bioihbjkbjnl/mcl2 huggingface dataset:
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of GAP-134 Administered Intravenously
Condition: Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the safety, tolerability and pharmacokinetics of single intravenous
      (IV) doses of GAP-134 in healthy subjects. GAP-134 will be administered as a 24-hour
      infusion.
    


Intervention name(s): GAP-134
Intervention type(s): Drug
Intervention description(s): atrial fibrillation 24-hr IV infusion; 1-minute IV bolus; PO
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition
Condition: Parenteral Nutrition
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to evaluate the safety and tolerance of ClinOleic or Lipoplus or
      SMOFlipid lipid emulsions. After 6 weeks of each lipid emulsion, Omegaven (fish oil) was
      added for a further 4 weeks. The safety and tolerance was evaluated after each lipid emulsion
      cycle by biochemistry, hematology and coagulation variables, vital signs and adverse events.
      We also analysed fatty acid profiles in plasma or erythrocyte phospholipids, antioxidant
      enzyme activities, lipid peroxidation products, plasma lipids and pro-inflammatory cytokine
      production after in vitro stimulation of whole blood by lipopolysacharide in HPN patients.
      The non-interventional group of healthy controls was included for comparison.
    

Detailed description: 
      Intravenous lipid emulsions (LEs) are an indispensable part of home parenteral nutrition
      (HPN). All commercially obtainable LEs are applicable for HPN in providing a source of energy
      and essential fatty acids. The originally used soyabean oil-based LE (Intralipid) have been
      suspected of being associated with a higher risk of pro-inflammatory lipid-mediator
      production due to their high content of n-6 polyunsaturated fatty acids. The more modern
      mixes of soyabean oil, and/or olive oil, and/or fish oil LEs with beneficial responses
      compared with Intralipid are available. Given that there are no clear clinical
      recommendations for LE application in HPN, we performed this cross-over design, phase 4 study
      comparing ClinOleic, Lipoplus or SMOFlipid in chronic intestinal failure patients with
      additional escalation of fish oil using Omegaven.
    

Intervention name(s): ClinOleic (baseline); ClinOleic + Omegaven; Lipoplus (baseline); Lipoplus + Omegaven; SMOFlipid (baseline); SMOFlipid + Omegaven
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Lipid emulsion in pharmacy compounded all-in-one admixture; Lipid emulsion in pharmacy compounded all-in-one admixture; Lipid emulsion in pharmacy compounded all-in-one admixture; Lipid emulsion in pharmacy compounded all-in-one admixture; Lipid emulsion in pharmacy compounded all-in-one admixture; Lipid emulsion in pharmacy compounded all-in-one admixture
Other intervention name(s): ClinOleic 20% Baxter; ClinOleic 20% Baxter + Omegaven 10% Fresenius Kabi; Lipoplus 20% BBraun Melsungen; Lipoplus 20% BBraun Melsungen + Omegaven 10% Fresenius Kabi; SMOFlipid 20% Fresenius Kabi; SMOFlipid 20% Fresenius Kabi + Omegaven 10% Fresenius Kabi
Intervention MeSH terms: SMOFlipid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lipid emulsion; olive oil; fish oil; intestinal failure; home parenteral nutrition
Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)
Condition: Post-Menopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to asses the safety and efficacy of MK0429 in postmenopausal women with osteoporosis.
    


Intervention name(s): MK0429
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Pharmacoepigenetics of Bipolar Disorder Treatment
Condition: Antipsychotic Agents; Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      Insulin is a hormone produced by the body to regulate blood sugar. Insulin resistance is a
      state when the body is not using insulin correctly, and more insulin is needed to maintain
      normal blood sugar. Insulin resistance is common in bipolar patients and even more common in
      bipolar patients treated with antipsychotics. Insulin resistance from antipsychotics can lead
      to type 2 diabetes, metabolic syndrome and cardiovascular disease and is known to lead to
      worse psychiatric outcomes (less mood stability) and lower life expectancies in bipolar
      disorder. Abnormal regulation of the folate cycle is known to play a role in
      antipsychotic-induced insulin resistance and the main endpoint to the folate cycle is the
      production of methyl donors for DNA methylation. DNA methylation is critical as it regulates
      how genes are expressed. Thus, changes in DNA methylation may play a role in the disease
      process of antipsychotic-induced insulin resistance. The purpose of this study is to examine
      the differences in the DNA methylation of candidate tissues known to have a role in the
      development of insulin resistance. The three groups of bipolar patients to be studied are 1)
      antipsychotic treated patients with impaired glucose tolerance, 2) antipsychotic treated
      patients with normal glucose tolerance and 3) lithium treated patients with normal glucose
      tolerance. Group 1 will be compared to groups 2 and 3 in order to assess how DNA methylation
      in the skeletal muscle and fat tissue changes due to medication effects (group 2 vs. 3) and
      medication side effects (group 1 vs. 2). Secondary analyses include the analysis of how fats
      are processed in skeletal muscle and fat tissue in relation to antipsychotic-induced insulin
      resistance and the correlation of DNA methylation across different tissues. The investigators
      hypothesize that antipsychotic-induced insulin resistance is to due changes in the way DNA is
      expressed (through epigenetic changes) which causes further changes in the way fats are
      processed in the body eventually leading to insulin resistance. This work is based on
      preliminary findings however further work is needed to identify the true mechanisms behind
      antipsychotic-induced insulin resistance and in particular, the main tissue in which this
      mechanism occurs.
    

Detailed description: 
      This study will be composed of 2 visits. The first visit will be used as a screening visit
      for inclusion of the three groups of patients for the second visit where the outcomes will be
      collected (e.g., tissue samples for DNA methylation and lipidomic analysis).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Bipolar patients treated with Lithium or an antipsychotic
Back School Efficacy on Low Back Pain and Quality of Life of Workers. COPCORD STUDY (Stage II)
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is an intervention, Phase II COPCORD study. (COPCORD= Community Oriented Program to
      Control Rheumatic Diseases). The purpose of this study is to find if Back School training has
      any benefit on low back pain of the workers in a pharmaceutical factory in Tehran suburbs.
    

Detailed description: 
      A back school will be held on at the Modava Pharmaceutical Factory, in Tehran suburbs. We
      estimate that this prospective study will include almost one third of the 70 workers in the
      factory. The study provides objective data and subjective information from patients. The
      clinical benefits of back school on low back pain and quality of life will be reported at the
      beginning and the end of intervention and after a period of 6 months follow up.
    

Intervention name(s): Back School
Intervention type(s): Behavioral
Intervention description(s): All the workers undergo a clinical examination for low back pain, by two trained practitioner. Those workers who are diagnosed for mechanical low back pain during the last six months fulfill a self report Quality of Life Questionnaire (SF36). The objective level of low back pain will obtain by a visual analogue scale. Then a back school training course will be held in 6 sessions, in 6 consecutive weeks. Two previously trained physiotherapists are responsible for the training course. Each series will have 10 participants. They will learn vertebral column anatomy and its function at the first session. The proper posture and exercises to reduce or inhibit low back pain are taught in the next 4 sessions. The 6th session is arranged for answering questions and checking how exercises are performed.
A visual analogue scale and quality of life assessment will be held at the end of the last session and the end of the sixth month.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low back pain
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in
      combination with the patient's oral diabetes medications and exenatide, for their ability to
      control blood sugar in patients with type 2 diabetes.
    


Intervention name(s): Insulin Lispro Protamine Suspension; Insulin Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously once a day at bedtime; Administered subcutaneously once a day at bedtime
Other intervention name(s): LY275585[P]; Lantus
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Protamines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating the Psychophysiological Effects of a Smartphone-Based Mindfulness Task
Condition: Chronic Pain; Depression, Anxiety
MeSH terms: Chronic Pain; Depression
Study type: Interventional

Summary: 
      The aim of the present study is to evaluate the psychophysiological effects of a smart phone
      based mindfulness meditation app (MMA) for individuals with clinically significant symptoms
      of major depression and/or anxiety, or symptoms of chronic pain. Specifically, the study aims
      to examine parasympathetic tone using HRV (primary outcome), mind-wandering and present
      awareness, mood symptoms, and breath focus in groups of participants who self-report
      clinically significant symptoms of depression and/or anxiety (DA), chronic pain symptoms
      (CP), as well as control participants who do not meet our criteria for either (Controls (C).
      All study groups will be randomized to a mindfulness meditation app (MMA+) condition or a
      mindfulness meditation condition without the app (MMA-) after a brief stress-induction
      procedure.
    


Intervention name(s): Mindfulness Meditation
Intervention type(s): Behavioral
Intervention description(s): A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Bisoprolol With Metoprolol Succinate Sustained-release on Heart Rate and Blood Pressure in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicentre, randomized, open-label parallel trial to demonstrate the superiority
      and/or non-inferiority of bisoprolol on metoprolol succinate sustained-release (SR) tablet in
      subjects with mild to moderate primary hypertension.
    

Detailed description: 
      Primary objectives:

      To demonstrate that bisoprolol is superior in mean ambulatory heart rate and/or non-inferior
      in mean ambulatory DBP as compared with metoprolol SR in the last 4 hours after 12-week
      active treatment in subjects with mild to moderate essential hypertension (EH).

      Secondary objectives:

        1. To compare the efficacy of the 2 study drugs by 24h ambulatory monitoring by several
           parameters at different times (Example: blood pressure, heart rate, their variability,
           etc...) after 12-week treatment from baseline among subjects with mild to moderate EH

        2. To evaluate safety of the two drugs

        3. To evaluate the treatment compliance of the two drugs
    

Intervention name(s): Bisoprolol; Metoprolol
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol will be escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic systolic blood pressure (SBP) was greater than or equal to (>=) 140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) was >=90 mmHg measured every 4 weeks.; Subjects will receive metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol will be escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
Other intervention name(s): Concor; Betaloc SR
Intervention MeSH terms: Metoprolol; Bisoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Bisoprolol; Hypertension; Blood pressure; Heart rate
The Influence of EMG-triggered Robotic Movement on Function and Mobility of Stroke Patients
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      Rehabilitation of lower limbs after a stroke supported by robots aims to return to
      independence and minimize disability caused by the incident, but the results have been mixed.
      Objective of the study was to assess the changes in gait capabilities, muscle tone and daily
      activities in patients after a recent stroke who underwent a 6-week supervised rehabilitation
      process using exercises on the LUNA EMG neurorehabilitation robot. A total of 60 participants
      with impaired motor function and gait after subacute stroke were included in the study. Each
      patient was randomly assigned to an intervention (robot) or control group (RG or CG). All
      patients, except standard therapy, underwent 1 session of therapy per day, 5 days a week for
      6 weeks. People with RG had 30 minutes of training sessions on the Luna EMG robot, while CG
      received exercises on the lower limb rotor. Patients were evaluated before the start of the
      study, and then after 2, 4 and 6 weeks of therapy using the Ashworth scale, Rivermead
      mobility index (RMI), Repty functional index, Time Up and Go test (TUG) and muscle
      circumference on the thigh.
    


Intervention name(s): Luna EMG; lower limb rotor
Intervention type(s): Device; Device
Intervention description(s): The duration of the overall therapeutic intervention in both groups will be the same.; The duration of the overall therapeutic intervention in both groups will be the same.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke,; rehabilitation,; EMG-triggered rehabilitation,; robotic-assisted movement,; gait
Open Label Randomized Clinical Study to Promote a Healthy Lifestyle in Medical Students
Condition: Healthy; Obesity; Nutrition, Healthy; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The main medical and social purpose of the project "It's trendy to be healthy!" is the
      promotion of healthy lifestyles and healthy eating among student youth. The relevance of this
      project is beyond doubt, as the WHO called obesity a non-communicable epidemic, and according
      to research by the Jane Schiller University of Germany (Germany), as mentioned above, Ukraine
      topped the list of the countries with high mortality due to malnutrition
    


Intervention name(s): nutrition program and modification of physical activity; synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU); vitamin D3
Intervention type(s): Other; Dietary Supplement; Dietary Supplement
Intervention description(s): nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily); one synbiotic sachet (3g), BID, for 3 month traetment; vitamin D3, oral, 2000IU BID, for 3 month treatment
Other intervention name(s): Acidolac; Olidetrim
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: gut microbiota; vitamin D; personalized nutrition; lifestyle in students; synbiotic; depression
Polyester Patch in Massive Rotator Cuff Repair Improves Healing
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      The purpose of this study was to assess the impact and potential advantage of a novel
      synthetic patch augmentation in repair of massive rotator cuff (RC) tears, using clinical and
      radiological approaches. The investigators hypothesized that implanting this patch will
      improve individual shoulder function, while reducing re-tear rates compared to the current
      literature.
    

Detailed description: 
      To evaluate this, patches were implanted into 54 shoulders and prospectively followed up
      clinically and radiologically.
    

Intervention name(s): arthroscopic rotator cuff repair with a polyester patch
Intervention type(s): Procedure
Intervention description(s): Patients were operated under general anesthesia and a supraclavicular nerve block, in a beach-chair position with 80° forward shoulder flexion and traction between 3-5 kg. After washing and draping a standard viewing portal was placed at the dorsal softspot. Further portals included, a lateral, a dorso-lateral, an antero-lateral and an anterior portal. If additional pathologies were present, they were treated simultaneously and mostly involved the long head of the biceps tendon, treated with tenodesis or tenotomy respectively. After a thorough bursectomy, the rupture was fully visualized and thereafter its size was estimated. Following debridement of the footprint, we used a triple row repair and implanted the patch.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        54 patients (38 male / 16 female) 54 shoulders (29 right / 25 left) Mean patient age at the
        time of surgery was 65 years (range 41 - 75).
      
Keywords: arthroscopic rotator cuff repair; patch augmentation
Safety and Dose Ranging Study for OWL-EVO1 as a Lung Cancer EVOC® Probe (Evolution)
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The Evolution study is a phase 1a and 1b study evaluating the safety and pharmacokinetics of
      D5- ethyl-βGlucuronide as well as the target dose for the probe to maximize the difference
      between controls and subjects with lung cancer.

      The phase 1a study will be designed as a single ascending dose study in healthy volunteers
      and will be conducted in a phase 1 trial unit with a primary objective to assess safety of
      the probe. A subsequent phase 1b study will be conducted at clinical sites and will aim to
      find the optimal dosing and breath sampling protocol to maximize the accuracy of the breath
      test.

      Evolution Phase 1 is a multicentre study; Phase 1a will be conducted at a Phase 1 facility in
      Belgium and Phase 1b will be conducted in the UK.
    

Detailed description: 
      Owlstone has recently pioneered the EVOC approach which enables active investigation of
      disease specific pathways by administering probe compounds to patients and measure its signal
      on breath. In the Evolution study, Owlstone Medical aims to evaluate one such EVOC probe
      strategy based on the administration of the probe OWL-EVO1.

      The Evolution study consist of phase 1a, in which the safety and pharmacokinetics of OWL-EVO1
      are assessed; in this part of the study up to 21 healthy volunteers will be recruited. The
      probe will be administered for the first time in humans in a single ascending dose design.
      Five different doses of the probe are planned to be administered across 5 different cohorts.
      This part of the study will be conducted at a Phase 1 unit in Belgium. Participating subjects
      will be administered a dose of the EVOC probe; up to 8 breath samples, using Owlstone's
      RECIVA, will be collected in a 24h wash-out.

      In the subsequent Phase 1b, research will aim to identify the most optimal dose and timing of
      the breath test to maximise the discriminative signal between lung cancer patients (cases)
      and healthy controls. Up to 50 cases and 50 controls will be recruited in selected sites in
      the UK. The Phase 1b has been designed as an adaptive trial design. Participating subjects
      will be administered the probe and will provide up to 7 breath samples over a 240 minute
      wash-out.

      This study is intended to provide proof of concept for the use of OWL-EVO1 as a probe for
      breath-based detection of lung cancer.

      This will be an important step towards creating a breath-based screening approach for lung
      cancer.
    

Intervention name(s): OWL-EVO1
Intervention type(s): Diagnostic Test
Intervention description(s): EVOC probe
Other intervention name(s): OWL-EVO1 Breath Biopsy Test; D5-ethyl-βD-glucuronide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Lung Cancer; Diagnostic Test; Diagnostic Breath Test