bioihbjkbjnl/mcl2 huggingface dataset:
Prospective Randomized Endovascular Therapy in Multiple Sclerosis - PREMiSE
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The Departments of Neurology and Neurosurgery are conducting this research study to evaluate
      the safety and effectiveness of intravascular angioplasty for the treatment of venous
      narrowing in the treatment of Multiple Sclerosis (MS).
    


Intervention name(s): Selective Venography followed by therapeutic balloon angioplasty; Control arm
Intervention type(s): Device; Other
Intervention description(s): Venography followed by therapeutic balloon angioplasty; Venography and sham angioplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Singe Dose Study of PF- 06946860 in Healthy Adult Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      PF-06946860 in healthy adult Japanese participants following single dose administration.
    


Intervention name(s): PF-06946860; Placebo
Intervention type(s): Biological; Other
Intervention description(s): PF-06946860 administered subcutaneously; Placebo administered subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
International Clinical Trial to Evaluate Efficacy and Safety of Multiple Subcutaneous Injections of BCD-085 in Various Doses in Patients With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      BCD-085-2 is a next step in clinical investigation of BCD-085. BCD-085 is a monoclonal
      antibody to interleukin 17. During BCD-085-2 trial patients with moderate to severe plaque
      psoriasis, in whom poor response to previous treatment including UV-therapy and biologic
      drugs was registered, will receive 40, 80 or 120 mg of BCD-085 subcutaneously at weeks 0, 1,
      2, 4, 6, 8, 10. Efficacy and safety parameters will be evaluated.
    


Intervention name(s): BCD-085; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): monoclonal antibody to interleukin 17
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: interleukin 17; monoclonal antibody; psoriasis
Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Single Dose Lacosamide in Subjects With Renal Impairment Compared to Healthy Subjects
Condition: Healthy; Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the Pharmacokinetics (PK) of oral administered Lacosamide in renal impaired
      subjects and healthy subjects.
    


Intervention name(s): Lacosamide tablet
Intervention type(s): Drug
Intervention description(s): Single dose of 100 mg Lacosamide tablet
Other intervention name(s): Vimpat
Intervention MeSH terms: Lacosamide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Lacosamide; Vimpat; Single Dose; Pharmacokinetics; Renal Impairment
Efficacy of Classification Based 'Cognitive Functional Therapy' in Patients With Non Specific Chronic Low Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      A randomized controlled trial of the efficacy of classification based cognitive functional
      physiotherapy according to the system proposed by Peter O'Sullivan as compared to manual
      therapy and exercise in patients with non specific chronic low back pain.

      The investigators hypothesis was that treatment targeted at the mechanism behind the problem
      from a multidimensional perspective would be superior to traditional treatment.
    

Detailed description: 
      NSCLBP is widely viewed as a multifactorial biopsychosocial pain syndrome. It has been
      proposed by several authors that NSCLBP represents a vicious cycle associated with different
      combinations of maladaptive; cognitive (negative beliefs, fear avoidance behaviours,
      catastrophising, depression, stress, lack of pacing and coping), physical (pain provocative
      postures, movement patterns and pain behaviours) and lifestyle (inactivity, rest) behaviours
      that act to promote pain and disability. However a recent systematic review suggests that
      this change in paradigm and our new understanding of NSCLBP has not resulted in clinical
      trials utilizing multidimensional classification systems or targeted interventions based on
      the underlying mechanisms. line with this shift in paradigm a novel multidimensional
      classification system has been developed incorporating the biopsychosocial model, which
      subgroups patients based on their presentation of. with matched interventions directed at the
      maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.
    

Intervention name(s): Cognitive Functional Therapy; Manual therapy and exercise
Intervention type(s): Other; Other
Intervention description(s): A novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their presentation with matched interventions directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder. The intervention is called 'cognitive functional therapy' as it directly challenges these behaviours in a functionally specific and graduated manner.; Patients in this group was treated with joint mobilization or manipulation techniques applied to the spine or pelvis primarily and was designed to be consistent with best current manual therapy practice in Norway. The particular dose and techniques were at the discretion of the treating therapist, based on each participant's objective and physical examination findings. In addition most of the patients in this group was given exercises or a home exercise program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Functional Therapy; Manual Therapy and Exercise; Chronic Low Back Pain; Randomized Controlled Trial; Subclassification
Exploration of Cerebral Pathophysiology During and After CABG Using CPB
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Observational

Summary: 
      Purpose:

      The purpose of this study is to examine cerebral oxidative and inflammatory stress and
      cerebral hemodynamics during and after coronary artery bypass grafting and correlate with
      postoperative cognitive function.
    

Detailed description: 
      Postoperative cognitive decline is a well-known and well-described complication following
      coronary artery bypass grafting. Severity ranges from postoperative delirium to stroke, but
      the majority of patients with postoperative cognitive decline following coronary artery
      bypass grafting have decline in recent and remote memory in particular.

      The reason for the cognitive decline is still not fully understood though many reasons have
      been proposed.

      Inflammation and oxidative stress may contribute to the postoperative cognitive dysfunction
      which may also be in combination with a reduced cerebral autoregulation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with ischemic heart disease admitted for coronary artery bypass grafting with the
        use of cardiopulmonary bypass
      
Biospecimen description: 
      Whole blood Serum
    
Keywords: coronary artery bypass grafting; cardiopulmonary bypass; Cerebral oxidative stress; Cerebral inflammatory stress; Cerebral hemodynamics; Postoperative cognitive dysfunction
Evaluating an Internet-based Program for Anxious Adolescents
Condition: Anxiety
Study type: Interventional

Summary: 
      Anxiety is a common mental health problem for Canadian adolescents. Anxiety that is diagnosed
      as a disorder and serious enough to require treatment affects up to 10% of all adolescents by
      the age of 16. The median age of onset is 11 years, making these disorders some of the
      earliest to develop. Anxiety disorders can have serious negative effects on a young person's
      personal relationships, school performance, and family life. These disorders may not be
      discovered by adolescents, parents and health care providers. Even if anxiety disorders are
      discovered, adolescents may not get the right therapy. Anxious adolescents can become sick if
      their anxiety is not treated properly. The investigators will carry out research to test
      Breathe, an Internet-based treatment for adolescents with anxiety problems. Adolescents can
      use this treatment from home via the computer. Breathe will include information materials and
      personalized homework assignments to help anxious adolescents learn ways to manage anxiety.
      More information can be found and www.TheBreatheStudy.com
    

Detailed description: 
      This study is a randomized controlled trial (RCT) with two groups, an Internet-delivered
      cognitive behavioural therapy (CBT) experimental group (Breathe) and a resource webpage
      (control group; considered treatment as usual for youth waiting for services). The
      investigators will evaluate several methodological processes and outcomes through the
      following objectives:

        1. To determine the effectiveness of a self-guided Internet-based CBT program with limited
           telephone and email support in reducing anxiety symptoms among adolescents with
           mild-to-moderate anxiety as compared to a usual self-help intervention, a resource-based
           webpage.

        2. To explore mediators and moderators of the Internet-based CBT program.

        3. To determine the effectiveness of a self-guided Internet-based CBT program in improving
           quality of life as compared to a usual self-help intervention.

        4. To determine adherence to a self-guided Internet-based CBT program.

        5. To determine the cost-effectiveness of the Internet-based CBT program.
    

Intervention name(s): Breathe; Resource Webpage
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Six web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program.; Static webpage listing anxiety resources.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Study of Coronary Heart Disease (CHD) & Heart Failure (HF) Risk in Prostate Cancer Patients, Taking Casodex or Not
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Heart Failure; Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      A retrospective cohort study performed in the GPRD,UK. All patients with incident prostate
      cancer identified between 1 Jan 1999 and 31 Dec 2005 and a frequency-matched cohort of the
      general population will be followed- up for two outcomes; CHD including acute myocardial
      infarction or death from coronary heart disease and HF until Dec 31, 2006. Outcomes will be
      validated through requests to primary care physicians. Incidence rate´ratios of CHD and HF in
      the two cohorts will be calculated. In the cohort of prostate cancer the relative risk of CHD
      and HF associated with the use of bicalutamide compared to non-use will be estimated.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        GPRD containing computerized information entered by general practitioners in the UK
      
Keywords: Prostate cancer; pharmacoepidemiology study
Utility and Validity of a High-intensity, Intermittent Exercise Protocol
Condition: Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of this study is to identify an exercise-induced fatigue protocol to mimic
      central and peripheral acute fatigue effects associated with participation in vigorous
      dynamic sports activities and to understand the expected central (cardiovascular) and
      peripheral (muscular) impact of this protocol.
    

Detailed description: 
      Fatigue-related parameters (BORG, heart rate, blood lactate level, concentric/eccentric force
      of the quadriceps muscle) will be measured before and after different short-term
      high-intensity, intermittent exercise protocols.
    

Intervention name(s): Fatigue protocol
Intervention type(s): Other
Intervention description(s): During the fatigue protocol, participants will sprint forward 5 m, cut at a 90° angle, sprint forward another 5 m, and backpedal 5 m. This activity will be repeated 4 times before participants will complete a series of hurdle activities. First, they will perform 2-legged jumps over 5 hurdles that are 30 cm high, turn, and repeat the jumps. Second, they will perform side-stepping exercises over the 5 hurdles. Third, they will complete four 5-m lateral shuffles.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant will randomly be assigned to two different fatigue protocols, on separate days. The first protocol is a high-intensity, intermittent exercise protocol and will be performed until complete exhaustion. The second protocol is a time-based variant of the previous protocol and will be performed during 5 minutes.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia
Condition: Bronchopulmonary Dysplasia
MeSH terms: Bronchopulmonary Dysplasia; Premature Birth; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended
      to treat premature infants with bronchopulmonary dysplasia. This study is to assess the
      safety and the efficacy of this study drug.
    

Detailed description: 
      Bronchopulmonary dysplasia (BPD) is most common cause of death of children who were born
      prematurely, with low birth weights. In addition, many children who were recovered from this
      disease are suffering from many side effects such as prolonged hospitalization, pulmonary
      hypertension, and failure to thrive.

      The purpose of BPD treatment is to make a baby be able to do spontaneous breathing and to
      spontaneous breathing a baby needs much energy and because of this a baby may have difficulty
      to feed. For this reason, medication with steroid, diuretic and respiratory drugs are
      currently used. However, there is no effective cure so far.

      It has been reported that bone marrow derived mesenchymal stem cells (BM-MSC) can
      differentiate to pulmonary epithelial and pulmonary endothelial cells. Some animal studies
      showed that BM-MSC differentiated to bronchial cells and type 2 pneumocytes in rats with
      pneumonia and improve the fibrosis that occur after administration of bleomycin. Based on the
      findings, it is considered that mesenchymal stem cell therapy can help regenerate the damaged
      lung as well as BPD that cause lung inflammation, fibrosis, deficiency of type 2 pneumocytes,
      and so on.

      PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended
      to treat premature infants with BPD. The main purpose of this study is to evaluate the safety
      and the tolerability of this study drug and to establish the maximum toxicity dose. The
      latent efficacy will also be assessed.
    

Intervention name(s): Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
Intervention type(s): Biological
Intervention description(s): Dose A - 10 million cells per kg Dose B - 20 million cells per kg Single intratracheal administration
Other intervention name(s): PNEUMOSTEM®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Human Umbilical Cord Blood Derived Mesenchymal Stem Cells; Bronchopulmonary dysplasia; Premature infants
A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares LY900014, a drug that lowers blood sugar, with insulin lispro (Humalog).
      Both drugs are given by injection under the skin of the abdomen. The study will be conducted
      in healthy people to investigate how quickly and how much LY900014 is absorbed and the effect
      of different doses of LY900014 on blood sugar levels in comparison with insulin lispro. The
      study will last about 7 to 12 weeks for each participant, including screening and follow up.
      Screening is required within 28 days prior to entering the study.
    


Intervention name(s): LY900014; Insulin Lispro
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): Ultra-Rapid Lispro; LY275585; Humalog
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy and Safety of BGG492 as Adjunctive Treatment in Patients With Partial Onset Seizures
Condition: Partial Onset Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy and safety of BGG492 as adjunctive treatment in patients
      with partial onset seizures.
    


Intervention name(s): Investigational new drug, company code: BGG492; Placebo; Investigational new drug, company code: BGG492
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Seizure frequency; nervous system diseases; brain diseases; neurologic manifestations; adjunctive treatment; AEDs; antiepileptic drug
RRISC Study: Reduction of Restenosis In Saphenous Vein Grafts With Cypher Sirolimus-Eluting Stent.
Condition: Stable Angina; Unstable Angina; Coronary Artery Disease; Saphenous Vein Graft Disease
MeSH terms: Coronary Artery Disease; Angina Pectoris; Angina, Stable; Angina, Unstable
Study type: Interventional
Phase: Phase 2

Summary: 
      Context: Sirolimus-eluting-stents have improved the benefits of percutaneous interventions in
      native coronary arteries reducing the occurrence of restenosis and repeated
      revascularization, however saphenous vein grafts have been always excluded form randomized
      trials.

      Objective: To evaluate the angiographic and clinical impact of sirolimus-eluting-stents with
      respect to bare-metal-stents in degenerated vein grafts.

      Design: Double-blind randomized controlled non-industry-sponsored trial.

      Setting: A single-center tertiary-care referral hospital.

      Patients: All patients are randomly allocated to sirolimus-eluting-stent implantation or the
      corresponding bare-metal-stent. All patients are followed clinically and repeated
      angiographic follow-up is performed in all at 6-months.

      Main outcome measure: Primary end-point is 6-months angiographic in-stent late loss.
      Secondary end-points include: binary angiographic in-stent and in-segment restenosis,
      intravascular-ultrasound-measured neo-intimal hyperplasia volume and all the clinical events
      (death, myocardial infarction, target-lesion and target-vessel revascularization).
    


Intervention name(s): sirolimus-eluting stent; bare metal stent
Intervention type(s): Device; Device
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Iron Absorption From Tef-injera in Women of Reproductive Age
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Interventional

Summary: 
      Anemia is one of the most common health problems all over the world with around half of
      preschool-aged children (<5 years) and one third of women affected. Nutritional iron
      deficiency is a major reason for anemia in infants, young children and women of reproductive
      age who have especially high iron requirements that are difficult to meet in regions where
      the major diet is based on plant foods. So in Ethiopia, where injera is the major staple
      food. Despite high levels of iron in tef, the most favored cereal for injera, the iron
      bioavailability is assumed to be very low due to the high levels of phytic acid found in tef.

      The aim of this study is to determine the iron bioavailability in women from injera prepared
      in a traditional way and investigate the potential of methods to improve the bioavaiability.
      Therefore, a 50/50 and a 25/75 blend of FeSO4 and NaFeEDTA for iron fortification will be
      evaluated. Further the potential positive impact of phytic acid reduction on the iron
      bioavailability will be investigated. The phytic acid reduction will be achieved in two
      different ways, by addition of whole grain wheat as source of phytase and addition of a
      commercially available microbial phytase. The studies will be conducted in healthy women
      using stable isotope techniques.
    


Intervention name(s): FeSO4; reduction of phytate; NaFeEDTA
Intervention type(s): Other; Other; Other
Intervention MeSH terms: Fe(III)-EDTA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: NaFeEDTA; phytate; injera; iron absorption
ADIPOA - Clinical Study
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary:

      To study the safety of a single injection of autologous adipose derived mesenchymal stromal
      cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).

      Secondary:

      To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal
      cells on patients with moderate or severe osteoarthritis of the knee (OA).
    


Intervention name(s): Autologous adipose derived stem cells administrated for intra-articular use; Autologous adipose derived stem cells administrated for intra-articular use
Intervention type(s): Biological; Biological
Intervention description(s): Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues.; Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. The first patient will be followed during 12 weeks before inclusion of the second patient.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment