bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with Parkinson's disease (PD) are heavily inclined towards a sedentary lifestyle.
      This is caused by a combination of physical impairments and cognitive dysfunction. However,
      regular physical activity in PD is highly desirable, for two reasons. First, physical
      activity has positive generic effects in preventing complications such as cardiovascular
      diseases, type II diabetes mellitus, osteoporosis and certain cases of cancer. Secondly,
      physical activity has additional disease-specific merits in PD such as depression, sleep
      disturbances and constipation. These effects lead to raised quality of life. Furthermore,
      animal studies suggest that physical activity could slow down disease progression.

      Simply informing patients about the importance of physical activity is not enough to initiate
      and maintain an adequate level of physical activity. We propose to develop a physical
      activity promoting program for sedentary patients with PD in order to raise their level of
      daily physical activity.

      Objective: The first aim of the study is to investigate whether a physical activity promotion
      program will result in an increase in physical activity in sedentary patients with PD.

      The second aim is to demonstrate an increase in physical fitness and quality of life.
    

Detailed description: 
      no extensive description
    

Intervention name(s): Physical therapy aimed to move safely; Physical Therapy aimed to improve Physical Activity
Intervention type(s): Other; Other
Intervention description(s): Physical Therapy according to the Dutch guidelines for Physical Therapy in Parkinson's Disease solely focused on safety of movement.
Duration program: 2 years Maximum number of sessions: 35 per year Duration sessions: 30 minutes; Physical Therapy according to the Dutch guidelines for Physical Therapy in Parkinson's Disease combined with a coaching program aimed to promote the level of physical activity Duration program: 2 years Maximum number of sessions: 35 per year Duration of sessions: 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson; Physical Therapy; Physical Activity
Salt Study: Inhibited Breathing Pattern and Sodium Inhibitors in Sodium Sensitivity of Blood Pressure
Condition: Hypertension
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      The purpose of this study is to test the hypothesis that blood pressure sensitivity to high
      sodium intake in healthy humans is characterized by increased urinary excretion of two
      endogenous sodium pump inhibitors, marinobufagenin (MBG), and ouabain-like compound (OLC).
      The study also tests the hypothesis that women who breathe slowly and have high resting end
      tidal CO2 at rest are more likely to have low plasma renin activity and sodium sensitivity of
      blood pressure than those who breathe more rapidly and maintain lower end tidal CO2.
    

Detailed description: 
      The experiments will involve a common procedure of sodium restriction followed by sodium
      loading of normotensive (having normal blood pressure) humans. However, the first experiment
      will involve continuous urine collection throughout the experimental period in a smaller
      group of men and women, while the second experiment will involve urine collection only at the
      end of each diet period in a larger group of normotensive women. If, as expected, experiment
      one shows that sodium loading produces MBG increases that are sustained throughout the sodium
      loading period, then experiment two will also be able to address a third issue: that is
      whether MBG or OLC response to sodium loading is specific to breathing pattern or sodium
      sensitivity. It is hypothesized that women with inhibited breathing who are sodium sensitive
      will show higher levels of MBG, even before sodium loading, but also following sodium
      loading.

      Each participant will be seen at the Clinical Research Unit for a screening visit and on days
      6 and 12, and consume a low sodium diet for 6 days followed by a high sodium diet for 6 days.
      Research staff will meet with the participant at regular intervals for meal provision and
      transfer of 24-hr urine collections (if applicable). Respiration and blood pressure will be
      measured on the last day of each sodium diet.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community
      
Keywords: salt; blood pressure; breathing
Characterizing the Effects of Family History of Alcoholism on Alcohol Analgesia
Condition: Effects of Family History of Alcoholism and Sex on Alcohol Analgesia
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      Self-medication of pain with alcohol is a common, yet risky, behavior. Evidence suggests
      family history of alcoholism may affect the degree to which alcohol use relieves pain, but
      the independent contributions of expectation and conditioning have not been previously
      studied. Interactive effects of sex and family history are also currently unclear. This
      project addresses this gap in knowledge and will inform further research and
      clinical/translational efforts for reducing risk associated with these behaviors.
    


Intervention name(s): Ethanol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.; A beverage that does not meaningfully increase breath alcohol concentration.
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will receive an active oral dose of alcohol or placebo in a counterbalanced manner.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: alcohol effects; pain
A Clinical Study of Adherence to Methylprednisolone Aceponate in Different Carriers
Condition: Adherence, Patient; Chronic Eczema
MeSH terms: Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      Untersuchung der Adhärenz zur topischen Standardtherapie bei Patienten mit chronischem
      Handekzem in Abhängigkeit von der Galenik
    

Detailed description: 
      Prospective, randomized, parallel grouped, single-blinded (investigator), monocentric
      objective assessment of the adherence to the treatment with topical methylprednisolone
      aceponate (Advantan®) depending on the type of vehicle in patients with hand eczema treated
      according to the current Guideline.
    

Intervention name(s): Adherence to topical standard therapy assessed
Intervention type(s): Behavioral
Intervention description(s): Adherence defined as percentage of patients applying at least aimed daily dose
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized single-blind
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Lidocaine 5% Patch Supplementation to Intra-articular Bupivacaine Dexmedetomidine After Arthroscopic Knee Surgery
Condition: Dexmedetomidine; Lidocaine 5% Patch; Arthroscopic Knee Surgery; Intra-articular
Study type: Interventional

Summary: 
      Surgery of the knee is a very common procedure which can be very painful and sufficient
      postoperative pain treatment is often problematic. The aim of this work was to study the
      effects of supplementation of intra-articular bupivacaine dexmedetomidine with lidocaine 5%
      patch after arthroscopic knee surgery under general anesthesia and its role in improving
      quality of anesthesia.
    


Intervention name(s): Lidocaine 5% patch with Dexmedetomidine Bupivacaine; Dexmedetomidine Bupivacaine
Intervention type(s): Drug; Drug
Intervention description(s): 10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique and a patch of lidocaine 5% was applied to the skin between the arthroscopic ports; 10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique without a patch of lidocaine 5%
Intervention MeSH terms: Lidocaine; Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were allocated into 2 groups, 20 patients in each received 10 ml 0.5 % bupivacaine and 1µg/kg dexmedetomidine diluted in 10 ml saline injected intra-articularly; group A: no patch, group B: a patch of lidocaine 5% was applied to the skin.
Masking: None (Open Label)
Primary purpose: Treatment
MACCE After Endoscopic Vein Harvest for CABG
Condition: Complications Due to Coronary Artery Bypass Graft
Study type: Observational

Summary: 
      Most patients undergoing coronary artery bypass grafting (CABG) will require long saphenous
      vein (LSV) harvesting from the leg. This has been reported to be associated with a
      significant morbidity (leg swelling, pain, infection, bruising, wound discharge) in up to 50%
      of patients. Endoscopic vein harvesting (EVH) which has been reported to be associated with a
      reduction in these complications was implemented within the investigators' service in 2012.
      Although some initial reports of concerns regarding graft patency when the LSV is harvested
      by EVH, NICE and European Cardiology Society (ESC/EACTS) guidelines 2014 supported the use of
      the EVH technology. Last year a service evaluation in the investigators' department showed
      significant cost benefit of EVH as compared to open vein harvest (OVH) in a matched group (50
      EVH and 50 OVH patients). The purpose of this study is to evaluate this group further to
      assess the incidence of MACCE (Major adverse cardiac and cerebrovascular event) and patient's
      quality of life (QOL) at least 1 year after their surgery. MACCE will be assessed by
      contacting the patient's GP and/or Cardiologist and QOL questionnaire (SF12v2) will be sent
      to patients along with a patient information sheet. It is estimated that data collection
      would be completed within 3 months of start.
    


Intervention name(s): Quality of Life Questionnaire; MACCE review
Intervention type(s): Other; Other
Intervention description(s): Quality of Life Questionnaire will be completed at least 1 year after their surgery.; MACCE will be assessed by contacting the patient's GP and/or Cardiologist at least 1 year after their surgery.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Fifty patients who underwent EVH (Study group) were part of our service evaluation when EVH
        was introduced to our practice. These patients were matched with patients undergoing CABG
        during the same period but where the LSV was harvested by OVH (50 patients, control group).

        This service evaluation showed a significant cost benefit when EVH was used in terms of
        reduction in the inhopsital stay, leg wound pain, leg wound infection and need to attend
        wound clinic. The current study is an extension of the service evaluation to assess how
        these patients are doing at least a year after their surgery in terms of MACCE, QOL,return
        to normal activities and survival
Comparing Insulin Aspart With Fast-acting Insulin Human in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of the trial is to compare pharmacokinetics (at
      which rate the body eliminates the substance from the body) of insulin aspart with
      fast-acting insulin human following intravenous (IV) infusion or intramuscular (IM) injection
      in Japanese subjects with type 1 diabetes mellitus.
    


Intervention name(s): insulin aspart; insulin human; insulin aspart; insulin human
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): At the first treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. At the second treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.; At the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.At the second treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.; At the first treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. At the second treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.; At the first treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. At the second treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment Of Symptomatic Asthma In Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to investigate whether in childhood salmeterol/ fluticasone
      propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd
      delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally
      we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms
      of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing
      management of asthma in children.
    

Detailed description: 
      A multicentre, randomised, double blind, parallel group study to compare the efficacy and
      safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100mcg with
      Fluticasone propionate (Flixotide®) 200mcg, both delivered twice daily via the DISKUS
      inhaler, in the treatment of children aged 6-12 years with symptomatic asthma.
    

Intervention name(s): Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg; fluticasone propionate 2 x 100 mcg
Intervention type(s): Drug; Drug
Intervention description(s): comparator; comparator
Other intervention name(s): Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: salmeterol/fluticasone combination; Asthma; bronchial hyperresponsiveness; Children; symptom control
Evaluation of DEX-IN During Outpatient Procedures
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared
      with placebo and active control (fentanyl), in subjects undergoing painful outpatient and
      office based procedures.
    


