bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Dietary Omega-3 Fatty Acids in Various triOMEG Sausages on the HS-Omega-3 Index in Healthy Individuals
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      New approaches to increase eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in our
      diet are needed, but any new approach needs to demonstrate the bioavailability of EPA+DHA,
      and its safety and palatability. The HS-Omega-3 Index is a prime parameter to demonstrate
      bioavailability in the long-term. Study hypothesis is that increased intake of EPA+DHA will
      increase the HS-Omega-3 Index. Study aim is to investigate how supplementing various sausages
      with omega-3 fatty acids influences the HS-Omega-3 Index in healthy volunteers, as compared
      to unsupplemented matching sausages. Safety and palatability of the sausages are also to be
      assessed.
    

Detailed description: 
      Randomized, placebo-controlled, mono-center comparison of two matching groups of sausages
      (active vs. control). The study will be conducted according to Good Clinical Practice.
      Randomization will be computer-generated by the sponsor. Sealed envelopes will be provided to
      the Investigator bearing individual randomization numbers, containing individual
      randomization results. Thus, in case of need, one sealed envelope can be opened to learn the
      randomization result of one patient without overall unblinding.

      Study participants will be requested to ingest approx. 80 g / day of the experimental
      sausages during the day at a time of their convenience. Study participants will be provided
      with the investigational product free of charge. If necessary, the investigational product
      will be shipped to study participants. Study participants will receive the exact amount of
      sausages to complete the study.
    

Intervention name(s): Sausage: Triomeg; Sausage: Control
Intervention type(s): Other; Other
Intervention description(s): Commercial sausages enriched with 330 - 510 mg EPA+DHA / 100 g Approximate average composition of active product per 80 g Sausage (Triomeg): 250 mg EPA+DHA as ethyl-ester Energy content 500 kJ (120 kcal), protein 12 g, Carbohydrates 0.8 g, total fat 9 g, of which 2.8 g saturated fatty acids, 4.5 g monounsaturates, 1.4 g polyunsaturates. sodium 0.66 g.; Control sausage: as active, but no EPA+DHA ethyl-ester.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Omega-3 Index; Bioavailability; Eicosapentaenoic acid; Docosahexaenoic acid; Fortified food
Normal Saline Flushes at 12 vs 24 Hours Intervals for Maintaining Peripheral Intravenous Catheters Patency
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Children admitted in a ward often require a peripheral intravenous catheter to provide access
      for administration of medications, nutrients, fluids, blood products. Vascular access in
      children is a frequent and stressful procedure that should be performed as infrequently as
      possible in order to reduce the child's pain experience and the child's and family's level of
      distress. The maintenance of patency of indwelling catheters is therefore relevant to
      minimize need for replacement and children discomfort.

      Recent studies investigated the most effective and safe method of maintaining peripheral
      intravenous lock (peripheral IVL) in children. Most of these studies focused primary on the
      use of heparin versus saline flushes, showing similar efficacy of the two approaches.

      To the best of the investigators knowledge no study addressed the issue of the optimal
      flushing frequency of normal saline . The aim of this study was to evaluate the efficacy of
      normal saline flushes, at 12 and 24 hours intervals.
    


Intervention name(s): Flushing with positive pressure; Normal saline; MicroClave ICU Medica
Intervention type(s): Procedure; Drug; Device
Intervention description(s): Placement of a sterile plug (MicroClave ICU Medica, a neutral displacement connector) on the needle cannula and flushing with positive pressure with saline solution (BD PosiFlush XS Syringes, filled with 3 ml of saline)
Other intervention name(s): Isotonic saline solution; Physiological saline solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Peripheral intravenous catheter; Peripheral intravenous lock; Normal saline; Patency; Management; of peripheral; intravenous catheter
TC-A Registration Study
Condition: Primary Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis; Avascular Necrosis
MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid; Necrosis
Study type: Interventional

Summary: 
      This is a prospective, randomized, multicenter clinical study to compare the safety and
      efficacy of TC-A PS total knee system with TC-PLUS Solution PS total knee system in Chinese
      subjects.
    

Detailed description: 
      Osteoarthritis (OA), also known as degenerative joint disease or hyperostosis, is the most
      common cause of knee arthritis. Pain, dyskinesia and disability induced by osteoarthritis
      impact severely on the subject's health and quality of life. Knee osteoarthritis is very
      common in the elderly population. As life expectancy has increased, the incidence of
      osteoarthritis rose significantly during the 20th century. For people over 60 years of age,
      approximately 50% show signs of osteoarthritis on x-rays, among which 35% -50% show clinical
      signs. For people over the age of 75, 80% had osteoarthritis symptoms.

      There has been an increase in imported knee prostheses during the past decade, so that
      surgeons now have more choices of implants. However, the high cost of imported prostheses has
      become a barrier to the development of TKA in China and caused many OA subjects requiring
      immediate TKA to have to delay or miss their surgery. The development and promotion of
      high-quality domestic joint implants and surgical instruments is the key to the development
      of TKA technique in China.

      The primary objective of this study is to demonstrate non-inferiority of subjects implanted
      with the TC-A PS total knee system compared to a randomized concurrent control group of
      subjects implanted with the TC-PLUS Solution PS total knee system in terms of Knee Society
      Clinical Score (KSCS) at 1 year.
    

Intervention name(s): TC-A PS Total Knee Replacement System; TC-PLUS Solution PS Total Knee Replacement System
Intervention type(s): Device; Device
Intervention description(s): Subject will be implanted with the TC-A PS Total Knee Replacement System; Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System
Other intervention name(s): TC-A PS; TC-PLUS Solution PS
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subject was randomized to receive the treatment of investigational device or the comparator.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Rheumatoid arthritis; Post-traumatic arthritis; Avascular necrosis; AVN
A Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Two Oral Doses of GSK557296 in a Study in Men With Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine if an on demand dosing of 50 mg or 150 mg of GSK557296 demonstrates superior
      efficacy with respect to duration of intra vaginal ejaculatory latency time (IELT) during an
      8 week study period compared to placebo in men with primary premature ejaculation. An
      assessment of the safety and tolerability of all doses of GSK557296 will be performed as well
      as an assessment for change in the Index of Premature Ejaculation (IPE) from baseline and at
      the end of the 8 weeks of treatment. During the active treatment period study participants
      will be limited to a maximum of 40 doses of GSK557296, or placebo, spilt as 20 doses for both
      4 week intervals.
    


Intervention name(s): GSK557296; GSK557296; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg GSK557296; 150 mg GSK557296; placebo
Other intervention name(s): 50 mg; 150 mg
Intervention MeSH terms: Diketopiperazines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Proof of Concept; Double Blind
An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
Condition: Sepsis; Prematurity
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I open label multi-dose study to investigative the pharmacokinetics and
      safety of cefazolin in infants <121 days of age and < 28 weeks gestation with suspected
      sepsis. There will be two cohorts of 6 infants each: 1) >48 hours of age and ≤28 days and 2)
      >28 days of age and <121 days of age. The study requires administration of the study drug
      over 2 days followed by 1 week of safety monitoring. Six 200 µL pK samples will be obtained
      over the 2 days of drug administration. The risks are reasonable vs. the benefits and have
      been minimized appropriately. There may be benefit to the subjects (administration of
      empirical antimicrobial therapy), and information from the study may benefit a large number
      of other infants in whom the drug is currently being administered despite the lack of PK data
      in this population.
    


Intervention name(s): cefazolin
Intervention type(s): Drug
Intervention description(s): Cefazolin dosing - administered for 48 hours Dosage
≤28 days of age 25 mg/kg IV q12 29-120 days of age 25 mg/kg IV q8
Intervention MeSH terms: Cefazolin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sitagliptin and Kinetics of Triglyceride-rich Lipoproteins Apolipoprotein B48 and B100 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-IV), and has
      been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes
      mainly through incretin hormone-mediated improvements in islet function [13]. Although
      clinical studies to date indicate that fasting lipid levels are minimally affected by DPP-IV
      inhibitor treatment [14-16], animal studies suggested that DPP-IV inhibition reduce
      intestinal triglycerides (TG) absorption and apolipoprotein (apo) production [17] and
      increased chylomicron catabolism [18]. Interestingly, a recent study supporting this
      hypothesis showed that vildagliptin therapy was able to reduce postprandial intestinal
      triglyceride-rich lipoproteins (TRL) particles in patients with type 2 diabetes [19].
      Recently, our group has reported that sitagliptin treatment significantly reduced plasma apo
      B-48 and TG concentrations in the postprandial state. Moreover, animal studies showed that
      sitagliptin decreased intestinal secretion of intestinal apo B-48, mainly by increasing level
      of glucagon-like peptide (GLP)-1 [20]. Therefore, the present study was designed to examine
      the effects of sitagliptin on the kinetics of TRL apo B-48 and in patients with type 2
      diabetes. A possible reduction in postprandial atherogenic TRL apo B-48-containing
      lipoprotein levels by sitagliptin would add to therapeutic utility of this DPP-4 inhibitor
      and suggest the potential to reduce cardiovascular risk in patients with type 2 diabetes.
    


Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin 100 mg/d for 6 weeks; Placebo for 6 weeks
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sitagliptin; diabetes; apolipoprotein B48 and B100
A Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Adult and Adolescent Patients With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the dose response relationship among four doses of indacaterol as
      well as placebo delivered via the TWISTHALER® device.
    


Intervention name(s): indacaterol; formoterol; placebo to indacaterol; placebo to formoterol; short acting β2-agonist
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).; Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.; Placebo TWISTHALER® device; Placebo AEROLIZER® device; 100 μg/ 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: QMF; indacaterol; Twisthaler®
Ketamine- Propofol Versus Pethidine- Propofol in ERCP
Condition: Sedation in ERCP
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators aim to investigate the differences between ketamine propofol and pethidine
      propofol during ERCP in respect to endoscopist satisfaction.
    

Detailed description: 
      The investigators aim to investigate the differences between ketamine propofol and pethidine
      propofol during ERCP in respect to endoscopist satisfaction, amount of propofol consumption
      Any desaturation or apnea will be recorded when the oxygen saturation (SpO2) dropped to <90%
      , time for recovery ,post-operative nausea and vomiting, hallucinations and Ramsey sedation
      scores of all patients will be recorded perioperatively. The Aldrete score was used to
      measure recovery from anesthesia at 5 and 10 min after the procedure.
    

Intervention name(s): ketamine- propofol; pethidine- propofol
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg x kg(-1) ketamine + 1.2 mg x kg(-1) propofol.; 1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction
Other intervention name(s): N01AX03 - Propofol; meperidine - Propofol
Intervention MeSH terms: Meperidine; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: ketamine; propofol; pethidine; ERCP; endoscopist
Bioequivalence Study of Tipranavir Stored at Controlled Temperature Compared With Tipranavir Stored at Controlled Refrigerated Conditions, Orally Co-administered With Ritonavir in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this trial was to establish the bioequivalence of Tipranavir (TPV) 250 mg
      self emulsifying drug delivery system (SEDDS) capsules that had been stored at a controlled
      temperature of 30°C and controlled relative humidity (RH) of 70% in comparison with TPV 250
      mg SEDDS capsules stored at controlled refrigerated conditions between 2°C and 8°C
    


Intervention name(s): TPV - Room condition; TPV - Refrigerated conditions; Ritonavir (RTV)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Stimulation
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This research is being done to learn if computer tasks that challenge the brain (cognitively
      stimulating tasks) can improve memory and other types of thinking. The study will compare the
      effects of different versions of the computer tasks. It also will compare the task
      performance of different groups of people.
    


Intervention name(s): Computerized cognitively stimulating activities
Intervention type(s): Behavioral
Intervention description(s): The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Dry Needling in Cervical Pain
Condition: Cervical Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The presence of latent myofascial trigger points (MTrPs) in the angular muscle of the scapula
      is one of the possible causes of non-specific neck pain. Dry needling (DN) and ischaemic
      compression (IC) techniques may be useful for the treatment of these MTrPs. Methods: 80
      participants were divided into two groups: the dry needling group, which received a single
      session of DN on the angular muscle plus hyperalgesia (n=40), and the IC group, which
      received a single session of IC on the angular muscle plus hyperalgesia (n=40). Pain
      intensity, pain pressure threshold (PPT), range of motion (ROM) and quality of life were
      assessed at baseline, immediately after, 48 hours and one week after treatment.
    


Intervention name(s): dry needling; Ischaemic compression
Intervention type(s): Device; Other
Intervention description(s): Active trigger point puncture of the angularis scapulae muscle; Ischaemic compression at the active trigger point of the angularis scapulae muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: dry needling; physiotherapy techniques; cervical pain; pain
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in
      participants with moderate to severe plaque psoriasis.
    


Intervention name(s): Mirikizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY3074828
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: IL-23; dermatology
The Efficacy and Safety of Repeat-dose Potenfill for Temporary Penile Enhancement
Condition: Penile Girth Enhancement; Penile Enhancement
Study type: Interventional

Summary: 
      This clinical study is for small-penis syndrome males who have previously been treated with
      hyaluronic acid filler for the purpose of increasing their penis.

      This study will determine the long-term efficacy and safety of Potenfill.
    


Intervention name(s): Potenfill
Intervention type(s): Device
Intervention description(s): Maximum: 22ml
Other intervention name(s): hyaluronic acid filler
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety Study of HZT-501 in Reducing the Risk of Ibuprofen-associated Ulcers
Condition: Peptic Ulcer
MeSH terms: Peptic Ulcer; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of
      development of ibuprofen-associated ulcers in patients who require long-term daily use of
      ibuprofen.
    

Detailed description: 
      HZT-501 is a combination product including ibuprofen and the acid reducing agent famotidine.
      The study is designed to determine whether the combination product reduces the rate of ulcer
      development in subjects who require long-term daily use of ibuprofen.

      Subjects will be assigned randomly, in approximately a 2:1 ratio, to treatment with either
      HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) or ibuprofen (800 mg) three times daily for a
      24 week treatment period or until they develop either an endoscopically-diagnosed upper
      gastrointestinal ulcer and/or prohibitive toxicity. Subjects will visit the study center for
      Screening and at Weeks 4, 8, 16, and 24. Physical exams will be performed, and clinical
      laboratory measurements made, at selected times during the study. Endoscopic exams will be
      performed during Screening and at Weeks 8, 16, and 24. Subjects will be contacted four weeks
      following study completion.
    

Intervention name(s): HZT-501; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): HZT-501: Ibuprofen 800mg/famotidine 26.6mg orally 3 times daily for 24 weeks; Ibuprofen 800mg orally 3 times daily for 24 weeks
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ibuprofen; famotidine; ulcers; NSAIDS; pain; arthritis; chronic regional pain syndrome; chronic soft tissue pain; osteoarthritis; rheumatoid arthritis; chronic low back pain