bioihbjkbjnl/mcl2 huggingface dataset:
Periacetabular Osteotomy.A Prospective Study With Reference to Cartilage, Migration and Bone Density
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of performing a periacetabular osteotomy
      on patients with hip dysplasia.
    

Detailed description: 
      The cause of osteoarthritis in hip dysplasia is thought to be attributable to increased joint
      contact pressures secondary to decreased acetabular coverage of the femoral head and/or
      incongruity of the articular surfaces. The investigators' hypothesis is that when
      periacetabular osteotomy is performed and contact pressure on cartilage reduced, additional
      joint degeneration will be slowed or prevented unless irreparable damage to the cartilage has
      happened at the time periacetabular osteotomy is performed. Hence, the purposes of this study
      are:

        -  to develop an unbiased and precise method for measurement of the thickness of the
           articular cartilage in the hip joint because such a method can be used to evaluate the
           effect of periacetabular osteotomy and also to give a more precise
           indication/contraindication for surgery;

        -  to evaluate the migration of the acetabulum postoperatively and 6 months after surgery
           by use of RSA to examine the stability of the osteotomy; and

        -  to examine bone mineral density in acetabulum 1 and 2 years after surgery in order to
           find out whether the change in load distribution will affect bone density of the
           acetabulum over time in a way that in the area where more load is applied, bone density
           will increase, and in areas with less load, bone density will decrease;

        -  to examine the labrum in the hip joint.
    

Intervention name(s): 1 Periacetabular osteotomy
Intervention type(s): Procedure
Intervention description(s): pelvic osteotomy to increase acetabular coverage
Other intervention name(s): periacetabular osteotomy
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cartilage thickness; RSA; DEXA; ultra sound; MRI; osteoarthritis; periacetabular osteotomy
Safety and Efficacy Study of AGS-004 During Analytical Treatment Interruption
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and effectiveness of AGS-004, an immune
      therapy, for HIV-infected individuals. Safety and effectiveness will be tested while the
      individuals are both taking antiretroviral therapy (ART) medication and interrupting ART
      medication.
    

Detailed description: 
      The purpose of this study is to determine the safety and effectiveness of AGS-004, an immune
      therapy, for HIV-infected individuals. Safety and effectiveness will be tested while the
      individuals are both taking antiretroviral therapy (ART) medication and interrupting ART
      medication
    

Intervention name(s): AGS-004; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): HIV-1 Immune Therapy; Inactive Placebo Injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Validity of the PortionSize App to Measure Children's Food Intake
Condition: Nutritional Assessment
Study type: Interventional

Summary: 
      The purpose of this study is to assess the validity of the PortionSize™ app to quantify
      children's own dietary intake and children's intake by parents or caregivers.
    

Detailed description: 
      The investigators will recruit 40 dyads (40 children aged 7-12 years old and 40 parents or
      caregivers) using a convenience sample for this pilot study. Children and their parents or
      caregivers will be trained to use the PortionSize app at Pennington Biomedical Research
      Center (PBRC). Children will use the PortionSize app and estimate food intake from
      pre-weighed meals (simulated meals) at PBRC clinic. Children will not consume the simulated
      meals. Children's parents or caregivers will also use the PortionSize app and estimate the
      food intake of their children (at least one meal and a snack each day) for two consecutive
      days at home.
    

Intervention name(s): Validation of the PortionSize app
Intervention type(s): Device
Intervention description(s): The investigators will recruit 40 dyads (40 children aged 7-12 years old and 40 parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers will be trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children will use the PortionSize app and estimate food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children will not consume the simulated meals. Children's parents or caregivers will also use the PortionSize app and estimate the food intake of their children (at least one meal and a snack each day) for two consecutive days at home.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dietary Assessment
Herbert Screw vs Lag Screw Fixation in Anterior Mandibular Fracture Treatment
Condition: Mandibular Fractures
MeSH terms: Mandibular Fractures; Fractures, Bone
Study type: Interventional

Summary: 
      14 patients having recent anterior mandibular fracture divided into two groups. Group A has 6
      patients and treated using Herbert bone screw, and group B has 6 patients and treated using
      lag screw.

      Clinical follow-up was conducted after 24-hours, one, four, six, and twelve weeks. In
      addition, a radiographic investigation was performed after twelve weeks to estimate the mean
      bone density across the fracture line.
    


Intervention name(s): Herbert screw; Lag screw
Intervention type(s): Other; Other
Intervention description(s): Fracture line exposed through intra-oral approach. bone reduction into proper anatomical occlusion and application of Herbert screw; Fracture line exposed through intra-oral approach. bone reduction into proper anatomical occlusion. Application of either lag screw according to Champy's osteosynthesis lines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Cesarean Scar After Three Different Uterine Closure Technis
Condition: Cesarean Section, Repeated; Cesarean, Uterine Scar Thickness; Cesarean, Residual Myometrial Thickness
Study type: Interventional

Summary: 
      The study compares three techniques of uterine closure on myometrium thickness at the site of
      uterine scar of women who underwent repeated cesarean section. Cesarean scar will be
      evaluated by transvaginal ultrasound six months after cesarean.
    


Intervention name(s): Single layer closure; Double layer closure; Doble layer closure with trimming
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Uterine incision will be approximated with continuous unlocked suture, including a narrow band of the endometrial layer, without trimming incision edges.; The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.; Uterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Biomarker Establishment for Superior Treatment of PTSD
Condition: PTSD
Study type: Observational

Summary: 
      The purpose of Biomarker Establishment for Superior Treatment of PTSD is to accelerate
      research on the discovery of biological, neurological and neuroimaging markers for Post-
      Traumatic Stress Disorder (PTSD). The investigators hope to validate and extend the network
      efficiency and verbal memory biomarker for PTSD. The investigators hope to learn whether
      there are pretreatment biological factors that can predict response to therapy. They want to
      do this by understanding the brain network function, relating EEG to functional magnetic
      resonance imaging, and application of network analysis tool.
    


Intervention name(s): Psychotherapy
Intervention type(s): Other
Other intervention name(s): Cognitive Processing Therapy; Prolonged Exposure
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We will assess and acquire data on these Veterans across the course of the project prior to
        and after receiving Prolonged Exposure (PE) or Cognitive Processing Theory (CPT) treatment
        at VA Palo Alto (VAPAHCS) and the Albuquerque VA.
      
Keywords: veterans; post traumatic stress disorder; depression
Efficacy of a Nurse Telephone Follow-up on Pain Intensity After Removal of Tonsils in Children
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a nurse telephone follow-up to parents of
      children who underwent a removal of their tonsils would be effective in reducing pain
      intensity, complications and resort to other healthcare services
    

Detailed description: 
      Tonsillectomy in children is a common elective day surgery. In the United States, 530 000
      children under 15 years of age underwent a tonsillectomy in 2006. This minor surgery
      generates moderate to severe pain and many postoperative complications, both in the early
      postoperative phase and for at least 7 days. Patients are discharged home a few hours after
      tonsillectomy, and parents take over their child's care. But not all parents have the ability
      and knowledge required to adequately manage the pain and complications. This sub-optimal care
      situation has a significant impact on the child's convalescence and can lead to poor pain
      management, dehydration, poor rest and sleep quality, nausea, vomiting as well as an increase
      in the risk of secondary haemorrhage. Many interventions have been evaluated to improve pain
      management, such as education strategies for parents or children and tools to guide parents.
      However, none of these strategies have obtained significant results on children's pain
      intensity post-tonsillectomy.

      A nurse telephone follow-up can significantly reduce pain intensity of adults who undergo
      ambulatory surgery. This intervention is defined as multiple telephone calls made to the
      patient by a nurse, after discharge, to provide information, and review discharge
      prescriptions and management of care by the patient himself or by a care-giver. Only a few
      studies have explored nurse telephone follow-up for children who underwent tonsillectomy. The
      design of these studies, including the time-periods chosen for data collection, were not
      properly determined to adequately evaluate the impact of the intervention on management of
      pain and prevention of postoperative complications. Thus, we planned to determine if a nurse
      telephone follow-up, made to parents following their child's tonsillectomy, would contribute
      to decrease pain intensity, incidence of postoperative complications and resort to other
      healthcare services.
    

Intervention name(s): Telephone follow-up
Intervention type(s): Other
Intervention description(s): The intervention group received a telephone follow-up by a nurse on the 1st, 3rd, 5th and 10th postoperative day.
Other intervention name(s): Nursing interventions; Nursing follow-up
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: pediatric; tonsillectomy; pain management; nurse follow-up
Progressive Metabolic Adaptations to Low Intensity Exercise Training and Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      the investigators first aim is to determine the effect of low intensity exercise (without
      weight loss) on insulin sensitivity, muscle lipid metabolism, and factors regulating these
      processes in skeletal muscle after 1 day, 2 wks, 12 wks of training, and again after 3 days
      without exercise in obese adults. the investigators second aim is to determine the effect of
      combining low intensity exercise training with 10% weight loss on insulin sensitivity, muscle
      lipid metabolism, and factors regulating these processes in skeletal muscle.

      Although a single 40 minute session of exercise at a low exercise intensity will not improve
      insulin sensitivity, the investigators anticipate adaptations after two weeks of exercise
      training (6 session/wk; 12 session total) will improve insulin sensitivity and be accompanied
      by a reduction in fatty acid intermediates and a reduction in markers for pro-inflammatory
      activation in muscle. the investigators anticipate changes in insulin sensitivity, fatty acid
      partitioning, and pro-inflammatory markers the day after the last session of a 12 wk training
      program (without weight-loss) will be similar to that measured after 2 weeks of training. the
      investigators anticipate insulin sensitivity, accumulation of fatty acid intermediates, and
      pro-inflammatory activation will be markedly improved after 10% weight loss when measured the
      day after exercise. the investigators would expect the improvements in Insulin sensitivity,
      accumulation of fatty acid intermediates, and markers of inflammatory stress will be
      significantly attenuated when measured 3 days after the most recent exercise session, but
      beneficial effects of 10% weight loss on these metabolic endpoints will persist when compared
      with before weight loss.
    


Intervention name(s): Exercise Training; Weight Loss with continued Exercise Training
Intervention type(s): Other; Other
Intervention description(s): During the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, ~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week; After the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Insulin Sensitivity; Exercise Training; Weight Loss; Fat Metabolism
Effect of Dietary Fat Type in Combination With High Protein on Plasma Homocysteine Levels
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the investigators address the research question of whether palm olein will
      have a positive influence on plasma total homocysteine levels in human volunteers provided
      with high-protein diets formulated from common Malaysian foods.

      Hypothesis: There is a significant difference on the effects of the three experimental oils
      (palm olein, olive and coconut oil) on plasma tHy levels and the other markers of coronary
      heart disease (CHD) risk measured.
    

Detailed description: 
      The experimental are comprise of 30% kcal fat, 20% kcal protein and 50% kcal carbohydrate.
      Each of the test fat [palm olein (POo), virgin olive oil (OO) and coconut oil (CO)]
      contributes to two-thirds of total dietary fat will be compared.

      Three meals a day providing 2000 kcal, including breakfast, lunch and dinner will be provided
      for the 5-weeks period of each fat rotation.

      45 volunteers are fed with normal cooking oil for 3 weeks for standardisation purpose. They
      were then stratified into 3 groups according to gender, homocysteine and cholesterol level.
      The volunteers will be randomized, blinded and will undergo a 3 arms crossover intervention.
      Each intervention will take 5 wk with 2 wk wash out in between.

      Baseline blood samples will be taken while other blood samples will be collected at week-4
      and -5 of the study.
    

Intervention name(s): Olive Oil, Palm Olein Oil, Coconut Oil
Intervention type(s): Dietary Supplement
Intervention description(s): Effect of dietary fat type in combination with high protein on plasma homocysteine levels; 5 wk each with 2 wk wash out in between
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Palm olein; homocsyteine; Cholesterol; lipoproteins; Interleukins; CRP; Blood Pressure; Total homocystein; Serum lipid profile; Serum apolipoproteins; Inflammatory markers
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
Condition: Skin Infections, Bacterial
MeSH terms: Infections; Communicable Diseases; Cellulitis; Skin Diseases, Infectious; Bacterial Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects
      (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses,
      or impetigo (bullous and non-bullous).
    


Intervention name(s): Retapamulin Ointment, 1%
Intervention type(s): Drug
Intervention description(s): 1% Ointment
Other intervention name(s): Retapamulin Ointment; 1%
Intervention MeSH terms: Retapamulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SID; impetigo; pharmacokinetics; Retapamulin ointment, 1%; Skin abnormalities; Dermatoses; pediatric; infection; SITL
Patient Outcomes of Staged Ridge-splitting Using Piezo-electric Surgery in Atrophic Posterior Mandible
Condition: Alveolar Ridge Augmentation
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      This study aims to evaluate the clinical and radiographic outcomes of different staged
      ridge-splitting techniques for management of severely resorbed lower jaws in the posterior
      region. The study is designed as a clinical trial, so that three different interventions
      would be compared for a conclusion highlighting the relative best of them.
    

Detailed description: 
      In the context of the care of severely resorbed lower jaws in the posterior region, the
      purpose of this study is to evaluate the clinical and radiographic outcomes of several
      stepwise ridge-splitting procedures. The study is supposed to be a clinical trial, with the
      purpose of comparing three distinct therapies in order to get a result that highlights which
      of them is the most effective in comparison to the others.
    

Intervention name(s): Modified Ridge-Splitting
Intervention type(s): Procedure
Intervention description(s): Unlike the conventional ridge-splitting where bone grafting is done in the same visit after ridge splitting, modified ridge splitting involves splitting the ridge only at the first visit, then bone grafting is done either alone afterwards in the second visit (Modified 3-Staged Ridge-Splitting Group) and dental implants will be placed in the third visit, or, as in the Modified 2-Staged Ridge-Splitting Group, bone grafting and dental implants placement will be done in the second visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles
Condition: Lateral Periorbital Wrinkles
Study type: Interventional
Phase: Phase 3

Summary: 
      To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to
      placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile
      and to compare two different application schemes of Xeomin. Each subject will be treated on
      the right and left eye area, using the same dose but different application schemes (i.e. 3 or
      4 injection sites).
    

Detailed description: 
      Conducted in Europe
    

Intervention name(s): IncobotulinumtoxinA (Xeomin); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intramuscular injection at day 0, at 3 and 4 injection sites per eye (4 x 3 or 3 x 4 units = 12 units per eye); Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
Intervention MeSH terms: incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment