bioihbjkbjnl/mcl2 huggingface dataset:
Caffeine Supplementation, Resistance Training and Blood Antioxidant Status
Condition: Caffeine
Study type: Interventional

Summary: 
      The purpose of this study is to verify the effect of acute caffeine intake on resistance
      training volume and blood antioxidant status, in a randomised, double-blind,
      placebo-controlled crossover trial.
    

Detailed description: 
      Caffeine is one of the most commonly consumed psychoactive substances in the world. Several
      previous studies confirmed that caffeine improves several aspects of exercise performance,
      including resistance training outcomes. Interestingly, caffeine and its catabolic products,
      theobromine and xanthine, exhibit antioxidant and prooxidant properties. Additionally,
      resistance training promotes the generation of reactive oxygen species, which are important
      for the cellular adaptation process.

      Hovewer, to the best of our knowledge, there is no information as to how caffeine combined
      with resistance training affects blood antioxidant status. Therefore, the aim of this study
      was to examine acute effects of caffeine supplementation on resistance training volume and
      blood antioxidant status in resistance trained men.
    

Intervention name(s): Caffeine supplementation; Placebo treatment
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Two identical experimental sessions with a one-week interval between sessions (to allow complete recovery and ensure substance wash-out) will be taken. During the experimental sessions, participants will ingest caffeine in dose of 3 mg/kg of body mass. Caffeine will be provided in capsules containing the individual amount of caffeine and will be administered orally 60 min before the onset of the exercise protocol.; The experimental procedure for each particpant will include placebo supplementation. The manufacturer of the caffeine capsules will also prepare identical placebo capsules filled out with a microcrystalline cellulose. Placebo will be administered orally 60 min before the onset of the exercise protocol.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sports performance, resistance training, nutrition, athlete
A Study of a GLP-1 Analogue in Patients With Type 2 Diabetes Treated With Metformin.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This 6 arm study will evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of
      multiple doses and regimens of a GLP-1 analogue in patients with type 2 diabetes who are
      treated with a stable dose of metformin. Patients will be randomized to receive either
      subcutaneous placebo, or subcutaneous GLP-1 analogue, 5mg, 10mg or 20mg weekly, or 10mg or
      20mg every 2 weeks. All patients will continue on their existing metformin treatment regimen
      throughout the study. The anticipated time on study treatment is <3 months, and the target
      sample size is 100-500 individuals.
    


Intervention name(s): Placebo; taspoglutide; taspoglutide; taspoglutide; taspoglutide; taspoglutide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): sc weekly; 20mg sc weekly; 10mg sc every 2 weeks; 5mg sc weekly; 10mg sc weekly; 20mg sc every 2 weeks
Intervention MeSH terms: Glucagon-Like Peptide 1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current Therapy
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to evaluate safety and tolerability as defined by the
      frequency of the adverse events (AEs) of flu-like symptoms (FLS) [chills, pyrexia, myalgia,
      and asthenia], injection site reactions (ISRs), and injection site reaction pain (ISR-P),
      over 24 weeks of treatment (the active comparator period) with PLEGRIDY 125 microgram (μg)
      subcutaneous (SC) every 2 weeks versus current SC IFN-β therapy in participants with
      Relapsing Remitting Multiple Sclerosis (RRMS).
    


Intervention name(s): peginterferon beta-1a; interferon beta-1a; interferon beta-1b
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SC every 2 weeks; Per Summary of Product Characteristics (SMPC); Per SMPC
Other intervention name(s): PLEGRIDY, BIIB017; Rebif; Betaferon, Extavia
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Interferon beta-1b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Effects of Rehabilitation Using the "Wii" on Upper Limb Kinematics in Chronic Stroke Patients.
Condition: Post-stroke Hemiparetic Patients (at Least 6 Months Post Stroke); Age Between 18-75 Years
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate changes in strategies of hemiparetic upper limb
      movement in chronic stroke patients following rehabilitation using the "Nintendo Wii". The
      investigators hypothesize that patients will increase their use of compensatory strategies
      following this rehabilitation.
    

Detailed description: 
      The principal aim of this study is to evaluate changes in strategies of hemiparetic upper
      limb movement in chronic stroke patients following twelve one hour sessions of rehabilitation
      using the "Nintendo Wii" over a period of four weeks, and to compare with a group of patients
      receiving traditional upper limb rehabilitation of the same duration. The investigators
      hypothesize that the use of compensatory strategies will increase in the group receiving the
      "Wii" rehabilitation while they will decrease in the group receiving traditional
      rehabilitation. The investigators further hypothesize that this will have an impact on the
      functional benefit with a greater improvement of function in the group receiving traditional
      rehabilitation.
    

Intervention name(s): WII Rehabilitation; Traditional rehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 30 patients will receive "Wii" rehabilitation of 15 minutes (tennis, boxing and golf), in comparison with 10 healthy subjects.; 30 patients will receive the traditional rehabilitation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Hemiparesis,; Rehabilitation,; WII,; Upper limb,; Movement strategies.
Cereal-based Products Fortified With Legumes and Effects on Body Weight Management
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Legumes are high nutritional quality foods and constitute a rich source of proteins and
      dietary fibers which have been associated with appetite regulation and body weight
      management. The purpose of the study is to investigate the effects of regular consumption of
      a cereal-based snack fortified with legumes on body weight reduction.
    

Detailed description: 
      Overweight/obese, non-diabetic subjects will participate in the study. Subjects will follow a
      12-week energy-restricted dietary intervention supplemented with a certain amount of a
      cereal-based snack fortified with legumes daily. The effects of dietary intervention on body
      weight reduction will be examined.
    

Intervention name(s): cereal-legume snack; cereal snack
Intervention type(s): Other; Other
Intervention description(s): cereal-legume biscuit; cereal biscuit
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Overweight/obese non diabetic subjects will follow an energy-restricted diet and supplemented with a cereal-based snack fortified with legumes (intervention group) or a common cereal snack (control group) for 12 weeks. Body weight, anthropometric, clinical and biochemical characteristics will be evaluated at the beginning and at the end of the study.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cereal-based snack fortified with legumes; body weight reduction
People Living With HIV/AIDS, Nitrate, Endotelial Function, Arterial Stiffness and Skeletal Muscle Oxygenation
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      Administration of antiretroviral therapy has brought benefits for infective human
      immunodeficiency virus-1 (HIV-1)-patients, reducing the number of AIDS-related morbidity and
      mortality. However, it is responsible for intensifying complications triggered by the chronic
      inflammatory state associated with virus infection, such as cardiovascular diseases. The
      current study evaluated effects of single dose (140mL) of Beetroot Juice (BJ) on macro and
      microvascular endothelial function in HIV-1-patients undergoing antiretroviral terapy, once
      BJ was shown to be effective in improving these physiological parameters in uninfected
      individuals.
    


Intervention name(s): Beetroot Juice; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 140ml of Beetroot Juice containing on avarege 9 mmol of nitrate; 140ml of Beetroot Juice (nitrate free)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV/AIDS; Arterial stiffness; Flow mediated-dilatation; Muscle oxygenation parameters; Microcirculation; Dietary Nitrate
Combination Therapy With Dalfampridine and Locomotor Training for Chronic, Motor Incomplete Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy, safety, and tolerability of treatment
      with dalfampridine in combination with locomotor training in persons with chronic, motor
      incomplete SCI.
    

Detailed description: 
      Research suggests that combining therapies could result in important gains in restoring
      function and improving quality of life in persons with spinal cord injury (SCI). Locomotor
      training is an activity-dependent rehabilitation therapy that provides repetitive stepping
      facilitated by manual assistance and body weight support on a treadmill. Recent studies
      report improvements in walking and standing in individuals with motor incomplete SCI that
      have undergone intensive standardized locomotor training therapy. Extended release
      dalfampridine (also known as fampridine or 4-aminopyridine [4-AP]) is a broad spectrum
      potassium channel blocker that has been shown in animal studies to increase conduction of
      action potentials in demyelinated axons. Dalfampridine was recently approved by the U.S. Food
      and Drug Administration (FDA) as a treatment to improve walking in persons with multiple
      sclerosis (MS). Demyelination is also a prominent feature of incomplete SCI that contributes
      to the clinical presentation of persons with these injuries.

      The purpose of this study is to determine the efficacy, safety, and tolerability of treatment
      with dalfampridine in combination with locomotor training in persons with chronic, motor
      incomplete SCI. We hypothesize that persons undergoing combination therapy with dalfampridine
      and locomotor training will show significantly greater improvements in walking speed and
      other measures of SCI function than those receiving locomotor training alone.
    

Intervention name(s): Dalfampridine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dalfampridine 10 mg tablet, twice-daily, for 10 weeks; Placebo tablet, twice daily, for 10 weeks.
Other intervention name(s): Ampyra; Fampridine Sustained Release (Fampridine-SR); 4-Aminopyridine (4-AP)
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spinal Cord Injuries; 4-Aminopyridine; Physical Therapy Modalities; Randomized Controlled Trial; Rehabilitation; Walking
EuroPainClinics® Study V (Prospective Observational Study)
Condition: Back Pain; Intervertebral Disc Herniation
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional

Summary: 
      In this prospective observational trial the effect of the Endoscopic discectomy microinvasive
      therapy should be examined in (approximately 500) adult patients with low back pain.
    


Intervention name(s): Endoscopic disectomy
Intervention type(s): Procedure
Intervention description(s): Endoscopic discectomy is an established method for treatment of lumbar disc herniation. Edoscopic discectomy provides a safe and minimal access corridor for lumbar discectomy. The technique also allows early postoperative mobilization and faster return to work.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy (HRT)
Condition: Postmenopausal Vasomotor Symptoms; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Recent large randomized, placebo-controlled studies assessing the health effects of HT
      question the overall benefits of long term HT, especially with respect to cardiovascular
      disease. However, recently menopausal women with severe hot flushes were mostly excluded from
      these trials. This was unfortunate since vasomotor symptoms may reflect different vascular
      sensitivity to estrogen or its deficiency, and therefore, the vascular responses to HT in
      women with and without hot flushes can differ.

      Aims of the present project are

        1. to compare vascular, cardiac and sympathetic function in recently menopausal women with
           or without severe vasomotor symptoms

        2. in a randomized placebo controlled clinical trial investigate vascular response to oral
           and trans-dermal HT.
    

Detailed description: 
      We recruit 160 healthy postmenopausal women between ages 48-55. Eighty women must have severe
      vasomotor symptoms (at least seven severe or moderate hot flush attacks per day) whereas 80
      comparators must be symptomless (no hot flushes). Thorough vascular function and risk factor
      assessments will be done, including clinical assessment of autonomic nervous system,
      endothelial function measurements, 24-hour ECG and blood pressure evaluation, and lipid and
      various other vascular surrogate marker measurements. In the first part of the study we
      compare these baseline measurements between women with or without severe vasomotor symptoms.
      In the second part of the study the women are randomized to receive placebo, oral estrogen,
      oral estrogen plus progestin or transdermal estrogen for 6 months. After the treatments the
      baseline assessments are repeated.
    

Intervention name(s): 17-b-estradiol; 17-b-estradiol + medroxyprogeterone acetate; 17-b-estradiol hemihydrate; placebo pill + gel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2mg oral daily for 6 months; 2mg E2 + 5mg MPA daily for 6 months; 1 mg skin gel daily for 6 months; placebo daily for 6 months
Other intervention name(s): Indivina; Divigel
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postmenopausal vasomotor symptoms; Hot flush; Vascular function; Cardiac function; Cardiovascular risk factor
SHOX2_PTGER4 DNA Methlyation in Lung Cancer
Condition: Lungcancer
MeSH terms: Lung Neoplasms
Study type: Observational

Summary: 
      Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung
      cancer diagnosis.

      In this study a control group consisting of COPD patients with a CT-scan of the chest no
      older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of
      lung cancer will be included.

      SHOX2 and PTGER4 will be analyzed via PCR.
    

Detailed description: 
      Data on SHOX2 and PTGER4 DNA Methylation suggest possible use as a biomarker for early lung
      cancer diagnosis.

      In this study a control group consisting of COPD patients with a CT-scan of the chest no
      older than 6 weeks and a control group of patients with a nodule and ruled out diagnosis of
      lung cancer will be included.

      A total of 150 patients will be enrolled in this study. SHOX2 and PTGER4 will be analyzed via
      PCR of blood plasma samples.
    

Intervention name(s): lung cancer
Intervention type(s): Genetic
Intervention description(s): PCR for SHOX2 and PTGER4
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        lung cancer, benign nodule
      
Biospecimen description: 
      plasma
A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
Condition: Synechia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack
      after FESS.
    

Detailed description: 
      MediENT is designed to minimize lateralization of the middle turbinate, which can cause
      scarring and obstruction of key sinus openings after endoscopic sinus surgery.
    

Intervention name(s): MediENT; MeroPack
Intervention type(s): Device; Device
Intervention description(s): MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT; MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT
Other intervention name(s): MeroPack
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: synechia; Fess; sinus surgery
Comparative Effects of a2 Skim Milk on Mild Cognitive Impairment in Older Adults
Condition: Mild Cognitive Impairment; Adults
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The aim of the study is to compare the effects of powdered skim milk containing A2 β-casein
      only versus conventional powdered skim milk containing A1 and A2 β-casein milk on cognition,
      inflammation, and dietary intake in adults aged 65-75 years.
    


Intervention name(s): a2Milk skim milk powder; Yili skim milk powder
Intervention type(s): Other; Other
Intervention description(s): a2Milk skim milk powder (1L) containing A2 β-casein only; Yili skim milk powder (1L) containing A1 and A2 β-caseins
Other intervention name(s): Treatment group; Control group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Sayana-Uniject Volumetric Delivery
Condition: Volume Delivery
Study type: Observational

Summary: 
      The purpose of this study is to determine the volumetric delivery of the Uniject.
    

Detailed description: 
      Observe subjects deliver the drug None used
    

Intervention name(s): Uniject
Intervention type(s): Other
Intervention description(s): single use container
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        nurses
      
Keywords: volume delivery
Telehealth Intervention for Youth With T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Hospitalization of youth with established diabetes is both costly and frequently preventable.
      Poor glycemic control is a risk factor for hospitalization and is also associated with
      adolescent age and lower socioeconomic status. This is a randomized, controlled trial for
      high-risk adolescent youth with T1DM and suboptimal glycemic control with an intervention arm
      and usual care control arm matched for frequency of contacts. There will be 110 subjects with
      T1DM and HbA1c>8%, aged 13 to 17 years, recruited from the Diabetes Program at Boston
      Children's Hospital and followed for 6 months. The intervention will be implemented by a
      diabetes nurse educator and social worker, who will each have monthly contact with the
      adolescent and a parent/guardian through a telehealth (videoconference) visit. Care will be
      guided by a diabetes action plan. Telehealth interventions have been utilized successfully in
      both adults and youth with diabetes. They facilitate frequent contact with the care team
      allowing barriers to adherence to be addressed, education to be reinforced, care plans to be
      updated, and diabetes-specific family support to be provided.
    


Intervention name(s): Telehealth Intervention; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan;; Standard diabetes care- typically a visit with a diabetes health care provider every 3 months and referrals to a dietitian or mental health specialist as deemed appropriate; Study participation reminder cards twice per month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes mellitus; adolescents