bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Knee Kinematics for Subjects Implanted With Either a ConforMIS or Traditional Knee Implant
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      A better understanding of knee joint kinematics is important to explain the premature
      polyethylene wear failures within total knee arthroplasties (TKAs) and to help design a
      prosthesis that most closely approximates the normal knee. Previously, most experimental
      studies of knee kinematics have involved cadaveric, in vitro analyses, or have not tested the
      knee in a weight-bearing mode. Others have used exoskeletal linkages and skin markers that
      permit error due to undesired motions between markers and the underlying bone. More recently,
      fluoroscopy has been used to assess in vivo kinematics for subjects having a TKA.

      ConforMIS has attempted to follow a clearly different path than the major orthopaedic
      companies. They have chosen to offer patients a personalized knee implant based off of each
      patient's femoral and tibial bone geometry. The hypothesis is that these subjects will
      experience a more normal-like kinematic pattern, eliminating paradoxical anterior sliding
      during weight-bearing knee flexion. Therefore, the objective for this study is to analyze the
      in vivo kinematics for 25 patients implanted with a personalized ConforMIS TKA and 25
      patients implanted with a traditional TKA design to determine if there are any kinematic
      differences between these TKA designs.
    

Detailed description: 
      Each subject will be asked to perform five activities in one continuous sequence: (1) stand
      up from a chair, (2) walk up stairs, (3) walk down stairs, (4) level walking, and (5) a deep
      knee bend. Subjects will be video recorded from the waist down while performing the
      activities. The speed level of each trial will be based on the comfort level of the patient.
      The fluoroscopic images will be stored digitally for subsequent analysis on secure servers
      and workstations at the University of Tennessee.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are at least 6 month post-op with a ConforMIS knee replacement or a standard
        total knee replacement who meets the inclusion/exclusion criteria
      
Keywords: kinematics; knee joint
Promoting Antiretroviral Therapy Among Serodiscordant Couples to Reduce HIV Transmission
Condition: HIV
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of reducing HIV transmission among
      sero-discordant couples by applying comprehensive intervention components.
    

Detailed description: 
      A cluster-randomized controlled trial was carried out in forty counties from 16 cities. The
      strategy of Social Marketing was applied to influence sero-discordant couples' behavioral
      changes including safer sexual intercourses, regular HIV testing for the negative partners,
      antiretroviral therapy initiation.
    

Intervention name(s): comprehensive intervention components
Intervention type(s): Behavioral
Intervention description(s): ART promotion, Couple testing and consulting promotion, and Condom use promotion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; serodiscordant couples HIV sero-conversion; anti-retroviral therapy; intervention
A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in
      healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of
      food on PF-06669571 plasma concentrations will be be evaluated after a single dose of
      PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days
    


Intervention name(s): PF-06669571; PF-06669571; PF-06669571; PF-06669571; PF-06669571; PF-06669571; PF-06669571
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo; Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo; Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days; Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days; Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme; Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme; Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days. This dose may be reached by a titration scheme
Intervention MeSH terms: PF-06669571
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: First in human; single ascending dose study; multiple ascending dose study; safety and tolerability; pharmacokinetics; food effect; Parkinson's Disease
Pharmacist-initiated Intervention Trial in OsteoArthritis (PhIT-OA)
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Osteoarthritis (OA) is a major public health concern. Currently, there are at least 3 million
      Canadians afflicted with this condition with a 50% increase predicted by 2020. It is
      estimated that 85% of Canadians are afflicted with OA by age 70. As such, using the current
      health care structure, it is doubtful that the health system can keep pace with this
      increasing demand. Alternative health care delivery strategies must be investigated.

      The purpose of this study is to assess if a pharmacist-initiated intervention for individuals
      with knee pain with a high likelihood of knee OA will lead to an improvement in the quality
      of care for these individuals.

      We are hopeful that results of this study will show better management of knee osteoarthritis
      by a pharmacist-initiated intervention (which means that it is the pharmacist who will start
      the process for an intervention that includes exercise and an educational program when
      compared to no intervention. If this is the case, by implementing the proposed intervention
      program, subjects could be diagnosed earlier, the burden of illness on individuals could be
      diminished through an appropriate intervention program, and economic savings could be
      embraced.

      Hypothesis: Community pharmacists can identify patients with likely knee OA and initiate a
      multidisciplinary intervention that will improve quality of care and outcomes.
    

Detailed description: 
      This will be a pilot study of a multidisciplinary intervention for individuals with knee pain
      with a high likelihood of knee OA that could be a model for other chronic diseases. The
      intervention will be multidisciplinary such that it will be initiated by community
      pharmacists with referral to a comprehensive OA treatment program at the provincial arthritis
      center involving physiotherapists. In addition, formal communication will be initiated with
      their family doctor. Those in the usual care group will receive an educational OA pamphlet.
      The primary objective of this pilot project is to determine the proportion of patients who
      meet the Arthritis Foundation's Quality Indicator Set for osteoarthritis in the treatment arm
      compared to those in the usual care arm. Specifically, this indicator set focuses on health
      service provision within the first few months of diagnosis which includes physical
      examination, radiographs, education, exercise, weight loss, assistive devices and
      pharmacologic therapy.
    

Intervention name(s): Pharmacist-Initiated Intervention in OsteoArthritis (PhIT-OA)
Intervention type(s): Procedure
Intervention description(s): See Detailed Description.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pharmacist-initiated Intervention Trial in OsteoArthritis
Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)
Condition: Atherosclerosis; Hypercholesterolemia; Coronary Heart Disease
MeSH terms: Heart Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing
      treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg
      alone in further reducing LDL-C concentrations.
    


Intervention name(s): Ezetimibe; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral tablets: ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin); oral tablets: placebo to match ezetimibe 10 mg once daily for 6 weeks (plus continued simvastatin)
Other intervention name(s): SCH 58235
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Postprandial Insulin Secretion, Oxidative Stress and Gastrointestinal Peptides in Patients With Type 2 Diabetes Versus Healthy Subjects
Condition: Type 2 Diabetes; Postprandial Oxidative Stress
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Insulin secretion, plasma lipids, oxidative stress markers and gastrointestinal peptides will
      be measured in patients with type 2 diabetes versus healthy subjects in a fasting status and
      in response to standard meals (at times 0', 30', 60', 120' and 180').
    


Intervention name(s): Bagueutte Cheese Gourmet (Crocodille); Cous-cous sandwich; McCountry sandwich (McDonald's)
Intervention type(s): Other; Other; Other
Intervention description(s): 180g, energy 452.8 Kcal/1895.7 kJ, composition: carbohydrates 49,2 g (44,55%), proteins 18,5 g (16,74%), lipids 18,8 g (38,7%), of which saturated 6,8 g, monounsaturated 6,0 g, polyunsaturated 5,0 g.; 235 g, energy 455,88 Kcal /1907,4 kJ, composition: carbohydrates 59,54 g (52,24%), proteins 12,47 g (10,57% %), lipids 18,85 g (37,31%), of which saturated 6,2 g, monounsaturated 11,49 g, polyunsaturated 28,26 g; 150g, 455 kcal/1903,72 kJ, composition: carbohydrates 31 g (27,25%), proteins 24 g (21,1%), lipids 26 g (51,43%), of which saturated 10 g (38,45%)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Diet; Gastrointestinal peptides; Insulin secretion; Oxidative stress; Plasma lipids; Postprandial; Type 2 diabetes
Pharmacogenetics of Propofol and Depth of Anesthesia
Condition: Anesthesia; Propofol
Study type: Observational

Summary: 
      Propofol, (2,6-diisopropylphenol) is a short-acting anesthetic drug used for induction and
      maintenance of anesthesia.

      The aim of this study is to evaluate plasma concentrations of propofol in relation to depth
      of anesthesia, measured by continuous EEG and to correlate plasma concentrations with genetic
      analyses of liver enzymes responsible for drug elimination.

      Our hypothesis is that there is an individual requirement of Propofol plasma concentration
      depending on genetic differences in drug elimination.

      200 patients, ASA classification 1, planned for elective surgery of a duration of at least 30
      minutes will be included in this study.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        200 patients, ASA classification 1 planned for elective surgery of at least 30 minutes
        duration
      
Keywords: propofol; depth of anesthesia; pharmacogenetics; Depth of anesthesia in correlation to plasma concentrations of propofol
Internet-delivered Cognitive Behavior Therapy for Adolescents With Functional Gastrointestinal Disorders: a Pilot Study
Condition: Irritable Bowel Syndrome; Functional Gastrointestinal Disorders
MeSH terms: Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      This pilot-study aims to evaluate the treatment effects and feasibility of an
      internet-delivered CBT-program for adolescents with functional gastrointestinal disorders.
    

Detailed description: 
      Functional gastrointestinal disorders (FGID), including irritable bowel syndrome (IBS),
      functional dyspepsia (FD) and functional abdominal pain (FAP), are common in adolescents and
      associated with impaired quality of life. In adults with IBS, internet-delivered CBT leads to
      reduced symptoms and increased quality of life, but studies in children are lacking. This
      pilot-study aim to evaluate the treatment effects and feasibility of an internet-delivered
      CBT-program for adolescents with FGID.

      Method: Pilot study with a pre-post-design and no control group. The internet-delivered
      CBT-program lasted for 8 weeks and included weekly therapist support, consisting of online
      messages and telephone calls. Assessment points were baseline, post-treatment and 6 months
      follow-up.

      Analysis: Effect sizes and within-group differences were calculated in an intent-to-treat
      analysis using Cohens' d and Student's t-test.
    

Intervention name(s): Internet-delivered CBT
Intervention type(s): Behavioral
Intervention description(s): The internet-treatment consisted of six modules during 8 weeks. Part 1: education about FGID and the treatment model. Part 2: individual symptom behavior. Part 3: toilet habits, or other common symptom behavior. Part 4 and Part 5: Exposure during 4 weeks. Part 6: relapse prevention.
Parents received four modules over 8 weeks consisting of psycho-education about FGID and the treatment model, increased positive time with the child in order to reduce attention to pain, parental symptom behavior, support child exposure and relapse prevention.
The therapists gave feedback weekly . All participants had at least 1 telephone call from their therapist during the fifth and sixth week of treatment.
Other intervention name(s): Internet-delivered Exposure-based Cognitive Behavior Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Functional gastrointestinal disorders; FGID; Recurrent abdominal pain; Abdominal pain; pain-related functional gastrointestinal disorders
Acupuncture for Vulvodynia: A Pre-pilot Study
Condition: Vulvodynia; Vulvar Vestibulitis; Dyspareunia; Pain
MeSH terms: Dyspareunia; Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

Summary: 
      Vulvodynia is a women's pain condition. Women have pain in their vulva, the area in their
      genitals between the vagina and labia (lips of the vagina). They also have pain when they
      have sexual intercourse or insert anything in the vagina. Sometimes they have so much pain,
      that they cannot have sex.

      This research is being done for two reasons. The first reason is to test a set of special
      needles called double-blinded acupuncture needles to give acupuncture treatments (one is a
      real needle and the other is a fake needle). The second reason is to develop a protocol
      (checklist) that will be used in this and future studies, and to identify and resolve any
      procedural problems. The protocol will be first tested by the principal investigator who is
      also an acupuncturist. The investigator will perform acupuncture using the protocol, if
      necessary change the protocol, and then teach a second acupuncturist using the modified
      protocol how to use the double-blinded acupuncture needles.

      The real needle called the penetrating needle penetrates the skin. The fake needle called the
      non-penetrating placebo touch needle does not penetrate the skin but it touches the skin so
      it feels like a needle is being inserted. It has a blunt tip.

      Participants can't see which needle they are getting acupuncture with because the needles are
      housed in a double-blinded needle device which has two tubes (an inner and an outer) that
      neither the acupuncturists nor the participants can see through.

      If a fake acupuncture needle can be used in acupuncture research like a sugar pill is used
      for drug studies to see how well the real medicine works, the investigators can see how
      effective acupuncture is. The investigators will be testing these needles to treat
      participants with vulvodynia.
    


Intervention name(s): Active Acupuncture; Placebo Acupuncture
Intervention type(s): Other; Other
Intervention description(s): Active Acupuncture two times per week for 5 weeks; Placebo Acupuncture two times per week for 5 weeks
Other intervention name(s): Penetrating Acupuncture Needle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Effect of Dexamethasone in Combination With Paracetamol and Ibuprofen on Postoperative Pain After Spine Surgery
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The analgesic effect of dexamethasone is not well described, but studies have shown that
      dexamethasone can be a safe part of a multimodal analgesic strategy after surgery. Our
      purpose is to investigate if dexamethasone in combination with paracetamol and ibuprofen has
      an increased analgesic effect compared to paracetamol and ibuprofen alone, on postoperative
      pain after spine surgery. Our hypothesis is that dexamethasone can reduce postoperative pain
      and reduce opioidconsumption and side effects compared to placebo.
    

Detailed description: 
      The analgesic effect of dexamethasone is not well described, but studies have shown that an
      intermediate dosis of dexamethasone (0.11-0.2 mg/kg) can be a safe part of a multimodal
      analgesic strategy after surgery. Dexamethasone has an opioid-sparing effect and reduces pain
      during rest and mobilisation. Our purpose is to investigate if dexamethasone in combination
      with paracetamol and ibuprofen has an increased analgesic effect compared to paracetamol and
      ibuprofen alone, on postoperative pain after herniated disk surgery. Our hypothesis is that
      dexamethasone can reduce postoperative pain and reduce opioidconsumption and side effects
      compared to placebo.
    

Intervention name(s): Dexamethasone; Placebo; Morphine; Zofran; Paracetamol; Ibuprofen
Intervention type(s): Drug; Other; Drug; Drug; Drug; Drug
Intervention description(s): Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation; Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation; Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.; Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed; Tablet Paracetamol 1 g orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.; Tablet Ibuprofen 400 mg orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
Intervention MeSH terms: Acetaminophen; Dexamethasone; Ibuprofen; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; Analgesia; Postoperative; Dexamethasone; Spine surgery
Dexamethasone With Super-hydration for Prevention of Postoperative Nausea and Vomiting
Condition: Nausea and Vomiting, Postoperative
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      Postoperative nausea and vomiting (PONV) are the most common and distressing side effects
      following Laparoscopic cholecystectomy
    

Detailed description: 
      In the operating room, standard monitors included electrocardiogram, noninvasive arterial
      blood pressure, arterial oxygen saturation, and end-tidal carbon dioxide were connected. All
      patients received standardized anesthetic technique. At the end of surgery, gastric contents
      were suctioned via an orogastric tube before extubation. Atropine and neostigmine (1/2.5 mg)
      was given slowly I.V. to antagonize the residual neuromuscular block. Then, the trachea was
      extubated. Then, patients were transferred to the post-anesthesia care unit in a stable
      condition. Patients were allowed to drink liquids as soon as requested.
    

Intervention name(s): Dexamethasone; 10 ml/kg Ringer's lactate; 30 ml/kg Ringer's lactate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 5 mg I.V. Dexamethasone just before induction; Intra-operative 10 ml/kg Ringer's lactate solution .; Intra-operative 30 ml/kg Ringer's lactate solution .
Other intervention name(s): Decadron; Normal hydration; super-hydration
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dexamethasone; Super-hydration; Laparoscopic Cholecystectomy; Nausea; Vomiting; Postoperative