bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Hypergranulation Tissue After Gastrostomy Tube Placement
Condition: Soft Tissue Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The primary objective of this study is to compare the incidence of postoperative
      hypergranulation tissue formation after gastrostomy tube placement among children randomized
      to one of three treatments, in addition to measuring tube dislodgements and rates of resource
      utilization for complications.
    

Detailed description: 
      Hypergranulation tissue is one of the major immediate complications of gastronomy tube
      placement. This study aims to determine if using a foam dressing upon placement will prevent
      its formation, as it has been demonstrated as an effective treatment in healing
      hypergranulation tissue formation post-operatively. Study participants will be randomized
      into one of three treatments after gastronomy tube placement (1) standard care, (2) plain
      foam treatment or (3) silver foam dressing. These treatments will be applied for 30 days
      post-operatively in addition to standard care of cleaning the gastronomy site daily with soap
      and water, if assigned to foam intervention. All study materials are free for duration of 30
      day intervention and participation will not interfere with routine post-operative care of
      gastronomy tube site. The total duration of trial will be 6 months and will not require
      additional study visits outside of routine care. The rate of G-tube dislodgements and
      associated outcomes will also be measured during the trial.
    

Intervention name(s): Standard Hydrocolloid Dressing; Silver Hydrocolloid Dressing
Intervention type(s): Procedure; Procedure
Intervention description(s): Treatment placed over insertion site.; Place dressing against skin under gastrostomy tube
Other intervention name(s): FDA Class II-K medical products; Hollister Wound Care (Hollister Incorporated); FDA Class II-K medical products; Hollister Wound Care (Hollister Incorporated)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypergranulation tissue; Gastrostomy tube; Hydrocolloid dressing; Silver hydrocolloid dressing; Gastrostomy tube dislodgement; Wound infection; Peristomal skin breakdown
Investigating Clinical Indicators of Spine Related Dysfunction Patterns. A Clinical Study on Neck Pain Patients.
Condition: Neck Pain; Neck Disorders
MeSH terms: Neck Pain
Study type: Observational [Patient Registry]

Summary: 
      The goal of is this study is to investigate the reliability and validity of a classification
      system for neck pain patients. In a previous study clinical experts were asked about the
      clinical criteria they considered to be determinative for 5 predefined dysfunction patterns
      in patients with neck problems: 1) articular, 2) myofascial, 3) neural, 4) central, and 5)
      sensorimotor control dysfunction pattern. This Delphi survey revealed a list of pertinent
      anamnestic and clinical criteria per dysfunction pattern.

      In the present study we will collect anamnestic and clinical data of 200 neck pain patients.
      This will be obtained by approximately 20 clinicians that fill out a standardized
      registration form at the intake of their patients with neck pain.

      The therapists and patients will receive an informed consent that clarifies the purpose of
      the study and what happens next with the collected data.

      Per patient the therapist indicates the dominant clinical pattern based on his/her
      experience. Prior to the data analysis, the researchers will be blinded to the patient
      identification data. Subsequent, the registration forms will be screened for the presence of
      clinical criteria (obtained from previous Delphi study), independent of the therapist's
      diagnosis/conclusions. A second independent researcher will gather this information, which
      will be used for statistical analysis, in order to investigate which clinical criteria can be
      considered as determinative for a particular pattern. Outcome measures for these analysis
      are:

        -  sensitivity and classification specificity

        -  (positive and negative) likelihood ratios

        -  odds ratios

        -  diagnostic accuracy
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients suffering from neck pain
      
Keywords: Diagnostics, clinical criteria, clincal reasoning, neck pain
Multiple Ascending Dose Study of SPC4955 in Healthy Subjects
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study safety and tolerability of SPC4955 in healthy subjects.
    


Intervention name(s): SPC4955; SPC4955; SPC4955; SPC4955; SPC4955; Saline 0.9%
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 3 Weekly SC injections; 3 Weekly SC injections; 3 Weekly SC injections; 3 Weekly SC injections; 3 Weekly SC injections; 3 Weekly SC injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; LDL; HDL; apoB; hyperlipidemia; LNA-oligonucleotide
SIngle Port vs Standard TEP for Primary Inguinal Hernia Repair
Condition: Primary Unilateral Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      This study is carried out to determine if laparoscopic inguinal TEP repair of the hernia
      using a mesh carried out with only 1 port (hole) results in the reduction of post- operative
      pain and use of painkillers, shorter hospital stay and lesser complications than that carried
      out using conventional 3 ports.
    

Detailed description: 
      100 patients undergoing laparoscopic TEP ( Total extraperitoneal repair) inguinal hernia
      repair under general anaesthesia will be randomized into 2 groups by the closed envelope
      method. In case of difficulty in Single port TEP inguinal hernia repair, the procedure will
      be converted to conventional 3 port repair for patient safety.

      2 groups of participants: Group A will undergo laparoscopic TEP inguinal hernia repair with 3
      ports (10 mm , and 2 ports of 5 mm ).

      Group B will undergo laparoscopic TEP inguinal hernia repair with a single port (12 to 15 mm
      transumbilical).

      Patient will be informed at consenting that 3 wound plasters will be applied to their abdomen
      regardless of whether they are in the single port or 3- ports group so that they would not
      know which group they have been randomized to. The blind will only be lifted after pain score
      and area of pain has been recorded before discharge.
    

Intervention name(s): Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ); Group B will undergo laparoscopic TEP inguinal hernia repair with a single port
Intervention type(s): Procedure; Procedure
Intervention description(s): laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).; Group B will undergo laparoscopic TEP inguinal hernia repair with a single port LESS (12 to 15 mm transumbilical).
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inguinal Hernia; Primary; laparoscopic surgery; single port surgery
Rapid Renal Sympathetic Denervation for Resistant Hypertension
Condition: Hypertension, Resistant to Conventional Therapy
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The Covidien OneShot™ ablation system use is to deliver low-level radio frequency (RF) energy
      through the wall of the renal artery to denervate the human kidney.
    

Detailed description: 
      Unique to the OneShot™ ablation system is the ability to deliver the desired helical
      treatment pattern for optimal Renal Denervation (RDN) with a single balloon based-treatment,
      eliminating user variance inherent in the currently available point-by-point approach. In
      addition, technological improvements have been incorporated. The OneShot™ RF generator has a
      touchscreen, user friendly interface; catheter advancement is made safer with the use of a
      guidewire; two radiopaque markers on the catheter enable more precise device positioning; and
      the irrigated catheter tip reduces the risk of overheating and clot formation during RF
      delivery. By offering a more reliable single treatment approach, coupled with enhanced
      ease-of use and reduced procedure times, this technology has the potential to significantly
      expand clinical adoption of catheter-based renal sympathetic denervation.
    

Intervention name(s): Covidien OneShot™ System
Intervention type(s): Device
Intervention description(s): Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
Other intervention name(s): Covidien OneShot™ Renal Denervation System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Kidney Diseases; Kidney Failure, Chronic; Vascular Diseases; Cardiovascular Diseases; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Contralateral Effects of Russian Current on Adolescent Athlete
Condition: Treatment Side Effects
Study type: Interventional

Summary: 
      The strength loss associated with immobilization causes long term decreases in performance
      and loss of hours of participation for athletes during rehabilitation period to regain a
      competitive form. Therefore, reducing such effects throughout the immobilization period is
      highly preferable. Cross-educational strength transfer to the inactive muscle by means of
      unilateral strength training may provide an opportunity to avoid strength loss and atrophy.
    

Detailed description: 
      After injury and/or surgery, neuromuscular electrical stimulation is widely used to train
      muscles and enhance muscle strength. and some studies have found it to be superior to
      voluntary exercise after immobilization . One of the preferred common NMES techniques for
      muscle strengthening is the Russian current (RC) It stimulates almost all muscle motor units
      to contract synchronously, resulting in a greater muscle hypertrophy. While some studies
      exist to confirm the efficacy of this current in the Russian language, there is very little
      evidence to support its use in English literature. The aim of our study is to investigate the
      effectiveness of cross education of Russian current on the strength of the contralateral
      inactive biceps and triceps muscles of the affected elbow in pediatrics athletes to decrease
      some of the negative effects of immobilization on muscle tissue and enhance recovery.
    

Intervention name(s): Russian current; elbow support
Intervention type(s): Other; Device
Intervention description(s): One of the preferred common neuromuscular electrical stimulation techniques for muscle strengthening is the Russian current (RC) It stimulates almost all muscle motor units to contract synchronously, resulting in a greater muscle hypertrophy.; tennis elbow brace is recommended to decrease pain and improve function by restricting the movement of the forearm or relieving loads on the origin of the muscles of the extensor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tennis Elbow; Cross-Training; Electrical Stimulation
Healthy Weight for Teens
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      POWER is uniquely positioned to evaluate characteristics of multi-component PWM programs that
      are associated with "favorable" health outcomes for treatment-seeking youth with obesity. The
      POWER Data Coordinating Center developed ranking reports of the 33 participating sites based
      on weight status change at 6 months. An in-depth review of program design of 4
      "top-performing" sites was conducted. A unique feature identified was offering an individual
      program orientation session to patient-families prior to the start of the multi-component PWM
      program. This orientation helped patient-families better understand the program's
      expectations, and offered an opportunity to evaluate readiness to change, barriers for making
      lifestyle changes, and mental health problems. This information was used to tailor the
      intervention to better meet the needs of participating patient-families. When a survey of
      program characteristics was conducted of the 33 participating sites, this "top-performing
      site" was the only one to offer such a program orientation session prior to patient-families
      starting the PWM program. Therefore this program feature was included as part of the "bundle
      of program enhancements" (BPE) for this proposed pragmatic pilot study.
    


Intervention name(s): Telehealth Encounter
Intervention type(s): Behavioral
Intervention description(s): Contact will be made with participants via Face Time or Skype.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Yttrium Y 90 Ibritumomab Tiuxetan and Rituximab in Treating Patients With Previously Untreated Marginal Zone Lymphoma
Condition: Marginal Zone Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone
Study type: Interventional
Phase: Phase 2

Summary: 
      Zevalin may be an effective therapy for newly diagnosed marginal zone lymphoma (MZL).
    

Detailed description: 
      This phase II study will assess the clinical response rate to Ibritumomab Tiuxetan in
      patients with untreated nodal, splenic and non-gastric extranodal MZL as well as in
      antibiotic resistant patients with mucosa-associated lymphoid tissue (MALT) gastric lymphoma.
    

Intervention name(s): Rituximab; Ibritumomab Tiuxetan
Intervention type(s): Drug; Drug
Intervention description(s): IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³; IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:
0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³
Other intervention name(s): Rituxan; IDEC-C2B8; Chimeric anti-CD20 monoclonal antibody; Zevalin
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Marginal Zone Lymphoma; Non-gastric extranodal Marginal Zone Lymphoma; Splenic Marginal Zone Lymphoma; Nodal Marginal Zone Lymphoma; Gastric Marginal Zone Lymphoma; MZL; Non-gastric extranodal MZL; Splenic MZL; Nodal MZL; Gastric MZL
A Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
Condition: Degenerative Disc Disease
MeSH terms: Spinal Diseases; Intervertebral Disc Degeneration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objectives of the study are to evaluate the safety and preliminary efficacy of a single
      administration of AGA111 for lumbar interbody fusion in patients with degenerative disc
      disease.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled, phase 1/2 study to evaluate the safety and
      preliminary efficacy of single administration of AGA111 for lumbar interbody fusion in
      patients with degenerative disc disease. A total of 60 participants will be enrolled and
      randomized to placebo, AGA111 0.25 mg, or AGA111 0.5 mg at 1: 1: 1 ratio. All participants
      will undergo lumbar interbody fusion and receive study treatment during the surgery.
    

