bioihbjkbjnl/mcl2 huggingface dataset:
Trunk Oriented Exercises Versus Whole-body Vibration for Duchenne Muscular Dystrophy
Condition: Muscular Dystrophy, Duchenne Type
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      The abdominal muscles play an important role in stabilizing the trunk and providing postural
      stability. Children with Duchene muscular dystrophy have weak muscles, which may impair
      postural adjustments. These postural adjustments are required for gait and dynamic balance
      during the daily living activities.
    


Intervention name(s): trunk oriented exercise; whole body vibration
Intervention type(s): Other; Other
Intervention description(s): trunk oriented exercises include: stretching exercises, stabilization exercises (active or active-assisted), arm exercises in fixed trunk position, trunk-oriented exercises (active or active-assisted), trunk mobilization (sitting and lying position), and functional reaching exercises with different ranges of motion in shoulder elevation; WBV application technique. The children assume a full squatting position on a vibration platform. The apparatus will set at a frequency of 30 Hz, an amplitude of 2 mm, and a duration of 5 min. The children were instructed to remain in squatting position after the vibration started and to report any discomfort that arose. At the end of 5 min, the vibration turned off automatically. Thereafter, the children rested for 1 min. They were then asked to stand on the vibration platform while supported by the therapist for 5 min, with the same parameters as those used in the squatting position. The total time of application of WBV in each session was 10 min.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Low Level Laser Therapy in Accelerating Tooth Movement For Dental Crowding Cases
Condition: Maxillary Crowded Teeth
Study type: Interventional

Summary: 
      26 participants from the Orthodontic Department at University of Damascus Dental School will
      be randomly assigned into two groups. In the experimental group, a low level laser with a
      wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15
      seconds per point will be applied on each tooth of the six upper incisors according to this
      protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be
      applied in the center of each half from both the buccal and palatal sides which means 4
      application points and a total energy of 8 j per each tooth. Control group will undergo
      typical orthodontic treatment with the laser device applied the same manner but without being
      turned on (to get the placebo effect for pain reduction effect). This procedure will be
      repeated after 3, 7, 14 days and each 15 days from the beginning of the second month till the
      end of the leveling and alignment stage.
    

Detailed description: 
      The long time needed for orthodontic treatment is considered one of the biggest obstacles
      which make patients refuse to undergo treatment. It also has many disadvantages including
      higher caries rates, gingivitis, and root resorption. It also combined commonly with pain,
      which reducing patient acceptance and cooperation with treatment.

      Low level laser therapy in orthodontic has shown pain-reducing effects with an effect in
      biomodulation which lead to increased orthodontic tooth movement rate and reducing risk of
      root resorption.

      A recent systematic review states that low level laser therapy has shown efficiency in
      accelerating orthodontic tooth movement, but there is a need for more studies to determine
      the best protocols regarding energy and frequency. A review of the literature shows that
      there is no randomized controlled trails evaluating its efficiency in accelerating
      orthodontic tooth movement in regard of dental crowding cases, which is the main purpose of
      this study.
    

Intervention name(s): low level laser therapy
Intervention type(s): Radiation
Intervention description(s): low level laser therapy is intended to accelerate tooth movement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Early Treatment Versus Delayed Conservative Treatment of the Patent Ductus Arteriosus
Condition: Patent Ductus Arteriosus; Surgery; Necrotizing Enterocolitis; Intestinal Perforation
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing; Intestinal Perforation; Ductus Arteriosus, Patent
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary goal of the trial is to compare two different Patent Ductus Arteriosus (PDA)
      treatment approaches: 1) an "early treatment" approach or 2) a "conservative" approach. For
      the purposes of the study infants will be enrolled if they are delivered before 28 weeks
      gestation and have a moderate/large PDA present at 5-7 days after birth.

      The hypothesis is: treatment of a moderate size patent ductus arteriosus (PDA) will decrease
      the time needed for assisted respiratory support, diuretic therapy, and gavage feeding
      assistance, in addition to decreasing the incidence of ductus ligations or need for future
      outpatient cardiology follow-up appointments. The investigators hypothesize that one or more
      of these benefits will occur without an increase in the time taken to achieve full enteral
      feedings or in the incidence of necrotizing enterocolitis (NEC) or spontaneous intestinal
      perforations (SIP).The investigators will be comparing the effectiveness of early
      pharmacologic treatment with a control group of conservatively managed infants who will only
      receive treatment if they meet specific criteria for "rescue treatment".
    

Detailed description: 
      Prior studies showed that, if a moderate/large Patent Ductus Arteriosus (PDA) is still
      present at 5 days after birth (among infants delivered at 23 and 0/7 to 25 and 6/7 weeks
      gestation) or at 7 days after birth (among infants delivered at 26 and 0/7 to 27 and 6/7
      weeks gestation), it will persist for at least another 4-12 weeks if it is left untreated.
    

Intervention name(s): pharmacologic treatment of the PDA; no pharmacologic treatment of the PDA; NSAID
Intervention type(s): Other; Other; Drug
Intervention description(s): Following randomization, infants will be treated with medications used to produce PDA closure.; Following randomization, infants will NOT be treated with medications used to produce PDA closure (unless they develop rescue criteria at a later point in time).; Indomethacin, ibuprofen or acetaminophen will be used as standard of care treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Early routine, mandated PDA treatment versus Conservative treatment only if Rescue criteria are met
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: patent ductus arteriosus; patent ductus arteriosus ligation; necrotizing enterocolitis; spontaneous intestinal perforation
Evaluation of a Video Game for Adolescents and Young Adults With Cancer
Condition: Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of playing the interactive video game,
      Re-Mission, on patient outcomes, including adherence to medical treatment regimes, self-care
      behaviors, quality of life, stress, communication, control, and knowledge.
    

Detailed description: 
      POPULATION: Approximately 340 patients will be enrolled in this study. Patients will be 13 to
      29 years of age with any cancer (original diagnosis or relapse), currently receiving
      treatment and expected to be on treatment for at least 4 - 6 months following Baseline
      assessment, and able to communicate effectively in English, Spanish, or French. Approximately
      170 patients will be enrolled in each of the two treatment groups. Each group will receive
      either the "Re-Mission" video game and a popular interactive video game, or just the popular
      interactive video game.

      DESIGN: This is a multi-center, randomized trial, with patients randomized to one of two
      groups. One group (50% of patients) will receive the active intervention, which is the
      psycho-educational video game module called Re-Mission and a popular video game (hereafter
      "RE-MISSION") and another group (50 % of patients) will be in a game control group and
      receive a popular video game only (hereafter "GAME CONTROL. The games in the RE-MISSION and
      GAME CONTROL groups are delivered on identical mini, personal computers (hereafter
      "Mini-PC").

      INTERVENTION: Each patient in the RE-MISSION group will be asked to play "Re-Mission" along
      with the popular video game for at least one hour a week for a period of ten to fourteen
      weeks. "Re-Mission" presents a 3-D environment in which the player can manipulate a humanoid
      character inside the virtual body of a patient with cancer. Game-play consists of guiding the
      character to destroy cancer cells and other "enemies" in the body (e.g., bacteria) while
      avoiding injury or weakness. During the process of playing the game and guiding the character
      through a series of missions, the player learns about chemotherapy and other medical
      treatments, health-promoting self-care behaviors, infections, and pain management. In
      addition, the game has also been designed to facilitate the patient's ability to share
      knowledge and concerns with others.

      DURATION OF STUDY: 9 -12 months
    

Intervention name(s): Re-Mission
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Cancer; Video game; Adolescent; Young adult
The Oslo Stan vs Lactate Observational Study
Condition: Fetal Monitoring
Study type: Observational

Summary: 
      The main aim of the study is to compare the clinical performance of two adjunctive methods to
      CTG in intrapartum fetal monitoring: FBS with measurement of scalp lactate and ST analysis of
      the fetal ECG.
    

Detailed description: 
      We use Lactate as a standard adjunctive method in our hospital but we have STAN software
      available ( is demasked) in our CTG monitors. We will include all women in labour with an
      intern scalp monitoring and analyse the CTG, the lactate samples and the STAN signals in the
      same patient and

        -  Study the relationship between the decision-to-delivery interval and neonatal morbidity
           in deliveries monitored by scalp lactate measurement

        -  Compare the diagnostic capability of both methods to identify fetuses at risk of hypoxia

        -  Compare the false negative alerts from both methods

        -  Explore the temporal and quantitative relation between fetal lactate metabolism and ST
           interval changes of the fetal ECG
    

Intervention name(s): STAN ( St wave analysis) and fetal blood sample-lactate
Intervention type(s): Diagnostic Test
Intervention description(s): The CTG will be analysed by an expert group additional to the standard procedure that have been done in Labour already. The STAN analysis will be decrypted/ demasked anonymously by the Company producing these machines.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women in labour who are monitored with CTG and FBS scalp lactate. CTG monitoring is
        achieved by an internal scalp electrode combined with a pressure-sensitive external
        contraction transducer. FBS is performed at the decision of the obstetrician. Capillary
        blood is obtained from the fetal head and analyzed with a bed-side test (Lactate Pro). The
        monitoring procedures described above are identical with the current clinical routine at
        the department.

        The department utilizes S31 fetal monitors (Neoventa Medical AB©, Sweden), which are
        equipped with the hard and software tool for ST analysis. Once the scalp electrode is
        attached, ST analysis will be performed and recorded continuously. ST information is
        blinded in labor, i.e. clinical management will only be based on CTG and FBS if indicated.
      
Keywords: CTG; Fetal blood sampling - Lactate; ST waveform analysis
University Student Intervention to Increase Organ Donation
Condition: Organ Donation; Health Behavior
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of brief organ donation video
      interventions on consent for organ donation among college and university students. Our
      hypothesis is that the organ donation video interventions will be superior to lay health
      websites for increasing organ donation consent.
    

Detailed description: 
      This randomized controlled trial will involve 600 intervention and 600 control university
      students. Students will be randomized to 1 of 3 arms: a 5-minute video by the U.S. Department
      of Health and Human Services, a 5-minute video by the study principal investigator, or a
      health-related website by the Centers for Disease Control. After viewing the intervention,
      participants will be asked questions including whether they would like to consent to organ
      donation on their state electronic registry.
    

Intervention name(s): HRSA Video Intervention; PI Video Intervention; CDC Health Website Intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: Randomized Controlled Trial; Healthcare Disparities
Effects of Propofol and Ketofol on Core Body Temperature in MRI
Condition: Children
Study type: Interventional

Summary: 
      Investigators researched the effect of two different types of drugs on core body temperature
      during magnetic resonance imaging. The hypothesis is in ketamine group, thermo disregulation
      is not as distinct as in propofol group, due to its positive effect on thermo regulation
    

Detailed description: 
      Intravenous anesthetics may impair thermoregulation. Absorption of radiofrequency waves by
      the body surface may result in heating, especially in small children during magnetic
      resonance imaging (MRI). Investigators applied two different intravenous anesthetics as
      propofol and ketamine and studied the effect of these drugs on core body temperature.

      All patients aged between 6 months-10 years were administered midazolam and atropine. After
      that 1 mg/ kg of propofol was applied in group I, and 0,1 ml/kg of propofol ketamine mixture
      ( 10 mg/ml each) was applied in group II. Core body temperatures were taken before and after
      MRI and compared.
    

Intervention name(s): propofol; Ketamine propofol mixture
Intervention type(s): Drug; Drug
Intervention description(s): propofol, midazolam and atropine administration via intravenous cannula.; Administration of ketamine propofol mixture, midazolam and atropine via intravenous cannula
Other intervention name(s): propofol 1%; ketofol
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: core body temperature; magnetic resonance imaging; propofol; ketofol
Effects of Insulin Detemir and NPH Insulin on Renal Handling of Sodium, Fluid Retention, and Weight in Type 2 Diabetic Patients
Condition: Diabetes Type 2; Weight Gain
MeSH terms: Diabetes Mellitus, Type 2; Body Weight; Weight Gain
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis: Changing type 2 patients treatment from Insulin Insulatard to Insulin Detemir
      will increase their excretion of sodium in the urine and thereby decrease their extracellular
      volume and body weight. 24 patients are divided into 2 groups and their insulin treatment is
      shifted while their body composition, sodium excretion, weight and extracellular volume is
      monitored.
    

Detailed description: 
      Type 2 diabetic patients experience weight gain when receiving insulin treatment. There has
      been reports that the weight gain is less or absent when patients are treated with Insulin
      Detemir. Patients with diabetes have increased total body sodium and increased extracellular
      volume. We hypothesize that part of the weight gain seen is due to increase in extracellular
      volume and that the lesser weight gain seen in patients treated with Detemir is due to an
      lesser increase in extracellular volume. We believe that the cause of this difference is the
      different pharmacokinetic properties of insulin Detemir. Insulin Detemir i protein bound and
      is therefore not excreted in the kidneys. This may cause less sodium reabsorption, than with
      other insulins, and therefore less increase in extracellular volume.

      We test this hypothesis by examining urinary sodium excretion, extracellular volume by GFR
      measurements, Body composition by DEXA scan, body weight, and 24 hour blood pressure.In
      patients that are changed from Insulin Insulatard to Insulin Detemir and back.
    

Intervention name(s): Insulin Detemir; Insulin Insulatard; Insulin Detemir, Insulin Insulatard
Intervention type(s): Drug; Drug
Intervention description(s): Dosage is individual but fixed in study period (if possible). Detemir is given once daily, Insulatard is given twice daily.; Fixed doses in study period (if possible). Insulin Detemir once daily, Insulin Insulatard twice daily.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Weight gain in insulin treated type 2 diabetes; extracellular volume; insulin treatment; sodium retention
Evaluation of the Relative Bioavailability and Food Effect of GDC-9545 in Healthy Females of Non-Childbearing Potential
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomized, three-period, six-sequence crossover study of
      GDC-9545 administered to healthy females of non-childbearing potential to determine the
      relative bioavailability of the Phase 3 capsule formulation to the Phase 1 tablet formulation
      in the fasted state and the effect of food on the Phase 3 capsule formulation.
    


Intervention name(s): GDC-9545 Tablet, Fasted: Treatment A; GDC-9545 Capsule, Fasted: Treatment B; GDC-9545 Capsule, Fed: Treatment C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.; One dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.; One dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water within 30 minutes of eating a high-fat meal.
Other intervention name(s): Giredestrant; RO7197597; RG6171; Giredestrant; RO7197597; RG6171; Giredestrant; RO7197597; RG6171
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy
Condition: Proliferative Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional

Summary: 
      Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with
      conventional 20, 23, and 25-gauge vitrectomy were compared.
    

Detailed description: 
      The 424 eyes of 347 patients of PDR who underwent vitreous surgery for persistent vitreous
      hemorrhage or progressive proliferative membrane were evaluated.
    

Intervention name(s): Vitrectomy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Proliferative diabetic retinopathy; Vitrectomy
Laparoscopic Hernia Defect Obliteration With ProFlor-E
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      This feasibility study highlights the features of the 3D dynamic responsive prosthesis
      ProFlor-E® for fixation free obliteration of inguinal hernia defect
    

Detailed description: 
      The 3D dynamic-responsive prosthesis for inguinal hernia repair ProFlor-E® recently
      introduced to the market has been laparoscopically employed for the repair of one recurrent
      inguinal hernia previously managed with anterior open approach. The scope of this feasibility
      study is to demonstrate that the positive effects of the 3D implant already proven in open
      inguinal hernia repair are also effective or even superior for the laparoscopic of
      recurrent/bilateral inguinal hernias compared to conventional treatment concept.
    

Intervention name(s): ProFlor laparoscopic technique
Intervention type(s): Device
Intervention description(s): Inguinal hernia repair laparoscopic
Intervention model: Sequential Assignment
Intervention model description: feasibility study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inguinal hernia; Laparoscopic inguinal hernia repair; Inguinal hernia defect obliteration; Fixation free hernia repair; Regenerative scaffolds