bioihbjkbjnl/mcl2 huggingface dataset:
Aerobic Exercise on Ventilatory Efficiency in CAD Patients
Condition: Coronary Artery Disease; Exercise Addiction; Complication, Cardio-respiratory
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the present study was to test the hypothesis that patients with coronary
      artery disease with lower aerobic fitness exhibit greater responsiveness on improving
      ventilatory efficiency after aerobic exercise training.
    

Detailed description: 
      Measurements of ventilatory efficiency during cardiorespiratory exercise testing typically
      expressed as the minute ventilation/ carbon dioxide production ratio have been validated to
      be useful in assessing the presence and severity of both heart and lung diseases. In this
      context, previous studies have showed ventilatory inefficiency in patients with coronary
      artery disease suggests abnormalities in the distribution of ventilation and perfusion in the
      lungs. In addition, a growing body of studies has demonstrated that lower ventilatory
      efficiency during exercise is considered an important predictor of risk mortality,
      hospitalization, and other outcomes than peak VO2.
    

Intervention name(s): Aerobic exercise training
Intervention type(s): Other
Intervention description(s): The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary artery disease; Exercise; Ventilatory efficiency
A Randomized, Open Label, Single Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Exforge® and G-0081 in Healthy Male Volunteers
Condition: Healthy Male Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Design : randomized, open label, single-dose, 2-way cross-over design

      Phase : Phase I
    


Intervention name(s): Exforge®; G-0081
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amlodipine, Valsartan Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Caudal Epidural Block on Intraoperative Blood Loss During Hypospadias Repair
Condition: Hypospadias
MeSH terms: Hypospadias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      From September 2014 to March 2015, 57 consecutive patients with hypospadias who are candidate
      for surgery will be enrolled in this randomized clinical trial.

      Regional ethics committee of Isfahan University of Medical Sciences approved the protocol of
      the study and all parents will sign a written informed consent.

      Inclusion criteria are age between 6 months to 15 years and hypospadias with any severity.
      Exclusion criteria are coagulopathy, history of previous failed surgery, skin infection ,
      parents' disagreement with the protocol and any cardiac problem that made epinephrine
      injection contraindicated.

      All selected patients will randomly allocate to one of the two groups: group A will receive
      caudal epidural block (CEB) plus general anesthesia before surgery and group B will receive
      general anesthesia before surgery and CEB afterwards. The surgical procedures will be
      performed by a single pediatric urologist (FA). The surgical technique will be tubularized
      incised plate in all cases.

      Intraoperative blood loss will be determined by weighing all surgical gauzes used during
      procedure with a digital scale measure to the nearest 0.01 gram, every 10 minutes to minimize
      the effect of water vaporization on gauzes weights.

      In addition to blood loss, operation time, dose of fentanyl used during procedure and length
      of the urethral plate defect will be recorded for each patient by trained nurses.

      Demographics and disease characteristics as well as operation details will be compared in the
      two studied groups.
    


Intervention name(s): Bupivacaine; General anesthesia; Dilute epinephrine injection; Fentanyl; dextrose plus sodium chloride.; neostigmine and atropine; Hypospadias repair
Intervention type(s): Drug; Procedure; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): Injection of Bupivacaine in the epidural space (0.25%, 0.33mg/Kg); Induction with thiopental sodium 5 mg/Kg, atracurium 0.4 mg/Kg and fentanyl 2 mcg/Kg and maintenance with isoflurane and a combination of oxygen and nitrous oxide; Injection of 1/100000 epinephrine solution along all incision lines; fentanyl 2 mcg /Kg that is repeated during surgery whenever the heart rate or blood pressure increased more than 20% of its baseline; Four mL/Kg/hr of 5% dextrose plus 0.04 mL/Kg/hr of 20% sodium chloride. Each mL of blood loss was replaced by 3 ml of Ringer's solution; Injection of 0.04 mg/Kg of neostigmine and 0.02 mg/Kg of atropine, intravenously at the end of operation.; Surgical repair of hypospadias, using tubularized incised plate technique
Other intervention name(s): Caudal block
Intervention MeSH terms: Atropine; Epinephrine; Fentanyl; Bupivacaine; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Oslo Antioxidant Study
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to test whether increasing the total intake of
      antioxidants to middle-aged smoking men increases the antioxidant defence, reduces oxidative
      damage, and improves biomarkers for oxidative stress.

      The secondary objectives is to test whether this strategy improves other cardiovascular risk
      markers including platelet function, lipid levels, inflammation, and markers of endothelial
      damage.
    

Detailed description: 
      In this study men smoking 5 or more cigarettes daily will be invited to participate. We will
      only include individuals with high cardiovascular risk (men rather than women, smokers rather
      than nonsmokers, middle-aged to elderly rather than young individuals), in order to recruit
      people with presumed high oxidative stress who might be most likely to show an effect and
      benefit from our intervention.

      at the time of inclusion, participants will be randomized to three groups; control group,
      kiwi group or phytochemical group. The kiwi group will consume three kiwis a day, whereas the
      phytochemical group will consume an array of antioxidant-rich food stuffs. The intervention
      period is eight weeks.

      Blood samples will be collected before and after the intervention period.
    

Intervention name(s): Antioxidant-rich food items
Intervention type(s): Drug
Intervention MeSH terms: Antioxidants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Antioxidants; Phytochemicals; Oxidative stress; Inflammation; Endothelial function
Levodopa for the Treatment of Residual Amblyopia
Condition: Amblyopia
MeSH terms: Amblyopia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of oral levodopa and
      patching versus oral placebo and patching as treatment for residual amblyopia in children 7
      to <13 years old with visual acuity of 20/50 to 20/400 in the amblyopic eye.
    

Detailed description: 
      Amblyopia is the most common cause of monocular visual impairment in both children and young
      and middle-aged adults. Both patching and atropine are accepted treatment modalities for the
      management of moderate amblyopia in children. Despite best efforts with conventional
      amblyopia treatment, many older children and teenagers with amblyopia fail to achieve normal
      visual acuity in the amblyopic eye. In a previous PEDIG study where children 7 to 12 years
      old were treated with atropine and patching, only 36% of the children with moderate amblyopia
      and only 23% of the children with severe amblyopia achieved 20/40 or better acuity.

      Many clinicians have recognized that conventional therapies with patching and atropine have
      not been universally successful and have sought alternatives. PEDIG has discussed for several
      years the problem of residual amblyopia and how the remaining visual acuity deficit could be
      reduced. A number of research groups have evaluated the short term use of oral
      levodopa-carbidopa as an adjunct to patching therapy for older children.
    

Intervention name(s): Levodopa/Carbidopa; Placebo; Patching
Intervention type(s): Drug; Drug; Other
Intervention description(s): Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid; Oral placebo tid; Two hours of daily patching
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: amblyopia, levodopa
Antimony Plus Pentoxifylline in Cutaneous Leishmaniasis
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether pentoxifylline associated to pentavalent
      antimony has a higher cure rate than pentavalent antimony alone in the treatment of cutaneous
      leishmaniasis.
    


Intervention name(s): Pentoxifylline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients with cutaneous leishmaniasis treated with pentavalent antimony/Meglumine antimoniate 20mg/kg/day during 20 days and pentoxifylline pills 400mg three times a day during 20 days.; Patients with cutaneous leishmaniasis treated with pentavalent antimony/metilglucamine 20mg/kg/day during 20 days and placebo pills three times a day during 20 days.
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cutaneous leishmaniasis; Pentoxifylline; Meglumine antimoniate; L. braziliensis
The Effects of Nutrition Supplementation and Resistance Exercise During Hemodialysis
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      To test the hypothesis that an exercise session combined with adequate nutritional
      supplementation improves skeletal muscle protein accretion during a hemodialysis session.
    


Intervention name(s): nutritional supplementation; exercise
Intervention type(s): Drug; Behavioral
Intervention description(s): 2 oral ingestions per study visit of protein supplement containing a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat; 6 study visits over a 12-month period; resistance training on a duel leg press consisting of 3 sets of 8-12 repetitions; the first 5 study visits over a 12-month period
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acupuncture for the Treatment of Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Insomnia is a common and disabling condition associated with psychiatric and medical
      comorbidities and often persists despite currently available treatments. Acupuncture has been
      reported to benefit individuals with insomnia and can decrease hyperarousal. This blinded RCT
      will investigate the impact of a standardized acupuncture protocol on insomnia, daytime
      symptoms, and hyperarousal.
    

Detailed description: 
      Insomnia is a common problem that is disabling and that frequently persists despite available
      medical and behavioral approaches. It is associated significant psychiatric and medical
      comorbidities and high medical and societal costs. Benzodiazepine receptor agonists (BzRA's)
      and cognitive behavioral therapies are common treatments, but despite these, insomnia remains
      a pervasive problem. Complementary and alternative medicine (CAM) treatments are being used
      widely for the treatment of insomnia, but many of these modalities have sparse research
      support. There are numerous reports in the Traditional Chinese Medicine (TCM)literature of
      dramatic benefits of acupuncture for the treatment of insomnia, but carefully designed
      studies are limited. Insomnia has been associated with hyperarousal and acupuncture has
      documented effects on autonomics with a shift towards parasympathetic predominance. In
      consultation with experts in acupuncture and TCM, we developed a protocol for the treatment
      of insomnia and have used it clinically with good success.

      We will be conducting a 3-year exploratory pilot randomized-controlled blinded trial (RCT) of
      this protocol on 56 adults with insomnia disorder, utilizing a control condition involving
      placement of placebo needles. We seek to determine the effect size of this acupuncture
      intervention in comparison to the control condition in preparation for a more definitive
      study, with the future primary aim to determine if acupuncture is effective and well
      tolerated in the treatment of insomnia. Measures will include self-report and objective
      measures of sleep quality and duration including polysomnography (PSG). Secondary-exploratory
      aims will be to determine the impact of this acupuncture protocol on daytime symptoms of
      insomnia such as fatigue, anxiety, and depression as well as to explore the impact of
      acupuncture on self-report and objective measures of hyperarousal.
    

Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): Acupuncture, derived from the TCM literature, specific for insomnia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Primary insomnia; Insomnia disorder; Acupuncture
Study of the Reaction of the Brain to Various Stimulations
Condition: Corticospinal Plasticity; Neuromuscular Plasticity
Study type: Interventional

Summary: 
      Physical activity is considered a therapeutic strategy in its own right in a vast majority of
      disabling chronic disorders. It leads to an increase in physical and probably cognitive
      capacity, thanks to its effects on both metabolism (muscle hypertrophy, improvement in
      oxidative metabolism) and the nervous system (neuroplasticity). Nonetheless, even though
      there is a consensus on the positive effects of physical exercise (PE) on cerebral
      plasticity, the physiological mechanisms by which PE affects neuroplasticity, in particular
      depending on the mode of muscle contraction, are still hypothetical. Moreover, several recent
      studies have shown that mental learning (ML) by motor imagery improves motor performance,
      thus making it of interest in a context of rehabilitation, in particular in situations where
      PE is transient of definitively impossible. Yet, the mechanisms and brain structures involved
      in motor learning by ML have not been established so far. Finally, on the basis of clinical
      observations concerning the key role of sensory input in motor function, the hypothesis that
      increased demand on this input by electrical stimulation (ES) as a means to improve motor
      function has been proposed. However, the mechanisms by which this type of stimulation could
      induce neuroplasticity is still to be elucidated.
    


Intervention name(s): physical training; mental training; electrical stimulation
Intervention type(s): Other; Other; Other
Intervention description(s): workout on treadmill requiring the muscles of the lower limbs mostly in concentric (ascent) or eccentric (downhill); The task to imagine for the training group will be an abduction of the thumb; electrical stimulation of the muscles
Intervention model: Single Group Assignment
Intervention model description: this study is interventional because of it acts on the physical and respiratory capacities of patients
Masking: None (Open Label)
Primary purpose: Other
Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety
      and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to
      when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.
    


Intervention name(s): Epratuzumab sc; Epratuzumab iv
Intervention type(s): Biological; Biological
Intervention description(s): Active substance: Epratuzumab, Pharmaceutical form: Solution for injection, Route of Administration: Subcutaneous,; Active substance: Epratuzumab, Pharmaceutical form: Solution for Infusion, Route of Administration: Intravenous,
Other intervention name(s): CDP3194; EMAB
Intervention MeSH terms: Epratuzumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic Lupus Erythematosus
Motivational Interviewing for Weight Loss
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity; Weight Loss
Study type: Interventional

Summary: 
      The investigators studied the effect of motivational interviewing (MI) on self-efficacy,
      health behaviors, and health outcomes in overweight children and adolescents (ages ranging
      from 10 to 18 years).
    

Detailed description: 
      One empirically supported intervention with a large evidence base for improving adult
      outcomes in behavioral health-related disorders is Motivational Interviewing (MI). MI is
      strongly rooted in the client-centered therapy of Rogers (1951). Its relational stance
      emphasizes the importance of understanding the client's internal frame of reference and
      displaying unconditional positive regard for the client. Motivational interviewing can thus
      be defined as a client-centered, directive method of therapy for enhancing intrinsic
      motivation to change by exploring and resolving ambivalence. MI manifests through specific
      strategies, such as reflective listening, summarization, shared decision making, and agenda
      setting.

      Adolescent participants exposed to motivational interviewing in conjunction with usual care
      (diet and exercise program) are expected to endorse greater self-efficacy, report increased
      engagement in healthy behaviors, demonstrate a decrease in body weight and report improved
      psychological outcomes. While motivational interviewing has been shown to increase adults'
      motivation to make healthy behavior changes, few adolescent studies have demonstrated this
      effect.
    

Intervention name(s): Motivational Interviewing (Treatment Group); Social Skills Training (Control Group)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Motivational interviewing (MI) can be defined as a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.; Within the social skills training framework, advice is given to clients and sessions are focused on assigning goals for clients to work towards without specific regard for their readiness to change. The intervention is aimed at finding appropriate ways to navigate typical social situations (e.g., how to negotiate with parents).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Motivational Interviewing; Child and Adolescent Self-Efficacy; Health Behaviours
Effect of Liraglutide on Gastrointestinal Absorption of Several Drugs and Potential Influence of Liraglutide on Intragastric pH
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The trial is conducted in Europe. The aim of the trial is to investigate if there is any drug
      to drug interaction between liraglutide and atorvastatin (Lipitor®), lisinopril (Zestril®),
      griseofulvin and digoxin (Lanoxin®).
    


Intervention name(s): liraglutide; placebo; atorvastatin; lisinopril; griseofulvin; digoxin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3; Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively; One single dose of 40 mg. Tablet; One single dose of 20 mg. Tablet; One single dose of 500 mg. Tablet; One single dose of 1 mg. Tablet
Intervention MeSH terms: Liraglutide; Griseofulvin; Digoxin; Lisinopril; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment