bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This study is to evaluate that the magnetic resonance imaging (MRI)-guided transurethral
      ultrasound therapy system is safe and feasible to ablate prostate tissue in men with
      localized prostate cancer.
    

Detailed description: 
      Profound Medical Inc. has developed a novel technology called the MRI-guided transurethral
      ultrasound therapy system. The technology is developed for patients with organ confined
      prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of
      prostate tissue.

      The treatment is conducted completely within an MRI suite, which enables real-time
      temperature images of the heated region to be acquired as the ultrasonic treatment is
      delivered. Using MRI thermometry during treatment, dynamic temperature feedback control over
      the intensity of the ultrasound beams and rotation of the Ultrasound Applicator can shape the
      pattern of thermal coagulation accurately and precisely in the prostate gland, thereby
      reducing the risk of possible damage to important surrounding anatomy such as the rectum,
      urinary sphincters, neurovascular bundles and pelvic bone. This coagulation method,
      therefore, has the potential to have lower complication rates than conventional therapies.
    

Intervention name(s): MR-Guided Transurethral US Ablation of Prostate Tissue
Intervention type(s): Device
Intervention description(s): The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.
Other intervention name(s): Prostate Ablation Device: PAD-105
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostate Cancer; High intensity transurethral ultrasound ablation; MRI-guided; Minimally invasive; Real-time temperature feedback control
A Long-Term Safety Study to Evaluate Methylphenidate HCL Tablets at Multiple Dose Levels in Adults With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety of methylphenidate HCL
      extended-release tablets at five dose levels in adults with Attention Deficit Hyperactivity
      Disorder (ADHD)
    

Detailed description: 
      This is a multicenter, open-label, dose-titration, long-term study to evaluate the long-term
      safety of five dose levels of methylphenidate HCL extended-release tablets, 36 mg, 54 mg, 72
      mg (two 36 mg tablets), 90 mg (one 36 mg tablet plus one 54 mg tablet), and 108 mg (two 54 mg
      tablets) per day in adults with ADHD. At the baseline visit, all patients will initiate
      treatment with 36 mg of methylphenidate HCL extended-release tablets. The dose will be
      increased in 18 mg increments every seven days (+/-2 days) until an individualized dose is
      achieved. An individualized dose is achieved when there is at least a 30% improvement on the
      ADHD Investigator Symptoms Rating Scale (AISRS) and a Clinical Global Impression -
      Improvement (CGI-I) score of 1 or 2, or until the maximum dose of 108 mg is achieved. If a
      limiting adverse event occurs, the dose will be titrated downward by 18 mg. This dose is then
      the individualized dose. Once an individualized dose is achieved, patients will remain on
      that dose for approximately six months or one year, as assigned at the time of enrollment.
      Patients will be given a prescription for a one-month supply of drug and a pharmacy card at
      each visit. Safety assessments include monitoring adverse events, blood pressure, pulse,
      weight, and electrocardiograms (ECG) throughout the study. The study hypothesis is that
      methylphenidate HCL extended-release tablets in doses of 36 mg, 54 mg, 72 mg, 90 mg, and 108
      mg per day will have an acceptable safety profile for the management of ADHD in adults.

      Patients will start treatment with 36 mg extended-release tablets of methylphenidate HCL per
      day. The dose will be increased in 18 mg increments every 7 days (+/-2 days) until they
      achieve their individualized dose or reach a maximum dose of 108 mg daily. Following the
      patient's titration, the patient will remain on the individualized dose for approximately 6
      months or one year as determined at the time of enrollment.
    

Intervention name(s): methylphenidate hydrochloride extended-release tablets
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder, ADHD, Attention Deficit Disorder Adult
Physical Activity Intervention Tailored for Rural Men
Condition: Physical Inactivity; Sedentary Behavior; Weak; Muscle
Study type: Interventional

Summary: 
      The goal of this project is to develop a scalable physical activity intervention tailored to
      rural men. We will recruit participants nationwide from ResearchMatch data base, emails, and
      social media posts. Participants will have access to health education materials hosted on
      Healthie, a health coaching software platform, and provided an activity monitor (e.g.,
      Fitbit) to support behavior change. The health education materials provide participants with
      education, motivation, and support for making health behavior change (e.g., increasing
      physical activity levels). We will measure physical activity behaviors, psychosocial, and
      several health outcomes
    


Intervention name(s): No BS just Fitness
Intervention type(s): Behavioral
Intervention description(s): The participants receive lessons on the physical activity guidelines, goal setting, physical activity planning, habit development, identity formation, and how to apply all these tools together. In addition, there are numerous resources provided to other existing web resources, including exercise videos and other informational webpages (e.g., USDA nutritional recommendations).
Intervention model: Single Group Assignment
Intervention model description: This study uses a single-arm study with all participants receiving the intervention
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physical activity; sedentary behavior; strength training; mHealth; rural; scalable
Manual Therapy in the Treatment of Hemophilic Arthropathy of the Ankle
Condition: Hemophilia
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Introduction: Hemophilic ankle arthropathy is manifested by degenerative functional
      alterations (deficit of muscle strength, mobility and proprioception), intra-articular
      alterations and chronic pain. Manual therapy techniques are used to treat soft tissue
      adhesions, relieve pain and reduce tissue sensitivity.

      Design. randomized pilot trial. Aimed: To evaluate the safety and effectiveness of a protocol
      by manual therapy techniques in patients with hemophilic ankle arthropathy.

      Patients: 24 patients with ankle arthropathy will be recruited for inclusion in the study.
      Patients will be recruited in seven centers, from different regions of Spain.

      Intervention: Each session will last approximately 50-60 minutes, with 1 physiotherapy
      session per week for a period of 3 weeks. Patients will be evaluated at baseline, after the
      intervention, and after a follow-up period of 3 weeks. The treatment program includes 10
      exercises that must be administered bilaterally.

      Measuring instruments and study variables: Visual Analog Scale and pressure algometer (joint
      pain); Leg motion (ankle range of motion); and Haemophilia Joint Health Score (joint health).
      At the same time, the study will allow to determine joint bleeding caused by applied
      physiotherapy treatment.

      Expected results: To demonstrate the safety of this Physiotherapy technique in patients with
      hemophilia. Likewise, an improvement in ankle pain, joint motion, joint health and pressure
      pain threshold.
    


Intervention name(s): Manual therapy
Intervention type(s): Other
Intervention description(s): Each session will last approximately 50-60 minutes, with 1 physiotherapy session per week over a period of 3 weeks. Each session is made up of 10 steps, of which 9 correspond to manual interventions commonly used in the field of manual therapy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Prescription Opioid Effects in Abusers Versus Non-Abusers
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the abuse liability of oxycodone in individuals with,
      and without, a history of prescription opioid abuse.
    

Detailed description: 
      Prescription opioid abuse is becoming an increasingly widespread and serious public health
      concern. The 2001 National Household Survey on Drug Abuse report revealed that the number of
      first-time users of prescription opioid medications for non-medical reasons reached 2 million
      in the year 2000, a number that has quintupled since 1984. Despite this trend, little
      experimental research has been directed towards understanding who may be abusing these
      medications, and under what conditions. The study will examine the reinforcing, subjective,
      performance, and physiological effects of oxycodone. Because it is not clear who is abusing
      prescription opioids, the medication effects will be compared in drug abusers and non-drug
      abusers.
    

Intervention name(s): oxycodone 15 mg; oxycodone 30 mg; Placebo 0 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15 mg/70 kg oxycodone administered once per day, orally.; 30 mg/70 kg oxycodone administered once per day, orally.; 0 mg placebo dose administered once a day, orally.
Other intervention name(s): immediate-release oxycodone; immediate-release oxycodone; 0 mg
Intervention MeSH terms: Oxycodone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Opiate; Opioid; Abuse Liability; Abuse Potential
A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.
Condition: Seizure Disorders
MeSH terms: Seizures; Epilepsy
Study type: Interventional

Summary: 
      Subjects will be asked to substitute their usual vitamin and mineral supplement/s with
      FruitiVits for seven consecutive days.
    

Detailed description: 
      The study will involve 12 subjects between 4 and 8 years of age, who routinely use
      comprehensive micronutrient supplementation as part of their dietary management.

      Primary Hypothesis:

      FruitiVits is an acceptable source of vitamin, mineral and trace elements for patients on a
      Ketogenic diet.

      Secondary Hypothesis:

      FruitiVits will be well accepted and tolerated when given orally to children on a Ketogenic
      diet.
    

Intervention name(s): FruitiVits
Intervention type(s): Dietary Supplement
Intervention description(s): Daily administration of FruitiVits dietary supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Lateral Bony Wall Repositioning in Maxillary Sinus Floor Augmentation
Condition: Maxillary Sinus Augmentation
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the present prospective randomized controlled study is to clinically and
      histologically investigate the safety and efficacy of bony wall repositioning compared to
      rotary window preparation with membrane coverage in maxillary sinus floor augmentation.
    

Detailed description: 
      40 patients were randomly divided in two study groups after radiological and clinical
      evaluation. Both groups received bone grafting by a xenogeneic bone substitute (BSM,
      cerabone, botiss biomaterials GmbH, Zossen, Germany) using the lateral approach. In the bony
      wall group (BW), following piezosurgery the retrieved bony wall was repositioned. In the
      collagen membrane group (CM), the lateral window was created by rotary instruments, covered
      via a native collagen membrane (collprotect, botiss biomaterials GmbH, Zossen, Germany).
      After 6 months, biopsies were taken to analyze both approaches in terms of new bone
      formation. Duration of treatment, the number of perforations, postoperative patient
      discomfort were registered. Established histopathological analysis and histomorphometrical
      measurements to analyze the tissue reactions and the tissue distribution, i.e., the fractions
      of newly formed bone tissue (NB), of remaining bone substitute material (BSM) and connective
      tissue (CT), were conducted.
    

Intervention name(s): Maxillary sinus augmentation
Intervention type(s): Procedure
Intervention description(s): The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization.
Other intervention name(s): Sinus lift
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 40 patients underwent sinus floor augmentation - 20 patients treated by bony wall repositioning, 20 patients treated by collagen membrane coverage
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: maxillary sinus; xenogeneic graft; collagen membrane; lateral bony wall repositioning; piezoelectric surgery
Uptake of Telemedicine System Trial in Rual Canton
Condition: Diabetes Retinopathy; Diabetes Macular Edema
MeSH terms: Macular Edema; Retinal Diseases; Diabetes Mellitus
Study type: Observational [Patient Registry]

Summary: 
      To evaluate the impact of telemedicine system in rural hospitals for diagnosis and treatment
      of Diabetes retinopathy and Diabetes macular edema.
    

Detailed description: 
      Telemedicine system mainly contains a comprehensive eye examination electric-records
      (E-record), which can transfer the fundus pictures from rural hospitals to professional
      Graders (golden standard for a diagnose of Diabetes Retinopathy (DR) and Diabetes Macular
      Edema(DME)). In Zhongshan Ophthalmic Center (ZOC). By this system, the investigators can
      evaluate the capacity of rural eye doctors about the diagnosis of DR/DME, and give proper
      suggestions for the treatment and revisit plan.
    

Intervention name(s): 90 D; fundus camera and grader
Intervention type(s): Device; Device
Intervention description(s): rural doctors exam eye fundus by 90 D; taking fundus pictures and graded by graders in ZOC
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        age > 40y, diagnosed (Diabetes Retinapathy)DR, 10% normal patients
      
Keywords: sensibility; specificity; positive predictive value; negative predictive value; Cost-effectiveness
Comparison of VoLumen and Breeza Oral Contrast Agents in Pediatric Patients
Condition: Inflammatory Bowel Diseases
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      In this research study, two different oral contrast materials that can be used for CT or MR
      enterography will be studied. This study is designed to compare which oral contrast material
      (VoLumen or Breeza) is preferred by pediatric patients and which provides higher quality
      exams.
    

Detailed description: 
      VoLumen, a low Hounsfield unit 0.1% barium sulfate suspension that also contains sorbitol and
      a gum, is the most common oral contrast material used in children and adults undergoing CT
      and MR enterography (advanced imaging tests used to evaluate the bowel lumen and bowel wall
      in children and adults, usually with suspected or known Crohn disease). This contrast
      material is typically administered orally to non-sedated patients during the 45-60 minute
      period prior to imaging. The goal of oral contrast material administration is to completely
      fill the small bowel with fluid at the time of imaging. Benefits of oral contrast material at
      cross-sectional enterography include: improved delineation of bowel from non-bowel structures
      in the abdomen and pelvis, improved accuracy when assessing bowel wall thickness, and
      improved visualization of mucosal hyper-enhancement in the setting of active intestinal
      inflammation.

      In some children (and adults), the standard-of-care contrast agent (VoLumen) is poorly
      tolerated. This is likely due to a variety of factors, including taste, texture, and the
      volume that is required to be consumed. Recently, a new oral contrast material called "Breeza
      for neutral abdominopelvic imaging" (or simply Breeza) has become available for use at CT and
      MR enterography. This agent contains sorbitol, mannitol, and xantham gum (a thickening
      agent), and it is marketed as a "flavored beverage" as it contains no active ingredient
      (e.g., barium sulfate). A single study performed in adult volunteers has shown that this new
      agent performs similar to VoLumen, has a superior taste, and is associated with greater
      willingness for repeat drinking.

      The objective of our study is to compare our standard-of-care oral contrast material to the
      newly available contrast material in a prospective, randomized, blinded manner. Primary
      outcomes will include degree of small bowel opacification, distention of the terminal ileum,
      and patient acceptance/tolerability.
    

Intervention name(s): Barium Sulfate; Flavored beverage Oral Contrast
Intervention type(s): Other; Other
Intervention description(s): Barium Sulfate Oral Contrast-VoLumen; Flavored beverage for neutral abdominal/pelvic imaging
Other intervention name(s): VoLumen; Breeza
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Gene Expression Profiling in Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      One of the goals of the Kansas City Diabetes Consortium is to identify and characterize genes
      and their products that are associated with T1DM. Characterization of such genes and their
      products can aid in developing new tools for risk assessment, development of new prevention
      strategies and monitoring progression of disease.

      Study design: Descriptive, basic science pilot study. The results of this pilot study will be
      used to help design a much larger study to address the importance of viral response and
      autoimmune diabetes.
    

Detailed description: 
      The hypothesis is that viral responsive genes are up-regulated prior to the onset of symptoms
      of Type 1 Diabetes (T1DM) and may correlate with increased expression of interferon alpha.

      Both genetic and environmental factors contribute to risk of development of T1DM. There are a
      number of conflicting reports associating viral infections and T1DM in genetically
      susceptible individuals and causality has not been proven. Viruses may not have a large role
      in the initiation of islet cell autoimmunity but more of a role in acceleration of the
      disease leading to overt symptoms. There are no studies describing viral responsive gene
      expression in these individuals.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female subjects 7-14 years of age

          -  New onset T1DM

          -  Five years post onset of T1DM
      
Biospecimen description: 
      Whole Blood saved frozen for 1 year
    
Keywords: viral response genes
The Clinical Effect of Vitamin K Administration in Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this study is to examine the possible clinical effects associated with vitamin K
      supplementation on the glycemic control, insulin sensitivity and lipid profile of type II
      diabetic patients.
    


Intervention name(s): Vitamin K; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 1mg; Lactose
Intervention MeSH terms: Vitamin K
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Effect of Intracameral Injection of Mydriatic Plus Anaesthetic Combination on Corneal Endothelial Count in Phaco
Condition: Corneal Endothelial Cell Loss; Mydriasis; Cataract
MeSH terms: Cataract; Mydriasis; Corneal Endothelial Cell Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      Study evaluates safety of intracameral injection of Fydrane (tropicamide 0.02%, phenylephrine
      0.31% and lidocaine 1%) on corneal endothelium, and efficiency in maintaining pupillary
      dilatation during phacoemulsification surgery.
    

Detailed description: 
      in this prospective randomized controlled study, 30 eyes of 30 patients undergoing
      phacoemulsification with intraocular lens (IOL) implantation, were assigned into 2 groups. 15
      eyes (Fydrane group) received 0.2ml of Fydrane just after the first incision. While 15 eyes
      (Reference group) received a topical regimen of one drop of each of cyclopentolate
      hydrochloride 1% and tropicamide 1 %, every 15 min for 1 hour preoperatively. The main
      outcome measures were safety on corneal endothelium, by comparing the preoperative and 3
      weeks postoperative corneal endothelium cell count in the two groups. Efficacy was also
      evaluated by measuring pupil size using surgical caliper at certain timings during surgery:
      before capsulorhexis and before intraocular lens (IOL) implantation, in both groups.
    

Intervention name(s): Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).
Intervention type(s): Drug
Intervention description(s): Fydrane®. The active substances in Fydrane are: tropicamide 0.04 mg (anticholinergic), phenylephrine hydrochloride 0.62 mg (alpha sympathomimetic) and Lidocaine hydrochloride 2 mg (amide type local anaesthetics) for each 0.2 ml dose, equivalent to 0.2 mg of tropicamide, 3.1 mg of phenylephrine hydrochloride and 10 mg of lidocaine hydrochloride for 1 ml.
Other intervention name(s): Mydrane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: corneal endothelial cell count; Fydrane; mixed mydriatic and anaesthetic combination; intracameral mydriatic; mydriasis; phacoemulsification