bioihbjkbjnl/mcl2 huggingface dataset:
Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit (Firefly Sheffield)
Condition: Neonatal Neuroimaging
Study type: Interventional

Summary: 
      This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for
      imaging viable neonate and infant populations. This MR system has a smaller size and design
      features that may make it more feasible to locate the system in close proximity to care areas
      for neonates (birth - 1 month) and infants (>1 month to two years), such as clinical neonatal
      intensive care units (NICUs) and other infant and neonatal care departments.
    

Detailed description: 
      This study investigates a novel magnetic resonance imaging (MRI) system designed by GEHC for
      imaging viable neonate and infant populations. This MR system has a smaller size and design
      features that may make it more feasible to locate the system in close proximity to care areas
      for neonates (birth - 1 month) and infants (>1 month to two years), such as clinical neonatal
      intensive care units (NICUs) and other infant and neonatal care departments.

      This is a two-phase prospective clinical study evaluating the performance and safety of the
      investigational MRI device for neonates and infants, including:

        -  Phase 1 - Initial feasibility assessment and optimization study (Phase 1) which may
           include hardware and software modifications. These studies are guided by a series of MR
           scanning procedures defined in sequential Sponsor-provided MR Procedure Documents

        -  Phase 2 - Controlled image and data collection study based on Phase 1 results, in which
           optimized scan procedure(s) according to MR Procedure Document(s) will be provided at
           the start of Phase 2 scanning and a fixed hardware and integrated software configuration
           will be applied for all subjects.

      Investigator feedback on scanning conducted under each MR Procedure Document will be
      documented. Because the device is intended for use in viable neonate and infant populations,
      clinical data are required that cannot be conducted in any other populations or simulated on
      non-human models. Clinical images and associated data as well as assessments of image
      quality, workflow, and usability will be collected.

      Images, associated image data, and subject data collected in both phases of this study may be
      used for future engineering development and activities that support MR product development,
      including Sponsor-authorized scientific and marketing activities. Summary evaluation of
      safety and performance from Phase 1 and Phase 2 may be used in support of regulatory
      submission, including filings for European CE mark.
    

Intervention name(s): 3.0 T Neonatal MRI scanner
Intervention type(s): Device
Intervention description(s): eligible subjects will undergo neonatal MRI scan procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: MRI Scanner; NICU
Clinical and Sonographic Diaphragm Evaluation Post-plication
Condition: Diaphragmatic Plication; Unilateral Diaphragmatic Paralysis; Diaphragm Ultrasonography
MeSH terms: Respiratory Paralysis; Paralysis
Study type: Observational

Summary: 
      Objectives: We aim to clarify the role of diaphragm ultrasonography (DUS) in evaluating the
      outcome of surgical diaphragmatic plication (SDP) in adults with symptomatic unilateral
      diaphragmatic paralysis (UDP).
    


Intervention name(s): surgical diaphragmatic plication
Intervention type(s): Procedure
Intervention description(s): The plication was done by the same surgeon either via a 7-8 cm long lateral thoracotomy and entrance to the pleural cavity through the eighth intercostals space on the affected side or using VATS (video-assisted thoracoscopic surgery) procedure. It was performed under single lumen intubation general anaesthesia. The diaphragm with the abdominal content was pushed caudally till the normal position of the copula achieved. At this position a fold of about 5 cm is made using traction forceps of the reluctant diaphragm. Polypropylene sutures (zero or 1) were used to perform the plication of the diaphragm. in making a fold on itself. The plication was performed using interrupted polypropylene U-stitches; usually, it started from posterior part to the anterior part of the diaphragm. We merged every two rows with continuous polypropylene sutures. The diaphragm became tough and firm and returned to its normal position. An intercostal tube was inserted, and the thoracotomy was closed in layers.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        symptomatic unilateral diaphragmatic paralysis patients who underwent surgical
        diaphragmatic plication presented during a period from January 2015 to January 2020.
      
Keywords: Diaphragmatic eventration; Diaphragm; Dyspnea
Hyperthermia and the Amelioration of Autism Symptoms
Condition: Autism Spectrum Disorder
MeSH terms: Hyperthermia; Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      The febrile hypothesis of Autism Spectrum Disorder (ASD) stems from the observation that
      clinical symptoms improve during fever. This fever induced amelioration of symptoms could be
      due to one of three possible causes, (1) the direct effect of temperature; (2) a resulting
      change in the immune inflammatory system function associated with the infection or fever;
      and/or (3) and increase in the functionality of a previously dysfunctional Locus
      Coeruleus-Noradrenerigic (LC-NA) system. Little has been done to explore the potential direct
      effect an increased body temperature may have on autism symptomology. Parental reports have
      demonstrated that during febrile episodes children with ASD have improved social cognition
      and language skills, and decreased disruptive behaviors. In order to further explore the
      direct temperature effect, further investigation is needed, which the investigators propose
      below. The investigators propose to complete a one year double blind crossover study with 15
      children with ASD between the ages of 5 and 17 years old. Five children with ASD will
      complete a control protocol prior to beginning the full protocol with 10 additional ASD
      children. This will allow for any needed amendment of protocol parameters prior to completion
      of the full protocol.
    


Intervention name(s): Hydroworx Pool at 98 degrees Fahrenheit; Hydroworx Pool at 102 degrees Fahrenheit
Intervention type(s): Other; Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 5 to 17 diagnosed with Autism Spectrum Disorder will be enrolled.
      
Biospecimen description: 
      Buccal samples collected for DNA and RNA extraction.
    
Keywords: Autism; ASD; Aspergers; Autism Spectrum Disorder
Prognostic Value of Myocardial Fibrosis Quantified Using CMR in Patient With Dilated Cardiomyopathy
Condition: Cardiomyopathy, Dilated
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional

Summary: 
      : Fibrosis, in general, is a scarring process, which is characterized by fibroblast
      accumulation and excess deposition of extracellular matrix (ECM) proteins, which leads to
      distorted organ architecture and function. The contribution of fibrogenesis to impaired
      cardiac function is increasingly recognized. The fibrotic ECM causes increased stiffness and
      induces pathological signaling within cardiomyocytes resulting in progressive cardiac
      failure. Also, the excessive ECM impairs mechano-electric coupling of cardiomyocytes and
      increases the risk of arrhythmias. But today patient treatment and prognosis is based on
      ejection fraction quantification, QRS duration, and symptoms.

      Hypothesis: the increased level of fibrosis quantified using T1 mapping technique, compared
      with normal value, is of prognostic value in patient with dilated cardiomyopathies under
      optimal treatment.

      Methods: 330 patients are planned to be included and followed for 2 years
    


Intervention name(s): CMR using T1 mapping technique
Intervention type(s): Other
Intervention description(s): the level of myocardial fibrosis for patient suffering of cardiomyopathy dilated will be quantified using CMR T1 mapping technique
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
11C-Metomidate PET Versus Adrenal Vein Sampling in Primary Aldosteronism
Condition: Primary Hyperaldosteronism
MeSH terms: Hyperaldosteronism
Study type: Interventional

Summary: 
      Rationale: Primary hyperaldosteronism (PA) is the most frequent and possibly curable form of
      secondary hypertension. The diagnosis and targeted treatment of PA is essential because of
      high vascular morbidity associated with PA as compared to essential hypertension with
      comparable blood pressure levels. PA is usually caused by either a unilateral
      aldosterone-producing adenoma (APA) or by bilateral adrenal hyperplasia (BAH). Distinction
      between APA and BAH is critical since the former may be cured by adrenalectomy, and the
      latter needs life-long medical therapy with mineralocorticoid receptor antagonists (MRA).
      Studies demonstrate that adrenalectomy benefits also BAH patients with dominant nodule(s)
      producing the most of aldosterone excess. The distinction between unilateral and bilateral PA
      can be made by adrenal vein sampling (AVS), as recommended by The Endocrine Society 2008
      guideline. Currently, in Finland the diagnosis is based on computed tomography (CT) scanning
      which does not distinguish between aldosterone-producing and common non-functioning adrenal
      nodules and has limited accuracy detecting small adrenal masses. Since AVS is invasive,
      dependent on skilled radiologist and costly, there is a need for an accurate, non-invasive
      functional imaging such as 11C-metomidate positron emission tomography (MTO-PET).

      Objective: To assess diagnostic ability of MTO-PET as compared to AVS in PA. Secondary
      objectives: To compare if standardized uptake values (SUVs)in MTO-PET imaging are similar in
      histologically diagnosed nodular hyperplasia versus adenoma. To assess the diagnostic
      accuracy of adrenal CT as compared to MTO-PET and AVS. To assess the complete and partial
      remission rates (blood pressure response expressed in Daily Defined Dosages, medical therapy,
      use of potassium supplements) after allocating subjects to MRA-therapy or adrenalectomy at 1
      and 5 years.
    


Intervention name(s): 11C-Metomidate Positron Emission Tomography
Intervention type(s): Procedure
Intervention description(s): Dose of intravenous 11C-Metomidate injection is 440MBq and emission scanning of upper abdomen. PET/CT imaging will be done using the Discovery PET/CT VCT or 690 scanner (General Electric Medical Systems, Milwaukee, WI, USA)
Intervention MeSH terms: Metomidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Primary aldosteronism; Aldosterone producing adenoma; Bilateral adrenal hyperplasia; Metomidate-Positron emission tomography
Ursodeoxycholic Acid in Bariatric Surgery
Condition: Non-alcoholic Fatty Liver Disease; Morbid Obesity
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Obesity, Morbid
Study type: Interventional

Summary: 
      In an open-label trial, 20 otherwise healthy morbidly obese patients scheduled for bariatric
      surgery will be administered 20 mg/kg/day ursodeoxycholic acid for three weeks until the day
      before surgery. The maximum dose will be 3 g/day. Twenty other patients will serve as
      controls. Serum from days 1 and 21 will be analyzed for routine liver tests, bile acids, a
      complete lipid profile including FA and in addition for 7α-hydroxy-4-cholesten-3-one and
      fibroblast growth factor 19 (FGF-19), markers for bile acid synthesis its intestinal
      stimulation. For the evaluation of insulin resistance and possible pre-diabetes, plasma will
      be taken for the estimation of homeostasis model assessment (HOMA) index and oral glucose
      tolerance test (OGTT) will be performed at days 1 and 21. At surgery, a liver biopsy (0.5-1
      g) and a white adipose tissue (WAT) specimen (1 cm2) will be taken and immediately frozen in
      liquid nitrogen for messenger ribonucleic acid (mRNA) and protein preparation for
      quantitative real-time polymerase chain reaction (RT-PCR) and Western analysis, respectively,
      histopathological Non-alcoholic fatty liver disease (NAFLD) grading, and measuring of hepatic
      and white adipose tissue (WAT) lipase activity. In all patients at randomization, abdominal
      ultrasound will be performed for the detection of NAFLD and gallstones and a blood sample
      will be taken for the analysis of polymorphisms of hepatic lipid synthesis, storage, fatty
      acid (FA) oxidation and export genes. Six month after operation, HOMA, OGTT and abdominal
      ultrasound will be repeated.
    


Intervention name(s): Ursodeoxycholic Acid (UDCA)
Intervention type(s): Drug
Intervention description(s): 20mg/kg/day UDCA in three weeks
Intervention MeSH terms: Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ursodeoxycholic acid; fatty liver disease; morbid obesity; bariatric surgery; NAFLD
Genetics, Brain Structure and Thinking Skills in Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      The purpose of this research is to better understand the genetic, biochemical, cognitive and
      behavioral symptom abnormalities that contribute to autism spectrum disorders. The
      investigators anticipate recruiting at least 100 participants with autism spectrum disorder
      and large head size, at least 100 participants with autism spectrum disorder without large
      head size and at least 40 healthy siblings. Biological parents are expected to be recruited
      only as genetic changes are identified in individuals with autism spectrum disorders to
      better understand the nature of these genetic changes. Participants are asked to complete
      cognitive testing, a blood draw, urine collection and measurement of his/her height, weight
      and head circumference. Parents or caregivers may be asked to complete a diagnostic
      evaluation and will complete questionnaires that examine the participant's medical and family
      history as well as his/her current symptoms, functioning, and quality of life. A brief report
      simply listing and giving a basic description of any behavioral diagnostic information,
      autism symptoms, adaptive functioning, and a listing of results from cognitive testing will
      be provided as part of this study.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We anticipate recruiting 80 participants with autism spectrum disorder and large head size,
        80 participants with autism spectrum disorder without large head size and 40 healthy
        siblings. Biological parents are expected to be recruited only as genetic changes are
        identified in individuals with autism spectrum disorders to better understand the nature of
        these genetic changes.
      
Biospecimen description: 
      About 6 tubes of blood or up to 50 ml (3-4 tablespoons) and 30 mL of urine will be collected.
    
Keywords: Autism; PTEN; macrocephaly
The Effects of Extracorporeal Shock Wave Therapy in Patients With Coccydynia: A Randomized Controlled Trial
Condition: Coccydynia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of extracorporeal shock wave therapy
      (ESWT) on the outcomes of coccydynia.
    

Detailed description: 
      Coccydynia is pain in the coccygeal region, and usually treated conservatively.
      Extracorporeal shock wave therapy (ESWT) was incorporated as non-invasive treatment of many
      musculoskeletal conditions. However, the effects of ESWT on coccydynia are less discussed.
      The purpose of this study is to evaluate the effects of ESWT on the outcomes of coccydynia.
      Patients were allocated to ESWT (n=20) or physical modality (SIT) group (n=21) randomly, and
      received total treatment duration of 4 weeks. The visual analog scale (VAS), Oswestry
      disability index (ODI), and self-reported satisfaction score were used to assess treatment
      effects. The VAS and ODI scores were significantly decreased after treatment in both groups,
      and the decrease in the VAS score was significantly greater in the ESWT group. The mean
      proportional changes in the ODI scores were greater in the ESWT group than in the SIT group,
      but the between-group difference was not statistically significant. The patients in the ESWT
      group had significantly higher subjective satisfaction scores than SIT group. The
      investigators concluded that ESWT is more effective and satisfactory in improving discomfort
      and disability caused by coccydynia than the use of physical modalities. Thus, ESWT is
      recommended as an optimal treatment option for patients with coccydynia.
    

Intervention name(s): Extracorporeal shock wave therapy (ESWT); SWD combined IFC
Intervention type(s): Device; Device
Intervention description(s): The patients received 2000 shots of extracorporeal shock wave therapy in the coccyx area per session for four sessions (one session a week for 4 consecutive weeks). The frequency used was 5 Hz and the pressure was 3-4 bar.; The shortwave diathermy (SWD) was the inductive mode with a coil at a frequency of approximately 27.12 MHz. The shortwave diathermy applicator was placed over the sacrococcygeal area. The treatment duration was 20 minutes. After completing the SWD treatments, the patients received the interferential current (IFC) treatment. IFC provides deeper electrical stimulation. The electrical current was applied to the gluteal area using four electrodes from 2 channels of the stimulator. The four electrodes were set on the gluteal area. The carrier frequency, typically 4000 Hz and 4100 Hz and designed to interfere with each other, resulted in a beat frequency of 100 Hz within the treated area. The treatment duration was 20 minutes. The protocol was set as 3 times per week for a period of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coccydynia; Extracorporeal shock wave therapy; Disability
Platelet Rich Plasma During Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Can platelet rich plasma applied to nerve bundles at time of surgery help the nerve bundles
      heal? Subjects undergoing a Radical Prostatectomy who meet study inclusion/exclusion criteria
      will be consented to receive an intraoperative application of platelet-rich plasma, made from
      their own blood at the time of surgery, for application onto their neurovascular bundles in
      an effort to improve the healing process. Subjects will be followed for an additional 18
      months to determine the efficacy and safety of this procedure.
    


Intervention name(s): Autologous Platelet-Rich Plasma; Angel Concentrated Platelet Rich Plasma System
Intervention type(s): Other; Device
Intervention description(s): Platelets that are collected from the subject during the radical prostatectomy, for prostate cancer. The platelets are concentrated in a device to 1,000,000 platelets/mL and applied topically once to the neurovascular bundle during the surgery.
Other intervention name(s): PRP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Resuvastatin Treatment for Symptomatic Middle Cerebral Artery Stenosis Based on High-resolution Magnetic Resonance Imaging
Condition: Intracranial Arterial Stenosis
MeSH terms: Constriction, Pathologic
Study type: Interventional
Phase: Phase 4

Summary: 
      1. It is a multicenter, open-label, sing arm study to evaluate the effects of treatment of
           Rosuvastatin 10-20mg in volume and morphology of atherosclerotic plague by reducing
           LDL-C level to or less than 70mg/dl.

        2. Ischemic stroke patients will be enrolled within 1 month after stroke onset.

        3. Patients will be visited at 0m, 1m, 3m, 6m, 9m, 12m, 18m and 24m.
    


Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): Rosuvastatin, 10mg for 4-weeks, then according to the results of the LDL-C, adjust dose of rosuvastatin, maximum to 20 mg/d, to reduce LDL-C under 70 mg/dl for two years.
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ketamine vs Hydromorphone
Condition: Laparoscopic Gastric Bypass; Obesity; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will help to determine if investigators can minimize narcotic use in laparoscopic
      gastric bypass patients while maintaining adequate pain control. This will allow
      investigators to minimize the negative side effects of narcotics which is a goal in this
      population.
    

Detailed description: 
      The study will be a head to head observational study of patients who have undergone gastric
      bypass surgery. The methods of intraoperative anesthesiology will be Ketamine or Narcotic.
      Both are FDA approved methods of delivering anesthesia.

      The amount of narcotics a patient receives is part of the medical record post-operatively
      will be followed from post-anesthesia care unit (PACU) through to discharge. The amount of
      narcotics needed to control the patient's pain (converted to morphine equivalent units) and
      pain scores (a hospital standard measure) will be collected for 48 hours for the study, or
      until discharge, whichever occurs sooner. The conversion to a morphine equivalent unit allows
      investigators to compare different narcotics the patient may receive in a more standardized
      way. The results will be analyzed and compared between the two groups.
    

Intervention name(s): Ketamine; Narcotics; pain scale
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Anesthesia of only Ketamine; The narcotic group will receive no ketamine but rather a more standard anesthetic; 0-10 pain scale. 0 = no pain and 10 = worst pain
Other intervention name(s): Ketalar
Intervention MeSH terms: Ketamine; Narcotics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other