of 8 and 80 years old. Investigators will use a large group of healthy subjects
      representative of the general public over a wide age range in males and females to evaluate
      the generalisability of the health benefits of blueberry consumption.
    

Intervention name(s): Wild Blueberry Powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Freeze-dried whole fruit blueberry drink.; Freeze-dried placebo powder
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, cross-over, double-blind, placebo-controlled study.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: (Poly)phenols; Blueberries; Anthocyanins; Cognitive function; Vascular function
Effects of Inspiratory Muscle Training in Pulmonary Hypertensive Patient
Condition: Inspiratory Muscle Training
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Although the progressive nature of pulmonary hypertension (PH), including the impairment of
      respiratory muscle function, studies have demonstrated beneficial effects of physical
      exercise on the functional limitations caused by the disease in this population, being an
      important collaborator to the conventional drug therapy.Respiratory muscle training (RMT)
      improves functional capacity and quality of life (QoL) in patients.A randomized controlled
      trial was conducted to evaluate the effectiveness of this protocol on respiratory muscle
      strength and endurance, functional capacity. 18 subjects were allocated in 2 groups, group A
      was control group and group B was experimental group. Group A or Control group received deep
      breathing exercises. Group B received 30 minutes of IMT 6days weekly for 2 weeks by using a
      pressure threshold device. The purpose of this study was to investigate the effects of
      inspiratory muscle training (IMT) in PAH. To evaluate effectiveness of IMT mouth pressure
      device ,functional capacity using 6 minute walking test (6MWT)health assessment via SF 36
      questionnaire were used before and after training protocol.
    


Intervention name(s): Deep Breathing Exercise; Inspiratory muscle Training
Intervention type(s): Other; Other
Intervention description(s): control groups received deep breathing exercise 6 days a week for two weeks. Deep breathing exercises includes diaphragmatic breathing and pursed lip breathing.; Treatment group received inspiratory muscle training 20 minutes 6 days a week for two weeks.IMT was done by using pressure threshold device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Structured Exercise Training Program Versus Hypocaloric Hyperproteic Diet in Obese Anovulatory Infertile Patients With PCOS
Condition: Polycystic Ovary Syndrome; Anovulation; Infertility
MeSH terms: Polycystic Ovary Syndrome; Infertility; Anovulation; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Lifestyle modifications are successfully employed in polycystic ovarian syndrome (PCOS)
      improving menstrual cycles and fertility. Unfortunately, the compliance over the time is very
      low. Recently, we have showed a high adherence to structured exercise training (SET) program
      in women with PCOS. The current study will be aimed to compare the efficacy of the SET
      program with a diet program on the reproductive function in obese anovulatory infertile PCOS
      patients.
    

Detailed description: 
      Forty obese anovulatory infertile PCOS patients who wish to conceive will be allocated in two
      study-groups according to their desire: structured exercise training (SET) group (n. 20) will
      undergo a SET program, whereas diet group (n. 20) will undertake a hypocaloric hyperproteic
      diet. The duration of the study will be of 24 weeks. At baseline, after 12 and 24 weeks
      clinical, endocrine and metabolic evaluations will be performed in each patient and all
      reproductive events obtained throughout the study will be recorded.
    

Intervention name(s): Structured exercise training; Hypocaloric hyperproteic diet
Intervention type(s): Behavioral; Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Structured exercise training program; Infertility; Menstrual cycle; PCOS; Treatment
Comparative Efficiency of Three Regimen, CEFci, CEF and EC as Neoadjuvant Chemotherapy for Primary Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV, prospective, single-center, open-label, randomized, controlled study.
      Eligible patients are randomly assigned into three groups. The investigators propose to
      evaluate and compare the efficacy and safety of different neoadjuvant chemotherapies in women
      with primary breast cancer.
    


Intervention name(s): 5-FU（intravenous infusion）+epirubicin+cyclophosphamide; 5-FU（intravenous bolus）+epirubicin+cyclophosphamide; epirubicin+cyclophosphamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5-FU 200mg/m2 per day from day 1 to day 28 （Continuous intravenous infusion）; epirubicin 65mg/m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed; 5-FU 500mg/m2 per day on day 1 and day 8（intravenous bolus）; epirubicin 65mg /m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed.; epirubicin 65mg/m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed.
Other intervention name(s): CEFci; CEF; EC
Intervention MeSH terms: Cyclophosphamide; Fluorouracil; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary Breast Cancer
Rapid Biochemical Diagnostics of Traumatic Brain Injury
Condition: Traumatic Brain Injury; Concussion, Mild; Bone Fracture
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries; Fractures, Bone
Study type: Interventional

Summary: 
      The objective of the study is to confirm the clinical relevance of the novel biomarker for
      traumatic brain injury (TBI) detection. Samples of blood, urine and saliva will be collected
      from a) patients with suspected TBI (isolated), b) patients with orthopedic injury, and c)
      healthy controls. The sponsor will do biochemical investigations for the samples to evaluate
      the presence, level and structure of the targeted biomarker.
    

Detailed description: 
      The study will analyze and compare the levels of certain biomolecules and cellular
      degradation products which are released upon a brain injury and which become detectable in
      the body fluids. Patients with a traumatic brain injury are supposed to express these
      biomarkers in their body fluids while orthopedic trauma patients and healthy controls are
      supposed to be undetectable with respect to these biomolecules. The study is a case-control
      study where the study subjects with a property (injured) are compared to subjects without the
      property (healthy). The brain injury patient group will consist of subjects who entered the
      Emergency Department of the hospital with a suspected TBI. The orthopedic patient group will
      consists of patients who were admitted with a bone fracture in the limbs, but without a
      suspected TBI. The control group will consist of healthy subjects who will be recruited to
      the study by the activities of the study personnel.

      The entire study is split into two successive parts. In the first Part I, 18 - 24 subjects
      will be recruited in each group. In the second part, the number of the patients with
      suspected TBI will be added to up to 100 in order to receive an adequate number of samples
      and to gain sufficient statistical significance between the brain injury severities and in
      successive sampling time points.

      The collected samples and relevant clinical data of each subject will be supplied to the
      sponsor who will perform to the samples 1) Biochemical analysis for the presence and level of
      the biomarker, and 2) Biomarker profiling and structure analysis by LC/MS.
    

Intervention name(s): Sample collection
Intervention type(s): Diagnostic Test
Intervention description(s): Samples of blood, urine and saliva will be collected at up to five successive time points.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Total of 160 patients Phase 2a, 60 patients divided in three groups with TBI, orthopedic injury, and healthy volunteers (controls).
Phase 2b: 100 patients with concussion and mild traumatic brain injury.
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: TBI; Mild traumatic brain injury; Concussion; Diagnostics; Rapid test; Traumatic Brain Injury; mTBI
Safety and Tolerability of NN9068 in Healthy Male Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate the
      safety, tolerability, level of drug exposure and effect of NN9068.

      The trial participants will be randomised to 4 different treatments in trial, receiving trial
      products in a pre-defined order.
    


Intervention name(s): insulin degludec/liraglutide; insulin degludec; liraglutide; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single, simultaneous dose of NN9068, injected s.c. (under the skin); Single, simultaneous dose of NN1250, injected s.c. (under the skin); Single, simultaneous dose of NN2211, injected s.c. (under the skin); Single, simultaneous dose of placebo, injected s.c. (under the skin)
Other intervention name(s): NN9068; NN1250; NN2211
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Liraglutide; Insulin, Long-Acting; Xultophy
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Conservative Treatment in Patients With Symptomatic Femoroacetabular Impingement
Condition: Symptomatic Femoroacetabular Impingement
MeSH terms: Femoracetabular Impingement
Study type: Interventional

Summary: 
      This is a single-group, prospective, intervention study. A total of 30 participants with
      unilateral symptomatic femoroacetabular impingement will be included into the study. The
      intervention consists in neuromuscular training for the lower limb muscles (12 weeks, 2
      times/week supervised training, 2 times/week home training). The training includes physical
      exercises routinely used worldwide in clinical settings. No control intervention group was
      included into the study because nowadays there is no standard conservative treatment for
      patients with symptomatic femoroacetabular impingement. Assessments will be performed at (1)
      baseline, (2) mid-intervention, (3) end-intervention, and (4) follow-up. Clinical,
      functional, neuromuscular and self-reported parameters will be collected during assessments.
    


Intervention name(s): Neuromuscular training
Intervention type(s): Other
Intervention description(s): Neuromuscular training for the hip and lower limb muscles.The training program is divided into 3 phases, and includes specific exercises for improving the hip range of motion, muscle strength of the hip and lower limb muscles, as well as the trunk stability and coordination. The intervention lasts 12 weeks. Patients will train 2 times/week with a physical therapist and 2 times/weeks alone at home.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range
Condition: Aging
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to assess subjects' satisfaction linked to the pan facial management
      of rejuvenation with injections of Azzalure® and Restylane® fillers.

      This will be an open, multi-centre study.
    


Intervention name(s): Botulinum Toxin Type A (Azzalure); Restylane ranges
Intervention type(s): Drug; Device
Intervention description(s): Powder for solution for injection; Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Candidate Gene Association Study With Injury in Elite Male Youth Football Players
Condition: Injuries; Genetic Change
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      Understanding how candidate genes, previously associated with injury susceptibility,
      influence the incidence of muscle, bone, ligament, and tendon injuries across the development
      pathway of elite footballers may provide valuable insight into inherent injury predisposition
      to support the long-term development of every individual. Therefore, the aim of the present
      study was to investigate the association between candidate genetic variants and muscle, bone,
      ligament, and tendon injuries in elite football with sub-analysis of the influence of age and
      maturation on injury susceptibility.
    

Detailed description: 
      Genetic variants in several candidate genes which code for structural constituents (COL1A1
      rs1800012, COL1A2 rs412777, COL5A1 rs12722 and ACTN3 rs1815739), regulatory components (ACE
      rs1799752, ESR1 rs2234693 and MMP3 rs679620) and transcription factors (VDR rs2228570 and
      GDF5 rs143383) affecting the form, function and injury susceptibility of muscle, bone,
      ligament, and tendon tissue will be associated with overall injury, non-contact, bone,
      ligament, tendon and apophysitis injury risk in elite male youth and adult footballers.
    

Intervention name(s): Genetic variants
Intervention type(s): Genetic
Intervention description(s): COL1A1 rs1800012, COL1A2 rs412777, COL5A1 rs12722, ACTN3 rs1815739, ACE rs1799752, ESR1 rs2234693, MMP3 rs679620, VDR rs2228570 and GDF5 rs143383
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Elite male youth football players
      
Biospecimen description: 
      DNA
    
Keywords: SNP; Apophysitis; Fracture; Strain; Sprain; Genetic; Injury
Trial of Low Field Magnetic Stimulation Augmentation of Antidepressant Therapy in Treatment-Resistant Depression
Condition: Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional

Summary: 
      This study is looking at the safety and efficacy of low field magnetic stimulation (LFMS) for
      treating patients with treatment resistant depression who are taking an antidepressant that
      is not working for them.
    


Intervention name(s): Low Field Magnetic Stimulation (LFMS); Sham LFMS
Intervention type(s): Device; Device
Intervention description(s): The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.; Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Treatment Resistant Depression
A Study of Transcranial Direct Current Stimulation (tDCS) to Treat Depression
Condition: Depressive Disorder, Major; Bipolar Disorder
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Depression is a common illness with an approximate lifetime prevalence of 17 %, conferring a
      large burden of disease in the community, often due to inadequate treatment. Thus there is
      interest in the therapeutic potential of non invasive, novel forms of brain stimulation, such
      as transcranial direct current stimulation (tDCS). Two small studies have been published in
      the last two years indicating that 20 minutes of either 1 or 2mA tDCS over 5 or 10 sessions
      is safe, painless and well tolerated. The investigators' own pilot data (N=30) also suggests
      the technique has antidepressant effects and is safe (5-10 sessions of tDCS at 1 mA).

      This study will extend previous findings, testing a more definitive tDCS approach (also left
      prefrontal anodal stimulation) with a longer treatment course (15 sessions), at 2 mA (which
      has been found to be safe and more effective than 1 mA in cognitive studies), and in a larger
      sample (N=68), using a placebo-controlled design.

      It is hypothesised that active tDCS (15 sessions) will have greater efficacy than sham
      treatment (15 sessions) in reducing the severity of depressive symptoms in patients in an
      episode of major depression. A second hypothesis is that 15 sessions of tDCS will not cause
      any significant adverse effects or cause decline in neuropsychological functioning in
      comparison to a sham control.
    


Intervention name(s): Transcranial direct current stimulation
Intervention type(s): Device
Intervention description(s): tDCS will be given every weekday. For each session, tDCS will be given continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm, 35 cm2) covered by sponges soaked in saline will be used, held in place by a head band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash as described in the safety section above). For sham stimulation, the current will be left on for another 30s, then gradually reduced to zero over another 30 seconds, so that the initial tingling sensation experienced by subjects will be identical for the two groups. The stimulator will be placed behind the subject's head so any adjustments to the current by the operator are not evident. This sham procedure resulted in successful blinding in our pilot study.
Other intervention name(s): Eldith DC-Stimulator (CE certified)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Treatment; Transcranial direct current stimulation
BE Study of the Combinations of Gemigliptin 50mg and Metformin HCl Extended Release 1000mg in Comparison to Each Component Administered Alone.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the safety/tolerability and pharmacokinetics of the combinations of
      gemigliptin 50mg and metformin HCl extended release 1000mg in comparison to each component
      administered in healthy male volunteers.
    


Intervention name(s): gemigliptin and metformin HCl extended release; gemigliptin/metformin HCl sustained release
Intervention type(s): Drug; Drug
Intervention description(s): Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day; Administration of combination of gemigliptin 50mg/metformin HCl sustained release 1000mg, for 1day.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Internet-based Group Contingency Management to Promote Smoking Abstinence
Condition: Cigarette Smoking
Study type: Interventional

Summary: 
      The purpose of the study is to develop and test an Internet-based group contingency
      management program designed to promote smoking cessation.
    


Intervention name(s): Full Group Contingency; Mixed Group Contingency
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This group (n = 20) will earn vouchers based only on team (n = 4) performance. Only if all members of the team submit a negative sample (CO ≤ 4 ppm), will they each earn a voucher.; This group (n = 20) will earn vouchers based on both individual and team (n = 4) performance. If an individual submits a negative sample (CO ≤ 4 ppm), s/he will earn a voucher. Additionally, bonus vouchers will be earned if all team members submit negative samples.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Cigarette; Smoking; Nicotine; Contingency Management; Voucher Reinforcement; Smoking Abstinence; Internet; Internet-based Treatment; Group Contingencies