bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of a Training Protocol With the Cervical Device in Subjects With Deep Cervical Muscle Strength Deficit.
Condition: Muscle Weakness; Cervical Disability
MeSH terms: Muscle Weakness; Paresis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the clinical results produced by a training protocol
      with the new device for cervical treatment (CDAT) and the conventional training protocol (CT)
      versus a control group (C) in subjects with cervical deep muscle strength deficit and mild
      neck disability.
    

Detailed description: 
      Cervical pain is in many cases a decrease in the quality of life.The cervical spine is the
      most mobile region of the spine which also must be strong enough in order to support the
      weight of the skull. Deficits in deep cervical muscle strength are related to different
      clinical conditions: cervicogenic dizziness, cervical radiculopathy, cervical
      mechanical-chronic, cervical pain and cervical instability. Training protocols can help to
      improve pain, cervical function, posture and cross-sectional area. However, there are no
      training protocols in subjects with mild disability and strength deficit of the deep cervical
      muscle, including deep neck extensor and flexor muscles. The cervical device treatment (CDAT)
      allows us to train the cervical flexor and extensor muscle in a simple and comfortable way.
    

Intervention name(s): Training protocol with the device cervical for treatment (CDAT); Conventional training protocol
Intervention type(s): Other; Other
Intervention description(s): Training protocol with the cervical device for treatment (CDAT); Conventional training protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a randomized controlled trial with 3 different groups
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: neck pain; exercise therapy; muscle weakness; telerehabilitation; neck muscles
Role of Epoxyeicosatrienoic Acids in Chronic Allograft Nephropathy - The TRANSPLANT-EETs Study
Condition: Kidney Transplant Recipients
MeSH terms: Kidney Diseases
Study type: Interventional

Summary: 
      Endothelial lesions within the transplanted kidney are a major determinant of chronic
      allograft nephropathy. Epoxyeicosatrienoic acids (EETs) are endothelium-derived
      hyperpolarizing factors with anti-inflammatory, antiproliferative and vasodilator properties.

      The main goal of the investigators' study is to evaluate whether genetic polymorphisms of
      specific enzymes responsible for the bioavailability of EETs are associated with
      post-transplant kidney function.

      To this end, 80 kidney transplant recipients will be included. Prespecified genetic
      polymorphisms of CYP 2J2, CYP 2C8, CYP 2C9, CYP 2C9, CYP 2C19 and EPHX2 will be determined.
      Kidney function will be recorded 3, 6, 12 and 36 months after transplantation. Flow-mediated
      dilatation, EETs and circulating biomarkers of endothelial function will be measured in the
      radial artery.

      The expected results of this study to provide preliminary evidence supporting a beneficial
      role of an increase in the bioavailability of EETs in kidney transplant recipients.
    


Intervention name(s): Blood sampling; flow-mediated distal stimulation of the forearm radial artery by cutaneous heating
Intervention type(s): Procedure; Procedure
Intervention description(s): Blood sampling is done for Kidney transplant recipients for evaluation of the polymorphisms and EETs dosage; Flow-mediated distal stimulation of the forearm radial artery by cutaneous heating for Kidney transplant recipients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Guanfacine Immediate-release Electrocardiogram Results (QTc) Study
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of immediate-release guanfacine hydrochloride, administered at
      therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females
    


Intervention name(s): immediate release guanfacine hydrochloride; moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6.; Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6.; Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.
Other intervention name(s): Tenex; Avelox
Intervention MeSH terms: Moxifloxacin; Guanfacine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: QT/QTc
Treatment of Intrabony Defects With L-PRF Membrane With or Without Collagen Membranes
Condition: Periodontal Bone Loss; Periodontal Diseases
MeSH terms: Alveolar Bone Loss; Periodontal Diseases
Study type: Interventional

Summary: 
      For patients having periodontal intrabony lesions, three treatment modalities were executed
      to evaluate the effect of protecting Leukocyte rich -Platelet Rich Fibrin harvests (applied
      in the bony defects) with resorbable collagen membranes. Clinical Outcomes recorded were the
      Plaque index (PI), Gingival index (GI), probing depth reduction (PD), Clinical attachment
      level (CAL), and radiographic defect depth changes.

      For the biochemical evaluation: levels of PDGF-BB and VEGF obtained from crevicular fluid by
      Perio-Paper strips were assessed using ELIZA.
    

Detailed description: 
      -  Patients having 2-3 osseous bony wall infrabony periodontal lesions are enrolled in the
           present study. They have to be free from any systemic disease that contraindicates
           periodontal surgeries.

        -  Baseline data are obtained including the GI, PI, PD, CAL and preoperative paralleling
           periapical radiographs.

        -  Full thickness mucoperiosteal flaps are elevated and thorough debridement of the
           periodontal bony defect is performed.

        -  for OFD group; following debridement and saline irrigation, wound closure proceeds.

        -  for the L-PRF group; L-PRF is prepared and applied within the defect before primary
           closure.

        -  for the L-PRF + CM: similar procedure like the second group is performed but with an
           additional protective layer of collagen membrane on top of the defect before wound
           closure.

        -  from the second day postoperative; Periopaper strips are used to obtain a crevicular
           fluid sample from the sulcus

        -  At 6 months postoperative: the same baseline clinical measurements are obtained.
    

Intervention name(s): L-PRF; OFD; CM
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): a blood sample is obtained from the patient, and centrifuged to prepare a leukocyte platelet rich fibrin harvest that is applied within the derided lesion.; Full thickness flap elevation to gain access to the infrabony lesion for debridement followed by flap closure.; Xenogeneic collagen membranes that are used as barrier membranes in guided tissue regeneration of periodontal defects
Other intervention name(s): Leukocyte platelet rich fibrin; Open flap Debridement; Collagen membrane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients?
Condition: Spinal Anesthesia Administration
Study type: Interventional

Summary: 
      Spinal anesthesia depends on being able to locate physical landmarks on a patient's body. In
      obese patients, the commonly used landmarks may be difficult or even impossible to feel. In
      addition, the spine can be hidden beneath a layer of fatty tissue.

      Ultrasound is useful for finding the correct injection site in pregnant patients, but the
      usefulness of ultrasound has not been adequately evaluated in non-pregnant patients. The
      potential benefits for obese patients from the use of ultrasound include shortening the
      duration of the procedure, increasing patient comfort, decreasing the total number of
      attempts, and aiding in the choice of appropriate needle length for the patient.

      The investigators hypothesize that there is no difference in time to perform a spinal
      anesthetic when landmarking with ultrasound as compared to tactile landmarking in patients
      with BMI > 35.
    


Intervention name(s): Ultrasound guidance; Palpation of Tuffier's line; Spinal anesthetic
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.; Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal.; Subcutaneous local infiltration with a 25g needle we be performed prior to the spinal. Neuraxial technique will be attempted midline with a 25 gauge whitacre needle in the sitting position. Spinals will be attempted on either L2-L3, L3-L4, L4-L5 interspaces. The amount and type of local anesthetic/intrathecal narcotic will be left to the discretion of the Anesthetist.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Effect of Consuming Beans for One Month on Blood Lipids, Satiety, Intake Regulation and Body Weight
Condition: Overweight; Obesity; Metabolic Syndrome; Diabetes; Hypertension
MeSH terms: Hypertension; Overweight; Metabolic Syndrome; Body Weight
Study type: Interventional

Summary: 
      This project investigates the effect of regular consumption of commercially available
      processed white beans (5 cups per week) on food intake, body weight, blood pressure, satiety
      hormones and glycemic response over a 4-week period. We have chosen to provide participants
      with canned white beans, the most accessible and frequently consumed bean in North America.
      They are inexpensive, a good source of high quality nutrients and ready to eat. Based upon
      published literature and short-term studies conducted in our laboratory, we hypothesize that
      regular consumption of commercially available canned beans will increase satiety and improve
      the control of food intake, body weight, blood glucose and blood lipids.
    

Detailed description: 
      The metabolic syndrome is a clustering of chronic disease risk factors, including abdominal
      obesity, dyslipidemia, elevated blood pressure and elevated fasting blood glucose.

      A main treatment for metabolic syndrome is lifestyle modification (alterations in diet and/or
      physical activity patterns) resulting in weight loss.

      Beans are easily incorporated into the diet and may lead to the attainment and maintenance of
      healthy a body weight and improved metabolic control.

      Canned baked navy beans (with tomato sauce) have a low glycemic response following
      consumption, however, whether this effect has long-term benefits on glycemic control requires
      further investigation.

      OBJECTIVE

      To determine the effect of consuming 5 cups per week of commercially available canned navy
      beans over 4 weeks on risk factors associated with the metabolic syndrome.

      Subjects

      Inclusion criteria: Men and women (n=16) between 35 and 55 years of age with a body mass
      index (BMI) of 27 to 40 kg/m2.

      Exclusion criteria: smoking or any major surgery/medical condition within the last 6 months,
      use of medications that could interfere with the study outcomes, gastrointestinal, liver or
      kidney disease and women who were pregnant/lactating
    

Intervention name(s): navy beans added to regular diet
Intervention type(s): Other
Intervention description(s): 5 cups per week of commercially available white beans for 4-weeks
Other intervention name(s): Heinz beans
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: beans; pulses; satiety; appetite; obesity; overweight; diabetes; metabolic syndrome; hypertension; blood glucose; insulin; cholesterol; HDL; LDL; leptin; GLP-1; adiponectin; Peptide YY; diet
A Study to Measure Relationship Between Antimüllerian Hormone and Initial Dose of Menopur®
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      AME is a non-interventional, prospective, longitudinal and multicenter study. This study aims
      to measure the relationship between antimüllerian hormone serum level (AMH), as measured by a
      fully automated assay and the initial dose of Menopur® HP-hMG 600 IU/mL prescribed for
      infertile women undergoing their first IVF/ICSI cycle in the current practice.
    


Intervention name(s): Menotrophin
Intervention type(s): Drug
Other intervention name(s): Menopur® HP-hMG
Intervention MeSH terms: Menotropins
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Specialized fertility centers.
Investigating Outcomes of Lower Limb Trauma
Condition: Trauma
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      This is an observational study, which aims to firstly develop a sensor-based objective
      mobility assessment. This will then be used to profile and compare the outcomes of patients
      who undergo amputation with those who have limb salvage surgery following a traumatic injury
      to their lower limb.
    

Detailed description: 
      In the setting of severe trauma, the decision whether to amputate or save a limb is common,
      and extremely difficult to make. Due to improving reconstructive surgical techniques there
      are currently no clear criteria for amputation. Although limb salvage appears desirable in
      most situations, numerous articles in the scientific literature have shown that it is
      associated with increased pain, complications, duration of hospital stay, rehabilitation
      time, and overall costs. These factors may be acceptable if the patients benefited from
      improved functional outcome. However, studies comparing amputation to limb salvage
      consistently report no significant difference in functional outcome between the two groups.

      A major limitation in the methodology of the fore mentioned studies is the use of
      self-reported questionnaires to determine functional outcome. Questionnaires are subjective,
      and often lack specificity, and therefore may not be truly representative of functional
      outcome. Furthermore, lack of useful information during long-term post-operative care
      prevents adaption and optimisation of rehabilitation strategies.

      The investigators plan on using a wearable sensor to develop an objective mobility assessment
      tool for patients having either amputation or limb salvage surgery after lower limb trauma.
      This would result in a reliable and accurate comparison, which may help healthcare
      professionals make an informed decision between amputation and limb salvage in the future.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Participants who have been treated following lower limb trauma at the Imperial College NHS
        Trust sites will be recruited for this study.
      
Keywords: Trauma; Limb reconstruction; Amputation; Functional outcome; Sensing
BIOSURE™ HEALICOIL™ PK Bone In-growth Study
Condition: Deficiency of Anterior Cruciate Ligament
Study type: Observational

Summary: 
      The study seeks to document the bone in-growth into the BIOSURE™ HEALICOIL PK screw as
      measured by CT scans. Patients' improvement in pain and function will also be followed
      through various outcome measures.
    

Detailed description: 
      The primary objective of the current study is to assess bone in-growth in the BIOSURE™
      HEALICOIL™ Interference screw in the tibial tunnel of patients undergoing ACL reconstruction
      with soft tissue grafts; tunnel widening and change in IKDC knee and subjective scores will
      also be documented.
    

Intervention name(s): BIOSURE™ HEALICOIL™ PK Interference Screw
Intervention type(s): Device
Intervention description(s): Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing ACL reconstruction
      
Keywords: ACL; BIOSURE; HEALICOIL; PEEK; In-Growth
Efficacy of Lactobacillus GG With Diosmectite in Treatment Children With Acute Gastroenteritis
Condition: Diarrhea
MeSH terms: Gastroenteritis; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Treatment diarrhea with Lactobacillus GG or smectite has proven efficacy. A randomized,
      double blind, placebo-control trial was performed to assess the effectiveness of both LGG and
      smectite in management of children with acute gastroenteritis (AGE).
    

Detailed description: 
      ESPGHAN agreed to use probiotics, with proven efficacy, and smectite in treatment of AGE as
      an adjunct to standard rehydration therapy. Among probiotics Lactobacillus GG were found to
      be beneficial in meta-analyses. Treatment with LGG was associated with a significant
      reduction in diarrhea duration.

      A recent review systematically evaluated the efficacy of smectite in treating acute
      infections diarrhea in infants and children.
    

Intervention name(s): Smectite; Placebo; Lactobacillus GG
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.; Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.; All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite
Other intervention name(s): Smecta; glucose; Dicoflor 30
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diarrhea; probiotics; diosmectite
Egg Donor Recipient Characteristics Preferences
Condition: Egg Donor Recipient Characteristics
Study type: Observational

Summary: 
      To identify the characteristics in an egg donor that are important to a recipient and to see
      if those characteristics change over time.
    

Detailed description: 
      No study has explored how recipients' attitudes and reactions change over time regarding the
      selection criteria for their donors. Consequently, programs have no guidance in how to
      counsel prospective recipients as to whether their donor preferences will change over time.
      Participants will complete a survey at 4 points in time as they go through the process of
      selecting an egg donor and pursuing a pregnancy using that egg donor.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are planning to undergo an egg donor cycle are eligible
      
Keywords: egg donor; recipients; donor characteristics
Bilateral vs. Unilateral Erector Spinae Plane Block
Condition: Postoperative Pain; Cholecystitis; Gallstone
MeSH terms: Cholecystitis; Gallstones; Pain, Postoperative
Study type: Interventional

Summary: 
      The importance of multimodal analgesia for postoperative pain management is well known and
      regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector
      spinae plane block (ESB) is a new defined and effective regional anesthesia technique. But
      two injections can be unconfortable for some patients. With this study, we aimed to compare
      the analgesia effect of bilateral and unilateral ESP block for laparoscopic cholecystectomy.
    


Intervention name(s): Bilateral ESP Block; Unilateral ESP Block; Intravenous Morphine patient controlled analgesia device
Intervention type(s): Procedure; Procedure; Device
Intervention description(s): Bilateral ESP Block will be performed at T8; Unilateral ESP Block will be performed at T8 (right side); 24 hour morphine consumption will be recorded
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: erector spinae plane block; postoperative pain; laparoscopic cholecystectomy
Effects of Psilocybin in Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label pilot study seeks to investigate the safety and efficacy of psilocybin in
      persons with chronic anorexia nervosa (AN). Psilocybin has previously been demonstrated to
      decrease depression and anxiety and increase long-term positive behavior change in other
      populations. The investigators seek to determine whether similar changes can be safely
      produced in people with AN when psilocybin is administered in a supportive setting with close
      follow-up. The investigators' primary hypotheses are that psilocybin is safe to administer in
      people with AN, that it will reduce measures of anxiety and depression, and that it will lead
      to increased quality of life. The investigators will also assess a number of exploratory
      measures related to eating disorder pathophysiology.
    


Intervention name(s): Psilocybin
Intervention type(s): Drug
Intervention description(s): Participants will undergo up to four moderate to high dose psilocybin sessions. Dosing at the first session will be 20 mg. For subsequent sessions participants will either remain at their previous dose, or increase by increments of 5 mg up to a maximum of 30 mg.
Intervention MeSH terms: Psilocybin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment