bioihbjkbjnl/mcl2 huggingface dataset:
Collagen Matrix With Tunnel Technique Compared to CTG for the Treatment of Periodontal Recessions
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The aim of this study is to compare the efficacy of dental root coverage using the tunnel
      technique with connective tissue graft (CTG) and the same technique with collagen matrix for
      treatment of multiple gingival recessions Miller Class I and II.

      This study is a randomized-controlled clinical trial of 6 months duration.
    

Detailed description: 
      According to the medical databases, there are limited randomized clinical trials comparing
      xenogenic collagen matrix and CTG used with the tunnel technique. The collagen matrix is a
      possible alternative to connective tissue graft.

      The purpose of this clinical study is to compare short-term (3-6 months) outcomes of a root
      coverage using the tunnel technique with the collagen matrix and the same technique with CTG
      for the treatment of multiple recessions Miller class I and II.

      Twenty eight patients are enrolled in the study. Patients in the test group are treated with
      xenogenic collagen matrix using the tunnel technique whereas patients in the control group
      with CTG. Clinical recordings are obtained at baseline and after 3 and 6 months. The
      percentage of average recession coverage (ARC) is evaluated after 3 and 6 months after the
      surgery.
    

Intervention name(s): Surgery:The tunnel technique for covering gingival recession
Intervention type(s): Other
Intervention description(s): The surgery starts with the sulcular incisions in the region of recessions, which enable access for the supraperiosteal preparation. The procedure is extended into the mucosal tissue using the tunneling knives. The partial-thickness flap is performed at the buccal site. Only the papillary regions are fully detached with the periosteum. The graft is placed into the tunnel and stabilized with absorbable sutures.The mobilized mucous flap is advanced coronally and stabilized with non-absorbable suspensory sutures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: gingival recession; mucogingival surgery; collagen matrix; connective tissue graft; tunnel technique
The Effects of Tele-Yoga in Ankylosing Spondylitis Patients
Condition: Ankylosing Spondylitis; Yoga
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of tele-yoga on functional level, disease
      activity, spinal mobility, balance, aerobic capacity, sleep quality, anxiety, depression,
      stress, mindfulness and quality of life in patients with ankylosing spondylitis
    

Detailed description: 
      Yoga is an ancient discipline that emerged in India thousands of years ago, designed to bring
      balance and health to the physical, mental, emotional and spiritual dimensions of the
      individual.Due to its therapeutic effects, yoga can be considered as an alternative approach
      for those with rheumatic disease. Because of Covid-19, which has changed the world and the
      lifestyle of people, tele-yoga practice can be considered as an alternative instead of
      traditional face-to-face yoga classes. The use of online platforms provides a good
      environment for yoga training at home. The aim of this study is to investigate the effects of
      tele-yoga on functional level, disease activity, spinal mobility, balance, sleep quality,
      depression, mindfulness and quality of life in patients with ankylosing spondylitis.

      60 AS patients who meet the inclusion criteria will be assigned to the tele-yoga or waiting
      list control group by the block randomization method. Patients in the tele-yoga group will
      participate in tele-yoga sessions with a maximum of 5 people in each group by
      video-conference method for 8 weeks, 3 days a week. Assessments will perform just before
      starting to study and after the 8-week tele-yoga program. Patients in the waiting list
      control group will be asked to continue their normal physical activities during the 8-week
      study, not to start a new exercise program, and to report any changes in the drug or dosage
      used. Control group's assessments will be performed when they are included in the study and
      at the end of 8 weeks. After these assessments, patients who wish will participate in the
      tele-yoga program.
    

Intervention name(s): Tele-yoga
Intervention type(s): Other
Intervention description(s): Tele-yoga training 3 days a week for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ankylosing spondylitis; yoga
Effect of Low Carbohydrate Versus Low Fat Diet in the Treatment of Dyslipidemia in Obese Children With Metabolic Syndrome
Condition: Metabolic Syndrome; Obesity; Dyslipidemias
MeSH terms: Metabolic Syndrome; Dyslipidemias; Syndrome
Study type: Interventional

Summary: 
      Two-arm, parallel design with children between the ages of 10 - 18 with obesity and metabolic
      syndrome randomized (15 per group) to reduced-carbohydrate diet or a reduced-fat diet for 8
      weeks.
    

Detailed description: 
      Two-arm, parallel design with participants randomized (15 per group) to reduced-carbohydrate
      diet or a reduced-fat diet for 8 weeks. Anthropometric evaluations, lab work for lipid
      levels, insulin and C peptide levels, resting energy expenditure evaluation, DXA scan and
      cardiovascular markers will occur at baseline during the initial clinic visit. Individual
      dietary counseling will be provided at baseline and as well as weekly diet-specific support
      will be provided with a phone call from the PI. Dietary intake will be assessed with weekly
      food records (weeks 1-8). The return visit on week 8 will include a visit identical to the
      initial visit except the resting energy expenditure will not be revaluated, and the
      participants will be asked to answer a questionnaire about the diet they were consuming.
    

Intervention name(s): Carbohydrate restricted group; Standard low fat diet
Intervention type(s): Other; Other
Intervention description(s): Prescribed low carbohydrate diet with set recipes; Diet with less than 20% total calorie intake from dietary fats
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dietary intervention; Anthropometric measure; Lipid profile; Augmentation Index; Flow mediated dilation; DXA scan; Nuclear magnetic resonance lipid profile
Study to Evaluate Hemodynamic Response to to a Sublingual Dose of Glyceryl Trinitrate in Subjects Receiving TA-1790, Sildenafil Citrate, and Placebo
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the hemodynamic response to a sublingual dose of
      glyceryl trinitrate in subjects receiving oral TA-1790, sildenafil citrate, and placebo.
    


Intervention name(s): TA-1790; Sildenafil citrate; Placebo; Nitrostat
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 TA-1790 100 mg capsules; 2 sildenafil citrate 50 mg capsules; 2 placebo capsules for TA-1790 100 mg capsules; glyceryl trinitrate tablet, USP 0.4 mg
Intervention MeSH terms: Sildenafil Citrate; Nitroglycerin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
A Study of First-Line Ambrisentan and Tadalafil Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the two treatment strategies; first-line combination
      therapy (ambrisentan and tadalafil) versus first-line monotherapy (ambrisentan or tadalafil)
      in subjects with Pulmonary Arterial Hypertension. This will be assessed by time to the first
      clinical failure event.
    


Intervention name(s): ambrisentan; tadalafil
Intervention type(s): Drug; Drug
Intervention description(s): ambrisentan (target dose: 10mg); tadalafil (target dose: 40mg)
Intervention MeSH terms: Ambrisentan; Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension; Ambrisentan; Sponsor Rest of World: GSK; Tadalafil; PAH; Sponsor US: Gilead
The Utility of Timed Segmental Withdrawal During Screening Colonoscopy
Condition: Colonoscopy
Study type: Interventional

Summary: 
      The purpose of colonoscopy (colon examination with flexible tube and a camera) is to find
      early precancerous growth in the colon (polyps) and remove them before they turn into cancer.
      The doctor performing the procedure will first advance the colonoscope to the end of the
      colon (cecum) and then he will examine the colon for polyps while he is withdrawing the
      colonoscope. The period of time that the doctor spent examining the colon called "withdrawal
      time". Usually doctors will spend at least 6 minutes examining the colon after he reached the
      cecum. The investigators are proposing that dedicating half of the withdrawal time during
      colonoscopy in examining the right side of the colon, will increase the detection of polyps
      in the right side of the colon.
    

Detailed description: 
      Research design: This is a prospective, randomized trial comparing the ADR between patients
      undergoing a screening colonoscopy in four different groups: 1) at least 3 minutes from the
      total withdrawal time dedicated to the right side of the colon, 2) at least 4 minutes from
      the total withdrawal time dedicated to the right side of the colon, 3) 6 minutes total
      withdrawal time regardless of time spent in any segment, 4) 8 minutes total withdrawal time
      regardless of the time spent in any segment. Randomization will be done in blocks after
      stratification. Four gastroenterologists and two fellows matched base on similar ADR and
      stratified on each arm of the study (segmental versus non-segmental withdrawal) will be
      performing the procedures. The estimated sample size of the four arms of the study is 400
      patients.
    

Intervention name(s): colonoscopy
Intervention type(s): Procedure
Intervention description(s): colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Screening colonoscopy; Surveillance colonoscopy
The Assessment of Physiotherapy Practice Validation as a Measure in Physiotherapy Student
Condition: Assessment, Self; Clinical Performance
Study type: Observational

Summary: 
      The objective of this study is to determine the reliability and validity of the assesment of
      physiotherapy practice (APP) in physiotherapy students. Concretely the study aims to verify
      if the APP created by the professors of specific methods of intervention in physiotherapy
      course is a reliable tool to evaluate student performance of history taking and physical
      examination in the same course.
    

Detailed description: 
      Before evaluating this scale, the investigators want to verify the effectiveness of this
      online practice in the COVID period by processing the Mind Genomics questionnaire.

      After the fist online results of this practice evaluation the investigators have to interpret
      and evaluate the APP.
    

Intervention name(s): Observational study
Intervention type(s): Other
Intervention description(s): a reliability - validity study
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Students of the specific methods of intervention in physiotherapy course of Catholic
        University of Murcia, Spain
      
Keywords: physiotherapy; student; assesment tool
Extended Antibiotic Therapy in Postoperative of Laparoscopic Cholecystectomy in Acute Cholecystitis
Condition: Acute Cholecystitis
MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute cholecystitis (AC) is a very common complication of cholelithiasis, encountered in 20%
      of symptomatic patients.

      Nowadays laparoscopic cholecystectomy (LC) is the standard treatment in mild and moderates
      forms of diseases and antibiotic therapy in the postoperatory of these patients remains under
      discussion. However in the beginning, AC presents itself as an steril process, the
      obstruction of the cystic duct initiates a cascade of inflammation, ischaemia and necrosis,
      as well as bacterial proliferation within the gallbladder lumen. Bactibilia was a significant
      factor associated with total, as well as infectious, operative complications. Regarding this,
      for some authors, monotherapy with amoxicillin clavulanic (AMC) would be the best treatment
      after LC in patients with mild and moderate cholecystitis without intraoperative
      complications such as bile peritonitis, cholangitis, gallbladder perforation or abscess. In
      the other hand, others do not prescribe antimicrobial treatment after surgery in these
      selected patients.

      There is controversy regarding the postoperative treatment with antibiotics in patients with
      mild and moderate cholecystitis and all the evidence about this topic.

      Therefore, investigators decided to conduct a prospective randomized study in patients
      undergoing laparoscopic cholecystectomy for acute mild and moderate cholecystitis cancer. The
      patients will be randomized to receive AMC or placebo after surgery. With this study
      investigators intend to prove that are no clinical differences in postoperative outcomes
      between patients treated with AMC and placebo.

      The primary aim of the trial is to assess that there are no benefits in the use of
      postoperative antibiotics in patients whit mild or moderate acute cholecystitis in whom a
      laparoscopic cholecystectomy was performed.
    

Detailed description: 
      Double blind randomized clinical trial
    

Intervention name(s): Amoxicillin clavulanic; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 g per day divided into 3 oral intakes of 1 g each (2 pill of Amoxicillin Clavulanic every 8 hrs). This treatment will begin on postoperative day 1 for 5 days.; 1 pill of the same characteristics as Amoxicillin clavulanic every 8 hs. This will begin on postoperative day 1 for 5 days.
Other intervention name(s): Optamox; Lactose
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute cholecystitis.; Amoxicillin clavulanic
Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke in Posterior Circulation
Condition: Posterior Circulation Brain Infarction
MeSH terms: Ischemic Stroke; Brain Infarction; Infarction
Study type: Interventional

Summary: 
      There is few randomized controlled clinical to investigated the impact of anesthetic type on
      outcome in patients with acute ischemic stroke in posterior cerebral circulation. It is
      unknown whether the choice of anesthesia is impacted on the outcomes for these patients or
      not. The investigators will perform a randomized controlled pilot clinical trial of general
      anesthesia versus local anesthesia/conscious sedation to explore and find out a potential
      fact whether anesthetic type alters perioperative neurological function in patients with
      acute ischemic stroke in posterior cerebral circulation.
    


Intervention name(s): General anesthesia; Local anesthesia/concious sedation; Spontaneous breath; Controlled ventilation
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Patients will be injected with propofol, remifentanil and muscular relaxant with controlled ventilation.; Patients will be injected with propofol and remifentanil.; Patients will be kept spontaneous breath.; Patient will be kept with controlled ventilation.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Anesthesia Methods; Acute Ischemic Stroke; Endovascular Treatment
Registry of Non-primary Angioplasty at Hospitals Without Surgery On-site
Condition: Coronary Artery Disease; Heart Attack; Angina
MeSH terms: Coronary Artery Disease; Myocardial Infarction
Study type: Observational [Patient Registry]

Summary: 
      This is a simple registry of patients undergoing PCI at hospitals without surgery on-site who
      were participants in the CPORT-E project. The aim of the registry is simple data collection
      and reporting to respective State Departments of Health. The registry population consists of
      patients undergoing diagnostic cardiac catheterization for suspected CAD at hospitals without
      SOS and who require PCI.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patient population includes inpatients and outpatients undergoing diagnostic cardiac
        catheterization for suspected coronary artery disease (CAD) at hospitals without SOS.
Neurally Targeted Cognitive Training to Augment CBT Outcomes in Pediatric Anxiety
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study will assign participants with anxiety to cognitive behavioral therapy (CBT) with
      computerized cognitive training (CCT). In addition, the study will have a control group and
      enroll age- and gender-matched anxious children assigned to CBT.

      The hypothesis of this trial is that CCT with CBT will further increase task control network
      (TCN) activation and connectivity.

      Both groups will have one CBT therapy session each week for 12 weeks. However, for
      participants in the CCT arm plus CBT they will also receive up to 4 weeks of at home CCT to
      complete during the two weeks prior to the first CBT session and during the two weeks after
      the first CBT session. CCT is to be done at home for approximately 30 minutes per day, 5 days
      per week. Additionally, participants in the CCT arm plus CBT will receive CCT for 30 minutes
      just prior to CBT sessions 4-12.

      Each group will also have pre and post therapy functional magnetic resonance imaging (fMRI)
      and be asked to complete anxiety severity interviews and questionnaires throughout the study
      as well as after the treatment.

      Update as of 4/7/2020: Enrollment and in-person-only interactions/interventions are
      temporarily paused due to COVID-19 and are expected to resume in the future. This is not a
      suspension of IRB approval.

      Update as of 7/20/2020: Enrollment and in-person-only interactions/interventions are resumed.
    


Intervention name(s): Cognitive behavioral therapy (CBT); computerized cognitive training (CCT)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The CBT intervention will consist of 12 weekly 60 minute sessions of the manualized therapy, adapted from the Coping Cat program, for the treatment of pediatric anxiety disorders.; CCT intervention will consist of approximately 30 minutes of CCT games prior to each CBT session, to engage cognitive control capacity prior to receipt of CBT. The CCT games will be designed to target focused attention, response inhibition, working memory and multiple simultaneous attention to constitute a general executive function training, and activate neural systems associated with executive function/cognitive control. Difficulty of the games will be titrated individually and by session to avoid boredom and progressively activate the functional systems underlying cognitive control.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: anxious; Cognitive behavioral therapy; Computerized cognitive training
Dietary Interventions in Prediabetes
Condition: Impaired Fasting Glucose; Pre Diabetes; Liver Fat
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Assessment of glucose metabolism and liver fat after 12 week dietary intervention in pre
      diabetes subjects. Subjects will be randomized to either high fat (olive oil
      supplemented),high carb/high fiber (beans supplemented) and high carb/low fiber diets.
      Glucose metabolism will be assessed by labeled oral glucose tolerance test and liver fat by
      magnetic resonance spectroscopy pre randomization and at 8 and 12 week after starting dietary
      intervention.
    


Intervention name(s): Dietary intervention
Intervention type(s): Dietary Supplement
Intervention description(s): three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon β-1a (Avonex®)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study aims to compare the effect of daily oral treatment of laquinimod capsules 0.6
      milligrams (mg) with the effect of placebo capsules (capsules that contain no active
      medication) as well as with the effect of an existing Multiple Sclerosis (MS) injectable
      drug: Interferon β-1a (Avonex®).
    


Intervention name(s): Laquinimod; Placebo; Avonex®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Laquinimod will be administered per dose and schedule specified in the arm description.; Placebo matching to laquinimod will be administered per schedule specified in the arm description.; Avonex® will be administered per dose and schedule specified in the arm description.
Other intervention name(s): Interferon β-1a
Intervention MeSH terms: Interferons; Interferon beta-1a; Interferon-beta
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment