bioihbjkbjnl/mcl2 huggingface dataset:
Comparation Between Two Surgical Techniques With Acellular Dermal Matrix in Treatment of Gingival Recessions
Condition: Gingival Recession; Gingival Diseases; Mouth Diseases; Periodontal Atrophy; Periodontal Diseases; Stomatognathic Diseases
MeSH terms: Periodontal Diseases; Gingival Recession; Mouth Diseases; Gingival Diseases; Stomatognathic Diseases; Periodontal Atrophy
Study type: Interventional

Summary: 
      The gold standard for the treatment of gingival recession, is the coronal repositioning of
      the flap associated with the subepithelial connective tissue graft. The acellular dermal
      matrix (ADM) has been used as a substitute a subepithelial connective tissue graft in
      periodontal plastic surgery and mucogengivais, and has achieved similar results. The use of
      ADM has the advantage of avoiding possible pre and postoperative complications, as well as
      overcome the limitations presented by autograft. The different surgical techniques used for
      root coverage seek predictability and success. For this, besides the type of incision
      placements flap and graft are of utmost importance because the healing benefit and outcome.

      The aim of this study is to compare two surgical techniques for root coverage and evaluate
      which one provides better cosmetic results and less morbidity . 20 adults , nonsmoking
      patients , showing multiple bilateral gingival recessions , class I or II Miller located in
      canine, first and second premolars are selected. Both techniques use the ADM as a graft.
      However , in one Quadrant partial flap will be held together with relaxing incisions through
      an incision intrasucular , ADM will be positioned 1 mm apical to the cementoenamel junction
      (CEJ) and the flap will be positioned 1 mm coronal CEJ. In the opposite quadrant a minimally
      invasive technique periosteal envelope above does not use relaxing incisions , preserves the
      buds will be held , as well as avoiding any scars, the graft will be used to ADM. The
      clinical parameters (probing depth, clinical attachment level, bleeding on probing index,
      height and width of the gingival retraction and height and thickness of keratinized gingiva)
      will be evaluated 2 weeks after the basic periodontal therapy and after 6 and 12 months to
      surgical procedures. In addition, measurements of photographic gingival recession with the
      aid of software will be performed.
    


Intervention name(s): root coverage
Intervention type(s): Procedure
Intervention description(s): Root coverage with acellular dermal matrix using two techniques: advanced positional flap ou tunneling,
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: root coverage; gingival recession; periodontal surgery
Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas Cardiomyopathy
Condition: Chronic Chagasic Myocarditis
MeSH terms: Chagas Cardiomyopathy; Cardiomyopathies; Myocarditis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of treatment with G-CSF in
      patients with chronic heart failure secondary to Chagas disease.
    


Intervention name(s): Treatment with G-CSF (Granulocyte colony stimulating factor); Placebo saline
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.; Subjects will be randomly assigned to receive treatment saline for five days, during 4 cicles.
Other intervention name(s): G-CSF; Saline
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chagas disease; G-CSF; Cell therapy
Surgical Pain Control With Ropivacaine by Atomized Delivery
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this trial is to determine the effect of spraying a local anesthetic called
      Ropivacaine (numbing medicine) into the abdominal cavity prior to surgery. Ropivacaine is a
      local anesthetic used to block pain in the body. There are studies showing that Ropivacaine
      decreases the pain of surgery with minimally invasive (laparoscopic) appendix and gallbladder
      removal but has not been tried in robotic pelvic surgery.
    

Detailed description: 
      Practice guidelines from the American Society of Anesthesiologists peri-operative techniques
      for pain management have remained essentially unchanged over the last 10 years (3). Current
      acute pain-management strategies include 1.) Epidural or intrathecal opioids 2.)
      Patient-controlled devices delivering systemic opioids and 3.) Regional techniques such as
      peripheral nerve blocks and post-incisional infiltration with local anesthetics.

      The use of epidural and systemic opioids results in significant side-effects such as
      post-operative nausea and ileus which often lead to increased hospital stay. The literature
      supporting the benefit of preincisional infiltration with anesthetics remains equivocal.

      A recently published study describes the use of intraperitoneal Ropivacaine (2mh/kg) during
      laparoscopic appendectomy(4). The study was a randomized, double-blinded, placebo-controlled
      study using Ropivacaine (vs placebo) injected through the laparoscopic ports prior to the
      start of the appendectomy in 63 patients(4).

      Patients treated with Ropivacaine had a significant decrease in visual analog pain scores
      post-operatively and had decreased narcotic use during their hospital stay compared to
      placebo. There were no side-effects found with the one-time use of the Ropivacaine.

      The results of the above study and review of an additional 24 randomized controlled trials
      conducted from 1993-2003 are not felt to be generalizable to pelvic surgery where port
      placement and the operative procedures vary significantly. Hence this study was undertaken to
      investigate the role of intraperitoneal Ropivacaine as an adjuvant to muscle relaxants and
      narcotics at the time of pelvic surgery.
    

Intervention name(s): Intraperitoneal Ropivacaine (AIR); Atomized Intraperitoneal Saline (AIS)
Intervention type(s): Drug; Drug
Intervention description(s): Ropivacaine 2 mg/kg per lean body mass up to no more than 200mg total dose will be atomized and delivered into the peritoneal cavity at the completion of surgery.; Atomized saline will be administered to the peritoneal cavity at the completion of surgery.
Other intervention name(s): Ropivacaine; Placebo
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Surgical Pain Management; Robotic surgery; Ropivacaine
Evaluation of the Efficacy and Safety of ADL5945 for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain
Condition: Opioid Induced Constipation
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      Morphine and related opioid analgesics are known to slow gastrointestinal (GI) motility and
      reduce intestinal secretion through their binding to μ opioid receptors (MORs) within the GI
      tract. The most common symptoms associated with the effects of opioids are constipation and
      nausea and/or vomiting. Moreover, constipation is a common and distressing side effect of
      long-term opioid therapy.

      The primary objective of this study was to compare ADL5945, a MOR antagonist, with placebo in
      the treatment of opioid-induced constipation (OIC) in adults taking long-term opioid therapy
      for chronic noncancer pain.
    


Intervention name(s): Placebo; ADL5945 0.1 mg; ADL5945 0.25 mg
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opioid therapy; constipation; chronic noncancer pain; mu opioid receptor antagonist; ADL5945
Teen CHAT: Improving Physician Communication With Adolescents About Healthy Weight
Condition: Communication; Obesity; Nutrition; Physical Activity; Sleep
Study type: Interventional

Summary: 
      The purpose of this study is to teach primary care physicians effective ways to counsel
      overweight and obese adolescent patients to attain a healthy weight. Fifty physicians and up
      to 660 adolescent patients from Duke University Health System (DUHS) Primary Care Clinics
      will take part in this study.

      Patients will be identified by research study staff and asked if they would be willing to
      have their clinic visit audio recorded for research purposes. There are three phases of data
      collection. First, baseline encounters (n=200, 4 per physician) are audio recorded. Then,
      half of the physicians will be randomized to receive a tailored web-based intervention
      containing information about evidence-based techniques to help adolescents attain a healthy
      weight. A new set of 200 encounters (4 per physician) will be audio recorded. Then, all
      physicians will receive a Summary Report that outlines the adolescent's high risk behaviors
      that contribute to weight (sweetened beverages, fast food, breakfast, physical activity,
      screen time, and sleep) and a new set of 200 encounters will be audio recorded.

      Data will be collected by trained data technicians, in-person and over the phone. Data is
      collected on laptop computers and then downloaded into password protected electronic files on
      a secure network server. All participants (adolescent patients and physicians) will be
      assigned a code number that is the sole identifier on all study data forms. Prior to and
      after coding, digital files will be stored in password protected directories to which only
      the data technicians and project manager have access. The web-based intervention will be
      password protected.
    


Intervention name(s): Web-based intervention targeting MD communication; Summary Report
Intervention type(s): Behavioral
Intervention description(s): Web-based intervention targeting MD communication; Summary Report detailing 6 risk factors for adolescent overweight/obesity developed by study team
Other intervention name(s): Tailored Web-based intervention developed by study team; Tailored Summary Report
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Phase 1/2 Study of KHK7580 for Secondary Hyperparathyroidism in Patients Receiving Hemodialysis
Condition: Hyperparathyroidism
MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single
      and multiple administration of KHK7580 for secondary hyperparathyroidism in patients
      receiving hemodialysis
    


Intervention name(s): KHK7580
Intervention type(s): Drug
Intervention description(s): Oral administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: patients; receiving; hemodialysis; Secondary
Safety and Dose Finding Study of NS-065/NCNP-01 in Boys With Duchenne Muscular Dystrophy (DMD)
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objective of this study is to evaluate the safety of a high (80mg/kg) and low
      (40mg/kg) dose of NS-065/NCNP-01 delivered as an intravenous infusion in patients with
      Duchenne Muscular Dystrophy (DMD) amendable to exon 53 skipping. Additional objectives
      include tolerability, muscle function and strength, pharmacokinetics and pharmacodynamics.
    

Detailed description: 
      This is a Phase II, multiple center, 2-period, randomized, placebo-controlled, dose finding
      study of NS-065/NCNP-01 administered by infusion once weekly for 24 weeks to ambulant boys
      ages 4-<10 years with DMD. Two dose level cohorts will be enrolled. Period 1 of this study
      will be conducted in a double-blind fashion. Randomized patients will receive weekly IV
      infusions of NS-065/NCNP-01 or placebo for the first 4 weeks of their participation (Period
      1) and NS-065/NCNP-01 by IV infusion for weeks 5-24 (20 weeks of active treatment - Period
      2). Analysis of safety data from Period 1 of the 40mg/kg dose cohort will be completed prior
      to enrolling patients in the 80mg/kg dose cohort.

      Patients completing the 24-week study will be eligible for an open-label extension study.

      Clinical efficacy will be assessed at regularly scheduled study visits, including functional
      tests such as the six-minute walk test (6MWT), time to stand (TTSTAND), time to run/walk 10
      meters (TTRW), time to climb 4 stairs (TTCLIMB) and quantitative muscle testing (QMT). All
      patients will undergo a muscle biopsy of the bicep at baseline and a second muscle biopsy at
      Week 24.

      Safety will be assessed through the collection of adverse events (AEs), blood and urine
      laboratory tests, electrocardiograms (ECGs), vital signs, and physical examinations
      throughout the study.

      Serial blood samples will be taken at four of the study visits to assess the pharmacokinetics
      of the study drug.
    

Intervention name(s): NS-065/NCNP-01; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nebivolol for the Prevention of Left Ventricular Systolic Dysfunction in Patients With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy; Cardiomyopathy; Heart Failure
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Cardiomyopathies
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective is to determine whether nebivolol, a beta-blockade drug, can prevent the
      development of heart disease in patients with Duchenne muscular dystrophy aged 10 to 15
      year-old.
    

Detailed description: 
      A 1.25 mg-test dose will be administrated to assess the treatment tolerance before
      randomization. A forced titration of nebivolol and placebo will be performed with 2 weeks
      periods. Full dose of nebivolol and placebo is 5mg/day (7.5mg/day for patients whose weight
      is>60kg).
    

Intervention name(s): Nebivolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A 1.25mg-test dose will be administrated to assess the treatment tolerance before randomization. A forced titration of nebivolol will be performed with 2 weeks periods. Full dose of nebivolol is 5mg/day (7.5mg/day for patients whose weight is>60kg); A 1.25mg-test dose of nebivolol will be administrated to assess the treatment tolerance before randomization. A forced titration of placebo will be performed with 2 weeks periods. Full dose of placebo is 5mg/day (7.5mg/day for patients whose weight is>60kg)
Intervention MeSH terms: Nebivolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Nebivolol; beta-blockade treatment
To Demonstrate the Relative Bioavailability of Cefzil 500 mg Cefprozil Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to Demonstrate the Relative Bioavailability of Cefzil 500 mg
      Cefprozil Tablets Under Fed Conditions.
    


Intervention name(s): Cefprozil 500 mg Tablets (Sandoz, GmbH); Cefzil (Cefprozil) 500 mg Tablets (Bristol-Myers Squibb, USA)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cefprozil; Cephalosporins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotics
Assessing the Effects of Mechanical Unloading on Repair Version-1
Condition: Heart Failure; Transplant; Failure, Heart
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The mechanism by which heart failure initiates and progresses and the mechanisms of heart
      repair remain unclear.

      The left ventricular assist device (LVAD) is a therapy to stabilise patients while they await
      their transplant. The LVAD helps pump blood around the body, giving the heart an opportunity
      to recover. During surgery, the apical core tissue is routinely removed to allow the
      implantation of the device (this tissue is normally discarded). Some patients demonstrate
      cardiac recovery, allowing the device to be removed without later needing a transplant. As
      part of the LVAD removal procedure, the section around the device might need to be removed
      (this tissue is normally discarded). To further understand the cellular and molecular
      mechanisms by which the heart is repaired, the investigators wish to utilise this surplus
      tissue for research purposes. The collection of this tissue is part of routine treatment and
      does not represent additional risk for the patient for research purposes. Some patients might
      still require a transplant following VAD treatment. The native heart is removed from these
      patients (routinely discarded) and replaced by a donor heart. The investigators wish to
      utilise this discarded tissue for research purposes, so that the investigators can identify
      the cellular and molecular factors involved in cardiac repair and which distinguish
      responsive and non-responsive patients. Heart transplant recipients who require
      extracorporeal membrane oxygenation will have an additional heart biopsy sample taken for
      research purposes when performed as part of routine clinical practice. There is no additional
      risk to the patient for research purposes. Heart failure patients scheduled for
      transplantation (who have not received a VAD) will be recruited prior to transplantation and
      their native heart retained for research purposes. An additional peripheral blood sample will
      be collected from all patients for research purposes when performed for routine clinical
      practice.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic heart failure and require mechanical unloading using a left ventricular assist
        device.
Doctor-Patient Communication About Colorectal Cancer Screening
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to learn more about doctor-patient communication about colon
      cancer screening. This study will also look to see if there are differences in those who get
      colon cancer screening based on the discussion the doctor had with the patient.
    


Intervention name(s): surveys
Intervention type(s): Behavioral
Intervention description(s): The intervention will be the audio-recording of the physician-patient consultation, patient and doctor surveys. These audio recordings will be coded. It will also include follow-up phone calls with patients.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Five health centers of the NYC RING will participate in this project. All are located in
        underserved urban communities within the Bronx.
      
Keywords: Doctor-Patient Communication; questionnaire; survey; 12-017
Influenze of Approach in Reversed Shoulder Prosthesis
Condition: Outcomes Assessments, Patients; Rotator Cuff Arthropathy
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      To determine the differences in the placement of the glenoid implant of the inverted
      prostheses when they are implanted using a superior approach and using an anterior approach.
    

Detailed description: 
      Inverted prostheses have proven to be effective in the treatment of all those pathologies
      that involve a deterioration of the rotator cuff (secondary arthropathy, acute fractures,
      sequelae of fractures, tumor surgery and revision surgery). Despite this, numerous
      complications have been described after the use of inverted prostheses, such as glenoid
      erosion, infections, dislocation, or aseptic loosening. The most frequent complication
      related to the use of inverted prostheses is glenoid erosion that can occur in up to 96% of
      cases. This complication appears early in the evolution, usually before 2 years after
      surgery. Its clinical significance is not yet clear, but it seems that it may be a cause of
      long-term prosthetic loosening. To avoid the development of glenoid erosion, the best option
      is to place the glenoid component low, so that if the glenoid component is flush with the
      lower margin of the glena, the chances of developing glenoid erosion are significantly
      reduced. Two types of approaches have been used to implant these prostheses, the
      deltopectoral and the superior anterior approach. Each of them has its advantages and
      disadvantages, so that deltopectoral seems to improve surgical exposure and therefore favors
      the best placement of the glenoid component, but sacrifices the subscapularis tendon,
      increasing the risk of dislocation of the components. On the contrary, the superior anterior
      approach respects the subscapularis tendon, reducing the risk of dislocation of the
      components but gives worse surgical exposure.
    

Intervention name(s): Reverse Shoulder Arthroplasty
Intervention type(s): Procedure
Intervention description(s): implantation of a reversed shoulder prostheses through two different surgical approaches
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: reverse shoulder arthroplasty; scapular notch; deltopectoral; anterosuperior approach