Intervention name(s): AGA111; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AGA111 is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.; Placebo is locally administered in an ABC carrier at the intervertebral space during the lumbar interbody fusion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Immunogenicity & Safety Study of Adenovirus Type 5 (AD5) Based Oral Norovirus Vaccines
Condition: Norovirus Infections
MeSH terms: Caliciviridae Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the immunogenicity of VXA-G1.1-NN with repeat-dose administration at Day 1 and
      varying boost schedules (Week 4, 8 or 12 post initial dose) in healthy adults aged 18-55,
      inclusive, and to assess the safety and tolerability of VXA- G1.1-NN with repeat-dose
      administration at varying boost schedules (Week 4, 8 or 12) in healthy adults aged 18-55,
      inclusive
    


Intervention name(s): VXA-G1.1-NN
Intervention type(s): Biological
Intervention description(s): Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of XTR004 Radiotracer in Healthy Volunteers
Condition: Coronary Artery Disease (CAD); Myocardial Ischemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      XTR004 is a 18F-labeled myocardial perfusion positron emission tomography tracer use to
      measure myocardial perfusion and myocardial blood flow. XTR004 binds to the myocytes and
      targets respiratory chain complex 1 in the mitochondria.This phase I study investigated the
      safety, biodistribution, radiation dosimetry and Pharmacokinetics of XTR004 in 10 healthy
      Chinese adults volunteers.
    

Detailed description: 
      XTR004 is a 18F-labeled myocardial perfusion PET tracer, the first one developed in China by
      Sinotau Pharmaceutical Group. XTR004 targets and binds to the mitochondrial complex I
      protein. XTR004 reflects myocardial function at a molecular level. In pre-clinical studies
      XTR004 demonstrated high myocardial first-pass extraction and prolonged retention, allowing
      for early or delayed imaging. XTR004 can be clinically used to measure myocardial perfusion
      and myocardial blood flow. This Phase I study will be open-labeled, nonrandomized, single
      center study. Enrolled 10 healthy Chinese adults who meet all of the inclusion and none of
      the exclusion criteria. Subjects will receive 6-8 mCi of XTR004 via IV injection. Safety and
      tolerability will be observed. Biodistribution, pharmacokinetics, and dosimetry will be
      investigated.
    

Intervention name(s): XTR004
Intervention type(s): Diagnostic Test
Intervention description(s): Single dose intravenous injection of XTR004. Serial whole-body PET scan will be obtain after injection, blood and urine collection after injection for the assessment of pharmacokinetics.
Intervention model: Single Group Assignment
Intervention model description: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: coronary artery disease; positron emission tomography; myocardial perfusion imaging; XTR004
Open-Label Extension Assessing Long-Term Safety Of Rosiglitazone In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label extension to study 49653/461, to assess the long-term safety of
      rosiglitazone (extended release tablets) in subjects with mild to moderate Alzheimer's
      Disease.
    


Intervention name(s): rosiglitazone
Intervention type(s): Drug
Intervention description(s): Extended Release Tablets
Intervention MeSH terms: Rosiglitazone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Rosiglitazone
Effectiveness of Massage Therapy With Active Component and Therapeutic Exercise in Cervical Pain
Condition: Neck Pain; Chronic Pain
MeSH terms: Chronic Pain; Neck Pain
Study type: Interventional

Summary: 
      It is an interventional study that proves the eficacy of the manual therapy with active
      manual therapy and combined with exercise in cervical pain.
    

Detailed description: 
      The study will be divided in two different groups:

        -  A control group (group A) : they will receive a treatment with manual therapy and
           physical exercise.

        -  An experimental group (group B) : they will receive the previous treatment, but also the
           pacient's do active muscle active contraction.

      The exercise is compound by a home program of several exercises with diferent difficulties.

      The contraction will consist on a combination of concentric and isometric work. being the
      patient's pain threshold the one that will guide us to the choice of the predominance of
      concentric or isometric contraction . Both groups will be joined by a five-minute work on
      pain education.
    

Intervention name(s): Manual therapy active; Manual therapy
Intervention type(s): Other; Other
Intervention description(s): massage or ischemic compression with active contraction, tha will be isometric or concentric.; massage or isquemic compression without contraction
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: blind
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: neck pain; exercise; Endurance; Training; Intervention