bioihbjkbjnl/mcl2 huggingface dataset:
Effect of an Abdominal Hypopressive Technique Program on Pelvic Floor Muscles and Urinary Incontinence in Women
Condition: Mild Pelvic Floor Dysfunction
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      Abdominal hypopressive technique (AHT) is a therapy created for the treatment of the pelvic
      floor dysfunctions in the postpartum. In the last years it has been extended out of such
      medical context but there is a lack of scientific evidence, and the endurability of the
      effects of this technique are unknown. The investigator´s aim was to evaluate the effect of a
      12 weeks AHT program on 1) the tone of the pelvic floor muscles and 2) on urinary
      incontinence, in women out of the postpartum phase. In addition the investigators looked for
      the endurability of its effect.

      Methods: The investigators performed a cross-over blinded intervention study of 4 month
      duration, in which women, stratified by age, were randomly assigned to a sequence of AHT-no
      AHT or no AHT-AHT. The AHT program consisted of 30 minute sessions, 3 days per week during 2
      months. The investigators compared the effect of AHT versus no AHT, and of no AHT after 2
      months versus AHT.

      The endpoints were the differences in perineal tonometry, and urinary incontinence symptoms,
      as measured by the ICIQ_SF. Comparisons were tested with student t tests, paired or unpaired
      as adequate.
    


Intervention name(s): Abdominal hypopressive technique
Intervention type(s): Other
Intervention description(s): postural technique based on self-elongating, body axis anteriorization, shoulders extension, and maintenance of an expiratory apnea as long as possible
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Association Between SMA Flow and AGI in Critically Ill Patients
Condition: Gastrointestinal Dysfunction; Critical Illness
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      Acute gastrointestinal injury (AGI) is related to poor outcomes of critically ill patients
      [1] through many underlying mechanisms [2]. It is also a part of the process of multiple
      organ dysfunction syndrome (MODS). However, the morbidity of acute gastrointestinal
      dysfunction in critically ill patients is highly underestimated due to the scarcity of
      accurate measurement and thus the causes are still unclear.

      In this study, investigators are going to apply the technique of point-of-care ultrasound
      (POCUS) evaluation on the bowel diameters, wall thickness and movement combined with
      intra-abdominal pressure to determine the occurrence of AGI. The superior mesenteric artery
      (SMA) blood flow is also evaluated by POCUS to find out the association between SMA blood
      flow and AGI.
    

Detailed description: 
      1. Patients are recruited within 24 hours of our surgical ICU admission. The patients are
           mostly admitted for post-surgery monitor in case of complications due to their baseline
           health conditions. In some cases, patients are admitted from the emergency room because
           of severe sickness. Those who are with deep sedation and mechanical ventilation during
           the first ultrasound evaluation are eligible for the study.

        2. Written informed consent was obtained from all patients or next of kin before the
           recruitment.

        3. Information will be collected at enrollment, including demographic characteristics,
           diagnosis, and so on.

        4. There will be two phases of ultrasound evaluation. In Phase One, investigators perform
           ultrasound evaluation within 24 hours after ICU admission to investigate the SMA blood
           flow in supine position using POCUS. In Phase Two, starting after the enteral feeding
           has been initiated, usually within 3 days after the enrollment, ultrasound evaluation on
           GI function will be performed according to gastrointestinal and urinary tract sonography
           ultrasound (GUTS) protocol using POCUS. GUTS protocol includes the ultrasound
           measurement for bowel diameter, bowel wall thickness, peristalsis combined with
           intra-abdominal pressure(IAP) measured through ureteral catheterization. All
           measurements would be used to calculate GUTS score to grade the AGI [4].
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted into the Department of Critical Care Medicine of Peking Union Medical
        College Hospital, who were eligible of inclusion criteria, were included in the study.
      
Keywords: Regional blood flow; Gastrointestinal dysfunction; Critical care
the Effect of Erector Spinae Plane Block on Fentanyl Consumption During Abdominal Hysterectomy
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study aims to evaluate the effects of erector spinae plane block on intraoperative
      fentanyl consumption in patients undergoing abdominal hysterectomy under general anesthesia.

      To our knowledge, no study in the literature demonstrates this effect.
    

Detailed description: 
      This study will be performed in Fayoum University hospital after approval of the
      institutional ethics committee and written informed consent. This study will be conducted as
      a prospective, randomized, double-blind, parallel-group clinical trial.

      Inclusion criteria:

        -  American Society of Anesthesiologists (ASA) physical status I, II patients who will be
           scheduled for elective abdominal hysterectomy.

        -  Age range above 18.

      Exclusion criteria:

        -  Patient refusal.

        -  Significant renal, hepatic and cardiovascular diseases.

        -  History of allergy to one of the study drugs.

        -  Any contraindication to regional anesthesia such as local infection or bleeding
           disorders.

        -  Chronic opioid use, history of chronic pain and cognitive disorders.

      The patients will be randomized into two groups: ESP block group who will receive
      preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side and
      Control group who will undergo the same procedure but with an injection of 20 ml of saline on
      a 1:1 ratio using a computer-generated random table. The patient's assigned group information
      will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the
      ESP block and will not be involved in further data collection or patient care. The patients
      and both the surgical and anesthesia teams, who are responsible for patient care and data
      collection are blinded from the group assignments.
    

Intervention name(s): ESP block
Intervention type(s): Procedure
Intervention description(s): ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side
Other intervention name(s): regional anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will be conducted as a prospective, randomized, double-blind, parallel-group clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study on the Efficacy of Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Leaf Extract in Adults With Osteoarthritis of the Knee.
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to assess the effectiveness of alpha-D Glucosamine
      Sulfate/Standardized Extract of Ginkgo Biloba Leaf versus a comparator product on
      osteoarthritis pain as assessed by the between group change in WOMAC™ Osteoarthritis Index
      Pain Subscale using Visual Analogue Scale (VAS) scores in subjects with osteoarthritis of the
      knee.
    


Intervention name(s): Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract; Placebo
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Osteoarthritis; Knee; Glucosamine Sulfate; Ginkgo Biloba; WOMAC; Joint Health Wellness; Interleukin-1-beta
Metabolic Effects of High-amylose Wheat-based Rusks.
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      Amylose-amylopectin ratio may influence the rate of starch digestion. This randomized
      controlled study evaluated the postprandial metabolic effects of amylose-rich- wheat- based
      rusks in overweight subjects.
    


Intervention name(s): Test meal
Intervention type(s): Other
Intervention description(s): Participants received in random order a test meal (900Kcal, 100g carbohydrates) containing rusks prepared with amylose-rich wheat flour or conventional flour. Blood samples were collected at fasting and every 30 minutes over 4 hours. Breath hydrogen was evaluated as a marker of intestinal fermentation. Participants underwent Visual Analogue Scale to assess subjective appetite sensations.
Other intervention name(s): Acute test meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
An Investigation of Light Therapy for Cancer-related Fatigue (The LITE Study)
Condition: Cancer
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Cancer-related fatigue is one of the most common and distressing symptoms associated with a
      cancer diagnosis.Fatigue related to cancer often appears before a diagnosis, worsens during
      treatment, and lasts for years after treatment in up to 35% of patients. Despite the
      long-term effects of cancer-related fatigue, the treatment options available are not always
      appropriate or helpful for all patients.Light therapy is an effective treatment for other
      disorders related to fatigue. The purpose of the study is to investigate the role of light
      therapy on quality of life, sleep patterns, and physical measures of immune function and
      stress hormones in individuals with post-treatment cancer-related fatigue.
    


Intervention name(s): Bright white light; Dim red light
Intervention type(s): Device; Device
Other intervention name(s): Light box; LiteBook; Light box; LiteBook
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: fatigue; sleep; quality of life; light; cancer
Uroflow Measurement With Electromyography (EMG) to Identify Lower Urinary Tract Symptoms (LUTS): Conducted on Healthy Children
Condition: Lower Urinary Tract Symptoms; Urologic Diseases
MeSH terms: Urologic Diseases; Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      Nowadays there is a growing interest towards non-invasive assessment of urinary dysfunctions
      in clinical practice. The tendency to use uroflowmetry as a first-line screening tool is
      based on the inexpensiveness, time efficiency, comfort of the patient, etc. However, it is
      stated that uroflowmetry as a stand-alone study lacks the potential to make an accurate
      diagnosis. In regard to this, the International Continence Society indicated that the
      addition of pelvic floor electromyography might increase the accuracy of this assessment.
      Despite this recommendation, uroflowmetry in combination with electromyography has not been
      conducted in a healthy population.

      The initial objective of this study was to examine whether adding electromyography to
      standard uroflowmetry in a healthy paediatric population would change the representation of
      parameters, especially of voiding patterns. In addition, the influence of several factors on
      uroflow parameters was analysed to complement current literature.
    


Intervention name(s): Uroflow; Uroflow/EMG; US
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): Isolated uroflow measurement; Uroflow measurement with superficial EMG testing of the pelvic floor; Ultrasound of post void residual urine
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        continent children with normal development: community sample
Perpetrator DDI Potential of Givinostat as Inhibitor and Inducer of CYP3A and P-gp Activity
Condition: Drug-Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the givinostat (ITF2357) potential drug-drug interaction (DDI) at
      level of CYP3A-mediated metabolism and P-glycoprotein (P-gp) transport.
    


Intervention name(s): ITF2357 Givinostat 10mg/mL; Midazolam 1Mg/Ml (Pf) Inj Syringe 5Ml; Midazolam Oral Liquid Product; Dabigatran Etexilate 75 MG [Pradaxa]; Clarithromycin 500Mg Tab
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose: 10 mg/mL; Dosage form: oral suspension; Dose: 1 mg/ml; Dosage form: solution for injection/infusion or rectal administration; Dose: 2.5 mg; Dosage form: oromucosal solution; Dose: 75 mg; Dosage form: hard capsules; Dose: 500 mg; Dosage form: immediate-release film-coated tablets
Other intervention name(s): Givinostat
Intervention MeSH terms: Clarithromycin; Midazolam; Dabigatran; Givinostat hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: An Open-label, Single-center, Three-part Study in Healthy Subjects
Masking: None (Open Label)
Primary purpose: Treatment
Safety And Tolerability Study Of RN564 In Women With Osteopenia And Healthy Men.
Condition: Osteopenia; Osteoporosis; Bone Disease
MeSH terms: Osteoporosis; Bone Diseases, Metabolic; Bone Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of RN564 in women with
      osteopenia and healthy men.
    


Intervention name(s): RN564
Intervention type(s): Biological
Intervention description(s): Intravenous, single dose with experimental dose
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 1; Osteopenia; RN564
Decreased T1 Times and Impaired Myocardial Contractility in Anabolic Androgenic Steroids Users
Condition: Focal Fibrosis
MeSH terms: Fibrosis
Study type: Observational

Summary: 
      Anabolic androgenic steroids (AAS) abuse may have a toxic on myocardium that could lead to
      cardiac alterations. Clinical cases reported myocardial fibrosis in AAS users. However,
      recent studies did not find myocardial fibrosis in AAS users using T1-mapping technique. The
      aim of this study was to evaluate cardiac structure by cardiovascular magnetic resonance
      (CMR) with late-gadolinium enhancement (LGE), cardiac T1-mapping and extracellular volume
      (ECV). We also evaluated the cardiac contractility in AAS users.
    

Detailed description: 
      Twenty strength-trained AAS users (AASU) age 29±5 yr, 20 age-matched strength-trained AAS
      nonusers (AASNU), and 10 sedentary controls (SC) were enrolled.

      Cardiac structure was assessed by LGE, T1-mapping and ECV. Cardiac contractility was
      evaluated as cardiac strain by CMR (feature tracking) and echocardiography (speckle tracking)
    

Intervention name(s): Cardiovascular Magnetic Resonance; Transthoracic echocardiography
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): The patients underwent to CMR examination on a Philips Achieve 1.5 device. Images were acquired coupled to the electrocardiogram and during respiratory pause, in four chambers, short axis and long axis of the left ventricle, in the same exact location in different sequences. A gradient - echo sequence (steady-state free precession) was used to evaluate cardiac function (functional evaluation). We will also evaluate T1 weighted images (T1 -relaxation times) and T2, performed sequentially, through spin-echo pulse (black-blood), triple inversion recovery sequence, for the morphological evaluation; The images were collected by the Vivid E9. The patients were submitted to one-dimensional (M-mode), two-dimensional (B-mode), and three-dimensional (three-dimensional) echocardiographic studies. The images obtained were associated with pulsed, continuous and color Doppler.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Anabolic androgenic steroids users and nonusers were recreational weightlifters or amateur
        bodybuilding athletes who were recruited from gymnasiums.

        Sedentary control group was recruited from community sample.
      
Keywords: anabolic steroid; T1-mapping; cardiac structure
A Multicenter Survey of the Indications for Esophagogastroduodenoscopy (EGD)
Condition: Digestive System Abnormalities; Endoscopy
MeSH terms: Digestive System Abnormalities
Study type: Observational

Summary: 
      Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology
      diseases. The investigators want to find which symptoms can support for positive endoscopic
      findings through this multicenter study.
    

Detailed description: 
      Esophagogastroduodenoscopy (EGD) become more and more common in diagnosing gastroenterology
      diseases. And there are indications for EGD. Here, investigators want to find which symptoms
      can strongly support for positive endoscopy findings. So, investigators design the study to
      record the symptoms in detail and diagnosis, and then analysis symptoms and the rate of
      endoscopic findings.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All of the patients need esophagogastroduodenoscopic procedures
      
Keywords: Esophagogastroduodenoscopy; Paediatric
Prognostic Factors for Patients With Advanced Colorectal Cancer Treated With Cetuximab.
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Italian, multicentre, non comparative trial in patients with advanced Colorectal
      Cancer(CRC)and KRAS wild-type, defined by molecular evaluation.

      Patients will receive Cetuximab + FOLFIRI until disease progression, unacceptable toxicity
      developed or patient refusal.

      The aim of this study is to assess the prognostic role of PTEN in terms of Progression free
      survival.

      Although the role of Cetuximab as first line treatment in metastatic CRC will be soon
      established, it is still unclear which is the best schedule for Cetuximab and the role of
      biological factors in order to select the most appropriate subset of pts for recommending
      Cetuximab. The data supporting a benefit of Cetuximab in KRAS wild-type pts open the
      perspective to study the role of other molecular markers in this subset of pts.

      On the basis of these considerations this study is aimed at testing a different schedule of
      Cetuximab and better characterize the prognosis of pts for which Cetuximab is appropriate.
    

Detailed description: 
      Pts meeting eligibility criteria will be registered, providing the availability of material
      for molecular analysis. Tumour specimens and blood sample will be collected to perform
      genomic, ICH and proteomic analyses in order to identify the molecular characteristics of
      tumour.

      After the availability of KRAS evaluation, only the data of KRAS wild-type pts will be
      collected.

      Access to registration system will be allowed via web.

      Patients,KRAS wild-type receive:

      - Cetuximab+FOLFIRI: cetuximab 500 mg/ m² starting dose, following everytwo- week doses of
      500 mg/ m², given d1, followed after 1 hour by FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV
      100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an
      intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU
      bolus injection on days 1 and 2
    

Intervention name(s): Cetuximab; FOLFIRI
Intervention type(s): Drug; Drug
Intervention description(s): cetuximab 500 mg/ m² starting dose, following everytwo- week doses of 500 mg/ m², given d1,; irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2
Intervention MeSH terms: Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal Neoplasms; KRAS; PTEN
Efficacy of Er: YSGG Laser in Treatment of Peri-implantitis
Condition: Peri-Implantitis
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm
      removal from implant surface in various peri-implant defect morphology in the treatment of
      peri-implantitis as a primary objective.

      To assess the morphological changes and the biological response (biocompatibility) of implant
      surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process
      to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow
      Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives.
    

Detailed description: 
      This study will be carried out to evaluate the efficacy of Er: YSGG laser on oral biofilm
      removal from implant surface in various peri-implant defect morphology in the treatment of
      peri-implantitis as a primary objective.

      To assess the morphological changes and the biological response (biocompatibility) of implant
      surface after Er: YSGG laser therapy through Profilometer analysis and cell culture process
      to detect attachment, differentiation, and mineralization of Isolated rat Bone Marrow
      Mesenchymal stem cells (rBMMSCs) respectively as secondary objectives.

      The study was designed as an Ex Vivo study. Four periodontally and systemically healthy
      volunteers of both gender are included in this study for the formation of in vivo plaque
      biofilm. Each volunteer will wear a hard resin splint carrying six rough (machined implant;
      3.3mm diameter, 8mm length) for 4 days to accumulate dental plaque naturally on the titanium
      surfaces of the implants.

      Therefore, 24 implants will be assessed for Er: YSGG laser therapy in different bone defect
      simulators.
    

Intervention name(s): Er: YSGG laser; no therapy
Intervention type(s): Device; Other
Intervention description(s): Er: YSGG laser decontamination of infected implant surfaces to simulate peri-implantitis therapy; new sealed implant without any surface treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: two group control and test group test group divided into four subgroups
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Er: YSGG laser therapy; Peri-Implantitis