bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Atorvastatin on Prevention of Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery
Condition: Aortic Surgery; Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Acute kidney injury(AKI) is a common and severe complication after the cardiac surgery.
      Postoperative AKI increases the in-hospital stay, intensive care unit(ICU) stay and
      postoperative mortality. Aortic surgery is the most risky surgery that causes the
      postoperative AKI, and the incidence of AKI after aortic surgery is about 50%.

      Statin is a 3-hydroxy-3-methyl-glutaryl co-enzyme A (HMG CoA) reductase inhibitors and is
      used primarily to lower the level of plasma cholesterol. Apart from the antilipid effect,
      statin has pleiotropic effects include anti-inflammation, decrease of oxidative stress,
      recovery of endothelial cell injury and stabilization of thrombus.

      The pathology of AKI after aortic surgery include not only hypoperfusion of renal blood flow
      but also thromboembolism, inflammatory reaction after use of cardiopulmonary bypass(CPB) and
      oxidative stress. Therefore, the incidence of AKI after aortic surgery can be expected to
      decrease after the perioperative use of statin because of the pleiotropic effects of it. The
      aim of this study is to examine the association between preoperative statin treatment and the
      incidence of postoperative acute kidney injury(AKI) in patients undergoing aortic surgery
    


Intervention name(s): Atorvastatin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg (PO) once daily for 6 days; 80 mg (PO) once daily for 6 days
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: aortic surgery; postoperative acute kidney injury; statin; the patient undergoing aortic surgery
Immediate Effect of Dry Needling on Trigger Points
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      The immediate effects (0-30 minutes) of a dry needling intervention on a trigger point on
      their viscoelastic properties (tone, elasticity and stiffness)
    

Detailed description: 
      Objectives: To investigate the immediate effects of a dry needling puncture on the
      viscoelastic properties (tone, stiffness and elasticity) of a trigger point (TP) located in
      the infraspinatus muscle in participants with non-traumatic chronic shoulder pain.

      Methods: Forty-eight individuals who presented non-traumatic chronic shoulder pain were
      recruited. The presence of a TP in the infraspinatus muscle of the painful side was confirmed
      by an experienced physiotherapist with a palpatory exam according to Travell and Simons
      criteria. The TP was marked and the viscoelastic properties including tone, stiffness and
      elasticity were measured with the MyotonPro device by an evaluator. After the first set of
      measurements (T1), an experienced physiotherapist applied a dry needling puncture to the TP
      with a pistoning technique to obtain a local twitch response (LTR) with an Optimed 40 x 0.30
      mm single use acupuncture needle. The same set of measurements was repeated immediately after
      the dry needling (T2) and 30 minutes later (T3). Repeated measures ANOVA and post-hoc tests
      were used to assess changes in viscoelastic properties over time with a significant level set
      at 0.05.
    

Intervention name(s): Dry needling
Intervention type(s): Procedure
Intervention description(s): Insertion of a Optimed 40mm x 0.30 single use, sterile acupuncture needle into a active trigger point in the infraspinatus muscle
Intervention model: Single Group Assignment
Intervention model description: One group, one measurement of the viscoelastic properties with the MyotonPro of a single trigger point before the dry needle insertion, one measurement with the MyotonPro right after and 30 minutes later
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myofascial trigger points,; dry needling,; stiffness
Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      We propose to demonstrate that epidural stimulation (ES) can be used to recover significant
      levels of autonomic control of cardiovascular and respiratory function as well as the ability
      to voluntarily control leg movements below the injury level. This intervention would provide
      an immediate therapeutic alternative to individuals who now have no recourse for treatment.
    

Detailed description: 
      We will enroll 4 research participants who have sustained a motor complete SCI to participate
      in the proposed experiments. Participants will be screened for eligibility, followed by 80
      days of usual care, epidural implantation, 80 days of cardiovascular epidural stimulation
      training, 80 days of voluntary movement (VM) epidural stimulation training and finally 80
      days of stand epidural stimulation training. These interventions are done in sequential
      order, however they are cumulative. In between each intervention, participants will undergo
      motor and cardiovascular experiments and assessments.
    

Intervention name(s): 5-6-5 Specify electrode; Restore Advance Pulse Generator
Intervention type(s): Device; Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Epidural Stimulation
Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity
Condition: Type 1 Diabetes; Eating Disorder
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Feeding and Eating Disorders
Study type: Observational

Summary: 
      The purpose of the study is to investigate how people with type 1 diabetes experience and
      manage their diabetes, eating, and weight. Summary of the Study: If you choose to
      participate, you will complete a set of questionnaires and a structured interview. You will
      then wear a continuous glucose monitor and use your cell phone to answer study questions for
      a period of 3 days. The questions come in the form of regular phone calls between the hours
      of 8:00 a.m. and 10:00 p.m. Each call takes only a minute or two to complete. You will also
      be asked to call in and answer study questions at other times during the day, especially
      after eating. The study involves a minimum of 2 clinic visits to Duke. Participants who live
      greater than 1.5 hours from Duke can be approved to take part in the study by phone/Skype.
      Participants will receive and return study materials through the mail.
    

Detailed description: 
      Eating disorders (ED) are far more prevalent among individuals with type 1 diabetes (T1D)
      than the general population. Yet what accounts for the increased prevalence of ED in T1D, and
      how to effectively treat these patients is unknown. ED in T1D is dangerous. T1D patients with
      ED not only engage in behaviors common among non-diabetic ED patients (like binge eating),
      but also might omit insulin to prevent weight gain. The goal of this study is to understand
      the psychophysiological precipitants to ED behavior among T1D patients.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        UNC and Duke Endocrine Clinics Community of the Durham, Chapel Hill and Raleigh area
      
Keywords: Type 1 Diabetes; Type 1 Diabetes Mellitus; Eating Disorders; Insulin Omission
Phase 2 Study of Apixaban Reversal by Ciraparantag as Measured by WBCT
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, single-blind, placebo-controlled study to assess the efficacy and
      safety of ciraparantag administered to healthy volunteers anticoagulated with apixaban
      measuring clotting times using Whole Blood Clotting Time (WBCT).
    

Detailed description: 
      This is a randomized, single-blind, placebo-controlled assessment of the efficacy and safety
      of ciraparantag administered to healthy volunteers measuring clotting times using WBCT as
      determined by the manual testing method. All subjects will undergo screening up to 36 days
      prior to enrollment.

      All enrolled subjects are to receive 10 mg apixaban orally for 3.5 days (every 12 hours on
      Days 1-3 and once on the morning of Day 4). On Day 4, subjects who achieve sufficient
      anticoagulation (WBCT ≥20% above baseline) are randomized and will receive a single dose of
      study drug (ciraparantag or placebo) intravenously (IV) approximately 3 hours after the
      apixaban dose, followed by serial testing of manual WBCT.

      Subjects are enrolled sequentially into 3 ciraparantag dose cohorts. There will be a safety
      review after completion of treatment in one cohort and prior to initiation of treatment in
      the subsequent cohort.
    

Intervention name(s): Ciraparantag; Placebo; Apixaban
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ciraparantag (administered over 10 minutes); Saline for injection; Apixaban 10mg given twice daily (q12h)
Other intervention name(s): PER977; AMAG 977; PBO
Intervention MeSH terms: Apixaban
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ciraparantag; PER977; Apixaban; Whole Blood Clotting Time (WBCT)
Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      Increased postprandial plasma triglycerides are associated with increased cardiovascular
      risk. Chronic consumption of carbohydrates is associated with increased levels of
      triglycerides. Very few studies have assessed the effect of acute consumption of
      carbohydrates on plasma triglycerides and lipoprotein production and clearance. The present
      study aims to assess the effects of acute administration of glucose and fructose on hepatic
      and intestinal lipoprotein production.
    

Detailed description: 
      Each subject will be studied twice 4-6 weeks apart in random order in this single blinded
      study. A nasoduodenal tube will be sited under fluoroscopic guidance the day prior to the
      study.In study A they will receive intraduodenal intralipid (20% at 60 ml/hour) alongside 60
      ml/hour of 20% dextrose or fructose for 15 hours starting at 4am. In study B they will
      receive 60 ml/hour of intraduodenal intralipid with 60ml/hour of normal saline for 15 hours
      from 4am. A pancreatic clamp (octreotide with replacement glucose, insulin, glucagon and
      growth hormone) will be started at 7am. From 9am an iv bolus of deuterated-glycerol
      (d5-glycerol) along with a regular infusion of deuterated leucine (L-[5,5,5-2H3]. Regular
      blood samples will be drawn to assess lipoprotein kinetics.
    

Intervention name(s): Intraduodenal glucose or fructose
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Intestinal lipoprotein; Apo B48 and apoB100; Pancreatic clamp
Shortystrap Effectiveness in the Treatment of the Pathology Pubic and Abdominal Pathology in Athletes
Condition: Pubic and Abdominal Pathology
Study type: Interventional
Phase: Phase 2

Summary: 
      The pubic and abdominal pathology is common among athletes. It leads to a shutdown of
      physical activity for several months, and requires rehabilitative care, or surgery for a
      permanent cure. Shortystrap is designed to avoid surgery and allow the continuation of
      sports.
    


Intervention name(s): Shortystrap
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: athletes
Thrombectomy Revascularization of Intracranial Vessel OcclusioN by Originating From Japan (TRON1-Japan)
Condition: Acute Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional

Summary: 
      To evaluate the efficacy and safety of catheter-based thrombectomy for reperfusion by
      removing a thrombus in a cerebral blood vessel in patients with acute cerebral infarction
      (within 8 hours after onset), in whom intravenous administration of tissue plasminogen
      activator (t-PA) is not indicated or reperfusion cannot be achieved by intravenous t-PA
      administration.
    


Intervention name(s): Thrombectomy Device T-01
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Reducing Antibiotic Use for Uncomplicated Urinary Tract Infection in General Practice by Treatment With Uva Ursi (UU)- a Comparative Effectiveness Trial
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      It is well known that "over-treatment" of straightforward infections should be avoided as far
      as possible. Evidence-based data on non antibiotic treatment options for common conditions
      are therefore needed urgently. This randomised-controlled double blind trial examines whether
      initial herbal treatment with Uva Ursi, and antibiotic treatment only if symptoms persist,
      reduces antibiotic consumption in uncomplicated urinary tract infections (UTI) without a
      negative effect on symptom course and rate of recurrent UTIs. In total, 430 patients
      presenting with typical UTI symptoms will be included by their GPs and receive randomised
      either herbal treatment with uva ursi (antibiotics only if symptoms persist), or initial
      antibiotic treatment. Patients record symptom severity and drug intake in a diary and
      complete a final questionnaire after 28 days.
    


Intervention name(s): Arctuvan; Fosfomycin; Placebo to Arctuvan; Placebo to Fosfomycin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): application of a herbal drug; application of an antibiotic drug; application of Placebo to Arctuvan; application of Placebo to Fosfomycin
Intervention MeSH terms: Fosfomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Uva Ursi; fosfomycin; uncomplicated urinary tract infection of women
A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      An in situ model will be used to evaluate and compare enamel remineralization of human enamel
      specimens after single use of experimental children's toothpastes.
    


Intervention name(s): Fluoride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fluoride Toothpaste; Fluoride free toothpaste
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Lybrido for Female Sexual Dysfunction
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      The Lybrido study is a double-blind, randomized, placebo-controlled study with a 4-week
      baseline establishment period, 16 week treatment period and a follow up period for a total of
      26 weeks on study. Subjects are randomly to one of seven treatment arms. The study
      investigates the effective dose of Lybrido in increasing the number of satisfactory sexual
      episodes in the domestic setting in 210 healthy female subjects with hypoactive sexual desire
      disorder and low sensitivity for sexual cues (30 subjects per group).
    


Intervention name(s): Placebo; Sildenafil; Testosterone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solid Oral Dosage. Maximum every other day (on an as needed basis); Solid Oral Dosage. Maximum every other day (on an as needed basis); Solid Oral Dosage. Maximum every other day (on an as needed basis)
Intervention MeSH terms: Sildenafil Citrate; Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: HSDD
Parents Workgroup About Emotion Regulation
Condition: Autism Spectrum Disorders
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is examine emotional regulation and reflective functioning in
      parents of children with Autism Spectrum Disorders (ASD) before and after an educational
      training (four sessions of group workshops). Our experimental aims are the following: 1)
      examine parental emotion regulation and reflective functioning in daily life, 2) examine
      child emotion regulation in their daily life 3)Learn about the training efficacy for ASD
      parents. This research study will help to formulate innovative treatment methods to reinforce
      positive emotion regulation and reflective functioning in both ASD children and their
      parents.
    

Detailed description: 
      The parents will answer questionnaires and Parent Development Interview (PDI) and the Five
      Minute Free Speech Sample (FMSS) as well as a number of other questionnaires.

      Parents will be randomized between intervention group and control group. First session

        -  Introduction

        -  Setting expectations and goals

        -  General explanation of emotions and their development.

        -  How to recognize emotions? Why is it important to recognize them?

        -  Minding parents and child emotions. Second session

        -  Emotion Regulation (general explanation).

        -  Strategic for emotion regulation (Adults)

        -  Strategic for emotion regulation (children)

        -  Parental emotion regulation and the influence on the child emotion regulation

        -  Difficulties in ER among children with ASD Third session

        -  Three steps method: Feel, Think-Rethink, Regulate.

        -  Theory, explanation and implementation.

        -  Discussion: Role play of challenging highly affective parent-child interaction

      Fourth session:

        -  Three steps method: Feel, Think-Rethink, Regulate.

        -  Theory, explanation and implementation.

        -  Discussion: Role play of challenging highly affective parent-child interaction The
           parents will do another PDI and will fill up the questionnaires
    

Intervention name(s): emotion regulation training
Intervention type(s): Behavioral
Intervention description(s): This is a workshop for parents that help them to understand how to deal with emotions generally and specifically with their ASD children's emotion
Other intervention name(s): Regulative Parenting
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Three Small Doses of HCG Versus Booster Dose of HCG on Ovum Pickup Day
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles
      triggered with GnRH agonist. Two strategies are compared supplementing the luteal phase with
      three small doses (500 IU) of HCG and giving a booster dose of HCG (1500 IU) on the day of
      ovum pickup.
    


Intervention name(s): IVF/ICSI; Human Chorionic Gonadotropin
Intervention type(s): Procedure; Drug
Intervention description(s): Given in different doses and timing to support the luteal phase
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Alcoholic-carrier Solutions Within Devices (HFA134a-MDI or Respimat®) on Breath Alcohol Measured by Ethylometer in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study objective is to determine the effect of the ethanolic solutions inhaled from the
      Metered dose inhaler (MDI) (15.5 mg, 31.2 mg and 62.4 mg of ethanol) and from Respimat® (18.4
      of ethanol) on the breath alcohol measurements in healthy volunteers.

      Secondary aim is to determine the linear dose-effect for the HFA 134a-MDI doses. An open,
      randomized, four-way-cross-over design is chosen. The randomization is balanced and
      stratified in accordance with predicted values of the volunteers of Total Lung Capacity (TLC)
    


Intervention name(s): Ethanolic Solution From HFA134a-MDI - low; Ethanolic Solution From HFA134a-MDI - medium; Ethanolic Solution From HFA134a-MDI - high; Ethanolic Solution From Respimat®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Norflurane; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
A Preliminary Study to Explore Clinical Endpoints in Patients (Male) With Diarrhea-predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to explore and examine endpoints that allow evaluation of the
      "clinically significant improvements, focusing on the patient's chief complaint and the
      severity of major IBS symptoms" by this drug in patients with diarrhea-predominant irritable
      bowel syndrome (IBS).
    


Intervention name(s): Ramosetron; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Irribow; YM060
Intervention MeSH terms: Ramosetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: diarrhea; IBS; Colonic diseases; YM060
Effects of Hi-maize Resistant Starch on Insulin Sensitivity
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of a dietary fiber, resistant starch,
      on insulin sensitivity. Low insulin sensitivity is a risk factor for some diseases including
      type 2 diabetes and heart disease. This study will show if consuming resistant starch can
      help improve insulin sensitivity in overweight and obese people.
    


Intervention name(s): Hi-maize starch (Low dose); Hi-maize starch (High-dose); Control (starch)
Intervention type(s): Other; Other; Other
Intervention description(s): resistant starch; resistant starch; rapidly digestible starch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: insulin resistance; dietary fiber; resistant starch