Intervention name(s): DEX-IN; Fentanyl; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IN Dexmedetomidine + IV placebo; IN Placebo + IV Fentanyl; IN Placebo + IV Placebo
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Peri-procedural pain; Pain; Anxiety; Analgesia; Anxiolysis
A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, participants with type 1 diabetes (T1D) will take the study drug LY900014 and
      insulin degludec. The reason for this study is to evaluate the amount of time with glucose
      values within target range.
    


Intervention name(s): LY900014; Insulin Degludec
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Celecoxib After Percutaneous Coronary Intervention
Condition: Coronary Arteriosclerosis
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Several studies including ours have reported that celecoxib improves endothelium-dependent
      vasodilation and reduces inflammation and neointimal hyperplasia. Our hypothesis is that
      celecoxib may reduce the late luminal loss after coronary stent implantation
      (paclitaxel-eluting stent.
    


Intervention name(s): Celecoxib
Intervention type(s): Drug
Intervention description(s): celecoxib: loading and maintenance for 6 months
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Health Related Quality of Life and Disease Prevalence of Children From Spain at 6-8 Years of Age Who Participated in a Qualifying Infant Formula Study at Birth
Condition: Quality of Life
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the influence of the type of feeding in the first
      year of life on the behavior and health-related quality of life at 6-8 years of age.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children 6 - 8 years of age
Determination of Changes in Total Body Stores of Vitamin A in Response to Orange Maize Consumption by Zambian Children
Condition: Vitamin A Status With Maize Feeding
Study type: Interventional

Summary: 
      Determination of liver stores of vitamin A will be determined before and after consumption of
      high pro-vitamin A orange maize, compared to low provitamin A white maize.
    

Detailed description: 
      This study will determine the change in total body stores of vitamin A in response to feeding
      orange maize for 90 days. This will be compared to two other groups of children that are fed
      white maize, one of which will get a vitamin A supplement at the estimated average
      requirement.
    

Intervention name(s): Orange maize feeding; Vitamin A supplement; Oil only
Intervention type(s): Other; Other; Other
Intervention description(s): This group was fed orange maize.; This group received a dose of vitamin A at the estimated average requirement each feeding day of the intervention.; This group received a small amount of plain oil without vitamin A.
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: vitamin A; maize; total body reserves; Condition is vitamin A status.; Focus: change in vitamin A status with maize feeding.; Focus: feeding orange maize to children for 90 days.; Focus: total body reserves of vitamin A.
A Study of Clofarabine in Japanese Paediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukaemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is primarily to assess the safety, tolerability and
      pharmacokinetics (PK) of clofarabine intravenously administered to pediatric patients with
      relapsed or refractory acute lymphoblastic leukemia (ALL) or for whom no other therapy with
      greater potential clinical benefit exists. The dosing regimen for the intravenous (IV)
      clofarabine is 30 or 52 mg/m2/day for 5 consecutive days. The secondary objectives are to
      document the activity of clofarabine and to explore the impact of deoxycytidine kinase (dCK)
      promoter polymorphism on PK and treatment outcome.
    

Detailed description: 
      This is a Phase I Study of Clofarabine in Japanese Paediatric Patients With Relapsed or
      Refractory Acute Lymphoblastic Leukaemia.

      Subjects will receive intravenous administration of clofarabine at 30 or 52 mg/m2/day (2
      hours) for 5 consecutive days and then the administration will be withheld until Day 14. If
      there is no evidence of recovery in neutrophil (≥750/mm3) and/or platelet count
      (≥50,000/mm3), the therapy may be withheld up to Day 42. However, in the absence of
      progression based on the judgment of the investigator after each cycle of treatment and the
      benefit of continued treatment is judged to exceed the risk, subjects may receive up to a
      total of six cycles. If a subject is receiving two or more cycles, a written consent must be
      obtained prior to start of Cycle 2.

      When a subject completes the final dose, the safety will be observed and followed-up for 45
      days after the final study drug administration.

      Cohort 1 will receive 30 mg/m2/day x 5 days at Cycle 1 and will be assessed for tolerability.
      Samples will be drawn to assess pharmacokinetics at this dose. If subjects do not develop
      adverse events indicative of dose limiting toxicity (DLT) at Cycle 1, the dose will be
      increased to 52 mg/m2/day x 5 days from Cycle 2 and the subjects will be assessed for safety
      and activity only.

      Cohort 2 will receive 52 mg/m2/day x 5 days at Cycle 1 and will be assessed for the
      tolerability. Samples will be drawn to assess pharmacokinetics at this dose.

      Whether or not proceeding to Cohort 2 after the Cycle 1 of Cohort 1 is completed will be
      determined by the sponsor based on the assessment of the safety data and the recommendation
      of the Data Safety Monitoring Board (DSMB).
    

Intervention name(s): Clofarabine
Intervention type(s): Drug
Intervention description(s): Intravenous, 30 mg/m2, 52 mg/m2
Other intervention name(s): Evoltra, Clolar, JC0707
Intervention MeSH terms: Clofarabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment