bioihbjkbjnl/mcl2 huggingface dataset:
Managing Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to determine which pain management strategy continuous analgesic
      pump or orally-should be used in the management of children with cerebral palsy.
    

Detailed description: 
      A prospective randomized controlled trial will be performed on up to 150 subjects who will
      undergo a tendoachilles lengthening, Strayer's procedure, epiphysiodesis of the femur or
      femoral osteotomy metal work removal.

      Subjects will be randomized into two groups: the first group will have an anesthetic pain
      pump device supplemented with oral analgesia and the second group will only receive oral
      analgesia. The anesthetic continuous device will be used continuously for 48 hours and with a
      flow rate of 2ml/hour of 0.25% bupivacaine diluted in accordance to patient weight. Subjects
      in both groups will receive oral analgesia according to their pain requirements. The amount
      of oral analgesia used will be documented over 12-hour intervals in a patient diary over a 4
      day period. Subjects will have their pain score assessed daily with the use of the
      Non-Communicating Children's Pain Checklist-Postoperative Version. Their overall satisfaction
      with post-operative pain management will be assessed at the end of the study with the use of
      the Parent Total Quality Pain Management questionnaire.
    

Intervention name(s): oral analgesic; intravenous analgesic per pump
Intervention type(s): Drug; Drug
Intervention description(s): per clinical standard of care; per clinical standard of care
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Pain management; Cerebral Palsy
A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome
Condition: Primary Sjögren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to initially observe the safety and effectivity of RC18 in
      Participants with Primary Sjögren's Syndrome.
    


Intervention name(s): Placebo; RC18 240 mg; RC18 160 mg
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Patients received the test group Placebo weekly administered subcutaneously for 24 times.; Arm Description:Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.; Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Styloid Chain Calcification to the Patient With the Temporomandibular Joint Disorder
Condition: Styloid-Stylohoid Syndrome; Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Joint Diseases
Study type: Observational

Summary: 
      The aim of the study was to evaluate any relation between elongated styloid process (ESP) and
      type of Temporomandibular Joint Disorders (TMD).
    

Detailed description: 
      The styloid process (SP) of the temporal bone is a long conical cartilaginous projection lies
      anterior to the mastoid process. Patients who have ESP or styloid chain calcification are
      usually asymptomatic, only 4% are symptomatic. Symptoms vary as different syndromes which
      related affected anatomic structures by calcified process or ligament. Temporomandibular
      Dysfunction (TMD) describe the temporomandibular joint (TMJ) disfunction that divided three
      branches according to temporomandibular joint's disc status: non-displacement (ND),
      displacement with reduction (DWR) and displacement without reduction (DWoR). Since orofacial
      pain shows similar features in both ESP or styloid chain calcification and TMD, it is
      possible to confuse and misdiagnosis both of these clinical conditions. This study aimed to
      investigate the length and calcification pattern of the styloid process in patients with TMD
      diagnosis.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients have at least one of these clinic conditions: TMJ pain, mouth opening restriction,
        joint sound, joint function disorder.
      
Keywords: magnetic resonance imaging; cone beam computed tomography; temporomandibular dysfunction; Styloid-Stylohoid Syndrome
Oral Bioavailability of Two Solid Formulations of GLPG0259.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the relative bioavailability of two solid oral
      formulations of GLPG0259 administered after a meal.
    


Intervention name(s): GLPG0259 fumarate; GLPG0259 free base
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose, two capsules each containing 25 mg of GLPG0259 fumarate; single oral dose, GLPG0259, 50 mg solid formulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Safety; Tolerability; Pharmacokinetics
Expansion of the Weigh Smart Pediatric Group Family Oriented Weight Management Program Through the Use of Telehealth
Condition: Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      There has been a steep rise in the prevalence of obesity among children and adults in the
      United States. The Weigh Smart program, a family based weight management program was
      developed in 2005 with significant improvement in the severity of obesity among children in
      the Baltimore are participating in the group program with limited impact outside the region
      due to transportation. Trial of the group program (nutrition, exercise) delivered via
      telehealth through fruit street on the Eastern Shore and Western Maryland with use of
      noninvasive lifestyle tracking options (drink water aquarium app for water consumption and
      fitbit- steps, sleep monitoring) provides novel options for expansion of family- based
      lifestyle intervention to underserved areas. Investigators plan as a pilot study to assess
      the sensitivity of noninvasive measures for the detection of sleep apnea (pediatric sleep
      questionnaire (PSQ) and fitbit re: sleep data) in comparison to clinically indicated
      polysomnography among children with clinical suspicion for sleep apnea.
    

Detailed description: 
      . Trial of the group program (nutrition, exercise) delivered via telehealth through fruit
      street to families of overweight and obese children between 7-17 years of age referred from
      selected pediatric practices on the Eastern Shore of Maryland and Western Maryland with use
      of noninvasive lifestyle tracking options (drink water aquarium app for water consumption and
      fitbit charge 3- steps, sleep monitoring) provides novel options for expansion of family-
      based lifestyle intervention to underserved areas. Investigators plan as a pilot study to
      assess the sensitivity of noninvasive measures for the detection of sleep apnea (pediatric
      sleep questionnaire (PSQ) and fitbit charge 3 sleep data) in comparison to clinically
      indicated polysomnography among children with clinical suspicion for sleep apnea.
    

Intervention name(s): Weigh Smart Telehealth intervention
Intervention type(s): Behavioral
Intervention description(s): Trial of the group program (nutrition, exercise) delivered via telehealth through fruit street on the Eastern Shore and Western Maryland with use of noninvasive lifestyle tracking options (drink water aquarium app for water consumption and fitbit - steps, sleep monitoring) provides novel options for expansion of family- based lifestyle intervention to underserved areas. We plan as a pilot study to assess the sensitivity of noninvasive measures for the detection of sleep apnea (pediatric sleep questionnaire (PSQ) and fitbit sleep data) in comparison to clinically indicated polysomnography among children with clinical suspicion for sleep apnea.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
#KindGirlsInACTion: A Programme for the Promotion of Mental Health of Female Adolescents
Condition: Quality of Life; Eating Disorders; Eating Behavior; Psychological; Emotion Regulation; Body Image; Relations, Interpersonal
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      The #KindGirlsInACTion project started in 2017 and developed and implemented a
      psychotherapeutic intervention program in Portuguese female adolescents. This program aimed
      to improve the overall quality of life and well-being of the participants, and specifically
      to promote a qualitative improvement in body image and interpersonal relationships, through
      the promotion of self-compassion, compassion and psychological flexibility.
      #KindGirlsInACTion is a school-based program, with 9 sessions over 9 weeks. It is essentially
      practical and interactive, with exercises created specifically for the program, as well as
      the regular practice of mindfulness.
    


Intervention name(s): #KindGirlsInACTion
Intervention type(s): Behavioral
Intervention description(s): 9-session weekly cognitive-behavioural intervention to promote psychological well-being and prevent body image and eating-related disordered behaviours.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intervention Programme; School-based; Adolescence; Girls; Psychological well-being; Compassion; Psychological flexibility; Positive body image
Effects of β-glucans on Gut Permeability and Microbiota in Elderly
Condition: Elderly; Bowel Symptoms; Prebiotics
Study type: Interventional

Summary: 
      The investigators aim was to compare healthy young adults, senior orienteers (model of
      healthy ageing) and elderly with gastrointestinal symptoms on intestinal permeability,
      microbiota compositions and well-being. In addition, assess whether 3 weeks of oral intake of
      soluble or dispersible forms yeast-dervied beta-glucan could improve intestinal barrier
      function against drug-induced barrier disruption vs placebo for a cohort of elderly people
      with gastrointestinal symptoms, in a randomized double blinded placebo-controlled cross-over
      clinical trial.
    

Detailed description: 
      Baseline samples for measurements of intestinal permeability (multisugar test), microbiota
      composition (faecal samples) and well-being (questionnaires) were collected during the first
      week for:

      Young healthy adults (healthy young controls) Senior orienteers (healthy elderly controls)
      Elderly with gastrointestinal (GI) symptoms

      Thereafter only the elderly with GI symptoms continued into the randomized cross-over trial
      where they were blindly and randomly distributed one of the following: Soluble yeast-derived
      beta-glucan, dispersible (whole) yeast-derived beta-glucan and placebo. Each supplement was
      taken for 3 weeks with a 1 week washout until all participants had taken all supplements.
      Towards the end of each supplement period, samples for measurement of intestinal permeability
      and microbiota were collected, in addition to questionnaires being filled out.
    

Intervention name(s): yeast-beta glucan
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3 study products (2 different forms of yeast-beta glucan and a placebo) taken in a cross-over design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: elderly; prebiotics; permeability; clinical trial; Microbiota; Health
Comparison of the Femoral Prothesis-rotation in Conventional X-ray, in Axial CT Slices and 3D-reconstructed CT
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      Femoral component rotation in total knee arthroplasty (TKA) has been considered an important
      factor for outcome. However, measurement of femoral component rotation is difficult to
      perform.

      Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique),
      axial CT slices and 3D reconstructed CT images.

      It was the hypothesis that measurements on radiographs are comparable to measurement on CT
      images.

      Measurements of femoral TKA rotation will be measured three times by three different
      observers and inter- and intraobserver reliability is calculated. The absolute values of each
      measurement method is noted in degrees.
    

Detailed description: 
      Femoral component rotation in total knee arthroplasty (TKA) has been considered an important
      factor for outcome. However, measurement of femoral component rotation is difficult to
      perform.

      Femoral TKA component rotation can be assessed on special radiographs (Kanekasu technique),
      axial CT slices and 3D reconstructed CT images.

      It was the hypothesis that measurements on radiographs are comparable to measurement on CT
      images.

      In agreement with our standard diagnostic algorithm for patients with pain and problems after
      TKA CT images as well as Kanekasu radiographs are performed. If the Kanekasu radiograph is
      comparable reliable, it could be possible to use this radiograph instead.

      Measurements of femoral TKA rotation will be measured three times by three different
      observers and inter- and intraobserver reliability is calculated. The absolute values of each
      measurement method is noted in degrees. The measurements are performed with two weeks
      interval and the different observers are blinded to their previous and the measurements of
      the others.

      The absolute difference of femoral TKA rotation is calculated between and inter the groups
      investigated.

      Intra class correlation coefficients are calculated for inter- and intraobserver reliability.
    

Intervention name(s): Kanekasu radiographs
Intervention type(s): Other
Intervention description(s): No interventions are performed here. All patients undergo CT and special radiographs of the knee to assess femoral TKA rotation.
Other intervention name(s): Femoral component rotation; total knee prothesis; X-ray; kanekasu-technic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: total knee arthroplasty; total knee prothesis; X-Ray; Kanekasu radiographs; femoral component rotation; effects
Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of
      ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.
    


Intervention name(s): Ibrutinib; IMBRUVICA
Intervention type(s): Drug; Drug
Intervention description(s): Ibrutinib (test treatment) 140 milligram (mg), tablet.; IMBRUVICA (reference treatment), 140-mg capsule
Other intervention name(s): Ibrutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose Versus Multiple Doses of Dexamethasone in Children With Acute Bronchiolitis
Condition: Bronchiolitis
MeSH terms: Bronchiolitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to determine the effectiveness of five-day treatment versus a single dose of
      oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first
      episode of acute bronchiolitis presenting in the Emergency Department
    


Intervention name(s): dexamethasone
Intervention type(s): Drug
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bronchiolitis; pediatrics; corticosteroids
Postprandial Inflammatory Response in Healthy Men: Effect of Dietary Fat Source, Obesity and Age
Condition: Healthy; Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The nature of dietary lipids, age and perivisceral adiposity could alter the postprandial
      inflammatory response. It is supposed that there is a relationship between the postprandial
      inflammatory response and the repartition of fat and lean mass, which could partially explain
      the muscle mass loss with age.

      The aim of this study is to compare the inflammatory response of a normal meal or high fat
      meal (from different fatty acids sources) between young lean and young obese and aged lean
      and aged obese men.
    

Detailed description: 
      32 healthy volunteers will be separated into four groups: 8 young lean men, 8 young obese
      men, 8 aged lean men and 8 aged obese men. They will come to the center four times after
      inclusion, with 2 to 4 weeks wash out each time. At the first visit they will undergo
      different test to evaluate their body composition, glucose tolerance, resting energy
      expenditure, and muscular strength. At the other three visits, people will undergo a kinetic
      blood sampling, urine and biopsies of adipose tissue over a period of 8h after ingestion of a
      test meal. The different meals tested (Oleic acid vs palmitic acid vs no lipid) will be given
      in a random way over the three visits. Before each of these three visits, a controlled diet
      will be established. At the last visit body composition and muscular strength will be
      evaluated.
    

Intervention name(s): Mashed potatoes; Mashed potatoes + Oleic acid; mashed potatoes + Palmitic acid
Intervention type(s): Other; Other; Other
Intervention description(s): Mashed potatoes: Potatoes + Skim milk powder; Mashed potatoes with 1g/Kg of weight, of lipids with 75% of Oleic Acid; Mashed potatoes with 1g/Kg of weight, of lipids with 32% of palmitic acid
Intervention MeSH terms: Palmitic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Inflammatory response; High-fat meal; cytokines; Body composition
Uterus Transplantation LD - Feasibility Study - Sahlgrenska - BMC
Condition: Mrk Anomaly; Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      Medical know-how concerning uterus transplantation will be transferred to new site by
      structured process involving theory, animal workshops and a clinical feasibility study on
      human subjects.
    

Detailed description: 
      Medical know-how concerning uterus transplantation will be transferred to new site by
      structured process involving theory, animal workshops and surgery.

      Theory and common animal workshops have been ongoing for 3 years. The team from Bellevue
      Medical Centre is affiliated to St Joseph, University, Beirut
    

Intervention name(s): uterus transplantation surgery and IVF
Intervention type(s): Procedure
Intervention description(s): IVF before surgery living donor uterus transplantation ET
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: uterus; infertility; transplantation
Effect of Metabolic Therapy in Patients With Chronic Ischemic Heart Disease
Condition: Coronary Artery Disease; Type II Diabetes Mellitus
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with coronary artery disease have an abnormal cardiac metabolism. The hypothesis of
      this study is that shifting cardiac metabolism from free fatty acids to glucose will improve
      myocardial ischemia
    

Detailed description: 
      The present study will evaluate the effect of free fatty acid inhibition with Trimetazidine
      on silent myocardial ischemia and total ischemic burden in coronary artery disease patients
      with type II diabetes.

      Patients will undergo ambulatory ECG monitoring at baseline and will be randomized to receive
      on top of thei standard anti-anginal therapy trimetazidine or placebo for 6 months. Patients
      will repeat the ambulatory ECG monitoring at the end of the study
    

Intervention name(s): Trimetazidine
Intervention type(s): Drug
Intervention MeSH terms: Trimetazidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: coronary artery disease; diabetes mellitus
Postoperative Desogestrel for Endometriosis Related Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      Endometriosis is one of the most common disease in reproductive aged women.Surgical
      intervention has a significant symptoms relief. However, symptom recurrence is often after
      surgery. This study aims to determine the efficacy of Desogestrel compared with placebo in
      pain symptom of symptomatic endometriosis patient undergo conservative surgery . The primary
      outcome measurement is pain score at 6 months after surgery.
    

Detailed description: 
      After conservative surgery, the patients are randomized to Desogestrel and placebo groups.
      VAS pain score are compared after complete 6 months
    

Intervention name(s): Desogestrel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months; Placebo capsule takes 1 capsule before bedtime for 6 months
Other intervention name(s): Cerazette
Intervention MeSH terms: Desogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endometriosis; Desogestrel; Placebo
Single Anastomosis Sleeve Jejunal Bypass as a Revisional Bariatric Procedure
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      single anastomosis sleeve jejunal bypass as a revisional procedure after weight regain or
      failure after laparoscopic sleeve gastrectomy, gastric plications or laparoscopic adjustable
      gastric band
    

Detailed description: 
      in this study the investigators aim to test the efficacy of single anastomosis sleeve jejunal
      bypass as a revisional procedure after weight regain or failure after laparoscopic sleeve
      gastrectomy, gastric plications or laparoscopic adjustable gastric band
    

Intervention name(s): SAS-J
Intervention type(s): Procedure
Intervention description(s): Single Anastomosis Sleeve Jejunal Bypass
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment