bioihbjkbjnl/mcl2 huggingface dataset:
Pre-hospital Advanced Therapies for Control of Hemorrhage - Pelvis
Condition: Hemorrhage; Pelvic Fracture
MeSH terms: Hemorrhage; Hip Fractures
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the use of pelvic binders in the ambulance
      setting improves outcomes including mortality in patients with pelvic fractures.
    

Detailed description: 
      The goal of this prospective, randomized clinical trial is to determine whether prehospital
      use of a commercial pelvic binder will improve morbidity and mortality in patients with
      pelvic fractures. We hypothesize that prehospital placement of pelvic binders will reduce
      hemorrhage and need for resuscitation and will improve overall mortality in patients with
      pelvic fractures. In addition, we hypothesize that pelvic splinting via external compression
      will improve patients' pain regardless of whether they have a pelvic, acetabular, or proximal
      femur fracture.
    

Intervention name(s): Pelvic Binder
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigating Hearing Aid Frequency Response Curves
Condition: Hearing Loss, Sensorineural; Hearing Loss, Bilateral
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Loss, Bilateral
Study type: Interventional

Summary: 
      Internal research on the manufacturer's hearing aid products has idenitfied areas in which
      the investigators can improve the hearing aid frequency response curve. This study aims to
      investigate the current freqeuncy response curve in the manufacturer's products to variations
      of these curves to determine if hearing aid users prefer the variations over the
      manufacturer's standard curve.
    

Detailed description: 
      Internal testing has identified areas in which the investigators can improve the performance
      of the manufacturer's hearing aid products. This should potentially lead to increased hearing
      aid user satisfaction due to an improvement in sound quality. However, the investigators are
      currently unsure if implementing these new frequency response curves will be preferred by the
      manufacturer's clients. Therefore, a study is proposed in which hearing aid users will
      compare the manufacturer's current frequency response curve to variations made to the curve
      and determine which one they prefer while listening to live speech/music or while streaming
      speech/music.
    

Intervention name(s): Hearing Aid - Standard Curve; Hearing Aid - Variation #1; Hearing Aid - Variation #2; Hearing Aid - Variation #3; Hearing Aid - Variation #4
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): Our current hearing aids which will be programmed to our standard frequency response curve.; Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.; Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.; Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.; Hearing aids that will have the frequency response curve adjusted and fit to the participant's hearing loss.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hearing Loss; Hearing Aids; Frequency Response Curves
Serotonin Transporter Concentrations in Women With a History of Anorexia Nervosa
Condition: Eating Disorders; Anorexia Nervosa
MeSH terms: Anorexia; Feeding and Eating Disorders; Anorexia Nervosa
Study type: Observational

Summary: 
      This study will compare the concentrations of serotonin transporter in the brains of women
      with a history of anorexia nervosa who are currently maintaining a normal weight to those of
      healthy women of normal weight.
    

Detailed description: 
      Anorexia nervosa (AN) is a serious eating disorder that is associated with substantial
      morbidity and mortality. Despite being dangerously underweight, people with AN believe that
      they are overweight, and frequently exhibit symptoms of depression and anxiety. Other
      symptoms of AN include the following: resistance to maintaining a healthy body weight; fear
      of gaining weight or becoming overweight; and denial of the seriousness of one's current low
      body weight. Relapse rates for AN are extremely high. Serotonin is a neurotransmitter, or
      chemical messenger, that affects mood, impulse control, and appetite. A serotonin transporter
      is a specialized protein that allows cells to communicate with each other by using serotonin.
      Disturbances in the serotonergic system, the network of nerve cells that uses serotonin as
      its neurotransmitter, may contribute to the behaviors that are characteristic of AN. This
      study will compare women with a history of AN who are now maintaining a normal weight to
      healthy women of normal weight in terms of the concentration of serotonin transporter in
      their brains.

      Participants in this observational study will undergo one positron emission tomography (PET)
      scan and one magnetic resonance imaging (MRI) scan. Both will be used to measure the
      concentration of the serotonin transporter. A radioactive tracer will be used for the PET
      scan, and will be administered via an intravenous catheter line. No treatment will be
      provided in this study.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be women who have recovered from anorexia nervosa and are currently
        living in the local community.
      
Keywords: Serotonin Transporter; Positron-Emission Tomography
Effects of Triglycerides on Age-Related Cognitive Function Decline in Older Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single centre, 2 part study in older subjects. Part 1 (Pharmacokinetic [PK]
      Assessment) is a double blind, randomized, placebo-controlled 4-period crossover study
      investigating the PK profile of four different doses of GSK2981710. Eight subjects will
      receive a single dose of GSK2981710 10 gram (g), 20 g, 30 g, 40 g or placebo in the morning
      and have PK assessments (every 0.5 hrs up to 8 hrs post-dose) throughout the day in each
      period. Each subject will complete a total of four dosing sessions and 4 days of PK
      assessments in 2 weeks. The Part 1 PK data will be used for dose selection and
      pharmacodynamic (PD) assessment period in Part 2. If the data from Part 1 is inconclusive, an
      additional 8 subjects may be recruited and Part 1 repeated (possibly dropping some doses) to
      increase confidence. A subject's total participation in Part 1 of the study will last a
      maximum of approximately 7 weeks including screening. Subjects who have completed Part 1 may
      be screened for eligibility and enrolled for Part 2.

      Part 2 (PD Assessment) is a double blind randomized, placebo-controlled 2-period crossover
      design with 14-day treatment periods investigating the efficacy (cognitive performance) and
      tolerability (gastrointestinal [GI] side effects) of single daily dose of GSK2981710 selected
      from Part 1. Part 2 of the study will include the Screening period, two Baseline assessments
      (6-8 days before each Treatment period) and two 14-day treatment periods separated by a
      minimum 7-day washout period and follow-up visit of 3 to 5 days. Approximately 50 to 80
      subjects will be randomized to either GSK2981710 or placebo. The PD assessments will be
      performed on 6 occasions for each subject: at 2 baselines (6 to 8 days before Day 1 of each
      treatment period), post-dose on the Day 1 of each treatment period to assess acute effects
      and on Day 15 of each treatment period (which is the day after the final dose) to assess
      chronic effects. A subject's total participation in Part 2 of the study will last
      approximately up to 12 weeks including screening.
    


Intervention name(s): GSK2981710; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Will be available as 10 g medium-chain triglycerides (MCT) powder sachet that will be mixed with 125 - 250 milliliters (ml) water in a shaker and taken within 15 minutes of completion of breakfast; Will be available as matching powder that will be mixed with 125 - 250 milliliters (ml) water in a shaker and taken within 15 minutes of completion of breakfast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Consumer Healthcare; Ketones; Medium Chain Triglycerides; Age related cognitive decline; GSK Nutrition
A Pilot Study of Efficacy and Tolerability of Levetiracetam Monotherapy in Subjects With Childhood Absence Epilepsy
Condition: Epilepsy; Childhood Absence Epilepsy; Seizures
MeSH terms: Epilepsy; Seizures; Epilepsy, Absence
Study type: Interventional

Summary: 
      Childhood absence epilepsy (CAE) is a form of generalized epilepsy syndrome. Clinically these
      seizures are manifest with a sudden, brief (3-15 second) loss of awareness followed by a
      quick recovery to baseline. Keppra (levetiracetam) is approved by the U.S. Food and Drug
      Administration (FDA) to treat partial seizures in adults. It is currently being studied in
      children with partial seizures. Absence seizures can be difficult to detect clinically,
      therefore the response to therapy will be determined both by clinical observation and by 24
      hour EEG recordings. The researchers hope that with this information they will learn how well
      it works for the treatment of childhood absence epilepsy and at what dose. This is an
      open-label, dose-ranging pilot study of levetiracetam in subjects with newly diagnosed
      childhood absence epilepsy. Approximately 20 patients will be needed to study effectiveness
      and dose requirements. Subjects must not be on any antiepileptic medication at the time of
      entry into the study. Male and female subjects from the ages of 4 to 10 years of age may
      participate.
    

Detailed description: 
      This is a 12 week ( 12 week treatment phase), dose ranging pilot study on the effectiveness
      of levetiracetam for the treatment of childhood absence epilepsy. It consists of 1 phase. The
      treatment phase where the optimal medication dose will be defined. Absence seizures are often
      brief and subtle with no postictal manifestations. As a result, clinical observation alone is
      inadequate to assess the seizure Therefore, both subjective clinical response
      (parental/caregiver assessment) and EEG recordings are an important part of evaluation of
      treatment response. A 6 hour outpatient video-EEG study (including 3 minutes of
      hyperventilation), followed by an 18 hour ambulatory EEG recording - for total 24 hour EEG
      recording will be done before treatment and every 2 weeks after each dose plateau is reached
      )
    

Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Keppra; Epilepsy; Childhood Absence Epilepsy; Seizures
Effect of Pain Control on the Diagnosis of Acute Appendicitis on the Diagnostic Accuracy of General Surgeon
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The pain control in surgical abdomen has been in debate in masking the correct diagnosis. We
      would like to investigate the effect of pain control on the diagnostic accuracy of surgeon in
      suspicious appendicitis patients.

      We would give morphine or placebo to the patients suspected of appendicitis randomly and in
      double-blinded manner, and then surgeons would exam the patient and give the impression for
      the possibility of the appendicitis(grading 1 to 4).

      With this grading, we compare these impression between two groups.
    


Intervention name(s): Morphine
Intervention type(s): Drug
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: appendicitis; diagnosis
Application of 3D Printing Technique in Small Pulmonary Nodule Localization
Condition: Lung Neoplasm; Thoracic Surgery, Video-Assisted
MeSH terms: Lung Neoplasms; Multiple Pulmonary Nodules
Study type: Interventional

Summary: 
      The trial is to evaluate the efficacy and safety of three-dimensional printed navigational
      template in the clinical application of small peripheral lung nodule localization.
    

Detailed description: 
      Localization of small lung nodule is challenging due to the difficulty of nodule recognition
      during VATS. A three-dimensional printed navigational template was designed to aid
      percutaneous lung nodule localization, and its feasibility has been confirmed in previous
      study. The trial was conducted to confirm the non-inferiority of template-guided method to
      conventional CT-guided method in terms of localization accuracy.
    

Intervention name(s): template-guided localization; CT-guided localization
Intervention type(s): Device; Other
Intervention description(s): Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization.; Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Printing, Three-dimensional
rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP
Condition: Purpura; Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 3

Summary: 
      The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known
      hospitals in China. In order to report the efficacy and safety of Recombinant Human
      thrombopoietin combining with Dexamethasone for the treatment of adults with primary immune
      thrombocytopenia (ITP), compared to High-dose Dexamethasone therapy.
    

Detailed description: 
      The investigators are undertaking a parallel group, multicentre, randomised controlled trial
      of 200 primary ITP adult patients from 14 medical centers in China. One part of the
      participants are randomly selected to receive recombinant human thrombopoietin (given
      subcutaneously at a dose of 300Units/kg for7-14 consecutive days, following with a flexible
      dosage depending on platelet count until the 28th day), combining with dexamethasone (given
      intravenously at a dose of 40 mg per day for 4days, the others are selected to receive
      high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4
      days). Platelet count was evaluated before and after treatment, in order to report the
      conversion ratio of primary ITP to chronic ITP.
    

Intervention name(s): recombinant human thrombopoietin (rhTPO); dexamethasone; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Patients in recombination treatment group take rhTPO( subcutaneously , 300U/kg for 14 consecutive days, followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 28th day), in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days); Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.
Other intervention name(s): Recombinant Human Thrombopoietin; Recombinant Human TPO; rhTPO combine with Dexamethasone; Recombinant Human Thrombopoietin combine with Dexamethasone; Recombinant Human TPO combine with Dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Recombinant Human Thrombopoietin; rhTPO; Dexamethasone
M7583 Relative Bioavailability of Tablet Compared to Powder-in-capsule
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study consisting of 2 parts: Part 1 aims to investigate the relative
      bioavailability of tablet formulation (test treatment) and Powder in capsule (PiC)
      formulation (reference treatment) of M7583 under fasted conditions. The aim of Part 2 is to
      determine and compare the single dose Pharmacokinetic (PK) profile of M7583 tablet under
      fasted and fed conditions to assess the food effect.
    


Intervention name(s): M7583
Intervention type(s): Drug
Intervention description(s): Subject will receive either M7583 PiC or M7583 tablet formulation orally under fasted conditions in part 1 followed by M7583 tablet formulation under fed condition in part 2 of the study.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: M7583; Healthy Subjects; Cross-over
A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the safety, tolerability, and PK of various
      increasing single and multiple doses of VBP15 in healthy adult subjects.
    


Intervention name(s): VBP15; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Safety; tolerability; pharmacokinetics; adult; volunteers
Premolar Autotransplantation in Juvenile Dentition: Quantitative Assessment of Vertical Bone and Soft Tissue Growth
Condition: Traumatic Dental Injury; Tooth Aplasia
Study type: Observational

Summary: 
      Objective:

      Premolar autotransplantation represents an effective therapeutic option for the treatment of
      juvenile dentition in traumatic dental injury with tooth loss. Numerous studies report on the
      osteoinductive potency of the method, however, to date no quantitative data has been
      provided. The objective of this prospective clinical study was to quantitatively assess the
      bone and soft tissue levels after autogenous premolar transplantation by clinical and
      radiographic parameters.

      Materials/Methods:

      In the study 26 premolars were transplanted in 20 patients after traumatic dental injury
      (n=10) or tooth aplasia (n=16) in the upper front. Standard clinical parameters were
      evaluated. Based on a standardized photo documentation, the relative soft tissue level was
      measured in comparison to the healthy adjacent teeth. Radiographic findings involved the
      evaluation of root resorption, pulp canal obliterations and the relative bone height. Patient
      satisfaction was determined using a standardized questionnaire.
    


Intervention name(s): premolar autotransplantation
Intervention type(s): Procedure
Intervention description(s): Autogenous tooth transplantation of premolars to the anterior maxilla to stimulate bone and soft tissue growth.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients (mean age 13.6, f:10, m:10) suffering from tooth loss in the anterior maxilla
        (13-23). Thirteen patients suffered from traumatic dental injury (TDI) with subsequent
        tooth loss (n=16 transplants). In 7 patients, aplasia of teeth in region 13 to 23 was
        present (n=10 transplants).
Confocal Laser Micro-endoscopy in Chronic Obstructive Pulmonary Disease (COPD) and Lung Transplant Recipients
Condition: Lung Transplantation; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Aspects of confocal laser micro-endoscopy (CLME) and morphometry in chronic obstructive
      pulmonary disease (COPD) and lung transplant recipients is described and will be correlated
      with clinical findings in order to described small airway remodelling in these patients.
    

Detailed description: 
      In early phases of COPD, changes in small airway characteristics may develop. Elastin decay
      and matrix remodelling could be responsible for these changes. Using CLME changes of in the
      bronchiolar wall and alveolar ducts can be visualized, described and measured.

      In lung transplant recipients, CMLE will be performed to distinguish characteristics of
      distal airways in stabile patient in contrast to patients with bronchiolitis obliterans
      syndrome.

      In both groups data will be correlated with CT findings, pulmonary function tests and
      anatomopathological results.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients referred for a bronchoscopic procedure will be asked to undergo CLME. 3 pools will
        be made: COPD patients according to their pulmonary function test, lung transplant
        recipients and patients with normal spirometric results. In all groups the difference
        between active smokers and no-smokers will be made.
      
Keywords: Confocal Laser Scanning Microendoscopy; Small airways; COPD; Lung transplantation
Observe the Frequency of Extra-Axial Symptoms in Korean Ankylosing Spondylitis (AS) Patients
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      This was a prospective mono-country, multi-center study of the frequency of extra-axial
      manifestations (EAMs) in Ankylosing Spondylitis (AS) participants treated with adalimumab in
      routine clinical practice.
    

Detailed description: 
      A baseline assessment was performed prior to the first dose of adalimumab. Participants
      received 40 mg of adalimumab every other week for one year. Study visits were conducted at
      12, 28, 36 and 52 weeks. All participants were to have one follow-up approximately 70 days
      after the last dose of adalimumab.
    

Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention description(s): Adalimumab pre-filled syringe, administered by subcutaneous injection
Other intervention name(s): Humira; ABT-D2E7
Intervention MeSH terms: Adalimumab
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        General Hospital
      
Keywords: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score; EAMs; Adalimumab